Focusing on Risk Communication About Medicines

Bahri, Priya; Harrison‐Woolrych, Mira

doi:10.2165/11640990-000000000-00000

Cited by 5 publications

(6 citation statements)

References 27 publications

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“…A previous study has clearly shown that the core of successful risk management lies on effective risk communication (22). This is also a main finding in our study: it seems important to improve the community pharmacists' knowledge on this subject and this is strongly connected with communication and information that arises from the pharmacovigilance system.…”

Section: Discussionsupporting

confidence: 70%

Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal

Duarte

Ferreira

Soares

et al. 2016

Clinical Research and Regulatory Affairs

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A Risk Management Plan (RMP) is a detailed description of the activities and interventions designed to identify, characterize, prevent, or minimize risks relating to medicine's use. The objective of this article is to assess RMP-related knowledge of community pharmacists and explore the reasons behind any potential issues with its use. This study has two focus points: (1) A cross-sectional survey within a sample of pharmacies in the area covered by the South Pharmacovigilance Center; and (2) a focus group (FG) with key-informants, in order to increase the explanatory scope of quantitative results. In total, 41.6% of the participants in the study knew what a risk management plan was, but 50% rated their knowledge as poor. According to focus group participants, this lack of knowledge seems to be related to three main factors: (i) this subject not being addressed during graduation training; (ii) professionals' attitude; and (iii) lack of communication among different stakeholders. It is recommended that there is enhanced academic training in risk management. There is an important call for attitudinal change interventions and further investigation in monitoring RMP use and impact. A closer articulation between the regulator, the pharmaceutical society, associations, and industry is needed to promote and boost this topic among community pharmacists. ARTICLE HISTORY

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Section: Discussionsupporting

confidence: 70%

Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal

Duarte

Ferreira

Soares

et al. 2016

Clinical Research and Regulatory Affairs

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“…[7,23,24] Although several studies have evaluated the impact of DHPCs on a range of outcomes, these have not assessed variation between healthcare professions. [5,6,25,26] Evaluating the effectiveness of risk communication has become a focus area in recent years, [27] as evidenced by Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action which involves medicines regulators across Europe (http://www.scopejointaction.eu). An understanding of variation in and the determinants of response to regulatory safety communications among GP practices, and ideally individual general practitioners, may allow for those that do not alter their prescribing to be provided with tailored information and supports to promote safe medication use.…”

Section: Discussionmentioning

confidence: 99%

Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron

Moriarty

Razzaque

McDowell

et al. 2018

Preprint

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Introduction Pharmacovigilance may detect safety issues after marketing of medications, and this can result in regulatory action such as direct healthcare professional communications (DHPC). DHPC can be effective in changing prescribing behaviour, however the extent to which prescribers vary in their response to DHPC is unknown. This study aims to explore changes in prescribing and prescribing variation among GP practices following a DHPC on the safety of mirabegron, a medication to treat overactive bladder (OAB). Methods This is an interrupted time series study of English GP practices from 2014-2017. NHS Digital provided monthly statistics on aggregate practice-level prescribing and practice characteristics (practice staff and registered patient profiles, Quality & Outcomes Framework indicators, and deprivation of the practice area). The primary outcome was monthly mirabegron items as a percentage of all OAB drug items. The exposure was a DHPC issued by the European Medicines Agency in September 2015. Variation between practices in mirabegron prescribing before and after the DHPC was assessed using the systematic component of variation (SCV). Multilevel segmented regression with random effects quantified the change in level and trend of prescribing after the DHPC. Practice characteristics were assessed for their association with a reduction in prescribing following the DHPC. Results This study included 7,408 practices. During September 2015, 88.9% of practices prescribed mirabegron and mirabegron composed a mean of 8.2% (SD 6.8) of OAB items. Variation between practices was classified as very high and the median SCV did not change significantly (p=0.11) in the 6 months after the September 2015 DHPC (12.4) compared to before (11.6). Before the DHPC, there was a monthly trend of 0.294 (95%CI, 0.287, 0.301) percentage points increase in mirabegron percentage. There was no significant change in the month immediately after the DHPC (-0.023, 95% CI -0.105 to 0.058) however there was a significant reduction in trend (-0.036, 95% CI -0.049 to -0.023). Higher numbers of registered patients and patients aged ≥65 years, and practice area deprivation were associated with having a significant decrease in level and slope of mirabegron prescribing post-DHPC. Conclusion Variation in mirabegron prescribing was high over the study period and did not change substantively following the DHPC. There was no immediate prescribing change post-DHPC, although the monthly growth did slow. Knowledge of the degree of variation in and determinants of response to safety communications may allow those that do not change prescribing to be provided with additional supports.

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“…Results from a poster presentation at the meeting comparing the HTA appraisals in France and the UK for 38 cancer drugs suggest that the assessment of value for these drugs is very similar despite the contrasting approaches in these countries [6]. The analysis showed that, in the UK, the estimated quality-adjusted life years (QALYs) gained ranged from 0.018 to 1.85, and incremental cost per QALY values ranged from £1,800 to £458,000.…”

Section: Contrasting Approaches Give Similar Valuementioning

confidence: 99%

“…An editorial by Priya Bahri of the EMA and Mira Harrison-Woolrych of the New Zealand Pharmacovigilance Centre [6], concludes that, ultimately, the usefulness of all our efforts in pharmacovigilance manifests itself in our ability to communicate practical advice for the safe use of medicines. This advice should achieve improved patient health outcomes… .…”

Section: Aim: To Improve Health Outcomesmentioning

confidence: 99%

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Focusing on Risk Communication About Medicines

Cited by 5 publications

References 27 publications

Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal

Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal

Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron

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