scholarly journals The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

2016 ◽  
Vol 10 (33) ◽  
pp. 681-689
Author(s):  
Tsey Sabblah George ◽  
Mimi Darko Delese ◽  
Asamoa-Amoakohene Abena ◽  
Ashie Adela
Keyword(s):  
Healthcare Professional ◽  
Risk Minimization

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey

2019 ◽  
Vol 33 (2) ◽  
pp. 121-133 ◽  
Author(s):  
Joanna Lem ◽  
Muhammad Younus ◽  
Jalal A. Aram ◽  
Shahrzad Moosavi ◽  
Klaus Freivogel ◽  
...  
Keyword(s):  
Healthcare Professional ◽  
Lessons Learned ◽  
Risk Minimization ◽  
Additional Risk ◽  
The Eu

Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA

2019 ◽  
pp. 216847901987104 ◽  
Author(s):  
Arnela Boskovic ◽  
Mathias Møllebæk ◽  
Susanne Kaae
Keyword(s):  
Healthcare Professional ◽  
Healthcare Professionals ◽  
Phenomenological Approach ◽  
Professional Communication ◽  
European Medicines Agency ◽  
Risk Minimization ◽  
Regulatory Requirement ◽  
Regulatory Decision ◽  
Legal Obligations ◽  
Local Company

Background: Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA. Methods: European MAHs (n = 6) and EMA representatives (n = 2) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation. Results: The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA’s internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice. Conclusion: DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.

Risk-minimization hedging under nonoptimal exercising

2011 ◽  
Vol 13 (4) ◽  
pp. 63-93
Author(s):  
Dmitriy Levchenkov ◽  
Thomas Coleman ◽  
Yuying Li
Keyword(s):  
Risk Minimization

Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

2020 ◽  
Vol 15 (3) ◽  
pp. 181-189
Author(s):  
Omotayo Fatokun
Keyword(s):  
Informed Consent ◽  
Drug Use ◽  
Perceived Risk ◽  
Adverse Drug Events ◽  
Community Pharmacists ◽  
Risk Minimization ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Off Label ◽  
Written Informed Consent

Background: While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists’ beliefs regarding these measures in Malaysia. Objectives: This study examined community pharmacists’ beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures. Methods: A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia. Results: The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002). Conclusion: The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

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