Risks in pharmacy practice research

Abstract

Pharmacy practice research plays a significant role in the advancement and innovation of pharmacy practice and of the pharmacy profession. Through research, novel and extended pharmacy services were developed, evaluated, and implemented. Risks could arise across the research process, and this study aimed to identify the risks and limitations that are encountered when conducting pharmacy practice research and determine strategies to mitigate such risks. The methodology was divided into two phases. Phase 1 involved the identification of limitations and risks from the identified pharmacy practice research studies. This phase included the development and validation of a search strategy, inclusion, and exclusion criteria to identify pharmacy practice research studies considered in the study. Research studies were identified from published studies extracted from PubMed® and from local dissertations extracted from the Open Access Repository of the University of Malta from the year 2015-2022. Risks and limitations were subsequently identified from the retrieved pharmacy practice research studies. Phase 2 included a literature review and a focus group discussion to put forward risk mitigation strategies. A total of 58 local studies, and 399 published studies were included in the review. The majority of the local studies were set in a hospital pharmacy (n=27) where development and implementation of a tool (n=14) was the most common data collection method employed. In contrast almost half (49%) of the reviewed published studies were conducted in a community setting. The most prevalent theme or topic in both local and published studies was extended pharmacy services or intervention which was identified in 20 and 135 studies respectively. For published studies, the most frequently employed study design was Randomised Controlled Trial (n=60) where limited generalisability (n=29) and risk of social desirability bias, unblinding, and small sample size (n=15) were the top two most reported limitations whereas time constraints (n=20) and small sample size (n=19) were the two most reported limitations for local studies. Time constraints including short follow up period and short duration to measure the effect of the intervention may be mitigated through designing an appropriate time frame for data collection, recruitment, and intervention duration period. Results of the focus group discussion and literature review suggest that closely matching the sample to the target population to ensure representativeness would minimise the risk of generalisability bias. Ensuring respondents’ anonymity when assessing self-reported goals, and proper question formatting such as avoiding vague concepts and socially desirable wording, encourages truthful responses from participants and ensures a more accurate response, minimising social desirability bias. A small sample size can be addressed by extending the duration of recruitment period, informing participants of the study’s goals and benefit to the society, and ensuring risks are minimised if a test may be required. Awareness of possible limitations and risks that may be encountered in conducting pharmacy practice research studies would allow future researchers to design and plan their research project in a manner that would minimise such risks, ensuring improved quality and robust research.