Suchergebnisse

In 2018/2019 there were a number of initiatives for collaboration between Member States in the European Economic Area (EEA) and the European Commission published a Proposal for a Regulation on Health Technology Assessment. In view of the perceived benefits from collaboration, the experiences and challenges of these collaborative initiatives and the possible implications of the proposed legislation, a study of the evidence on attitudes, perceived impacts and the motivational factors towards European Member State collaboration regarding the pricing and reimbursement of medicines was conducted. This study adopted an evidence–based management approach by Barends and Rousseau. The main findings showed that Member States differed in their motivation for collaboration for different pharmaceutical activities. Member States favoured voluntary co-operation for all activities of pricing and reimbursement except for relative effectiveness assessments where Member State authorities had divergent attitudes and prioritised activities related to the sustainability of their healthcare systems and access to medicines. Contrastingly pharmaceutical companies strongly favoured mandatory cooperation for evaluation. Member States motivation for collaboration was highly dependent on the purpose, political will, implementation climate and cultural factors. Currently, with the experiences of ongoing collaborations, following the progress of the discussion at Council, and with a number of inititatives for new pharmaceutical strategy and policy, it is proposed that Member States use their trust, expertise and knowledge of application of evidence-based decision making for pricing and reimbursement of medicines and apply it to decide the future model for Member State collaboration. The applicability of principles of evidence-based management to pharmaceutical policy can be used as a starting point. ; peer-reviewed

In 2018/2019 there were a number of initiatives for collaboration between Member States in the European Economic Area (EEA) and the European Commission published a Proposal for a Regulation on health technology assessment. In view of the perceived benefits from collaboration, the experiences and challenges of these collaborative initiatives and the possible implications of the proposed legislation, a study of the evidence on attitudes, perceived impacts and the motivational factors towards European Member State collaboration regarding the pricing and reimbursement of medicines was conducted. This study adopted an evidence–based management approach by Barends and Rousseau. The main findings showed that Member States differed in their motivation for collaboration for different pharmaceutical activities. Member States favoured voluntary co-operation for all activities of pricing and reimbursement except for relative effectiveness assessments where Member State authorities had divergent attitudes and prioritised activities related to the sustainability of their healthcare systems and access to medicines. Contrastingly pharmaceutical companies strongly favoured mandatory cooperation for evaluation. Member States motivation for collaboration was highly dependent on the purpose, political will, implementation climate and cultural factors. Currently, with the experiences of ongoing collaborations, following the progress of the discussion at Council, and with a number of inititatives for new pharmaceutical strategy and policy, it is proposed that Member States use their trust, expertise and knowledge of application of evidence-based decision making for pricing and reimbursement of medicines and apply it to decide the future model for Member State collaboration. The applicability of principles of evidence-based management to pharmaceutical policy can be used as a starting point.

In 2018/2019 there were a number of initiatives for collaboration between Member States in the European Economic Area (EEA) and the European Commission published a Proposal for a Regulation on Health Technology Assessment. In view of the perceived benefits from collaboration, the experiences and challenges of these collaborative initiatives and the possible implications of the proposed legislation, a study of the evidence on attitudes, perceived impacts and the motivational factors towards European Member State collaboration regarding the pricing and reimbursement of medicines was conducted. This study adopted an evidence–based management approach by Barends and Rousseau. The main findings showed that Member States differed in their motivation for collaboration for different pharmaceutical activities. Member States favoured voluntary co-operation for all activities of pricing and reimbursement except for relative effectiveness assessments where Member State authorities had divergent attitudes and prioritised activities related to the sustainability of their healthcare systems and access to medicines. Contrastingly pharmaceutical companies strongly favoured mandatory cooperation for evaluation. Member States motivation for collaboration was highly dependent on the purpose, political will, implementation climate and cultural factors. Currently, with the experiences of ongoing collaborations, following the progress of the discussion at Council, and with a number of inititatives for new pharmaceutical strategy and policy, it is proposed that Member States use their trust, expertise and knowledge of application of evidence-based decision making for pricing and reimbursement of medicines and apply it to decide the future model for Member State collaboration. The applicability of principles of evidence-based management to pharmaceutical policy can be used as a starting point.

