In 2020, the National Medicines Safety Agency (ANSM) recorded a worrying increase in reports of drug shortages: 2,446 reports in 2020 against 1,504 reports in 2019, knowing that the same drug may be subject to several reports during the same year. All classes of drugs were affected by these shortages, including drugs of major therapeutic interest (MITM), that is to say drugs whose “transient, total or partial unavailability is likely to lead to a public health problem (endangering the prognosis, significant loss of opportunity for patients) “according to the ANSM.
This is why the Agency has just imposed on pharmaceutical laboratories to constitute a minimum safety stock of 2 months for all MITMs marketed in France. “By strengthening the existing legal mechanisms, the obligation to have safety stocks makes it possible to anticipate more effectively the risks of out-of-stock MITMs and to improve their availability for patients in France “underlines the ANSM in a press release. The list of drugs considered essential and affected by this obligation will be published during the month of October.. The laboratories will have one semester to implement this reinforced stock obligation, when it has been decided by the ANSM.
Different reasons for the drug shortage
These shortages or risks of drug stock shortages have multifactorial origins:
- difficulties that arose during the manufacturing of raw materials or finished products
- quality defects on drugs
- insufficient production capacity
- fragmentation of the manufacturing stages.
All classes of drugs are affected by stockouts or the risk of stockouts. Among those considered essential, we find cardiovascular drugs, drugs for the nervous system, anti-infectives and anti-cancer drugs.
Source:
Availability of drugs: the ANSM publishes guidelines for the development of shortage management plans, ANSM, August 2021
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