Oral Contraceptive

Aka: Oral Contraceptive, Birth Control Pill

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II. Epidemiology

  1. United States: 18 million users
  2. Average length of use: 4.8 months
  3. Efficacy
    1. Typical use: 3-5% failure rate
    2. Perfect use: 0.1% failure rate

III. Benefits

  1. Long Term benefits
    1. Ovarian Cancer risk decreased (30-50% reduction)
    2. Endometrial Cancer risk decreased (30-50% reduction)
    3. Fibrocystic Breast disease decreased Incidence
    4. Acute Pelvic Inflammatory Disease risk decreased
  2. Menses Effects
    1. Increased Menstrual Cycle regularity
    2. Decreased blood loss
    3. Decreased Incidence of Dysmenorrhea
    4. Endometriosis risk reduced
  3. Ovulation Inhibition effects
    1. Decreased functional Ovarian Cysts
    2. Decreased Ectopic PregnancyIncidence

IV. Precautions: Risks associated with Oral Contraceptive use

  1. Cardiovascular Risk in Tobacco users (especially over age 35 years) is an FDA black box warning
  2. Venous Thrombosis or Pulmonary Embolism
    1. Precautions
      1. Avoid in women who use Tobacco over age 35 years
      2. Avoid if personal or Family History of venous thrombosis
    2. Overall Relative Risk = 2-3
    3. Risk appears highest with the highest levels of sustained Estrogen (Ortho Evra, NuvaRing)
      1. Risk decreases with lower dose Estrogen OCPs (20 mcg Estrogen)
    4. Thromboembolism risk (per 10,000 person years)
      1. Perspective
        1. All women of child-bearing age: 1-3 per 10,000 person years
        2. Pregnant women: 29 per 10,000 person years
        3. Postpartum: 200-300 per per 10,000 person years
      2. Levonorgestrel OCPs: 3-4 per 10,000 person years
      3. Desogestrel and Gestodene OCPs confer a higher risk
        1. General: 6-8 per 10,000 person years
        2. New users in first year: 10 per 10,000 person years
      4. Drospirenone (Yasmin) may also have higher risk
        1. 4-10 per 10,000 person years
        2. Sheldon (2002) BMJ 324:869 [PubMed]
      5. Ortho Evra appears to have a higher thrombosis risk than Oral Contraceptives
        1. 4-10 per 10,000 person years
        2. Cole (2007) Obstet Gynecol 109(2 Pt 1):339-46 [PubMed]
    5. References
      1. (1995) Lancet 346:1575-88 [PubMed]
      2. Jick (2000) BMJ 321:1190 [PubMed]
      3. Lidegaard (2012) BMJ 344:e2990 [PubMed]
      4. Spitzer(1996) BMJ 312:83-8 [PubMed]
      5. Raymond (2012) Obstet Gynecol 119(5):1039-44 [PubMed]
      6. Vandenbroucke (2001) N Engl J Med 344:1527 [PubMed]
  3. Cerebrovascular Accident
    1. See Cerebrovascular Accident Risk in Women
    2. Tobacco Abuse with Oral Contraceptive
      1. Odds Ratio: 3.6
    3. Migraine Headache with aura with Oral Contraceptive
      1. See Migraine Headache in Women
      2. Incidence of CVA in Migraine with Aura off OCP: 18 per 100,000 per year
      3. Incidence of CVA in Migraine with Aura on OCP: 30 per 100,000 per year
      4. Migraine Headache without aura is not a contraindication to OCP in age <35 and otherwise healthy
        1. Do not use if Tobacco Abuse or over age 35 years
        2. Limit Ethinyl Estradiol dose to 20 mg or less
          1. Monthly: Loestrin 24 Fe, Microgestin 1/20
          2. Seasonal: Lybrel, Lo-Seasonique
      5. References
        1. (2012) Presc Lett 19(3): 14 [PubMed]
  4. Myocardial Infarction
    1. Mechanisms
      1. Progestin related effect and HDL effect
      2. Increased risk with higher Estrogen dose
      3. Increased risk with higher age, Blood Pressure and Tobacco exposure
    2. Incidence of arterial events (Myocardial Infarction or Cerebrovascular Accident)
      1. No OCP: 3 arterial events per 10,000 women under age 50 years
      2. On OCP: 4-5 arterial events per 10,000 women under age 50 years
    3. Relative Risk
      1. Oral Contraceptive alone: 3
      2. Combined with Tobacco Abuse: 10
    4. References
      1. Lewis(1996) BMJ 312:88-90) [PubMed]
      2. (2012) Prescr Lett 19(8): 44-5
  5. Breast Cancer
    1. Studies have shown Relative Risk of 1.24 (20%) with both standard and low Estrogen dose
      1. No risk 10 years after stopping Oral Contraceptive
      2. Lancet (1996) 347:1713-27 [PubMed]
      3. Morch (2017) N Engl J Med 377:2228-2239 +PMID: 29211679 [PubMed]
    2. Some retrospective study shows no increased risk
      1. Marchbanks (2002) N Engl J Med 346:2025-32 [PubMed]

