Category Archives: Drug Saf

Authors’ Response to Braillon’s Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”.

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Authors’ Response to Braillon’s Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”.

Drug Saf. 2018 Aug 17;:

Authors: Simoons M, Seldenrijk A, Mulder H, van Roon E, Bakker R, Ruhé H

PMID: 30120740 [PubMed – as supplied by publisher]

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Improving Information on Maternal Medication Use by Linking Prescription Data to Congenital Anomaly Registers: A EUROmediCAT Study.

Improving Information on Maternal Medication Use by Linking Prescription Data to Congenital Anomaly Registers: A EUROmediCAT Study.
Drug Saf. 2015 Jul 8;
Authors: de Jonge L, Garne E, Gini R, Jordan SE, Klungsoyr K, … Continue reading

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Actual Use of Medications Prescribed During Pregnancy: A Cross-Sectional Study Using Data from a Population-Based Congenital Anomaly Registry.

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Actual Use of Medications Prescribed During Pregnancy: A Cross-Sectional Study Using Data from a Population-Based Congenital Anomaly Registry.
Drug Saf. 2015 Jun 4;
Authors: de Jonge L, de Walle HE, d… Continue reading

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P-Glycoprotein-Mediated Drug Interactions in Pregnancy and Changes in the Risk of Congenital Anomalies: A Case-Reference Study.

P-Glycoprotein-Mediated Drug Interactions in Pregnancy and Changes in the Risk of Congenital Anomalies: A Case-Reference Study.

Drug Saf. 2015 May 29;

Authors: Daud AN, Bergman JE, Bakker MK, Wang H, Kerstjens-Frederikse WS, de Walle HE, Groen H, Bos JH, Hak E, Wilffert B

Abstract
INTRODUCTION: Drug use in pregnancy is very common but may cause harm to the fetus. The teratogenic effect of a drug is partly dependent on the drug level in the fetal circulation, which is associated with the transport across the placenta. Many drugs are substrates of P-glycoprotein (P-gp), an efflux transporter that acts as a protective barrier for the fetus. We aim to identify whether drug interactions associated with P-gp promote any changes in fetal drug exposure, as measured by the risk of having children with congenital anomalies.
METHODS: In this study, cases (N = 4634) were mothers of children with congenital anomalies registered in the EUROCAT Northern Netherlands registry, and the reference population were mothers of children (N = 25,126) from a drug prescription database (IADB.nl).
RESULTS: Drugs that are associated with P-gp transport were commonly used in pregnancy in cases (10 %) and population (12 %). Several drug classes, which are substrates for P-gp, were shown to have a higher user rate in mothers of cases with specific anomalies. The use of this subset of drugs in combination with other P-gp substrates increased the risk for specific anomalies (odds ratio [OR] 4.17, 95 % CI 1.75-9.91), and the addition of inhibitors further increased the risk (OR 13.03, 95 % CI 3.37-50.42). The same pattern of risk increment was observed when the drugs were analyzed separately according to substrate specificity.
CONCLUSIONS: The use of drugs associated with P-gp transport was common during pregnancy. For several drug classes associated with specific anomalies, P-gp-mediated drug interactions are associated with an increased risk for those specific anomalies.

PMID: 26017034 [PubMed – as supplied by publisher]

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Identifying associations between maternal medication use and birth defects using a case-population approach: an exploratory study on signal detection.

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Identifying associations between maternal medication use and birth defects using a case-population approach: an exploratory study on signal detection.

Drug Saf. 2013 Nov;36(11):1069-78

Authors: de Jonge L, Zetstra-van der Woude PA, Bos HJ, de Jong-van den Berg LT, Bakker MK

