Clinical Dilemmas and a Review of Strategies to Manage Drug Shortages

Abstract

The mounting number of drug shortages has created a health care crisis, requiring changes in management strategies as well as clinical practice. The expanded phased approach outlined here provides a consistent, systematic approach for the management of drug shortages.

Community Pharmacists: On the frontline of health service against COVID-19 in LMICs

“…The reported frequency of medication shortages worldwide has been increasing in recent years and has been described as a healthcare crisis in itself. 11,12 Problems with local ordering, local or national distribution, or manufacturing can all result in supply problems that can lead to regional or national shortages. The medication distribution system in Nigeria is in a state of chaos and consists of open drug markets, and the activities of patent and proprietary medicine vendors (PMV), community pharmacies, private and public hospitals, importer, distributors and wholesalers, and pharmaceutical manufacturers.…”

Why drug shortages are an ethical issue

“…16 With this in mind, it has been recognised that those making decisions about allocating resources need to "broaden (their) ethics analysis to reach beyond individually focused principles such as autonomy, beneficence, and nonmaleficence, to values focused on the common good, such as solidarity, communal beneficence and stewardship". 9(p42) Drug shortages also threaten the development of evidence and the practice of evidence-based medicine by impeding clinical research, with trials being made smaller, modified or halted altogether 17 and by making it difficult for clinicians to follow evidence-based clinical practice guidelines. 18,20 Finally, drug shortages harm health systems as they lead to governments and organisations having to commit significant resources to overseeing and managing the situation, and potentially paying more for alternative medications than they would normally spend.…”

“…Certain drug classes are particularly vulnerable to drug shortages, including central nervous system agents, anti-infective agents, cardiovascular drugs, dermatology drugs, gastrointestinal drugs, hormones and synthetic substitutes, electrolytic, caloric and water balance agents, and cancer medicines. 1 This means that some of the most disadvantaged populations, such as critically ill patients, 17,18 or patients with rare metabolic diseases, 5 are most likely to face the additional burden of drug shortages, thus increasing already existing inequities in health care delivery.…”

Why drug shortages are an ethical issue

“…Drug shortages also threaten the development of evidence and the practice of evidence-based medicine by impeding clinical research, with trials being made smaller, modified or halted altogether 17 and by making it difficult for clinicians to follow evidence-based clinical practice guidelines. 18,20 Finally, drug shortages harm health systems as they lead to governments and organisations having to commit significant resources to overseeing and managing the situation, and potentially paying more for alternative medications than they would normally spend.…”

“…9 The need for such triage, and its ethical implications, has been recognised by many organisations, which have attempted to develop guidelines for resource allocation in the setting of drug shortages. These guidelines have tended to emphasise the need for procedural integrity and justice, engaging all stakeholders-including clinicians, patients and managers-in decisions about how scarce resources should be allocated, and aiming for consistency, objectivity, transparency, accountability and clear methods for communicating decisions (for examples see references 9,17,19,[22][23][24]. It has also been noted that organisations have an ethical obligation to prepare for drug shortages by conserving supplies and by ensuring that the organisation is ready to respond to any shortage that arises.…”