Medicines Shortages

The problem

Problems caused by medicines shortages are serious, threaten patient care in hospitals and require urgent action.

Medicines are not simple items of commerce, they are an essential component of patient care and in the hospital sector they must be administered to the patient in a timely manner. This is particularly the case for patients taking medicines which have a significant clinical consequence when doses are missed, such as anti-psychotics, anti-epileptics, immunosuppressives and anti-cancer drugs.

Shortages of such medicine place the ability to provide timely administration of a particular medicine under threat.

Managing medicines shortages and ensuring continuity of supply can also cause the diversion of significant amounts of the time and attention of a hospital pharmacist from other tasks important in the provision of high quality, safe and efficacious care.

Furthermore, the medicines shortage problem can undermine efforts to reduce costs in health systems as often, in the case of shortage, a more costly alternative must be used – or worse, a less effective alternative.

Solutions

Each part of the supply chain has responsibilies.

For prescribers:

  • to be aware of the problem;
  • to discuss with hospital pharmacists potential changes to prescribing policies if necessary; and,
  • to take due notice of hospital pharmacy communications on the issue

For hospital pharmacists:

  • to be vigilant and alert to the issue of medicines shortage;
  • to share relevant information of forthcoming shortages with colleagues, including hospital management and prescribers;
  • use, and keep up to date, pharmacy skills to identify other solutions when a shortage occurs, which might eventually include small scale production of medicine without a marketing authorisation; and,
  • consider contingency arrangements for theoretical shortages.

For wholesalers:

  • communicate effectively to hospital pharmacies about likely and current shortages, and in a timely manner;
  • make appropriate use of quotas as a tool to ensure fair distribution when demand exceeds supply; and,
  • prioritise replenishment of supplies over routine delivery when a shortage is relieved.

For manufacturers:

  • provide adequate notice and alert of manufacturing problems;
  • provide within such notifications information on how imminent the shortage is, the expected duration of the shortage, whether alternatives are available, and the size of the manufacturer’s share of the market for the product;
  • provide active assistance to hospital pharmacies in the management of shortage problems, such as maintaining dedicated helplines;
  • ensure maintenance of adequate “buffer stocks” of medicines, especially for critical medicines such as those used by emergency departments in hospitals;
  • conduct customer audits and surveys to assess the performance of supply arrangements and to identify any potential improvements; and
  • otherwise work with urgency to bring to an end the shortage difficulties currently being experienced across Europe, including route cause analysis of why the problems are occurring and how they might be resolved most quickly.

Further investigation required

EAHP also consider that due to the scale of the problem, its cross-border nature, its impacts on patient care and its relationship to EU law, a European investigation of the problem involving the European Commission, European Medicines Agency, and European Heads of Medicines Agencies, is required.

See the full EAHP statement here 

EAHP Shortage Surveys

Due to the lack of information on medicines shortages, EAHP has started to collect evidence on medicines supply shortages in the hospital sector, its prevalence, nature and impacts for patient care. To date EAHP has published the results of 2 surveys:

From 19th March to 11th June 2018 EAHP is collecting new data on medicines shortages. More information here.

Recent Developments

 

Last update: 19 March 2018