Medicine Shortages

Abstract

Medicine shortages are caused when disruptions in the supply chain affect patient accessibility to medicines. Clinical, economical and humanistic impacts on the patients, healthcare professionals and the national health systems result from lack of accessibility to medicines. The aims of this research were to (i) study the perception of family doctors, pharmacists and patients when facing medicine shortages in the community setting (ii) evaluate the rationale of exemption from registration due to a justified public health need in accordance with Article 20 of the Medicines Act Chapter 458 of the Laws of Malta, (iii) develop criteria to classify and measure risk associated with evaluating an application for an Article 20 exemption. The methodology was divided into three studies: 1. Development and validation of three questionnaires intended for family doctors, patients and pharmacists to study their experience with medicine shortages in a community pharmacy setting. 2. Formulation of a database to retrospectively analyse and examine trends in Article 20 applications from October 2020 to April 2022. 3. Establishment of a critical therapeutic class list through focus group discussion and development of a risk matrix tool to optimise processing of Article 20 exemption applications. The questionnaire was answered by 50 pharmacists, 20 family doctors and 200 patients. All the pharmacists (N=50), 18 family doctors and 113 patients experienced medicine shortages in the last 5 years from community pharmacy setting. When patients were asked if medicine shortages were solved to their satisfaction, 49 patients stated that the alternative medicine recommended was not effective, 29 patients stated that no alternative was available, 16 patients stated that alternative medicine caused unwanted side effects and 10 patients stated that medicine alternative was higher in price. Family doctors and pharmacists were asked about impact medicine shortages had on patient care. Twenty pharmacists and 11 doctors stated that it caused distress and inconvenience, 12 doctors and 8 pharmacists stated that medicine shortage lead to sub-optimal treatment, 11 doctors and 9 pharmacists stated increase in expense to patient, 9 doctors and 7 pharmacists stated cancellation of care, 8 doctors and 15 pharmacists stated delays in treatment and 6 doctors and 12 pharmacists stated medication error. Descriptive statistics of retrospective analysis of Article 20 exemptions was carried out with 636 applications being approved and 25 applications rejected. The most prominent reason for requesting an Article 20 exemption (247 applications) was interim supply until the National Health System finalizes the tender. Through focus group discussion, risk matrix categories for risk severity and risk probability were identified. The risk critical numbers were identified and categorized into ranges. For a low risk to patient the range was identified to be 1-4, for medium risk the range was identified to be 5-10, for high risk the range was identified as 12-25. Six hundred and thirty-six medicines were prevented from shortage through the granting of an Article 20 exemption to ensure continuous access of medicines to patients. A risk prioritization tool was found useful to limit the impact of medicine shortages on the patient. The study showed that evaluating the rationale and generating trends observed from Article 20 exemptions granted determines which medicines most likely be in shortage prospectively whereby mitigation of such shortages can be carried out nationally.