Pharmacist Vaccinators: Review of the Issues and Liability Risks

James L. Lindon, PharmD, PhD, JD

Disclosures

May 21, 2014

Question

What are the liability risks for pharmacists who perform vaccinations?

Response from James L. Lindon, PharmD, PhD, JD
Pharmacy Law Attorney, Lindon & Lindon, LLC, Cleveland, Ohio

All 50 states allow vaccinations to be administered by pharmacists.[1] In general, pharmacists must meet training requirements to be certified to administer immunizations and must perform record-keeping requirements. States vary regarding the ages of patients pharmacists are allowed to vaccinate, types of vaccines pharmacists are able to administer, and whether pharmacists can prescribe immunizations or must administer vaccines under protocol.[2]

Physician reaction to widespread use of pharmacist-performed vaccinations is mixed. A recent survey by Hurley and colleagues found that one third of primary care physicians have concerns regarding pharmacist vaccinators.[3] In 2011, physicians and local health directors in North Carolina opposed bills allowing for the expansion of pharmacist immunization authority. Concerns included[4]:

  • Fragmentation of medical care;

  • Inadequacy of pharmacist training;

  • Removal of necessary screening, interventions, and discussions that occur during primary care visits; and

  • Increased patient health risks from "erosion" of physician scope of practice.

However, many associations, such as the Centers for Disease Control and Prevention and the US Department of Health and Human Services, have positive positions regarding pharmacists as vaccine providers and encourage pharmacists to promote and provide vaccinations.[5]

Vaccines are big business. In April 2014, Novartis sold the majority of its vaccine division to GlaxoSmithKline for $7.1 billion.[6] And, not surprisingly, the vaccine business has a significant history of legal issues. In the 1970s, legal decisions and damages against vaccine manufacturers occurred, despite supporting scientific evidence, on behalf of patients claiming injury from the diphtheria, pertussis, tetanus (DPT) vaccine. These lawsuits caused increases in liability and prices, and manufacturers halted production, resulting in vaccine shortages. In order to curtail the risk for endemic disease, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986 to reduce liability and address concerns of the public. The National Vaccine Injury Compensation Program (NVICP), created under the NCVIA, is a "no-fault" compensation program that allows those injured by vaccines to obtain compensation from a fund created by an excise tax on each vaccine dose.[7] The Act states that vaccine manufacturers could not be liable for "unavoidable, adverse side effects."[8]

The American Medical Association has been critical of lawsuits concerning vaccines and supportive of use of vaccinations by physicians.[9] The NCVIA established a committee from the Institute of Medicine to review the literature on adverse effects associated with vaccines.[7] Still, the NCVIA faced legal challenges. Whatever the merits of the litigation, by the end of 1984, only 1 US company still manufactured the DPT vaccine. Other vaccines were facing the prospects of similar scarcity. Still, critics of vaccine law properly point out that removing all legal consequences of producing "defective" products vitiates powerful incentives to make those products as safe as reasonably possible -- and may even promote manufacturer recklessness, at least in theory.[9]

These important legal issues reached the desk of the highest court in the land. In 2011, the US Supreme Court refused to hear appeals on a case that legally upheld a requirement for mandatory vaccinations by a public school district in West Virginia challenged by a mother with religious objections and a physician's note for her child.[10] Also in 2011, the Supreme Court decided in favor of the vaccine manufacturer in Bruesewitz v. Wyeth, a lawsuit claiming that Wyeth was negligent in updating its DPT vaccine, resulting in avoidable harm.[8]

Though such legal shields are in place, it would be improper to conclude that there is absolutely no possibility of professional liability in vaccination programs. The Bruesewitz case provides legal protection for producers of allegedly defective vaccines and protects against probing litigation into whether a safer vaccine might have been possible.

The Bruesewitz case would appear to leave a vaccinated patient able to sue if, for example, the vaccination was administered improperly by a pharmacist. Where the pharmacist does not use "ordinary care" to avoid giving an intramuscular vaccination intravenously, an actionable tort may occur. Likewise, where the pharmacist does not use "ordinary care" to ascertain if a patient had an allergy to eggs before administering selected vaccines, there may also be liability. Such causes of action are not directed to a possible defect of the vaccine itself but to the professional care in administration.

As pharmacist scope of practice broadens, it's likely that the risk for liability will increase. When there are more patients being vaccinated, certain costs and certain benefits will almost surely rise as well. To reduce risks, pharmacists and all persons involved in the vaccination process should be as well trained as possible. For those misadventures that are unfortunately bound to happen, professional liability coverage (also known as errors and omissions insurance) is available.

Check your policy to see whether participation in a vaccination program is an exclusion. A so-called umbrella policy or coverage by a deeper-pocketed employer may also provide legal protection. Pharmacists should also make an extra effort to establish rapport with local physicians, nurse practitioners, and physician assistants in the event that medical cooperation is desired. A team approach is good for all concerned.

As pharmacist vaccinators are sharing this important role with other healthcare professionals, they should consider improving communication with all members of the team. Hurley and colleagues[3] found that primary care physicians consider communication from alternative prescribers to be unsatisfactory. As the electronic medical record continues to advance, stage 2 of meaningful use for hospitals and eligible providers includes a standard for reporting immunizations to a registry or database.[11] This will eventually help all locations where physicians and healthcare teams access and evaluate a medical history to provide treatment.

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