Medicines In Australia Research Articles

An Analysis of Australia's Legal Framework for Access to More Affordable but Unapproved Medicines and Biologics.

Approved medicines are not always sufficient to address the needs of patients so several legal pathways exist to enable access to unapproved medicines for treatment purposes. This article is the first to provide an in-depth analysis of this regulatory framework that governs access to unapproved medicines in Australia with a specific focus on affordability-motivated access. Legislation, regulations, and guidelines were critically analysed to identify the de jure basis for importation and supply of unapproved medicines in Australia. Most pathways for accessing unapproved medicines do not permit importation or supply for non-clinical justifications such as affordability. This is problematic as it fails to recognize that a medicine being unavailable is equivalent to a medicine being unaffordable for a patient. Better alignment can be achieved by permitting importation and supply of unapproved medicines if justified by good medical practice, which includes considerations of equity and access. It is also shown that the provisions of the Special Access Scheme Category A could be interpreted broadly to expand its use. As medicines become more expensive and cost-barriers to treatment are more prevalent, ignoring affordability as a valid criterion for importing medicines is a significant oversight of current regulation.

Unravelling the Association Between Uncertainties in Model-based Economic Analysis and Funding Recommendations of Medicines in Australia.

Health technology assessment is used extensively by the Pharmaceutical Benefits Advisory Committee (PBAC) to inform medicine funding recommendations in Australia. The PBAC often does not recommend medicines due to uncertainties in economic modelling that result in delaying access to medicines for patients. The systematic identification of which uncertainties can be reduced with alternative evidence or the collection of additional data can help inform recommendations. This study aims to characterise different types of uncertainty in economic models and empirically assess their association with the PBAC recommendations. A framework was developed to characterise four types of uncertainties: methodological, structural, generalisability and parameter uncertainty. The first two types were further subcategorised into parameterisable and unparameterisable uncertainty. Data on uncertainty and other factors were extracted from PBAC's Public Summary Documents of first submissions for 193 medicine (vaccine)-indication pairs including economic modelling between 2014 and 2021. Logistic regression was used to estimate the average marginal effect of each type of uncertainty on the probability of a positive recommendation. The PBAC more often raised issues regarding parameter uncertainty (95%) and parameterisable structural uncertainty (83%) than generalisability uncertainty (48%) and unparameterisable methodological uncertainty (56%). The logistic regression results suggested that the PBAC was more likely to recommend a medicine without unparameterisable methodological, generalisability, and parameterisable structural uncertainty by 15.0%, 10.2 %, and 17.6%, respectively. Parameterisable methodological, unparameterisable structural and parameter uncertainty were not significantly associated with the PBAC recommendations. This study identified the uncertainties that had significant associations with PBAC recommendations based on the first submission. This may help improve model quality and reduce resubmissions in the future, thus improving patients' access to medicines.

Environmental impact of inhaled medicines: A Thoracic Society of Australia and New Zealand position statement.

Globally, more than 1.2 billion inhalers are purchased for asthma and chronic obstructive pulmonary disease (COPD) annually. In Australia and New Zealand, pressurized metered dose inhalers (pMDIs) are the leading delivery device prescribed and pMDI salbutamol can be purchased over the counter in Australia. These inhalers are a major contributor to healthcare related greenhouse gases. This is due to the propellants that they currently contain which have extremely high global warming potential (GWP). In this position paper, we report the findings of a Thoracic Society of Australia and New Zealand (TSANZ) working group on the environmental impact of inhaled respiratory medicines. We reviewed the use of inhaled medicines in Australia and New Zealand and their contribution to climate change and other environmental degradation. We propose strategies for health professionals and consumers to reduce environmental impact in the management of airway diseases. These include accurate diagnosis to avoid unnecessary treatment, better disease control to minimize the need for reliever therapy and actively choosing inhaler devices with lower environmental impacts when clinically appropriate. Inhaler selection should be tailored to the individual, aiming to achieve the best possible clinical outcome. Choosing an appropriate inhaler for an individual involves consideration of factors such as dexterity, inspiratory capacity and cost. In our current climate emergency and with the availability of lower carbon alternatives, health professionals should also consider environmental impact.

