key: cord-353872-hajtlw9k
authors: Cox, Shereen
title: To dispense or not to dispense: Lessons to be learnt from ethical challenges faced by pharmacists in the COVID‐19 pandemic
date: 2020-08-25
journal: Dev World Bioeth
DOI: 10.1111/dewb.12284
sha: 
doc_id: 353872
cord_uid: hajtlw9k

The year 2020 is facing one of the worst public health situations in decades. The world is experiencing a pandemic that has triggered significant challenges to healthcare systems in both high and low‐middle income countries (LMICs). Government policymakers and healthcare personnel are experiencing real‐life ethical dilemmas and are pressed to respond to these situations. Many possible treatments are being investigated, one of which is the use of hydroxychloroquine or chloroquine. These drugs are approved for use by patients with systemic lupus erythematosus (SLE), rheumatoid arthritis, and malaria. The demand for these products has increased, and the stocks are depleting for the patient population for whom the drugs are intended initially. Although both innovator and generic pharmaceutical manufacturers are making plans for increased production, there are challenges with global supply chains disruption and the retention of supplies for local markets. This may cause countries that rely on the importation of pharmaceuticals to be out of stock of supplies for an extended period. There are allegations of off‐label prescribing and hoarding. Pharmacists are the custodians and dispensers of medications and are faced with the task of assessing prescriptions and making decisions about the allocation of these products. This paper seeks to 1) highlight some of the ethical challenges of dispensing hydroxychloroquine by pharmacists during the COVID‐19 pandemic, 2) identify some of the responses to these issues from various regulatory authorities in the USA, and 3) recommend approaches to assist pharmacists in their decision‐making process, especially in LMICs.

hydroxychloroquine/chloroquine in COVID-19 patients. 9

Subsequent trials, however, have yielded preliminary results that indicate the drugs did not benefit COVID-19 patients, but may, in fact, cause harm. 10 One of these studies, an observational study based on the health records of almost 100,000 patients around the world and published in the Lancet recently, 11 indicated that hydroxychloroquine had a sharply higher risk of death and heart problems in patients compared to those who did not receive the drug and that it did not provide a benefit. This study was, however, retracted by the authors on June 4, 2020 due to doubts about the veracity of the data used and the analyses conducted. 12 Another study with healthy individuals, published in the New England Journal of Medicine on June 3, 2020 found that taking hydroxychloroquine after high-risk or moderate-risk exposure to SARS-CoV-2 did not prevent illness. 13 Prior to the emergency approval, community pharmacists observed a surge in prescriptions for hydroxychloroquine resulting in shortages in both high and low-middle income countries (LMIC). 14, 15, 16 To further complicate the matter, one of the largest generic suppliers of hydroxychloroquine to LMICs, India, decided to put an export ban on the product, which they withdrew shortly after, but this created a disruption in the global supply chain, particularly affecting

LMICs. 17 The experience of dispensing hydroxychloroquine for the treatment of COVID-19 highlighted ethical issues that may have generated moral distress among some pharmacists due to the uncertainties regarding the drug. Some pharmacists may not wish to dispense, while others support "a right to try" even in the outpatient | 3 COX setting. 18, 19 The initial outcry regarding hydroxychloroquine by pharmacists was due to concerns regarding 1) shortage of medication for regular patients suffering from serious chronic diseases such as systemic lupus erythematosus (SLE), malaria and rheumatoid arthritis (RA), 2) misuse and hoarding of drugs through physician prescribing for self and loved ones, and 3) prescribing in response to patient demand. 20 What will be the consequences of refusal? How will her/his refusal affect the relationship with the physician, the patient, and the business? To adequately respond to these questions of an ethico-legal nature, the pharmacist must be guided by law, professional Codes of Ethics, and an evidence-based standard of practice. This paper will address the concerns by examining recent policies, position statements, and responses of professional boards and associations, drug regulatory agencies, and the application of ethical principles to assist pharmacists in their decision-making process.

The pursuit of the right medicine for the treatment of any disease is hinged on the core ethical principles of beneficence (acting to ben- Hence the moral conundrum of to dispense or not dispense continues.