Abstract
BACKGROUND: The effects of many drugs on the unborn child are unknown. In a case-population design, drug exposure of cases is compared with that of a source population; this kind of study can be useful for generating signals.
OBJECTIVE: To see whether a comparison of drug use rates from the birth defect registry EUROCAT NNL (cases) with prescription rates from a population-based prescription database, the IADB (population), could be used to detect signals of teratogenic risk of drugs.
METHODS: We defined 3,212 cases from the EUROCAT NNL database, a population-based birth defect registry in the Northern Netherlands and 29,223 population controls from the IADB, a prescription database with data from community pharmacies in the same geographical area, born between 1998 and 2008. We classified the malformations of the 3,212 cases into several malformation groups according to organ system (based on the International Classification of Diseases codes and the EUROCAT guidelines). If a child had multiple malformations in several organ systems (n = 253, 7.9 %), he/she was counted in all the categories represented. For several groups of malformations we calculated rate ratios (RR) and 95 % confidence intervals for drugs acting on the central nervous system and for drugs considered to be safe for use in pregnancy. The RRs were based on first-trimester drug use rates from the cases in the EUROCAT NNL database and prescription rates from the population controls in the IADB.
RESULTS: For drugs acting on the central nervous system we found significantly increased RRs for the anti-epileptic drug valproic acid and for some selective serotonin reuptake inhibitors. For drugs considered to be safe only the anti-hypertensive methyldopa showed significantly increased RRs.
CONCLUSION: We show that a case-population study is a suitable method for detecting signals of possible teratogenicity, provided that the teratogenic effects and the drugs under study are as specific as possible and the drugs are widely used.

PMID: 23828658 [PubMed – indexed for MEDLINE]

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Angiotensin-converting enzyme inhibitor treatment and the development of urinary tract infections: a prescription sequence symmetry analysis.

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Angiotensin-converting enzyme inhibitor treatment and the development of urinary tract infections: a prescription sequence symmetry analysis.

Drug Saf. 2013 Nov;36(11):1079-86

Authors: Pouwels KB, Visser ST, Bos HJ, Hak E

Abstract
BACKGROUND: Angiotensin-converting enzyme inhibitors (ACEi) can reduce urine output, especially when treatment is first started. Since bacterial clearance from the urinary tract is dependent on urine output, it was hypothesized that ACEi may also increase the risk of urinary tract infections (UTIs).
OBJECTIVE: Our objective was to assess the risk of UTIs associated with ACEi therapy initiation in the general population.
METHODS: A prescription sequence symmetry analysis was performed with the Dutch ‘InterAction Database’ (IADB.nl) pharmacy prescription database. We selected all patients from the IADB who were incident users of both ACEi and nitrofurantoin (a proxy for UTIs). A relatively short maximum time-span of 4 weeks between both prescriptions was used to limit time-variant confounding. The sequence ratio was calculated by dividing the number of individuals starting ACEi first and nitrofurantoin second by the number of individuals starting nitrofurantoin treatment first and ACEi second. We adjusted for trends in prescribing and estimated 95 % confidence intervals using exact confidence intervals for binomial distributions. To evaluate whether the effect is specific to ACEi and to assess whether the possible mechanism behind an increased risk of UTIs is related to the renin-angiotensin-aldosterone system, we also estimated the risk for β-adrenoceptor antagonists (β-blockers).
RESULTS: In total, 22,959 incident users of ACEi therapy were eligible for analysis. Of these, 161 patients started ACEi therapy within 4 weeks prior to or after nitrofurantoin therapy initiation. A total of 101 (63 %) started ACEi therapy first followed by nitrofurantoin treatment, while 60 (37 %) patients started nitrofurantoin treatment first, which corresponds to a statistically significant adjusted sequence ratio (ASR) of 1.68 (95 % CI 1.21-2.36). No association was found between β-blockers and UTI treatment (ASR 1.01, 95 % CI 0.74-1.38).
CONCLUSIONS: A significant excess of patients received UTI medication prescriptions following the first month after ACEi initiation. This prescription sequence asymmetry suggests that ACEi initiation increases the risk of developing UTIs.

PMID: 23832709 [PubMed – indexed for MEDLINE]

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Use of acid-suppressive drugs in pregnancy and the risk of childhood asthma: bidirectional crossover study using the general practice research database.

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Use of acid-suppressive drugs in pregnancy and the risk of childhood asthma: bidirectional crossover study using the general practice research database.
Drug Saf. 2013 Nov;36(11):1097-104
Authors: H… Continue reading

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Post-approval safety issues with innovative drugs: a European cohort study.

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Post-approval safety issues with innovative drugs: a European cohort study.
Drug Saf. 2013 Nov;36(11):1105-15
Authors: Mol PG, Arnardottir AH, Motola D, Vrijlandt PJ, Duijnhoven RG, Haaijer-Ruskamp F… Continue reading

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The effects of antitussive treatment of ACE inhibitor-induced cough on therapy compliance: a prescription sequence symmetry analysis.

