Innovative tools to investigate risk in pharmaceutical processes

Abstract

Risk is part of our daily language and is used in a variety of contexts. Taking a risk is an option and not an unavoidable action. The key to success is to mitigate the hazards and threats by applying techniques of 'risk management', maximising the chance of a successful outcome and limiting the chance of failure. Risk management, being a preventive and predictive tool, is increasingly becoming a fundamental part of processes also for pharmaceutical and biopharmaceutical sectors as it combines aspects of economics, quality management systems, standards, global harmonisation, new strategic models and allied responsibility. In this scenario, risk management includes systematic procedures for the evaluation, control, communication and reassessment of risks to the quality of a medicinal product across its lifetime. These procedures should also be extended to pharmaceutical processes, such as, in the prescribing and dispensing of medications. The aim of this research was to evaluate the risks of prescribing by pharmacists compared to prescribing by medical practitioners taking antibiotics as a first real case scenario. As part of a background study, interviews with industries extraneous to pharmacy, namely banking, insurance, airline, telephony and food were held to better understand the meaning of risk and the applicability of risk management in various industries. The aim of conducting the interviews was to assess the potential of extrapolating strategies used in these industries to pharmacy. Information gathered during these interviews was compiled, however, it was noted that common words, such as, 'hazard', 'probability, and 'threat' used during the discussions and which are related to risk needed to be standardised before embarking on the assessment of risks in pharmaceutical processes. A glossary comprising risk xviii management terminology particularly for use in a pharmaceutical setting was developed to address this issue. After developing the glossary, the potential risk of pharmacists prescribing a selected number of antibiotics compared to the risk of medical practitioners' prescribing was assessed. Two self-administered questionnaires, one for medical practitioners (APQMedPract) and one for pharmacists (APQPhann) were developed and validated to establish pharmacist's contribution in prescribing antibiotics. Both questionnaires were validated using a two-round Delphi technique. A regression model to statistically analyse and identify differences, if any, of risks involved when antibiotics are prescribed by medical practitioners and pharmacists was developed. The total sample size consisted of 180 medical practitioners and 209 pharmacists. The main risks of pharmacist prescribing a selected number of antibiotics as perceived by medical practitioners were an increased bacterial resistance (51 %, n=92), misdiagnosis (50%, n=90) and possible therapeutic failure (48%, n=86). Pharmacists were regarded as being competent to treat common infections by only 36% (n=64) of physicians, with the main reason given being that pharmacists do not have access to patient records (62%, n=112). Medical practitioners with less than 10 years of professional experience gave a higher rating for pharmacist competence when compared to medical practitioners with 10 or more years of experience (p=0.004). Medical practitioners rated topical fusidic acid (22%, n=37) and mupirocin (21 %, n=35) for bacterial skin infections as velY appropriate antibiotics to be prescribed by pharmacists. Medical practitioners participating in this study were against pharmacist prescribing rights (68%, n=120) due to inadequate clinical training (78%, n=94), inaccessibility of patient records (60%, n=72) and lack of privacy in pharmacies (48%, n=58). These reasons are all modifiable through system changes, such as the introduction of a prescribing course, documentation of patient details on a pre-formulated template and changing physical layout in pharmacies. The main risks of pharmacist prescribing a selected number of antibiotics as perceived by pharmacists were misdiagnosis (57%, n=120), increased bacterial resistance (53%, n=1l1) and possible therapeutic failure (50%, n=105). When evaluating pharmacist's competence as perceived by pharmacists themselves, 50% (n=105) claimed that they felt competent prescribing antibiotics and 93% (n=191) felt comfortable prescribing medicines besides antibiotics for other minor ailments. Lactulose solution was the medication that most pharmacists felt comfortable prescribing (83%, n=158). There was no statistically significant difference between pharmacist's years of practice and competence to prescribe (p=0.787). Pharmacists rated co-amoxiclav for an uncomplicated upper respiratory tract infection (51 %, n=104) and tobramycin drops for bacterial conjunctivitis (50%, n=102) as very appropriate antibiotics for pharmacist prescribing. Pharmacists in this study were in favour of pharmacist prescribing (77%, n=159). Reasons given were that such prescribing would increase their importance as members of the healthcare team (64%, n=102), pharmacists are highly trained professionals (63%, n=100) and are experts in pharmacotherapeutics (60%, n=95). Pharmacists (91%, n=190) claimed that they would be more willing to prescribe if prescribing was done within a collaborative framework with medical practitioners. The risk factors considered in the regression model were extracted from results obtained from APQMedPract and APQPlmnn. These were 'misdiagnosis', 'possible therapeutic failure', 'undercover treatment', 'development of bacterial resistance', 'increased incidence of interactions' and 'patients not taking medications'. The healthcare professional, whether a medical practitioner or a pharmacist, was not found to be a significant predictor of the risk score in the regression model (p=O.l 03). This research evaluated ways how risk in pharmaceutical processes can be measured and made progress in moving the fulcrum of risk management from an art to science by adopting a quality risk management (QRM) approach. Risks involved in pharmacist prescribing a selected number of antibiotics were identified, analysed and evaluated as pmi of the risk assessment exercise. Risk reduction strategies, such as, strengthening the collaboration with medical practitioners to ensure a smoother introduction of pharmacist prescribing in Malta, were proposed and the need for review and communication of risks implicated in antibiotic prescribing by pharmacists were highlighted. This research study can help pharmacists identify risk scenarios III different pharmaceutical processes, rank and analyse the different risks, devise risk management plans and implement risk mitigation strategies to improve outcomes in various pharmaceutical settings. Other case scenarios that can be studied using the same QRM approach adopted in this study are the risks of pharmacists prescribing simvastatin 10mg and other statins.