Introduction: There have been concerns with the availability and affordability of EMA's recently approved medicines with a conditional approval in Korea. This needs to be addressed to provide future guidance to the authorities in Korea. Objective: Compare the availability and affordability of medicines with a conditional approval by the European Medicine Agency (EMA) among 12 countries (US, UK, France, Germany, Switzerland, Italy, Japan, Canada, Taiwan, Australia, New Zealand and Korea) in light of access to medicine concerns in Korea. Methods: 13 medicines were selected and compared in terms of their availability and affordability across 12 countries. Approval rate for the selected medicines and time lag to approval on the basis of EMA's approval dates were calculated. Reimbursement status and prices were compared as proxies of affordability. Results: The average approval rate was 31.9% for the selected medicines for all countries outside the EU countries. The highest rate was in US (69.2%) followed by Korea and Switzerland (46.5%). An average of 238days was taken among the countries for approval. The US (Median -355 days) was the country where the medicines were most rapidly approved. Korea (152 days) ranked the fifth most rapidly approving country. An average listing or reimbursement rate for all countries was 54.1%. The US ranked 100% for the listing of their approved medicines followed by Germany (92.3%). Korea (66.7%) ranked eighth. Price dispersion ranged from 1.1 to 2.8. Korean prices of the selected medicines were found to be neither high nor low. Conclusions: Korea was found to be a country where marketing authorization for more medicines tended to be made and subsequent reimbursement and pricing were not rigid even generous compared to other Asian-pacific countries. Korean drug benefit policies for listing and pricing did not appear to hinder access to medicines even with a conditional approval in comparison with others.

The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.

Introduction: The World Health Organization identified Pharmaceutical and Therapeutics Committees (PTCs) at district and hospital levels as one of the pivotal models to promote rational use of medicines (RUM). This is endorsed by the Government in South Africa. Formulary development and management is one of the main functions of PTCs. This study aimed to describe the formulary management activities among PTCs in public hospitals in Gauteng Province, South Africa, following initiatives to promote RUM in South Africa. Methods: Qualitative, nonparticipatory, observational study, observing 26 PTC meetings. Data were coded and categorized using NVivo9 ® qualitative data analysis software. Themes and sub-themes were developed. The themes and sub-themes on formulary management are the principal focus of this paper. Results: More than half of the observed PTCs reviewed their formulary lists. There was variation in the review process among institutions providing different levels of care. Various aspects were considered for formulary management especially requests for medicines to be added. These included cost considerations (mainly focusing on acquisition costs), evidence-based evaluation of clinical trials, patient safety, clinical experience and changes in the National Essential Medicines List (NEML). The tertiary PTCs mostly dealt with applications for new non-EML medicines, while PTCs in the other hospitals mainly requested removal or addition of EML medicines to the list. Conclusion: This is the first study from Gauteng Province, South Africa, reporting on how decisions are actually taken to include or exclude medicines onto formularies within public sector hospitals providing different levels of care. Various approaches are adopted at different levels of care when adding to- or removing medicines from the formulary lists. Future programs should strengthen PTCs in specialized aspects of formulary management. A more structured approach to formulary review at the local PTC level should be encouraged in line with the national approach when reviewing possible additions to the NEML.

INTRODUCTION: The World Health Organization identified Pharmaceutical and Therapeutics Committees (PTCs) at district and hospital levels as one of the pivotal models to promote rational use of medicines (RUM). This is endorsed by the Government in South Africa. Formulary development and management is one of the main functions of PTCs. This study aimed to describe the formulary management activities among PTCs in public hospitals in Gauteng Province, South Africa, following initiatives to promote RUM in South Africa. METHODS: Qualitative, nonparticipatory, observational study, observing 26 PTC meetings. Data were coded and categorized using NVivo9(®) qualitative data analysis software. Themes and sub-themes were developed. The themes and sub-themes on formulary management are the principal focus of this paper. RESULTS: More than half of the observed PTCs reviewed their formulary lists. There was variation in the review process among institutions providing different levels of care. Various aspects were considered for formulary management especially requests for medicines to be added. These included cost considerations (mainly focusing on acquisition costs), evidence-based evaluation of clinical trials, patient safety, clinical experience and changes in the National Essential Medicines List (NEML). The tertiary PTCs mostly dealt with applications for new non-EML medicines, while PTCs in the other hospitals mainly requested removal or addition of EML medicines to the list. CONCLUSION: This is the first study from Gauteng Province, South Africa, reporting on how decisions are actually taken to include or exclude medicines onto formularies within public sector hospitals providing different levels of care. Various approaches are adopted at different levels of care when adding to- or removing medicines from the formulary lists. Future programs should strengthen PTCs in specialized aspects of formulary management. A more structured approach to formulary review at the local PTC level should be encouraged in line with the ...

