Effects of Different Types of COVID-19 Vaccines on Menstrual Cycles of Females of Reproductive Age Group (15-49): A Multinational Cross-Sectional Study.

Background Globally, there are more than 474 million cases and around 6 million deaths due to COVID-19. The case fatality rate was 0.5-2.8% while for 80-89 years old, it was 3.7-14.8%. Given the seriousness of this infection, prevention becomes critical. Hence, the introduction of vaccines led to a significant reduction (> 75% protection) in COVID-19 cases. On the other hand, patients seeking help for serious pulmonary, cardiovascular, neurological, and gynecological complaints have also been recorded. Clinical studies on the effects of vaccination focused mostly on life-or-death results rather than reproductive outcomes such as menstruation, fertility, or even pregnancy outcomes. This survey was conducted to get more evidence on the association between menstrual cycle irregularities and some globally most prevalent COVID-19 vaccines. Methods An online cross-sectional survey was conducted by a team from Taif University, Kingdom of Saudi Arabia, from January to June 2022 on females within the reproductive age group (15-49 years) using a semi-structured questionnaire. Data were analyzed using SPSS Statistics version 22.0 and presented as frequency and percentage. The chi-square test was applied for the association and a p-value of <0.05 was considered significant. Results A total of 2381 responses were included. The mean age of respondents was 25±7.7 years. Around 1604 (67%) participants observed post-vaccination menstrual changes, and the findings were significant (p< 0.001). A strong association (p=.008) was found between the type of vaccine and changes in the menstrual cycle in participants (AstraZeneca 11 (36%)) after one dose. A strong association (p=.004) was also seen between the type of vaccine (Pfizer 543 (83%)) and menstrual changes after the booster dose. Cycles became irregular 180 (36%) or prolonged 144 (29%) in females inoculated with Pfizer after two doses of vaccination (p=0.012). Conclusion Post-vaccination menstrual irregularities were reported by females of reproductive age, especially the new vaccines. Prospective studies for similar insights are needed. Finding the co-occurring impacts of vaccination and COVID-19 infections in the wake of the emerging new long-haul COVID-19 phenomena is crucial for reproductive health.

Capacity Building for Health Technology Assessment in Jordan: Institutionalization and Its Use in Pricing and Reimbursement Decisions.

OBJECTIVES: This study aimed to describe the process of the institutionalization of health technology assessment (HTA) in Jordan. In particular, this study presents local policy perspectives on capacity building for HTA and the progress made toward its use in pricing and reimbursement decisions. HTA CAPACITY BUILDING: University-based education and professional development training in pharmacoeconomics and pharmaceutical policy have been the starting points to create a receptive environment, necessary expertise, and local tools across many settings in Jordan. International collaboration with HTA supporting bodies helped to build connections and informed policy development on local levels through projects, meetings, and discussions. HTA INSTITUTIONALIZATION AND ITS USE IN PRICING AND REIMBURSEMENT DECISIONS: Institutionalizing HTA in the King Hussein Cancer Center and the Royal Medical Services was the driving factor for HTA implementation and practice advancement; nevertheless, process transparency and experience sharing through reports and publications are still limited. The Jordan Food and Drug Administration's pricing and formulary decisions require pharmacoeconomic consultation in selected cases according to the Jordanian Drug Law. Nevertheless, there is a lack of local methodological guidelines for conducting HTA. In addition, HTA practitioners and the regulatory scope of future HTA activities in Jordan cannot be determined yet. RECOMMENDATIONS AND FUTURE DIRECTIONS: Over the past 2 decades, Jordan has crossed a number of milestones and advanced further to implement HTA as a tool for evaluating health interventions. As a next step, legislation is needed to mandate the use of HTA and to enhance transparency in decision-making processes.

Hospital unit costs in Jordan: insights from a country facing competing health demands and striving for universal health coverage.

