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Guideline Summary
Guideline Title
Progestogen-only pills.
Bibliographic Source(s)
Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2009 Jun. 17 p. [44 references]
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2008 Nov. 17 p. [44 references]

2011 is the date of planned revision.

Scope

Disease/Condition(s)

Pregnancy prevention

Guideline Category
Counseling
Evaluation
Management
Prevention
Risk Assessment
Treatment
Clinical Specialty
Family Practice
Internal Medicine
Obstetrics and Gynecology
Preventive Medicine
Intended Users
Advanced Practice Nurses
Nurses
Pharmacists
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)

To provide evidence-based recommendations and good practice points for clinicians on the use of progestogen-only pills as an option to prevent pregnancy

Target Population

Women considering use of progestogen-only pills as an option to prevent pregnancy

Interventions and Practices Considered

Evaluation/Risk Assessment

  1. Assessment of medical eligibility criteria for use of progestogen-only pills
  2. Medical history and clinical assessment

Counseling/Management/Treatment

  1. Counseling women on the risks, benefits, and uncertainties of progestogen-only pills
    • Mode of action of progestogen-only pills
    • Contraceptive efficacy
    • Missed pills and efficiency
    • Vomiting (or severe diarrhoea) and efficiency
    • Drug interactions and efficiency
    • Return of fertility
    • Side effects and discontinuation
    • Weight change
    • Depression and mood change
    • Headache
    • Cardiovascular disease and breast cancer
  2. Initiation of progestogen-only pills
    • Postpartum (breast or bottle feeding)
    • Following abortion or miscarriage
  3. On-going use of progestogen-only pills and follow up
  4. Management of bleeding problems
Major Outcomes Considered
  • Contraceptive efficacy
  • Unintended pregnancy rate
  • Side effects of progestogen-only pills

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Evidence is identified using a systematic literature review and electronic searches were performed for: MEDLINE (CD Ovid version) (from 1996–2008); EMBASE (1996–2008); PubMed (1996–2008); The Cochrane Library (to 2008) and the US National Guideline Clearing House. The searches are performed using relevant medical subject headings (MeSH), terms and text words. The Cochrane Library is searched for systematic reviews, meta-analyses and controlled trials relevant to progestogen-only pills. Previously existing guidelines from the FSRH (formerly the Faculty of Family Planning and Reproductive Health Care), the Royal College of Obstetricians and Gynaecologists (RCOG), the World Health Organization, and the British Association for Sexual Health and HIV (BASHH), and reference lists of identified publications are also searched.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Level of Evidence

Ia Evidence obtained from meta-analysis of randomised trials

Ib Evidence obtained from at least one randomised controlled trial

IIa Evidence obtained from at least one well-designed controlled study, without randomisation

IIb Evidence obtained from at least one other type of well-designed quasi-experimental study

III Evidence obtained from well-designed non-experimental descriptive studies, correlation studies and case studies

IV Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities

Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Selected key publications are appraised using standard methodological checklists similar to those used by the National Institute for Health and Clinical Excellence (NICE). All papers are graded according to the Grades of Recommendations Assessment, Development and Evaluation (GRADE) system. Recommendations are graded as in the table below, using a scheme similar to that adopted by the Royal College of Obstetricians and Gynaecologists (RCOG) and other guideline development organisations. The clinical recommendations within this Guidance are based on evidence whenever possible. Summary evidence tables are available on request from the Clinical Effectiveness Unit (CEU).

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The Draft One Guidance document is written, providing recommendations and good practice points based on the literature review. The Clinical Effectiveness Unit has overall responsibility for writing the Guidance document. The Multidisciplinary Group and other peer reviewers should highlight inconsistencies and errors or where the text is incomprehensible. A Multidisciplinary Group Meeting is held, comprising stakeholders and including service user representation, representation from the Facility of Sexual and Reproductive Healthcare (FSRH) Education Committee and, where possible, representation from the FSRH Clinical Effectiveness Committee (CEC) and FSRH Council. A one-day meeting is held with the Multidisciplinary Group to discuss the Draft One Guidance document.

