Categories
Outpatient Practice

Who Should Treat Hepatitis C?

An August 2022 study in the MMWR found that only 1 out of 3 people with hepatitis C are getting treated… and all of the patients in the study had health insurance. What are the barriers to treatment and how can we overcome them?

Summary Points:

  • Hepatitis C is common: 2 million Americans have chronic active infection.
  • Hepatitis C is under-treated: only 1 out of 3 insured Americans diagnosed with hepatitis get treated.
  • New therapy regimens have simplified the treatment of hepatitis C
  • It is time for primary care physicians and advance practice providers to treat most patients with hepatitis C

 

Hepatitis C is incredibly common. Worldwide, 100 million people have been infected and 71 million have chronic liver disease from the virus… that’s 1% of the world’s population! Here in the United States, hepatitis C has infected 1.5% of Americans and 2 million Americans have chronic active infection. More than 75% of infected people have no symptoms and do not realize that they are infected. Once initially infected, two-thirds of people go on to have chronic active infection. Of those, about one out of five will develop cirrhosis about 20 – 30 years after the initial infection.  It causes 19,000 deaths per year in the U.S. It is the most common cause of chronic liver disease and is the leading reason for liver transplantation.

Because it is so common and because most patients are initially asymptomatic, the Centers for Disease Control and the United States Preventive Services Task Force both recommend that all adults > 18 years of age be tested at least once for hepatitis C. The screening test is a simple and widely available blood antibody test. If the screening test is positive, then the next step is a blood hepatitis C RNA test to determine if the patient has chronic active infection. If the RNA test is negative, then the patient has resolved the infection and does not have chronic hepatitis C. But if the RNA test is positive, then the patient has a chronic infection and and should be considered for treatment.

Prior to 1991, hepatitis C was incurable. For the next 20 years, alpha interferon and ribavirin were the only available treatments. However, these drugs had significant toxicity, required a very long duration of treatment, and only resulted in cure of 6% of treated patients. Over the past 10 years, new anti-viral drugs have been developed that can cure the vast majority of patients and only require 8 to 12 weeks of treatment. So, why aren’t more people being treated and cured?

There are not enough hepatologists

Unlike most infections, the treatment of hepatitis C has been the realm of hepatologists, rather than infectious disease specialists or primary care physicians. However, hepatologists are relatively few in number. Most hepatologists do a 1-year hepatology fellowship following completion of a 3-year gastroenterology fellowship. Hepatology is a relatively new subspecialty. In 2006, the first board examination for hepatology was offered and there are only 59 hepatology fellowship training programs in the United States. Currently, there are 7,296 U.S. healthcare providers whose self-described practice is > 50% hepatology. However, the majority of these are gastroenterologists and advance practice providers with only a minority being board-certified hepatologists. There is little financial incentive for gastroenterology fellows to train for an extra year to become hepatologists. A study published in the January 2021 edition of Hepatology Communications found that the median total compensation for hepatologists in the U.S. is $320,728 which was less than the total compensation for gastroenterology assistant professors at $329,600. In other words, the reward for doing a hepatology fellowship is that you make less money than you would had you not done the extra year of training.

Most hepatologists practice at a relatively few large, referral hospitals. Consequently, most hospitals do not have a hepatologist on their medical staff, thus requiring patients with hepatitis C to travel long distances in order to be evaluated and treated by a hepatologist. This has resulted in a geographic barrier for most patients and is a contribution to the low rate of infected patients getting treated.

What is so complicated about treating hepatitis C?

Treating most infections is relatively simple: you get a culture, you give an inexpensive antibiotic for 5-7 days, and you’re done. But treating hepatitis C is a lot more complicated and requires specialized testing, counseling, expensive medications, and laboratory follow-up. The current recommendations for treatment are published jointly by the American Association for the Study of Liver Disease and the Infectious Disease Society of America. This is a lengthly document that is daunting for most non-hepatologists. A Simplified HCV Treatment Algorithm for Treatment-Naive Adults Without Cirrhosis is available that summarizes the recommendations in just 1 page:

Initial evaluation. Once a patients are diagnosed with hepatitis C, they need to undergo a series of laboratory tests including:

    • FIB-4 calculation. This is based on the patient’s age and three blood tests (AST, ALT, and platelet count). An on-line calculator is available to easily determine the FIB-4 score.
    •  Cirrhosis assessment. Cirrhosis can be identified by a FIB-4 score > 3.25, liver biopsy, transient elastography (“Fibroscan”), imaging (CT or ultrasound), clinical evidence of cirrhosis, or laboratory test (such as the “Fibrosure” blood test).
    • CBC
    • Liver function tests
    • Glomerular filtration rate
    • Hepatitis C viral load (HCV RNA)
    • HIV test
    • Hepatitis B surface antigen
    • Pregnancy test (for women of childbearing potential)

Treatment regimens. There are 12 drugs approved to treat hepatitis C and choosing among them can be formidable for non-hepatologists. Different drug regimens are used for different viral genotypes. In addition, several drugs that were approved in the past 10 years have been recently discontinued as more effective newer medications have been introduced. The result is that physicians who do not keep up with new developments in hepatitis C medications on a regular basis often feel uneasy prescribing treatments. Fortunately, there are two currently recommended medication treatments for hepatitis C in patients without cirrhosis, regardless of which genotype of hepatitis C patients are infected with:

    1. Mavyret – glecaprevir (300 mg) + pibrentasvir (120 mg) for 8 weeks
    2. Epclusa – sofosbuvir (400 mg) + velpatasvir (100 mg) for 12 weeks.

Laboratory monitoring. The newer hepatitis C medications do not require routine lab monitoring. This is a significant improvement over previous drugs that required regular blood tests during treatment. Because of the possibility of drug interactions, patients with diabetes taking hypoglycemic drugs should have their glucose levels checked periodically and patients taking warfarin should have their INR levels checked periodically.

Post-treatment testing. 12 weeks after completing treatment, patients should have liver enzymes checked. They should also have a hepatitis C RNA level checked at that time to confirm that they are cured. Those patients who continue to have detectable HCV RNA may require referral to a specialist.

The two drugs used to treat hepatitis C are expensive. Mavyret costs $34,000 for an 8-week course if purchased out of pocket ($13,000 to $16,000 if purchased using GoodRx). Eclusa costs $31,000 for a 12-week course ($11,000 to $19,000 if purchased using GoodRx). Because of their expense, most commercial insurance companies require prior authorization when these medications are prescribed and this poses another barrier for non-hepatologists who are less familiar with the drugs.

The simplified recommended treatment regimen for patients with compensated cirrhosis is very similar to that used for patients without cirrhosis with the main difference being that Mavyret can be used for any genotype of hepatitis C but Eclusa can only be used for genotypes 1, 2, 4, 5, & 6. To make things utterly simple, if prescribing Mavyret, the same management protocol can be used whether or not a patient has compensated cirrhosis.

The simplified treatment regimens are applicable to most patients with chronic hepatitis C infection. Patients not eligible for one of the two simplified regimens will likely require referral to a specialist. This includes patients with:

  • Prior hepatitis C treatment
  • End-stage renal disease
  • Decompensated cirrhosis 
  • HIV or HBsAg positive
  • Current pregnancy
  • Known or suspected hepatocellular carcinoma
  • Prior liver transplantation

So, who should treat hepatitis C?

It is clear that the shear number of Americans infected with hepatitis C is too great for all patients to be treated by the country’s relatively few hepatologists. But fortunately, the newer regimens are very protocolized, making their use much simpler that previous regimens. Because of this, two groups of providers are now in position to treat most patients with hepatitis C.

  1. Primary care physicians. In the past, primary care physicians referred patients with hepatitis C to hepatologists or gastroenterologists for treatment. The drugs were toxic, expensive, and required complex regular monitoring. Furthermore, busy primary care physicians did not want to deal with insurance prior authorization for drugs that they were not very familiar with. The simplicity of the new treatment regimens now makes it easier for primary care physicians. All that is required is creation of a hepatitis C order set in the electronic medical record and a fairly straight forward prior authorization that the office nurses can usually do on their own.
  2. Advance practice providers. Treatment regimens that are based on protocols are ideal for nurse practitioners and physician assistants. This can be a great option for larger primary care groups or for hospitals that designate an advance practice provider to specialize as the go-to hepatitis C treatment provider.

A time for change…

In summary, the number one cause of chronic liver disease and number one indication for liver transplantation can now be cured relatively easily. In communities that lack easy access to a trained hepatologist, the newer hepatitis C treatment regimens lend themselves to implementation by either primary care physicians or advance practice providers. In order to improve the numbers of Americans who are cured of hepatitis C before it results in cirrhosis, we must overcome historical barriers to treatment. Our hospitals can help by sponsoring CME programs to train primary care physicians in hepatitis C management and by financially supporting advance practice providers to specialize in hepatitis C management.

September 22, 2022

Categories
Epidemiology Inpatient Practice Outpatient Practice

2022-23 Influenza Season Predictions

You would think that August would bring a lull in the work of U.S. influenza epidemiologists. But August is when we get some of the most important information that predicts what our winter flu season will look like. And the projections are a little scary this year.

The best predictors of North American influenza in our winter is Australian influenza during our summer. Normally, influenza season in Australia starts in April and runs through October, corresponding with winter in the Southern Hemisphere. What happens with influenza in Australia usually fairly closely matches what happens later in the year in the United States. Thus, by examining the epidemiological data from the Australian Department of Health’s Influenza Surveillance, we can predict when influenza cases will start to be seen, what age groups will be affected, what serotypes will be predominant, and what severity will occur here in the United States and Canada.

Recent U.S. influenza seasons

Over the past 3 influenza seasons, we have seen an inverse relationship between COVID cases and influenza. One of the primary reasons for fewer influenza cases when COVID cases increase is social distancing and mask-wearing to prevent COVID. It turns out that these measures help prevent COVID but they are even more effective to help prevent influenza. We can see that effect in the 2019-20, 2020-21, and 2021-22 influenza seasons.

The graph above shows seven previous influenza seasons in the United States. The 2019-20 influenza season (green line) started off quite severe with sustained high numbers of cases from December through March. The onset of the COVID pandemic in the United States in March 2020 marked the closure of schools, work from home initiatives, and public masking. This coincided with a precipitous fall in influenza-like infections at the end of March.

The 2020-21 influenza season (pink line) was the mildest in recent history with only a small peak in cases of influenza-like infections in November and December. At this time, social distancing and masking were more ubiquitous and the COVID vaccines were not yet widely available. It was not until the summer of 2021 that influenza-like infections began to rise – this was a time when COVID vaccines were widely available and it was generally believed that the end of the COVID pandemic was in sight. Consequently, mask mandates were discontinued, children returned to schools, and workers returned to their workplaces. This created conditions that allowed influenza to have a summer rebound.

The 2021-22 season is in red with red triangles. It peaked in December, much earlier than usual. This coincides with the rise in case numbers of the Omicron variant of COVID that caused people to resume masking and social distancing in December. Once these measures to prevent the spread of COVID went back into effect in December 2021, the frequency of influenza-like infections fell.

The exceptional influenza season was the H1N1 outbreak in 2009-10 when cases began to increase in August and peaked in September and October. This represented an unusually early influenza season that caught physicians off-guard. Making matters worse, this particular H1N1 strain had not circulated for decades and was not predicted to appear that season with the result that it was not covered by that season’s flu shots. These factors together resulted in an unusually large number of cases and large numbers of deaths, particularly among younger people who had no natural immunity to H1N1.

What we are learning from Australia

When will influenza season start?

In the last several years, the influenza season in the U.S. has mirrored the influenza season in Australia that occurs earlier in the year. So, what is Australia telling us this year? First, we are likely to see influenza cases start to increase earlier than normal this season. The graph below shows the last several seasons of positive influenza testing in Australia.

The current influenza season is in red. It began much earlier than in past years and also peaked much earlier. Cases began to rise in late April which corresponds to late October in the Northern Hemisphere. Cases peaked in late May in Australia which corresponds to late November in the U.S. By late July, the Australian influenza season was pretty much over – this would correspond to late January in the United States and Canada. So based on these data, we should expect to see influenza cases start to increase in October 2022 with peak numbers in November and December 2022.

How severe will influenza be this year?

Hospitalization data from Australia predicts that this will be an average year with respect to influenza severity. The graph below shows the number of influenza hospitalizations in Australia over the past several seasons. The current season is in red with hospitalizations mimicking the case number graph above. Hospitalizations began to increase in April and were back to baseline by late July. 

Based on this data, in the United States, we should expect influenza-related emergency department visits and hospitalizations to peak in November and December 2022.

What ages will be most affected?

A unique finding during the current Australian influenza season has been the propensity to affect children. The graph below shows the number of laboratory-confirmed influenza cases by age.

The largest case rates have been in people under age 20. This would predict that U.S. pediatricians will be seeing more influenza than U.S. internists this season.

Will the influenza vaccine cover it?

The vast majority of cases of influenza in Australia were influenza A with unusually few cases of influenza B as shown in the graph below.

The seasonal influenza vaccines in Australia this year included the following serotypes:

Egg-based quadrivalent influenza vaccines:

  1. A/Victoria/2570/2019 (H1N1)pdm09-like virus;
  2. A/Darwin/9/2021 (H3N2)-like virus;
  3. B/Austria/1359417/2021-like (B/Victoria lineage) virus; and
  4. B/Phuket/3073/2013-like (B/Yamagata lineage) virus.

