7 minute read
VACCINE ETHICS
BY JULIE JANEWAY,
associate principal, Foley, Baron, Metzger and Juip, PLLC
IN THE AGE OF COVID-19
The public clamor for vaccine access is causing ethical, and in some cases legal, issues that the vast majority of medical community members have never seen. Every year, we work through those who are eager, hesitant or even outright resistant to flu vaccines, regular childhood immunizations or immunizations required for employment, military service and more. But this is different. Pharmacists are again being called upon (and happily, willingly stepping up) to facilitate a public COVID-19 immunization campaign. This is the largest such effort in American history, with more people needing a vaccine than has ever before been experienced.
Simple economic theory tells us that when the supply of a needed commodity is limited, demand increases, and COVID-19 vaccines are the hottest commodity around.1 That means those who have control of these scarce resources have a sort of power over who gets access to the needed commodity. Limiting this discussion to pharmacy professionals, most don’t even recognize such power, but some are acutely aware and choose to use it to unethical or even illegal ends. The most infamous of examples involves the Wisconsin pharmacist who made the unilateral decision to destroy hundreds of doses of vaccines meant for his medical frontline coworkers because of his personal beliefs about its effects and the nefarious objectives of the pharmaceutical industry. Leaving his beliefs aside, this pharmacy “professional” made a decision for hundreds of other people about whether or not they received at least some level of protection from a danger they were facing on a daily basis. He took not only that personal decision from each and every worker, but he appropriated it for himself – the most unethical of decisions. That pharmacist didn’t just take away personal control, he took away hope and possibly life. Pharmacists, pharmacy technicians and student pharmacists have been on the front lines since the beginning of this pandemic and know first-hand the sense of powerlessness and the loss of control felt by so many they serve and serve beside. It is in the face of this that the morality, ethics and law related to vaccine administration have become so relevant. Morality concerns what an individual believes is right and wrong.2 Ethics is adherence to a code of conduct or behavior. 3 American author and philosopher Aldo Leopold told us that “ethical behavior is doing the right thing when you know no one else is watching – even when doing the wrong thing is perfectly legal.”4 Ethical behavior is even harder when one is making decisions about allocating a scarce resource among so many people who need it. In the case of pandemic-related medical treatment and vaccines, prioritizing who gets it and when has been an excruciating exercise. We should all be glad if we were not called upon to make such monumental decisions. Pharmacists didn’t think they would have to make them – until they started making appointments and telling people they weren’t yet “eligible,” or deciding between precious vaccines going to waste or calling whoever they could just to make sure those doses went in arms. Turning away vulnerable, desperate people is painful. And making that pain go away can lead to some unethical decisions, often colored by individual morality. For example, say a pharmacist, pharmacy technician or another pharmacy employee decides to fill appointments with their personal friends and family members, thereby failing to offer the appointments to the pharmacy’s eligible patients and community members first. Even if the family and friends were eligible (and it is a whole different story if they weren’t), the pharmacist has an ethical and legal fiduciary duty to the patients of the pharmacy to act in their best interests, not in the pharmacist’s own or those of their friends. Similarly, under the law of agency, the pharmacist is also responsible for the acts of those who assist the pharmacist and has a duty to supervise such individuals. The pharmacist is legally responsible for their actions as well, and if they break the law (even if it is a temporary law), the pharmacist is legally responsible.5 A situation like this can have multiple variants. What if I fill all the appointments with people I think should have the shots, because I think they are sicker than other eligible people? These are decisions that medical ethicists, public health officials, physicians, researchers and other qualified people have made for the good of our state and communities. Do not unilaterally second-guess that structure, because you may not be privy to the bigger algorithm in which that structure resides. What if the eligible
family or friends who are called first are patients of the pharmacy? Okay, and so much the better. Schedule away. What constitutes being a patient of the pharmacy? Prescriptions filled designate a patient of the pharmacy, not items bought in the store in which the pharmacy occupies space. The word patient means a person who is ill or undergoing treatment for a medical condition or disease.6 There is a legal relationship established with a pharmacist because the pharmacist has reviewed, checked and filled the medication that will comprise some or all of the treatment for the patient, and the patient has acted in reliance.7 Many independent pharmacies are in an ethical quandary about getting involved with the vaccine program – not because they are unwilling to do their part, but financial and staffing issues may make it unfeasible. Conversely, pharmacies may face criticism and backlash for not participating in the vaccine program. It is a complex ethical conundrum. I have no advice other than to hunt for alternative resources for your patients if participating in the vaccine effort is not a possibility. Make those resources as widely available as possible. Perhaps work with another pharmacy or administration site, but try and do something to let your patients and community know you are not just abandoning them because you don’t care. Communication and transparency are key. Also included in the vaccine participation decision-tree are the issues of data reporting, employee training, state and federal certifications, and building or integrating the necessary data and computer infrastructure. The integration of pharmacy systems and software with government reporting and tracking software can be a challenge, as well the fact that somebody has to do the tracking. On the issue of data reporting, it is important that it be honest, accurate and complete with regard to race and ethnicity data. It may be tempting to report more ethnic or minority vaccinees than may have actually been administered to improve statistics, especially in communities that may have a reputation for being less than equitable. It may also be tempting for some to exclude the race and ethnicity of vaccinees entirely. In all instances: wrong, unethical and illegal. These are medical records,8 even if they are not in an individual’s personal medical record with their physician or hospital. The records may violate state and federal laws if they are intentionally altered or an individual intentionally leaves out the data required to be reported to the state or any other agency.9 While this may be stating the obvious, do not “fake” patients, if doses had to be wasted, in order to seek reimbursement. That is federal program fraud, healthcare fraud, a violation of the state and federal false claims acts, and wire or mail fraud. And don’t lie or try to cover it up either (words to live by about every transgression or violation). Also, maintain robust security and inventory control systems to prevent anyone from purloining vaccine and selling it on the side. That would be a viper’s nest of legal problems that no one wants to encounter. Finally, here are some additional legal issues to consider: • Every person you are administering a vaccine to is now a patient of the pharmacy. You are responsible for: - Ensuring patients of the pharmacy have up-to-date allergy and interaction information on file that is checked before administration of the dose. - Ensuring that social distancing is maintained at all times. - Documenting and properly reporting the administration of the vaccines and any other required information or data. - Proper post-administration observation for any reactions to the vaccine for the appropriate recommended timeframe. - Ensuring that second-dose appointments are made and reminders provided by some preferred method. • Store, thaw and use all vaccine properly and in compliance with all CDC and manufacturer requirements and guidelines. • Properly dispose of remaining amounts or expired/improperlystored doses, and document waste fully. • Until the CDC approves pooling remaining amounts of vaccine in vials, you cannot pool. In the event something goes wrong and a patient sues, you will want the federal immunity provided under the Public Readiness and Emergency Preparedness (PREP) Act, so comply fully with all requirements of the vaccine administration program to ensure that it will cover you in the event you need it.
References available upon request from the MPA office.