BACKGROUND: Public providers in Jordan are facing increasing health demands due to human crises. This study aimed to benchmark the unit costs of hospital services in public providers in Jordan to provide insights into the outlook for public health care costs. METHODS: The unit costs of hospital services per admission, inpatient days, outpatient visits, emergency visits and surgical operations were estimated using the standard average costing method (top-down) for the fiscal year 2018-2019. The unit costs per inpatient day were estimated for nine specialities and staff in Jordanian dinars (exchange rate JOD 1 = USD 1.41). RESULTS: The average unit cost per admission in Jordan was JOD 782.300 (USD 1101.80), the per inpatient day cost was JOD 236.600 (USD 333.20), the per bed day cost was JOD 172.900 (USD 244.90), the per outpatient visit cost was JOD 58.400 (USD 82.30), the per operation cost was JOD 449.600 (USD 633.20) and the per emergency room visit cost was JOD 31.800 (USD 44.80). The specialities of ICU/CCU and OB/GYN presented the highest unit costs per inpatient day across providers: JOD 377.800 (USD 532.90) and JOD 362.600 (USD 510.70), respectively. The average salaried unit cost of staff depended mainly on year of employment. Nonetheless, the unit costs varied depending on the service utilization, type of service and organizational outlet. CONCLUSIONS: Knowledge of how unit costs vary across public providers in Jordan is essential to outline cost control strategies and inform future research. Institutionalization of the cost information system and high-level governmental support are necessary to generate a routine practice of collecting and sharing cost information.

Implementation Road Map of Health Technology Assessment in Middle-Income Countries: The Case of Jordan.

OBJECTIVES: Health technology assessment (HTA) can increase the appropriateness and transparency of pricing and reimbursement decisions. Jordan is still in the early phase of its HTA implementation, although the country has very limited public resources for the coverage of healthcare technologies. The study objective was to explore and validate priorities in the HTA road map for Jordan and propose to facilitate the preferred HTA status. METHODS: Health policy experts from the public and private sectors were asked to participate in a survey to explore the current and future status of HTA implementation in Jordan. Semistructured interviews with senior policy makers supported by literature review were conducted to validate survey results and make recommendations for specific actions. RESULTS: Survey and interview results indicated a need for increased HTA training, including both short courses and academic programs and gradually increasing public funding for technology assessment and appraisal. Multiple HTA bodies with central coordination can be the most feasible format of HTA institutionalization. The weight of cost-effectiveness criterion based on local data with published reports and explicit decision thresholds should be increased in policy decisions of pharmaceutical and nonpharmaceutical technologies. CONCLUSION: Currently, HTA has limited impact on health policy decisions in Jordan, and when it is used to support pharmaceutical reimbursement decisions, it is mainly based on results from other countries without considering transferability of international evidence. Policy makers should facilitate HTA institutionalization and use in policy decisions by increasing the weight of local evidence in HTA recommendations.

Drug Selection for Formulary Inclusion: An Exploratory Case Study of Oncology Medicines in Jordan.

BACKGROUND: Access to healthcare services including innovative treatments is one of the most important objectives of healthcare system in Jordan. This research summarized one of the actual practices pertaining to health priority setting in Jordan with official requirement to use cost-effectiveness analysis. OBJECTIVES: To address the role of economic evidence to inform the decisions and rationales drawn by health policy experts to optimize resources mobilization for new cancer drugs. METHOD: The research reported a case study of formulary setting priority in Jordan. Documentary collation and analysis of a secondary source (meeting minutes) produced by decision committee were conducted by the research team. The decisions and rationales shaped by panelists for 22 newly registered oncology drugs at Jordan Food and Drug Administration were reviewed and described. RESULTS: It was found that the absence of official health economic guidelines in the country and informal use of cost-effectiveness analysis by the panelists appeared to flaw the importance of incremental cost-effectiveness ratio (ICER). Nevertheless, "the lower the ICER, the better the drug" was the primary factor in all committee's decisions to inform resources mobilization. Despite of the latter, 7 drugs were selected for formulary inclusion for different oncology disease areas in Jordan. CONCLUSIONS: Priority setting for new cancer drugs is not well-informed in Jordan. Nevertheless, this research revealed different disadvantages that appear to militate against the perspective of the study. Recommendations for implementation and enhancement of health economic evaluation include further investment in capacity building (eg, prepare qualified health economists) and create incentive to improve availability and accessibility of local data.

Investigating the Effect of Syrian Refugees on the Pharmaceutical Sector in Jordan.