Cell-based quadrivalent influenza vaccines:

  1. A/Wisconsin/588/2019 (H1N1)pdm09-like virus;
  2. A/Darwin/6/2021 (H3N2)-like virus;
  3. B/Austria/1359417/2021 (B/Victoria lineage)-like virus; and
  4. B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

Although it is still too early to be confident of Australian vaccine effectiveness, we can look at whether the strains seen during the flu season corresponded to the strains covered by the influenza vaccines. In all, 97.4% of influenza A (H1N1) isolates were antigenically similar to the vaccine components. 93.2% of influenza A (H3N2) isolates were antigenically similar to the corresponding vaccine components. And all of the influenza B isolates were similar to the corresponding vaccine components. The U.S. quadrivalent influenza vaccine for the 2022-23 season has identical components to the egg-based quadrivalent influenza vaccine used in Australia. Therefore, it is likely that this season’s flu shots will cover the strains of influenza that we are likely to see in North America.

What we should do in the U.S.

Based on the Australian experience, there are several steps that we should take to prepare ourselves for the 2022-23 influenza season:

  1. Start vaccinating early. It takes about 2 weeks for immunity to develop after a flu shot. Therefore, we should insure that most Americans get vaccinated in September this year if case numbers begin to rise in October as anticipated. If cases peak in late November, as expected, then people who wait until December or January to get vaccinated will have waited too long.
  2. Target kids for vaccination. With children being disproportionately affected by influenza in Australia, it is likely that we will see the same trend in the U.S., particularly as schools return to in-person classes.
  3. Prepare for a surge of hospitalizations in November and December. Normally, this is a low-census period for medical admissions in American hospitals. It is also a time when many people get elective surgeries over the winter holidays and before the end of the calendar year to take advantage of annual insurance deductibles. If the early influenza peak occurs as expected, we may need to institute routine pre-op influenza testing for elective surgeries much as was done with COVID testing during the worst of the COVID pandemic.
  4. Anticipate the effect of Thanksgiving travel. Thanksgiving and Christmas holidays are times when many Americans travel to be with family. The Australian influenza season predicts that U.S. influenza cases may be peaking around Thanksgiving. This could result in holiday travel accelerating influenza spread this year.

No one can predict the influenza season with 100% accuracy. But if historical trends follow, then the U.S. will likely experience a similar season as Australia. Given that most Americans are starting to relax as the COVID-19 case numbers fall, we could be especially vulnerable to influenza this year, particularly if it comes early and preferentially affects children as expected.

August 10, 2022

Categories
Epidemiology Inpatient Practice Outpatient Practice

Preparing For Monkeypox

Monkeypox is spreading rapidly across the United States. There are steps that every hospital and every medical practice need to take now to protect patients and healthcare workers. As of yesterday, there were 6,326 known cases and undoubtedly considerably more that have gone undiagnosed. Infected patients will be presenting to your hospital, office practice, and emergency department in the next few weeks.

Where did monkeypox come from?

Monkeypox is a type of orthopoxvirus that is related to smallpox. It was first found in monkeys in a Danish research lab in 1958. The virus is not unique to monkeys, however, and has since been found in various mammalian species in Western Africa. Humans have sporadically become infected after contact with infected animals. Although most human cases have been reported in Africa, there have been occasional clusters of cases in other countries over the past 20 years.

One of the most notable clusters occurred in the United States in 2003 when 47 Americans became infected with monkeypox that originated from an infected giant Gambian rat that had been imported from West Africa for sale as an exotic pet. The rat then infected a group of captive prairie dogs that were also sold. Of the 47 cases, all but one person acquired monkeypox directly from an infected animal. In only one case was there human-to-human transmission (from a child to mother).

In July 2021, a traveler from Nigeria was diagnosed with monkeypox in Texas. In November 2021, a second travel-related case was diagnosed in Maryland. The current outbreak began on May 7 2022 when a travel-related case was diagnosed in the United Kingdom. Later that month, cases were diagnosed in Massachusetts and New York. Since that time, the number of cases has been growing exponentially. Because of lack of familiarity with the disease and difficulty in obtaining diagnostic tests, it is likely that most cases initially went undiagnosed and that the true number of U.S. cases is much higher.

How is it spread?

Because the initial cases were reported in gay men, there is a misconception that monkeypox is a sexually-transmitted disease, like syphilis or HIV. It is not. Monkeypox is primarily spread by skin-to-skin contact, similar to MRSA. Thus, the initial cases occurred in gay men not because they had sex with other men but because they had close skin contact with infected men. Although the virus can also be spread by respiratory secretions, it is not as contagious as other respiratory viruses, such as COVID. Therefore, it requires closer and/or more prolonged exposure for airborne transmission. However, because it can be spread by both contact and airborne routes, both contact and airborne isolation is recommended for inpatients. Other points to know about monkeypox transmissibility:

  • It can be transmitted to and from pets
  • Bed linens, clothing, eating utensils, and drinking glasses can be infectious
  • Infected persons remain contagious until scabs have all crusted over and a layer of new skin has developed
  • Usual hospital disinfectants can eliminate the virus
  • The average incubation period is 7 days and persons can be contagious during the incubation period

Signs, symptoms, and diagnosis

As of today, most cases have been in men who have sex with men. However, since monkeypox virus is spread by skin contact (rather than sexual contact), the demographic of infected people is expected to rapidly change in the next few weeks. A person does not have to be gay or to even have sex with another person to become infected. Common signs and symptoms reported in a recent article in the New England Journal of Medicine include:

  • Rash – 95% (with 64% having <10 lesions)
    • Anogenital – 73%
    • Trunk or limbs – 55%
    • Face – 25%
    • Palms or soles – 10%
  • Fever – 62%
  • Lethargy – 41%
  • Myalgia – 31%
  • Headache – 27%
  • Pharyngitis – 21%
  • Lymphadenopathy – 56%

Because 98% of the 528 patients reported in this article were either gay or bisexual men, the incidence of anogenital lesions may be higher than in other patients. The rash is most frequently described as vesiculpustular (53%) but can present as a macular rash (4%), multiple ulcers (19%), or single ulcer (11%). Additional photos of the rash can be found on the CDC website.

Image: UK PHS

The diagnosis is made using swabs of skin lesions – preferably 2 swabs, each from a different lesion. Testing is done by orthopoxviral PCR and results can be available in 2-3 days. Specimen handling procedures can vary from lab to lab so be sure to follow specific instructions from the lab that the sample will be sent to. Until recently, testing was only available through the CDC and results could take 1-2 weeks. Now, testing is available through local health departments as well as several commercial labs making it possible to submit specimens as a regular send-out test from U.S. hospitals. Serology testing is also available through the CDC but the turn around time is 14 days.

Treatment

In cases reported during this outbreak, the mortality rate is low and in most people, the disease is self-limited and of mild-moderate severity. Consequently, to date, only a minority of patients receive anti-viral treatment (5% in the New England Journal of Medicine study). Certain patients are at higher risk of severe disease and these patients should be targeted for treatment:

  1. Those with severe disease (hemorrhagic disease, confluent lesions, sepsis, encephalitis, or other conditions requiring hospitalization)
  2. Immunocompromised persons
  3. Children (particularly those < 8 years old)
  4. Persons with exfoliative skin disorders (atopic dermatitis, psoriasis, etc.)
  5. Pregnant or breast-feeding women
  6. People with monkeypox complications (secondary bacterial skin infection; severe gastroenteritis; bronchopneumonia; etc.)
  7. Involvement of anatomic areas at risk of permanent injury (eyes, mouth, anus, genitalia, etc.)

The treatment of choice is tecovirimat (TPOXX). This drug is currently only available through the Strategic National Stockpile. Physicians have to contact either their state health department or the CDC (770-488-7100 or email at Poxvirus@cdc.gov). The dose is 600 mg PO BID x 14 days given within 30 minutes after a full meal of moderate/high fat. Drug side effects can include headache and nausea. TPOXX may reduce blood levels of midazolam and may increase levels of repaglinide.

Other treatments that may be effective but have less scientific data to support their use include intravenous Vaccinia immune globulin, cidofovir, and brincidofovir.

Vaccination

There are two vaccines available that are effective against monkeypox.Both of these are live virus vaccines (unlike most routine vaccines such as COVID vaccines or flu shots). The JYNNEOS vaccine contains a live non-replicating virus. The ACAM200 vaccine contains a live replicating virus.

JYNNEOS is given as 2 injections with the second dose given 4 weeks after the first dose. Full immune response develops 2 weeks after the second dose. The most common side effects are fatigue, headache, and myalgias. Unlike ACAM200, the JYNNEOS vaccine is not contraindicated in immunocompromised persons, pregnancy, or HIV infection.

The ACAM200 vaccine contains a live replicating Vaccinia virus that is given as a single dose. Because ACAM200 contains a replicating virus, it is contraindicated in immunocompromised persons, HIV infection (regardless of immune status), pregnancy, persons with heart disease, children < 1 year old, persons with eye conditions requiring topical steroids, and persons with a history of exfoliative skin disorders (eczema, atopic dermatitis, etc.). Although most side effects of ACAM200 are mild, 1 out of every 175 persons receiving it develop myocarditis or pericarditis. It takes 4 weeks for maximal immune development after vaccination.

Both vaccines are available from the Strategic National Stockpile. Because of limited supply (particularly of the JYNNEOS vaccine), widespread vaccination of the public and of most healthcare workers is not currently advised. Currently, the CDC only recommends pre-exposure prophylaxis vaccination for people at very high-risk of exposure (primarily laboratory workers performing diagnostic testing for monkeypox). The CDC anticipates expanding the indications for pre-exposure prophylaxis vaccination to broader populations as supplies of the vaccine increase in the future.

Most monkeypox vaccines are currently being given for post-exposure prophylaxis. When given within 4 days of exposure, vaccination can prevent the disease and when given between 4-14 days after exposure, vaccination can reduce the severity of monkeypox infection. Persons who should be prioritized for vaccination include:

  • Known contacts who are identified by public health via case investigation, contact tracing, and risk exposure assessments
  • Persons with a sexual partner in the past 14 days who was diagnosed with monkeypox
  • Persons who have had multiple sexual partners in the past 14 days in a jurisdiction with known monkeypox
  • Healthcare workers with a high risk exposure such as:
    • Unprotected contact with skin, lesions, or bodily fluids of a patient with monkeypox
    • Aerosol-generating procedures without N-95 mask and eye protection

Healthcare workers with an intermediate risk exposure should be offered post-exposure vaccination on a case-by-case basis and after discussion of the risks and benefits with the exposed healthcare worker. Intermediate risk exposures include: (1) being within 6 ft of an infected unmasked patient for more than 3 hours when the healthcare worker was not wearing a mask and (2) contact with patient’s clothing, skin lesions, or soiled linens while wearing gloves but not wearing a gown.

Healthcare workers with a low risk exposure generally do not require post-exposure vaccination. Low risk exposures include: (1) entering an infected patient’s room without wearing eye protection, (2) being in a room with an infected patient while wearing gown, gloves, eye protection and at least a surgical mask or (3) being within 6 feet of an unmasked patient for less than 3 hours without wearing at minimum, a surgical mask. Additional information about managing exposed healthcare workers can be found on the CDC website.

Isolation recommendations for infected outpatients

The vast majority of people infected with monkeypox can be treated as an outpatient. In order to control the spread of monkeypox in the community, it is essential that infected persons adhere to proper isolation procedures at home for the duration of infectivity. Infected persons remain contagious for 2-4 weeks. Isolation can be discontinued when until all symptoms have resolved, including full healing of the rash with formation of a fresh layer of skin in areas of vesicles and ulcers. Isolation practices include:

  • Remain in the home with no contact with other people
  • Avoid close physical contact, including sexual and/or close intimate contact, with other people.
  • Avoid sharing utensils or cups. Items should be cleaned and disinfected before use by others.
  • Do not share items that will be worn or handled with other people or animals.
  • Wash hands often with soap and water or use an alcohol-based hand sanitizer, especially after direct contact with the rash.
  • Avoid contact with pets
  • Launder and disinfect items that have been worn or handled and that have been touched by a lesion
  • Do not dry dust or sweep as this may spread the virus
  • Do not wear contact lenses (because of risk of spreading the virus to the eyes)
  • Clean and disinfect surfaces with an Environmental Protection Agency-registered disinfectant. If other household members are responsible for cleaning, they should wear a medical mask and disposable gloves, at a minimum
  • If the infected person must leave home for medical care or for an emergency, cover the lesions, wear a well-fitting mask, and avoid public transportation

Infection control in the outpatient office

Although not as contagious as COVID, there is still a risk of an outpatient with monkeypox infecting other patients or healthcare workers. All employees of outpatient medical practices need to be familiar with monkeypox infection control practices to minimize the risk of spreading the infection. Specific measures include:

  • Utilize telemedicine for patients known or suspected to have monkeypox
  • If using pre-registration procedures in advance of patients arrival to the office, include questions about monkeypox signs and symptoms
  • Place patients with known or suspected infection in a private exam room with the door closed. These patients should be escorted from the building entrance directly to the exam room and should not wait in a waiting area
  • Have patients with known or suspected infection wear a surgical face mask with areas of skin rash covered
  • Healthcare workers entering an exam room of a patient with known or suspected infection should wear a disposable gown, gloves, eye protection, and an N-95 mask
  • Use disposable paper exam table drapes and patient gowns. Dispose of these materials using medical waste trash bags and do not shake out gowns or drapes
  • When the patient leaves, sanitize the room surfaces. Most standard hospital disinfectants will suffice. A list of cleaning products can be found on the Environmental Protection Agency website.