Bring Out Your Dead: A Review of the Cost Minimisation Approach in Health Technology Assessment Submissions to the Australian Pharmaceutical Benefits Advisory Committee.

Published literature has levied criticism against the cost-minimisation analysis (CMA) approach to economic evaluation over the past two decades, with multiple papers declaring its 'death'. However, since introducing the requirements for economic evaluations as part of health technology (HTA) decision-making in 1992, the cost-minimisation analysis (CMA) approach has been widely used to inform recommendations about the public subsidy of medicines in Australia. This research aimed to highlight the breadth of use of CMA in Australia and assess the influence of preconditions for the approach on subsidy recommendations METHODS: Relevant information was extracted from Public Summary Documents of Pharmaceutical Benefits Advisory Committee (PBAC) meetings in Australia considering submissions for the subsidy of medicines that included a CMA and were assessed between July 2005 and December 2022. A generalised linear model was used to explore the relationship between whether medicines were recommended and variables that reflected the primary preconditions for using CMA set out in the published PBAC Methodology Guidelines. Other control variables were selected through the Bolasso Method. Subgroup analysis was undertaken which replicated this modelling process. While the potential for inferior safety or efficacy reduced the likelihood of recommendation (p<0.01), the effect sizes suggest that the requirements for CMA were not requisite for recommendation. The Australian practice of CMA does not strictly align with the PBAC Methodology Guidelines and the theoretically appropriate application of CMA. However, within the confines of a deliberative HTA decision-making process that balances values and judgement with available evidence, this may be considered acceptable, particularly if stakeholders consider the current approach delivers sufficient clarity of process and enables patients to access medicines at an affordable cost.

Trends in use of medicines for opioid agonist treatment in Australia, 2013–2022

BackgroundThere are limited longitudinal data on national patterns of opioid agonist treatment (OAT). This study describes 10-year trends in the sales of OAT medicines in Australia. MethodsA descriptive and time-series analysis of methadone, sublingual (SL) buprenorphine (+/−naloxone), and long-acting injectable (LAI) buprenorphine sold in Australia between 2013 and 2022 was performed. Total units sold were converted into an estimate of the number of clients that could be treated over a 28-day period with that amount of medicine (‘client-months’). ResultsBetween January 2013 and December 2022, the estimated number of client-months on: any OAT increased by 50 % to 53,501, methadone decreased (−8.5%), SL buprenorphine increased (+78%), and LAI buprenorphine increased substantially after September 2019. In January 2013, 78 % of OAT client-months received methadone. By December 2022, 48 % received methadone, 26 % SL buprenorphine, and 26 % LAI buprenorphine. Between 2013 to 2022, OAT client-months per capita were highest in the state of New South Wales. Over the study period, greater increases in OAT were observed in very remote areas (88%) compared to major cities (53%). The number of client-months in non-community pharmacy settings remained stable from 2013 to 2019/20, before increasing markedly. The introduction of LAI buprenorphine was associated with an immediate, sustained increase of 1,636 OAT client-months, and further increases of 190 OAT client-months each month. ConclusionPatterns of OAT have shifted over the last 10-years with buprenorphine (SL/LAI) now the most common OAT used in Australia. The introduction of LAI buprenorphine has expanded OAT access, particularly in non-community pharmacy settings, and in remote areas.

Prevalence of Australians exposed to potentially cardiotoxic cancer medicines: a population-based cohort study

