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Can unintended pregnancies be reduced by dispensing a year’s worth of hormonal contraception?
EVIDENCE SUMMARY
A 2013 systematic review studied the effect of dispensing a larger amount of pills on pregnancy rate, abortion rate, and overall cost to the health care system.1 Three of the 4 studies analyzed found lower rates of pregnancy and abortion, as well as lower cost despite increased pill wastage, in the groups that received more medication. The 1 study that didn’t show a significant difference between groups compared only short durations (1 vs 4 months).
The systematic review included a large retrospective cohort study from 2011 that examined public insurance data from more than 84,000 patients to compare pregnancy rates in women who were given a 1-year supply of oral contraceptives (12 or 13 packs) vs those given 1 or 3 packs at a time.2 The study found pregnancy rates of 2.9%, 3.3%, and 1.2% for 1, 3, and 12 or 13 months, respectively (P < .05; absolute risk reduction [ARR] = 1.7%; number needed to treat [NNT] = 59; relative risk reduction = 41%).
More pills lead to longer use of contraception
The systematic review also included a 2011 trial of 700 women starting oral contraceptives.3 It randomized them to receive a 7- or 3-month supply at their initial visit, then evaluated use of oral contraception at 6 months. All women were invited back for a 3-month follow-up visit, at which time the 3-month supply group would receive additional medication.
Fifty-one percent of the 7-month group were still using oral contraceptives at 6 months compared with 35% of the 3-month group (P < .001; NNT = 7). The contrast was starker for women younger than 18 years (49% vs 12%; NNT = 3). Notably, of the women who stopped using contraception, more in the 3-month group stopped because they ran out of medication (P = .02). Subjects in the 7-month group were more likely to have given birth and more likely to have 2 or more children.
A 2017 case study examined proposed legislation in California that required health plans to cover a 12-month supply of combined hormonal contraceptives.4 The California Health Benefits Review Program surveyed health insurers and reviewed contraception usage patterns. They found that, if the legislation passed, the state could expect a 30% reduction in unintended pregnancy (ARR = 2%; NNT = 50), resulting in 6000 fewer live births and 7000 fewer abortions per year.
RECOMMENDATIONS
The Centers for Disease Control and Prevention (CDC)’s Selected Practice Recommendations for Contraceptive Use recommend prescribing or providing as much as a 1-year supply of combined hormonal contraceptives at the initial visit and each return visit.5
The American College of Obstetricians and Gynecologists (ACOG) supports over-the-counter access to oral contraceptives, effectively allowing an unlimited supply.6
EDITOR’S TAKEAWAY
Adequate evidence of benefits and strong support from the CDC and ACOG should encourage us to offer 1-year supplies of combined oral contraceptives. Even though the higher-quality studies reviewed also showed a cost savings, up-front patient expense may remain a challenge.
1. Steenland MW, Rodriguez MI, Marchbanks PA, et al. How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other measures of consistent and correct use? A systematic review. Contraception. 2013;87:605-610.
2. Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117:566-572.
3. White KO, Westhoff C. The effect of pack supply on oral contraceptive pill continuation: a randomized controlled trial. Obstet Gynecol. 2011;118:615-622.
4. McMenamin SB, Charles SA, Tabatabaeepour N, et al. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception. 2017;95:449-451.
5. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65:1-66.
6. Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. Committee Opinion No. 544: Over-the-counter access to oral contraceptives. Obstet Gynecol. 2012;120:1527-1531.
EVIDENCE SUMMARY
A 2013 systematic review studied the effect of dispensing a larger amount of pills on pregnancy rate, abortion rate, and overall cost to the health care system.1 Three of the 4 studies analyzed found lower rates of pregnancy and abortion, as well as lower cost despite increased pill wastage, in the groups that received more medication. The 1 study that didn’t show a significant difference between groups compared only short durations (1 vs 4 months).
The systematic review included a large retrospective cohort study from 2011 that examined public insurance data from more than 84,000 patients to compare pregnancy rates in women who were given a 1-year supply of oral contraceptives (12 or 13 packs) vs those given 1 or 3 packs at a time.2 The study found pregnancy rates of 2.9%, 3.3%, and 1.2% for 1, 3, and 12 or 13 months, respectively (P < .05; absolute risk reduction [ARR] = 1.7%; number needed to treat [NNT] = 59; relative risk reduction = 41%).
More pills lead to longer use of contraception
The systematic review also included a 2011 trial of 700 women starting oral contraceptives.3 It randomized them to receive a 7- or 3-month supply at their initial visit, then evaluated use of oral contraception at 6 months. All women were invited back for a 3-month follow-up visit, at which time the 3-month supply group would receive additional medication.
Fifty-one percent of the 7-month group were still using oral contraceptives at 6 months compared with 35% of the 3-month group (P < .001; NNT = 7). The contrast was starker for women younger than 18 years (49% vs 12%; NNT = 3). Notably, of the women who stopped using contraception, more in the 3-month group stopped because they ran out of medication (P = .02). Subjects in the 7-month group were more likely to have given birth and more likely to have 2 or more children.
A 2017 case study examined proposed legislation in California that required health plans to cover a 12-month supply of combined hormonal contraceptives.4 The California Health Benefits Review Program surveyed health insurers and reviewed contraception usage patterns. They found that, if the legislation passed, the state could expect a 30% reduction in unintended pregnancy (ARR = 2%; NNT = 50), resulting in 6000 fewer live births and 7000 fewer abortions per year.
