Knowledge and decisions about maternal immunisation by pregnant women in Aotearoa New Zealand.

BACKGROUND: Maternal vaccinations for influenza and pertussis are recommended in New Zealand to protect mothers and their infant from infection. However, maternal immunisation coverage in New Zealand is suboptimal. Furthermore, there is unacceptable inequitable maternal immunisation rates across the country with Maori and Pacific women having significantly lower maternal immunisation rates than those of other New Zealanders. METHODS: This research set out to explore what pregnant/recently pregnant Maori and Pacific women knew about immunisation during pregnancy and what factors influenced their decision to be vaccinated. A semi-structured interview guide was developed with questions focusing on knowledge of pertussis and influenza vaccination during pregnancy and decision-making. Maori and Pacific women aged over 16 years were purposively sampled and interviewed in Dunedin and Gisborne, New Zealand between May and August 2021. Interviews were analysed following a directed qualitative content approach. Data were arranged into coding nodes based on the study aims (deductive analysis) informed by previous literature and within these participant experiences were inductively coded into themes and subthemes. RESULTS: Not all women were aware of maternal vaccine recommendations or they diseases they protected against. Many underestimated how dangerous influenza and pertussis could be and some were more concerned about potential harms of the vaccine. Furthermore, understanding potential harms of infection and protection provided by vaccination did not necessarily mean women would choose to be vaccinated. Those who decided to vaccinate felt well-informed, had vaccination recommended by their healthcare provider, and did so to protect their and their infant's health. Those who decided against vaccination were concerned about safety of the vaccines, lacked the information they needed, were not offered the vaccine, or did not consider vaccination a priority. CONCLUSIONS: There is a lack of understanding about vaccine benefits and risks of vaccine-preventable diseases which can result in the reinforcement of negative influences such as the fear of side effects. Furthermore, if vaccine benefits are not understood, inaccessibility of vaccines and the precedence of other life priorities may prevent uptake. Being well-informed and supported to make positive decisions to vaccinate in pregnancy is likely to improve vaccine coverage in Maori and Pacific Island New Zealanders.

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.

Analysing the landscape for prescription to non-prescription reclassification (switch) in Germany: an interview study of committee members and stakeholders.

BACKGROUND: Non-prescription medicines are increasingly used in Germany, aided by prescription-to-non-prescription reclassification (or switch). This study aimed to examine the barriers and enablers to reclassification of medicines in Germany and provide recommendations for change. METHODS: Face-to-face conversational interviews with purposively selected key informants in Germany were conducted in 2017 by a researcher informed in the area. Interviews were transcribed, coded in NVIVO and systematically analysed using a framework approach. RESULTS: Twenty-four interviews were conducted with 32 participants including members of the committee considering reclassifications, and representatives from government, industry, health insurance, academia, and pharmacy, medical, and patients' organisations. A range of enablers and barriers emerged that influence reclassification including effects on the committee and process, or the desire of pharmaceutical companies to pursue reclassifications. Enabling market factors included the large population and a culture of self-medication. Enabling health system factors include the pharmacy-only category. Some pharmacy factors appeared enabling (e.g. a positive experience after reclassifying emergency contraception) while others appeared to hinder reclassification (e.g. insufficient pharmacy practice research). Some medical factors were enabling (e.g. reported waiting times) and others limited reclassification (e.g. opposition to some reclassifications). Some committee and government openness to reclassification and self-medication reportedly enabled reclassification, while conservatism was considered a barrier, particularly for classifications with special conditions for supply such as initial doctor diagnosis or other complexities. Some improvements to the committee constitution and considerations were recommended. Some participants found the reclassification process after the committee recommendation opaque, with opportunity for delays and political interference. Industry factors included both enablers such as capability in reclassification, and barriers, such as a perceived low market potential of some reclassifications, and doubt that some candidates would be approved. A need for more data emerged strongly, both pre-reclassification in applications, and post-reclassification. Many participants saw merit with reclassification in non-traditional areas such as hypertension, diabetes and oral contraception. CONCLUSIONS: Many factors influence reclassification in Germany. Recommended improvements included aspects of the process and committee consideration, and more data collection. Sufficient market exclusivity linked to data collection could aid the generation of evidence to aid committee considerations and encourage more applications of high quality.

