Dataset Information

Combined hormonal contraceptive use in Europe before and after the European Commission mandated changes in product information.

ABSTRACT:

Objectives

We investigated combined hormonal contraceptives (CHC) prescribing patterns (focusing on combined oral contraceptives; COC) in three countries (Netherlands, Denmark, United Kingdom) in a time period preceding and in a time period following the European Commission's decision to update product information, and we estimated changes in incidence of venous thromboembolism (VTE) between the two periods.

Study design

We conducted a drug utilization analysis and a cohort study using routinely collected data. We calculated number, proportion and incidence rate of new users, switchers, and stoppers of COC in both time periods. VTE incidence was calculated in new users of COC and in all women aged 18-49?years.

Results

In all countries, the largest proportion (> 75%) of new users used COC containing levonorgestrel, norethisterone, or norgestimate, (i.e., indicated by European Medicines Agency (EMA) as the safest preparations) in both time periods. Switching did not demonstrate a clear pattern towards these types of COC and distribution of stoppers was similar in both time periods. While the proportion of new users initiating COC containing levonorgestrel, norethisterone, or norgestimate increased slightly, this did not translate to a decrease in the overall VTE incidence.

Conclusion

All three countries had the greatest proportion of women initiating a COC containing levonorgestrel, norethisterone, or norgestimate, and this proportion increased in the period after the European Commission decision albeit the increase was small due to the high percentage of use before the decision. This did not translate into a measureable change in the incidence of VTE.

Implications

Both before and after the European Commission's decision, the largest proportion of new users started with combined oral contraceptives containing levonorgestrel, norethisterone, or norgestimate. Earlier studies had already indicated an increased risk of VTE associated with COC containing other progestogens compared with these preparations, so it is possible that physicians were already preferentially prescribing COC containing levonorgestrel, norethisterone, or norgestimate to new users.

SUBMITTER: Khialani D

PROVIDER: S-EPMC7286180 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

Combined hormonal contraceptive use in Europe before and after the European Commission mandated changes in product information.

Khialani Deeksha D Jones Mary Elizabeth ME Szépligeti Szimonetta Komjáthiné SK Ording Anne Gulbech AG Ehrenstein Vera V Petersen Irene I van Hylckama Vlieg Astrid A

Contraception: X 20200114

<h4>Objectives</h4>We investigated combined hormonal contraceptives (CHC) prescribing patterns (focusing on combined oral contraceptives; COC) in three countries (Netherlands, Denmark, United Kingdom) in a time period preceding and in a time period following the European Commission's decision to update product information, and we estimated changes in incidence of venous thromboembolism (VTE) between the two periods.<h4>Study design</h4>We conducted a drug utilization analysis and a cohort study ...[more]

PMID: 32550533

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Project description:BACKGROUND:Searching for health information online is increasingly common and is an obvious source of information about oral combined hormonal contraceptives (CHCs) and their risks. However, little is known about how publicly available websites address the risks of CHCs, particularly venous thromboembolism (VTE). OBJECTIVE:The aim was to explore the information available to women about VTE and other risks of CHCs on websites available through commonly used search engines. METHODS:A qualitative study was conducted to explore whether and how websites about CHCs in Denmark, Germany, Netherlands, Slovakia, Spain, and the United Kingdom make reference to VTE and other CHC risks. A systematic search procedure was adopted across the six countries, based on relevant keywords. The search was carried out using the Google search engine by fluent/native speakers of each language. A content analysis approach was conducted to extract information from the selected websites. RESULTS:A total of 357 websites were reviewed. Nearly all (343/357, 96.1%) the websites mentioned VTE as a risk of CHCs, with approximately half referring to other side effects as well. One-fifth (92/357, 25.8%) of the websites provided suggestions about the best contraceptive method to use, and only a minority (23/357, 6.4%) recommended women discuss CHCs with their health professionals. Sites were generally run by the media (110/357 30.8%) or medical services from nongovernmental organizations (140/357, 39.2%). Only a minority of websites referred to organizations such as the European Medicines Agency (11/357, 3.1%). CONCLUSIONS:Despite the large number of websites containing information about oral CHCs and their risks, particularly VTE, only a limited number referred to information from accredited health agency sources. We argue this is a missed opportunity for accredited health agencies to share high-quality information to assist women using CHCs to make informed decisions about contraception.

