Территориальная организация и проблемы рекреационного лесопользования в Крыму

В статье рассмотрены ресурсный потенциал, пространственная организация, экологические проблемы рекреационного лесопользования в Крыму, предложены принципы устойчивого развития лесных рекреационных территорий.У статті розглянуто ресурсний потенціал, просторова організація, екологічні проблеми рекреаційного лісокористування в Криму, запропоновано принципи стійкого розвитку лісових рекреаційних територій.The recreational potential, the space organization, ecologic problems of the recreational forest management in Crimea are considered in this article. Principles of the sustainable development of forest recreational territories are proposed

National medicines policies – a review of the evolution and development processes

OBJECTIVES: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs. METHODS: The number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa. RESULTS: The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5–10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring. CONCLUSIONS: To date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses

Objectives: To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession – a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal – on utilization of, as a proxy for access to, antipsychotic medicines. Methodology We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. Results: Both countries’ policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. Conclusions: Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended – increased use of generics – and likely unintended – slightly decreased overall sales, possibly consistent with decreased access to needed medicines – impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes

Added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020: retrospective cohort study

OBJECTIVES To evaluate the added benefit and revenues of oncology drugs, explore their association, and investigate potential discrepancies between added benefit and revenues across different approval pathways of the European Medicines Agency (EMA). DESIGN Retrospective cohort study. SETTING Oncology drugs and their indications approved by the EMA between 1995 and 2020. MAIN OUTCOME MEASURES Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the United States, France, Germany, and Italy, two medical oncology societies, and a drug bulletin. All retrieved ratings were recategorised using a four point ranking scale to indicate negative or non-quantifiable, minor, substantial, or major added benefit. Revenue data were extracted from publicly available financial reports and compared with published estimates of research and development (R&D) costs. Finally, the association between added benefit and revenue was evaluated. All analyses were performed within the overall study cohort, and within subgroups based on the EMA approval pathway: standard marketing authorisation, conditional marketing authorisation, and authorisation under exceptional circumstances. RESULTS 131 oncology drugs with 166 indications were evaluated for their added benefit by at least one organisation within the required timeframe, yielding a total of 458 added benefit ratings; 189 (41%) were negative or non-quantifiable. The median time to offset the median R&D costs ($684m, £535m, €602m, adjusted to 2020 values) was three years; 50 of 55 (91%) drugs recovered these costs within eight years. Drugs with higher added benefit ratings generally had greater revenues. Negative or non-quantifiable added benefit ratings were more frequent for conditional marketing authorisations and authorisations under exceptional circumstances than for standard marketing authorisations (relative risk 1.53, 95% confidence interval 1.23 to 1.89). Conditional marketing authorisations generated lower revenues and took longer to offset R&D costs than standard marketing authorisations (four years compared with three years). CONCLUSIONS While revenues seem to align with added benefit, most oncology drugs recover R&D costs within a few years despite providing little added benefit. This is particularly true for drugs approved through conditional marketing authorisations, which inherently appear to lack comprehensive evidence. Policy makers should evaluate whether current regulatory and reimbursement incentives effectively promote development of the most effective drugs for patients with the greatest needs

Inpatient prescribing of dual antiplatelet therapy according to the guidelines:a prospective intervention study

