Medicine shortages continue to be the order of the day and are a problem for many users, both in Spain and in Europe.
rReasons for this drug supply shortage they are complex, from manufacturing issues, industrial quotas, legal parallel trade, and unexpected spikes in demand due to epidemics or natural disasters to pricing, which is decided at the national level.
The EU is increasingly dependent on third countries, mainly India and China.
In Spain the
Spanish Agency for Medicines and Health Products (AEMPS) reports semi-annually on the problems of
drug supply there have been, what their impact has been and what measures have been taken to tackle them.
What was the reason that caused this problem?
According to the AEMPS, behind this supply difficulty were manufacturing problems (31.6%), an unforeseen increase in demand (20.1%), lack of capacity of the manufacturing plant (16.0%) and inconveniences with the supply of active ingredients (11.5%).
Impact on patients
drug shortage it has dramatic consequences for patients in terms of worsening symptoms, disease progression, and reduced protection against infectious diseases. Also
can drive to poor patient care, substitution for less effective and/or more toxic treatments, increased medication errors, and risk of exposure to counterfeit drugs.
Situation in Spain
801 medicines have suffered supply shortages during the
first half of 2021which represents 2.4 of the total authorized drugs in Spain, according to the
BOE. However, the Ministry of Health points out that the shortage of the drugs with the greatest impact, that is, those that cause a greater disorder to the patient, account for 0.2% (82 presentations) of the total authorized presentations.
mainly affected drugs for the nervous system.
Proposals to solve the shortage problem
What are these recommendations?
Strengthen the obligation of pharmaceutical companies to notify unexpected stockouts and risks of stockouts as soon as they are identified.
Sufficient advance notice may be required in the event that pharmaceutical companies withdraw drugs from the market for commercial reasons.
Establish detailed and harmonized drug shortage notification criteria.
Allow patients themselves to report drug shortages.
Ensure effective and transparent communication about which medicines are experiencing supply problems with a public database at EU level.
Establish an independent and proactive monitoring system for medicines stocks in the European Union to anticipate the risks of shortages in the initial stages.
Require pharmaceutical companies to prepare and present plans for the prevention and management of drug shortages.
That pharmaceutical companies be obliged by law to maintain safety stocks of medicines of high therapeutic importance at the EU level.
Adapt the joint procurement model used for COVID-19 vaccines to buy medicines affected by supply problems and distribute them fairly between Member States.
Promote public production strategies when necessary to guarantee the availability of essential medicines and therapies.
Adapt the regulatory framework to authorize hospital pharmacists to prepare and distribute drugs of great therapeutic importance in the event of a shortage. Including the case of withdrawal of a drug from the market for commercial reasons.
Guarantee that pharmaceutical companies comply with their legal obligations and establish dissuasive sanctions in case of non-compliance.
AEMPS website reports that there are 491 drug presentations affected by supply problems.