A qualitative exploration of the over-the-counter availability of oral contraceptive pills in Australia.

INTRODUCTION: The prevention of unintended pregnancy is a public health issue affecting women worldwide. In Australia, women are required to get a prescription to obtain the oral contraceptive pill (OCP), which may limit access and be a barrier to its initiation and continuing use. Changing the availability of the OCP from prescription-only to over-the-counter (OTC) is one solution, however, to ensure success policymakers need to understand women's preferences. Telehealth services also might serve as an alternative to obtain prescriptions and increase accessibility to OCPs. This study aims to explore the preferences for OTC OCPs among Australian women, and whether the expansion of telehealth impacted women's preferences. METHODS: A mixed methods approach was used to explore women's preferences regarding access to the OCP. Focus group discussions (FGDs) were conducted to organically identify the preferences followed by an empirical ranking exercise. Three FGDs in two phases were conducted, pre and post-expansion of telehealth in Australia due to the COVID-19 pandemic. Convenience sampling was employed. The technique of constant comparison was used for thematic analysis where transcripts were analysed iteratively, and codes were allowed to emerge during the process to give the best chance for the attributes to develop from the data. RESULTS: Thematic analysis revealed that women perceived OTC availability of OCPs as a mechanism to increase the accessibility of contraception by reducing cost, travel time, waiting time, and increasing opening hours. They also believed that it would increase adherence to OCPs. However, some potential safety concerns and logistical issues were raised, including pharmacist training, access to patient's medical history, the ability to discuss other health issues or undertake opportunistic health screening, adherence to checklists, and privacy in the pharmacy environment. Following the expansion of telehealth, accessibility issues such as opening hours, travel time, and location of the facility were considered less important. CONCLUSIONS: The participants expressed their support for reclassifying OCPs to OTC, particularly for repeat prescriptions, as it would save valuable resources and time. However, some safety and logistical issues were raised. Women indicated they would balance these concerns with the benefits when deciding to use OTC OCPs. This could be explored using a discrete choice experiment. The expansion of telehealth was perceived to reduce barriers to accessing OCPs. The findings are likely to be informative for policymakers deciding whether to reclassify OCPs to OTC, and the concerns of women that need addressing to ensure the success of any policy change.

Five years of non-prescription oseltamivir: effects on resistance, immunization and stockpiling.

OBJECTIVES: In 2007 New Zealand (NZ) became the first country to make oseltamivir (Tamiflu®) available off-prescription. This study investigated the extent of pharmacist supply of oseltamivir over 5 years, including during the influenza A(H1N1) pandemic, and the impact of pharmacist supply of oseltamivir on influenza virus oseltamivir susceptibility, personal stockpiling and influenza vaccine uptake. METHODS: Randomly selected community pharmacies in NZ reported oseltamivir provision by prescription and through pharmacist supply from 1 January 2007 to 15 September 2011. Oseltamivir resistance data on influenza viruses isolated during influenza surveillance from 2008 to 2011 were obtained, along with influenza vaccine uptake data from 2005 to 2011 and influenza detection data. RESULTS: Seventy of 85 eligible pharmacies completed the study (82% response rate). Most supplies of oseltamivir throughout the 5 years were dispensed against a prescription rather than pharmacist supplied, with pharmacist supply responsible for 11% of supplies during the pandemic years (2009-10) versus 27% and 31% during 2007 and 2008, respectively. Pharmacist-supplied oseltamivir did not appear to be associated with the development of resistance, with identified likely stockpiling or with a decline in influenza immunization. Pharmacist supplies largely matched the timing of influenza in the community and peaked in June 2009, as did prescription supplies. CONCLUSIONS: Five years of non-prescription oseltamivir in NZ has resulted in no significant change in the development of resistance or rates of influenza immunization. Supplies remained modest and significant consumer stockpiling through pharmacist supply has not occurred, even during the influenza A(H1N1)pdm09 pandemic in 2009 and 2010. Pharmacists could be better utilized in ensuring fast distribution of antivirals to influenza sufferers during a pandemic.

