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.