Clinical practice remains the remit of the clinician, and when a drug is prescribed by a clinician, it is usually based on the premise that the clinician is acting in the best interests of the patient. Contemplating this obligation, to achieve equity and justice, the pharmacist may need to apply a risk-benefit assessment to help guide in the decision-making process. 40 There are several possible risks in this situation: 1) perceived risk of harm by preventing the SARS-CoV-2 positive patient from receiving medicine that could improve health, 2) perceived risk of harm to the SARS-CoV-2 positive patient due to adverse effects from an unproven medicine, and 3) potential risk of harm to the patients with SLE and RA who cannot access their usual medicines because of shortages. The potential benefits would be the respective patient groups accessing the medications and overall improvement of health. If the first risk is considered plausible and the pharmacist decides to cooperate with the physician and dispense to the COVID-19 patient, one can assert that the pharmacist assumes a beneficent role, which is a duty to support the treatment decision of the physician by dispensing the medicine to the patient. 41 In this context, the duty would be to dispense, albeit off-label. 42 However, as The Board of Pharmacy in Vermont advised their pharmacists to use an "enhanced DUR" to dispense hydroxychloroquine. 51 The DUR could be submitted as a policy response to the misuse of hydroxychloroquine in institutional settings such as government hospitals because of the overarching goal of:

"improving the quality of care for patients, individually and as populations, by striving to prevent the use of unnecessary or inappropriate drug therapy, prevent adverse drug reactions and improve overall drug effectiveness". 52

Governments and local pharmacy groups in LMICs may be able to decide on a DUR policy for in-demand medications during epidemics in their countries to guide pharmacists on judiciously dispensing to prevent panic prescribing, off-label use, and hoarding of these drugs.

However, a policy is only as good as the extent to which there is compliance. If similar policies regarding indication-based prescribing or enhanced DUR are adopted, there is another challenge to be ad- 

As the global demand for these drugs increases during the COVID pandemic, pharmacists are faced with another issue of managing resources during a period where demand exceeds supply. 59 Certainly, the effects of the global demand will be felt much greater and for much longer in LMICs. This is primarily because these countries rely on the importation of these drugs. Some innovator and generic companies in the USA and Europe are making commitments to boost production; however, these will be relevant only for those countries in which they already have existing marketing authorizations. 60 

Lisa Tessman, in a recently published paper on moral distress in healthcare, presents a compelling argument that there is a place for reflection and personal growth when a medical practitioner experiences moral distress. 64 Her adopted definition of moral distress as "one or more negative self-directed emotions or attitudes that arise in response to one's perceived involvement in a situation that one perceives to be morally undesirable" is suitable to describe the situation faced by pharmacists during the COVID-19 pandemic. 65 The plethora of uncertainties surrounding the acceptability of hydroxychloroquine in the treatment of COVID-19, coupled with shortages associated with over-prescribing and misuse, has created a morally undesirable situation for community pharmacists. While two of the most influential regulatory agencies, the US FDA and the EMA issued emergency use orders for hospitalized patients and clinical trial use only, off-label prescribing remains a concern. 66 issued a joint statement calling for the prescribing of a medication to be for "legitimate medical reasons" that is based on "evidence-based science" which would strengthen the decision to refuse to dispense. 68 However, a survey organized by the National Community Pharmacy Association (NCPA), a US pharmacy owners' association, identified that the majority of community pharmacists support 59 dispensing hydroxychloroquine. 69 It was not clear whether the pharmacists in this survey were also owners as this presented additional consideration of whether the financial implications of not dispensing the drug influenced their opinion. Pharmacists also faced challenges of inter-professional conflicts with physicians, warnings of professional misconduct, and the lack of consensus from regulators. It would be important to explore whether the COVID-19 pandemic situation has affected community pharmacists in terms of moral distress and the associated challenges outlined in this paper. The reflective aspect when one experiences moral distress helps to guide the moral agent in how she/he conducts her/himself in future scenarios.

In their recommendation to address moral distress among community pharmacists, Astbury and Gallagher, suggest a "systemic approach to further enquiry and evaluation that seeks to promote the competency and confidence of pharmacists as moral agents whilst addressing the structural barriers to morally congruent practice". 70

The 

I want to acknowledge Jan Helge Solbakk. Professor Rosemare de la Cruz Bernabe, PhD Reidar Pedersen, Professor for comments that significantly improved the manuscript.

I have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest on the subject matter or materials discussed in this manuscript. 

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US FDA revoked the emergency authorization for the use of Hydroxychloroquine in the treatment of COVID-19. The letter stated "Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use