The views of women and pharmacists on the desirability of a progestogen-only pill over the counter. Results of a survey in Germany, Italy and Spain.

PURPOSE: To explore the perceived need and enthusiasm for over the counter (OTC) progestogen-only pills (POP). MATERIALS AND METHODS: A web-based survey of 1000 sexually active women (16-45) and 100 pharmacists in Germany, Italy and Spain. RESULTS: Despite not wanting to conceive, 5-6% of women in each country were not using contraception and 8-20% were using methods less effective than condoms. At least 74% of respondents felt knowledgeable about the different contraceptives available but at least 1/3 had experienced difficulty accessing oral contraceptive (OCs) in the past two years. The cost of contraceptives, the need to see a doctor and long waits for appointments were cited as barriers for not using OCs. The majority agreed they would discuss with their doctor the decision to buy the POP, consult about side effects and other reproductive health issues. Over 2/3 of pharmacists in each country would be very, or fairly, likely to recommend the POP, agreeing that the benefits included improved access for women, and offered them more independence. CONCLUSIONS: Asked directly, women in Germany, Spain and Italy currently using contraception are positive about a POP OTC. Pharmacists are also positive, with the overwhelming majority in favour of providing POPs.

[Socio-economic impact of allergic rhinitis and perspectives of appropriate therapy]. / Sozioökonomische Auswirkungen der allergischen Rhinitis und Perspektiven einer adäquaten Therapie.

Allergic rhinitis is a very common disease that causes high economic costs. Furthermore inadequate treatment can lead to bronchial asthma. Against this background, drugs for the treatment of allergic rhinitis should be evaluated from a comprehensive medical-economic perspective. The new combination of an antihistamine and a corticosteroid, introduced in the market in 2013, emerges as useful pharmaceutical alternative, both with regard to the medical outcome parameters as well as cost-effectiveness.

Adherence in tamoxifen therapy after conversion to a rebate pharmaceutical in breast cancer patients in Germany.

BACKGROUND: The aim of this study was to investigate the risk of therapy discontinuation in breast cancer patients treated with tamoxifen with and without conversion to a rebate pharmaceutical (tamoxifen) and to analyze the negative consequences of rebate contracts on the compliance of breast cancer patients among gynecologist and general practitioner practices in Germany. METHODS: This retrospective analysis was performed using the IMS Disease Analyzer® database. Women with a diagnosis of breast cancer and first time prescription of tamoxifen in the time from January 2008 until December 2011 were selected. Main outcome measure was the incident the hormone treatment discontinuation rates within 3 years after index date. Treatment discontinuation of tamoxifen was defined as 90 days without this or alternative hormonal therapy (aromatase inhibitors) during that time. RESULTS: In total, 3,620 patients were included in the persistence analysis. 1,712 (47.3%) patients were converted to a rebate product. Within 3 years of follow-up, the discontinuation rates increased to 51.5% for switched patients and 46.3% for patients without switch (p < 0.01). Hazard ratios for 3-year risk of tamoxifen therapy discontinuation were adjusted for age, sex, gynecologist care, patient and physician's residency, baseline co-morbidities (osteoporosis, diabetes, depression and thrombosis, side effects). These analyses comprised a significantly increased risk for treatment discontinuation for patients who were switched to a rebate pharmaceutical compared to patients without conversion to a rebate pharmaceutical (HR: 1.27, CI: 1.05 - 1.53, p = 0.014). CONCLUSIONS: This analysis underlines an association between the initiation of rebate contracts and a negative impact on the compliance of breast cancer patients on an adjuvant hormonal treatment The impact of rebate contracts on the health of patients and the health care costs should be evaluated in further therapeutic fields through additional research projects. *both authors contributed equally to the manuscript.

Frequency of hospitalizations prior to and after conversion to a rebate pharmaceutical in depression patients in Germany.

