Ensuring access to novel COVID-19 therapeutics in Pacific island countries and areas.

Problem: As of November 2022, over 417 397 confirmed cases and 2631 deaths related to coronavirus disease (COVID-19) were reported in Pacific island countries and areas (PICs). Most PICs have faced challenges accessing therapeutics recommended for the treatment of COVID-19 due to their high demand worldwide and supply chain constraints. Context: The World Health Organization (WHO) coordinates and provides tailored technical and operational support to 21 PICs. Since the start of the pandemic, WHO has worked with partners to establish a mechanism to ensure equitable access to three novel COVID-19 therapeutics (tocilizumab, molnupiravir and nirmatrelvir/ritonavir) for lower-income countries, including 11 eligible PICs. Action: WHO coordinated the requests, procurement and distribution of the three novel therapeutics. In addition, WHO supported PICs by providing trainings in clinical management of COVID-19, developing critical supply needs estimates, and facilitating regulatory approval of clinical therapeutics, including emergency use authorization. Lessons learned: The main barriers to procurement of novel COVID-19 therapeutics were identified as prolonged negotiations with licence holders, sourcing funding, the high cost of therapeutics and limited capacity to provide safety monitoring. Discussion: Uninterrupted supply and availability of essential medicines in the Pacific region is dependent on external and local sourcing. To overcome procurement barriers and ensure access to novel COVID-19 therapeutics in PICs, WHO's pandemic support to Member States focused on strengthening regulatory requirements, safety monitoring and supply chain activities.

Pharmacists as patient advocates: A series of case studies illustrating the impacts of a regular pharmacist service in residential aged care (nursing homes).

Background: Medicine-related problems are common in older people living in residential aged care facilities (RACFs). Recognising the significant medicine-related problems, the Australian government has announced a $345 million funding package to employ on-site pharmacists in RACFs starting in 2023. The new on-site pharmacists are to provide a range of clinical services to reduce medicine-related adverse events, promote quality use of medicines, and improve clinical governance and education. Underpinning these services, the authors argue that pharmacists play the critical role as resident advocates. Objective: This study aims to demonstrate how pharmacists can enhance their advocacy responsibility within and beyond the clinical environment to not only reduce medicine-related adverse events but also improve residents' overall health and quality of life. Methods: This study uses a case series methodology to demonstrate pharmacists' diverse roles in advocating for residents and their families. The case studies were based on participants enrolled in the Reducing Medicine-Induced Deterioration and Adverse Reactions (ReMInDAR) trial, a randomised controlled trial testing the effects of a regular pharmacist service across the Australian RACFs. Results: Pharmacists' advocacy ranged from persistence in follow-up with a resident's general practitioner (GP) to ensure the GP was aware that a patient was experiencing bleeding and bruising while on an anticoagulant, to advocating for a new bed for a resident with peripheral oedema who had been sleeping in his chair due to fear of falling out of his current bed. Conclusions: Our trial focussed on pharmacists serving as the residents' advocate to improve their overall health and quality of life, rather than just addressing a list of medicine-related problems. The pharmacist model used in the ReMInDAR trial supports pharmacists to work to their full scope of practice, helps guide the Australian government's new on-site pharmacist program, and serves as an exemplar pharmacist in aged care model internationally.

Risk factors predictive of adverse drug events and drug-related falls in aged care residents: secondary analysis from the ReMInDAR trial.

BACKGROUND: Residents of aged-care facilities have high rates of adverse drug events. This study aimed to identify risk factors for adverse drug events in aged-care residents. METHOD: This was a secondary study using data from a multicentre randomised controlled trial. Data from 224 residents for whom there was 6 months of baseline information were analysed. We assessed the risk of adverse drug events and falls (post hoc) in the subsequent 6 months. Adverse events were identified via a key word search of the resident care record and adjudicated by a multidisciplinary panel using a modified version of the Naranjo criteria. Covariates identified through univariable logistic regression, including age, sex, medicines, physical activity, cognition (Montreal Cognitive Assessment), previous adverse events and health service use were included in multivariable models. RESULTS: Overall, 224 residents were included, with a mean age of 86 years; 70% were female. 107 (48%) residents had an adverse drug event during the 6-month follow-up. Falls and bleeding were experienced by 73 (33%) and 28 (13%) residents, respectively. Age (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.01-1.10), weight (OR 1.02, 95% CI 1.002-1.04), previous fall (OR 2.58, 95% CI 1.34-4.98) and sedative or hypnotic medicine use (OR 1.98, 95% CI 1.52-2.60) were associated with increased risk of adverse drug events. Increased cognition (OR 0.89, 95% CI 0.83-0.95) was protective. Risk factors for falls were previous fall (OR 3.27, 95% CI 1.68-6.35) and sedative or hypnotic medicines (OR 3.05, 95% CI 1.14-8.16). Increased cognition (OR 0.88, 95% CI 0.83-0.95) was protective. CONCLUSION: Our results suggest residents with a previous fall, reduced cognition, and prescription of sedative or hypnotic medicines were at higher risk of adverse drug events and should be considered for proactive prevention.