Evidence of suboptimal maternal vaccination coverage in pregnant New Zealand women and increasing inequity over time: A nationwide retrospective cohort study.

BACKGROUND: Adequate maternal vaccination coverage is critical for the prevention and control of infectious disease outbreaks such as pertussis, influenza, and more recently COVID-19. To guide efforts to increase vaccination coverage this study examined the extent of vaccination coverage in pregnant New Zealand women over time by area-level deprivation and ethnicity. METHODS: A retrospective cohort study was used consisting of all pregnant women who delivered between 01 January 2013 and 31 December 2018, using administrative health datasets. Outcomes were defined as receipt of influenza or pertussis vaccination in any one of the relevant data sources (National Immunisation Register, Proclaims, or Pharmaceutical collection) during their eligible pregnancy. Ethnicity was prioritised as Maori (NZ indigenous), Pacific, Asian, and Other or NZ European and deprivation was defined using New Zealand Index of Multiple Deprivation (IMD). RESULTS: Between 2013 and 2018, Asian women had the highest maternal vaccination coverage (36%) for pertussis, while Maori and Pacific women had the lowest, 13% and 15% respectively. Coverage of pertussis vaccination during pregnancy in low deprivation Maori women was 24% and 28% in Pacific women. This is in comparison to 30% and 25% in high deprivation Asian and European/Other women, respectively. Similar trends were seen for influenza. CONCLUSION: Between 2013 and 2018 maternal vaccination coverage increased for pertussis and influenza. Despite this coverage remains suboptimal, and existing ethnic and deprivation inequities increased. There is an urgent need to focus on equity, to engage and support ethic communities by creating genuinely accessible, culturally appropriate health services.

Influences on Pregnant Women's and Health Care Professionals' Behaviour Regarding Maternal Vaccinations: A Qualitative Interview Study.

The uptake of maternal influenza and pertussis vaccinations is often suboptimal. This study explores the factors influencing pregnant women's and health care professionals' (HCPs) behaviour regarding maternal vaccinations (MVs). Pregnant/recently pregnant women, midwives, pharmacists and general practice staff in Waikato, New Zealand, were interviewed. The analysis used the behaviour change wheel model. Interviews of 18 women and 35 HCPs revealed knowledge about MVs varied with knowledge deficiencies hindering the uptake, particularly for influenza vaccination. HCPs, especially midwives, were key in raising women's awareness of MVs. Experience with vaccinating, hospital work (for midwives) and training increased HCPs' knowledge and proactivity about MVs. A "woman's choice" philosophy saw midwives typically encouraging women to seek information and make their own decision. Women's decisions were generally based on knowledge, beliefs, HCPs' emphasis and their perceived risk, with little apparent influence from friends, family, or online or promotional material. General practice's concentration on children's vaccination and minimal antenatal contact limited proactivity with MVs. Busyness and prioritisation appeared to affect HCPs' proactivity. Multi-pronged interventions targeting HCPs and pregnant women and increasing MV access are needed. All HCPs seeing pregnant women should be well-informed about MVs, including how to identify and address women's questions or concerns about MVs to optimise uptake.

A service evaluation to explore Maori experiences of direct-acting antiviral hepatitis C treatment in Aotearoa New Zealand.

