Preventable drug-related morbidity in community pharmacy: development and piloting of a complex intervention.

Background: Preventable drug-related morbidity (PDRM) arising in the community is a problem of unacceptable magnitude. Effective interventions to reduce this problem will avoid unnecessary patient harm and waste of resources for the health care system.

Objective: To develop and pilot an intervention to manage the risk of PDRM in community pharmacy, underpinned by validated PDRM indicators. Setting Portuguese community pharmacy.

Method: Our work was informed by the Medical Research Council framework for the development and evaluation of complex interventions. Human error theory was considered as a theoretical framework for developing the intervention. Additionally, this stage consisted of a literature review, followed by two focus groups (17 community pharmacists) and interviews with 8 professional leaders. A 4-component intervention, was developed: (1) operationalisation of 4 validated PDRM indicators in dispensing encounters ('dispensing' indicators), and operationalisation of 25 validated indicators in patients enrolled in pharmaceutical care programmes ('follow-up' indicators), (2) pharmacist resource pack, (3) pharmacists' training and (4) support scheme. Piloting consisted of a feasibility study in 15 community pharmacies and an acceptability study with participating pharmacists (n = 16). Main outcome measures Proportion of cases with counselling (dispensing indicators); proportion of cases assessable, proportion of cases at risk and proportion of cases with risk minimisation actions (follow-up indicators).

Results: Operationalization of dispensing indicators resulted in counselling in 44.1 % of cases (n = 666). Factors influencing acceptability included pharmacists' perceptions of patients' characteristics, interest and informational needs, as well as perceptions on the relevance of safety information. For follow-up indicators, data were available to assess most cases (93/105, 88.6 %). About half of the assessable cases were at risk of a PDRM event (n = 49; 51.6 %); pharmacists undertook risk minimization actions in 23 cases (46.9 %). Lack of time and inter-professional issues emerged as important factors influencing acceptability.

Conclusions: A novel risk management intervention was developed. Feasibility and acceptability of the 4-component intervention in Portuguese community pharmacy provided 'proof of concept', whilst highlighting aspects that need further refinement to better measure and maximise efficacy in future evaluative research.