Frailty trajectory over one year among residential aged care (nursing home) residents.

Objectives: Large population-based studies examining frailty trajectory found a linear increase in frailty over time. The pattern in which frailty changes over time for an individual person is less well-described. We examined the frailty trajectory of older adults living in aged-care in Australia. Materials and methods: This secondary study used data from a randomised controlled trial involving 39 aged-care facilities in Australia. The trial intervention was an on-going pharmacist-led intervention occurring every 8 weeks over 12 months aimed at preventing medicine-induced deterioration and adverse reactions. Frailty was assessed using the Frailty Index. Participants were categorised as non-frail, pre-frail and frail. Individual frailty trajectory over 12 months was visualised using the alluvial plot. Case notes were examined to explore reasons for any rapid transitions in frailty status. Results: A total of 248 participants was included. At baseline, 40.3% were non-frail and 59.7% were pre-frail. The proportion of participants who were non-frail and pre-frail decreased over time; 15.7% were frail at 6 months and 23.4% were frail at 12 months. Overall, twenty different combinations of frailty transitions were identified over 12 months. Retrospective analysis of case notes suggest that death or transition from non-frail to frail was often preceded by hospitalisation, falls, medication change or clinically significant deterioration in grip strength or cognition. Conclusion: The degree of frailty increased over time, but there were variations in the individual trajectories. Regular monitoring of events that precede changes in frailty status is needed to identify strategies to prevent further deterioration in residents' conditions.

Medicine-related problems: A recurrent issue among residents living in nursing homes.

Aim: To examine the incidence and nature of medicine-related problems over time experienced by nursing home residents. Method: We analyzed records collected in the Reducing Medicine-Induced Deterioration and Adverse Events (ReMInDAR) trial. The trial pharmacists provided services to reduce medicine-induced deterioration and adverse reactions for residents every 8-weeks over a year. The problems identified by the pharmacists were documented in reports and subsequently classified independently by research pharmacists using the D.O.C.U.M.E.N.T system. The number and type of problems at each service and time to develop a new problem post first session were assessed. All analyses were performed using R software (Version 4.1.1). Results: The cohort was 115 nursing home residents who received 575 services. In the 12-months, a total of 673 medicine-related problems or symptom reports were identified in 112 residents. Most residents (75%) experienced a new medicine-related problem by the fourth month post the first assessment. After the first session, the proportion of residents with a new medicine-related problem or symptom report declined at each repeated pharmacy session (59% at visit 2 vs. 28% at visit 6, p < 0.01). Conclusion: Residents living in nursing homes frequently experience medicine-related problems. Our results suggest clinical pharmacist services performed every 4-months may have the potential to reduce the medicine-related problems in nursing homes.

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

OBJECTIVE: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions. DESIGN AND SETTING: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities. PARTICIPANTS: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine. INTERVENTION: Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months. COMPARATOR: Usual care (Residential Medication Management Review) provided by accredited pharmacists. OUTCOMES: Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life. RESULTS: 248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength. CONCLUSIONS: The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.

A cross-sectional analysis of falsified, counterfeit and substandard medicines in a low-middle income country.