ABSTRACT
ObjectivesPatients with atrial fibrillation (AF) have an increased risk of developing stroke, and oral anticoagulants (OACs) are commonly used in stroke prevention. The CHA2DS2-VASc score has been proved to be a simple and effective tool for stroke risk assessment which guides the selection of treatment with OACs. This score is calculated using disease diagnoses; however, a range of different versions exist, making comparability questionable.
The aim of this study was to compare CHA2DS2-VASc scores in OAC treated patients with a hospital-confirmed diagnosis of AF in Scotland using different subsets of ICD-10 codes.
Approach This is a retrospective study, covering AF patients in Scotland who received at least one prescription for any OAC between January 2009 and June 2014. The Prescribing Information System (PIS) was used to identify patients with OAC prescriptions, while the Scottish Morbidity Records (SMR) provided patients' diagnoses. Different sets of ICD-10 codes, using varying definitions, were used to classify the stroke risk in AF patients in order to account for heterogenous definitions applied in previously published studies. The main differences in codes used were the inclusion or exclusion of unclassified stroke (ICD-10 code I64), and the inclusion of pulmonary embolism (PE) (I26) as either "prior thromboembolic event" or "vascular disease".
ResultsIn our study, a cohort of 71012 AF patients with OAC prescription were analysed. Using narrow disease definitions, 18.15% of patients were categorised as being at low risk of stroke (score 0-1), 74.80% at medium risk (score 2-5), and 7.04% at high risk (score 6-9). With an extended disease definition, including PE in "prior thromboembolic event", 14.81% of patients were at low risk (score 0-1), 72.60% at medium risk (score 2-5), and 12.59% at high risk (score 6-9); while including PE in "vascular disease", 14.99% of the patients had a score 0-1, 73.54% a score 2-5, and 11.48% a score 6-9.
Conclusion The change in score definitions makes a difference mainly in the number of patients categorised as very low risk or high risk. Standardisation in ICD-10 code definition of risk diseases could be useful in order to make the results comparable from different studies and further evaluate OAC choice according to risk group.

Objective: Irrational use of antimicrobials is a major driver of antimicrobial resistance, exacerbated by dispensing antibiotics without a prescription. Our previous study suggested this was a problem in the Republic of Srpska despite legislation. Since then, a number of activities have been initiated. Consequently, the study aimed to ascertain whether these multiple initiatives had reduced this. Methods: Patients visiting all community pharmacies in the Republic from October 2014 to July 2015 presenting with symptoms typical of an acute, viral, and mostly uncomplicated upper respiratory tract infection, with results compared to the previous study. If an antibiotic was suggested, the maximum allowance was €3/pack. Findings: Self‑medication with antibiotics significantly decreased from 58% to 18.5% of pharmacies. In both studies, most patients were offered over‑the‑counter medication. The most common reason for not dispensing an antibiotic was "antibiotics can be dispensed with a prescription only." The penicillins were the most dispensed antibiotic. Fewer patients than the previous study were given instructions about antibiotic use and no discussion on their side effects. Conclusion: While encouraging that self‑medication decreased significantly, 18.5% were disappointing given recent initiatives. Fewer instructions about antibiotics if an antibiotic was dispensed were also disappointing. This suggests the need for even stronger enforcement of the laws as well as further training of pharmacy personnel to ensure the future appropriate use of medicines