Infection control in the hospital

Only a small minority of patients will require admission to the hospital. Some of the indications for admission include pain management (such as severe anorectal pain), soft-tissue superinfection, pharyngitis limiting oral intake, eye lesions, acute kidney injury, myocarditis, and public health infection-control purposes. Infection control measures for hospitalized patients include:

  • Place patients with known or suspected infection in a private room with private bathroom and with the hallway door closed (negative airflow is not required)
  • Transport and movement of the patient outside of the room should be limited to medically essential purposes
  • When patients must be transported outside of their room, they should wear a medical mask and have any exposed skin lesions covered with a sheet or gown
  • Healthcare workers should wear a disposable gown, gloves, eye protection, and an N-95 mask
  • If aerosol-generating procedures are to be performed (e.g., intubation or bronchoscopy), use an airborne isolation room
  • Environmental services such as dry dusting, sweeping, or vacuuming should be avoided in rooms housing infected patients
  • Disposables such as paper towels should be disposed of using medical waste trash bags
  • Use surface cleaning products that are believed to be effective for emerging viral pathogens  (listed on the Environmental Protection Agency website)
  • Do not shake soiled linen, towels, and gowns. Soiled items should be enclosed in a proper laundry bag for transport to the laundry and staff handling laundry from infected patients should wear proper personal protective equipment as recommended by the CDC
  • Visitors should be limited to those essential for the patient’s care and wellbeing

Don’t think of monkeypox as a sexually-transmitted disease

Because the current outbreak has so far primarily affected men who have sex with men, monkeypox has developed a mistaken stigmata of being a sexually transmitted disease. It is important that we educate our patients and our co-workers that it is not necessary to have sex with someone to become infected with monkeypox. Measures that prevent spread of HIV and syphilis will not work with monkeypox. Abstinence will not stop it. Condoms will not stop it.

One of our best weapons against monkeypox is education.

August 3, 2022

Categories
Electronic Medical Records Medical Malpractice Outpatient Practice

The REMS Program And Abortion Laws – What Every Physician Needs To Know

If you or the doctors at your hospital prescribe any of these 11 drugs and live in states that have abortion laws, you need to take action IMMEDIATELY. The medical malpractice implications of teratogenic drugs (those that can cause embryofetal damage) are changing and physicians who prescribe these drugs need to protect their women patients from fetal damage and to protect themselves against future lawsuits.

The FDA created the REMS program (Risk Evaluation and Mitigation Strategy) in 2007 as a way to be sure that physicians take appropriate precautions when prescribing certain high-risk drugs. Typically, the REMS program will recommend physicians to have specific training and certification before being allowed to prescribe these drugs. The problem is that hospitals and pharmacies rarely verify that a physician has been certified for drugs on the REMS list and as a consequence, many physicians prescribe them without having the proper certification. Currently, the FDA lists 60 such drugs on the REMS website. I am most familiar with the REMS drug, mycophenolate mofetil. During my career, I have prescribed mycophenolate… a lot of mycophenolate… typically as an immunosuppressant for various lung diseases.

Mycophenolate, a REMS medication

Mycophenolate mofetil is often sold under the brand names CellCept or Myfortic. It is commonly used in patients who have undergone organ transplant to prevent rejection of those organs. It is also commonly used as an immunosuppressant drug to treat various autoimmune diseases. When used properly, it can be life-saving and is considerably safer than older immunosuppressant drugs, such as cyclophosphamide. In many patients, it is also safer than corticosteroids such as prednisone. The biggest problem with mycophenolate is that it is highly teratogenic. Overall, about half of women who become pregnant while taking mycophenolate will have a miscarriage and 1 out of every 4 live births have serious congenital malformations. Because of the very high risk of embryofetal damage, mycophenolate was added to the FDA’s REMS drug list in 2012.

The mycophenolate REMS requirements are:

  1. Physicians need to apply to the mycophenolate REMS website and undergo an on-line training program before prescribing mycophenolate.
  2. Once certified to prescribe mycophenolate, physicians must educate patients about the risk of miscarriage and fetal harm.
  3. Physicians must insure that women of childbearing potential use adequate contraception – preferably either vasectomy, tubal ligation, or an intrauterine device. In the absence of any of these 3 methods, women must use 2 forms of other approved contraception (for example, birth control pills + condoms).
  4. Women should have a pregnancy test at every office visit.
  5. Woman should be counseled about emergency contraception (Plan B) in the event of intercourse without adequate contraception.
  6. Women must be given the printed REMS information about mycophenolate precautions.
  7. Women should sign an agreement form acknowledging that they understand the risks of mycophenolate and agree to the requirements of the REMS program (note: this requirement was discontinued in January 2021).

All too often, I would see women of child-bearing potential in my office who had been started on mycophenolate by other physicians and who had never been informed about the REMS program. Frequently, these women were not using adequate contraception and were not undergoing regular pregnancy testing. Until last month in Ohio, if a woman became pregnant while taking mycophenolate, we could recommend pregnancy termination. Now, that is no longer an option if it is more than 6 weeks after her last menstrual period and the Ohio legislature has signaled that later this year, it intends to make pregnancy termination illegal in all pregnancies from the time of conception.

The heightened risk of malpractice lawsuits

The implication of anti-abortion laws, such as Ohio’s, is that if a woman becomes pregnant while taking mycophenolate, then there is a 25% chance that her baby will have severe congenital deformities. Children with these deformities can require life-long care and can be very expensive for families. Women taking mycophenolate because they have had an organ transplant or because they have chronic diseases such as lupus are generally not in a good position to provide care for the life of a child with serious birth defects and usually do not have the financial resources necessary for that care. This is especially true for my patients who have undergone lung transplant – the life expectancy after transplant averages about 6 years so these women will not be alive to care for a child with severe deformities.

We live in a litigious society. When faced with the birth of a child who will never grow up to be a normal adult and will incur large healthcare costs, women (or their widower spouses) will seek financial compensation to pay for these costs. Every personal injury attorney in the country knows that the person to name in a lawsuit is the person who has the most money. Hospitals and physicians are the ones with the most money. If a physician prescribed mycophenolate without having REMS certification to prescribe it or if there is no documentation that a woman was educated about pregnancy risks with mycophenolate, then that physician will be highly vulnerable in a malpractice suit.

The best defense for physicians is to get REMS certification before prescribing mycophenolate and adhere to the REMS requirements when prescribing it to any woman with child-bearing potential. The best defense for hospitals is to ensure that every physician prescribing mycophenolate has REMS certification. Electronic medical records make it easy for hospitals to determine which of their physicians are prescribing mycophenolate or other REMS drugs.

What other drugs are on the REMS list?

There are a variety of reasons that the FDA may put a drug on the REMS list. Some are on because of a high risk of anaphylaxis (Palforzia). Some are on because of a high risk of neurological toxicity (Abecma). Some are on the list because of risk of neutropenia (clozapine). Others are on the list because of a risk of over-sedation or addiction (buprenorphine). Of the 60 drugs on the REMS list, 11 are on the list because of the risk of embryofetal toxicity. The following is a list of these 11 drugs and what physician specialties are likely to be prescribing them.

A recent article in the American Journal of Obstetrics & Gynecology lists 141 drugs that are definite teratogens and 65 drugs that are considered to be potentially teratogenic. Of these 206 drugs, only 11 are included on the REMS list. However, the risk of embryofetal toxicity exists with all of these drugs and therefore the risk of medical malpractice lawsuits exists should a woman become pregnant while taking any medication known to be teratogenic and then develops fetal abnormalities.

Currently, 3% of all abortions performed in the United States are because of fetal abnormalities. This works out to about 28,000 per year. In states that ban abortion, these fetuses will go on to be infants with severe birth defects. The implication is that in the future, there will be potentially thousands of new malpractice suits filed each year against physicians who will be blamed for these birth defects because they prescribed a teratogenic drug to a woman who could not legally have her pregnancy terminated.

What physicians need to do right now

In medicine, doctors recognize that prevention is the best cure. The same goes for malpractice lawsuits. The best time to prevent a malpractice suit about a birth defect is before the woman becomes pregnant. To that end, there are measures that all physicians practicing in abortion-ban states should take now:

  • Know which drugs are teratogenic. The recent list from the American Journal of Obstetrics & Gynecology is a good starting point.
  • If you prescribe one of the 11 teratogenic drugs on the FDA’s REMS list, get your REMS certification and follow the REMS requirements.
  • If you prescribe a teratogenic drug that is not on the REMS list, develop a process for educating women of child-bearing potential about the risks of the drug.
  • Document, document, document. Include information in your office notes documenting patient discussions about drug teratogenicity, about contraception advice, and about any printed information that you gave them. 
  • Consider signed acknowledgement forms. In the past, this was a requirement of the mycophenolate REMS program. Even though it is no longer required by REMS, a signed form scanned into the electronic medical record is still a good practice since it can provide very strong malpractice defense.
  • Get comfortable recommending contraception. I have become at ease discussing contraception with my patients and their partners. If the woman is done having children, vasectomy is usually the safest and most effective option. For other women, I am a proponent of IUDs and although I do not place them myself, I know who to refer women to in order to get one. 
  • Educate women about Plan B. The “morning after pill” is available at pharmacies over the counter without a prescription and is effective up to 3 days after unprotected intercourse. Include information about Plan B in the educational materials you give patients when prescribing any teratogenic drug.
  • Understand your state’s abortion laws. In some states, it is (or will be) illegal for a physician to even discuss abortion with a woman or to advise her to travel to another state where abortion is legal. Be very careful what you write in the chart. A note in the electronic medical record stating: “She is 6 weeks pregnant while taking mycophenolate so I recommended she go to the Acme Abortion Clinic across the state line” could be your invitation for a prison sentence and revocation of your medical license. 
  • Do a malpractice insurance check-up. For physicians in Ohio who care for adults, there is a 1-year statute of limitations for filing a malpractice lawsuit. But for cases involving children, that statute of limitation extends to 1-year after the child’s eighteenth birthday. In other words, a physician who prescribed a teratogenic drug to a pregnant woman can be sued by the child 19 years later. Be sure that you either have a comprehensive claims-made policy or a tail coverage policy that will provide coverage long after you retire or leave your practice.
  • For hospital medical directors and administrators, use your electronic medical record’s prescribing database to identify physicians who prescribe REMS drugs and require that those physicians be REMS-certified.
  • For medical schools, education during pharmacology courses about teratogenicity and about the REMS programs has suddenly become considerably more urgent.

Abortion prohibitionists have long set their sights on laws to criminalize abortion. There are a myriad of unintended consequences of banning abortion and many of the the socioeconomic consequences will not be fully recognized for several years. For physicians, waiting several years to protect against medical malpractice suits for prescribing a teratogenic drug will be too late. The time for physicians and hospitals to protect their patients and themselves is right now.

July 16, 2022

Categories
Epidemiology Outpatient Practice

Abortion And The Five Whys

If you know four women, then statistically, one of them has had an abortion. The current Supreme Court recently overturned the opinion of a previous Supreme Court and now permits states (or the U.S. Congress) to make abortion illegal. By applying the “5 Whys” approach to abortion, we can learn the root causes of abortion and how to reduce the number of abortions without criminalizing abortion. We can also uncover the hidden costs of abortion bans.

The five Whys

The 5 Whys originated in the early 1900’s in Japan as a method to improve textile production. What does 100-year-old Japanese loom manufacturing have to do with abortion? As it turns out, a lot. Sakichi Toyoda was a Japanese industrialist who invented an automatic power loom that at the time was the most advanced weaving device in the world. He went on to found Toyota Industries, the manufacturer of Toyota automobiles. To address quality issues in manufacturing, he created the “Five Whys” approach. This utilized asking a series of five “Why” questions to determine the cause-and-effect relationship with any manufacturing process. This approach has been incorporated in Kaizen, lean manufacturing, and Six Sigma. It is also a key component of root-cause analysis that we use in hospital quality improvement today.

An example of the Five Whys is as follows: A hospital medical director learns from the infection control department that there have been a cluster of Clostridium difficile infections in certain rooms in the intensive care unit. To understand the root cause, the medical director asks a series of Why questions:

So, the solution to the hospital’s C. difficile problem was not to close ICU rooms or fire the housekeeping employee. The solution was for the purchasing department to buy the correct spray dispensers used with hypochlorite disinfectants. If all 5 of the “Why” questions had not been asked, the root cause would never have been determined and the C. difficile outbreak would not have been eliminated.

Asking 5 Whys can sometimes be overly simplistic. In the C. difficile example, there is one root cause identified at the fifth Why. Sometimes the root cause can be found at the second Why. Sometimes it takes 6 Whys. And sometimes, there are multiple root causes that can be identified at several levels of the Whys. The point is that it is necessary to continue to ask “Why” until the root causes are all identified.

Our country has taken a superficial approach to the issue of abortion. We have let our emotions stop at the first “Why” and have not done an adequate root-cause analysis of abortion. In half of our nation’s states, politicians have determined that many women are getting abortions and asked the first Why. The answer that they found is that there are doctors willing to perform abortions. Their solution has been to criminalize abortion. The problem is that they have not asked the other “Whys”. With abortion, the root causes are complex and can be found at each level of Whys.

The demographics of abortion in the U.S.