Project description:ObjectiveTo establish, in the context of the revised European Pharmacovigilance Directive and based on physicians' perspectives, how Summaries of Product Characteristics (SmPCs) could be more user friendly and better support physicians' interactions with patients, thereby improving patients' own understanding of their medicines.DesignQualitative focus group discussions (step 1), development of an alternative SmPC (step 2) and an online quantitative survey (step 3) comparing the alternative SmPC to the currently approved version.SettingOffice-based physicians (n=218) from all federal states of Germany.Participants218 German physicians participated, with an equal representation of office-based general practitioners and specialists. For step 1 (n=18), physicians were recruited who frequently consulted SmPCs.Outcome measuresPlanned and performed: Mayring's qualitative content analysis of focus group discussions (step 1), rating on a five-point Likert scale of preference of current versus alternative SmPCs (step 3).ResultsPhysicians confirmed the importance of SmPCs as a comprehensive source of medicinal product information, but were moderately satisfied with the current SmPCs, utilised it infrequently and were more likely to engage additional sources of information. The alternative SmPC was consistently preferred. It differed in the way information for particular patient groups was presented, included additional sections (synopsis, checklist for patient information) and used a tabular format. Physicians indicated that SmPCs should be available with search and hyperlink functions, as well as be automatically updated and integrated in available practice software or similar solutions.ConclusionsThis research contributes to the development of an official, reliable medicinal product information system meeting the needs of a modern information society while providing the reliability of an officially authorised source. In the context of health literacy, SmPCs should be established as the primary information source for healthcare professionals to ensure compliant and safe utilisation of medicinal products.

Project description:BACKGROUND/OBJECTIVES:Experiments in animal models have shown a positive association between in utero exposure to pharmacologic sex hormones and offspring obesity. The developmental effects of such hormones on human obesity are unknown. SUBJECTS/METHODS:Using data from a large, prospective pregnancy cohort study (n=19?652), with linkage to a national prescription registry, we evaluated the association between use of hormonal contraceptives before and after conception (defined from dispensed prescription data and characterized by last date of use relative to conception, 12 to >4 months before (n=3392), 4 to >1 months before (n=2541), 1 to >0 months before (n=2997) and 0-12 weeks after (n=567)) in relation to offspring overweight or obesity at age 3 years. RESULTS:We observed a weak, inverse association between early pregnancy use of a combination oral contraceptive and offspring overweight or obesity at age 3 (adjusted odds ratio (OR): 0.75, 95% confidence interval (CI): 0.53, 1.08) and a positive, but imprecise, association with use of a progestin-only oral contraceptive in early pregnancy (adjusted OR: 1.26, 95% CI: 0.79, 2.02). In general, no association was observed between the use of a hormonal contraceptive before conception and offspring overweight or obesity. A sensitivity analysis comparing combination oral contraceptive users in early pregnancy to other unplanned pregnancies without hormonal contraceptive use further strengthened the inverse association (adjusted OR: 0.70, 95% CI: 0.48, 1.02). Other sensitivity analyses were conducted to evaluate the robustness of the associations observed given varying assumptions. CONCLUSIONS:Pharmacologic sex hormones in early pregnancy may be inversely or positively associated with offspring overweight or obesity at age 3, depending on the specific formulation used. The present study provides support for the potential for environmental sources of hormonally active agents to exert developmental effects.

Dataset Information

Combined hormonal contraceptive use in Europe before and after the European Commission mandated changes in product information.

Objectives

Study design

Results

Conclusion

Implications

Publications

Combined hormonal contraceptive use in Europe before and after the European Commission mandated changes in product information.

Similar Datasets

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