Antimicrobial Dispensing Practices during COVID-19 and the Implications for Pakistan.

Antibiotics are one of the most frequently dispensed classes of medicines. However, excessive misuse and abuse enhances antimicrobial resistance (AMR). Previous studies in Pakistan have documented extensive dispensing of 'Watch' and 'Reserve' antibiotics, which is a concern. In view of this, there is a need to assess current dispensing patterns following COVID-19 in Pakistan. A cross-sectional study was undertaken, collecting dispensing data from 39 pharmacies and 53 drug stores from November 2022 to February 2023. Outlets were principally in urban areas (60.9%), with pharmacists/pharmacy technicians present in 32.6% of outlets. In total, 11,092 prescriptions were analyzed; 67.1% of patients were supplied at least one antimicrobial, 74.3% antibiotics, 10.2% antifungals and 7.9% anthelmintics. A total of 33.2% of antimicrobials were supplied without a prescription. Common indications for dispensed antibiotics were respiratory (34.3%) and gastrointestinal (16.8%) infections, which can be self-limiting. In addition, 12% of antibiotics were dispensed for the prevention or treatment of COVID-19. The most frequent antibiotics dispensed were ceftriaxone (18.4%) and amoxicillin (15.4%). Overall, 59.2% antibiotics were 'Watch' antibiotics, followed by 'Access' (40.3%) and 'Reserve' (0.5%) antibiotics. Of the total antibiotics dispensed for treating COVID-19, 68.3% were 'Watch' and 31.7% 'Access'. Overall, there appeared to be an appreciable number of antibiotics dispensed during the recent pandemic, including for patients with COVID-19, alongside generally extensive dispensing of 'Watch' antibiotics. This needs to be urgently addressed with appropriate programs among pharmacists/pharmacy technicians to reduce AMR.

Adoption of new therapies in the treatment of Hepatitis: a verification of the accuracy of budget impact analysis to guide investment decisions.

OBJECTIVES: While there are good Budget Impact Analysis (BIA) guidelines, studies still register potential bias. To do this, we compared the results between theoretical and real-world evidence (RWE) expenditures for medicines for Hepatitis C: boceprevir (BOC) and telaprevir (TVR). While both are not currently recommended in treatment guidelines following recent developments, this is an emblematic case because for 4 years these medicines consumed considerable resources. METHODS: Theoretical results and RWE expenditures were compared regarding the incorporation of BOC and TVR in 2013-2014 into the Brazilian Public Health System. Theoretical values were extracted from Commission for Technology Incorporation Report and RWE expenditures were extracted from the administrative data records using deterministic-probabilistic linkage. RESULTS: The estimated number of patients treated (BOC+TVR) was 13,012 versus 7,641 (real). The estimated purchase price for BOC was US$6.20 versus US$11.07 (real) and for TVR was US$42.21 versus US$84.09 (average/real). The estimated budget impact was US$285.16 million versus US$128.58 million (real). CONCLUSION: This study demonstrates appreciable divergence (US$156.58 million) between the theoretical budget impact and RWE expenditures due to underestimated purchase prices and overestimated populations. The greater the degree of accuracy the more reliable and usable BIAs become for decision-making.

Budget impact analysis of medicines: estimated values versus real-world evidence and the implications.

OBJECTIVES: Budget Impact Analyses (BIA) of medicines helps managers in promoting health systems' sustainability when assessing the role and value of new medicines. However, it is not clear whether BIAs typically underestimate or overestimate the impact on real-world budgets. This retroactive analysis seeks to compare estimated values obtained by a BIA and Real-World Evidence (RWE) to guide discussions. METHODS: The estimated values were obtained through a BIA concerning the incorporation of adalimumab for the treatment of Rheumatoid Arthritis into the Brazilian Unified Health System (SUS) carried out retroactively and per international guidelines. RWE data was extracted from SUS computerized systems. We subsequently compared the number of treatments, costs, and Incremental Budget Impact (IBI). RESULTS: - The total number of treatments was underestimated by 10% (6,243) and the total expenditure was overestimated by 463% (US$ 4.7 billion). In five years, the total difference between the estimated values and real IBI reached US$ 1.1 billion. A current expenditure of US$ 1.0 was observed for every US$ 5.60 of estimated expenditure. CONCLUSION: - The higher estimates from the BIA might cause decision makers to be more cautious with the introduction of a new medicine to reduce the opportunity costs for other interventions.

Prevalence of chronic kidney disease using estimated glomerular filtration rate among diabetes patients attending a tertiary clinic in Botswana.

OBJECTIVES: Diabetes mellitus (DM) is one of the most common contributors of chronic kidney disease (CKD). The epidemiology of CKD, a concern among patients with DM, has not been studied in Botswana. Consequently, the objective of this study was to estimate its prevalence among these patients in Botswana to provide future guidance to both government personnel and physicians. METHODS: Observational cross-sectional study in a leading clinic in Botswana. Demographic and clinical data were obtained from patients through interviews and from their notes using a standard questionnaire. The study was conducted from July to October 2015. The estimated glomerular filtration rate (eGFR) was calculated using the Modification of Diet for Renal Disease equation. CKD was defined as an eGFR < 60 ml/min/1.73 m2. Multivariable logistic regression analyses were performed to assess the associations between CKD and potential factors. RESULTS: The mean age and duration of DM among study participants were 54.67 years (range 21-92 years) and 5.0 years, respectively. Over half, i.e. 213/370 (57.6%) and 232/370 (62.7%), had an average blood pressure greater than 140/90 mmHg and poor glycemic control (HbA1c > 7%), respectively. 31/370 patients (8.4%) had CKD. However, only 18/370 (4.9%) had a diagnosis of CKD documented in their charts. Age, level of education, and duration of diabetes were independently associated with CKD. CONCLUSION: The prevalence of CKD by estimated eGFR was low compared to most previous studies. However, half of patients with CKD are not documented resulting in the potential for prescription errors and drug toxicity. A substantial number of our patients had uncontrolled hypertension and poor glycemic control. Older age, low level of education and longer duration of DM were associated with CKD. There is a need to carry out prospective studies to determine the association and role of glycemic and blood pressure control in CKD causation among patients with DM in Botswana.