Cardiovascular disease (CVD) and cancer are leading causes of death and people with cancer are at higher risk of developing CVD than the general population. Many cancer medicines have cardiotoxic effects but the size of the population exposed to these potentially cardiotoxic medicines is not known. We aimed to determine the prevalence of exposure to potentially cardiotoxic cancer medicines in Australia. We identified potentially cardiotoxic systemic cancer medicines through searching the literature and registered product information documents. We conducted a retrospective cohort study of Australians dispensed potentially cardiotoxic cancer medicines between 2005 and 2021, calculating age-standardised annual prevalence rates of people alive with exposure to a potentially cardiotoxic medicine during or prior to each year of the study period. We identified 108,175 people dispensed at least one potentially cardiotoxic cancer medicine; median age, 64 (IQR: 52-74); 57% female. Overall prevalence increased from 49 (95%CI: 48.7-49.3)/10,000 to 232 (95%CI: 231.4-232.6)/10,000 over the study period; 61 (95%CI: 60.5-61.5)/10,000 to 293 (95%CI: 292.1-293.9)/10,000 for females; and 39 (95%CI: 38.6-39.4)/10,000 to 169 (95%CI: 168.3-169.7)/10,000 for males. People alive five years following first exposure increased from 29 (95%CI: 28.8-29.2)/10,000 to 134 (95%CI: 133.6-134.4)/10,000; and from 22 (95%CI: 21.8-22.2)/10,000 to 76 (95%CI: 75.7-76.3)/10,000 for those alive at least 10 years following first exposure. Most people were exposed to only one potentially cardiotoxic medicine, rates of which increased from 39 (95%CI: 38.7-39.3)/10,000 in 2005 to 131 (95%CI: 130.6-131.4)/10,000 in2021. The number of people exposed to efficacious yet potentially cardiotoxic cancer medicines in Australia is growing. Our findings can support the development of service planning and create awareness about the magnitude of cancer treatment-related cardiotoxicities. NHMRC Centre for Research Excellence in Medicines Intelligence, Cancer Institute NSW Early Career Fellowship.

Persistence and Adherence to Cardiovascular Medicines in Australia.

Background The burden of cardiovascular disease is increasing, with many people treated for multiple cardiovascular conditions. We examined persistence and adherence to medicines for cardiovascular disease treatment or prevention in Australia. Methods and Results Using national dispensing claims for a 10% random sample of people, we identified adults (≥18 years) initiating antihypertensives, statins, oral anticoagulants, or antiplatelets in 2018. We measured persistence to therapy using a 60-day permissible gap,and adherence using the proportion of days covered up to 3 years from initiation, and from first to last dispensing. We reported outcomes by age, sex, and cardiovascular multimedicine use. We identified 83 687 people initiating antihypertensives (n=37 941), statins (n=34 582), oral anticoagulants (n=15 435), or antiplatelets (n=7726). Around one-fifth of people discontinued therapy within 90 days, with 50% discontinuing within the first year. Although many people achieved high adherence (proportion of days covered ≥80%) within the first year, these rates were higher when measured from first to last dispensing (40.5% and 53.2% for statins; 55.6% and 80.5% for antiplatelets, respectively). Persistence was low at 3 years (17.5% antiplatelets to 37.3% anticoagulants). Persistence and adherence increased with age, with minor differences by sex. Over one-third of people had cardiovascular multimedicine use (reaching 92% among antiplatelet users): they had higher persistence and adherence than people using medicines from only 1 cardiovascular group. Conclusions Persistence to cardiovascular medicines decreases substantially following initiation, but adherence remains high while people are using therapy. Cardiovascular multimedicine use is common, and people using multiple cardiovascular medicines have higher rates of persistence and adherence.

A nationwide study of multimedicine use in people treated with cardiovascular medicines in Australia.