AIMS: Hepatitis C, and its associated life-limiting sequalae, disproportionately affect Maori. Despite availability of fully funded effective and well-tolerated oral direct-acting anti-viral agents (DAA), many in New Zealand remain untreated. This service evaluation aimed to explore the experiences of Maori who have received DAA treatment for hepatitis C, and their ideas for service improvement. METHODS: This qualitative service evaluation recruited eligible participants (Maori, 18 years+, DAA treatment since February 2019) through health care providers. Semi-structured interviews were undertaken over the telephone with consenting participants. General inductive analysis was used to generate themes contextualising findings within cultural contexts for Maori, as aligned with Maori methodological research practices. RESULTS: Twelve participants were interviewed. The physical and mental impact hepatitis C can have, and that treatment with DAA leads to improvement in these domains, were highlighted. Proactivity by health professionals was valued, including the benefit of wrap-around services to keep people connected throughout the treatment journey, with participants articulating the ability to self-advocate when needs were not met by other services. CONCLUSION: Findings can be used to enhance the development of further hepatitis C treatment services, based on Maori experiences of treatment and self-identified solutions for improvement in hepatitis C care.

Increasing Uptake of Maternal Pertussis Vaccinations through Funded Administration in Community Pharmacies.

Although maternal pertussis vaccination is recommended, uptake is suboptimal in New Zealand (NZ), despite full funding in general practice and hospitals. We determined whether funding maternal pertussis vaccination in community pharmacy increases its uptake. Pertussis vaccination during pregnancy was compared between non-contiguous, demographically similar regions of NZ. The pertussis vaccine was funded at pharmacies from Nov 2016 in one NZ region (Waikato), but not in comparator regions (Northland, Hawkes Bay). Vaccinations during pregnancy were determined from the National Immunisation Register, general practice and pharmacy claims data, and a maternity database. Comparisons were made using adjusted odds ratios (OR) and 95% confidence intervals (CI) for Nov 2015 to Oct 2016 versus Nov 2016 to Oct 2019. The odds of pregnancy pertussis vaccination increased in the post-intervention versus pre-intervention period with this increase being larger (p = 0.0014) in the intervention (35% versus 21%, OR = 2.07, 95% CI 1.89-2.27) versus the control regions (38% versus 26%, OR = 1.67, 95% CI 1.52-1.84). Coverage was lower for Maori versus non-Maori, but increased more for Maori in the intervention versus control regions (117% versus 38% increase). It was found that funding maternal pertussis vaccination in pharmacy increases uptake, particularly for Maori women. Measures to increase coverage should include reducing barriers to vaccines being offered by non-traditional providers, including pharmacies.

Mapping the maternal vaccination journey and influencing factors for Maori women in Aotearoa New Zealand: a qualitative study.

Introduction Uptake of maternal vaccinations (MVs) is suboptimal in Aotearoa New Zealand, particularly for Maori. Aim To describe Maori women's journeys regarding maternal pertussis and influenza vaccinations and explore influences on uptake. Methods Semi-structured interviews were conducted in Waikato, Aotearoa New Zealand, with pregnant or recently pregnant Maori women, and separately with Maori healthcare professionals (HCPs) to understand women's decisions regarding MVs and enablers and barriers to uptake. Results Nine women and nine HCPs were interviewed. Verbal communications from midwives, general practice and pharmacy strongly influenced women's journeys. Women's decisions appeared largely straight-forward, with influences including awareness, knowledge, underlying beliefs and previous MVs. Enablers for MV uptake included HCPs' discussions, pro-vaccination beliefs, and accessibility. Barriers for MV uptake included poverty (and transport), lack of awareness, insufficient knowledge of benefits, late presentation to the midwife and other commitments or challenges in the women's lives affecting prioritisation of the vaccine. Misconceptions, seasonality, and lower HCP emphasis impaired influenza vaccination uptake. Discussion With multiple barriers to accessing MVs, HCPs who see pregnant women are the primary resource to improve awareness, knowledge, and access through korero (discussions) with the woman and, where possible, being able to administer the vaccinations. These HCPs need to be well-informed, aware of likely concerns women may have and how to address them, encourage these discussions and preferably be trusted.

Is non-prescription oseltamivir availability under strict criteria workable? A qualitative study in New Zealand.

