Table 4.
Countries definitions.
| Country | Terms/concepts | Definition |
|---|---|---|
| Argentina | Medicines lacking | “known circumstances or facts that could jeopardize the supply of products and cause their temporary or definitive discontinuity in the market”1 |
| Australia | Shortage of a medicine | “There is a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine”2 (The Society of Hospital Pharmacists of Australian, SHPA, 2017) |
| Belgium | Unavailability of medicines on the Belgian market | “A drug is unavailable when enterprises that are responsible for the marketing of the drug are unable to deliver that drug for an uninterrupted period of four consecutive days to the community pharmacies, hospital pharmacies or wholesalers in Belgium.” (De Weerdt et al., 2015a) |
| Brazil | “Temporary discontinuation” “Definitive discontinuation” “Unplanned discontinuation of the manufacture or importation of medicines” |
of the manufacture or importation of medicines means that the license holder does not intend to cancel or does not intend to require the renewal of the registration of the product. of a product, in its turn, happens when the license holder intends to cancel or not to request the renewal of the registration of the product. Are those cases where quality, efficacy or safety properties of medicines are affected and may lead to a supply shortage in the market. (ISAGS, 2017) |
| Colombia | Medicines shortage | A situation which there is not enough supply to satisfy the demand of any medicine approved and marketed in at the country. (INVIMA, 2018) |
| Canada | Drug shortage | A situation in which an authorization holder for a drug is unable to meet the demand for the drug. Drug shortages can include temporary or permanent discontinuances in the production and supply of a drug (Videau et al., 2019) |
| Croatia | Disturbance on the medicines’ market | Not specific. |
| France | Drug shortage | A drug shortage is defined by law in France as an inability for a community pharmacy or a hospital pharmacy to deliver a drug within 72 h (Ministre des affaires sociales, Ministre de la santè, 2012). Additionally, drug shortages in France have been classified formally into two separate contexts of either stock or supply problems. A stock-related shortage is defined as the lack of possibility to manufacture a medicine, whereas a supply-related shortage is defined as a problem in the distribution chain that makes the supply of a medicine impossible, even if enough of the medicine has been manufactured (De Weerdt et al., 2015a). |
| Greece | Actual shortages Temporary interruptions in supply |
“Pertains to the lack of capability to fulfill the demand and the non-availability of a drug in the whole health care system, without the possibility to obtain that medicine from any source.” “It refers to situations when drugs are not commercially available,” mainly for commercial reasons, for a limited time duration (Bochenek et al., 2018). |
| Hungary | “Drug shortage” | As a term is reported to be widely used in the legislation, to report in case they are not able to supply, but without any association with a concrete formal definition (Bochenek et al., 2018). |
| Italy | Short supply | The Italian Medicines Agency (AIFA) defines medicines in short supply as: “Medicines which are not available or not to be found in the whole Italian market, because the marketing authorization holder (MAH) is unable to guarantee the correct and regular supply to meet patients’ needs.” (Bochenek et al., 2018). |
| Norway | Temporary disruption of a medicine’s marketing |
It is de facto considered to be a shortage as soon as it lasted for at least 2 weeks (Bochenek et al., 2018). |
| Peru | “Supply shortage” Unavailable Pharmaceutical Products Pharmaceutical product with limited supply |
Considered as an operational definition in the management of drug availability indicators employed by the public bodies within the Ministry of Health and Regional Governments. Essential pharmaceutical products not supplied in the national market. Product with limited provision in the pharmaceutical market, which could generate access problems (availability and affordability) for the population |
| Spain | Supply problem | The Spanish Agency for Medicines and Health Products (Spanish acronym: AEMPS), being part of the Spanish Ministry of Health Care, defined the “supply problem” as a situation in which the number of available units of a drug in the pharmaceutical trade channel is below the level of national or local consumption needs, being often due to problems in the manufacturing or distribution of a drug |
| United States | Medicines shortages | “A period when the demand or projected demand for a medically necessary drug in the United States exceeds its supply” (Center for Drug Evaluation and research 2018). |
| Uruguay | Declaration of interruption of sale Interruption of marketing |
Interruptions lasting 30 days or more. Due to exceptional interruptions by the manufacturer lasting less than 30 days, which must be communicated to and validated by the Department of Medicines. (ISAGS, 2017) |
1 Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. https://www.argentina.gob.ar/anmat
2 The Therapeutic Goods Administration. Medicine Shortages Information Initiative Available from: https://apps.tga.gov.au/prod/MSI/search#furtherinformation