Martine Kruijtbosch

95 Mo ra l r eason i ng pe r spec t i ves i n s i t ua t i on s o f d rug s ho r t ages INTRODUCTION Drug shortages affect health systems worldwide and are increasing in number and duration in both developed and developing countries. 1-7 Worldwide different national stakeholders (governments, pharmacy associations, hospitals, health insurers, wholesalers, marketing authorization holders (MAH), etc.) aim to prevent and solve drug shortages. Mostly by informing health professionals about (potential) drug shortages 1,3,6,8,9 and providing support materials and resources. 3,6 In the Netherlands, authorities and pharmacy practice detect different signals on potential drug shortages and authorities are informed later. 7 Authorities’ role to assist pharmacists to solve drug shortage problems is limited. Hence, pharmacists have to deal with the problem when the patient is at the counter. Regardless of their causes, drug shortages pose threats to the quality of pharmaceutical care and thus to patients’ well-being and safety. 3,10,11 Health professionals’ moral obligation to provide every citizen with access to appropriate healthcare is challenged, 2,9-14 which may result in professional and moral distress. 13,15 Pharmacists are particularly challenged because they often must inform the patient that a certain drug is unavailable. Moreover, pharmacists are responsible for the provision of appropriate drug therapy, and this professional duty is placed under pressure when a drug is unavailable. 16 Pharmacists have to judge whether the quality of alternative drug treatments is sufficient and whether these treatments are effective and safe for a patient. Drug shortages also challenge pharmacists to address different stakeholders and health professionals who may not always support patient-level solutions necessitated by a drug shortage. 4,9,17 In several countries, legislation requires authorization from the prescribers for generic substitution even during circumstances when a drug is clearly unavailable. Therapeutic drug substitution may be even more cumbersome. 18 This places further stress and pressure on pharmacists as they are challenged to find solutions for their patients and concurrently have to make agreements with prescribers. Pharmacists can also be challenged with patients who refuse to take alternative medicines or who are noncompliant with these medicines. 11,13 Pharmacists have reported that dealing with drug shortages has moral and economic implications. 6,11,19 Moral implications arise when pharmacists’ decisions may lead to suboptimal health outcomes for patients. 6,11,19 For example, in case pharmacists have to dispense potentially less suitable alternative medicines or less appropriate dosage forms. These decisions also have economic implications as, importing alternative drugs is often more expensive, and pharmacists need extra time and personnel to find solutions for drug shortage problems. The resulting increased pharmacy operation costs 3,9,11,13,20-22 are generally not compensated and may even hamper pharmaceutical care for other patients.