BackgroundIn 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.AimsThe 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.MethodsWe 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.ResultsThe 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.ConclusionsThere 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.

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. AIMSTo 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. METHODSThis 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. RESULTSThe 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 Ն55 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). CONCLUSIONSThe 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.

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