MONTREAL, April 16, 2012 /CNW Telbec/ - The Ordre des pharmaciens du Québec, together with the Collège des médecins du Québec, Association québécoise des pharmaciens propriétaires and Association des pharmaciens des établissements de santé du Québec this morning, announced the recommendations of the Working Committee on Drug Shortages.
"The growing number of shortages, along with their consequences for patients, calls for an overall analysis of the cause and the implementation of concrete solutions for preventing rather than enduring supply disruptions," explains Diane Lamarre, president of the Ordre des pharmaciens du Québec.
Dr. Charles Bernard, president and CEO of the Collège des médecins du Québec (CMQ), echoes this sentiment. "This has become a public health issue today. All the players involved must work together in a sincere and transparent manner to implement lasting solutions."
Based on best practices at the international level, the report makes nine recommendations aimed at securing the supply of pharmaceutical products.
The Committee's recommendations
The Committee recommends that the regulations and programs be reviewed by Health Canada so that they can be better adapted to deal with the problem of shortages. "Regulation is always slow to adapt to changes in the environment (...) no major change has been made to Health Canada's structure and programs," the report states. The Committee recommends requiring manufacturers to secure several supply sources for raw materials and several manufacturing sites when applying for authorization to market an essential drug. It is also calling for changes to some of Health Canada's practices.
Legislative changes should be guided by a "national vision and action plan for access" developed jointly by the health ministers in all provinces and territories, says the report.
The committee also recommends a legislative framework that would force pharmaceutical companies to give one year's notice before any voluntary production stoppage. "This type of notice is crucial so that we can come up with viable alternative solutions, whether finding new supply sources or identifying substitute medications, for example," explains Charles Fortier, president of the Association des pharmaciens des établissements de santé du Québec (A.P.E.S.). On the provincial level, the Committee recommends creating an entity that would be responsible for coordinating the management of shortages and centralizing key information in the event of a shortage. Since the coordinating entity would be notified of anticipated shortages and would take action when a shortage is announced, it would be able to prevent problem situations. "In the United States, the FDA acts as a coordinating entity. It was able to prevent 38 supply disruptions in 2010, 195 in 2011 and 18 in 2012, as of February 9" according to the report.
The report also examines incentives that could be introduced for producing drugs that are in short supply or less profitable. Incentives for ensuring a steady supply as well as penalties in the event of a shortage could also be systematically integrated into purchasing contracts and reimbursement agreements, according to the Committee.
Lastly, manufacturers, distributors and pharmacists are encouraged to review certain inventory management practices to ensure the security of the supply chain, as well as adopting ethical and responsible behaviours in the event of supply disruptions.
Normand Bonin, president of the Association québécoise des pharmaciens propriétaires (AQPP), says that "in a crisis, it is crucial to have solidarity and cooperation among pharmacists. This must surpass the context of commercial affiliations in order to facilitate the equitable use of available medicines."
The Committee members believe drug shortages are likely to become more frequent and could have serious consequences for the health of Quebecers if the proposed corrective measures are not implemented quickly. "There is no question that drugs save lives, and as such, they are an exceptional consumer product. Shortages like those we are seeing today are a new reality," says Diane Lamarre. "They call for the implementation of a customized legislative and organizational framework. Everything will be brought into play so that our governments and other stakeholders can act promptly on this issue."
About the Working Committee on Drug Shortages
The Working Committee on Drug Shortages was created by the Ordre des pharmaciens du Québec, with the mandate of examining the causes for supply disruptions and proposing solutions that could become part of a national strategy. Consisting of representatives of the OPQ, CMQ, AQPP, and A.P.E.S. as well as an industry expert, the committee began its work in March 2011.
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Ordre des pharmaciens du Québec
Anik Le Marquand