Lack of Vaccination Coverage in the Medical Office

This week a patient, going on a foreign trip, was required to fill out a vaccination and immunization record to obtain a visa. To his dismay he discovered his records were not available. On further questioning he realized his vaccinations were done at retail clinics and pharmacies up and down the Eastern seaboard. Yes, he had requested a record of the vaccination be sent to the office but it never arrived.

I am a firm believer in the recommendation of the CDC, American College of Physicians and Advisory Council on Immunization Practices. Their literature is displayed in my office and available as a resource to my patients. I find it abhorrent that CMS, through its Medicare Part D program, will pay for the shingles shots (Zostavax and Shingrix) and the pneumonia series (Prevnar 13 and Pneumovax 23) at the pharmacy but not at a doctor’s office. The pharmacies use these vaccinations as loss leaders to get individuals into the store hoping that they will buy additional items while there.

As a general internist and practitioner of adult medicine, I too use these vaccinations as a “loss leader.” When patients call for a vaccination and have not been seen in a long while we encourage an appointment. We check on prevention items recommended by the ACP. the AAFP and the USPTF and make sure the patients are current on mammograms, HPV or Pap testing, colonoscopies, eye exams, hearing evaluations, skin and body checkups and other essential health items. We make little or no money on vaccinations or immunizations but like the idea that once a patient is here we can provide a gentle reminder about those health tasks we all need to follow up on with some regularity.

I like the idea of making vaccinations and immunizations more convenient for patients. I just believe the same payment should be made if the patient is in your office or in the pharmacy. In addition, the law should require the pharmacy to send a record of the vaccination to the patient’s physician so we can have immunization records readily available.

The ACP, AMA, American College of Physicians and American Academy of Family Practitioners should be using their influence to encourage the Center for Medicare Services (CMS) to pay for these vaccines in doctors’ offices as well as in pharmacies and retail clinics. If encouragement doesn’t work then legal action is appropriate.

More on Shingrix, the Shingles Vaccine

Recently, the FDA approved a new shingles vaccine called Shingrix. It is a two shot series with the suggestion made that the second shot should be taken 2 – 6 months after the first one. Shingrix will replace the original shingles vaccine Zostavax. Shingrix is recommended in all patients over 50 years old.

For those of you who have had the original shot, Zostavax, the new vaccine is still recommended. It is covered by Medicare Part D which means you must take it in a pharmacy or walk in center not in your doctor’s office. While this makes NO sense, it is the rule. If you have had shingles it is still recommended you take the new vaccine (Shingrix).

Shingles is a skin rash and painful skin condition caused by the chicken pox virus Varicella. When you have chicken pox and complete the infection course you are immune but the virus remains alive forever, living in sensory nerve endings along the spinal cord. One third of adults will have an outbreak of this varicella virus which will appear along the path of a sensory nerve or dermatome on one side of your body. It will go through the full cycle of rash, pustule and then scab that the chicken pox did. A significant number of patients will continue to have pain over the involved skin for prolonged time periods in what we call post herpetic neuralgia. The pain is described as severe as an eye scrape, passing a kidney stone or going through labor and delivery.

The original shingles vaccine, Zostavax, protected against the rash 51% of the time and against post herpetic neuralgia 67% of the time. This efficacy dropped to about 30% after four years. The new vaccine, Shingrix protects against the rash over 90% of the time and against the pain syndrome 85-90% of the time while lasting for more than four years.

Only five percent (5%) of patients receiving Shingrix develop side effects. The most common are fever, myalgia and chills. In view of this, I am suggesting to my patients we allow the vaccine to be on the U.S. market for a year to see the adverse event profile and, if safe, we then start the series of shots.

New Non Live Shingles Vaccine Approved by FDA and ACIP

For several years the Advisory Committee on Immunization Practices (ACIP) has been encouraging adults to receive the shingles vaccine or Zostavax. Shingles is a recurrence of chicken pox which we had as children. The virus lives within the nerve endings near the spinal cord and recurs following sensory nerves at unexpected times producing a chicken pox like (herpetic) rash with pain on one side of your body. The lesions follow the pattern of the chicken pox with pustules crusting over the course of a week. During the rash, patients are contagious and can transmit the chicken pox virus to people not immunized against it or those people whose immunity is diminished. As the rash subsides, a large percentage of the patients continue to have pain along the path of that sensory nerve which can last forever in a post herpetic neuralgia.

Zostavax will prevent an outbreak of shingles in about 2/3 of those who receive the shot. It prevents the post rash pain syndrome in a much higher percentage of the recipients. It was this quality that made it easy for me to recommend the vaccine to my patients and to take it myself.

The shot’s major drawback was that it involved receiving an attenuated or modulated live virus. This prevented individuals on chemotherapy or with a weakened immune system from receiving this vaccine.

