title: Preventable drug-related morbidity in community pharmacy: development and piloting of a complex intervention.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: iMED.UL, Faculdade de Farmácia da Universidade de Lisboa, Lisbon, Portugal. mara.guerreiro@sapo.pt
authors.forename: Mara
authors.initials: M
authors.lastname: Pereira Guerreiro
authors.forename: Ana Paula
authors.initials: AP
authors.lastname: Martins
authors.forename: Judith Anne
authors.initials: JA
authors.lastname: Cantrill
mesh_terms: D003157:Community Pharmacy Services / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions; D005240:Feasibility Studies; D017144:Focus Groups / Q000379:methods; D005500:Follow-Up Studies; D006801:Humans; D009017:Morbidity; D010595:Pharmacists / Q000639:trends; D010865:Pilot Projects; D011174:Portugal; D024382:Professional Role; D016730:Program Development / Q000379:methods* / Q000592:standards; D011446:Prospective Studies; D012308:Risk Management