Before we can apply the 5 Whys to the issue of abortion, we first must examine the demographics of abortion. The World Health Organization reports that worldwide, about 73 million abortions are performed each year. This equates to 29% of all pregnancies ending in abortion. In the United States, the Centers for Disease Control reports that there were 629,898 abortions performed in 2019 (the latest year data is available). The Guttmacher Institute (which uses a more thorough accounting method) reports that there were 930,160 abortions performed in 2020. This works out to 1 out of 5 pregnancies in the United States ending in an induced abortion. The U.S. accounts for about 1.3% of abortions worldwide. Additional epidemiological facts include:

  • 24% of women under age 45 years old have had an abortion.
  • The most common reason for having an abortion is not being ready to have a child (25%), followed by unable to afford a child (23%), done having children (19%), not wanting to be a single mother (8%), not mature enough to raise a child (7%), interference with education or career (4%), maternal health problems (4%), fetal abnormalities (3%), and rape (< 0.5%).
  • Most women undergoing abortion are in their twenties: 34% of abortions are in women age 20-24 and 27% of abortions are in women age 25-29.
  • 12% of abortions are performed in teenagers with 3.2% under age 18.
  • Black and Hispanic women have disproportionately more abortions than White women. Black women account for 28% of abortions but Blacks make up 13% of the U.S. population. Hispanic women account for 25% of abortions but Hispanics make up 19% of the population. White women account for 39% of abortions but Whites make up 76% of the population.
  • 38% of women undergoing abortion reported no religious affiliation; 24% are Catholic; 17% are mainline Protestant; and 13% are evangelical Protestant.
  • 86% of women undergoing abortion are unmarried and 60% already have at least one child.
  • 75% of women undergoing abortion are low income: 49% live below the Federal poverty level and an additional 26% are at 100% – 199% of the Federal poverty level.
  • 53% of women paid for their abortion out-of-pocket. The average cost of a surgical abortion is $508 and of a medication-induced abortion is $535.
  • 51% of women were using birth control in the month that they became pregnant: 24% were using condoms and 13% were using oral contraceptive pills.
  • 88% of abortions occur in the first 3 months of pregnancy and 67% occur in the first 2 months of pregnancy.
  • 54% of abortions are currently performed by medication (mifepristone and misoprostol).
  • The largest number of abortions were performed in Texas, California, New York and California, however, these are also the states with the highest populations.
  • The states with the highest rates of abortion per 100,000 population are New York, New Jersey, and Maryland.

The demographics of women who undergo abortion is remarkably similar to the demographics of infant mortality. The United States has one of the highest infant mortality rates in the world – we rank 33rd out of 36 OECD countries with only Chile, Turkey, and Mexico having higher infant mortality rates. In states where women no longer have access to abortion, it follows that infant mortality rates will rise. Many of the states poised to criminalize abortion (with either outright bans or 6-week laws) already have very high infant mortality rates:

Applying the 5 Whys to abortion

Once we understand the demographics of abortion in the United States, we can apply the 5 Whys:

  1. Why are there abortions in the U.S.?
    1. Answer: because doctors performed abortions.
  2. Why are doctors performing abortions?
    1. Answer: because a lot of women requested them due to unwanted pregnancies.
  3. Why did women have unwanted pregnancies?
    1. Answer: because effective birth control was not used.
  4. Why wasn’t effective birth control used?
    1. Answer: most commonly because effective birth control methods were too costly and there were cultural barriers to their use.
  5. Why were there cultural barriers to birth control?
    1. Answer: because men and women were not adequately educated about birth control before they had sex.

If we stop after the first why, then the solution to humans having so many abortions is to make abortion illegal and prosecute doctors who perform abortion. But this will ultimately fail. History has showed us that in the past, when abortion was illegal, women still found ways to have abortions, in other words, making it illegal will not make abortions go away. This is especially true today since prior to 10 weeks gestation, a 2-pill form of abortion is safe and effective (mifepristone and misoprostol). Currently, these drugs are approved by the FDA, are readily available, and account for the majority of abortions in the U.S. Even if a future conservative U.S. Congress bans their use, these drugs will continue to be available as street drugs and from international sources – if the war on drugs cannot prevent a marijuana joint from being smuggled into the country for street sale, how can one expect the government to prevent 2 small pills from being smuggled in?

If we stop with the second why, then the solution is to prevent women from having intercourse. There are 3 main instincts that a species must have to keep from becoming extinct: (1) an instinct to eat, (2) an instinct to keep from being eaten, and (3) an instinct to procreate. To stop Homo sapiens from having sex is to somehow overcome one of the most powerful instincts that our species has had for the past 300,000 years and led to us being the dominant species on the planet. It just won’t work. We can pass laws and we can invoke religious decrees but neither is more powerful than instincts embedded in our genes.

At the third why, we find that about half of abortions were in pregnancies where no birth control method was used. In another 37%, inferior birth control methods were used (condoms and birth control pills). Condoms are notoriously unreliable and it is way too difficult for any person to remember to take a birth control pill every single morning for years at a time. IUDs are far more reliable but not all women can tolerate them. Vasectomies are even more effective but that would require men to take more responsibility than many of them want to – I’ve fought an uphill (and usually unsuccessful) battle with many husbands of my patients for who I prescribed teratogenic medications for their advanced lung disease and in who an unwanted pregnancy would likely result in the wife’s death or in severe fetal deformity. However, I suspect that if men had to choose for themselves between the discomfort of a vasectomy versus the discomfort of pregnancy, labor, and delivery, 100% of them would take the vasectomy.

At the fourth why, we find barriers to the use of birth control in the way of cost and cultural discouragement. The cost of contraception is directly proportional to the effectiveness of contraception. Calendar watching is free but is miserably ineffective. Condoms cost about a dollar each but are not much more effective. Nor are diaphragms which are about $25 each. Birth control pills cost about $180 per year and an IUD costs about $800 (but IUDs can last 12 years resulting in a depreciated cost of $65 per year). A hormonal implant costs about $1,000 and lasts for 3 years. A vasectomy costs about $1,000 and a tubal ligation costs about $6,000 with both giving a lifetime of highly effective birth control. The over the counter morning-after pill, Plan B (levonorgestrel), costs $45 and is about 85% effective. Because the majority of women undergoing abortion are low income and a large number have no health insurance, birth control costs are a major contribution to the number of abortions performed in the U.S. The sad reality is that even the most expensive form of birth control is less expensive than the average $8,800 cost to deliver a baby, and that does not even include the indirect cost of maternity leave and raising the child if not put up for adoption.

Even when men and women have health insurance or can afford to buy contraception out of pocket, there are numerous cultural barriers to using contraception. For example, the Catholic Church forbids its members to use any form of contraception and considers contraception to be a sin. The underuse of contraception is perhaps the reason why Catholics have disproportionately more abortions than women of other religions – 24% of women who undergo abortion are Catholic whereas only 21% of the American population is Catholic. Parenthetically, it is notable that 7 of the 9 current Supreme Court Justices are Catholic or were raised Catholic; all 6 of the justices voting to overturn Roe v. Wade are Catholic. Old-Order Amish communities also forbid contraception. Most other religions permit the use of contraception but usually only within the context of marriage.

At the fifth why, we find lack of education. In most states, sex education curricula decisions are left to local school boards. Consequently, there is enormous variation in what is taught in different school districts. Children in many religious-based schools get no education about contraception and children who are home-schooled may get no formal sex education at all. The Centers for Disease Control recommends that children be taught a minimum of 20 sex education topics but fewer than half of American high schools teach all 20 of these. The Guttmacher Institute reports that U.S. adolescents in 2019 received less sex education than in 1995. In short, our educational system, both public and private has failed in sex education and this failure is an important contribution to the number of abortions in the U.S.

So, how do we reduce the number of U.S. abortions?

First, we will never eliminate all abortions nor should abortions be illegal. As a medical student, I assisted in the delivery room with a 12-year-old who was delivering a baby… no 12-year-old should ever have to deliver a baby. Forcing a child, a rape victim, or an incest victim to carry and deliver a baby is truly punishing the victim. In addition to these situations, there will always be unplanned sexual encounters and contraception method failures.

Infrequently entered into the discussion is that in the half century since Roe v. Wade was decided, there have been enormous advances in neonatology that have saved the lives of thousands of children who would have previously died in infancy. However, these same advances have also allowed medical science to keep on life support those with severe fetal deformities and chromosomal abnormalities with no reasonable chance of ever having normal cognitive development or independent function. Fifty years ago, in the pre-Roe era, they would have died within minutes or hours of delivery. These fetal abnormalities can largely be detected by a combination of ultrasound and maternal serum screening tests, neither of which existed in the pre-Roe era. Currently, serious fetal abnormalities account for up to 3% of all abortions. With no access to abortion, these fetuses will now be born and can live for weeks, months, and sometimes even years requiring ventilators, feeding tubes, and 24-hour care. The CDC reported that the annual inpatient hospitalization costs of severe birth defects was $22.9 billion in 2013. That number will be considerably higher when these fetuses can no longer be legally aborted.

In all of these situations, an unwanted pregnancy puts unwanted health and financial demands on the woman. It also places her at a competitive disadvantage in the workplace that can result in gender income disparities and barriers to professional advancement. Adoption is often offered as the solution to unwanted pregnancies but the reality is that most women do not put the child of an unintended pregnancy up for adoption. There are approximately 2.8 million unintended pregnancies in the U.S. every year. The National Council for Adoption reports that in 2020, there were 55,659 public adoptions in the U.S. The USDA estimates that the cost to raise a child to age 18 is $284,000 and this does not include the indirect cost of career development impediment faced by the (often single) mother raising that child.  It may take 2 people to create a pregnancy but it is the woman who pays most of these costs, not the man. Simply making abortions illegal does nothing to address this and in fact, makes it considerably worse.

We can (and should) reduce the number of abortions in the United States. If she didn’t have to have an abortion, no woman would want to have an abortion – it’s not like it is a fun experience. No woman says “What should I do to have fun this weekend? Maybe go to a concert, or go see a movie, or maybe get an abortion?” America’s abortion problem is an unwanted pregnancy problem. The most effective way to reduce the number of abortions is to reduce the number of unwanted pregnancies and for that, we need to turn back to the five Whys and the following conclusions:

  1. We cannot rely on the fantasy of abstinence and chastity. $3.2 billion in child sex lawsuit settlements says that this didn’t work for a lot of Catholic priests so why should it work for everyone else?
  2. We need to improve and standardize sex education and contraception education in our private schools, public schools, and home schools.
  3. Birth control (including vasectomy) should be free for all Americans – 135 women could have an IUD for a year for the same taxpayer cost of one woman on Medicaid delivering an unwanted pregnancy.
  4. We cannot base laws and social expectations founded on unrealistic religious doctrines that defy the most basic elements of human nature.

What do the 5 Whys tell us about the hidden costs of abortion bans?

On the day that the current Supreme Court overturned Roe v. Wade, abortion became completely illegal or illegal after 6-weeks gestation in many states and undoubtedly will become illegal in more states in the months to come. There are hidden costs to everything and by looking at the 5 Whys of abortion, we must be prepared to pay for the hidden costs of abortion bans:

  1. Localities with laws making abortion illegal must also have counterbalancing laws mandating paid maternity leave, government-paid maternal healthcare, and government-paid childcare. Anything less is state-sponsored victimization of women.
  2. Localities with laws making abortion illegal must also have laws providing for the post-delivery healthcare costs of fetuses that have severe fetal deformities and chromosomal abnormalities.
  3. Localities with laws making abortion illegal after 6 weeks of gestation must also have laws providing unlimited free pregnancy testing so that pregnancy can realistically be identified before 6 weeks.
  4. Localities with laws making abortion illegal must be prepared for an increase in infant mortality and should begin investment in programs to reduce infant mortality.

I’m like most Americans

Being retired gives me a freedom that I never had when I was a practicing physician. I no longer have to withhold my opinions about controversial issues for fear of offending my patients who hold different viewpoints or fear of incurring the wrath of deans, department chairs, and hospital CEOs. I can now freely say what I believe.

Abortion is subject to basic economic supply and demand principles like most everything else in life. Making abortion illegal only addresses the supply side and does nothing for the demand side. Focusing only on supply was ineffective with Prohibition in the 1920’s and has been ineffective with marijuana laws today. Economics tells us that reducing supply of a product or service without reducing demand will only increase the price of that product or service – reducing supply alone does not eliminate demand.

When it comes to abortion, I believe it should be legal. But I also believe that we do too many abortions. In short, I’m like most Americans.

The way to reduce demand for abortions is to reduce unwanted pregnancies. By doing a root cause analysis of abortion in the United States using the 5 Whys, we can identify how to reduce the number of abortions by reducing unwanted pregnancies. The 5 Whys also uncover the unintended consequences and hidden costs of abortion bans. Our societal goal should be to make abortions fewer and not to make abortions felonies.

July 2, 2022

Categories
Emergency Department Outpatient Practice

Is The Albuterol Inhaler Obsolete?

For decades, the mainstay of asthma treatment has been a daily maintenance steroid inhaler coupled with an as-needed albuterol rescue inhaler. New evidence suggests that there are better options than albuterol and that it may be time to retire the albuterol inhaler for asthma.

Summary Points:

  • The 2022 Global Initiative for Asthma (GINA) guideline recommends using an asthma rescue inhaler containing formoterol + budesonide instead of a rescue inhaler containing albuterol
  • American physicians have been slow to adopt the GINA guidelines because of the black box warning previously required by the FDA on any inhaler containing long-acting β-agonists including formoterol
  • A new study showed that a rescue inhaler containing albuterol + budesonide was significantly better than a rescue inhaler containing albuterol alone
  • This new rescue inhaler will replace the albuterol inhaler for many patients with asthma

 

The metered-dose inhaler was invented in 1955, when 13-year-old Susie Maison asked her father why she had to take her asthma medication in a squeeze bottle and why it could not be put into a can, like hairspray. Her father was the president of Riker Laboratories (now 3M) and thought that his daughter was onto something. Within a year, Riker released the Medihaler-epi and Medihaler-iso, containing the β-agonists, epinephrine and isoprenaline, respectively. These gave way to the β-agonist inhalers that I prescribed in the 1980’s: Alupent (metaproterenol), Maxair (pirbuterol), Brethaire (terbutaline), Tornalate (bitolterol), Proventil (albuterol), and Ventolin (albuterol). With the international agreement to eliminate inhalers containing chlorofluorocarbons, all of these except albuterol were taken off the market by 2010.  And so, for the past 12 years, albuterol (also known as salbutamol outside of the United Stateshas been the sole short-acting β-agonist available in the United States.

Why use albuterol in asthma, anyway?