The aim of this study was to investigate the effect of Syrian refugees on the pharmaceutical sector in Jordan. Based on a standardized methodology developed by the WHO, Level II Facility (2009) structured questionnaires (including: medicine access [availability, affordability and geographical accessibility], quality, and rational use of medicines) were used to investigate the effect of Syrian refugees influx on the pharmaceutical sector in Jordan. Lists of essential medicines (N = 50) were included in the survey forms. The results showed more progress in all indicators for the public sector compared with the previous results in the 2009 survey and in comparison to the private sector. For example, access to medicines improved in the public sector while it decreased (if it did not remain the same) in the private sector. Also, average stock out duration time decreased dramatically in both public and private sectors. As indicated by the median price ratio (MPR), brand prices increased much in the public health facilities while they decreased by 23%-30% in the private sector. In northern areas where most Syrian refugees stay, a significant decrease in availability was noticed, in addition to the dramatic decrease in days of average stock out and adequate inventory record percentage of those medicines. In conclusion, despite the international help received to support health care provision and medications procurement for the refugees, more support is needed immediately.

Patterns of antiepileptic drugs use in epileptic pediatric patients in Jordan.

OBJECTIVE: To determine prescribing patterns of antiepileptic drugs (AEDs) in pediatric patients with confirmed diagnosis of epilepsy, and to provide knowledge of general practice of physicians. METHODS: The study was a multi-center crosssectional observational study, in specialized clinics for management of epilepsy in north, central and south Jordan. This study was conducted from January 2014 to July 2014. These were 3 from university tertiary care hospitals and 4 from governmental tertiary care hospitals. RESULTS: A total of 694 pediatric patients were included. Monotherapy AED use had the highest frequency 465 (67.0%), followed by dual therapy 162 (23.3%). The frequency of monotherapy in university hospitals was lower than governmental hospitals (p<0.05); however, Polytherapy was more frequent in younger children. Two old AEDs were most frequently prescribed as a monotherapy; Valproic acid 235 (50.5%) and carbamazepine 155 (33.3%). The most common combination in dual therapy was valproic acid with carbamazepine 28 (17.3%). The second most common combinations were carbamazepine with levetiracetam 21 (13.0%) or valproic acid with levetiracetam 20 (12.3%). CONCLUSION: Older AED remain first line drugs for use in both monotherapy and combination therapy for epileptic disorders. Polytherapy is associated with younger kids and being treated in a university hospital.

Multi-indication Pharmacotherapeutic Multicriteria Decision Analytic Model for the Comparative Formulary Inclusion of Proton Pump Inhibitors in Qatar.

PURPOSE: The formulary inclusion of proton pump inhibitors (PPIs) in the government hospital health services in Qatar is not comparative or restricted. Requests to include a PPI in the formulary are typically accepted if evidence of efficacy and tolerability is presented. There are no literature reports of a PPI scoring model that is based on comparatively weighted multiple indications and no reports of PPI selection in Qatar or the Middle East. This study aims to compare first-line use of the PPIs that exist in Qatar. The economic effect of the study recommendations was also quantified. METHODS: A comparative, evidence-based multicriteria decision analysis (MCDA) model was constructed to follow the multiple indications and pharmacotherapeutic criteria of PPIs. Literature and an expert panel informed the selection criteria of PPIs. Input from the relevant local clinician population steered the relative weighting of selection criteria. Comparatively scored PPIs, exceeding a defined score threshold, were recommended for selection. FINDINGS: Weighted model scores were successfully developed, with 95% CI and 5% margin of error. The model comprised 7 main criteria and 38 subcriteria. Main criteria are indication, dosage frequency, treatment duration, best published evidence, available formulations, drug interactions, and pharmacokinetic and pharmacodynamic properties. Most weight was achieved for the indications selection criteria. Esomeprazole and rabeprazole were suggested as formulary options, followed by lansoprazole for nonformulary use. The estimated effect of the study recommendations was up to a 15.3% reduction in the annual PPI expenditure. Robustness of study conclusions against variabilities in study inputs was confirmed via sensitivity analyses. IMPLICATIONS: The implementation of a locally developed PPI-specific comparative MCDA scoring model, which is multiweighted indication and criteria based, into the Qatari formulary selection practices is a successful evidence-based cost-cutting exercise. Esomeprazole and rabeprazole should be the first-line choice from among the PPIs available at the Qatari government hospital health services.

