Is Reclassification of the Oral Contraceptive Pill from Prescription to Pharmacist-Only Cost Effective? Application of an Economic Evaluation Approach to Regulatory Decisions.

BACKGROUND AND OBJECTIVE: Unplanned pregnancies can lead to poorer maternal and child health outcomes. The Australian Therapeutic Goods Administration committee rejected reclassifying a range of oral contraceptive pills (OCPs) from prescription to pharmacist-only medicines in 2015, mainly based on safety concerns. Improving access to OCPs may encourage some women to use contraceptives or switch from other contraceptive methods. However, some adverse events may increase and some women may stop using condoms, increasing their risk of sexually transmitted infections. This study aimed to estimate the cost effectiveness of reclassifying OCPs from prescription to pharmacist-only. PERSPECTIVE: Healthcare system. SETTING: Australian primary care. METHODS: A Markov model was used to synthesise data from a variety of sources. The model included all Australian women aged 15-49 years (N = 5,644,701). The time horizon was 35 years. Contraceptive use before reclassification was estimated using data from the Household, Income and Labour Dynamics in Australia (HILDA) survey, while survey data informed use after reclassification. Health outcomes included pregnancies, pregnancy outcomes (live birth, miscarriage, stillbirth, ectopic pregnancy and abortion), sexually transmitted infections, adverse events (venous thromboembolism, depression, myocardial infarction and stroke), ovarian cancer cases and quality-adjusted life-years. Costs included those related to general practitioner and specialist consultations, contraceptives and other medicines, pharmacist time, hospitalisations and adverse events. All costs were reported in 2016 Australian Dollars. A 5% discount rate was applied to health outcomes and costs. RESULTS: Reclassifying OCPs resulted in 85.70 million quality-adjusted life-years experienced and costs of $46,910.14 million over 35 years, vs. 85.68 million quality-adjusted life-years experienced and costs of $50,274.95 million with OCPs remaining prescription-only. Thus, reclassifying OCPs was more effective and cost saving. However, a sensitivity analysis found that more research on the probability of pregnancy in women not using contraception and not trying to conceive is needed. CONCLUSION: Reclassifying OCPs is likely to be considered cost effective by Australian decision makers.

Cost-Effectiveness of Reclassifying Triptans in Australia: Application of an Economic Evaluation Approach to Regulatory Decisions.

BACKGROUND: Migraine is a common, chronic, disabling headache disorder. Triptans, used as an acute treatment for migraine, are available via prescription in Australia. An Australian Therapeutic Goods Administration (TGA) committee rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to pharmacist-only between 2005 and 2009, largely on the basis of concerns about patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration and free up healthcare resources. OBJECTIVES: To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia. METHODS: The study design included decision-analytic modeling combining data from various sources. Behavior before and after reclassification was estimated using medical practitioner and patient surveys and also administrative data. Health outcomes included migraine frequency and duration as well as adverse events (AEs) discussed by the TGA committee. Efficacy and AEs were estimated using randomized controlled trials and observational studies. RESULTS: Reclassifying triptans will reduce migraine duration but increase AEs. This will result in 337 quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 years for all Australian adults older than 15 years (19.6 million). The incremental cost-effectiveness ratio was estimated to be A$17 412/quality-adjusted life-year gained. CONCLUSIONS: The incremental cost-effectiveness ratio is likely to be considered cost-effective by Australian decision makers. Serotonin syndrome, a key concern of the TGA committee, had little impact on the results. Further research is needed regarding pharmacist-only triptan use by migraineurs currently using over-the-counter medicines and by nonmigraineurs, the efficacy of triptans, and the risk of cardiovascular and cerebrovascular AEs and chronic headaches with triptans.

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.

Treatment of uncomplicated cystitis: analysis of prescribing in New Zealand.