Objective: Irrational use of antimicrobials is a major driver of antimicrobial resistance, exacerbated by dispensing antibiotics without a prescription. Our previous study suggested this was a problem in the Republic of Srpska despite legislation. Since then, a number of activities have been initiated. Consequently, the study aimed to ascertain whether these multiple initiatives had reduced this. Methods: Patients visiting all community pharmacies in the Republic from October 2014 to July 2015 presenting with symptoms typical of an acute, viral and mostly uncomplicated upper respiratory tract infection, with results compared to the previous study. If an antibiotic was suggested, the maximum allowance was Euro 3/ pack. Findings: Self-medication with antibiotics significantly decreased from 58% to 18.5% of pharmacies. In both studies, most patients were offered over-the-counter medication. The most common reason for not dispensing an antibiotic was 'antibiotics can be dispensed with a prescription only'. The penicillins were the most dispensed antibiotic. Fewer patients than the previous study were given instructions about antibiotic use and no discussion on their side-effects. Conclusion: Whilst encouraging that self-medication decreased significantly, 18.5% was disappointing given recent initiatives Fewer instructions about antibiotics if an antibiotic was dispensed was also disappointing. This suggests the need for even stronger enforcement of the laws as well as further training of pharmacy personnel to ensure future appropriate use of medicines.

Objective: Irrational use of antimicrobials is a major driver of antimicrobial resistance, exacerbated by dispensing antibiotics without a prescription. Our previous study suggested this was a problem in the Republic of Srpska despite legislation. Since then, a number of activities have been initiated. Consequently, the study aimed to ascertain whether these multiple initiatives had reduced this. Methods: Patients visiting all community pharmacies in the Republic from October 2014 to July 2015 presenting with symptoms typical of an acute, viral, and mostly uncomplicated upper respiratory tract infection, with results compared to the previous study. If an antibiotic was suggested, the maximum allowance was €3/pack. Findings: Self‑medication with antibiotics significantly decreased from 58% to 18.5% of pharmacies. In both studies, most patients were offered over‑the‑counter medication. The most common reason for not dispensing an antibiotic was "antibiotics can be dispensed with a prescription only." The penicillins were the most dispensed antibiotic. Fewer patients than the previous study were given instructions about antibiotic use and no discussion on their side effects. Conclusion: While encouraging that self‑medication decreased significantly, 18.5% were disappointing given recent initiatives. Fewer instructions about antibiotics if an antibiotic was dispensed were also disappointing. This suggests the need for even stronger enforcement of the laws as well as further training of pharmacy personnel to ensure the future appropriate use of medicines

BACKGROUND : Inappropriate use of antimicrobials is a key factor increasing antimicrobial resistance, a major global public health problem including in South Africa. Key drivers include antibiotics being dispensed without a prescription. OBJECTIVES : To determine the accessibility of antibiotics without a prescription in community pharmacies in urban areas in South Africa and determine whether counselling was provided when antibiotics were dispensed. PATIENTS AND METHODS : Prospective, observational study, employing simulated patients (SPs), presenting with upper respiratory tract infections (URTIs) and urinary tract infections (UTIs), undertaken to establish whether antibiotics can be obtained without a valid prescription in South Africa. This pilot study was conducted in privately owned (n = 20) and corporate (franchised, n = 14) community pharmacies in three regions in Gauteng Province. RESULTS : Antibiotics were sold in privately owned pharmacies without a prescription in 80% (16/20) of cases while no antibiotics were dispensed in corporate (franchised) pharmacies. Of the 16 pharmacies selling antibiotics without a prescription, pharmacist assistants were involved in 37.5% (n = 6) and counselling was not provided to 19% of SPs. Ciprofloxacin (42.9%) and metronidazole (28.6%) were the most common antibiotics dispensed. No antibiotics were dispensed for URTIs, only UTIs. CONCLUSIONS : Dispensing antibiotics without prescriptions can be common among privately owned pharmacies in urban areas in South Africa. Corporate pharmacies, which probably have a greater income, appear to follow current legislation banning such activities. To limit selling with no prescription, community pharmacists and assistants especially in urban areas should be educated on appropriate patient care and legal requirements, with dispensing electronically monitored. ; The School of Pharmacy Sefako Makgatho Health Sciences ; https://academic.oup.com/jacamr ; hj2022 ; Pharmacology