BACKGROUND: High prevalence of falsified, counterfeit and substandard medicines pose a threat to public health and treatment failure. This study aimed to investigate the quality of selected essential medicines available in Mongolia. METHODS: A cross-sectional study collected essential medicines from pharmacy outlets in Mongolia, during June and July, 2017. These products were then submitted for pharmacopoeial analysis and registration status. RESULTS: A total of 1770 samples from 118 pharmacy entities were purchased from wholesalers in urban and rural areas. Pharmacopoeial analysis found 179 (10.1%) samples or eleven product groups were unacceptable. The prevalence of substandard locally produced medicines (n = 105, 5.9%) was higher than imported equivalents [(n = 74, 4.17%, p = 0.0001)]. Approximately one-third of all unacceptable tests were related to assay (n = 73, 30.8%) and weight variation. Of 1770 samples, 76 (4.3%) were unregistered and the prevalence of unregistered samples was 3.8% in Ulaanbaatar city and 5.8% in rural areas, respectively. CONCLUSIONS: This study has indicated that falsified and substandard medicines are prevalent in Mongolia. Considerable effort is required by regulatory authorities, private manufacturers, as well as importers to increase the quality of essential medicines in Mongolia.

Availability, affordability and costs of pediatric medicines in Mongolia.

BACKGROUND: The Essential Medicines List for Children (EMLc) was developed by the World Health Organization (WHO) to assist member countries to achieve Millennium Development Goals (MDG). The Government of Mongolia has adopted a National Essential Drug List (NEDL) with the seventh update published in 2014. The objective of this study was to determine the accessibility, availability and costs of essential pediatric medicines in Mongolia. METHODS: A standardized methodology developed by the WHO and Health Action International (HAI) was employed to conduct a study on the availability, costs and affordability of pediatric medicines in Mongolia. A data collection tool collected information in regards to retail and wholesale availability and costs of essential pediatric medicines at pharmacy outlets during January and August of 2016. RESULTS: Availability of individual essential pediatric medicines varied across the country. The average availability of medicines was 72.6% in the public sector (9.1-100%). Correspondingly, average availability of all selected medicines in the private sector was 76.7% (26.7-100%). Lowest price medicines were 2.45 times higher than the international reference price (IRP) in the private sector and was 1.95 times higher in the public sector. The lowest cost medicines in the public sector were more affordable for all conditions. The least affordable treatment was estimated to be for respiratory tract infections, or otitis media using amoxicillin clavulanic acid, suspension costing up to 1.03 days wages. CONCLUSION: Procurement, supply and distribution of essential pediatric medicines needs to be regularly investigated in order to identify the availability and costs of pediatric formulations in Mongolia.

The Global Alliance for Infections in Surgery: defining a model for antimicrobial stewardship-results from an international cross-sectional survey.

BACKGROUND: Antimicrobial Stewardship Programs (ASPs) have been promoted to optimize antimicrobial usage and patient outcomes, and to reduce the emergence of antimicrobial-resistant organisms. However, the best strategies for an ASP are not definitively established and are likely to vary based on local culture, policy, and routine clinical practice, and probably limited resources in middle-income countries. The aim of this study is to evaluate structures and resources of antimicrobial stewardship teams (ASTs) in surgical departments from different regions of the world. METHODS: A cross-sectional web-based survey was conducted in 2016 on 173 physicians who participated in the AGORA (Antimicrobials: A Global Alliance for Optimizing their Rational Use in Intra-Abdominal Infections) project and on 658 international experts in the fields of ASPs, infection control, and infections in surgery. RESULTS: The response rate was 19.4%. One hundred fifty-six (98.7%) participants stated their hospital had a multidisciplinary AST. The median number of physicians working inside the team was five [interquartile range 4-6]. An infectious disease specialist, a microbiologist and an infection control specialist were, respectively, present in 80.1, 76.3, and 67.9% of the ASTs. A surgeon was a component in 59.0% of cases and was significantly more likely to be present in university hospitals (89.5%, p < 0.05) compared to community teaching (83.3%) and community hospitals (66.7%). Protocols for pre-operative prophylaxis and for antimicrobial treatment of surgical infections were respectively implemented in 96.2 and 82.3% of the hospitals. The majority of the surgical departments implemented both persuasive and restrictive interventions (72.8%). The most common types of interventions in surgical departments were dissemination of educational materials (62.5%), expert approval (61.0%), audit and feedback (55.1%), educational outreach (53.7%), and compulsory order forms (51.5%). CONCLUSION: The survey showed a heterogeneous organization of ASPs worldwide, demonstrating the necessity of a multidisciplinary and collaborative approach in the battle against antimicrobial resistance in surgical infections, and the importance of educational efforts towards this goal.