Asthma is an obstructive lung disease where the airways of the lungs become narrowed. This narrowing is caused by a combination of bronchospasm and inflammation. Bronchospasm is caused by contraction of the smooth muscles that line the airways and can be relieved by β-agonists, such as albuterol. Inflammation is caused by a group of biochemicals that cause white blood cells such as neutrophils, eosinophils, and lymphocytes in the airways to become activated resulting in swelling of the airway walls and secretion of mucus into the airways. Inflammation can be relieved by corticosteroids.

β-agonists can relieve the bronchospasm component of airway narrowing almost immediately but steroids take hours or days to relieve airway inflammation. Albuterol and other β-agonists only relieve bronchoconstriction and have no effect on inflammation. Albuterol’s duration of action is 3 – 6 hours. Therefore, in an asthma flare, β-agonists alone can provide partial short-term improvement in airway narrowing but will not relieve the underlying inflammation. For decades, asthma treatment has required albuterol and steroids to be given separately. Albuterol and other β-agonists are most commonly given by inhalation, either via a metered-dose inhaler or by a nebulizer. Steroids can be given via metered-dose inhalers on a scheduled basis for prevention of asthma flares. Steroids can also be given by pills (such as prednisone) or by intravenous infusions (such as methylprednisolone) once a patient’s asthma flares up.

The argument against inhalers containing only albuterol

This month, the MANDALA study was published in the New England Journal of Medicine that indicates that a combination of albuterol plus the corticosteroid budesonide in a single inhaler is better for relieving asthma symptoms than an albuterol-only inhaler. In this randomized double-blind study, 3,132 subjects with moderate to severe asthma at 295 different centers worldwide (including the U.S.) were given a rescue inhaler containing only albuterol or were given a rescue inhaler containing both albuterol and budesonide. Those subjects who received the albuterol + budesonide inhaler had 26% fewer severe asthma flares than those who received albuterol alone. The implication of the study is that when a person’s asthma flares up, treating both inflammation and bronchospasm is more effective than treating bronchospasm alone.

This reinforces the asthma treatment guidelines recommended by GINA (the Global Initiative for Asthma). GINA began as a collaborative effort of the U.S. National Institutes of Health and the World Health Organization and over the past 29 years, it has become the gold standard for asthma treatment recommendations. The 2022 GINA Report recommends that the first line asthma reliever treatment should initially be a combined formoterol (a long-acting β-agonist) + steroid inhaler and if this is not available, then the second line is to use two inhalers: an albuterol (a short-acting β-agonist) inhaler plus a separate steroid inhaler simultaneously. The formoterol + steroid inhaler is thus preferred over the albuterol only inhaler as a reliever medication.

The U.S. National Institutes of Health’s National Asthma Education and Prevention Program (NAEPP) updated their asthma treatment guidelines in 2020 and made similar recommendation for the use of a formoterol + inhaled corticosteroid combination inhaler for use as both a maintenance and a reliever inhaler in patients with moderate or severe asthma.

Formoterol is a long-acting β-agonist and is the ingredient in the inhaler, Foradil. It is also an ingredient in the combination inhalers Symbicort (formoterol + budesonide) and Dulera (formoterol + mometasone). Budesonide and mometasone are both inhaled corticosteroids. In 2003, the FDA required that all inhalers containing both long-acting β-agonists + inhaled corticosteroids (such as Symbicort and Dulera) include black box warnings in their package inserts. These warnings stated that long-acting beta agonists have been linked to increased death and that Symbicort, Dulera, and all other combined long-acting β-agonist + corticosteroid inhalers should only be used in patients with severe asthma not controlled by an inhaled corticosteroid alone. The black box warnings further specified that these combination inhalers should be discontinued as soon as possible once asthma is controlled. The black box warnings originated because of the SMART trial (Salmeterol Multicenter Asthma Research Trial) published in 2006. In this study, asthmatics were treated with salmeterol (a long-acting β-agonist) or placebo as a sole maintenance inhaler for asthma and the results indicated increased death in patients receiving salmeterol. An important criticism of this study is that patients were not treated with an inhaled steroid, just the inhaled salmeterol. The implication is that subjects in the SMART trial were only treated for bronchospasm and their airway inflammation was left untreated. Nevertheless, due to the SMART trial, the FDA required the black box warning of risk of death for any inhaler containing a long-acting beta agonist, including those in which the long-acting β-agonist is combined with an inhaled corticosteroid. In 2017, the FDA removed the black box warning on these combination inhalers after further studies showed that the combination inhalers were not associated with increased death (unlike the single agent long-acting β-agonist inhalers).

However, the previously required black box warnings have left an indelible imprint on American physician prescribing practices. Despite the removal of these warnings 5 years ago, many physicians remain hesitant to adopt the GINA guidelines recommending that combination long=acting β-agonist + inhaled corticosteroid inhalers be used as rescue inhalers. Furthermore, the use of inhalers such as Symbicort and Dulera as rescue inhalers is still considered off-label in the United States.

To make matters worse, the asthma management strategy of using a formoterol + inhaled corticosteroid combination inhaler as both a maintenance and a reliever inhaler has been referred to by the National Asthma Education and Prevention Program and others as “SMART” (Single Maintenance And Reliever Therapy). This unfortunate use of the term “SMART” to promote the use of a combination inhaler containing a long-acting β-agonist in asthma has been confused by many clinicians with the SMART study published in 2006 that condemned the use of long-acting β-agonists in asthma and resulted in the previous black box warnings. As a consequence, when many physicians hear about “SMART” asthma therapy, they think that this means “…don’t use long-acting β-agonists for asthma”.

The net result is that American physicians are considerably behind the rest of the world when it comes to using formoterol + corticosteroid inhalers as asthma reliever inhalers and instead continue to rely on albuterol-only inhalers. The graph below from the U.S. FDA shows that formoterol (diamonds) has a similar onset of action as albuterol (triangles) but has a longer effect than albuterol.

The pharmaceutical company, AstraZeneca, is now developing the combination albuterol + budesonide inhaler used in the MANDALA study that is currently only known as PT027. A new drug application was filed with the FDA last month for PT027 so we will likely see it commercially available in the United States in the near future. There is reason to hope that the albuterol + corticosteroid inhaler will be better accepted by American physicians as a rescue inhaler than the formoterol + corticosteroid inhalers.

Is this the end of albuterol?

I think the answer to that question is a pretty solid “No”. Albuterol will continue to be used in COPD and the probable high cost of the combination albuterol + budesonide inhaler will be a barrier to widespread replacement of albuterol-only inhalers in patients with asthma.

What about COPD? Albuterol-only inhalers will continue to be used in another obstructive lung disease, COPD. There is a general reluctance to use inhaled steroids in patients with COPD where, unlike asthma, inhaled steroids increase the risk of pneumonia in most COPD patients. Therefore, albuterol-only inhalers will likely continue to be used as reliever inhalers in patients with COPD.

What about mild asthma? The MANDALA study only looked at patients with moderate to severe asthma. There is a very large population of patients with asthma for whom albuterol-only inhalers seem to work well. This includes patients with exercise-induced asthma and asthma that is only triggered when a person inhales something that they are allergic to (such as cat antigens). These asthma patients were not included in the MANDALA study and so we do not know if the combination albuterol + budesonide inhaler works better than an albuterol-only inhaler for them. As a consequence, it is likely that AstraZeneca will only seek FDA approval for PT027 in those patients with moderate or severe asthma and not in those with mild asthma.

What about cost to patients? Once PT027 is approved by the FDA, it will likely be expensive. A generic albuterol inhaler costs about $30 whereas brand name albuterol is about $75 per inhaler. PT027 will probably be priced closer to brand name combination long-acting β-agonists + corticosteroid inhalers. These typically cost about $300 – $400 per inhaler (a generic formoterol + budesonide inhaler costs about $200 per inhaler). Price alone will make albuterol preferred by those asthmatics without prescription medication insurance. Even for those with insurance, high co-pays and high deductibles may preclude widespread adoption of PT027 as the asthma reliever inhaler of choice.

What about employers? Most employers leave the decision about which drugs will be covered by employee health insurance up to the commercial insurance companies. However, employers may want to pressure insurance companies to include PT027 on their health insurance formularies if the 26% reduction in severe asthma flares using PT027 is confirmed. Currently, asthma exacerbations result in a loss of 8.7 million work days and 5.3 million school days every year in the United States. The total cost of these missed work and school days is $3 billion per year. If the 26% reduction in severe asthma flares translates to a 26% reduction in missed work days and missed school days from asthma, then it may be cheaper overall for employers to include PT027 on their insurance formulary, even if they have to pay higher insurance premiums.

What about hospitals? Hospital formularies typically carry albuterol inhalers and for medical-legal reasons, there will continue to be hesitancy for hospitals to adopt the GINA recommendations of a combination formoterol + inhaled corticosteroid reliever inhaler for hospitalized asthma patients as long as this use is considered off-label by the FDA. Presumably, since it contains a short-acting β-agonist, PT027 will get an FDA approved indication as a reliever inhaler, making it more palatable for hospital pharmacies to replace albuterol on their formularies. However, the cost of PT027 (compared to albuterol-only inhalers) may be a barrier for widespread hospital use.

The bottom line is that for those people with moderate to severe asthma who are either wealthy or have superb prescription medication insurance, albuterol inhalers will likely become obsolete. For everyone else with asthma and for those with COPD, albuterol inhalers will be preferred.

June 28, 2022

Categories
Electronic Medical Records Outpatient Practice

We Need National Telemedicine Tumor Boards

Tumor boards have been shown to improve cancer outcomes by incorporating the expertise of many specialists in order to formulate a personalized treatment plan for each patient. These interdisciplinary management plans can give patients the best chance of cancer control or cure. Tumor boards typically consist of a surgeon, a medical oncologist, and a radiation oncologist but may also include a pathologist and a radiologist. Organ-specific tumor boards may consist of other specialists. For example, a thoracic tumor board may include a pulmonologist or a GI tumor board may include a gastroenterologist. Tumor boards allow specialists to bring their own expertise to an individual patient’s cancer treatment plan in order to determine the timing of surgery, the use of adjuvant or neoadjuvant chemotherapy, and the use of radiation therapy.

Summary Points:

  • Recent advances in cancer care have led to the evolution of different cancer-specific tumor boards
  • There is an unmet need to bring these cancer-specific tumor boards to rural and underserved areas of the country
  • Telemedicine tumor boards offer an opportunity to improve cancer treatment to all Americans
  • There are a number of obstacles that need to be addressed before national telemedicine tumor board implementation

 

Tumor boards have become even more important as advances in cancer genetics have resulted in many new treatments based on the molecular make-up of individual cancers. The advisability and timing of these newer treatments such as immunotherapy and driver-directed therapy can also be incorporated into the patient’s cancer treatment plan during tumor board discussions. Also, patients eligible for clinical trials of promising experimental treatments can be identified during tumor board discussions and enrolled in research studies.

In large medical centers, tumor boards typically meet once every week or two weeks. In smaller hospitals, tumor boards meet less frequently, often monthly. Each patient’s history, physical exam, radiologic staging study results, and tumor pathology results are reviewed. Specialists then develop a personalized cancer treatment plan tailored for that patient. A tumor board is far more efficient than having the patient see multiple physician specialists in their office for separate consultations and then having the physicians forward their individual recommendations to the primary care physician for coordination of care.

Survival of most cancers has improved significantly over the past several decades, largely due to development of new medications to treat cancers and to advances in cancer screening. But cancer is not one disease and cancer treatment has also become highly specialized. Oncologists used to be cancer generalists who were expert in the treatment of all forms of malignancy but now, medical and surgical oncologists specialize. The result is that there are different medical oncologists who treat lung cancer, gastrointestinal cancers, skin cancers, breast cancer, etc. As a consequence, tumor boards have also become specialized with different tumor boards for lung cancers, gynecologic cancers, and breast cancers. Large academic medical centers will often have 8-10 different tumor boards, each for a different type of cancer.

This specialization of oncologists and of tumor boards has posed a challenge for smaller hospitals and rural hospitals that do not have the luxury of multiple medical oncology specialists, surgical oncologists, or gynecologic oncologists. These hospitals either have to rely on general surgeons, general medical oncologists and general tumor boards or have to refer their newly diagnosed cancer patients to large medical centers for subspecialty evaluation that can sometimes be hundreds of miles away.

In the past, tumor boards were held in hospital conference rooms with physicians attending in-person. The COVID-19 pandemic showed us that multidisciplinary conferences could be just as effective when performed remotely. For more than 15 years, I led our medical center’s multidisciplinary interstitial lung disease conference which is the equivalent of a tumor board for non-cancer diseases such as pulmonary fibrosis. We found that our interdisciplinary discussions were just as easily done by a Zoom or Teams meeting as they were by in-person conferences. In fact, we had better attendance when the conferences went remote because physicians who practiced at off-site clinics could more easily attend.

A 2014 proof of concept study involving two Veterans Administration hospitals showed that virtual telemedicine tumor boards were both feasible and well-accepted by participants. The COVID-19 pandemic forced most hospital tumor boards to convert to virtual meetings. A study from the University of Pittsburgh demonstrated that virtual tumor boards during the COVID pandemic were very effective. But can we develop virtual tumor boards utilizing telemedicine technology to bring multidisciplinary expertise to smaller hospitals in order to improve cancer outcomes in rural and underserved areas of the country?

Lessons from institutional review boards

Institutional review boards (IRBs) are sometimes referred to as “human subjects committees” and are multidisciplinary groups that review clinical trials in medicine to ensure that medical experimentation involving humans is performed ethically and with appropriate study design. In the past, each hospital had its own IRB composed of volunteer reviewers. The volume of study proposals and the burden of IRB meetings by physicians, university faculty, and lay public members often resulted in long delays in getting clinical trial proposals approved.