Rating Scheme for the Strength of the Recommendations

Grades of Recommendations

A: Evidence based on randomised controlled trials

B: Evidence based on other robust experimental or observational studies

C: Evidence is limited but the advice relies on expert opinion and has the endorsement of respected authorities

Good Practice Point: where no evidence exists but where best practice is based on the clinical experience of the multidisciplinary group

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The Draft Two Guidance document is peer reviewed by the Multidisciplinary Group and the Facility of Sexual and Reproductive Healthcare (FSRH) Clinical Effectiveness Council (CEC). All written feedback on the Draft Two Guidance document is tabulated and the Clinical Effectiveness Unit (CEU) response to these comments is outlined. The Draft Three Guidance document is prepared based on written feedback and is sent to the Multidisciplinary Group and the FSRH CEC. In addition, two independent reviewers are identified by the CEC to provide feedback at this stage. Only minor comments can be accepted at this stage. The Final Guidance document is published by the FSRH. Proofreading of the Guidance is then performed by three members of the CEU team independently and comments collated and sent back by the Unit Director. A portable document format (PDF) version of the Guidance is made available on the FSRH website.

Recommendations

Major Recommendations

Note from the Faculty of Sexual & Reproductive Healthcare (FSRH) and the National Guideline Clearinghouse (NGC): The print version of this Clinical Effectiveness Unit (CEU) Guidance Document (issued in November 2008) contained some inconsistencies that the CEU has corrected in the June 2009 version. These corrections are to the United Kingdom (UK) Medical Eligibility Criteria for Contraceptive use for progestogen-only pill (POP) use (page 1 and page 2, Table 2 in the original guideline document), advice for women who miss or are late taking POP (page 3, Figure 1 in the original guideline document), and recommendations for timing of initiation of POP (page 5, Table 3 in the original guideline document). The recommendations below are unchanged.

The recommendation grades (A to C, Good Practice Point) are defined at the end of the "Major Recommendations" field.

What Should a Clinician Assess before Progestogen-only Pill (POP) Use?

Health professionals should be familiar with the United Kingdom Medical Eligibility Criteria (UKMEC) for progestogen-only pills. (Good Practice Point)

Table: Definitions of UK Medical Eligibility Criteria for Contraceptive Use Categories

UKMEC Definition of Category
Category  
UKMEC 1 A condition for which there is no restriction for the use of the contraceptive method.
UKMEC 2 A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.
UKMEC 3 A condition where the theoretical or proven risks usually outweigh the advantages of using the method.a
UKMEC 4 A condition which represents an unacceptable health risk if the contraceptive method is used.

aThe provision of a method to a woman with a condition given a UKMEC Category 3 requires expert clinical judgement and/or referral to a specialist contraceptive provider since use of the method is not usually recommended unless other methods are not available or not acceptable.

A clinical history should be taken to identify conditions given a UKMEC Category 3 or 4 for progestogen-only pill use. (Good Practice Point)

Blood pressure and an assessment of weight can be documented before starting a progestogen-only pill but this should be seen as part of a more general health check. (Good Practice Point)

What Information Should Be Given to Women Considering a POP?

Mode of Action

Women may be advised that traditional progestogen-only pills work by altering cervical mucus to prevent sperm penetration and for some women ovulation is also inhibited. (Grade C)

Women may be advised that the primary mode of action of the desogestrel-only pill is inhibition of ovulation. (Grade C)

Weight and Efficacy

Women may be advised that if used consistently and correctly all progestogen-only pills are more than 99% effective. (Grade C)

Women should be advised to take one progestogen-only pill at or around the same time every day and without a pill-free interval. (Grade C)

Women may be advised that there are no data to suggest that some progestogen-only pills are better at preventing pregnancy than others. (Grade B)

There is no evidence that the efficacy of progestogen-only pills (traditional or desogestrel-only) is reduced in women weighing >70 kilograms and therefore the licensed use of one pill per day is recommended. (Grade B)

Missed Pills and Efficacy

Women may be advised that if a traditional progestogen-only pill is more than 3 hours late or a desogestrel-only pill is more than 12 hours late they should:

  • Take the late or missed pill now
  • Continue pill taking as usual (this may mean taking two pills at the same time)
  • Use condoms or abstain from sex for 48 hours after the pill is taken. (Grade C)

Some women may consider that the desogestrel-only pill, with the 12-hour window, will improve pill taking and they should be supported in this choice. (Good Practice Point)

Vomiting (or Severe Diarrhoea) and Efficacy

If a woman vomits within 2 hours of pill taking another pill should be taken as soon as possible. (Grade C)