Drug pricing and reimbursement decision making systems in Mongolia.

BACKGROUND: It is essential to allocate available resources equitably in order to ensure accessibility and affordability of essential medicines, especially in less fortunate nations with limited health funding. Currently, transparent and evidence based research is required to evaluate decision making regarding drug registration, drug pricing and reimbursement processes in Mongolia. OBJECTIVE: To assess the drug reimbursement system and discuss challenges faced by policy-makers and stakeholders. METHODS: The study has examined Mongolian administrative documents and directives for stakeholders and analysed published statistics. Experts and decision-makers were interviewed about the drug pricing and reimbursement processes in Mongolia. RESULTS: Decisions regarding Mongolian drug registration were based on commonly used criteria of quality, safety, efficacy plus some economic considerations. A total of 11.32 billion Mongolian National Tugrugs (MNT) [5.6 million United States Dollars (USD)] or 12.1% of total health expenditure was spent on patient reimbursement of essential drugs. The highest reimbursed drugs with respect to cost in 2014 were the cardiovascular drug group. Health insurance is compulsory for all citizens; in addition all insured patients have access to reimbursed drugs. However, the decision making process, in particular the level of reimbursement was limited by various barriers, including lack of evidence based data regarding efficacy and comparative cost-effectiveness analysis of drugs and decisions regarding reimbursement. CONCLUSIONS: Drug registration, pricing and reimbursement process in Mongolia show an increasing trend of drug registration and reimbursement rates, along with lack of transparency. Limited available data indicate that more evidence-based research studies are required in Mongolia to evaluate and improve the effectiveness of drug pricing and reimbursement policies.

A questionnaire study of injections prescribed and dispensed for patients diagnosed with mild/moderate community-acquired pneumonia in Mongolia.

Purpose. The study aimed to determine the extent of and factors influencing the prescribing of injections for the treatment of mild/moderate community acquired pneumonia (CAP) in Mongolia. Methods. Questionnaires were developed and administered to medication providers (34 Pharmacists, 27 pharmacy technicians) and prescribers (22 general doctors and 49 medical specialists) working in Mongolia. Results. Cefalosporins were prescribed for patients with mild pneumonia and doctors tended to prescribe injectable cefalosporins (cefazolin) rather than oral dosage forms. This was supported by the questionnaire study with pharmacists and pharmacy technicians. Additionally, 23 pharmacists and pharmacy technicians indicated that OTC injectable cefalosporins (37.7%) and injectable aminopenicillins (33,9%) were frequently sold by pharmacies for the treatment of mild/moderate CAP. Doctors and particularly pharmacists in the questionnaire studies indicated choosing an injection was to avoid non-compliance problems. Conclusion. High levels of injectable prescribing of antibiotics were found in non-hospitalized patients with CAP in Mongolia. This prevalence level indicated that inappropriate injection prescribing is a public health hazard for Mongolia and requires consideration by the appropriate authorities.

Parenteral medication prescriptions, dispensing and administration habits in Mongolia.

High levels of injection prescribing were reported in Mongolia. Understanding the factors influencing the injection prescribing is essential to reduce their inappropriate use. The study evaluated the views, experiences and attitudes of community members associated with the prescribing of injections in Mongolia. A structured questionnaire focusing on respondents' characteristics, experiences and views about injections was developed and administered face-to-face to community members in Ulaanbaatar, Mongolia. Standard descriptive statistics were used to summarize demographic data and responses to the questionnaires. Dependent variables were compared using Kruskal-Wallis Tests for independence. Statistical analyses were performed using SPSS Version 21.0. Six hundred participants were approached and the response rate was 79% (n = 474). Almost half of the respondents were aged between 31 and 50 (n = 228, 48.1%) and 40.9% of respondents were male (n = 194). Most respondents were from Ulaanbaatar city (n = 407, 85.7%). All respondents had received injections in the past and 268 (56.5%) had received injection in the past year. The most common reason for having an injection in the past year was reported as treatment of a disease (n = 163, 60.8%), or for administration of vitamins (n = 70, 26.1%). Injections were prescribed by a doctor (n = 353, 74.9%), dispensed by a pharmacist (n = 283, 59.7%) and administered by a nurse (n = 277, 54.9%). Only 16% of all respondents had the expectation of receiving injections when they visited a doctor (n = 77). An important perception regarding injections was that they hastened the recovery process (n = 269, 56.8%). When asked their opinion about therapeutic injections, 40% of all respondents agreed that injections were a better medicine (n = 190) than oral medications, with older respondents strongly agreeing (p<0.001). Based on this total sample, approximately 1891 injections per 1000 patients were administered. The excessive injection use seems to be promoted by inappropriate prescribing, dispensing and administration of medication by doctors and others.