Multimorbidity and multimedicine use are common in people with cardiovascular disease and can lead to harms, such as prescribing errors and drug interactions. We quantified multimedicine use in people treated with cardiovascular medicines in a national sample of Australians. Cross-sectional study. Pharmaceutical dispensing claims for a 10% random sample of Australians. Australian adults dispensed any cardiovascular medicine between June and August 2019. None. We quantified the number and type of cardiovascular and non-cardiovascular medicines dispensed during the study period, and the number of unique prescribers, by age and sex. We identified 493,081 people dispensed any cardiovascular medicine (median age=67 years, 50.2% women). The population prevalence of cardiovascular medicine dispensing increased from 1.7% (n= 10,503) in people 18-34 years to 80.1% (n= 99,271) in people 75-84 years. Cardiovascular medicine dispensing varied by sex; women 18-34 years were more likely to be dispensed any cardiovascular medicine than men (male:female prevalence ratio [PR]=0.84, 95% confidence interval [CI]=0.81-0.87), whereas the prevalence of cardiovascular medicine dispensing was higher in men 35-44 years (PR=1.27, 95% CI 1.24-1.30) and 45-54 years (PR=1.24, 95% CI 1.22-1.26) and was similar between sexes in people ≥65 years. Overall, both women and men were dispensed a median of 2.0 (interquartile range [IQR]=1.0-3.0) cardiovascular medicines. Two-thirds of people ≥65 years (73.5%; n= 208,524) were dispensed ≥2 cardiovascular medicines, with 16.6% (n= 6736) of people ≥85 years dispensed five or more. Women and men were dispensed a median of 2.0 (IQR=1.0-5.0) and 2.0 (IQR=0.0-4.0) non-cardiovascular medicines, respectively, to treat comorbid conditions, commonly gastroesophageal reflux disease medicines (32.2% of women and 26.6% of men), antibiotics (28.7% of women and 22.4% of men), and antidepressants (26.3% of women and 15.9% of men). One quarter of both sexes had multiple prescribers for their cardiovascular medicines alone, whereas 54.5% (n= 134,939) of women and 49.9% (n= 122,706) of men had multiple prescribers for all medicines. Multimedicine use is common in people treated with cardiovascular medicines and presents a risk for inappropriate prescribing. Understanding the comorbid conditions commonly treated concurrently with cardiovascular disease can help improve co-prescribing guidelines and develop a person-centered approach to multimorbidity treatment.

Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia

National Regulatory Authorities (NRAs) globally are facing the challenge of evaluating pharmaceutical products in a speedy manner, whilst simultaneously ensuring adequate efficacy, safety and quality of approved products. Additionally, common expectations include that the evaluation process is competent, flexible, commensurate with risk, efficient and rapid. In 2014, the Australian regulatory system was out of step with global regulatory developments which led to a comprehensive regulatory review and reform process. As part of the reforms, two Facilitated Regulatory Pathways (FRP) were developed for prescription medicines: Priority Review (PR) and Provisional Approval (PA). Furthermore, regulatory reliance and recognition arrangements have been expanded with the Therapeutic Goods Administration (TGA) making increased use of evaluation reports by trusted NRAs. The new pathways have been utilised by the pharmaceutical industry in Australia since 2017, with the number of medicines going through these pathways gradually increasing. Additional facilitated pathways have been developed following the review, providing alternatives to the standard pathway for registration of prescription medicines in Australia. The reform is timely, helping to position Australia well in the current global regulatory climate.

Using electronic admission data to monitor temporal trends in local medication use: Experience from an Australian tertiary teaching hospital.

Background and aims: Medication usage varies according to prescribing behavior, professional recommendations, and the introduction of new drugs. Local surveillance of medication usage may be useful for understanding and comparing prescribing practices by healthcare providers, particularly in countries such as Australia that are in the process of enhancing nationwide data linkage programs. We sought to investigate the utility of electronic hospital admission data to investigate local trends in medication use, to determine similarities and differences with other Australian studies, and to identify areas for targeted interventions. Methods: We performed a retrospective longitudinal analysis using combined data from a hospital admissions administrative dataset from a large tertiary teaching hospital in Adelaide, South Australia and a hospital administrative database documenting medication usage matched for the same set of patients. All adult admissions over a 12-year period, between 1 January 2007 and 31st December 2018, were included in the study population. Medications were categorized into 21 pre-defined drug classes of interest according to the ATC code list 2021. Results: Of the 692,522 total admissions, 300,498 (43.4%) had at least one recorded medication. The overall mean number of medications for patients that were medicated increased steadily from a mean (SD) of 5.93 (4.04) in 2007 to 7.21 (4.98) in 2018. Results varied considerably between age groups, with the older groups increasing more rapidly. Increased medication usage was partly due to increased case-complexity with the mean (SD) Charlson comorbidity index increasing from 0.97 (1.66) in 2007-to-2012 to 1.17 (1.72) in 2013-to-2018 for medicated patients. Of the 21 medication classes, 15 increased (p < 0.005), including antithrombotic agents; OR = 1.18 [1.16–1.21], proton pump inhibitors; OR = 1.14 [1.12–1.17], statins; OR = 1.12; [1.09–1.14], and renin-angiotensin system agents; OR = 1.06 [1.04–1.08], whilst 3 decreased (p < 0.005) including anti-inflammatory drugs (OR = 0.55; 99.5% CI = 0.53–0.58), cardiac glycosides (OR = 0.81; 99.5% CI = 0.78–0.86) and opioids (OR = 0.82; 99.5% CI = 0.79–0.83). The mean number of medications for all admissions increased between 2007 and 2011 and then declined until 2018 for each age group, except for the 18-to-35-year-olds. Conclusion: Increased medication use occurred in most age groups between 2007 and 2011 before declining slightly even after accounting for increased comorbidity burden. The use of electronic hospital admission data can assist with monitoring local medication trends and the effects of initiatives to enhance the quality use of medicines in Australia.

