Pill Questions - What to Ask When Starting the OCP

The essential issues to address when starting the oral contraceptive pill (OCP) include:

• Has the woman considered all appropriate methods of contraception?
• Does the woman have any factors that would be a contra-indication for any form of contraception?
• Does the woman have any factors that may be benefited by a certain method of contraception, e.g. combined oral contraceptive pill (COCP) for heavy periods?
• Does the woman have an understanding of good sexual health, including prevention of sexually transmitted diseases? OCPs do not protect against sexually transmitted infections.
• Does the woman have a full understanding of using the preferred method of contraception, e.g. missed pill rules?
• Is the woman aware of the possible side-effects and their implications and appropriate action?

Advice and discussion

• All information should address the individual situation and concerns.
• Appropriate written information should be provided to all women prescribed the COCP.

• Check when the last period started and ensure the woman is not pregnant.
• If aged under 16 years, ask whether she has discussed using contraception with her parents. If she hasn't done so already, strongly encourage her to do so. The guidance for the provision of contraceptive services for under 16s was revised in July 2004.¹
• Discuss smoking: smoking increases the risks from the pill and this may be an opportunity to motivate the woman to stop smoking.

Efficacy

• Can be over 99% effective at preventing pregnancy, if used consistently and correctly.
• Other methods of contraception should be discussed and ensure that the woman is clear in her choice of the COCP.

Risk-benefit profile

Discuss the risks and benefits:²

• Advantages:
  • Menstrual pain and blood loss may be reduced.
  • Possible protection against osteoporosis.
  • Ovarian cancer: reduction in risk of ovarian cancer and ovarian cysts.
  • Endometrial cancer: reduction in the risk of endometrial cancer.
  • Colorectal cancer: risk of colorectal cancer may be reduced but this is uncertain.
• Disadvantages
  • No protection against sexually transmitted infections: advise that additional barrier contraception should be used as well, unless in a stable, long-term relationship.
  • Adverse effects include breakthrough bleeding, breast tenderness and mood changes.
  • Weight gain: no large effect on weight has yet been proven.^3,4
  • Venous thromboembolism (VTE): relative risk of VTE with COCP use can increase up to five-fold compared with non-users. The absolute risk is still low, and considerably lower than the risk in pregnancy. The risk of venous thrombosis (VT) is increased with obesity and greatest in the first year of COCP use. Approximate risks:²
    • Healthy non-pregnant women: about 5-10 cases per 100,000 per year
    • Second-generation pill users: about 15 per 100,000 per year
    • Third-generation pill users: about 25 per 100,000 per year
    • Pregnancy - estimated to be about 60 per 100,000 per year
  • To minimise the risk of VT before pelvic surgery or procedures that may require extensive immobilisation, COCPs should be stopped 2-4 weeks before the procedure, and should not be resumed until 2 weeks after complete mobility.
  • Myocardial infarction (MI): healthy non-smokers have no increased risk of MI with COCP use; COCP users with hypertension have a three-fold increased risk of MI compared with COCP users without hypertension; in COCP users who are heavy smokers (more than 15 cigarettes per day) the relative risk of MI may be up to 10 times that of smokers who do not use COCPs.
  • Stroke: very small increase in the absolute risk of ischaemic stroke with COCP use.
  • Breast cancer: any increased risk of breast cancer with COCP use is likely to be small. After 10 years since last use, the incidence of breast cancer is the same as in women who have never used COCPs.
  • Cervical cancer: the use of oral contraceptives for less than 5 years does not increase the risk of cervical cancer, but the risk increases when used for more than 5 years.
  • Liver cancer: primary liver cancer is rare in developed countries, and although COCP use increases the risk depending on duration of use, the absolute risk is very small.

Contra-indications

Ensure there are no contra-indications to the COCP:²

• Cardiovascular:
  • History of arterial thrombosis or VT, family history of VT, other known risk factors for VT
  • Clotting disorders
  • Ischaemic heart disease
  • Valvular heart disease
  • Atrial fibrillation
  • Pulmonary hypertension
  • Sickle cell anaemia
• Migraine:
  • Contra-indicated in migraine with typical focal aura, severe migraine regularly lasting over 72 hours despite treatment and migraine treated with ergot derivatives.
  • Use with caution in migraine without focal aura and migraine controlled with 5-HT1 agonist.
• Hepatic:
  • History of cholestatic jaundice of pregnancy
  • Disorders of hepatic excretion (Dubin-Johnson/Rotor's syndromes)
  • Infectious hepatitis of any type
  • Abnormal liver function tests
  • Porphyria
  • Liver adenoma
• Other:
  • Past history of pemphigoid gestationis
  • Haemolytic uraemic syndrome
  • Chorea
  • Otosclerosis
  • Hormone-dependent carcinoma
  • Undiagnosed vaginal bleeding
  • Recent trophoblastic disease
  • Pregnancy

Caution

Oral contraceptives are contra-indicated if more than one of the following are present, but may be used with caution if only one is present:

• Family history of arterial disease in first-degree relative with onset when aged under 45 years
• Diabetes mellitus
• Systolic blood pressure above 140 mmHg and diastolic above 90 mmHg (contra-indicated if above 160/100)
• Smoking (avoid if 40 cigarettes per day or more, or if aged over 35 years)
• Age over 35 years (avoid if over 50)
• Obesity (avoid if BMI above 39)

Interactions

• Drugs that induce hepatic enzyme activity, e.g. rifampicin, carbamazepine, phenytoin.
• Some broad-spectrum antibacterials, e.g. amoxicillin, doxycycline, may reduce the efficacy of COCPs by impairing the bacterial flora responsible for recycling of ethinylestradiol from the large bowel. FPA advice is that additional contraceptive precautions are needed whilst taking a short course of a broad-spectrum antibiotic and for 7 days after stopping. If these 7 days run beyond the end of a packet the next packet should be started without a break.
• If the antibiotic course exceeds 3 weeks, additional precautions become unnecessary. Additional precautions are also unnecessary when starting a COCP after taking an antibiotic for 3 weeks or more.

