Drug shortages in low- and middle-income countries: Colombia as a case study.

BACKGROUND: Drug shortages are a global problem. Analyzing shortages worldwide is important to identify possible relationships between drug shortages across countries, determine strategies that reduce drug shortages, and reduce the inequality in access to medicines between countries. In contrast to well-documented shortages in high-income countries, there are few studies that consider low- and middle-income economies. We evaluate drug shortages in one middle-income country, Colombia. METHODS: We collected data from INVIMA, the institution responsible for managing medicine shortage alerts in Colombia. We classified the data using the Anatomical Therapeutic Chemical (ATC) classification system and analyzed them using descriptive statistics. We considered a study period from 2015 to 2021 (vital medicines) and from 2010 to 2020 (non-vital medicines). RESULTS: In total, 173 unique ATC codes were in shortage. These included antidotes, alimentary tract and metabolism products, anesthetics, cardiac stimulants and antithrombotic agents. The major causes were manufacturing problems and few suppliers. Drug shortages substantially increased from 2020 to May 2021 due to the COVID-19 pandemic. Among resolved shortages, the average duration was 1.6 years with a standard deviation of 1.9 years. The longest, naloxone tablets, were in shortage for almost 10 years. CONCLUSIONS: Drug shortages are a persistent problem in Colombia. Government institutions have made progress in implementing systems and procedures to report them. However, the approaches implemented need to be maintained and refined. This study lays the groundwork for the analysis of drug shortages in other LMICs. We highlight the necessity of addressing drug shortages in their global context and reducing the inequality in access to medicines between countries.

Prescription Drug Shortages: Implications for Ambulatory Pediatrics.

OBJECTIVE: To describe contemporary drug shortages affecting general ambulatory pediatrics. STUDY DESIGN: Data from January 2001 to December 2015 were obtained from the University of Utah Drug Information Service. Two pediatricians reviewed drug shortages and identified agents used in ambulatory pediatrics. Shortage data were analyzed by the type of drug, formulation, reason for shortage, duration, marketing status, if a pediatric friendly-formulation was available, or if it was a single-source product. The availability of an alternative, and whether that alternative was affected by a shortage, also was noted. RESULTS: Of 1883 products in shortage during the study period, 314 were determined to be used in ambulatory pediatrics. The annual number of new pediatric shortages decreased initially but then increased to a high of 38 in 2011. Of the 314 pediatric shortages, 3.8% were unresolved at the end of the study. The median duration of resolved shortages was 7.6 months. The longest shortage was for ciprofloxacin 500-mg tablets. The most common class involved was infectious disease drugs. Pediatric-friendly dosage forms were affected in 19.1% of shortages. An alternative agent was available for 86% drugs; however, 29% of these also were affected. The most common reason for shortage was manufacturing problems. CONCLUSIONS: Drug shortages affected a substantial number of agents used in general ambulatory pediatrics. Shortages for single-source products are a concern if a suitable alternative is unavailable. Providers working in the ambulatory setting must be aware of current shortages and implement mitigation strategies to optimize patient care.

Desabastecimento de medicamentos: determinantes, conseqüências e gerenciamento / Drug shortage: determinants, consequences and management

O artigo analisa o desabastecimento de medicamentos como um problema que transcende o aspecto logístico da área de saúde, discutindo suas implicações para a qualidade, segurança e custo da assistência. A cadeia de abastecimento farmacêutico e os fatores que interferem na capilaridade da distribuição e na disponibilidade do medicamento são discutidos. Ressalta a contribuição da comissão de farmácia e terapêutica para a prevenção e gerenciamento do desabastecimento de medicamentos nos estabelecimentos de saúde. Sugestões de medidas para gestão do desabastecimento de medicamentos são apresentadas. Enfatiza-se a necessidade do medicamento ser considerado pelos componentes da cadeia logística um produto de saúde, com tratamento diferenciado dos bens de consumo comuns.

The present study analyzes drug shortage as a problem reaching beyond the logistic aspect of the health field and discusses its consequences with respect to quality, safety and cost of health care delivery. The pharmaceutical supply chain and the factors that determine the distribution and availability of drugs are discussed. The contribution of the Pharmacy and Therapeutics Committee in preventing and managing drug shortage in health institutions is stressed and measures for drug shortage management are suggested. Finally it is emphasized that drugs should be considered health products rather than consumer goods and as such be given a different treatment by the supply chain.