AIMS: To describe prescribing for women with suspected urinary tract infections, including suspected uncomplicated cystitis, in New Zealand. METHODS: Randomly selected community pharmacies participated in the study. Women attending the pharmacy in a 2-week period in 2012 for prescribed or non-prescription treatment of symptoms suggesting a urinary tract infection, or prophylaxis of a urinary tract infection, were invited to self-complete a questionnaire. Analysis focused on prescribing for women with symptoms of cystitis without complicating features. RESULTS: Valid questionnaires arising from a prescription treatment were received from 789 patients from 139 pharmacies. Questionnaire data indicated that 17% of women had symptoms of cystitis without complicating features. Most prescribing was for a first-line agent, trimethoprim (59%) or nitrofurantoin (14%), but norfloxacin was also common (21%). Women with self-reported antibiotic use for suspected cystitis in the past 6 months were more likely to be prescribed norfloxacin than those with no such use. Many prescriptions were for a dose or duration outside those recommended in New Zealand guidelines. CONCLUSIONS: While use of first-line agents is generally high, norfloxacin use could be reduced further. There is scope to understand clinical practice that deviates from guideline use regarding dose and duration.

Barriers to positive policy change that aims to increase access to medicines through reclassification: the case of oseltamivir in New Zealand.

OBJECTIVES: This study aims to identify and explore emergent barriers to consumers accessing oseltamivir without prescription following policy change introduced in New Zealand to increase access via community pharmacies. METHODS: Semi-structured interviews were conducted with 26 community pharmacists immediately following the first season of oseltamivir availability without prescription in October 2007. Interviews were transcribed verbatim and coded using a framework approach to identify themes. KEY FINDINGS: Non-prescription sales of oseltamivir were slow during this period. Participants acknowledged that they may have missed opportunities to recommend oseltamivir and attributed this to a range of reasons. Pharmacy-related barriers identified included limited pharmacist confidence, concerns about efficacy and safety of the product, location of the product in the pharmacy, affordability and the role of support staff. Many pharmacists adopted a 'risk-benefit analysis' that balanced symptom severity with perceived value for money. Consumer barriers included cost, limited awareness of availability and limited ability to correctly self-diagnose and manage influenza. CONCLUSIONS: Complexity in the factors that influenced pharmacist motivation to supply oseltamivir without prescription highlighted the potential for positive policy change to be hindered by multiple barriers. Greater understanding of such barriers is important for effective transition of medicines from prescription to non-prescription availability to achieve increased consumer access through reclassification. Concerns that pharmacists are influenced by commercial priorities when medicines are newly reclassified were not substantiated in this study.

Widening consumer access to medicines: a comparison of prescription to non-prescription medicine switch in Australia and New Zealand.

BACKGROUND: Despite similarities in health systems and Trans-Tasman Harmonization of medicines scheduling, New Zealand is more active than Australia in 'switching' (reclassifying) medicines from prescription to non-prescription. OBJECTIVES: To identify and compare enablers and barriers to switch in New Zealand and Australia. METHODS: We conducted and analyzed 27 in-depth personal interviews with key participants in NZ and Australia and international participants previously located in Australia, and analyzed records of meetings considering switches (2000-2013). Analysis of both sets of data entailed a heuristic qualitative approach that embraced the lead researcher's knowledge and experience. RESULTS: The key themes identified were conservatism and political influences in Australia, and an open attitude, proactivity and flexibility in NZ. Pharmacist-only medicine schedules and individuals holding a progressive attitude were proposed to facilitate switch in both countries. A pharmacy retail group drove many switches in NZ ('third-party switch'), unlike Australia. Barriers to switch in both countries included small market sizes, funding of prescription medicines and cost of doctor visits, and lack of market exclusivity. In Australia, advertising limitations for pharmacist-only medicines reportedly discouraged industry from submitting switch applications. Perceptions of pharmacy performance could help or hinder switches. CONCLUSION: Committee and regulator openness to switch, and confidence in pharmacy appear to influence consumer access to medicines. The pharmacist-only medicine schedule in Australasia and the rise of third-party switch and flexibility in switch in NZ could be considered elsewhere to enable switch.

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.