Screening before starting a COCP

• Women with a blood pressure consistently over 140 mmHg systolic or 90 mmHg diastolic should be advised against use of COCPs (contra-indicated if above 160/100).
• If a woman has a family history of VT in a first-degree relative under the age of 45 years, a thrombophilia screen should be performed.
• Factor V Leiden mutation is the most common genetic risk factor for deep vein thrombosis (DVT) and is present in 5% of the Caucasian population. Other possibilities are protein C or S deficiencies, or antithrombin III defect.
• Consider testing for STI (including chlamydia) in women with a high risk of STI:
  • Sexually active women under the age of 25 years.
  • Women over 25 years with a new partner, or who have had two or more partners in the previous 12 months.
• If applicable, ensure that cervical smears are up-to-date.

Starting the COCP

• Don't assume any knowledge. Go through the details of pill taking.
• Should be started on day 1 of the menstrual cycle, but can be started up to and including day 5 of the cycle without the need for additional contraception. If started outside this time period, exclude pregnancy and advise additional contraception for 7 days.
• Advise that it should be taken within 12 hours of the same time every day for 21 consecutive days. Contraceptive cover is still provided during the seven hormone-free days.
• After childbirth, women who are not breast-feeding: contraception is not needed in the first 3 weeks, and there is an increased risk of VT. If started later than 3 weeks postpartum, additional contraception is required for 7 days.
• After termination of pregnancy, it should be started on the day of the termination but can be started within 7 days to provide immediate contraceptive protection.
• Changing from a different COCP or progestogen-only pill (POP): when changing from a higher-dose to a lower-dose preparation, or from a progestogen-only pill, the current packet should be finished and the new brand started the next day, avoiding any pill-free interval.

Missed pills

Emphasise the need to take the pill at the same time each day but ensure that the woman knows what to do if a pill is missed, or if diarrhoea, vomiting or any other situation occurs which can reduce the effectiveness of the pill.

• If the pill is less than 12 hours late, protection is maintained.
• If the pill is more than 12 hours late, the missed pill should be taken as soon as possible, the packet continued as normal but extra precautions used for 7 days. If that 7 days runs into the pill-free week then the next packet should follow on without the usual break.
• Vomiting within 2 hours of taking the pill, or very severe diarrhoea, can affect absorption. If vomiting or severe diarrhoea last for more than 24 hours, follow advice as for missed pills.
• Use the seven-day extra-precaution rule for any problem of forgetting the pill, reduced absorption or drug interaction, e.g. antibiotic.

POPs are an alternative for women who choose not to use oestrogen or where oestrogen is contra-indicated.

Using the progestogen-only pill

• The woman should be aware of the high incidence of menstrual irregularities and the importance of regular pill-taking without missing tablets. Women should be advised to take the pill at the same time each day.
• POPs should usually be started on the first day of the period and then taken continuously.
• After childbirth, the POP can be started from day 21.
• After termination of pregnancy, the POP can be taken immediately.
• When changing from a COCP, the POP should be started at the end of the packet of COCPs, omitting the pill-free interval.

Contra-indications

• History of liver tumours
• Severe liver impairment
• Genital or breast cancer
• Severe arterial disease
• Undiagnosed vaginal bleeding
• Porphyria
• A history during pregnancy of idiopathic jaundice, severe pruritus or pemphigoid gestationis

Adverse effects and risks

• Amenorrhoea
• Breakthrough bleeding
• Breast tenderness
• Mood changes
• There is a small increased absolute risk of ovarian cysts
• There is a possible increased risk of breast cancer

Missed pills, vomiting or diarrhoea

• A POP is missed if it was taken more than 3 hours late - or 12 hours if using Cerazette®.⁵
• The missed pill should be taken immediately, and subsequent pills taken at the usual time. Additional contraceptive precautions should be taken for the following 2 days.
• Emergency contraception is recommended when one or more POPs have been missed or taken more than 3 hours late, and unprotected sex has occurred within 2 days after missed or late pills. The POP should be continued with additional barrier contraception until pills have been taken correctly on two consecutive days.
• Vomiting within 2 hours of taking the POP, or very severe diarrhoea: an additional contraceptive method should be used for any intercourse during the period of symptoms, and for 7 days after recovery.

• Ensure that there are no specific concerns that haven't been discussed.
• Usually three months' supply is initially prescribed and review planned when getting towards the end of the third packet. Earlier review if any problems or concerns.

1. Department of Health; Revised guidance for health professionals on the provision of contraceptive services for under 16s (July 2004).
2. Contraception, Clinical Knowledge Summaries (2008)
3. Gallo MF, Lopez LM, Grimes DA, Schulz KF, Helmerhorst FM. Combination contraceptives: effects on weight. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD003987. DOI: 10.1002/14651858.CD003987.pub3.
4. Gallo MF, Lopez LM, Grimes DA, et al; Combination contraceptives: effects on weight. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD003987. [abstract]
5. Cerazette® Guidance, Faculty of Family Planning and Reproductive Health Care (2003)

• First prescription of combined oral contraception, Faculty of Family Planning and Reproductive Health Care (2006)
• The Faculty of Family Planning and Reproductive Health Care