V. Indications

  1. Contraception
  2. Menstrual irregularities
  3. Endometriosis risk
  4. Acne Vulgaris

VI. Contraindications

  1. Absolute (based on ACOG and WHO guidelines)
    1. Venous Thrombosis history or risk
    2. Vascular disease
      1. Coronary Artery Disease
      2. Cerebrovascular Accident
    3. Liver disease (e.g. Viral Hepatitis, Cirrhosis)
    4. Undiagnosed Vaginal Bleeding
    5. Pregnancy
    6. Breast Cancer
    7. Migraine Headache with aura
      1. See Migraine Headache in Women
      2. See Cerebrovascular Accident Risk in Women
      3. Also contraindicated in Migraine Headache without aura in women over age 35 years or with Tobacco Abuse
    8. Tobacco Use
      1. ACOG: Any Tobacco over age 35 is contraindication
      2. Previously allowed if <15 Cigarettes per day and over age 35)
  2. Relative
    1. Hypertension
      1. Hypetension with vascular disease
      2. Systolic Blood Pressure >160 mmHg
      3. Diastolic Blood Pressure >99 mmHg
    2. Hyperlipidemia
      1. LDL Cholesterol >160 mg/dl
    3. Diabetes Mellitus with secondary complication
      1. Neuropathy
      2. Retinopathy
      3. Nephropathy
      4. Vascular Disease
      5. Diabetes Mellitus duration >20 years
    4. Postpartum <3 weeks
      1. Hypercoagulable state (risk of Thromboembolism)
      2. Consider IUD or Progestin-Only Pill instead
    5. Lactation (first 6 weeks to 6 months)
      1. Adverse effect on quality and quantity of milk
      2. Increased Hypercoagulability in the Postpartum Period
    6. Long leg cast or other prolonged immobility
    7. Non-Compliance
      1. Consider weekly Contraceptive Patch
      2. Consider Depo Provera or Norplant
  3. No significant increased risk with Oral Contraceptive
    1. Superficial Varicosities
    2. Bleeding Disorder
      1. OCP may be preventive in von Willebrand's
    3. Anticoagulation
    4. Sickle Cell Disease
    5. Obesity
    6. Hypertension (Controlled)
    7. Seizure Disorder
    8. Organic heart disease or Anticoagulant use
    9. Resolved Liver Disease
    10. Cervical Dysplasia or neoplasia
    11. Mitral Valve Prolapse (asymptomatic)
    12. Age over 35 years does not contraindicate OCP (unless Tobacco use)
      1. Considered safe if no other risk factors until age 55 years
      2. Choose agents with low Estrogen
      3. Monitor Blood Pressure and lipids
      4. Do not use if Tobacco use
      5. Seibert (2003) Ann Intern Med 138:54-64 [PubMed]
  4. References
    1. Petitti (2003) N Engl J Med 349:1443-50 [PubMed]

VII. Adverse Effects

  1. Estrogen
    1. Headache (10% new Incidence)
    2. Nausea
    3. Hypertension
    4. Leg Pain
    5. Varicosity
  2. Progestin
    1. Lipid abnormalities (lowers HDL-2)
  3. Adverse effects not associated with Oral Contraceptives
    1. Weight gain is not significant
      1. Hordinsky (2000) Eighth World Congress Int Gyn Endo

VIII. Preparations: Combined Contraceptive Formulations

  1. Monophasic
  2. Triphasic Progesterone
  3. Triphasic Estrogens (20-35 ug)

IX. Preparations: Cycle Types

  1. Standard: 21 days hormonal, 7 days Hormone free
  2. Extended: 24 day regimen, 4 days Hormone free
  3. Seasonal: 84 day regimen, 5-7 days Hormone free
    1. See Seasonal Oral Contraceptive Cycle