In 1968, the Western Institutional Review Board was founded as an independent ethical review organization that allowed hospitals to outsource their clinical trial reviews for a fee. Hospitals no longer needed to rely on internal human subjects committees and Western was able to turn proposals over more quickly than the hospital IRBs. Our university outsources most of our clinical trial reviews to Western and this has greatly expedited research. Over time, more independent IRBs arose and consolidated. Now, most clinical trials undergo their ethics review by independent IRBs such as Western (now known as WCG IRB). These independent IRBs can match ethics and research specialists with specific clinical trials in order to provide superior reviews in a shorter period of time.

Our nation’s tumor boards can learn a lot from the independent IRBs. By assembling a large group of specialists in the treatment of each type of cancer, state-of-the-art recommendations individualized to each patient’s cancer can be made anywhere in the country, or for that matter, anywhere in the world. And those recommendations can be made faster, thus allowing patients to get started on optimal treatment as quickly as possible. A criticism of American cancer research is that racial and ethnic minorities are often underrepresented as subjects in clinical trials. By better reaching these minorities through telemedicine tumor boards and identifying clinical trial candidates, such disparities could be reduced.

Barriers that need to be overcome

There are several obstacles that need to be addressed before national telemedicine tumor boards can be implemented:

  1. Medical licensure. In telemedicine, the medical encounter is legally considered to occur at the patient’s physical location and not the doctor’s location. As a consequence, physicians providing telemedicine must be licensed to practice medicine in the state that the patient is in at the time of the telemedicine encounter. A physician in Ohio cannot legally provide telemedicine care to a patient located in Florida unless that physician has a Florida medical license. For this reason, state-specific telemedicine tumor boards would be easy to implement from a medical licensure standpoint but a national telemedicine tumor board would require physician participants to have dozens of individual state medical licenses. The development of the Interstate Medical Licensure Compact may simplify the process of obtaining medical licenses in many states but not all states participate in the Compact. A national telemedicine tumor board could perhaps most easily be implemented in the Veterans Administration system since VA-employed physicians can practice in any state as long as they are licensed to practice in any one state.
  2. Cost. Physicians participating in hospital tumor boards are generally not compensated for their time – they participate pro bono as part of their professional duties to the hospital. A 2021 study from a single academic medical center found that the total cost in physician time to participate in the hospital’s 9 separate tumor boards was $648,183 per year. Currently, there is not a mechanism to pay for national telemedicine tumor boards and this would need to be addressed by Medicare and commercial insurance policy changes. Alternatively, this could be financed by subscription fees charged to participating hospitals.
  3. Radiographic and pathologic review. Like medical oncology and surgical oncology, radiologists have become subspecialized. Chest CT scans of patients with lung cancer are reviewed by a thoracic radiologist whereas brain MRIs of patients with brain tumors are reviewed by a neuroradiologist. Pathologists have become similarly subspecialized. Tumor boards at large academic medical centers are usually attended by the subspecialty radiologists and subspecialty pathologists who originally reviewed the patient’s materials. Smaller hospitals will typically only have general radiologists and general pathologists. A mechanism would need to be in place so that subspecialty radiologists could review original radiographic images and subspecialty pathologists could review full slides of tumor biopsy specimens. There are existing telemedicine solutions to both of these challenges but this could require smaller hospitals to purchase equipment and software to transmit radiographic and histologic images.
  4. Malpractice insurance. When a physician’s name appears on a treatment recommendation, that physician can be named in event of a medical malpractice lawsuit. Several years ago, I was a defense expert witness in a malpractice case involving a patient with a rare eosinophilic lung disease. The pathologist reviewing the lung biopsy slides called a pathologist in a different city who was a national expert in pulmonary pathology and asked that pathologist over the phone about the diagnostic significance of all of the eosinophils that were present on the biopsy slides. The second pathologist was named in the suit, even though he had only spoken by phone with the initial pathologist and had not, himself, seen the actual biopsy slides or provided a formal pathology report. Malpractice insurance coverage would need to be worked out before implementing a national telemedicine tumor board. Board participants would either need to have immunity against civil litigation or would have to be provided telemedicine malpractice insurance.
  5. Medical record access. Tumor board participants must have access to patients’ medical records. Many factors need to be considered when formulating a cancer treatment plan including laboratory test results, radiologic images, medication lists, drug allergies, past medical history, family history, social history, and the physical exam. All of these data must be available to tumor board specialists for them to provide the best recommendations for any given patient. Electronic medical records have improved physicians’ ability to access medical information at other hospitals, such as the ‘CareEverywhere’ app on Epic’s electronic medical record. Nevertheless, not all electronic medical record software are equally good at permitting cross-hospital patient information transfer. The success of a national telemedicine tumor board would be contingent on development of robust integrated electronic medical record networks.
  6. Patient selection. Not every cancer patient needs to be presented at a tumor board. For example, the management of a patient with stage 1A non-small cell lung cancer is pretty straight-forward – they get a lung lobectomy. But cancer treatment guidelines change rapidly and it can be difficult for the general oncologist or the general surgeon in a small, rural hospital to keep up with these guidelines. Not too many years ago, the standard of care for stage 1B lung cancer was surgery alone but several years ago, adjuvant chemotherapy was added, followed more recently by neoadjuvant chemotherapy. Last month, a study showed that neoadjuvant chemotherapy plus immunotherapy was better still. There would need to be some process in place to identify those patients who would benefit most from a national telemedicine tumor board. One option could be to refer only those patients that general tumor boards identify as needing discussion at a subspecialty telemedicine tumor board.

Somebody is going to make a fortune

Successful entrepreneurs identify unmet consumer needs and then figure out a way to meet those needs. Those who are successful in a large consumer market become wealthy. Providing specialized cancer treatment recommendations is currently an unmet healthcare need in much of the United States and throughout most of the world. A national telemedicine tumor board has the potential to be an enormous commercial success and has the promise of making whoever can pull it off rich.

However, most physicians did not go into medicine just to be wealthy, we go into medicine so that we can improve people’s lives. I can think of few better ways of improving large numbers of people’s lives than by ensuring that every cancer patient in the U.S. has access to prompt treatment recommendations from specialists up to date on the latest in evidence-based oncology. It is time for national telemedicine tumor boards.

June 22, 2022

Categories
Inpatient Practice Outpatient Practice

When Patients Threaten Doctors

A few years ago, one of our physicians was threatened by a patient who said he was “…going to come after you with my gun” because she refused to prescribe opioid pain medications for him. She was very distraught and came to me looking for measures to keep her safe in the workplace. In the past week, there have been several homicides at American healthcare facilities that have caused me to think back to that doctor.

Doctors and nurses facing the wrath of angry patients and their families is nothing new. Thirty-five years ago, when I was a fellow in training, a woman sent our division a letter saying that she was going to come to the hospital to kill all of the pulmonary and critical care doctors with her automatic rifle because her husband had died in our ICU. I had never even met her or her husband. What is different today compared to 35 years ago is that weapons are much more easily available and America has increasingly developed a culture of gun violence.

In the latter half of the last century, the United States was embracing greater degrees of gun control. In 1967, then governor Ronald Reagan signed the California Mulford Act that prohibited the public carrying of loaded firearms without a permit; violations were subject to a felony. At the time of signing, Reagan famously said that there was “…no reason why on the street today a citizen should be carrying loaded weapons”. The Mulford Act was notably supported by the NRA, which at the time was an organization primarily focused on the recreational use of guns and on gun safety. In 1993, the Brady Bill required mandatory criminal background checks on anyone purchasing firearms. In 1994, the Violent Crime Control and Law Enforcement Act banned the sale of assault rifles in the U.S.; the law had a 10-year limitation and expired in 2004. However, over the last 15 years, due largely to lobbying by special interest groups that promote gun availability, weapon laws have been rolled back. Coincident with this has been an increase in gun deaths, mass shootings, and healthcare shootings. Prior to the 1994 assault rifle ban, there were an average of 7.2 mass shooting deaths per year in the U.S. During the ban, that number dropped to 5.3 per year. After the ban expired in 2005, the average number of mass shooting deaths rose to 25 per year.

Shootings at healthcare settings

An FBI report found that there were 13,927 U.S. homicides in 2019. Firearms were by far the most commonly used weapons, accounting for 73% of the homicides.

Semi-automatic rifles (such as the AR-15 rifle) loom large in the public perception of homicides, largely due to their use in high-profile mass shootings. However, handguns are by far the most commonly used weapons in American homicides and account for 91% of firearm-related homicides. Firearms are also the method of choice for suicide in the United States and account for 53% of deaths by suicide per CDC data.

The CDC reports that in 2020, the firearm-related homicide rate was the highest that it has been in more than 25 years with a 35% increase compared to 2019. Overall, 45,222 Americans died from firearms in 2020. There have been a total of 18,882 gun-related deaths so far this year in the U.S. which puts us on a pace to exceed the 2020 number – and we have not even reached the busy summer homicide season. There have been 247 mass shootings so far this year and last Wednesday, there were fatal shootings at hospitals in Tulsa, OK and in Dayton, OH. Last Saturday, a physician and 2 nurses were stabbed in an emergency department in California. Our hospitals are becoming increasingly dangerous – The International Association for Healthcare Security and Safety reports that there was a 47% increase in hospital violent crimes in 2021 compared to 2020.

Violence against healthcare workers is incredibly common. According to the Bureau of Labor Statistics, healthcare providers account for 73% of all workplace injuries due to violence.  A hospital is one of the most dangerous places to work in the United States.

In a 2017 study of 346,343 emergency department visits, weapons were found in 3% of all ER visits with a total of 10,691 weapons confiscated at screening. Weapons were most likely to be found at hospitals that provide trauma and behavioral health services. Knives were the most common weapons found.

Hospital shootings are relatively rare but are usually widely publicized resulting in a greater awareness of shootings compared to other violent acts at hospitals. A 2012 study found that there were 154 shootings at healthcare facilities between 2000 and 2011 (12.8 per year). A more recent study found that there were 88 hospital shootings at healthcare facilities between 2012-2016 (17.6 per year). These data indicate that the annual number of hospital shootings is increasing.

What can we do to keep our healthcare workers safe?

There is no single best answer to this question because each healthcare setting is unique. Measures that are effective in an emergency department may not be practical nor effective in a free-standing medical office. Here are some of the steps that we took to improve healthcare worker safety in our own hospital and clinic building.

  1. Listen. When a doctor or nurse says that a patient has threatened them, take them seriously. Even if you believe that the threat is minimal, the person who has been threatened feels vulnerable and experiences trepidation. Take every patient threat seriously.
  2. Encourage reporting. Far too many violent incidents and threats in our nation’s hospitals go unreported. The most common reasons are (1) fear of retaliation, (2) lack of a clear reporting method, and (3) belief that nothing will be done. Reporting should be simple and easy. Ideally, there should be multiple options for reporting – by phone, email, on-line, in-person, etc.
  3. Engage hospital security. Keeping patients and employees safe is what they are trained to do. The security staff will have ideas about threat assessment and threat mitigation that you have not even thought about. For smaller, private medical practices that are not affiliated with a hospital, having on-site security personnel is not feasible. However, a healthcare security consulting company may be able to at least advise options for reducing the risk of staff being harmed.
  4. Video surveillance. Cameras can relatively easily be installed in parking areas, entryways, lobbies, and main corridors. Because the emergency department is the location of frequent violence against healthcare workers, extra cameras in the ER are generally warranted. In large hospitals, it is often optimal to have a member of the security staff continuously monitoring video feeds. Constant monitoring by a staff member may not be practical in a smaller outpatient office but video recordings can be very useful to substantiate threats if police become involved and signage announcing video surveillance can serve as a deterrent in some cases.
  5. Weapon-free zones. We have signs in our hospital and clinic building entrances stating that guns and other weapons are not permitted on premises. These signs are useful to make the hospital staff and general public feel safe but do very little to prevent a person from bringing a weapon inside. I was taught to recognize concealed guns carried by visitors to our ICU and have frequently identified people walking in with a handgun. In my outpatient pulmonary practice, I have unexpectedly encountered many holstered handguns during my auscultation of patients’ lungs from their backs. In Ohio, anyone can now carry a concealed handgun with no training or permit required and so I anticipate that even more people will ignore ‘No Guns Allowed’ signs.
  6. Limit door access. When our outpatient doctor was threatened after refusing to prescribe opioids, we put ID badge-access locks on the doors leading from the lobbies to the patient care areas. This required any patient or visitor to be escorted by an office staff member with badge access. We periodically receive threats from family members of ICU patients and so we have installed similar badge-access door locks to the ICU as well as other vulnerable locations such as the operating room and the emergency department. Creating this type of entrance barrier to an angry person with a weapon is one of the most effective preventive measures that we can take.
  7. Interior design. No only should staff have easy access to exits, but staff also need to know where all possible exits are. Mirrors and strategic positioning of reception desks can improve line-of-sight in corridors and lobbies. Interior spaces and parking areas should have adequate lighting. Enclosing reception desks can create a barrier to accessing adjacent patient care areas.
  8. Metal detectors. These are not practical at every hospital or outpatient office entrance. However, we do use metal detectors at our emergency department public entrance and the number of weapons that are found is astounding. This requires a security staff member to be stationed at the metal detector. It is not possible to use a metal detector at ambulance entrances to the emergency department so patients brought by ambulance must be manually searched or checked with a hand-held metal detector on arrival – this is particularly necessary for trauma and psychiatric patients arriving by ambulance since these patients are more likely to have weapons.
  9. Panic buttons. These are devices that can be placed in a physicians office or can be carried by the physician (or nurse) that send a signal directly to the security staff if the physician (or other healthcare worker) is confronted by a threatening person. We have frequently provided these to doctors who have received threats from patients, patient family members, or former employees. The won’t stop the first bullet from a gun but they might prevent the second bullet from being fired.
  10. Phone call code phrases. This is a simple measure that every hospital should utilize. Staff are taught that if there is person making a threat in their area, the staff call the security office and state the code words. In order to protect the safety of our own hospital’s staff, I won’t say what our code phrase is. But choose something that won’t be obvious to the general public such as “Please page Dr. G”. The code phrase then triggers security staff to immediately go to the location of the phone call.
  11. Run, Hide, Fight. Active shooter training should be available to every healthcare worker. The Ohio State University uses the Run, Hide, Fight procedure for students, faculty, and staff. We require Run, Hide, Fight training for some of our hospital employees and make the training optional for others, depending on the hospital location where they work. For an example of what the training involves, watch this short video created by the FBI.
  12. Safety training. In situations less emergent than active shooter situations, other tactics should be used. All staff should be trained to identify warning signs and escalating behaviors that can precede a violent assault. Training should also include de-escalation techniques, available alarms, behavior control methods, and location of safe areas. Free self-defense training is often seen as a valuable fringe benefit by healthcare workers.
  13. Involve the police. When a doctor receives a credible threat, contact the police. Be sure to save any evidence such as letters, emails, voicemails, or video recordings. Encourage staff to press criminal charges when appropriate. This may require financial support for legal assistance as well as paid time off for legal proceedings.
  14. First name ID badges. This is usually impractical for physicians who by necessity need ID badges stating their last names. But patients and visitors generally do not need to know the last names of nurses and other hospital employees. Instead of their ID badge reading “Carol Smith, RN”, consider having the ID badge simply read “Carol RN”. Identity concealment can be an important deterrent to a vindictive patient.
  15. Parking lot escorts. Any hospital employee who feels unsafe should have the option of being escorted by security staff from their car to the building and from the building to their car. Parking lots and parking garages are second only to the emergency department in numbers of violent assaults in hospitals.
  16. Provide counseling. A violent assault or the threat of violence is extraordinarily stressful for hospital staff. Unaddressed, this emotional stress can result in reduced employee performance, absenteeism, and employee resignation. Counseling should be available to staff through free employee assistance programs. Hospitals and large medical practices may be able to use internal resources such as social workers and mental health providers. Small medical practices may need to establish a relationship with private counselors.