Progressivity of out-of-pocket costs for Medicare-subsidised services and medicines in Australia.

ObjectivesIn line with affordability and equity principles, Medicare—Australia’s universal public health insurance system—has measures to limit out-of-pocket costs (OOPC), especially among lower income households. We examined the distribution of OOPC for Medicare-subsidised out-of-hospital services and prescription medicines, for Census households, according to their ability to pay. MethodsWe used 2016 Australian Census data linked to Medicare claims to obtain OOPC for out-of-hospital services and medicines in each household in 2017-18. We derived household disposable income by combining income information from the Census linked to income tax and social security data. All data were available from the Multi-Agency Data Integration Project, enabled through a partnership of various government agencies. We quantified OOPC as a proportion of equivalised household disposable income and calculated Kakwani indices (K) to measure progressivity. We also used linked National Health Survey data to analyse costs separately by chronic conditions. ResultsWe analysed 85% (n=6,830,365) of all Census private households. Overall, OOPC as a percentage of equivalised household disposable income decreased from 1.16% (out-of-hospital services) and 1.35% (prescription medicines) in the poorest decile to 0.63% and 0.34% in the richest decile, respectively. The regressive trend was less pronounced for out-of-hospital services (K = -0.06), with percentage OOPC relatively stable between the 2nd and 9th income deciles; while percentage OOPC decreased steeply with increasing income for medicines (K = -0.24). (Chronic conditions results will be presented—embargoed at time of submission) ConclusionOOPC for out-of-hospital Medicare services were mildly regressive while those for prescription medicines were distinctly regressive. Actions to reduce inequity in OOPC for medicines, such as reducing the co-payments for low income households should be considered.

Characterising the use of varenicline: an analysis of the Australian dispensing claims data.

Background and aimsIn Australia, patterns of use of smoking cessation medications and factors associated with their dispensing are currently not known. This study aimed to measure the demographic and clinical factors associated with varenicline dispensing compared with nicotine replacement therapy (NRT) and bupropion among first‐time users of Pharmaceutical Benefits Scheme (PBS) subsidised smoking cessation medicines in Australia and to characterise those who discontinued varenicline treatment prematurely.DesignRetrospective, population‐based study. Logistic regression was used to identify factors associated with varenicline dispensing compared with NRT and bupropion. Sensitivity analyses estimated the proportion of individuals who completed the recommended 12 weeks of varenicline treatment.Setting and participantsFirst‐time users of PBS subsidised smoking cessation medicines in Australia. Individuals first dispensed a smoking cessation medicine between 2011 and 2019 were identified from a 10% random sample of the national dispensing claims data.MeasurementsThe outcome for the regression analysis was the dispensing of varenicline compared with NRT and bupropion. The dispensing of a smoking cessation medicine was identified using the World Health Organization Anatomical Therapeutic Chemical Classification System and PBS item codes. Independent variables included demographic and clinical characteristics such as sex, age, concessional status, year of treatment initiation and comorbidities identified using the Rx‐Risk index. The proportion of people who discontinued varenicline treatment after the initiation pack was determined using prescription refill data.FindingsA total of 94 532 people had their first PBS subsidised smoking cessation medicine. Of these, 62 367 (66.0%) were dispensed varenicline, 29 949 (31.7%) NRT and 2216 (2.3%) bupropion. The odds of varenicline dispensing were higher in males (OR, 1.18; 95% CI, 1.14–1.21), but lower in older adults (0.86 [0.82–0.90] in above 30 years to 0.49 [0.47–0.52] in 61 years and above), among concession beneficiaries (0.44; 0.43–0.46), and those with congestive heart failure (0.60; 0.53–0.68), depression (0.61; 0.54–0.69), anxiety (0.70; 0.66–0.73), psychotic illness (0.39; 0.37–0.42), and chronic obstructive pulmonary disease (0.87; 0.82–0.92). The majority (37 670; 60.4%) of those dispensed varenicline discontinued treatment after the initiation pack. Anxiety and psychotic illnesses were significantly more prevalent in those who discontinued treatment. Only 2804 (4.5%) of those dispensed varenicline completed 12 weeks of treatment.ConclusionIndividuals dispensed varenicline in Australia appear to be healthier compared with those who are dispensed nicotine replacement therapy or bupropion.

