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Regulations concerning the contents of patient package inserts (known in the EU as “patient information leaflets” or PILs)
By Jacob Presson, Research Analyst at Cutting Edge Information.
Regulations concerning the contents of patient package inserts (known in the EU as “patient information leaflets” or PILs) have in the past erred on the side of caution, making sure that all of the necessary information about side effects and cross-prescription conflicts was included. Pharmaceutical companies have also been keen to provide all relevant information in order to reduce their risk of liability. But lost in this mix has been the patient himself, who is often confronted with a confusing and intimidating wall of information that neither educates them about the advantages of patient adherence nor informs them of the potential risks associated with the treatment.
June 17–18, 2014
Recently two independent government bodies have stepped up to try and fix this situation through a mix of regulatory changes and better communication with manufacturers. In January of 2013 the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK sent a detailed advisory letter to the Directorate General for Health and Consumers of the EU concerning PILs. The letter expresses many concerns about how PILs in their current form are too overwhelming to be effectively used by patients.
Citing the work of (the ambitiously dubbed) CHMEAGPPE (Commission on Human Medicines Expert Advisory Group on Patient and Public Engagement), there is a need for these PILs to use a design that is educational for patients instead of intimidating them. The letter also recommends the use of “new media” such as websites and emails so that patients are always able to look up the relevant information about a product. Other bold proposals include a mandated “balance of information” about potential benefits versus potential harm and a requirement for pharmaceutical companies to give patients further resources to educate themselves as needed.
Next, in February of 2013 the Office of the Inspector General (OIG) for the Department of Health and Human Services in the US issued a critique of current FDA guidelines on high risk drugs. According to the OIG the package inserts don’t provide enough information about the drug’s effectiveness and sometimes fail to adequately protect the patient’s health.
While the reaction to the possibility of new legislation on pharma communication with patients is understandably often negative, these documents have several positives for companies to explore:
Better Communication with Patients: Especially in the case of the MHRA recommendations, the proposed guidelines are hoping to allow companies to use more intuitive ways of displaying information, whether through interactive webpages or simply more readable PILs, so that companies aren’t stuck with blaring warning messages at the top of every sheet of paper given to a patient.
More Balanced Approach to PILs/Package Inserts: Companies are now going to be able to present data about benefits and side effects on equal footing so that patients will be more informed about the drugs they are taking. Rather than thinking about side effects as they take the medication, patients will have a more positive outlook on their course of treatment.
Better Dialogue Between Patients, Doctors, and Companies: Patients that have been well informed about the course of treatment being given to them will be able to better engage their prescribing physician or specialist about side effects and benefits. This can turn into positive feedback for visiting MSLs and give doctors valuable information about the product they’re giving out.
About the AuthorJacob Presson is a Research Analyst at Cutting Edge Information, providing market research to pharmaceutical companies.