X. Efficacy

  1. High failure rate with P450 inducer medications
    1. Antiepileptic medications with 6% risk of pregnancy
    2. See Oral Contraceptive Drug Interactions
  2. Higher Oral Contraceptive failure rate in obese women
    1. Weight over 70 kg: Relative Risk of pregnancy 1.6
    2. Even higher risk with low Estrogen doses
    3. Holt (2002) Obstet Gynecol 99:820-7 [PubMed]

XI. Protocol: Starting the pill

  1. See Oral Contraceptive Selection
  2. Typical start (start at first sunday after Menses)
    1. Begin pill on first Sunday after onset of Menses
    2. If Menses start on Sunday, then start pill Day 1
      1. Use barrier Contraception for Days 1-7
    3. If pill started after Day 5:
      1. OCP may not suppress Ovulation for first cycle
      2. Use barrier Contraception for first month
  3. Quick start (start at time other than post-Menses)
    1. Last Menstrual Period within last 5 days
      1. Start Oral Contraceptive now
      2. Use backup Contraception for 1 week
    2. Last Menstrual Period >5 days
      1. Obtain pregnacy test and if negative proceed
      2. No unprotected intercourse since LMP
        1. Start Oral Contraceptive
        2. Follow protocol as for LMP within 5 days
      3. Last unprotected intercourse was >5 days ago
        1. Counsel that Urine Pregnancy Test not conclusive
        2. Can start Oral Contraceptive without fetal harm
      4. Unprotected intercourse within last 5 days
        1. Offer Emergency Contraception
        2. Follow protocol for last intercourse >5 days ago
    3. References
      1. Lesnewski (2006) Am Fam Physician 74:105-12 [PubMed]

XII. Protocol: Missed Pills

  1. After first cycle:
    1. Start new pack 7 days after last active pill
  2. If pill missed:
    1. One Pill Missed
      1. Take forgotten pill when remembered
      2. Take next pill as scheduled
    2. Two or more pills missed in a row
      1. Take one pill as soon as remembered
      2. Dispose of the missed pills
      3. Use backup Contraception for at least 7 days
      4. Consider Emergency Contraception
        1. Indicated for 2 or more missed pills and unprotected intercourse in the prior 5 days
        2. Consider especially if occurs during the first week of the Menstrual Cycle
      5. If occurs during the last week of the Menstrual Cycle (immediately before Hormone-free interval)
        1. Skip Placebo pills and immediately start new OCP pack OR
        2. Use backup Contraception for 7 days if new pack is not immediately started
  3. If Vomited within 2 hours of taking pill
    1. Repeat pill and use backup method
  4. Vomiting or Diarrhea >48 hours
    1. Use backup Contraception until after Vomiting/Diarrhea resolves and until after 7 days of active pills taken
  5. References
    1. (2014) Prescr Lett 21(6):33-4
    2. (2015) Presc Lett 22(6): 31-2

XIII. Protocol: Switching to or from the pill

  1. Switching from one pill to another pill
    1. Do not stop one pill while waiting to start another - switch can be immediate
    2. May switch mid-cycle to another pill
      1. Could take one pack's pill today and another pack's pill tomorrow
      2. Could complete the current pack and start the next pack immediately after this one
  2. Switching to the Ortho Evra patch from the pill
    1. Overlap the pill with the patch for 2 days to allow the Hormone levels from the patch to get to a steady state
    2. Women should start the patch on the day before they take their last pill
  3. Switching to the NuvaRing (Vaginal Contraceptive Ring) from the pill
    1. Women should start the ring on the day after taking the last pill
    2. Switch may be made mid-way through a current patch
  4. Switching to the pill from the Ortho Evra patch or NuvaRing (Vaginal Contraceptive Ring)
    1. Allow for one day of overlap between the pill and the patch or ring
    2. Take the first pill one day before removing either the patch or ring
    3. Plan pill start so that enough Hormone remains in the older device (35 days for the ring, and 9 days for the patch)

XIV. Drug Interactions

  1. See Oral Contraceptive Drug Interactions

XV. References

  1. Dickey (1998) Managing Contraceptive Pill Patients
  2. Burkman (2001) Clin Obstet Gynecol 44(1):62-72 [PubMed]
  3. Cerel-Suhl (1999) Am Fam Physician 60(7):2073 [PubMed]
  4. Speroff (1993) Obstet Gynecol 81:1034-47 [PubMed]
  5. Lesnewski (2011) Am Fam Physician 83(5): 567-70 [PubMed]

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