People with weapons kill people

Gun control advocates often say “Guns kill people”. Gun rights advocates counter by saying “Guns don’t kill people, people kill people”. I think they are both wrong: people with weapons kill people. Guns just happen to be America’s weapon of choice. The United States has, by far, the highest gun-related homicide rate of all high-income countries. Our healthcare facilities are not immune to homicide and other forms of violence. Doctors will always be blamed by some people for their pain, for the outcome of their illness, or for the death of a family member. Our job as hospital leaders is to create a safe workplace so that our doctors can improve people’s lives without having to worry about losing their own.

June 8, 2022

Categories
Outpatient Practice

How To Do A Disability Exam

Physicians have two roles in disability determination: (1) recommending disability as the attending physician of their patients and (2) doing an independent medical examination consultation for disability granting organization (such as an insurance company or Social Security). These are two very different tasks.

First, it important to remember that we as physicians do not grant disability retirement. We can only recommend disability – disability retirement can only be granted by the employer, the insurance company overseeing the disability insurance policy for the employer, or the government agency providing disability benefits. Over the past 30 years, I have filled out hundreds of disability forms for my patients, done dozens of independent medical examinations for insurance companies or employers, and reviewed hundreds of independent medical examinations for organizations that grant disability. Here is what you need to know.

When is a patient disabled?

Put simply, a patient is disabled when they have a physical or mental impairment that prevents them from performing their job. The key words are “their job” – a medical condition that prevents someone from doing one job may not prevent that same person from doing a different job. For example, a partial foot amputation may be disabling for a road construction worker but not disabling for a telemarketer. Usually, disability benefits are granted when an employee can no longer do the job they were hired for, but some companies will not grant disability benefits if an employee can be retrained a different job within the company. For example, a factory worker who develops occupational asthma from a chemical used in manufacturing might be re-trained to work in the shipping department where finished products are stored.

In addition, disability is considered when the employee is unable to perform regular full-time duties despite reasonable accommodation. It is often far less expensive to the employer to provide an accommodation to an employee than to hire a replacement, train that replacement, and face increased disability insurance premiums if the employee goes on disability. As an example, an employer could assign an employee with knee arthritis an office on the first floor so that the employee does not have to walk up multiple flights of stairs every day.

Although there is a lot of variation between different disability-granting organizations, the common requirements to be granted disability include:

  1. The medical condition must either be new since the applicant began employment or if it is a pre-existing condition, it must have worsened since the date of initial employment.
  2. The medical condition must have a diagnosis (or tentative diagnosis). A symptom alone, such as shortness of breath, is generally not grounds for disability unless there is a diagnosis to go along with it (such as COPD).
  3. The medical condition must be of sufficient severity to prevent the applicant from doing their regular employment duties.
  4. The medical condition is expected to be “permanent”. This generally means lasting at least 12 months. In this sense, permanent does not necessarily mean forever.
  5. There must be objective evidence that the condition causes impairment. For this reason, it is very difficult for patients with chronic pain syndromes (migraine headache, fibromyalgia, etc.) to get disability without collaborating x-ray, EMG, or physical examination abnormalities. Similarly, applicants with conditions such as chronic fatigue syndrome that lack abnormalities on diagnostic tests are often denied disability.

The attending physician’s role

When a patient applies for disability through their employer, one of the first steps is for the employer (or employer’s insurance company) to contact the patient’s attending physician to get detailed medical information. Before giving out any information to the employer, the attending physician must confirm that the patient has given permission for release of their medical information. I was almost conned once when a patient’s ex-spouse sent me a letter requesting medical information posing as an employer. However, there was no signed release of information document and when I contacted the patient to clarify the medical information release, I found out that it was all a ploy.

These disability forms are often several pages long and can require as long as a half hour to complete. The time required to fill these forms out is usually not billable to the patient’s regular health insurance company so it is a good idea to have a written office policy for form completion with a fee schedule for filling out disability paperwork. Usually, payment of these fees is required in advance from the patient. If medical records are requested, then a per-page copying charge is also common practice. Although some disability insurance companies will pay a fee for the physician to complete these forms, most of the time it is the patient’s responsibility to pay for form completion. In my own practice, if the form only required a minute or two of my time, I would not bother to bill the patient – it often took more time to create the bill than it did to fill out the form. But for extensive forms, for patients with multiple disability applications, and for requests for extensive photocopies of medical records, I would require payment.

The information required will vary by employer/insurance company but in general, there are several things that they will want to know:

  1. What is your diagnosis? This should be a medical condition and not a just a symptom. If the patient’s work-up is in progress and you are not yet sure of the specific diagnosis, then indicate that the diagnosis is suspected. If the work-up is just beginning, then it is reasonable to report that you require “X” number of weeks to determine a diagnosis – in that situation, the patient can apply for temporary disability pending full medical evaluation.
  2. What are the disabling symptoms? Common symptoms contributing to disability include dyspnea, impaired mobility, visual impairment, angina, fatigue, cognitive impairment, etc.
  3. Is the patient’s medical condition permanent or temporary? Many conditions that are disabling today may improve with a treatment period of 6 months or so. Permanent disability means impairment lasting more than 12 months. Employers will generally be less strict about granting temporary disability benefits and will often approve temporary disability with a simple administrative approval. Permanent disability requires a more extensive process that generally involves getting one or more independent medical examinations and may involve a disability hearing.
  4. When did the condition become disabling? A condition that was disabling before the patient began his/her employment will generally result in denial of disability benefits.

Attending physicians have an inherent conflict of interest when filling out disability paperwork. The physician may not want to disappoint a patient with whom they have longstanding doctor-patient relationship. The physician may get pressured by the patient to help them get disability benefits. Or the physician may fear that the patient will leave the practice if the physician does not support their disability application. Because of this conflict of interest, most employers and disability insurance companies will require an independent medical examination prior to determination of permanent disability.

The independent medical examiner’s role

If the patient’s attending physician recommends disability retirement, the next step in the disability process is usually an independent medical examination (IME). This is done by an impartial physician having no relationship with the patient. The physician should be experienced with the patient’s medical condition and should be knowledgeable about the evaluation of impairment.

Agree on a fee

The IME should be billed to the employer or disability insurance company and not to the patient’s health insurance company. In a large medical practice, this will require you to make prior arrangements with your billing department so that the bill does not inadvertently go out to Medicare or the health insurance company. Most practices will set their fee schedule to charge more than whatever their best paying commercial health insurance contract will pay (anything over that contractural amount is written off). An IME is one of the few times that the physician actually gets paid the amount of their fee schedule. Before agreeing to do an IME, be sure that there is a fee schedule agreement in place. Most IMEs will be a level 4 or level 5 consult. Also, determine up front if additional testing will be covered. Usually, simple office tests such as an EKG or office spirometry will be covered but more extensive testing such as full pulmonary function tests, stress tests, and formal neuropsychological testing requires prior approval.

Review the records

An IME is essentially a consult and like any consult, it starts with a review of the medical records. These can range from a few pages of office notes to thousands of pages of electronic medical record print-outs. My practice was to review these prior to the patient’s office visit and then keep track of the time required. If the records are excessively voluminous, then get an agreement up front about an additional hourly fee for extensive record review.

Do a complete H & P

An IME is usually a comprehensive evaluation and should include a full history, past medical history, review of systems, physical examination, and summary of previous testing. The physical exam should at least cover the areas relevant to the patient’s symptoms. That means documenting a mental status exam in a patient applying for disability due to a psychiatric condition or documenting a cardiac exam in a patient applying for disability due to heart failure. Although it is important to be thorough, when it comes to your final report, more documentation is not necessarily better. I have seen IME reports in excess of 50 pages long with extraneous filler documentation. For example, when reporting a disability applicant’s dietary history, summarize it in 1-2 sentences and don’t list a menu of everything they ate in the past two weeks. Be complete but also be concise.

What is the diagnosis?

The primary diagnoses should be what you have determined that the patient has based on your evaluation. Frequently, your diagnosis may differ from the diagnosis given by the patient’s attending physician(s). Because the IME reports are often sent to the patient’s regular physicians, it is best to word your opinion non-judgmentally. Rather than saying “I determined that the patient has osteoarthritis and disagree with the patient’s treating doctor that she has rheumatoid arthritis”, it is better to state: “My diagnosis is osteoarthritis and I find no evidence of active rheumatoid arthritis at this time.” This allows the patient’s regular doctor to save face and avoids engendering a combative relationship between the doctor and the patient’s employer or disability insurance company.

State why the patient is impaired to perform regular full-time work duties

This generally requires you to have familiarity with the patient’s job description. Simply having a medical condition does not equate to disability; that medical condition must result in a physical or mental impairment that prevents the patient from doing their job. Whenever possible, include objective testing or physical examination findings that confirm impairment. For example, “The claimant has COPD with severe obstruction on spirometry and an oxygen saturation of 82% on room air that indicates a need for supplemental oxygen. The need for oxygen precludes continued work as a furnace repairman”.

Estimate recovery time

Permanent impairment generally implies that a patient will be disabled for more than a year. But that does not always mean that the patient will be disabled forever. For example, a patient with liver failure due to cirrhosis may be disabled today but may be able to return to work two years from now if the patient undergoes liver transplantation. Disability benefit recipients frequently undergo periodic re-evaluation to determine if benefits should be continued or terminated. It is within your purview to advise when such a re-evaluation should occur.

Know where to send the report

The physician performing the IME is being consulted by the employer, insurance company, or government agency that requested the IME. The final report should be addressed to them and not to the patient’s primary care physician or other treating physicians. It is best to not send copies to the patient’s attending physicians – that responsibility usually lies with the organization requesting your IME.

You are not the treating physician

Specialists are accustomed to providing treatment recommendations in consultation reports. An IME is a very different type of consultation. It only involves evaluation and not management. Nor will you be doing any follow-up. Do not prescribe medications.  Do not refer the patient to another specialist. Do not order tests without prior approval by the agency requesting the IME. Do not recommend specific treatments – the agency requesting your IME does not have the authority to prescribe medications or initiate work-ups. However, if you find something potentially life-threatening, the it is appropriate to call the patient’s attending physician to alert them. For example, I once did an IME that included getting a chest X-ray. The X-ray showed a probable undiagnosed lung cancer. I called the patient’s primary care physician so that he could initiate a work-up. I included documentation of the finding and my conversation with the attending physician in my IME report for medical-legal protection of both me and the agency requesting the IME.

Unsuitable for a job does not mean disabled for that job

Unlike conditions such as depression, schizophrenia, and bipolar disorder, personality disorders are rarely grounds for psychiatric disability. However, personality disorders can cause a person to be unsuited for a particular job. For example, a customer service employee with an anti-social personality disorder who punches one of the company’s clients does not warrant disability retirement on the basis of his personality disorder. Personality disorders usually originate in childhood and pre-date employment. One out of ten Americans have a personality disorder – there is not enough money in the U.S. economy to give them all disability retirement.

Similarly, an employee who who develops anxiety because of consistently poor job performance evaluations does not warrant disability retirement on the basis of anxiety disorder. A vegetarian who develops dysthymia when working at a slaughterhouse should not be put on psychiatric disability. These are jobs that they were never suited for in the first place.

Disability determination can be particularly difficult when an employee is not suited for a particular job and then that in turn results in psychiatric symptoms, such as anxiety, depression, or aggression.

