Drug Shortages From the Perspectives of Authorities and Pharmacy Practice in the Netherlands: An Observational Study

Abstract

Background: Drug shortages are a potential threat to public health. Reliable data on drug shortages is limited. The objective was to examine the extent and nature of potential drug shortages signaled by authorities and pharmacy practice in the NetherlandsMaterials and Methods: The primary working systems of Dutch authorities (Medicines Evaluation Board and Health and Youth Care Inspectorate) and the archives of pharmacy practice (Royal Dutch Pharmacists Association) from 2012 to 2015 were searched for number, characteristics, overlap, and date of signals on potential drug shortages. Also, the product characteristics of the potential drug shortages were analyzed from the two different sourcesResults: Authorities detected 2.6 times more signals on potential shortages than pharmacy practice. Only 438 (8%) out of 5,731 potential drug shortages were detected by both authorities and pharmacy practice. Signals were detected later by authorities than by pharmacy practice, especially on potential permanent shortages (median difference −180 days (IQR: −4 to −405 days)). Authorities detected by majority (72%) signals related to permanent shortages with relative overrepresentation of rectal products and anti-infectives for systemic use. In contrast, pharmacy practice detected by majority (71%) signals related to temporary shortages with relative overrepresentation of ocular and cutaneous products, anti-infectives for systemic use, products for sensory organs and dermatologicals.Conclusions: Authorities and pharmacy practice detected different signals on potential drug shortages with little overlap. Combining data from both authorities and pharmacy practice seems to be necessary in order to gain a more complete overview and maximum insight in potential drug shortages at a national level. Moreover, the finding that authorities were informed later than pharmacy practice causes concerns in terms of opportunities for authorities to assist pharmacy practice to find solutions for shortages.

The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study

“…According to the definition of drug shortages in France, short supply was not considered in the present study. The combination of data from both authorities and pharmacy practice has been suggested to improve the surveillance 31. This requires a standardisation of definition of drug shortages between European members.…”

Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages

“…Moreover, there is a distinct concern regarding medicine shortages when detailed management and mitigation guidance is lacking from higher authorities ( 58 , 59 ). The non-harmonized approach is reflected in the manner in which shortages are managed including risk assessment in some European countries for particular groups of medicines, generally life-saving ones.…”

“…In order to attain more reliable and accurate information, it would be recommendable that all actors in the supply chain incorporate their own data on shortages into a whole that would better foresee potential shortages on the horizon and communicate them with one another. The immediate advantages of such a measure would be that the individual actors would be able to detect a shortage as it appears ( 59 ). Only through a common shared network may information on shortages be used to combat and anticipate them.…”

Shortages of medicines in OECD countries

“…In France, a shortage longer than 72 hours must be notified. 16. Nearly all countries have an official notification form, template or tool available.…”

“…21. The magnitude of the shortage situation is challenging to measure, and perceptions of the problem differ between stakeholders 16 . The growing occurrence of medicine shortages is matched by an increasing number of academic publications on this topic in recent years.…”