Introduction

This document is part of the process for improving the quality of care in family planning. Medical eligibility criteria for contraceptive use (MEC), the first edition of which was published in 1996, presents current World Health Organization (WHO) guidance on the safety of various contraceptive methods for use in the context of specific health conditions and characteristics. This is the fifth edition of the MEC – the latest in the series of periodic updates.

In the MEC, the safety of each contraceptive method is determined by several considerations in the context of the medical condition or medically relevant characterstics; primarily, whether the contraceptive method worsens the medical condition or creates additional health risks, and secondarily, whether the medical circumstance makes the contraceptive method less effective. The safety of the method should be weighed along with the benefits of preventing unintended pregnancy.

This fifth edition of the MEC is divided into two parts. Part I describes how the recommendations were developed and Part II contains the recommendations and describes how to use them. The recommendations contained within this document are based on the latest clinical and epidemiological data. Several tools and job aids are available from WHO and other sources to help providers use these recommendations in practice.

This document covers the following family planning methods: low-dose (≤ 35 mcg ethinyl estradiol) combined¹ oral contraceptives (COCs), combined patch (P), combined vaginal ring (CVR), combined injectable contraceptives (CICs), progestogen-only pills (POPs), depot medroxyprogesterone acetate (DMPA), norethisterone enanthate (NET-EN), levonorgestrel (LNG) and etonogestrel (ETG) implants, emergency contraceptive pills (ECPs), copper-bearing intrauterine devices (Cu-IUDs), levonorgestrel-releasing IUDs (LNG-IUDs), copper-IUD for emergency contraception (E-IUD), progesterone-releasing vaginal ring (PVR), barrier methods (BARR), fertility awareness-based methods (FAB), lactational amenorrhoea method (LAM), coitus interruptus (CI), and female and male sterilization (STER).

For each medical condition or medically relevant characteristic, contraceptive methods are placed into one of four numbered categories. Depending upon the individual, more than one condition may need to be considered together to determine contraceptive eligibility. These conditions and characteristics include, among others: age, weeks/months postpartum, breastfeeding status, venous thromboembolism, superficial venous disorders, dyslipidaemias, puerperal sepsis, past ectopic pregnancy, history of severe cardiovascular disease, migraines, severe liver disease, use of CYP3A4 inducer, repeat use of ECPs, rape, obesity, increased risk of sexually transmitted infections, high risk of HIV infection, living with HIV, use of antiretroviral therapy.

Target audience

The intended audience for this publication includes policy-makers, family planning programme managers and the scientific community. The MEC aims to provide guidance to national family planning and reproductive health programmes in the preparation of guidelines for delivery of contraceptive services. It is not meant to serve as the actual guidelines but rather as a reference.

The guidance in this document is intended for interpretation at country and programme levels, in a manner that reflects the diversity of situations and settings in which contraceptives are provided. While it is unlikely that the classification of categories in this document would change during this process, it is very likely that the application of these categories at country level will vary. In particular, the level of clinical knowledge and experience of various types of providers and the resources available at the service delivery point will have to be taken into consideration.

Guideline development methods

The Guideline Development Group (GDG), convened by WHO on 14–15 May 2013, 9–12 March 2014 and 24–25 September 2014, consisted of 68 individuals representing a wide range of stakeholders. Their mandate was to review and, where appropriate, revise the guidance in the fourth edition of the MEC to develop the fifth edition.

For this revision process, the GDG prioritized the review of: (a) six topics identified as important to the field and/or those topics with new evidence that may warrant a change in the existing recommendation; (b) two topics for which interim guidance was issued following the publication of the fourth edition; (c) contraceptive eligibility recommendations for the inclusion of four new contraceptive methods in the fifth edition; and (d) two topics to provide greater clarity for the recommendations in the fourth edition relating to these topics, at the request of the Guidelines Review Committee. Therefore, recommendations for a total of 14 topics were reviewed for the fifth edition of the MEC.

The GDG considered the overall quality of the available scientific evidence, paying particular attention to the strength and consistency of the data, according to the Grading Recommendations, Assessment, Development and Evaluation (GRADE) approach to evidence review.² To formulate recommendations using the four MEC categories for contraceptive eligibility, the GDG considered potential harms related to contraceptive use, the GRADE evidence profiles, the benefits of preventing unintended pregnancy, and applied an approach towards values and preferences that prioritized the availability of a wide range of contraceptive options. The GDG reached its decisions through consensus, which entailed discussion, debate and consultation with experts to reconcile any disagreements. For certain recommendations, the GDG added clarification statements to provide further explanation or guidance on interpretation of the numerical classification. For each contraceptive method, the GDG considered the potential benefits and risks of its use with respect to each of the medical conditions or medically relevant physiologic or personal characteristics assessed (such as age, breastfeeding, smoking status).

Updated evidence. In many instances, either no new evidence has been identified since the publication of the fourth edition of the MEC (2009), or evidence emerging since that publication confirms previous research findings. Therefore, in many cases the recommendations that were published in the fourth edition have been reviewed and confirmed by the GDG with no changes made. For such recommendations that remained unchanged, the WHO Secretariat updated the evidence statements, references and citations that appear in the contraceptive method tables in Part II.

WHO will initiate a review of the recommendations in this document in four years. In the interim, WHO will continue to monitor the body of evidence informing these recommendations and will convene additional consultations, as needed, should new evidence necessitate reconsideration of existing recommendations. Such updates may be particularly warranted for issues where the evidence base may change rapidly. These interim recommendations will be made available on the WHO's web pages for sexual and reproductive health. WHO encourages research to address key unresolved issues related to establishing medical eligibility criteria for contraceptive use. WHO also invites comments and suggestions for improving this guidance.

Summary of reviewed recommendations

Fourteen topics (encompassing over 575 recommendations) were reviewed by the GDG during the 2014 revision of the MEC (see Table 1). The GRADE approach was applied to assess the quality of the available evidence, and this provided the basis for the formulation of recommendations (see central column). For some topics, multiple outcomes of interest and/or contraceptive methods were examined. For these topics, GRADE assessments of the quality of evidence are presented, either a single assessment or a range (see final column). An explanation of the process followed to select and prioritize these topics is included in Part I of the document, section 1.2: Methods, pp. 3–7 (Table 1.1). Other than the recommendations shown in Table 1, all other recommendations were confirmed by the GDG and did not undergo formal review for the updated fifth edition of the MEC. A summary of the changes between the fourth and fifth editions of this document is available in Part II, section 2.6, pp. 93–96.

Table 1

Topics reviewed for the Medical eligibility criteria for contraceptive use (MEC), fifth edition.

Footnotes

1

“Combined” refers to a combination of ethinyl estradiol and a progestogen.

2

Further information is available at the website of the GRADE working group: http://www​.gradeworkinggroup​.org/index.htm