BACKGROUND: The aim of this study was to investigate the frequency of hospitalization in depression patients with and without conversion to a rebate pharmaceutical and to show the negative consequences of rebate contracts on the health of patients with depression. METHODS: This retrospective study was performed using two databases that included data on ~ 10 millions patients gathered between July 2009 and June 2012. This study included adults (> 18 years) on an antidepressive drug therapy who had statutory health insurance with rebate contracts on antidepressive pharmaceuticals. RESULTS: In total, 47,968 patients on an antidepressive drug therapy were included in the persistence analysis using the IMS Disease Analyzer database. Of those, 26,651 patients were converted to a rebate product whereas 21,317 patients continued with the initial pharmaceutical product. After adjusting for the majority of demographic and clinical variables, the risk of hospitalization was 57% higher in patients who switched to a rebate pharmaceutical in comparison to patients who did not. When projected to the national level, this was found to equal an additional 34,157 patients hospitalized due to conversion to a rebate pharmaceutical resulting in direct inpatient costs amounting to 363.8 million EUR per year in Germany. CONCLUSIONS: Despite some limitations, this analysis presents a clear association between the initiation of rebate contracts and a negative impact on the health of patients on an antidepressive drug therapy.

Self-care with non-prescription medicines to improve health care access and quality of life in low- and middle-income countries: systematic review and methodological approach.

Objectives: This study aims to develop a structured framework to capture beneficial effects and determine the value of self-care for individuals and society in low- and middle-income countries (LMICs). A special focus is placed on self-medication with non-prescription medicines. Methods: PubMed, Google Scholar and websites of associations or organizations were systematically searched for economic studies on self-care and self-medication published between 2000 and 2021. The insights gained from the literature review were incorporated into the development of a decision tree model. Results: The literature review revealed a lack of research and available data on the role and value of self-care in LMICs. To help close the research gap a methodological framework was developed that defines different settings of self-care, their effects and relevant outcomes and allows a quantification with regard to self-medication in LMICs. Conclusion: Self-care offers individuals a convenient and reliable way to take care of their own health, especially in LMICs where access to health services can be challenging. In particular it is crucial to improve individuals access to clinically effective, safe and reliable non-prescription medicines.

Evidence for benefits and risks of tadalafil as a non-prescription medicine: review and evaluation using the Group Delphi technique to achieve consensus amongst clinical experts.

An evidence-based consensus meeting was held with urologists, a pharmacist and a cardiologist to perform a structured benefit-risk analysis of reclassifying tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor for treatment of erectile dysfunction (ED), to be available without prescription in Germany. As per the Brass process endorsed by regulatory authorities, an evidence-based Brass value tree was developed, which identified the incremental benefits and risks that should be considered above the safety and efficacy evidence required for prescription medicines. During the Group Delphi consensus meeting, the expert panel rated the likelihood and clinical impact of each benefit and risk on a scale of 0 (none) to 3 (high). Overall attribute scores were calculated from the product of the mean likelihood and mean clinical impact scores giving a possible score of 0-9. The overall benefit attribute scores ranged from 2.8 to 5.4. The overall risk attribute scores ranged from 0.2 to 2.2 though most were 1.0 or less (3 or more is generally considered to be of concern). On balance, the independent meeting scored the benefits of reclassification of tadalafil higher than the risks and considered the risk mitigation strategies of the packaging label and patient information leaflet (PIL) sufficient.

Reform of prescription drug reimbursement and pricing in the German social health insurance market: a comparison of three scenarios.

We review regulation of two important parameters for third-party payers and manufacturers of prescription drugs: regulation of reimbursement and pricing. We find that centralised regulation of reimbursement and pricing prevails in the 15 original EU member countries (EU-15) and in European Free Trade Association (EFTA) countries. Compared with countries such as Switzerland, The Netherlands, France and England, regulation in the German social health insurance system is rather unique. First, market approval is nearly always equivalent to reimbursement. Second, manufacturers are free to determine prices but internal reference prices restrict them from actually doing so for generics and therapeutic substitutes. In order to contain rising expenditures for prescription drugs in Germany, and to set incentives for physicians to consider the costs as well as the benefits of prescriptions, three reform scenarios are feasible. The first scenario maintains centralised reimbursement and centralised pricing; the second maintains centralised reimbursement but switches to decentralised pricing (similar to social health insurance in Israel and Medicare in the US). Third-party payers would be able to negotiate with manufacturers about discounts and market shares for genetic and therapeutic substitutes. In the third scenario, pricing and reimbursement would be decentralised (similar to private health insurance in the US). We suggest that the second scenario is a viable compromise between consumer protection and a more competitive and cost-effective market for prescription drugs in German social health insurance and other similar markets for prescription drugs.