Statin Selection in Qatar Based on Multi-indication Pharmacotherapeutic Multi-criteria Scoring Model, and Clinician Preference.

PURPOSE: Statin selection for the largest hospital formulary in Qatar is not systematic, not comparative, and does not consider the multi-indication nature of statins. There are no reports in the literature of multi-indication-based comparative scoring models of statins or of statin selection criteria weights that are based primarily on local clinicians' preferences and experiences. This study sought to comparatively evaluate statins for first-line therapy in Qatar, and to quantify the economic impact of this. METHODS: An evidence-based, multi-indication, multi-criteria pharmacotherapeutic model was developed for the scoring of statins from the perspective of the main health care provider in Qatar. The literature and an expert panel informed the selection criteria of statins. Relative weighting of selection criteria was based on the input of the relevant local clinician population. Statins were comparatively scored based on literature evidence, with those exceeding a defined scoring threshold being recommended for use. FINDINGS: With 95% CI and 5% margin of error, the scoring model was successfully developed. Selection criteria comprised 28 subcriteria under the following main criteria: clinical efficacy, best publish evidence and experience, adverse effects, drug interaction, dosing time, and fixed dose combination availability. Outcome measures for multiple indications were related to effects on LDL cholesterol, HDL cholesterol, triglyceride, total cholesterol, and C-reactive protein. Atorvastatin, pravastatin, and rosuvastatin exceeded defined pharmacotherapeutic thresholds. Atorvastatin and pravastatin were recommended as first-line use and rosuvastatin as a nonformulary alternative. It was estimated that this would produce a 17.6% cost savings in statins expenditure. Sensitivity analyses confirmed the robustness of the evaluation's outcomes against input uncertainties. IMPLICATIONS: Incorporating a comparative evaluation of statins in Qatari practices based on a locally developed, transparent, multi-indication, multi-criteria scoring model has the potential to considerably reduce expenditures on statins. Atorvastatin and pravastatin should be the first-line statin therapies in the main Qatari health care provider, with rosuvastatin as an alternative.

Implications of external price referencing of pharmaceuticals in Middle East countries.

INTRODUCTION: External price referencing (EPR) is applied frequently to control pharmaceutical prices. Our objective was to analyse how EPR is used in Middle Eastern (ME) countries and to compare the price corridor for original pharmaceuticals to non-pharmaceutical services not subjected to EPR. METHODS: We conducted a survey on EPR regulations and collected prices of 16 patented pharmaceuticals and 14 non-pharmaceutical services in seven Middle Eastern (ME) countries. Maximum and minimum prices of each pharmaceutical and non-pharmaceutical technology were compared to mean prices in the countries studied by using market exchange rates. Influencing factors of pharmaceutical prices were assessed by multivariate linear regression analysis. RESULTS: The average price corridor is narrower for pharmaceuticals (-39.8%; +35.9%) than for outpatient and hospital services (-81.7%; +96.3%). CONCLUSION: Our analysis revealed the importance of population size and EPR implementation on drug price levels; however, EPR results in higher pharmaceutical prices in lower-income countries compared to non-pharmaceutical services.

Comparison of the precision of the Topcon SP-3000P specular microscope and an ultrasound pachymeter.

AIM: To compare the precision of the Topcon SP-3000P noncontact specular microscope (NCSM) and the DGH 500 ultrasound pachymeter (USP). METHODS: Triplicate measurements of central corneal thickness (CCT) for 100 eyes were taken with an NCSM and a USP in 2 visits separated by 1 week. Repeatability was assessed by computing the differences between all 3 readings from each subject. Coefficients of repeatability and reproducibility were computed. RESULTS: MEAN CCT AS MEASURED BY EACH INSTRUMENT WERE: 518.53 ± 34.96 µm (range 417.33-592.67) and 516.94 ± 33.60 µm (range 431.67-582.67) for sessions 1 and 2 respectively, with the NCSM; 546.69 ± 36.62 µm (range 457.33-617.00) and 549.78 ± 35.26 µm (range 454.00-618.67) for sessions 1 and 2 respectively, with the USP. The ultrasound CCT measurements were consistently higher than those obtained with the NCSM in both sessions 28.17 ± 19.20 µm (mean ± SD, session 1) and 32.81 ± 14.04 (mean ± SD, session 2). The repeatability coefficient for the NCSM was better in both sessions than those for USP (±10 µm vs ± 12 µm in session 1 and ±8 µm vs ±10 µm in session 2). The reproducibility coefficient with the NCSM was half that with the USP (±21 µm vs ±41 µm). CONCLUSION: The SP-3000P NCSM is a more precise and reproducible instrument for measurement of CCT than the USP, but both instruments are reliable, useful instruments for measuring CCT.