Generating Real-World Evidence on the Quality Use, Benefits and Safety of Medicines in Australia: History, Challenges and a Roadmap for the Future.

Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health resources. Medication data linked with other routine collections enable evidence generation in pharmacoepidemiology; the science of quantifying the use, effectiveness and safety of medicines in real-world clinical practice. This review details the history of medicines policy and data access in Australia, the strengths of existing data sources, and the infrastructure and governance enabling and impeding evidence generation in the field. Currently, substantial gaps persist with respect to cohesive, contemporary linked data sources supporting quality use of medicines, effectiveness and safety research; exemplified by Australia’s limited capacity to contribute to the global effort in real-world studies of vaccine and disease-modifying treatments for COVID-19. We propose a roadmap to bolster the discipline, and population health more broadly, underpinned by a distinct capability governing and streamlining access to linked data assets for accredited researchers. Robust real-world evidence generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable health care and improve the health and well-being of all Australians.

Pharmaceutical industry payments and assisted reproduction in Australia: a retrospective observational study

ObjectivesTo investigate the extent and nature of pharmaceutical industry payments related to fertility and assisted reproduction in Australia.Design and settingThis retrospective observational study employed four databases compiled from publicly available...

\u201cDrugs to avoid\u201d to improve quality use of medicines: how is Australia faring?

BackgroundEach year, the French independent bulletin Prescrire publishes a list of medicines, “Drugs to avoid”, that should not be used in clinical practice as their risk-to-benefit ratio is unfavourable. This study assessed the market approval, reimbursement and use of these medicines in Australia.MethodsThe approval status of the medicines included in 2019 Prescrire “Drugs to avoid” list was assessed by searching the Australian Register of Therapeutic Goods website. Funding status was assessed on the Pharmaceutical Benefits Scheme (PBS) website, the Australian public insurance system. Use levels were determined by examining governmental reports on prescribing rates including the Australian Statistics on Medicines (ASM) reports, drug use reports released by the Drug Utilisation Sub Committee (DUSC) and PBS statistics.ResultsOf the 93 medicines included in the Prescrire 2019 “Drug to avoid” list included, 57 (61%) were approved in Australia in 2019 including 9 (16%) that were sold as over-the-counter medicines, 35 (38%) were listed on the PBS, 22 (24%) were registered but not listed on the PBS. Although most of these medicines were used infrequently, 16 (46%) had substantial use despite serious safety concerns. Dipeptidyl peptidase-4 (DPP-4) inhibitors were used by 22% of patients receiving a treatment for diabetes in 2016. More than 50,000 patients received an anti-dementia medicine in 2014, a 19% increase since 2009. Denosumab became the 8th medicine, in terms of total sales, funded by the Australian Government in 2017–2018.ConclusionsPrescrire’s assessments provide a reliable external benchmark to assess the current use of medicines in Australia. Sixteen “drugs to avoid”, judged to be more harmful than beneficial based on systematic, independent evidence reviews, are in substantial use in Australia. These results raise serious concerns about the awareness of Australian clinicians of medicine safety and efficacy. Medicines safety has become an Australian National Health Priority. Regulatory and reimbursement agencies should review the marketing and funding status of medicines which have not been shown to provide an efficacy and safety at least similar to alternative therapeutic options.