OBJECTIVES: in 2007, New Zealand became the first country to make oseltamivir (Tamiflu) available off prescription. Strict rules for supply were developed to ensure that potential public health benefits were balanced against possible risks. We wished to explore the success of implementing this unique decision through elucidating pharmacists' attitudes to and experiences of non-prescription supply of oseltamivir. METHODS: semi-structured interviews with a maximum variation sample of 26 community pharmacists were conducted and analysed using a framework approach. RESULTS: most participants were positive about non-prescription availability of oseltamivir with the majority appearing to apply the rules successfully. However, some rules were difficult to recall and/or frustrating. Supply did not appear to be driven by potential for commercial gain and the inappropriate requests were manageable. Some of these were driven by other health professionals. Pharmacists valued the manufacturer-supplied 'Pharmacist Protocol' and 'Consultation Record' and kept them ready for use. Certain rules potentially restricted consumer access and pharmacists were generally conservative about recommending the medicine. CONCLUSIONS: while pharmacists welcomed non-prescription oseltamivir, the rules for supply frustrated pharmacists and limited potential public health benefits. If medicines are reclassified with various rules of supply, multiple reminders of the rules for supply to pharmacists and other health professionals are desirable along with the rationale for such rules. Protocols and/or consultation pads for use at time of supply are likely to be valued and are an important aid where there is a risk of faulty recall of rules. Research in the first year of availability may highlight issues to address.

Pharmacists' views and desires regarding pharmacist administration of vaccines in New Zealand.

OBJECTIVES: To explore pharmacists' views and experiences of pharmacist-administered vaccinations, motivators and barriers to pharmacists administering vaccinations and their preferences for expansions to such services. METHODS: All practising pharmacist members (n = 3400) of the Pharmaceutical Society of New Zealand were invited to participate in an online survey in 2017. KEY FINDINGS: A total of 468 pharmacists completed the survey (14%). Most (86%) strongly agreed/agreed that pharmacists should provide vaccinations, primarily citing patient benefit, for example, convenience, potential for increased vaccination uptake, easing general practice burden and better utilisation of the pharmacist. Half had completed vaccinator training, mainly for professional satisfaction, to help public or community health and/or to provide a new service for their community. Trained pharmacists had administered influenza (95%), pertussis (47%), zoster (45%) and/or meningococcal vaccines (13%), with patient cost limiting some vaccination uptake. Cost or workplace constraints were leading reasons for the 17% not planning to undertake vaccinator training. Key barriers for pharmacy owners not offering vaccinations were set-up or other costs, insufficient funding (62%) or staffing/time concerns (27%). Some trained vaccinators (39%) wanted the recipient age lowered below 13 years, and 44% wanted intern pharmacists to be able to administer vaccinations. CONCLUSION: This study found strong support for this service, including benefits for patients, and for customer relationships. Identified barriers including service setup and patient costs could be reduced by expanding the categories (e.g. pharmacy students and technicians) of staff able to vaccinate and having more government funded vaccines available through pharmacies, therefore, improving access for patients.

Why are self-medication opportunities limited in Austria? An interview study and comparison with other countries.

BACKGROUND: Austria has high health resource use compared to similar countries. Reclassifying (switching) medicines from prescription to non-prescription can reduce pressure on health resources and aid timely access to medicines. Since Austria is less progressive in this area than many other countries, this research aimed to elucidate enablers and barriers to it reclassifying medicines and make recommendations for change in the context of similar research conducted elsewhere. METHODS: Qualitative research using a heuristic approach was conducted in Austria in 2018. Informed by their own "insider" and "outsider" knowledge, the authors identified themes from personal interviews with 24 participants, including reclassification committee members, government officials and stakeholders, before comparing these themes with earlier research findings. RESULTS: Significant barriers to reclassification included committee conservatism, minimal political support, medical negativity and few company applications. Insufficient transparency about committee decisions, expectations of adverse committee decisions and a limited market discouraged company applications. Austria's 'social partnership' arrangement and consensus decision making aided a conservative approach, but the regulator and an alternative non-committee switch process were enabling. Pharmacy showed mixed interest in reclassification. Suggested improvements include increasing transparency, committee composition changes, encouraging a more evidence-based approach by the committee, more pharmacy undergraduate clinical training, and companies using scientific advisory meetings and submitting high quality applications. CONCLUSION: Removing barriers to reclassification would facilitate non-prescription availability of medicines and encourage self-care, and could reduce pressure on healthcare resources.