Background: Inappropriate use of antimicrobials is a key factor increasing antimicrobial resistance, a major global public health problem including South Africa. Key drives include antibiotics being dispensed without a prescription. Objectives: To determine the accessibility of antibiotics without a prescription in community pharmacies in urban areas in South Africa, and determine if counselling was provided when antibiotics were dispensed. Patients and methods: Prospective, observational study, employing simulated patients (SPs), presenting with upper respiratory tract infections (URTIs) and urinary tract infections (UTIs), undertaken to establish if antibiotics can be obtained without a valid prescription in South Africa. This pilot study was conducted in privately owned (n=20) and corporate (franchised - n=14) community pharmacies in three regions in Gauteng Province. Results: Antibiotics were sold in privately owned pharmacies without a prescription in 80% (16/20) of cases while no antibiotics were dispensed in corporate (franchised) pharmacies. Of the 16 pharmacies selling antibiotics without a prescription, pharmacist assistants were involved in 37.5% (n=6) and counselling was not provided to 19% of SPs. Ciprofloxacin (42.9%) and metronidazole (28.6%) were the most common antibiotics dispensed. No antibiotics were dispensed for URTIs, only UTIs. Conclusion: Dispensing antibiotics without prescriptions can be common among privately owned pharmacies in urban areas in South Africa. Corporate pharmacies, which probably have a greater income, appear to follow current legislation banning such activities. To limit selling with no prescription, community pharmacists and assistants especially in urban areas should be educated on appropriate patient care and legal requirements, with dispensing electronically monitored.

BACKGROUND: Inappropriate use of antimicrobials is a key factor increasing antimicrobial resistance, a major global public health problem including in South Africa. Key drivers include antibiotics being dispensed without a prescription. OBJECTIVES: To determine the accessibility of antibiotics without a prescription in community pharmacies in urban areas in South Africa and determine whether counselling was provided when antibiotics were dispensed. PATIENTS AND METHODS: Prospective, observational study, employing simulated patients (SPs), presenting with upper respiratory tract infections (URTIs) and urinary tract infections (UTIs), undertaken to establish whether antibiotics can be obtained without a valid prescription in South Africa. This pilot study was conducted in privately owned (n = 20) and corporate (franchised, n = 14) community pharmacies in three regions in Gauteng Province. RESULTS: Antibiotics were sold in privately owned pharmacies without a prescription in 80% (16/20) of cases while no antibiotics were dispensed in corporate (franchised) pharmacies. Of the 16 pharmacies selling antibiotics without a prescription, pharmacist assistants were involved in 37.5% (n = 6) and counselling was not provided to 19% of SPs. Ciprofloxacin (42.9%) and metronidazole (28.6%) were the most common antibiotics dispensed. No antibiotics were dispensed for URTIs, only UTIs. CONCLUSIONS: Dispensing antibiotics without prescriptions can be common among privately owned pharmacies in urban areas in South Africa. Corporate pharmacies, which probably have a greater income, appear to follow current legislation banning such activities. To limit selling with no prescription, community pharmacists and assistants especially in urban areas should be educated on appropriate patient care and legal requirements, with dispensing electronically monitored.

Objective: Combined hormonal contraceptives (CHC) exhibit differing risks for cardiovascular and thrombotic events (VTE). A European referral process confirmed higher VTE risks for 3(rd) generation gestagens and drospirenone. CHC are now grouped in risk classes (RC) I, II, and III, with RC III having a higher risk than RC I and X (risk not yet known). Marketing authorization holders were obliged to implement pharmacovigilance measures and risk minimization measures including changes of prescribing information. The study assessed whether these activities induced changes in prescription patterns. Methods: German prescription data for 1.1 million women below 20 years of age were used to analyze the effects of interventions and potential influence factors using logistic regression. Descriptive statistics were calculated for prescriptions for 3.3 million women from January 2011 to March 2016. Results: Shares of RC I and RC X recipients rose substantially over the observation period, while RC III recipient share showed a steady decrease. The referral induced a slightly faster decrease in RC III and increase in RC X. The implementation of pharmacovigilance measures manifested no additional effect. Conclusion: The decrease in RC III share already observed before the referral process can be explained with pre-existing discussions around CHC. The effect attributable to the referral was statistically significant, although very small. While evidence for a connection between interventions and prescription change is only indirect, the study shows that routine data are suitable for impact analyses, and monitoring prescribing patterns can be recommended as feedback after regulatory or political interventions. This is being followed up.