Medicines reclassification from a pharmaceutical industry perspective: An international qualitative study.

BACKGROUND: Widening access to medicines through reclassification ('switching') of medicines from prescription to non-prescription is an international trend generally welcomed by community pharmacists. Research has focused on scheduling and committee deliberations affecting reclassification, rather than industry aspects, despite industry's role in driving reclassifications. The research aimed to identify how pharmaceutical industry and product-related factors influence reclassification, and to explore stakeholder acceptability of government or third-party driven reclassifications. METHODS: Sixty-five in-depth, semi-structured interviews were conducted with 80 key informants (including representatives from regulatory bodies, industry, pharmacy and medicine) in developed countries including the United States, the United Kingdom, Japan, Australia, and New Zealand. The questions explored barriers and enablers to reclassification at the local (micro-), regional (meso-) and global (macro-) levels. Analysis of transcribed interviews entailed descriptive and thematic approaches. RESULTS: Pharmaceutical industry decisions to drive medicine reclassification reflect characteristics of the company, product, and external environment at all levels. For the company, financial factors, company focus (e.g. on prescription business versus non-prescription business), and capability in non-prescription medicines and reclassification were common influences. Products with significant non-prescription market potential and a well-known prescription medicine brand name most suited reclassification, usually near patent expiry. Barriers included immediate generic entry post-reclassification, and a short-term profitability and/or prescription business focus. Some countries allow government or a third-party (including pharmacy) to drive reclassifications, with examples of successful reclassifications ensuing. Some industry and other participants held concerns about this practice, particularly in the United States. Concerns included insufficient resourcing, and the pharmaceutical company's business, potentially encouraging product withdrawal or legal challenge. CONCLUSIONS: This study is the first to explore both pharmaceutical industry factors affecting reclassification and acceptability of alternate drivers of reclassification. Factors beyond clinical safety and efficacy and the local reclassification environment can influence reclassification. Pharmacy-driven reclassification might be one alternative.

Widening consumer access to medicines through switching medicines to non-prescription: a six country comparison.

BACKGROUND: Switching or reclassifying medicines with established safety profiles from prescription to non-prescription aims to increase timely consumer access to medicines, reduce under-treatment and enhance self-management. However, risks include suboptimal therapy and adverse effects. With a long-standing government policy supporting switching or reclassifying medicines from prescription to non-prescription, the United Kingdom is believed to lead the world in switch, but evidence for this is inconclusive. Interest in switching medicines for certain long-term conditions has arisen in the United Kingdom, United States, and Europe, but such switches have been contentious. The objective of this study was then to provide a comprehensive comparison of progress in switch for medicines across six developed countries: the United States; the United Kingdom; Australia; Japan; the Netherlands; and New Zealand. METHODS: A list of prescription-to-non-prescription medicine switches was systematically compiled. Three measures were used to compare switch activity across the countries: "progressive" switches from 2003 to 2013 (indicating incremental consumer benefit over current non-prescription medicines); "first-in-world" switches from 2003 to 2013; and switch date comparisons for selected medicines. RESULTS: New Zealand was the most active in progressive switches from 2003 to 2013, with the United Kingdom and Japan not far behind. The United States, Australia and the Netherlands showed the least activity in this period. Few medicines for long-term conditions were switched, even in the United Kingdom and New Zealand where first-in-world switches were most likely. Switch of certain medicines took considerably longer in some countries than others. For example, a consumer in the United Kingdom could self-medicate with a non-sedating antihistamine 19 years earlier than a consumer in the United States. CONCLUSION: Proactivity in medicines switching, most notably in New Zealand and the United Kingdom, questions missed opportunities to enhance consumers' self-management in countries such as the United States.

Medicines adherence--evidence for any intervention is disappointing.

Interventions to improve adherence with medicines have been studied for many years. The outcomes, both for improved adherence and clinical indicators, have not been as positive as expected or hoped for. Any improvement in adherence that may occur has not necessarily translated to improved clinical outcomes. The studies are heterogeneous, often of poor quality, with different outcomes and measures of outcome, and with ill-defined interventions, such as a lack of information on specific content of an 'educational' intervention. It appears that interventions are very resource intensive with no cost-effectiveness studies. More research is required into interventions to improve medicines adherence before more health care funding is invested in labour-intensive interventions that appear logical but are not supported by evidence from quality research.

The General Practitioner-Pharmacist Collaboration (GPPC) study: a randomised controlled trial of clinical medication reviews in community pharmacy.

OBJECTIVES: There are conflicting results in studies of pharmacists undertaking medication reviews for older people. With increasing promotion and funding for 'medication reviews' there is a need for them to be standardised, and to determine their effectiveness and the feasibility of providing them from a community pharmacy. The objective was to determine whether involvement of community pharmacists undertaking clinical medication reviews, working with general practitioners, improved medicine-related therapeutic outcomes for patients. METHODS: A randomised controlled trial was carried out in people 65 years and older on five or more prescribed medicines. Community pharmacists undertook a clinical medication review (Comprehensive Pharmaceutical Care) and met with the patient's general practitioner to discuss recommendations about possible medicine changes. The patients were followed-up 3-monthly. The control group received usual care. The main outcome measures were Quality of Life (SF-36) and Medication Appropriateness Index. KEY FINDINGS: A total of 498 patients were enrolled in the study. The quality-of-life domains of emotional role and social functioning were significantly reduced in the intervention group compared to the control group. The Medication Appropriateness Index was significantly improved in the intervention group. Only 39% of the 44 pharmacists who agreed to participate in the study provided adequate data, which was a limitation of the study and indicated potential barriers to the generalisability of the study. CONCLUSION: Clinical medication reviews in collaboration with general practitioners can have a positive effect on the Medication Appropriateness Index. However, pharmacist withdrawal from the study suggests that community pharmacy may not be an appropriate environment from which to expand clinical medication reviews in primary care.

General practitioners' and pharmacists' perceptions of the role of community pharmacists in delivering clinical services.

BACKGROUND: Because community pharmacists are encouraged to provide clinical services, there is a need to determine the role perceptions of both community pharmacists and general practitioners (primary care physicians). Differing role perceptions are likely to result in barriers to pharmacists expanding their roles in health care. OBJECTIVES: The purpose of this study was to investigate whether community pharmacists' and general practitioner's perceptions of the role of community pharmacists may be a barrier to pharmacists increasing their role in medication management. Other potential barriers were also explored that could provide a framework for future research. METHODS: A postal survey to 900 and 1000 randomly selected community pharmacists and general practitioners, respectively, elicited the perceptions of these groups toward the role of community pharmacists. Likert scales were used to quantify the results. RESULTS: The results revealed a gap in perceptions regarding the role of the community pharmacist, with general acceptance of the technical roles but less acceptance of clinical roles by general practitioners. Barriers to increased involvement of community pharmacists in clinical services included a perceived lack of mandate, legitimacy, adequacy, and effectiveness by both groups. Also observed was a lack of readiness to change by community pharmacists. CONCLUSIONS: This study suggests that there are significant barriers to community pharmacists increasing clinical services, both from the community pharmacists themselves and from the general practitioners. Attention to change management in a complex environment will be necessary if community pharmacists are to change their role toward more clinical services.