Statin prescribing in Northern Ireland and England pre and post introduction of the quality and outcomes framework.

OBJECTIVE: The objective of this research was to examine differences in patterns of statin prescribing between Northern Ireland and England both before and after the introduction of the Quality and Outcomes Framework (QOF). SETTING: Primary care practices in Northern Ireland and England. Method Northern Ireland practices were matched with practices in England, statin prescribing data and QOF achievement scores (for the first year post-QOF) were obtained. Crude prescribing data from matched practices were manipulated to provide a data set of Defined Daily Doses (DDDs)/1,000 patients and cost/DDD/1,000 patients for each statin drug entity covering 1 year before and after the introduction of QOF. QOF achievements were converted into percentage scores for matched practices. MAIN OUTCOME MEASURE: Cost per defined daily dose (DDD) per 1,000 patients. RESULTS: Significantly less statins (DDD/1,000 patients) were dispensed in Northern Ireland compared with the matched region in England both before and after the introduction of QOF (P < 0.001). However, significantly more statins were dispensed in both regions after the introduction of QOF. As a result of the introduction of QOF, the cost/DDD/1,000 patients rose by pound13.17 in NI, but fell by pound3.76 in the matched region in England. CONCLUSION: Strategies should be considered to educate prescribers on cost-effectiveness by increasing their awareness of the negative budgetary impact resulting from early adoption of new and expensive statins and by encouraging generic prescribing.

Impact of Modified System of Objectified Judgement Analysis (SOJA) methodology on prescribing costs of ACE inhibitors.

BACKGROUND AND OBJECTIVES: System of Objectified Judgement Analysis (SOJA) is a structured approach to the selection of drugs for formulary inclusion. How- ever, while SOJA is a very important advance in drug selection for formulary purposes, it is hospital based and can only be applied to one indication at a time. In SOJA, cost has been given a primary role in the selection process as it has been included as a selection criterion from the start. Cost may therefore drive the selection of a particular drug product at the expense of other basic criteria such as safety or efficacy. The aims of this study were to use a modified SOJA approach in the selection of ACE inhibitors (ACEIs) for use in a joint formulary that bridges primary and secondary care within a health board in Northern Ireland, and to investigate the potential impact of the joint formulary on prescribing costs of ACEIs in that health board. METHODS: The modified SOJA approach involved four phases in sequence: an evidence-based pharmacotherapeutic evaluation of all available ACEI drug entities, a separate safety/risk assessment analysis of products containing agents that exceeded the pharmacotherapeutic threshold, a budget-impact analysis and, finally, the selection of product lines. A comprehensive literature review and expert panel judgement informed the selection of criteria (and their relative weighting) for the pharmacotherapeutic evaluation. The resultant criteria/scoring system was circulated (in questionnaire format) to prescribers and stakeholders for comment. Based on statistical analysis of the latter survey results, the final scoring system was developed. Drug entities that exceeded the evidence threshold were sequentially entered into the second and third phases of the process. RESULTS: Five drug entities (11 currently available in the UK) exceeded the evidence threshold and 22 of 26 submitted product lines containing these drug entities satisfied the safety/risk assessment criteria. Three product lines, each containing a different drug entity, were selected for formulary inclusion after budget impact analysis was performed. The estimated potential annual cost savings for ACEIs (based on estimated annual usage in defined daily doses) for this particular health board was 42%. CONCLUSION: The modified SOJA approach has a significant contribution to make in containing the costs of ACEIs. Applying modified SOJA as a practical method for all indications will allow the development of a unified formulary that bridges secondary and primary care.