State vaccination requirements have been in the news a lot recently with the latest U.S. measles outbreak originating in Disneyland in California. The MBA Health Law Section Council wanted to get the conversation started about vaccines by reposting an article written by Section Council member Josephine Babiarz in 2013 about mandatory flu vaccinations for medical staff. It is noted that there are significant differences between this inquiry into flu shots and proven, high efficacy vaccines which eradicate diseases such as measles.
Attached to the bottom of this blog in the related resources section are links to articles related to this latest measles outbreak, a link to the California School Immunization Law that has been a hot topic recently, a link to the Massachusetts laws on vaccinations and immunizations, and a link to a map of the United States showing the types of exemptions permitted by each state in their school immunization requirements. This blog post and related resources are meant to kick start a discussion about the current vaccine issues and potential need for intervention. Please feel free post your thoughts about this issue in the comments section.
By Josephine C. Babiarz
The current flu epidemic, with the attendant state of medical emergency, reminds us of the critical role of hospitals and staff in protecting public health. News reports describe the overwhelmed hospital resources, from the numbers seeking emergency assistance and the reduced hospital staff, who are themselves suffering from the flu. These developments shed even more glaring light on recent protests reported in the media, by hospital nurses refusing mandatory immunization as well as wearing protective masks as a barrier to disease transmission. Hospital administrators must continue to enforce the immunization policy; it is a significant and appropriate measure to protect patients, the public and in fact, other staff, from substandard practices. Immunization and regular testing of hospital staff for contagious disease is well established as the standard of care in today's hospitals. Massachusetts hospitals must provide the vaccines to staff free of charge.1 To ignore these standards, or claim they are not necessary, is to return the health care system to the days of "Typhoid Mary," a prospect which no one welcomes.
These immunization policies are required on both the federal and state levels. The United States government, still the standard bearer for global health, through the Food and Drug Administration, the Centers for Disease Control and the National Institutes of Health, along with the World Health Organization and innumerable other well-recognized international agencies, have all recognized how invaluable vaccination can be. Preventing a disease or an outbreak is simply preferable to treating it when it arrives.
There are persons for whom immunization is counter-indicated -- a small minority for whom the benefits of the vaccination are outweighed by imminent risks to the patient -- those individuals who have an allergy to the ingredients in the vaccine, those receiving chemotherapy, those who have had an organ transplant and the like. For the vast majority of individuals, particularly those in the "vulnerable" group -- those over 60 and under 18, or those with chronic conditions such as asthma and diabetes, the value of the immunizations far outweighs the risks.
Additionally, there is a long-standing recognition that hospitalization is the third leading cause of death in the United States. This statistic does not refer to deaths which are the expected outcome of disease or trauma and reflect the diagnosis or condition for which the patient was admitted. The statistic refers instead to iatrogenic disease -- disease that is actually caused by or due to medical treatment. High on the list of iatrogenic disease is nosocomial infection, which refers to infections transmitted to patients already in the hospital.2 These findings provide more than adequate support for the guidelines found in the State Operations Manual. This manual, published by Centers for Medicare and Medicaid Services, governs facilities receiving Medicare and Medicaid funds. CMS, through the manual, requires hospital administrators to evaluate staff for immunization status for designated infectious disease, develop policies to screen staff for infections likely to cause significant infectious disease or other risks, and also to develop policies stating when infected staff are restricted from providing direct patient care or required to remain away from the facility entirely.3 Since absences can disrupt patient care, preventative measures including immunization, become more important.
The commonwealth has clearly articulated policies on vaccination of healthcare personnel. The Massachusetts regulations require that personnel be vaccinated, whether working in hospitals, clinics, or long-term care facilities.4 Massachusetts hospitals are required to provide or arrange for vaccination at no cost to any personnel, as noted above. There are allowed exceptions to the vaccine, where it is medically contraindicated, is against the individual's religious beliefs, or if the individual declines the vaccine, and in the case of refusal, the individual must acknowledge in writing the consequences of such refusal.5 The mandate does not violate individual sovereignty, but does require a hospital take appropriate alternate measures to protect staff, patients and the public.
Operating within the inoculation guidelines, medical staff is the group most qualified to assess the benefits and risk of any particular medication, including vaccines, for either the public at large or for any specific individual. All medication approved by the FDA is accompanied by the required labeling which is written for the prescribing practitioner, not the patient. Labels contain at a minimum, the risks, benefits, counterindications, and all other relevant information which guide the prescriber in determining whether or not a product is appropriate for a patient. For those administering the medication, and not prescribing, the label still has value, because it alerts the nurse or pharmacist administering the dose to potential risks and side effects. All medical practitioners are expected to report to FDA any irregularities in the medication container, its color, and any adverse event or problem experienced by the patient for follow up.
The progress made in fighting infectious diseases, the on-going challenges in protecting hospitalized patients from adventitious diseases and the continuing quest for improvement in the US health care system require nothing less than universal and aggressive health care standards for medical professionals. These requirements are, in the author's opinion, among the most appropriate means to protect patients, medical staff and the public at large.
2Starfield, Barbara MD, MPH. "Is US Health Really the Best in the World?" JAMA 2000; Vol. 284 No. 4: 483-485; See also Grisanti, Ronald, D.C., D.A.B.C.O.; MS, Iatrogenic Disease: The Third Most Fatal Disease in the US, at www.yourmedicaldective.com/public/335.cfm; accessed Dec. 11, 2012.
3See http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf at pg 150ff; accessed Dec.11, 2012.
4See 105 CMR Secs 130, 140 and 150 respectively.
5105 CMR 130.325(F).
Josephine Babiarz is a member of the MBA Health Law Section Council. She is solely responsible for the views expressed in this article.