Health policy
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Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. ⋯ Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence.
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Comparative Study
Analysis of endpoints used in marketing authorisations versus value assessments of oncology medicines in Germany.
In Germany, a mandatory early benefit assessment (EBA) by the Federal Joint Committee (G-BA) is required for reimbursement of new marketing-authorised medicines. Additional benefit is based on patient-relevant endpoints in mortality, morbidity and health-related quality of life (HRQoL). We aimed to compare endpoints and related benefit categories used in marketing authorisation to those considered by G-BA in the field of oncology. ⋯ Mortality endpoints are accepted by EMA and G-BA. EMA accepted well established and clinically relevant morbidity endpoints (e.g. progression-free survival and response rate), which were mostly excluded by G-BA from their value decisions. The applicability of methods used for benefit assessments to HRQoL differs from the mortality and morbidity categories, and requires further clarification.
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Observational Study
The primary-secondary care interface: does provision of more services in primary care reduce referrals to medical specialists?
Great variation in referral rates between primary care physicians has been the main reason to influence physician's referral behaviour, by for example, stimulating extra services. This study investigated the extent to which the number of therapeutic and diagnostic services performed by primary care physicians influenced referrals. Data was derived from electronic medical records of 70 general practices for the period 2006 until 2010. ⋯ Only for two specific services was a significant association found: a lower referral rate for minor surgery for patient with sebaceous cysts (OR: 0.98) and a higher rate for Doppler diagnostic tests for patients with other peripheral arterial diseases (OR: 1.04). As the number of services in general practice was rarely associated with referrals, other measures might be more effective in changing referral behaviour. Another explanation for our results could be that certain preconditions have not been met.
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This review was conducted to document published literature related to physicians' knowledge, attitudes, and perceptions of generic medicines in low- and middle-income countries (LMICs) and to compare the findings with high-income countries. ⋯ The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels.
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Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe.
Pharmaceutical preparations are medicines that the pharmacist makes for the special needs of the patients that the pharmaceutical industry cannot comply for economic and logistic reasons. Pharmacy compounding is still an important component of pharmacy practice and a valuable therapeutical service that is an integrant part of the modern health care system, but its legislation is not harmonized among European and US countries. ⋯ Aim of this resolution is to harmonize quality assurance and standards for pharmacy-made medicinal products among European countries and to pass the gap in quality assurance and standards between preparation in pharmacies and medicines prepared by the pharmaceutical industry. This article will analyze the actual rules and technical norms that regulate compounding activity and the expectations resultants from the new European and US laws.