To address that issue Glaxo Smith Kline developed Shingrix which is a non-live, recombinant subunit vaccine injected into the muscle on two occasions. It is touted to prevent shingles in 90% of the recipients over a four year period. It will replace Zostavax as the shingles vaccine of choice. For those of us who already received Zostavax they are recommending that we boost our immunity by receiving this new vaccine as well.

I have always been quite conservative on recommending new pharmaceutical products until they have been on the US market for at least one year. With the decreased funding of the FDA, I will wait at least a year until I see what adverse reactions occur in the US population. In the meantime I will price the product and try and learn if private insurers and/or Medicare will pay for its administration.

Pharmacies, Vaccinations and Health Benchmarking

The state legislature in Florida decided it is legal and appropriate for pharmacists and pharmacies to begin administering vaccines against multiple diseases.  Their list of adult vaccines includes seasonal flu shots, pneumovax (pneumonia vaccine) and zostavax (vaccine to prevent shingles).  The rationale of the legislature is that access to doctors to receive these preventive vaccines is limited and difficult.

By refusing to administer vaccines in their office because it is time consuming and not profitable enough, my colleagues in primary care have not made my argument against permitting this any stronger. I thought prevention and administering vaccines was part of the job description in primary care.  I am not asking my colleagues to lose money, but I do believe there is a distinct difference between not making a large profit and losing money.  Isn’t it our professional and ethical responsibility to provide preventive services?

Over the years, the fall season and start of the school year have always provided an opportunity to remind patients that they were due for an annual checkup and to make positive suggestions on what other opportunities were available for them to try and prevent infectious or chronic disease. School-age children have been required to receive immunizations before entering school for obvious public health reasons.  This provides an opportunity to benchmark their growth and age goals and discuss healthy living as well. The visits came towards the end of the calendar year when most individuals had met their annual medical deductible so the out of pocket costs were not great.

As I walk into my local CVS I am confronted by ads for vaccines and same-day clinics. They remind me that physicians have lost this encounter to enhance the doctor/patient relationship and provide sound health advice for the future because administering vaccines isn’t very profitable.  Pharmacies often use vaccinations as a loss-leader to draw you in and get you to purchase other, more profitable, items.

I will continue to provide vaccines in my internal medicine office as I believe it is the professional and responsible thing to do.

Flu Shot Campaign Begins

As school bells ring out announcing a new school year and pigskins fly through the air announcing the arrival of a new football season, the Center for Disease Control and Prevention (“CDC”) begins its annual influenza vaccine campaign.  “Flu” or influenza is a viral illness associated with fever, severe muscle aches, general malaise and respiratory symptoms.  Most healthy children and adults can run a fever for 5 – 7 days and fight off the infection over a 10 day to three week period.  There is clearly a long period of malaise and debilitation in many that lasts for weeks after the acute febrile illness resolves.

The illness is especially severe and often lethal in the elderly, in infants, in patients with asthma and chronic lung disease and in those patients who have a weakened immune system due to disease or cancer treatments. Diabetics and heart patients are particularly vulnerable to the lethal effects of unchecked influenza.

The CDC recommends vaccinating all Americans over six years old against influenza.  Adults can receive an injection, or a nasal application.  The 2012 – 2013 vaccine has been updated from the 2011 – 2012 version based on samplings of current influenza viruses spreading around the world.   It takes about two weeks to develop antibodies and immunity to influenza after you receive the vaccination.  If you received the vaccine last season or had the flu last season you are still advised to receive the 2012 – 2013 vaccine this year because immunity fades with time.  Flu vaccine should have arrived in most physician offices and community health centers and pharmacies by mid- August.  The CDC advises taking the shot as soon as it is available.

The vaccines used are not live viruses so one cannot catch the flu from the vaccine. Side effects usually include warmth and tenderness at the injection site and rarely general malaise and low grade fever a day or so later.  The benefits of receiving the vaccine far outweigh these minor and rare ill effects which can be treated with an ice pack to the injection site and some acetaminophen.  Please call your doctor to set up an appointment for a flu vaccine.

For those individuals who catch the flu we still have several antiviral agents available to treat the illness. These agents should decrease the intensity or severity and duration of the flu. We try to use these medicines as infrequently as possible because the flu can develop resistance to them over time.

Prevention of disease is an ever increasing component of our everyday language. Vaccination against an infectious disease such as flu or influenza is clearly one of the more effective preventive strategies physicians have available to offer patients.  While you are making arrangements to receive your flu shot inquire about several other effective adult vaccines including Pneumovax to prevent bacterial pneumonia, Zostavax to prevent shingles and post herpetic neuralgia and Tdap to prevent whooping cough or pertussis and tetanus.