Crisis preparedness and management in pharmaceutical scenarios

Abstract

Crisis preparedness and management in pharmaceutical processes are crucial for ensuring quality, safety, efficacy and availability of medicinal products while mitigating risks to patients and public health. The aim of this research is to investigate crisis scenarios in pharmaceutical distribution (PD) and community pharmacy (CP). Study objectives are i) crisis scenario and crisis preparedness/management measure identification, ii) National Competent Authority (NCA) role evaluation and iii) development of crisis management strategies. Research methodology is composed of 3 phases. Phase I: Two focus groups (FG) were set-up, one for pharmaceutical distribution (FGPD) and one for community pharmacy (FGCP). Phase II: Two questionnaires, one for pharmacists working in pharmaceutical distribution (QPD) and one for community pharmacists (QCP) were developed. In the questionnaires a 1-5 scale was used for rating probability and severity of crisis scenarios. Risk Priority Numbers (RPNs) were obtained by multiplying probability and severity ratings. Questionnaire participants rated crisis measure effectiveness and feasibility from 1-5 and Mean Ratings (MRs) for effectiveness and feasibility were determined for each measure from participants’ ratings. Six case studies in the community pharmacy and pharmaceutical distribution settings were explored. Phase III: Results obtained from the focus groups and questionnaires were used to develop crisis management strategies for the pharmaceutical distribution and community pharmacy settings. FGPD (N=4) and FGCP (N=6) analysis identified the following common themes: i) lessons learnt from past crises, ii) potential crises and effectiveness/feasibility of crisis measures, iii) NCA role in crisis preparedness/management and inter-organisation collaboration in crisis scenarios. Cost and operational constraints were factors limiting the effectiveness/feasibility of crisis measures. QPD participants (N=22) rated trade restrictions, (RPN=13.53), sudden regulatory changes (RPN=12.54), and pandemic (RPN=12.48) as the highest risk crisis scenarios. For supply chain disruptions due to trade restrictions and pandemic, procurement of therapeutic alternative products and collaboration with external entities were rated as the most effective crisis measures (MR=4.2) while collaboration with external entities was the most feasible crisis measure (MR=3.9). For sudden regulatory changes, fostering of a positive working relationship with the regulatory authority was rated as an effective (MR=4.3) and feasible (MR=4.2) crisis measure. QCP participants (N=47) rated critical medicine shortage (RPN=14.43), medication error (RPN=12.3), and short notice unavailability of the pharmacist (RPN=12.24) as the highest risk crisis scenarios. Recommendation of alternative therapy as a crisis measure against critical medicine shortages was rated as effective (MR=3.9) and feasible (MR=3.4). SOPs for medicine dispensing as a crisis measure against medication errors was rated as both effective (MR=3.7) and feasible (MR=3.7), while recording of patient contact details by the pharmacy was rated as more effective (MR=4.1) but less feasible (MR=3.3). [...]