Dataset Information

Shaping medicinal product information: a before and after study exploring physicians' perspectives on the summary of product characteristics.

ABSTRACT:

Objective

To establish, in the context of the revised European Pharmacovigilance Directive and based on physicians' perspectives, how Summaries of Product Characteristics (SmPCs) could be more user friendly and better support physicians' interactions with patients, thereby improving patients' own understanding of their medicines.

Design

Qualitative focus group discussions (step 1), development of an alternative SmPC (step 2) and an online quantitative survey (step 3) comparing the alternative SmPC to the currently approved version.

Setting

Office-based physicians (n=218) from all federal states of Germany.

Participants

218 German physicians participated, with an equal representation of office-based general practitioners and specialists. For step 1 (n=18), physicians were recruited who frequently consulted SmPCs.

Outcome measures

Planned and performed: Mayring's qualitative content analysis of focus group discussions (step 1), rating on a five-point Likert scale of preference of current versus alternative SmPCs (step 3).

Results

Physicians confirmed the importance of SmPCs as a comprehensive source of medicinal product information, but were moderately satisfied with the current SmPCs, utilised it infrequently and were more likely to engage additional sources of information. The alternative SmPC was consistently preferred. It differed in the way information for particular patient groups was presented, included additional sections (synopsis, checklist for patient information) and used a tabular format. Physicians indicated that SmPCs should be available with search and hyperlink functions, as well as be automatically updated and integrated in available practice software or similar solutions.

Conclusions

This research contributes to the development of an official, reliable medicinal product information system meeting the needs of a modern information society while providing the reliability of an officially authorised source. In the context of health literacy, SmPCs should be established as the primary information source for healthcare professionals to ensure compliant and safe utilisation of medicinal products.

SUBMITTER: Vromans L

PROVIDER: S-EPMC3753505 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Publications

Shaping medicinal product information: a before and after study exploring physicians' perspectives on the summary of product characteristics.

Vromans Lisette L Doyle Gerardine G Petak-Opel Silvia S Rödiger Alexander A Röttgermann Martina M Schlüssel Elke E Stetter Eva E

BMJ open 20130821 8

<h4>Objective</h4>To establish, in the context of the revised European Pharmacovigilance Directive and based on physicians' perspectives, how Summaries of Product Characteristics (SmPCs) could be more user friendly and better support physicians' interactions with patients, thereby improving patients' own understanding of their medicines.<h4>Design</h4>Qualitative focus group discussions (step 1), development of an alternative SmPC (step 2) and an online quantitative survey (step 3) comparing the ...[more]

PMID: 23965932

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Project description:ObjectiveWe sought to explore physician perspectives on the prescribing of cannabinoids to patients to gain a deeper understanding of the issues faced by prescriber and public health advisors in the rollout of medicinal cannabis.DesignA thematic qualitative analysis of 21 in-depth interviews was undertaken to explore the narrative on the policy and practice of medicinal cannabis prescribing. The analysis used the Diffusion of Innovations (DoI) theoretical framework to model the conceptualisation of the rollout of medicinal cannabis in the Australian context.SettingInformants from the states and territories of Victoria, New South Wales, Tasmania, Australian Capital Territory, and Queensland in Australia were invited to participate in interviews to explore the policy and practice of medicinal cannabis prescribing.ParticipantsParticipants included 21 prescribing and non-prescribing key informants working in the area of neurology, rheumatology, oncology, pain medicine, psychiatry, public health, and general practice.ResultsThere was an agreement among many informants that medicinal cannabis is, indeed, a pharmaceutical innovation. From the analysis of the informant interviews, the factors that facilitate the diffusion of medicinal cannabis into clincal practice include the adoption of appropriate regulation, the use of data to evaluate safety and efficacy, improved prescriber education, and the continuous monitoring of product quality and cost. Most informants asserted the widespread assimilation of medicinal cannabis into practice is impeded by a lack of health system antecedents that are required to facilitate safe, effective, and equitable access to medicinal cannabis as a therapeutic.ConclusionsThis research highlights the tensions that arise and the factors that influence the rollout of cannabis as an unregistered medicine. Addressing these factors is essential for the safe and effective prescribing in contemporary medical practice. The findings from this research provides important evidence on medicinal cannabis as a therapeutic, and also informs the rollout of potential novel therapeutics in the future.

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Dataset Information

Shaping medicinal product information: a before and after study exploring physicians' perspectives on the summary of product characteristics.

Objective

Design

Setting

Participants

Outcome measures

Results

Conclusions

Publications

Shaping medicinal product information: a before and after study exploring physicians' perspectives on the summary of product characteristics.

Similar Datasets

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