Yacine Sellam, president of the Algerian Society for Regulatory Affairs & Pharmacoeconomics, looks at how European countries such as France and Belgium have countered medicine supply shortages and how Algeria can implement these solutions to address its own drug shortage issue.
This situation is not unique to Algeria. Medicine shortages are a growing problem affecting many other countries around the world
On May 2nd 2019, as the Algerian National Union of Community Pharmacists (SNAPO) reported 244 drugs to be “out of stock” in the market, the Algerian Ministry of Health, Population and Hospital Reform organized a press conference on the issue. The press conference led to a series of preventive and curative measures being announced, in addition to the establishment of weekly meetings with the watch committee, which has been in place since January 10th 2018, until the end of all such disruptions.
Shortages in Belgium
This situation is not unique to Algeria. Medicine shortages are a growing problem affecting many other countries around the world. In Belgium, for example, the Federal Agency for Medicines and Health Products (AFMPS) reported in July 2019 that 497 medicines were affected by supply-related problems, including Salbutamol for inhalation, used by asthmatics, and Amoxicillin, a frequently prescribed antibiotic. This situation has led a group of health professionals to sound the alarm in an editorial published in the Belgian daily newspaper Le Soir on July 14th.
This group stated that “sufficient availability of drugs is the responsibility of the pharmaceutical industry,” which remains “subject to strong profitability requirements,” while acknowledging that negotiations between it and the public authorities on the price awarded “can be difficult.” The group also called for a “global solution to this major problem at the European level,” while insisting on the maintenance on the market of “cheap molecules, sometimes not economically profitable, but which are essential for patient treatment”.
The French Case
France is another example of a European country heavily affected by this phenomenon. Indeed, a record number of 538 reports of shortage or supply tensions were recorded in 2017 by the National Agency for the Safety of Medicines (ANSM), compared to only 44 in 2008. On May 7th 2019, the ANSM announced “strong supply tensions concerning Prednisone and Prednisolone-based medicines”, which are essential for many patients suffering from allergies, asthma, multiple sclerosis, acute rheumatism and even some cancers.
To remedy this situation, an “anti-shortage” roadmap was unveiled on July 8th 2019 during a press conference held by Agnès Buzyn, the French Minister of Solidarity and Health. The plan in question, the final draft of which is expected in September 2020, advocates “targeted actions tailored to each of the players in the medicine value chain” and advocates for pharmacist intervention (already established in the law) to “replace the unavailable initially prescribed drug by another”. It aims to “promote transparency and the quality of information” while also promoting “European cooperation”.
A Europe-Wide Solution
In this respect, with a view to convergence and setting up of good practices, a first European guide was published on June 13th 2019. It relates to the notification of drug shortages in the European Union (EU) and is aimed at Marketing Authorization Holders (MAHs). This guide outlines the essential elements for a harmonized approach to detection, notification and management of disruptions, includes a harmonized definition of the word “shortage”, as well as underlining that early notification to competent authorities is a key aspect in the prevention and solving of supply shortages.
This European guide also underlines the responsibilities of MAHs in the EU in the notification of current or future shortages due to regulatory problems, quality defects and/or other causes. This includes, without being limited to, issues related to compliance with good manufacturing and/or distribution practices, non-compliant batches and recalls of drugs on the market. To do this, the European Medicines Agency (EMA) has developed a standard notification form for EU countries that do not yet have it.
In addition, MAHs are also expected to continuously monitor the supply and demand situation on their products, and to maintain open and uninterrupted communication with all stakeholders in the distribution chain, such as producers and wholesaler-dispatchers. Vigilance must of course be doubled in the case of drugs for which there are no alternatives, or where there are only a few, and where the interruption of supply gives rise to a potential risk to public health. For these cases, regulatory authorities may require MAHs to put in place plans to prevent shortages.
In the same spirit, and for a comparable purpose, a second European guide was published on July 4th 2019. It relates to good practices of communication to the public of problems related to the availability of medicines and is addressed to the national jurisdiction’s regulatory authorities. This guide specifies that, in addition to measures to optimize the notification and management of unavailability problems, improving communication of these issues to the public plays an important role in minimizing the potential impact of disruptions.
Indeed, the availability of relevant information, on time, is necessary to plan and rationalize the remaining stocks, as well as to prevent the creation of overstocks at the level of the distribution players and patients, likely to accentuate the shortage. The ultimate goal of this communication is helping to maintain and to improve confidence in the regulatory system.
The recommendations made in this second European guide are in fact a result of a survey of the practices in place in several EU countries and of the workshop organized by the EMA in November 2018. National competent authorities are asked to communicate all drug shortages and supply disruptions occurring at the national level as soon as they are confirmed by the MAHs, without any prior selection criteria.
It is also expected that each national regulatory authority will proceed to the publication of a systematic listing of shortages (but also drugs whose marketing authorizations have been withdrawn or revoked, sometimes declared in shortage) in form of an electronic catalogue that should be regularly updated and easily accessible on its website. For drugs that have a significant impact on patients, specific press releases are also required. In addition, the listing must include the start date of disruption, the estimate of the end date, the reasons for it, and the actions taken to deal with it. Therapeutic alternatives, where they exist, should also be communicated to health professionals and patients.
These good practices for management and communication around disruptions and tensions in medicine supply provide invaluable lessons for countries like Algeria experiencing similar issues. Stakeholders across the Algerian medicine supply chain should take note.
Original article (in French) published in El Watan newspaper on July 28th 2019: https://www.elwatan.com/pages-hebdo/sante/des-bonnes-pratiques-de-gestion-et-de-communication-au-public-28-07-2019