Innovative regulatory framework in community pharmacy

Abstract

The implementation of Good Pharmacy Practice (GPP) in Malta and the evolution of pharmacy regulatory science led to an innovative patient-centred approach in regulatory audit. The aim of the research is to establish a regulatory self-audit model in community pharmacy aiming at satisfying regulatory requirements while meeting patient needs. The methodology included (1) an analysis of the regulatory framework by a multidisciplinary focus group (n=3 patients, n=3 general practitioners, n=3 pharmacists), (2) design and validation of the self-audit protocol, (3) risk-based assessment defining regulatory criteria (N=76) as minor, major and critical and correspondingly classifying pharmacies in high (1 critical or above 5 major findings), medium (1-5 major) and low risk (only minor findings) categories, (4) competencies and regulatory self-audits and regulatory audits in 61 community pharmacies, (5) measurement of compliance agreement between regulatory and self-audits and of risk categorisation with the Kappa test, mean percentage compliance with the Wilcoxon Signed Ranks test (6) correlations between pharmacist characteristics and self-audit results with the Chi square test. (1) The focus group analysis optimised the methodology of the research by identifying 4 risk factors (resistance for the observation of patient-pharmacist interactions, oversights of legal requirements, need for higher pharmacist competencies and pharmacist work overload), 2 weaknesses (unacceptability of proactive initiatives by the pharmacist, lack of robustness in the self-audit) and 5 strengths (optimisation of clinical service, recognition of pharmacist’s role, reduction in redundant bureaucracy, meeting patient needs, personalised healthcare). (2) The self-audit protocol assessed pharmacist strengths, scientific interests, goals and opportunities for improvement, and regulatory criteria through a regulatory checklist. (3) The risk assessment identified 19 minor, 34 major and 23 critical regulatory criteria. (4) Pharmacists (34 female, mean age 43, range 25-73) reported ‘understanding patient needs’ (57.4%) and ‘patient-orientation’ (49.2%) as the two highest strengths, ‘personalised healthcare’ (44.3%) as the major area of interest, ‘service optimisation’ (49.5%) as the main goal and ‘continuous education’ (63.9%) as an opportunity for improvement. In the self-audits pharmacies reported higher regulatory compliance (94.7% ± 4.65) and were classified in lower risk-categories (low-risk=27, medium-risk=18, high-risk pharmacies=16) than in regulatory audits (82.7% ± 8.14; lowrisk= 2, medium-risk=13, high-risk pharmacies=46). Agreement between regulatory and self-audits was achieved for 9 out 76 criteria (p-value<0.05). The difference on mean percentage compliance between regulatory and self-audits was statistically significant (p=0.000) while agreement on regulatory and self-audits risk categorisation was not achieved (Kappa= 0.050, p=0.395). (5) ‘Understanding patient needs’ and ‘good communication skills’ were reported as main strengths by 67.6% and 47% of the pharmacists with more than 6 years of experience (p=0.000). Pharmacists below-30 and over-60 years-old assigned a lower regulatory self-audit risk compared to intermediate age-categories (p-value=0.041). A self-audit showed highly significant differences from the established regulatory audit. A less policing approach in audits may lead to achieve concordance between regulation and pharmacy practice. A GPP certificate based on pharmacist competencies, on regulatory compliance and on a pharmacy-risk analysis is proposed to addresses pharmacy educational needs and optimise pharmacy practice towards meeting patient needs.