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

Identifying the teaching content on substandard and falsified medical products in global pharmacy education as critical public health issue

Aim: To gain insight into the education about substandard and falsified (SF) medical products. Method: A digital survey was sent to 173 different schools of pharmacy around the world. Results: The response rate was 32% (55 responses, 37 countries). Most schools taught about SF medical products as a stand-alone course or as part of another course or module (67%), whereas 33% did not teach about the subject. The main focus of teaching was on detection (21%) and prevention (21%) of SF medical products, while reporting was taught the least (12%), indicating a knowledge gap in that area. A key barrier to introducing a new course that could close the gaps was insufficient time in pharmacy curriculum (n=33; 60%), while availability of ready-to-adopt course materials was considered as a helpful enabler. Conclusion: These insights can improve the understanding on what is already being taught on SF medical products, where the gaps are and inform the curriculum needed globally

Reported Challenges in Health Technology Assessment of Complex Health Technologies

Objectives: With complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies.  Methods: A survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination.  Results: A total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%).  Conclusions: Most challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases

Longitudinal study of Good Pharmacy Practice roles covered at the annual world pharmacy congresses 2003–2019

Background: Globally accepted roles of pharmacists are described in the Good Pharmacy Practice (GPP) standards, published by the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) in 2011. These standards provide a wide-ranging description of four main roles pharmacists fulfil. The global platform, where pertinent discussions around excellence and innovation in various pharmacy roles take place, is the annual congress of the pharmacy organisation representing the profession globally, FIP. Objectives: Given the world pharmacy congresses present and reflect on the most topical and contemporary matters, this longitudinal study aimed at creating a historical overview of the frequency of appearance of the different GPP roles in the programmes of the past 17 congresses (2003–2019). This is to distinguish the dominance of different roles over time and thus their relevance for the profession. Methods: The GPP standards served as a framework to create a set of keywords that were analysed for their frequencies of appearance in the programmes through text analysis. Trends in the four overarching GPP roles and at individual keyword level were analysed descriptively over time. Results: The study found that all four GPP roles appeared in the programme each year and none of them was significantly missing, neither in the decade preceding the publication of the GPP standards nor in the decade thereafter. Role 3 “Maintain and improve professional performance” was most frequently represented, also demonstrating an upward trend in appearance, together with Role 4: “Contribute to improve effectiveness of the health-care system and public health”. Trends emerged towards patient-centred clinical focus and positioning pharmacy as an important player in the health-care system—observed also at individual keywords level in areas such as health promotion—away from the more traditional product-centred practice roles such as compounding. Conclusions: GPP roles have been already covered by the FIP annual congresses (long) before 2011, when the GPP roles were formally adopted, and they stayed relevant in the decade after. The more pronounced dominance toward the roles related to improving professional performance and positioning pharmacy are in line with the trend that the rather technical topics in pharmacy are increasingly covered by specialised meetings and that the FIP annual congresses have moved toward more general, scholarly platforms for dialogue and conversation

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

When Reality Does Not Meet Expectations-Experiences and Perceived Attitudes of Dutch Stakeholders Regarding Payment and Reimbursement Models for High-Priced Hospital Drugs

This study aimed to identify the current experiences with and future preferences for payment and reimbursement models for high-priced hospital therapies in the Netherlands, where the main barriers lie and assess how policy structures facilitate these models. A questionnaire was sent out to Dutch stakeholders (in)directly involved in payment and reimbursement agreements. The survey contained statements assessed with Likert scales, rankings and open questions. The results were analyzed using descriptive statistics. Thirty-nine stakeholders (out of 100) (in)directly involved with reimbursement decision-making completed the survey. Our inquiry showed that currently financial-based reimbursement models are applied most, especially discounts were perceived best due to their simplicity. For the future, outcome-based reimbursement models were preferred, particularly pay-for-outcome models. The main stated challenge for implementation was generating evidence in practice. According to the respondents, upfront payments are currently implemented most often, whereas delayed payment models are preferred to be applied more frequently in the future. Particularly payment-at-outcome-achieved models are preferred; however, they were stated as administratively challenging to arrange. The respondents were moderately satisfied with the payment and reimbursement system in the Netherlands, arguing that the transparency of the final agreements and mutual trust could be improved. These insights can provide stakeholders with future direction when negotiating and implementing innovative reimbursement and payment models. Attention should be paid to the main barriers that are currently perceived as hindering a more frequent implementation of the preferred models and how national policy structures can facilitate a successful implementation

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

Real World Data in Health Technology Assessment of Complex Health Technologies

The available evidence on relative effectiveness and risks of new health technologies is often limited at the time of health technology assessment (HTA). Additionally, a wide variety in real-world data (RWD) policies exist among HTA organizations. This study assessed which challenges, related to the increasingly complex nature of new health technologies, make the acceptance of RWD most likely. A questionnaire was disseminated among 33 EUnetHTA member HTA organizations. The questions focused on accepted data sources, circumstances that allowed for RWD acceptance and barriers to acceptance. The questionnaire was validated and tested for reliability by an expert panel, and pilot-tested before dissemination via LimeSurvey. Twenty-two HTA organizations completed the questionnaire (67%). All reported accepting randomized clinical trials. The most accepted RWD source were patient registries (19/22, 86%), the least accepted were editorials and expert opinions (8/22, 36%). With orphan treatments or companion diagnostics, organizations tended to be most likely to accept RWD sources, 4.3-3.2 on a 5-point Likert scale, respectively. Additional circumstances were reported to accept RWD (e.g., a high disease burden). The two most important barriers to accepting RWD were lacking necessary RWD sources and existing policy structures. European HTA organizations seem positive toward the (wider) use of RWD in HTA of complex therapies. Expanding the use of patient registries could be potentially useful, as a large share of the organizations already accepts this source. However, many barriers still exist to the widespread use of RWD. Our results can be used to prioritize circumstances in which RWD might be accepted