How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.

BACKGROUND: In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development plans for medicines. AIMS: The present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTABs, and among HTABs, when applicants obtain parallel scientific advice from both a regulatory and an HTA perspective. METHODS: We analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cutoff date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTABs vs. those of the regulators, and between the answers of the participating HTA agencies. RESULTS: The analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTABs, there was a high level of agreement for all domains. CONCLUSIONS: There is evident commonality, in terms of evidence requirements between the EU regulators and participating HTABs, as well as among HTABs, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice.

Identifying how age and gender influence prescription drug use in a primary health care environment in Catalonia, Spain.

UNLABELLED: What is already known about this subject. Knowledge of prescription patterns in primary health care is an important tool in rational drug therapy. Age and gender are the principal determining factors of cost variability between medical practices, due to drug prescriptions. Age and gender are the principal determining factors of cost variability in relation to the therapeutic group. What this study adds. This study provides specific information on the use of drugs in the primary health care environment of the Catalan Health System, and the differences observed are analyzed with respect to age and gender of the population receiving care. The study shows that there is a high prevalence of drugs in the under 5 year old age group, and also in persons over 54 years of age. The variability found in the cost per patient suggests that adjustment should be made for age in practitioners' prescription evaluation procedures in primary health care in Catalonia. AIMS: To determine the prevalence and usage patterns of prescription drugs according to patients' age and gender, and to identify their relative importance in the prescription costs, in primary health care within the Catalan Health Institute. METHODS: This was a cross-sectional study using computerized pharmacy dispensing records for 5 474 274 members registered, during 2002. Twenty age-gender categories were established. Use of a drug group was defined as filling at least one prescription. The variables studied were age, gender, number of prescriptions and net cost. The prevalence of use, the number of prescriptions and cost issued to each age category were reported. RESULTS: The overall prevalence of drug use was 74.53% (women 80.93%, men 67.84%). This was higher in the group of 0-4 year-olds, and in the >or= 55 year-olds. Age (P < 0.001) produced a statistically more significant effect than gender (P < 0.05). The most used therapeutic groups were analgesics, nonsteroidal anti-inflammatory drugs, antiulcer drugs, anxiolytics, expectorants and mucolytics. The number of prescriptions and costs per patient rose with age and showed great variation in the use of these groups for patients in different age groups. The risk of prescription in women was 23% higher than in men (RR 1.23, 95% CI 1.11, 1.37, P < 0.001). CONCLUSIONS: The majority of subjects were exposed to one or more drugs. The variability in the number of prescriptions and in the prescribing cost per patient between the different age groups suggests that adjustments should be made for age in practitioners' prescription evaluation processes in primary health care in Catalonia.

[Patient safety in primary care: PREFASEG project]. / Seguridad del paciente en atención primaria: proyecto PREFASEG (PREscripción FArmacológica SEGura).

The Institut Català de la Salut (ICS) has designed and integrated in electronic clinical station of primary care a new software tool to support the prescription of drugs, which can detect on-line certain medication errors. The software called PREFASEG (stands for Secure drug prescriptions) aims to prevent adverse events related to medication use in the field of primary health care (PHC). This study was made on the computerized medical record called CPT, which is used by all PHC physicians in our institution -3,750- and prescribing physicians through it. PREFASEG integrated in eCAP in July 2010 and six months later we performed a cross-sectional study to evaluate their usefulness and refine their design. The software alerts on-line in 5 dimensions: drug interactions, redundant treatments, allergies, contraindications of drugs with disease, and advises against drugs in over 75 years. PREFASEG generated 1,162,765 alerts (1 per 10 high treatment), with the detection of therapeutic duplication (62%) the most alerted. The overall acceptance rate is 35%, redundancies pharmacological (43%) and allergies (26%) are the most accepted. A total of 10,808 professionals (doctors and nurses) have accepted some of the recommendations of the program. PREFASEG is a feasible and highly efficient strategy to achieve an objective of Quality Plan for the NHS.