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The effects of antitussive treatment of ACE inhibitor-induced cough on therapy compliance: a prescription sequence symmetry analysis.

Drug Saf. 2013…

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Inhaled corticosteroids and the occurrence of oral candidiasis: a prescription sequence symmetry analysis.

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Inhaled corticosteroids and the occurrence of oral candidiasis: a prescription sequence symmetry analysis.

Drug Saf. 2013 Apr;36(4):231-6

Authors: van…

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The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.

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The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.

Drug Saf. 2013 Jun 25;

Authors: Piening S, de Graeff PA, Straus SM, Haaijer-Ruskamp FM, Mol PG

Abstract
BACKGROUND: The usefulness and the impact of Direct Healthcare Professional Communications (DHPCs, or ‘Dear Doctor letters’) in changing the clinical behaviour of physicians have been debated. Changes in the current risk communication methods should preferably be based on the preferences of the healthcare professionals, to optimize the uptake of the message.
OBJECTIVE: The aim of this study was to assess whether safety issues are communicated more effectively with an additional e-mail sent by the Dutch Medicines Evaluation Board (MEB) than with the DHPC only.
METHODS: A randomized controlled trial was conducted amongst ophthalmologists and hospital pharmacists in the Netherlands, who were the target group of a DHPC that was issued for pegaptanib, a drug that is administered intra-ocularly in patients with macular degeneration. The intervention group (N = 110) received the pegaptanib DHPC, as well as the MEB e-mail. The control group (N = 105) received the traditional paper-based DHPC only. Two weeks later, the study population received an invitation to fill out an online questionnaire. Questions were asked about the respondents’ knowledge and attitude regarding the pegaptanib issue, and any action they had consequently taken. Additional questions were asked about their satisfaction with the DHPC and the e-mail, and their preferred source of such information.
RESULTS: Forty respondents (18.6 %) completed the questionnaire. Eighty-one percent of the respondents in the intervention group (N = 21) and 47 % of the control group (N = 19) correctly indicated that a serious increase in intra-ocular pressure could be caused by pegaptanib injections (Fishers’ exact test, p = 0.046). Nine respondents in the intervention group versus none of the control group respondents indicated that they had taken action in response to the pegaptanib safety issue (Fishers’ exact test, p = 0.01). The majority of both the intervention group and the control group confirmed that they would like to receive an MEB e-mail with safety information about drugs in the future (90 and 95 %, respectively).
CONCLUSION: The results of this study indicate that an additional e-mail might strengthen the uptake of the safety information provided to healthcare professionals, who prefer to receive an e-mail from the MEB as a source of such information, as well as the DHPC. This study may serve as a starting point for new strategies to improve risk communication regarding safety issues associated with drugs and its impact on prescribing.

PMID: 23797603 [PubMed – as supplied by publisher]

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Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire.

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire.

Drug Saf. 2013 Apr 4;

Authors: de Vries ST, Mol PG, de Zeeuw D, Haaijer-Ruskamp FM, Denig…

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Healthcare professionals’ self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands.

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Healthcare professionals’ self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands.

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Impact of Safety-Related Regulatory Action on Clinical Practice: A Systematic Review.

Impact of Safety-Related Regulatory Action on Clinical Practice: A Systematic Review.

Drug Saf. 2012 Apr 5;

Authors: Piening S, Haaijer-Ruskamp FM, de Vries JT, van der Elst ME, de…

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Comparing Adverse Event Rates of Oral Blood Glucose-Lowering Drugs Reported by Patients and Healthcare Providers: A Post-Hoc Analysis of Observational Studies Published between 1999 and 2011.

Comparing Adverse Event Rates of Oral Blood Glucose-Lowering Drugs Reported by Patients and Healthcare Providers: A Post-Hoc Analysis of Observational Studies Published between 1999 and 2011.

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Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class: An Analysis of European Public Assessment Reports.

Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class: An Analysis of European Public Assessment Reports.

Drug Saf. 2011 Nov 1;34(11):1101-14

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Preventable and non-preventable adverse drug events in hospitalized patients: a prospective chart review in the Netherlands.

Preventable and non-preventable adverse drug events in hospitalized patients: a prospective chart review in the Netherlands.

Drug Saf. 2011 Nov 1;34(11):1089-100

Authors: Dequito…

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