Table 2.
Overview of the reporting definitions of drug shortages.
| Source | Definition |
|---|---|
| National | |
| ANSM (ANSM, 2014) | Drugs for which unavailability cause a risk for public health and have no therapeutic alternative. |
| AEMPS (Agencia Española de Medicamentos Y Productos Sanitarios - AEMPS, 2015) | All drugs which experience supply problems are reported, except for those for which a rapid solution is expected. |
| BfArM (BfArM - Lieferengpässe, 2015) | A supply shortage is expected to go beyond 2 weeks interruption extradition to the usual extent or a significantly increased demand that cannot be adequately met. Only supply shortages of drugs listed, where special information needs of professionals are required. Currently, this is for prescription drugs that are intended primarily for the treatment of life-threatening or serious diseases for which no alternative preparations are available. |
| Belgian FAMHP (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten, 2014) | Holders of the market authorization should notify the Belgian FAMHP when a drug will be unavailable for a time period longer than 14 days. |
| Farmanco (Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie, 2014) | All supply problems of drugs are reported if it is expected that the drug will be undeliverable for a time period longer than 14 days. |
| Canadian Drug Shortage Databank (Canadian Drug Shortage Database, 2015) | As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a shortage on the communications platform. It is understood that the inability of a patient to receive their prescribed medicines at the first attempt to fill a prescription may not constitute a drug being in ‘shortage,’ as the drug may be available in other pharmacies or within the wholesale or distribution network (i.e., pharmacy supply chain), usually within a few days. |
| Australian Medicine Shortages Information Initiative (Australian Government - Department of Health - Therapeutic Goods Administration [TGA], 2015) | This information is based on the voluntary notification by sponsors in accordance with the agreed Protocol. |
| European | |
| EMA (European Medicines Agency, 2013) | Medicines shortages that affect or are likely to affect more than one EU MS, where the EMA has assessed the shortage and provided recommendations to patients and healthcare professionals across the EU. |