Feasibility and outcomes of a hepatitis C screening programme in community pharmacies.

AIMS: To ascertain the feasibility and outcomes of point-of-care testing for hepatitis C virus (HCV) antibodies in people with risk factors screened in community pharmacies. METHODS: Ten pharmacies in the Waitemata District Health Board piloted point-of-care antibody HCV screening with consenting participants. Individuals with a positive HCV antibody result had a confirmatory HCV RNA test performed at a local laboratory, with pharmacist follow-up to discuss the result. RNA positive individuals were referred to their general practitioner for further follow-up including antiviral therapy. Number of tests, number of positives and number treated were collected. Pharmacists completed a survey about their experiences. RESULTS: Of 192 participants, seven (3.6%) had positive tests on screening, four of whom had a positive RNA assay and received HCV medication, and one of whom had a positive RNA assay but has not yet received treatment. Two had negative RNA results. Pharmacist feedback was very positive with most wishing to continue the point-of-care testing service. Most wanted to be able to treat HCV in order to improve linkage to care. CONCLUSIONS: Pharmacy point-of-care testing with immediate results and pharmacist follow-up of positive results can aid diagnosis of HCV in at-risk populations and help treatment uptake.

Pertussis and influenza immunisation coverage of pregnant women in New Zealand.

BACKGROUND: Immunisation is an important public health policy and measuring coverage is imperative to identify gaps and monitor trends. New Zealand (NZ), like many countries, does not routinely publish coverage of immunisations given during pregnancy. Therefore, this study examined pregnancy immunisation coverage of all pregnant NZ women between 2013 and 2018, and what factors affected uptake. METHODS: A retrospective cohort study of pregnant women who delivered between 2013 and 2018 was undertaken using administrative datasets. Maternity and immunisation data were linked to determine coverage of pertussis and influenza vaccinations in pregnancy. Generalised estimating equations were used to estimate the odds of receiving a vaccination during pregnancy. RESULTS: From 2013 to 2018 data were available for 323,622 pregnant women, of whom 21.7% received maternal influenza immunisations and 25.7% maternal pertussis immunisations. Coverage for both vaccines increased over time, pertussis increased from 10.2% to 43.6% and influenza from 11.2% to 30.8%. The odds of being vaccinated, with either vaccine, during pregnancy increased with increasing age and decreasing deprivation. Compared to NZ European or Other women, Maori and Pacific women had lower odds of receiving a maternal pertussis (OR:0.55, 95% CI: 0.54, 0.57; OR:0.60, 95% CI: 0.58, 0.62, respectively) and influenza (OR: 0.69, 95% CI: 0.67, 0.71; OR:0.90, 95% CI: 0.87, 0.94, respectively) immunisations during pregnancy. Women were also more likely to be vaccinated against pertussis if they received antenatal care from a General Practitioner or Obstetrician compared to a Midwife. A similar pattern was seen for influenza vaccination. CONCLUSION: Gaps in maternal coverage for pertussis and influenza exist and work is needed to reduce immunisation inequities.

A Qualitative Study of Views and Experiences of Women and Health Care Professionals about Free Maternal Vaccinations Administered at Community Pharmacies.

