Risk Communication of New Drugs : A qualitative interview study

Abstract: Background: Pharmaceutical development has taken new ground in recent decades and placed new demands on the regulations. Since 2005, a risk management plan (RMP) has been required when applying for a first marketing authorization for a drug. The RMP forms the basis for how identified risks with the drug are to be managed. In the RMP for all drugs, regular measures (rRMM) such as summary of product characteristics (SPC) are applied. As only rRMM is not considered sufficient, additional measures (aRMM) are also applied, which can be, for example, extra training material for prescribers or patients. aRMM material is today distributed to prescribers via physical letters. Are aRMM materials communicated today in a way that fulfills the purpose of the regulations? Aim: The aim of this study is to gain knowledge through qualitative interviews with the pharmaceutical industry and regulatory authority in Sweden about how risks with drugs are communicated. Methods: Semi-structured individual interviews were conducted with 7 persons from the pharmaceutical industry and 1 person from the regulatory authority in Sweden, during March and April 2022. The interviews were transcribed and the data were analyzed with systematic text condensation. Results: The five main identified desired improvements in the communication of aRMMs are  these; 1. National common database for aRMM materials, 2. Flagging and availability in prescribing systems, 3. Swedish Medical Products Agency labeled materials, 4. Dialogue between healthcare, pharmaceutical companies and the pharmaceutical authority, 5. Diversity and availability of aRMM materials to patients.  Conclusion: aRMM is considered in itself to be an effective tool for managing and minimizing risks with medicines, but the measures lose effect and purpose due to lack of communication and understanding.