Clinical management of nausea and vomiting in pregnancy and hyperemesis gravidarum across primary and secondary care: a population based study

Objectives: To assess how nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG) are managed and treated across primary and secondary care.Design: Population-based pregnancy cohortSetting: Medical records (CPRD-GOLD) from EnglandPopulation: 417,028 pregnancies, during 1998-2014 Methods: Proportions of pregnancies with recorded NVP/HG diagnoses, primary care treatment and hospital admissions were calculated. Multinomial logistic regression was employed to estimate adjusted relative risk ratios (aRRRs) with 99% confidence intervals (CIs) for the association between NVP/HG management paths and maternal characteristics.Main Outcome Measures: NVP/HG diagnoses, treatments and hospital admissions. Results: Overall prevalence of clinically recorded NVP/HG was 9.1%: 2.1% had hospital admissions, 3.4% were treated with antiemetics in primary care only, and 3.6% had only recorded diagnoses. Hospital admissions and antiemetic prescribing increased continuously during 1998-2013 (trend p less than 0.001). Younger age, deprivation, Black/Asian/Mixed ethnicity, multiple-pregnancy were associated with NVP/HG generally across all levels, but associations were strongest for hospital admissions. Most comorbidities had patterns of association with NVP/HG levels. Among women with NVP/HG who had no hospital admissions, 49% were prescribed antiemetics, mainly from first line treatment (21% prochlorperazine, 15% promethazine, 13% cyclizine) and metoclopramide (10%). Of those admitted, 38% had prior antiemetic prescriptions (34% first-line, 9% second-line, 1% third-line treatment).Conclusion: Previous focus on hospital admissions has greatly underestimated the NVP/HG burden. Although primary care prescribing has increased, most women admitted to hospital have no antiemetics prescribed before this. An urgent call is made to assess whether admissions could be prevented with better primary care recognition and timely treatment

Estratégias para aumentar a sensibilidade da farmacovigilância em Portugal

OBJETIVO: Avaliar os resultados de intervenção para melhoria da quantidade e relevância das notificações de reacções adversas a medicamentos. MÉTODOS: Foi implementado um estudo controlado aleatorizado, por agrupamentos em farmacêuticos a exercer actividade profissional na região norte de Portugal, em 2007. Após aleatorização, 364 indivíduos foram alocados ao grupo de intervenção (261 na intervenção telefónica e 103 nos workshops); o grupo de controlo foi constituído por 1.103 farmacêuticos. Na intervenção educativa foram abordados a problemática das reacções adversas a medicamentos, o impacto na saúde pública e a notificação espontânea. Quanto à relevância, as reações adversas foram classificadas em graves e inesperadas. A análise estatística foi efectuada com base no princípio intention-to-treat; aplicaram-se modelos lineares generalizados mistos, utilizando o método penalized quasi-likelihood. Os farmacêuticos estudados foram seguidos durante um período de 20 meses. RESULTADOS: A intervenção aumentou três vezes a taxa de notificação espontânea das reações adversas (RR = 3,22; IC 95%: 1,33; 7,80) relativamente ao grupo de controlo. Houve incremento da relevância das notificações com aumento das reações adversas graves em cerca de quatro vezes (RR = 3,87; IC 95%: 1,29;11,61) e inesperadas em cinco vezes (RR = 5,02; IC 95%: 1,33;18,93), relativamente ao grupo de controlo. CONCLUSÕES: As intervenções educativas aumentam significativamente, por até quatro meses, a quantidade e a relevância das notificações espontâneas de reacções adversas a medicamentos por parte dos farmacêuticos da região norte de Portugal

Cost-effectiveness of pregabalin versus venlafaxine in the treatment of generalized anxiety disorder: findings from a Spanish perspective

The objective of the present study was to describe a new model of the cost-effectiveness of treatment of generalized anxiety disorder (GAD) and its application to a comparison of pregabalin versus venlafaxine extended-release (XR) from a Spanish healthcare perspective. Microsimulation techniques, including Hamilton Anxiety Scale (HAM-A) score, number of weeks with minimal or no anxiety (HAM-A ≤ 9), and quality-adjusted life-years (QALYs), were used to predict treatment outcomes for patients with moderate-to-severe GAD who would be treated with pregabalin vs venlafaxine XR. Expected levels of healthcare utilization and unit cost of care are derived from Spanish published sources. We express cost-effectiveness alternatively in terms of incremental cost per additional week with minimal or no anxiety, and incremental cost per QALY gained [in 2007 Euros (€)]. Considering costs of drug treatment only, the incremental cost [mean (95% confidence interval)] of pregabalin (vs venlafaxine XR) would be €96 (€86, €107) per additional week with minimal or no anxiety, and €32,832 (€29,656, €36,308) per QALY gained. When other medical care costs are considered, cost-effectiveness ratios decline to €70 (€61, €80) per additional week with no or minimal anxiety, and €23,909 (€20,820, €27,006) per QALY gained. We conclude that, using a new microsimulation model of the treatment of GAD, pregabalin appears to be cost-effective vs venlafaxine XR in a Spanish healthcare setting

Effect of medication review and cognitive behaviour treatment by community pharmacists of patients discharged from the hospital on drug related problems and compliance: design of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Drug related problems (DRPs) are common among elderly patients who are discharged from the hospital and are using several drugs for their chronic diseases. Examples of drug related problems are contra-indications, interactions, adverse drug reactions and inefficacy of treatment. Causes of these problems include prescription errors and non-compliance with treatment. The aim of this study is to examine the effect of <it>medication review </it>and <it>cognitive behaviour therapy </it>of discharged patients by community pharmacists to minimize the occurrence of drug related problems.</p> <p>Methods/Design</p> <p>A randomized controlled trial will be performed. Community pharmacists will be randomized into a control group and an intervention group. 342 Patients, aged over 60 years, discharged from general and academic hospitals, using five or more prescription drugs for their chronic disease will be asked by their pharmacy to participate in the study.</p> <p>Patients randomized to the control group will receive usual care according to the Dutch Pharmacy Standard. The medication of patients randomised to the intervention group will be reviewed by the community pharmacist with use of the national guidelines for the treatment of diseases, when patients are discharged from the hospital. The Pharmaceutical Care network Europe Registration form will be used to record drug related problems. Trained pharmacy technicians will counsel patients at home at baseline and at 1,3,6,9 and 12 months, using Cognitive Behaviour Treatment according to the Theory of Planned Behaviour. The patient's attitude towards medication and patient's adherence will be subject of the cognitive behaviour treatment. The counselling methods that will be used are <it>motivational interviewing </it>and <it>problem solving treatment</it>. Patients adherence towards drug use will be determined with use of the Medication Adherence Report Scale Questionnaire. There will be a follow-up of 12 months.</p> <p>The two primary outcome measures are the difference in occurrence of DRPs between intervention and control group and adherence with drug use. Secondary endpoints are attitude towards drug use, incidence of Re-hospitalisations related to medicines, functional status of the patient, quality of life and the cost-effectiveness of this intervention.</p> <p>Discussion</p> <p>Combining both medication review and Cognitive Behaviour Treatment may decrease DRPs and may result in more compliance with drug use among patients discharged from the hospital and using 5 or more chronic drugs.</p> <p>Trial registration</p> <p>Dutch Trial Register NTR1194</p