Background: In dual antiplatelet therapy (DAPT), low-dose acetylsalicylic acid is combined with a P2Y12 inhibitor. However, combining antithrombotic agents increases the risk of bleeding. Guidelines on DAPT recommend using this combination for a limited period of between three weeks and 30 months. This implies the risk of DAPT being erroneously continued after the intended stop date. Objective: The primary objective of this study is to assess the proportion of hospitalized patients treated with DAPT whose treatment deviated erroneously and unintentionally from the guidelines. We also assessed risk factors and the effect of a pharmacist intervention. Methods: All patients admitted to the Spaarne Gasthuis (Haarlem/ Hoofddorp, the Netherlands) who used DAPT between March 25th , 2019, and June 14th , 2019, were, in addition to receiving regular care, reviewed to assess whether their therapy was in line with the guidelines' recommendation and whether deviations were unintended and erroneous. In the event of an unintended deviation, the pharmacist intervened by contacting the prescriber by phone and giving advice to adjust the antithrombotic therapy in line with the guideline. Results: We included 411 patients, of whom 21 patients (5.1%) had a treatment that deviated from the guidelines. For 11 patients (2.7%), the deviation was unintended and erroneous. The major risk factor for erroneous deviation was the use of DAPT before hospital admission (OR 18.7; 95%Cl 4.79-72.7). In patients who used DAPT before admission, 18 out of 58 (31.0%) had a deviation from the guidelines of whom 8 (13.8%) were erroneous. For these eight patients, the pharmacist contacted the prescriber, and in these cases the therapy was adjusted in line with the guidelines. Conclusions: Adherence to the guidelines recommending DAPT was high within the hospital. However, patients who used DAPT before hospital admission had a higher risk of erroneous prescription of DAPT. Intervention by a pharmacist increased adherence to guidelines and may reduce the number of preventable bleeding cases

Antibiotic prescribing for children in general practice and adherence to treatment guidelines 2010-2012

Background Over 80% of antibiotics are prescribed in general practice, mainly for viral RTIs in children. In response, numerous efforts to improve antibiotic prescribing have been ongoing for decades. Treatment guidelines are developed to support GP decision-making on which RTIs require antibiotics. Yet, detailed information on adherence to RTI treatment guidelines for antibiotic prescribing in children is scarce. Trends in antibiotic use suggest an overall reduction in antibiotic rates for children since the late 1990s. On the other hand, antibiotics continue to be prescribed for non-specific URTIs diagnosis, and quite often as broad-spectrum products. The Netherlands has maintained low and stable antibiotic use in primary care. Even though, national guidelines for RTIs are generally accepted by Dutch GPs, antibiotic prescribing is not always in accordance with recommendations. Few studies have assessed adherence to RTI guidelines for children. Our study explores antibiotic prescribing patterns for fever, ear and respiratory infections in Dutch children 2010 - 2012. Our objective is to determine guideline adherence in antibiotic prescribing for different paediatric RTIs and choice of antibiotics. We also aim to examine potential variations in guideline adherence among GPs. Methods We use prescribing data and children’ diagnoses (ICPC-1) from NIVEL Primary Care Database. GP prescriptions include information on drug name (ATC), prescribing date and amount prescribed. Antibiotics are defined as antibacterial for systemic use (ATC code J01). We matched ICPC with clinical conditions from national guidelines. Different consultations concerning same health problem within a pre-set time frame are linked to one disease episode. First set of outcomes measure GP adherence to recommendations on whether or not to prescribe antibiotics for the diagnosis, while second one evaluate antibiotic types prescribed. Outcomes are defined by disease-specific indicators for outpatient antibiotic prescribing. Analysis SPSS is used to obtain overall incidence rates for each ICPC and % of disease episodes with prescribed antibiotics. We will calculate 95% CIs for overall figures and value range for each indicator at practice level. We will present the data by year and age groups. Multilevel analysis will be done for variability in antibiotic prescribing quality among general practices

Outer packaging labelling of medicines in Southern African Development Community (SADC) countries: comparative analysis of requirements and transition terms for harmonisation

Introduction: The COVID-19 pandemic highlighted an urgent need for harmonised requirements for the regulation of medicines. To fully implement harmonised medicines regulations across Africa, common technical standards of medicine regulations are needed. One such technical standard is the labelling of medicines on outer packaging. In this study, we compared outer packaging labelling requirements and transition terms for harmonization for countries in the Southern African Development Community (SADC) region. Methods: Data on legislation and/or regulatory guidelines for medicine outer packaging labelling from National Medicines Regulatory Authorities (NMRAs) were obtained for countries in the SADC region (n = 16) by February 2023. A detailed comparative content analysis was conducted to determine alignment with the requirements of the Southern African Development Community (SADC) harmonised labelling guidelines to assess readiness levels of each country to transition to the SADC harmonised labelling guideline for outer packaging of medicines. Results: Content analysis showed at least 11 out of 16 countries require national legal reform to transition to the SADC harmonised labelling guideline. In all cases where countries specified labelling requirements for outer packaging of medicines, these were stipulated in national medicines legislation. Conclusion: Even though there is a high level of alignment across the countries in terms of national labelling requirements, most countries in the SADC region would still require national legislative reform to transition to regional harmonised labelling requirements and then ultimately to continental requirements of the African Medicines Agency (AMA)