Common disability conundrums

  1. Asthma. A confident diagnosis of asthma requires both a history compatible with asthma and obstructive changes on spirometry. I have frequently seen patients who apply for disability due to treatment-refractory asthma who have had multiple spirometry tests that were all normal. These patients may have asthma but if they never have obstruction on pulmonary function testing, then their asthma is unlikely to be of sufficient severity to warrant disability retirement. Often, they have an alternative diagnosis, such as vocal cord dysfunction. Occupational asthma can be more problematic since patients may only have obstructive changes when they are actually in the workplace. In this situation, obtaining workplace spirometry is ideal. At the least, a methacholine challenge test in the pulmonary function laboratory to confirm inducible bronchospasm should be obtained.
  2. Diseases causing dyspnea. Like pain, dyspnea is a subjective symptom. However unlike pain, dyspnea has quantifiable findings with pulmonary testing. When patients claim disability due to conditions causing dyspnea, there must be objective evidence of pulmonary (or cardiac) impairment. This generally means a full set of pulmonary function tests for patients with lung disease. If the patient’s subjective dyspnea is out of proportion to the PFT findings, then a cardiopulmonary exercise test can be valuable. If the dyspnea is also significantly out of proportion to the exercise test findings, then disability retirement will generally be denied.
  3. Heart failure. Medical science has greatly improved the management of congestive heart failure over the past 25 years. With beta-blockers, ACE inhibitors, and cardiac rehab, patients can have substantial improvement in their exercise tolerance and even normalization of their left ventricular function over time. Do not rely solely on cardiac imaging tests and stress tests from many years in the past. If you are not sure of the patient’s current hemodynamic status, it is reasonable to ask that new testing be performed. However, do not rely on overly simplistic, “one-size-fits-all” ejection fraction thresholds for disability determination. For example, an ejection fraction of 40% might be disabling for longshoreman but not disabling for an accountant.
  4. Chronic pain syndromes. Pain is real but is unfortunately not objectively measurable. Moreover, major goals of comprehensive chronic pain management programs are not just to control pain (with medications, physical therapy, etc.), but also for the patient with chronic pain to be able to live as normal of a life as possible despite pain. Exercise is a major component of the management of chronic pain, particularly in conditions such as fibromyalgia. Disability retirement can often make chronic pain more difficult to manage by fostering a more sedentary lifestyle. For these reasons, conditions such as chronic migraine and fibromyalgia are rarely grounds for permanent disability unless these conditions are accompanied by objective findings on X-rays or other tests.
  5. Depression. Psychiatric conditions, such as depression, pose significant challenges for independent medical examiners. Unlike medical conditions such as heart failure and asthma, the examiner relies almost entirely on the patient’s history and the mental status exam. The degree of depression is important – major depression is generally disabling but dysthymia is generally not disabling. Also, disability applicants can sometimes overstate their symptoms in order to obtain disability – the use of inventory questionnaires that identify exaggeration, overstatement, or malingering can be valuable. Depression tends to improve with time and treatment, so re-examination for continuation of disability benefits in 1-2 years is usually advised. Sometimes, patients (or their attending physicians) will have significant improvement in dyspnea but will claim that return to the workplace will cause their depression to relapse. This is frequently more of an unfounded fear than a real threat. A compromise can be a gradual return to work with careful psychiatric follow-up during the return.
  6. Obesity. This is becoming an increasingly difficult issue for employers and disability insurance companies due to the rapid rise in obesity rates in the United States. Obesity by itself is generally not grounds for medical disability but the complications of obesity can be (arthritis, etc.).
  7. Sleep disorders. Sleep apnea and narcolepsy are very common.  In the past, these were almost always grounds for disability retirement. However, with advances in CPAP devices for sleep apnea, most workers with sleep apnea can be adequately controlled. Moreover, most current CPAP devices can be interrogated to determine patient compliance. Similarly, pharmacologic therapy has greatly improved outcomes in patients with narcolepsy. There are simply too many Americans with sleep disorders to give everyone disability retirement. In order to be impaired, there should be evidence of patient compliance with treatment and a recent polysomnography test (for sleep apnea) or multiple sleep latency test (for narcolepsy) while the patient is on maximal medical therapy in order to substantiate impairment.
  8. Cancer. In past editions of the American Medical Association’s Guides to Permanent Impairment, it was stated that patients with cancer should be considered impaired for 5 years after a cancer diagnosis. Cancer treatment has come a long, long way since then and simply having cancer does not imply that the patient is impaired from their cancer. For example, some leukemias can be cured with stem cell transplant. Chronic lymphocytic leukemia can be well-controlled with medications for years or decades. Patients with breast cancer are frequently able to be cured with surgery, radiation, and chemotherapy (even those with axillary lymph node involvement). Grounds for disability due to cancer can include disabling side effects of treatment (for example, nausea and vomiting from chemotherapy), progression of cancer despite treatment, and advanced cancer with no reasonable hope for response to treatment.
  9. Immunosuppression. Drugs used to chronically suppress the immune system are more widely used than ever before – for cancer chemotherapy, for transplant rejection prevention, and for inflammatory disease treatment. These drugs can impair the body’s ability to fight off infectious diseases. Many workers are regularly exposed to infectious diseases in their workplace: flight attendants in crowded aircraft, teachers in classrooms fully of children with colds, and healthcare workers caring for infected patients. Fortunately, most of these workplace exposures are to respiratory viruses. For viruses such as influenza and COVID, there are effective vaccines. Most of the other common respiratory viruses (such as common cold viruses) are generally not excessively risky to immunosuppressed persons. Instead, the immunosuppressed person’s greatest danger is from bacterial infections and opportunistic viruses such as CMV – these pathogens are generally not readily transmitted in a workplace. When assessing impairment from immunosuppression, the independent medical examiner should consider the risk of the specific pathogens that a disability applicant is likely to be exposed to in the workplace.
  10. COVID. In the beginning of the pandemic, some workers applied for disability if they had risk factors for severe COVID or death from COVID if they were to have a workplace exposure. This was a challenge because almost every workplace had the potential for exposure to infected people. Further, with COVID risk factors of age over 60 years old, obesity, hypertension, and diabetes, an enormous percentage of the U.S. workforce was at risk. Now, with effective vaccines that can prevent severe infection and death, there are few, if any, situations where workers with risk factors should be put on disability retirement. Nor should personal refusal to get vaccinated be grounds for disability retirement.

The importance of fair disability processes

Ultimately, disability benefits are paid by employees. Social Security disability is paid for by all of the workers who contribute to Social Security in the form of payroll taxes. Insurance companies fund disability benefits from employee disability insurance premiums. Workers compensation is funded by premiums paid by employers who then include the cost of those premiums in employee benefits. The role of the independent medical examiner is to ensure that those workers who are truly disabled have access to benefits and to protect those benefits from being used up by those who are not truly impaired.

May 16, 2022

Categories
Inpatient Practice Outpatient Practice Procedure Areas

Managing Pain In The Hospital

An important mission of the hospital is the relief of suffering and that includes relief of pain. Pain management programs are central to fulfilling this mission. The past decade has taught us that you cannot effectively manage pain with an opioid prescription alone. The combination of opioid addiction plus the COVID-19 pandemic has proven to be lethal for many Americans. Last year, there were 100,306 drug overdose deaths in the United States, up by 28.5% from the 78,056 overdose deaths in the previous year. The vast majority of these deaths were caused by natural or synthetic opioids and for many of these people, their addiction started with a pain medication initially prescribed by a doctor.

In the 1990’s, “Pain as the 5th vital sign” was the mantra of pain management services with the implication that physicians were not prescribing enough opioids and that it was our moral duty to prescribe more. The consequence of this campaign was that many of our patients became opioid-dependent. When we realized this, the pendulum swung the other way, with state medical boards restricting the amount and duration of opioid prescriptions that doctors could order. As a result, the supply of prescription opioids fell dramatically and the opioid-dependent population turned to illegal opioids. Coincident with this, inexpensive synthetic fentanyl became readily available on our streets and many Americans died of unintentional overdose due to the unpredictable concentrations of fentanyl in purchased quantities of street drugs.

The good news, is that we have a number of great alternatives to opioid pain medications for both acute and chronic pain management. However, a high-functioning hospital needs to have  more than just one of these pain management services.

What is pain, anyhow?

Pain exists when our peripheral nerves let us know that a part of the body is being injured. This is a great defense mechanism to avoid bodily harm, for example, pain is how we know to pull our hand away when we touch a hot stove. But pain can become pathologic when those pain nerves keep firing even though there is no avoidable injury – for example, the patient with bone metastases from cancer, the patient hospitalized after multiple trauma, the patient with chronic arthritis, or the patient recovering from a knee replacement surgery. In those situations, the pain nerves just keep firing away and there is nothing that the person can do by themself to make those nerves stop.

But there is a lot more to the perception of pain than just signal from a peripheral nerve. There are pain amplifiers that can turn the volume of pain up. The most important of these are fear, anxiety, and depression. Often, the presence of one of these modifiers can convert tolerable pain into intolerable pain.

What pain management services does the hospital need?

Comprehensive pain management does not boil down to having a single pain management service. Hospitals need to have a spectrum of options for treating pain in order to do the most good for the most people. All too often, the physicians or advance practice providers who are proficient with one type of pain management option are not proficient with other options.

  1. Acute pain services. These are inpatient providers, frequently anesthesiologists, nurse anesthetists, pharmacists, and/or nurse practitioners. These providers are very good at managing temporary pain, particularly post-operative pain and trauma-related pain. They will have experience in managing pain pumps and in selecting opioid and non-opioid pain medications that are meant to be used for limited numbers of hours or days. A larger hospital can afford to maintain an acute pain service but the low patient volume at a smaller hospital may make an acute pain management service cost-prohibitive. In order to serve our smaller, urban hospital, we created an acute pain telemedicine consultation service with providers located at our larger, tertiary care hospital located on the other side of town.
  2. Pain and palliative care services. These are providers who may work in either inpatient or outpatient areas and typically focus more on chronic pain management. They are usually physicians who have completed a palliative medicine fellowship who lead a team that may include nurse practitioners, physician assistants, pharmacists, and social workers. Cancer-related pain and sickle cell anemia-related pain are examples of their clinical focus. Although chronic opioid prescription may be a part of their practice, they will also typically address pain modifiers, such as fear and depression.
  3. Interventional pain services. These are physicians who have done fellowship training in interventional pain management and most commonly draw from anesthesiology, physical medicine & rehabilitation, and neurology. Their practice is generally outpatient and many include steroid injections, radiofrequency ablation, intrathecal pumps, sympathetic blocks, peripheral nerve stimulators, and spinal stimulators. They will often interface with outpatient therapies such as physical therapy, aqua therapy, and psychology. The procedures that they perform often require use of the operating room or an imaging area such as a cath lab or interventional radiology lab. Many of their procedures are done using moderate sedation but some may require general anesthesia.
  4. Sports medicine. These are family physicians, internists, or pediatricians who have done fellowship training in sports-related injuries and over-use injuries. Despite the name, sports medicine physicians treat many patients who are not athletes. They will often interface with physical therapists, athletic trainers, and orthopedic surgeons when directing specific treatments for injuries accompanied by pain.
  5. Complementary and alternative medicine. This includes a wide variety of services such as acupuncture, massage therapy, chiropractic treatments, yoga, and traditional Chinese medicine. Although physicians may be involved in alternative medicine, many of these providers are non-physicians. Many hospital medical directors take a jaded view of alternative medicine. However, these services can often de-amplify pain by reducing anxiety and fear. They can also provide a sense of control to patients with chronic pain that can make pain much more manageable. Regardless of what the hospital medical director may think, if the patient believes that these services work, then they can be beneficial.
  6. Inpatient physicians. Hospitalists, surgeons, and anesthesiologists are the first-line of pain management for most inpatients. However, the formal training that they get in pain management is highly variable. Clinical practice guidelines and treatment protocols can be very useful to ensure a hospital-wide standard of practice. Periodic continuing medical education events are also valuable. One of the most important roles of these physicians is to manage pain expectations. If patients are told that they are going to have post-operative pain before they actually have their surgery and they are told that their pain will be manageable with non-steroidal anti-inflammatory drugs and physical therapy, then those patients are less likely to require opioids post-operatively compared to patients who go into surgery unprepared to experience any pain after surgery.
  7. Outpatient physicians. Primary care physicians, surgeons, and emergency medicine physicians are the front-line of pain management for most outpatients. Once again, their formal training in pain management can be highly variable and so just as for inpatient physicians, clinical practice guidelines, treatment protocols, and periodic continuing medical education are usually necessary. Most state medical boards have state-specific rules and regulations regarding chronic opioid prescription and  it can be very difficult for the primary care physician to ensure that all of the monitoring and documentation requirements are met. A robust electronic medical record can help with this. But if there is a critical mass of patients receiving chronic opioid medications, an advanced practice provider dedicated to chronic, stable-dose opioid management can be cost-effective.

In addition to pain services that manage a spectrum of conditions, there are also disease-specific specialists needed to manage certain conditions. Migraine (often managed by neurologists) and fibromyalgia (often managed by rheumatologists) are two examples. Having a physician on the hospital medical staff who specializes in these conditions can help avoid primary care physicians ordering opioids out of frustration.

Match the patient with the pain service

Although there is frequently a lot of overlap between different types of pain services, to optimally meet the needs of the most patients, all seven of the above pain services need to be available – if not in each hospital, then at least somewhere in the community. No two patients are exactly alike when it comes to pain tolerance and pain perception. Treating fibromyalgia with chronic opioids just doesn’t work. Nor does bone metastasis pain with physical therapy. We should strive to match the patient’s type of pain with the right type of pain service.

Our natural tendency as humans is to use whatever tool we are familiar with to fix whatever problem we face (“When all you have is a hammer, everything looks like a nail”). When it comes to pain management, be sure that your hospital has a full toolbox.

February 19, 2022