GMO Medicines and hospital pharmacy practice: a review

AbstractResearch into gene therapy and genetically modified organism (GMO) medicines is intensifying. Whilst there are only a small number of GMO medicines which have successfully reached registration, Australian hospital pharmacy departments may find themselves in a position where they are required to handle, prepare and dispense this emerging class of therapy in a clinical trial setting. This article explores current literature concerning the management of GMO medicines in a hospital setting. Currently, the bulk of GMO medicines employ the use of viral vectors to deliver therapeutic genetic material into patients. The use of biohazardous agents such as viral vectors presents a new set of safety risks to both patients and pharmacy staff. Pharmacists need to be aware of the safety risks surrounding the use of GMO medicines and implement procedures to handle these medicines safely. Further, pharmacists will need to be familiar with the Gene Technology Act 2000 in addition to the state and federal regulations governing the use of medicines in Australia.

Analysis of drug shortages across two countries during pre-pandemic and pandemic times

Drug shortages have a negative impact on individual health outcomes for patients and health care systems more broadly. In recent years, regulatory bodies, such as the Therapeutic Good Administration in Australia, have provided information about an increasing number of drug shortages. It is reported that 90% of medicines in Australia are imported; this leaves Australia vulnerable to international drug shortages. It has been suggested that Australia is heavily reliant on the US as its primary source of medicines. To determine whether there are significant trends in the quantity, frequency, and nature of drug shortages between the US and Australia in a pre-pandemic and pandemic climate. This study mapped and analyzed drug shortages reported by both the United States Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) in 2019 and 2020. In 2019 (pre-COVID19), only 4% of US drug shortages were reported in Australia; this rose to 7% in 2020. Between 2019 and 2020, the number of US drug shortages increased by 37%, whilst the number of Australian drug shortages increased by 300%. The Australian pharmaceuticals market is indeed more vulnerable to drug shortages, particularly in the event of a global pandemic such as COVID-19. However, these shortages are not significantly influenced by the US drug market.

Risks of Squamous Cell Carcinoma of The Lip and Cutaneous Melanoma in Older Australians Using Hydrochlorothiazide (HTCZ)

IntroductionHCTZ is first-line treatment for hypertension and among the most commonly used medicines in Australia. Recent evidence suggests increased risks of lip and skin cancers in association with HCTZ use.&#x0D; Objectives and ApproachTo determine the risk of SCC of the lip and melanoma among people prescribed HCTZ in Australia we conducted a case-control study nested within a cohort of Department of Veterans’ Affairs clients 65 years and older in 2004-2015. We identified incident cases of SCC of the lip (lip cancer) and of cutaneous melanoma (malignant melanoma), each matched by sex and age with up to 20 controls through risk-set sampling. We ascertained HCTZ use from dispensing data and classified use according to ever/never use and cumulative use. We estimated odds ratios (ORs) associating HCTZ use with lip cancer and malignant melanoma using conditional logistic regression, adjusting for predefined confounders obtained from dispensing and hospitalisation data.&#x0D; ResultsFor lip cancer (45 cases) ever-use of HCTZ yielded an OR of 2.6 (95%CI: 1.4–5.0) and high HCTZ use (&gt;25,000mg) an OR of 4.7 (1.61–13.7). For malignant melanoma (659 cases) ever-use of HCTZ resulted in an OR of 1.2 (1.0–1.5) and high HCTZ use in an OR of 1.2 (0.8–1.8).&#x0D; Conclusion / ImplicationsOur study provides further evidence that the photosensitising properties of HCTZ may promote SCC carcinogenesis, and possibly melanoma, in susceptible sun-exposed tissues. Our findings are the first from the Australian population—already at elevated risk of developing skin cancer—and add to the growing body of data supporting the need for skin cancer prevention advice and behaviours, and potentially heightened surveillance, for individuals prescribed this medication.