Drug Interactions and Efficacy

Women using liver enzyme-inducing medications short term should be advised to use condoms in addition to progestogen-only pills and for at least 4 weeks after the liver enzyme-inducer is stopped. (Grade C)

Women using liver enzyme-inducing medications long term should be advised that the efficacy of progestogen-only pills is reduced and an alternative contraceptive method should be considered. (Grade C)

Women may be advised that the efficacy of progestogen-only pills is not reduced by use of non-liver enzyme-inducing antibiotics and additional contraceptive protection is not required. (Grade C)

Return of Fertility

Women may be advised that there is no delay in return of fertility following discontinuation of a progestogen-only pill, and, therefore, if pregnancy is not desired then another effective method of contraception should be used. (Grade C)

Side Effects and Discontinuation

Women should be advised that changes in bleeding patterns with progestogen-only pill use are common: 2 in 10 women have no bleeding, 4 in 10 women have regular bleeding and 4 in 10 women have irregular bleeding. (Grade C)

Weight Change

Women may be advised that there is no evidence of a causal association between progestogen-only pill use and weight change. (Grade C)

Depression and Mood Change

Women should be advised that mood change can occur with progestogen-only pill use but, there is no evidence of a causal association for depression. (Grade C)

Headache

Women should be advised that there is no evidence of a causal association between the use of a progestogen-only pill and headache. (Good Practice Point)

Women of any age with a history of migraine (with or without aura) may safely use progestogen-only pills (UKMEC 1 or 2). (Grade C)

Women who develop new symptoms of migraine with aura while using progestogen-only pills should be advised to seek medical advice, as investigation may be appropriate. Continued use may be considered (UKMEC 3). (Grade C)

Cardiovascular Disease and Breast Cancer

There is no causal association between progestogen-only pill use and cardiovascular disease (myocardial infarction (MI), venous thromboembolism (VTE) and stroke) or breast cancer. (Grade B)

When Can POPs Be Safely Started?

Postpartum (Breast or Bottle Feeding)

Progestogen-only pills can be started up to and including Day 5 of the normal menstrual cycle to provide immediate contraceptive protection. If started after this time condoms or abstinence are advised for 48 hours. (Grade C)

Progestogen-only pills can be started up to and including Day 21 postpartum (no additional contraceptive protection is required). If started after this time condoms or abstinence are advised for 48 hours. (Grade C)

Following Abortion or Miscarriage

Progestogen-only pills can be started at the time of abortion or miscarriage (<24 weeks' gestation) or within 5 days. If started after this time condoms are required for the next 48 hours. (Grade C)

Ongoing Use of POPs and Follow Up

In the absence of special problems, women may be given up to 12 months' supply of progestogen-only pills at their first and follow-up visits. Follow up should be tailored to the individual woman, who should be advised to return at any time if problems arise. (Grade C)

Women may be advised that a progestogen-only pill can be continued until the age of 55 years when natural loss of fertility can be assumed. Alternatively they can continue using a POP and have follicle-stimulating hormone (FSH) concentrations checked on two occasions 1–2 months apart. If both FSH measurements are >30 IU/l this is suggestive of ovarian failure and they may continue with a progestogen-only pill or barrier contraception for one further year (or 2 years if aged <50 years). (Good Practice Point)

Managing Bleeding Problems in Women Using a Progestogen-Only Pill

Women who have a change in bleeding pattern when using a progestogen-only pill need to be assessed and the risk of sexually transmitted infections, pregnancy or gynaecological pathology considered. (Good Practice Point)

There is no evidence that changing the type and dose of progestogen will improve bleeding, but this may help some individuals. If, after exclusion of other causes, bleeding patterns are still unacceptable then an alternative contraceptive method may need to be considered. (Good Practice Point)

Definitions:

Grades of Recommendations

A: Evidence based on randomised controlled trials (RCTs)

B: Evidence based on other robust experimental or observational studies

C: Evidence is limited but the advice relies on expert opinion and has the endorsement of respected authorities

Good Practice Point: Where no evidence exists but where best practice is based on the clinical experience of the multidisciplinary group

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate use of progestogen-only pills for contraception

Potential Harms
  • Altered bleeding patterns may occur with progestogen-only pill (POP) use. 20% of women will be amenorrhoeic; 40% will bleed regularly; 40% will have erratic bleeding.
  • Failure rates for traditional POPs vary (0.3 and 8.0 per 100 woman-years) but are lower for women aged over 40 years (0.3 per 100 woman-years) compared to younger women. Increasing parity is associated with an increase in efficacy but this may be linked to age.
  • Women using liver enzyme-inducing medications short term should be advised to use condoms in addition to progestogen-only pills and for at least 4 weeks after the liver enzyme-inducer is stopped.
  • Women using liver enzyme-inducing medications long term should be advised that the efficacy of progestogen-only pills is reduced and an alternative contraceptive method should be considered.

