European Medicines Agency initiatives and perspectives on pharmacogenomics

Pharmacogenomics, the study of variations of DNA and RNA characteristics as related to drug response, has become an integral part of drug development and pharmacovigilance, as reflected by the incorporation of pharmacogenomic data in EU product information. In this short review article, we describe recent European Medicines Agency initiatives intended to support further the implementation of pharmacogenomics in drug development and surveillance so that patients and the public can benefit from advances in genomic science and technology.     

Natural Medicines Comprehensive Database

Abstract

Well-documented, up-to-date, scientific information regarding the use of herbal medicines can be difficult to find. This article reviews the Natural Medicines Comprehensive Database Web sites. The Web sites contain a large database of information regarding herbal medicines.     

Translating vaccine policy into action: A report from the Bill & Melinda Gates Foundation Consultation on the prevention of maternal and early infant influenza in resource-limited settings

Immunization of pregnant women against influenza is a promising strategy to protect the mother, fetus, and young infant from influenza-related diseases. The burden of influenza during pregnancy, the vaccine immunogenicity during this period, and the robust influenza vaccine safety database underpin recommendations that all pregnant women receive the vaccine to decrease complications of influenza disease during their pregnancies. Recent data also support maternal immunization for the additional purpose of preventing disease in the infant during the first six months of life.     

How can we achieve relief of bowel and abdominal symptoms for patients with irritable bowel syndrome with constipation?

Current interventions for irritable bowel syndrome with constipation tend to target single symptoms of the disorder, with multiple symptom relief only achieved through the use of combinations of therapies. Hence, there remains an unmet need for well-tolerated and effective treatments for irritable bowel syndrome with constipation that target abdominal symptoms, including abdominal pain and bowel symptoms.     

Beliefs about hydroxyurea in youth with sickle cell disease

Background

Hydroxyurea reduces complications and improves health-related quality of life (HRQOL) in sickle cell disease (SCD) patients, however adherence remains suboptimal. Understanding patients’ views of hydroxyurea is critical to optimize adherence, particularly in adolescents and young adults (AYA). Study objectives were to assess beliefs about hydroxyurea using the Beliefs about Medicines Questionnaire (BMQ), and to examine the relationship of patients’ beliefs to their hydroxyurea adherence and HRQOL.

The European I-MOVE Multicentre 2013–2014 Case-Control Study. Homogeneous moderate influenza vaccine effectiveness against A(H1N1)pdm09 and heterogenous results by country against A(H3N2)

BackgroundIn the first five I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe) influenza seasons vaccine effectiveness (VE) results were relatively homogenous among participating study sites. In 2013–2014, we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in six European Union (EU) countries to measure 2013–2014 influenza VE against medically-attended influenza-like illness (ILI) laboratory-confirmed as influenza. Influenza A(H3N2) and A(H1N1)pdm09 viruses co-circulated during the season.MethodsPractitioners systematically selected ILI patients to swab within eight days of symptom onset.We compared cases (ILI positive to influenza A(H3N2) or A(H1N1)pdm09) to influenza negative patients. We calculated VE for the two influenza A subtypes and adjusted for potential confounders. We calculated heterogeneity between sites using the I² index and Cochrane's Q test. If the I² was <50%, we estimated pooled VE as (1 minus the OR) × 100 using a one-stage model with study site as a fixed effect. If the I² was >49% we used a two-stage random effects model.ResultsWe included in the A(H1N1)pdm09 analysis 531 cases and 1712 controls and in the A(H3N2) analysis 623 cases and 1920 controls. For A(H1N1)pdm09, the Q test (p = 0.695) and the I² index (0%) suggested no heterogeneity of adjusted VE between study sites. Using a one-stage model, the overall pooled adjusted VE against influenza A(H1N1)pdm2009 was 47.5% (95% CI: 16.4–67.0).For A(H3N2), the I² was 51.5% (p = 0.067). Using a two-stage model for the pooled analysis, the adjusted VE against A(H3N2) was 29.7 (95% CI: −34.4–63.2).ConclusionsThe results suggest a moderate 2013–2014 influenza VE against A(H1N1)pdm09 and a low VE against A(H3N2). The A(H3N2) estimates were heterogeneous among study sites. Larger sample sizes by study site are needed to prevent statistical heterogeneity, decrease variability and allow for two-stage pooled VE for all subgroup analyses.     

Informing patients about medicines—A hospital in-patient survey in England

Objective

To determine the frequency with which hospital in-patients receive information about medicines and whether this varies dependent on patient characteristics or hospitals.

Methods

Cross-sectional survey of medical in-patients in six hospitals in North West England.

Results

1218 questionnaires were completed sufficiently for analysis by medical in-patients. 534 (43.9%) respondents were informed fully about their medicines by a hospital doctor, nurse or pharmacist and 411 (33.9%) partly informed, but 272 (22.49%) had received no information or could not recall any. Fewer than 20% had received written medicines information. The majority of respondents (763; 62.6%) were not asked if they had any concerns or could not recall this. Patient factors including age, educational level and number of medicines taken did not influence whether or not medicines information was provided, but there were differences between hospitals.

Conclusion

There is considerable variation between hospitals in the frequency with which patients are given verbal and written information about medicines and are asked about any medicine-related concerns.

Practice implications

Informing patients about medicines while in hospital needs to be improved. Doctors, nurses and pharmacists all need to accept and co-ordinate responsibility for informing patients about medicines and asking if they have any concerns or questions.     

处方前置审核系统在提高中成药临床合理用药中的作用

目的：探讨处方前置审核系统在提高中成药临床合理用药中的作用。方法：对采用处方前置审核系统前后含有中成药处方用药情况进行分析。结果：采用处方前置审核系统后,中成药不合理用药发生率为6.63%,明显低于采用处方前置审核系统前44.50%。结论：采用处方前置审核系统可以有效提高处方内中成药合理用药水平,保证患者用药安全,处方前置审核系统将成为今后医院处方审核的重要模式。