An analysis of policies for cotrimoxazole, amoxicillin and azithromycin use in Namibia's public sector: Findings and therapeutic implications.

BACKGROUND: Despite Namibia's robust medicine use systems and policies, antibiotic use indicators remain suboptimal. Recent medicine use surveys rank cotrimoxazole, amoxicillin and azithromycin (CAA) among the most used medicines. However, there is rising resistance to CAA (55.9%-96.7%). Unfortunately, to date, there have been limited studies evaluating policies to improve antibiotic use in Namibia. AIM: To evaluate public sector pharmaceutical policies and guidelines influencing the therapeutic use of CAA antibiotics in Namibia. METHODS: Evaluate Namibia's pharmaceutical policies and guidelines for CAA use through quantitative text analysis. The main outcome variables were the existence of antibiotic policies, therapeutic indications per antibiotic and the type/level of healthcare facility allowed to use the antibiotic. RESULTS: Policies for antibiotic use were limited, with only the draft Namibia Medicines Policy having a statement on antibiotic use. Several essential antibiotics had no therapeutic indications mentioned in the guidelines. Twenty-nine antibiotics were listed for 69 therapeutic indications; CAA (49.3%) antibiotics and ATC J01C/J01D (48%) having the highest indications per antibiotic. For CAA antibiotics, this suggested use was mainly for acute respiratory infections (n=22, 37.2%). Published policies (58.6%-17/29) recommended antibiotics for use at the primary healthcare (PHC) level, with CAA antibiotics recommended mostly for respiratory tract infections and genitourinary infections. CONCLUSIONS: Policy and guidelines for antibiotic use in Namibia are not comprehensive and are skewed towards PHCs. Existing policies promote the wide use of CAA antibiotics, which may inadvertently result in their inappropriate use enhancing resistance rates. This calls for the development of more comprehensive antibiotic guidelines and essential medicine lists in tandem with local antimicrobial resistance patterns. In addition, educational initiatives among all key stakeholder groups.

Evaluating the Treatment Costs for Uncomplicated Malaria at a Public Healthcare Facility in Nigeria and the Implications.

BACKGROUND: Accurate information on the facility costs of treatment is essential to enhance decision making and funding for malaria control. OBJECTIVE: The objective of this study was to estimate the costs of providing treatment for uncomplicated malaria through a public health facility in Nigeria. METHODS: Hospital costs were estimated from a provider perspective, applying a standard costing procedure. Capital and recurrent expenditures were estimated using an ingredient approach combined with step-down methodology. Costs attributable to malaria treatment were calculated based on the proportion of malaria cases to total outpatient visits. The costs were calculated in local currency [Naira (N)] and converted to US dollars at the 2013 exchange rate. RESULTS: Total annual costs of N28.723 million (US$182,953.65) were spent by the facility on the treatment of uncomplicated malaria, at a rate of US$31.49 per case, representing approximately 25% of the hospital's total expenditure in the study year. Personnel accounted for over 82.5% of total expenditure, followed by antimalarial medicines at 6.6%. More than 45% of outpatients visits were for uncomplicated malaria. Changes in personnel costs, drug prices and malaria prevalence significantly impacted on the study results, indicating the need for improved efficiency in the use of hospital resources. CONCLUSION: Malaria treatment currently consumes a considerable amount of resources in the facility, driven mainly by personnel cost and a high proportion of malaria cases. There is scope for enhanced efficiency to prevent waste and reduce costs to the provider and ultimately the consumer.

Budget impact analysis of medicines: updated systematic review and implications.

This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.

An analytical framework for assessing drug and therapeutics committee structure and work processes in tertiary Brazilian hospitals.

University teaching hospitals usually provide tertiary care and are subject to early adoption of new technologies, which may compromise healthcare systems when uncritically adopted. Knowledge on the decision-making process - drug selection by drug selection committees or DTCs - is crucial to improve the quality of care. There are no models for studying the selection of drugs in Brazilian healthcare services. This study aims to discuss DTC structure and the processes regarding adoption of medicines in tertiary university hospitals in Brazil and to propose an analytical structure for providing direction for the future. State of the art content regarding drug selection processes and DTC procedures was reviewed in three databases. Information on the medicine selection process in a Brazilian gold standard teaching hospital was collected through observations and a review of existing procedures. A structured discussion on medicine selection and DTC procedures in tertiary hospitals ensued. This discussion resulted in findings that were organized in three dimensions, composing an analytical framework for the application in tertiary Brazilian hospitals (i) motivations for the adoption of drugs; (ii) necessary structural and organizational aspects for decision-making; and (iii) criteria and methods employed by the decision-making process. We believe that the suggested framework is compatible with tertiary Brazilian hospitals, because a gold standard in the country was able to conduct all its procedures in the light of WHO and international recommendations. We hope to contribute in producing knowledge which may hopefully be adopted in tertiary hospitals across Brazil.

Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs.

BACKGROUND: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. OBJECTIVE: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. METHODOLOGY: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. RESULTS: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. CONCLUSION: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.