Contraindications

Contraindications

A current diagnosis of breast cancer poses an unacceptable health risk (United Kingdome Medical Eligibility Criteria [UKMEC] 4), and a progestogen-only pill should not be used.

Qualifying Statements

Qualifying Statements

This document is not intended to serve alone as a standard of medical care, as this should be determined individually based on available clinical information.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2009 Jun. 17 p. [44 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2008 Nov (revised 2009 Jun)
Guideline Developer(s)
Faculty of Sexual and Reproductive Healthcare - Professional Association
Source(s) of Funding

Faculty of Sexual and Reproductive Healthcare

Guideline Committee

Clinical Effectiveness Unit

Composition of Group That Authored the Guideline

Clinical Effectiveness Unit (CEU): Dr Susan Brechin (Unit Director); Ms Lisa Allerton (Unit Researcher); Dr Madhuri Thakur (Former Unit Researcher)

Clinical Effectiveness Committee: Mrs Doreen Bell (Public Partner QIS Scotland/User Representative); Dr Amanda Britton (Lead in Contraception and Sexual Health – Hampshire Primary Care Trust (North and East)/General Training Committee Representative FRSH, CASH, Basingstoke, UK); Dr Jagruti Doshi (Subspeciality Trainee in Sexual and Reproductive Health/Clinical Standards Committee Representative FSRH, Margaret Pyke Centre, London, UK); Dr Tamsin Groom (Consultant in Sexual and Reproductive Health); Dr Kate Guthrie (Consultant in Sexual and Reproductive Health, Conifer House, Hull, UK); Dr Noel Mack (General Practitioner, Kemnay Medical Group, Kemnay, Aberdeenshire,UK); Dr Pauline McGough (Consultant in Sexual and Reproductive Health, Sandyford Initiative, Glasgow, UK); Ms Shelley Mehigan (Nurse Specialist in Contraception/Clinical Effectiveness Committee Representative FSRH, The Garden Clinic, Sexual Health Services, Upton Hospital, Slough, UK); Dr Radhika Shah (General Practitioner, Camden and Islington, London, UK with a special interest in reproductive health, and Clinical Medical Officer, Brook Young Persons Advisory Services/Education Committee Representative FSRH); Mrs Anne Simpson (Public Partner QIS Scotland/User Representative); Dr Anne Webb (Consultant in Sexual and Reproductive Healthcare, Abacus Clinics for Contraception and Sexual Health, Liverpool Primary Care Trust, UK). Written feedback was received from: Dr Alyson Elliman (Consultant in Sexual and Reproductive Health Care, Croydon Primary Care Trust, Croydon, UK); the FSRH Clinical Effectiveness Committee and two independent reviewers: Professor Ian Fraser (Professor of Reproductive Medicine, The Queen Elizabeth II Research Institute for Mothers and Infants, The University of Sydney, Sydney, Australia) and Professor Pier Georgio Crosignani (Director, Institute of Obstetrics and Gynaecology, Ospedale Maggiore Policinico, Mangiagalli e Regnia Elena, Milan, Italy)

Financial Disclosures/Conflicts of Interest

None

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2008 Nov. 17 p. [44 references]

2011 is the date of planned revision.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Faculty of Sexual and Reproductive Health Care Web site External Web Site Policy.

Print copies: Available from the Faculty of Sexual and Reproductive Health Care, 27 Sussex Place, Regent's Park, London NW1 4RG

Availability of Companion Documents

Discussion points and questions for progestogen-only implants developed by the Faculty of Sexual and Reproductive Healthcare are available at the end of the original guideline document External Web Site Policy.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI on July 13, 2009. The information was verified by the guideline developer on August 18, 2009.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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