OP544 Appraising Variation In Health Technology Assessment Of Novel Immuno-Oncology Medicines In Australia, Canada, France, And The United Kingdom

IntroductionDemonstrating the value of medicines through health technology assessment (HTA) systems is becoming increasingly complex. Innovative therapies – such as immuno-oncology (IO) agents – are testing limits of methodological approaches in markets with established HTA systems. The objective of this study is to understand how requirements, approaches, and decision-making differ between select HTA agencies with a focus on specific PD-1/PD-L1 (programmed death receptor-1/programmed death-ligand 1) agents and cancer indications, and to describe how this variation impacts patient access. To achieve this objective, we conducted a detailed HTA dossier review for several recently launched IO products across Australia (AU), Canada (CA), France (FR), and the United Kingdom (UK).MethodsContent experts reviewed HTA dossiers for pembrolizumab, nivolumab, and atezolizumab for non-small cell lung cancer (NSCLC) first-line monotherapy, NSCLC combination therapy, and adjuvant melanoma. A systematic analytic framework was developed to understand best-practice methodology across systems. Information on submitted data, patient/expert input, and access decisions were extracted; key themes were identified and refined through workshop discussion, and probed further through blinded primary research with eight individuals with current or recent experience of HTA systems.ResultsWe identified six major elements of variation impacting decision-making: evidentiary expectations for biomarkers, use/impact of patient-centered data; use/impact of real-world data, acceptance of surrogate endpoints, approaches for clinical data extrapolation, and accepted time horizons. Considerable variation in time to access was observed; for pembrolizumab (NSCLC first-line monotherapy), time from product registration to HTA decision ranged from 42 (CA) to 487 (AU) days; time from registration to listing ranged from 189 (CA) to 605 (AU) days.ConclusionsEvaluated HTA systems demonstrate a large degree of variability in approaches to decision-making for novel IO medicines; resultant access decisions and time to access are also highly variable. Inconsistency between systems and duplication of effort when assessing similar clinical/economic data could be contributing to limited or delayed patient access; the relationship merits further exploration. Assessed HTA systems are currently undergoing process revisions but expert input suggests that this is not expected to reduce variation, and could further increase complexity. The influence of parallel scientific advice programs between HTA agencies and regulatory bodies in reducing variation must also be determined.

A bitter pill to swallow: registered nurses and medicines regulation in remote Australia.

Access to essential medicines is a human right and an objective of the National Medicines Policy in Australia. Health workforce distribution characteristics in remote Australia implies registered nurses (RNs) may find themselves responsible for a broader range of activities in the medication management cycle than they would be elsewhere in the nation. The regulation of health professionals and their training requirements provides essential but complex protections for the public. These protections include the National Registration and Accreditation Scheme for health practitioners and the Australian Health Practitioner Regulation Agency. Other levels of control or regulation are also exerted over health professionals via mechanisms such as salaries and funding arrangements, insurance requirements, admitting rights to healthcare facilities, and legislation controlling the use of medicines and therapeutic devices. This study aimed to examine national legislation and regulations concerning the use of medications from a nursing perspective, focusing on the context of health service delivery in remote areas. Australian state and territory medicines legislation and regulations was interrogated for answers to the questions 'Can an RN prescribe a medication?', 'Can an RN dispense a medication?', 'Can an RN supply or issue a medication?' and 'Can an RN administer a medication?' Inconsistencies were identified nationally in the names and general structure of the legislation, the location of information relating to authorised roles with regards to medications and key terms used to describe medicines and the elements of the medication management cycle. Administrations of Schedule 4 and 8 medicine according to an order from an authorised prescriber are the only nationally consistent roles RNs are authorised to undertake with regards to medicines. Twenty-eight variations were identified with regards to additional authorisations for RNs. RNs make up more than half of the registered Australian health professional workforce and are the most consistently distributed across the nation, yet their legislated responsibilities in relation to working with medicines are inconsistent. Given the inconsistencies, RNs providing health care in remote Australia may be unable to undertake aspects of the medication management cycle that their work environment demands in the best interest of their patients and absence of other healthcare providers. The lack of legislative consistency nationally for medicines in Australia is likely to impede timely access to medications for patients. Regulatory inconsistencies may also result in RNs working well below or beyond their legal scope of practice, thereby creating clinical and workforce risks. Such risks are a significant matter for remote health service provision. Resolving these issues will require a collaborative national approach with consideration given to how the health workforce is distributed, current nursing responsibilities and relevant service delivery models for remote Australia.