Newer long-acting insulin prescriptions for patients with type 2 diabetes: Prevalence and practice variation in a retrospective cohort study

BACKGROUND: Little is known about prescription patterns of expensive non-recommended newer long-acting insulins (glargine 300 U/mL and degludec) for patients with type 2 diabetes mellitus (T2DM). AIM: To identify practice variation in, and practice- and patient-related characteristics associated with, the prescription of newer long-acting insulins to patients with T2DM in primary care. DESIGN AND SETTING: A retrospective cohort study in Dutch general practices (Nivel Primary Care Database). METHOD: A first prescription for intermediate or long-acting insulins in 2018 was identified in patients aged ≥40 years using other T2DM drugs. Per practice, the median percentage and interquartile range (IQR) of patients with newer insulin prescriptions were calculated. Multilevel logistic regression models were constructed to calculate intraclass correlation coefficients (ICCs) and quantify the association of patient and practice characteristics with prescriptions for newer insulins (odds ratios [ORs] and 95% confidence intervals [CIs]). RESULTS: In total, 7757 patients with prescriptions for intermediate or long-acting insulins from 282 general practices were identified. A median percentage of 21.2% (IQR 12.5–36.4%) of all patients prescribed intermediate or long-acting insulins per practice received a prescription for newer insulins. After multilevel modelling, the ICC decreased from 20% to 19%. Female sex (OR 0.77, 95% CI = 0.69 to 0.87), age ≥86 years compared with 40–55 years (OR 0.22, 95% CI = 0.15 to 0.34), prescriptions for metformin (OR 0.66, 95% CI = 0.53 to 0.82), sulfonylurea (OR 0.58, 95% CI = 0.51 to 0.66), or other newer T2DM drugs (OR 3.10, 95% CI = 2.63 to 3.66), and dispensing practices (OR 1.78, 95% CI = 1.03 to 3.10) were associated with the prescription of newer insulins. CONCLUSION: The inter-practice variation in the prescription of newer insulins is large and could only be partially explained by patient- and practice-related differences. This indicates substantial opportunities for improvement

Reporting of adverse events following immunizations in Ghana–Using disproportionality analysis reporting ratios

Background: Timely reporting of safety information post vaccination is pivotal for the success of any vaccination program. Reports of adverse events following immunization (AEFI) of 6 different vaccinations from Ghana were analysed for signals. Methods: De-identified data from active surveillance for AEFIs after 2009 AH1N1 influenza, yellow fever, meningitis, measles-rubella, pneumococcal-rotavirus and human papilloma virus vaccinations were used. All vaccinations occurred between January 2010 and December 2013. The ten most occurring events for each vaccination were captured and arranged using Medical Dictionary for Regulatory Authorities (MedDRA) Preferred Term (PT) and System Organ Classification (SOC) codes. Adverse event incidence rates were calculated for each vaccine type, and signals were generated using proportional reporting ratios (PRR). Results: A total number of 5,141 reports were analysed ranging from 33 (human papilloma virus) to 1958 (measles-rubella). Between 22% and 55% of all AEFIs per vaccine type were collected on the day of vaccination. For each vaccine type, at least 87% of all reported AEFIs occurred in the first 7 days post-vaccination. Multiple reports were received per vaccine type. For the MR vaccine, urticarial recorded the highest attack rate of 6.6 (95% CI 6.2, 7.1) per 100,000 vaccines. The AEFI with the highest PRR for both human papilloma and measles-rubella vaccines was abdominal pain, recording a PRR of 8.15 (95% CI 3.46, 19.23) and 43.75 (95% CI 17.81, 107.45) respectively. Conclusion: These results underscore the competency of public health systems in sub-Saharan African countries (like Ghana) to identify most frequently occurring and important vaccine related safety issues