Prevalence estimates of substandard drugs in Mongolia using a random sample survey.

To determine the prevalence of substandard drugs in urban (Ulaanbaatar) and rural (selected provinces) areas of Mongolia, samples of 9 common, therapeutically important drugs were collected from randomly selected drug outlets in Ulaanbaatar and 4 rural provinces by "mystery shoppers". Samples were analyzed by visual inspection, registration status, and biochemical analysis. Samples failing to meet all Pharmacopeia quality tests were considered substandard. In the rural provinces, 69 out of 388 samples were substandard, giving an estimated prevalence of substandard drugs of 17.8% (95% CI: 14.1-22.0). There were 85 unregistered samples, giving a prevalence estimate of unregistered drugs of 21.9%. (95% CI: 17.9-26.3). In the urban Ulaanbaatar districts, 112 out of 848 samples were substandard, giving an estimated prevalence of substandard drugs of 13.2% (95% CI: 11.0-15.7). There were 150 unregistered samples, giving a prevalence estimate of unregistered drugs of 17.7% (95% CI: 15.2-20.4). In the rural provinces, 35 out of 85 (41.2%) unregistered samples were substandard; whereas 34 out of 303 (11.2%) registered samples were substandard. (p < 0.0001) In the urban districts, 18 out of 150 (12.0%) unregistered samples were substandard, whereas 94 out of 698 registered were substandard. (13.5%) (p = 0.6). The prevalence of substandard and unregistered drugs is higher in rural provinces. There is a significant association between substandard and unregistered drugs in the provinces but not in the urban districts. The underlying causes for substandard drugs need to be further investigated in order to help formulate strategies to improve pharmacovigilance and the drug supply quality in Mongolia.

An evaluation of prescribing practices for community-acquired pneumonia (CAP) in Mongolia.

BACKGROUND: Community-acquired pneumonia (CAP) is a significant cause of morbidity and mortality in all age groups worldwide. It may be classified as mild/moderate or severe, the latter usually requiring hospitalisation. Although, there are many studies reported in relation to CAP, there is relatively little known about the treatment of CAP and its antibiotic use in Mongolia. The study aim was to evaluate prescribing practices for the treatment of mild/moderate CAP in Mongolia with respect to national prescribing guidelines. METHODS: Written prescriptions with a written diagnosis of CAP included were collected prospectively and sequentially for ten weeks from a purposefully selected sample of community pharmacies in rural and urban areas of Mongolia. The data collected included the patient's age, gender, medication details, frequency and number of doses prescribed. Evaluation was with respect to the Mongolian Standard Treatment Guidelines (2005, 2008). Statistical differences between groups were tested using the Chi-squared and Fisher's exact tests. RESULTS: Prescriptions were collected from 22 pharmacies and represented the prescribing practices of 118 doctors. The study enrolled 394 (193 adults and 201 children) patients, with a median age for children of 2.0 years (range: 0.03-12) and adults of 33.0 years (range: 13-92).The most commonly prescribed drugs were aminopenicillins, vitamins, and mucolytics, with the median number of drugs being three per prescription. Inappropriate drug selection was similar for adults (57.7%) and children (56.6%), and the major reason for an overall frequency of inappropriate prescribing for adults was 89.0% and for children 78.0%. Doctors in urban areas prescribed more inappropriate drugs than those in rural areas for both children and adults, p = .0014. The proportion of prescribed injections was 28.4% for adults and 9.0% for children, and for adults was significantly higher in urban areas. The prescribing standard for non-hospitalized patients in Mongolia states that injections should not be prescribed. CONCLUSIONS: The high level of inappropriate prescribing for mild/moderate CAP highlights the need to develop comprehensive and reliable procedures nationwide to improve prescribing practices in Mongolia.