Background: A policy to extend funding of maternal pregnancy influenza and pertussis vaccinations to community pharmacies could address low pregnancy vaccine uptake. The policy has been implemented in one region in New Zealand. This study explored the views and experiences of women eligible for the vaccines and health care professionals regarding funded maternal vaccinations in pharmacy. Methods: Women in late pregnancy or with an infant, and midwives, pharmacists, and general practice staff were selected purposively and interviewed regarding maternal vaccinations and the new policy, including their awareness and views of the funded vaccinations in pharmacies, and how this policy worked in practice. Enablers and barriers to vaccination by pharmacists were explored. Interviews were transcribed and analysed using a framework approach. Results: Fifty-three interviews were conducted. Most women and health care professionals viewed funded maternal vaccinations in pharmacies positively with respect to increasing awareness and providing delivery options. Many women received messages from pharmacies. Most pharmacies used posters, leaflets and/or verbal explanation to pregnant women to raise awareness of the vaccinations. Not all pharmacies provided these vaccinations, and frontline staff could help to raise awareness. Conclusion: Funded maternal vaccinations in pharmacies are generally well accepted and provide an opportunity to increase uptake and prevent disease.

Access to cannabidiol without a prescription: A cross-country comparison and analysis.

BACKGROUND: Recent legislative change has allowed increased access to cannabis products in many jurisdictions. In some locations, this includes over-the-counter (OTC) and/or online access to products containing cannabidiol (CBD), a non-intoxicating cannabinoid with therapeutic properties. Here we compared the availability of CBD products and the associated legislative and regulatory background in nine selected countries. METHODS: Accessibility of CBD products was examined in the USA, Canada, Germany, Ireland, United Kingdom, Switzerland, Japan, Australia, and New Zealand as of May 2020. Regulatory and other relevant documents were obtained from government agency websites and related sources. Relevant commercial websites and some physical retailers were visited to verify access to CBD-containing products and the nature of the products available. RESULTS: A range of CBD products appeared to be accessible without prescription in seven out of nine countries reviewed. Australia and New Zealand were the exceptions where clinician prescription was required to access any CBD-containing product. CBD products commonly available without prescription included oils, gel capsules, purified crystal and topical products. The daily recommended doses with orally administered non-prescription products were typically well below 150 mg and substantially lower than the doses reported to have therapeutic effects in published clinical trials (e.g., 300-1500 mg). The legal foundations enabling access in several countries were often unclear, with marketed products sometimes failing to meet legal requirements for sale. There was an obvious disparity between federal directives and available products in both the USA and European countries examined. CONCLUSIONS: There are a variety of approaches in how countries manage access to CBD products. Many countries appear to permit OTC and online availability of CBD products but often without legislative clarity. As consumer demand for CBD escalates, improved legislation, guidelines and quality control of CBD products would seem prudent together with clinical trials exploring the therapeutic benefits of lower-dose CBD formulations.

Adapting the Auckland Sleep Screening Tool for pharmacy: pharmacists' experience and feedback.

INTRODUCTION Insomnia has negative health effects and may indicate underlying serious conditions, but is underdiagnosed and often not discussed with a doctor. AIM This study aimed to explore the utility and workability in New Zealand community pharmacies of a 23-question sleep-screening tool adapted from the Short Auckland Sleep Questionnaire. METHODS A multidisciplinary advisory group (sleep specialist, general practitioner and pharmacists) discussed the tool, pharmacists' capability in managing insomnia and training needs for pharmacists, and recommended management strategies, including referral points. Twelve community pharmacists piloted the tool with people with insomnia who presented in pharmacies, recording the time it took to administer the tool. The pharmacists were then surveyed about their experiences with the tool and possible improvements. RESULTS Ten pharmacists took an average of 12.4 min (range 4-35 min) for each use of the screening tool with 62 people with insomnia. Most pharmacists found the screening tool easy to administer, organised and easy to follow and nine of 10 said it provided better information than their usual consultation. Seven of 10 pharmacists would use it again. Time limitations and low recruitment were potential barriers to usage especially for pharmacy owners. DISCUSSION The screening tool could provide a useful addition to pharmacists' toolkits, aiding information gathering and better than usual practice. The tool was acceptable to most pharmacists, but its use takes time and remuneration needs consideration.

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.

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.