RECOMMENDATIONS
The Centers for Disease Control and Prevention (CDC)’s Selected Practice Recommendations for Contraceptive Use recommend prescribing or providing as much as a 1-year supply of combined hormonal contraceptives at the initial visit and each return visit.5
The American College of Obstetricians and Gynecologists (ACOG) supports over-the-counter access to oral contraceptives, effectively allowing an unlimited supply.6
EDITOR’S TAKEAWAY
Adequate evidence of benefits and strong support from the CDC and ACOG should encourage us to offer 1-year supplies of combined oral contraceptives. Even though the higher-quality studies reviewed also showed a cost savings, up-front patient expense may remain a challenge.
EVIDENCE SUMMARY
A 2013 systematic review studied the effect of dispensing a larger amount of pills on pregnancy rate, abortion rate, and overall cost to the health care system.1 Three of the 4 studies analyzed found lower rates of pregnancy and abortion, as well as lower cost despite increased pill wastage, in the groups that received more medication. The 1 study that didn’t show a significant difference between groups compared only short durations (1 vs 4 months).
The systematic review included a large retrospective cohort study from 2011 that examined public insurance data from more than 84,000 patients to compare pregnancy rates in women who were given a 1-year supply of oral contraceptives (12 or 13 packs) vs those given 1 or 3 packs at a time.2 The study found pregnancy rates of 2.9%, 3.3%, and 1.2% for 1, 3, and 12 or 13 months, respectively (P < .05; absolute risk reduction [ARR] = 1.7%; number needed to treat [NNT] = 59; relative risk reduction = 41%).
More pills lead to longer use of contraception
The systematic review also included a 2011 trial of 700 women starting oral contraceptives.3 It randomized them to receive a 7- or 3-month supply at their initial visit, then evaluated use of oral contraception at 6 months. All women were invited back for a 3-month follow-up visit, at which time the 3-month supply group would receive additional medication.
Fifty-one percent of the 7-month group were still using oral contraceptives at 6 months compared with 35% of the 3-month group (P < .001; NNT = 7). The contrast was starker for women younger than 18 years (49% vs 12%; NNT = 3). Notably, of the women who stopped using contraception, more in the 3-month group stopped because they ran out of medication (P = .02). Subjects in the 7-month group were more likely to have given birth and more likely to have 2 or more children.
A 2017 case study examined proposed legislation in California that required health plans to cover a 12-month supply of combined hormonal contraceptives.4 The California Health Benefits Review Program surveyed health insurers and reviewed contraception usage patterns. They found that, if the legislation passed, the state could expect a 30% reduction in unintended pregnancy (ARR = 2%; NNT = 50), resulting in 6000 fewer live births and 7000 fewer abortions per year.
RECOMMENDATIONS
The Centers for Disease Control and Prevention (CDC)’s Selected Practice Recommendations for Contraceptive Use recommend prescribing or providing as much as a 1-year supply of combined hormonal contraceptives at the initial visit and each return visit.5
The American College of Obstetricians and Gynecologists (ACOG) supports over-the-counter access to oral contraceptives, effectively allowing an unlimited supply.6
EDITOR’S TAKEAWAY
Adequate evidence of benefits and strong support from the CDC and ACOG should encourage us to offer 1-year supplies of combined oral contraceptives. Even though the higher-quality studies reviewed also showed a cost savings, up-front patient expense may remain a challenge.
1. Steenland MW, Rodriguez MI, Marchbanks PA, et al. How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other measures of consistent and correct use? A systematic review. Contraception. 2013;87:605-610.
2. Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117:566-572.
3. White KO, Westhoff C. The effect of pack supply on oral contraceptive pill continuation: a randomized controlled trial. Obstet Gynecol. 2011;118:615-622.
4. McMenamin SB, Charles SA, Tabatabaeepour N, et al. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception. 2017;95:449-451.
5. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65:1-66.
6. Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. Committee Opinion No. 544: Over-the-counter access to oral contraceptives. Obstet Gynecol. 2012;120:1527-1531.
1. Steenland MW, Rodriguez MI, Marchbanks PA, et al. How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other measures of consistent and correct use? A systematic review. Contraception. 2013;87:605-610.
2. Foster DG, Hulett D, Bradsberry M, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol. 2011;117:566-572.
3. White KO, Westhoff C. The effect of pack supply on oral contraceptive pill continuation: a randomized controlled trial. Obstet Gynecol. 2011;118:615-622.
4. McMenamin SB, Charles SA, Tabatabaeepour N, et al. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception. 2017;95:449-451.
5. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65:1-66.
6. Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. Committee Opinion No. 544: Over-the-counter access to oral contraceptives. Obstet Gynecol. 2012;120:1527-1531.
EVIDENCE-BASED ANSWER:
Probably, although studies that looked directly at this outcome are limited. A systematic review showed that women who received a larger number of pills at one time were more likely to continue using combined hormonal contraception 7 to 15 months later (strength of recommendation [SOR]: A, consistent evidence from 2 cohort studies and 1 randomized, controlled trial), which might be extrapolated to indicate lower unintended pregnancy rates.
One of the large retrospective cohort studies included in the review demonstrated a significantly lower rate of pregnancy among women who received 12 or 13 packs of oral contraceptives at an office visit compared with 1 or 3 packs (SOR: B, large retrospective cohort study).
How often should you follow up on a patient with newly diagnosed hypothyroidism?
Six to 8 weeks after the start of levothyroxine therapy you should reexamine patients and measure their serum thyroid-stimulating hormone (TSH) (strength of recommendation [SOR]: C, common practice and expert opinion). If thyroid function is normal at that time, examine the patient and measure serum TSH again in 4 to 6 months because clearance of levothyroxine increases in the euthyroid (normal) state (SOR: C, expert opinion).
Once the proper maintenance dose of levothyroxine is achieved, evaluate the patient and obtain a serum TSH at least annually, or as clinically indicated (SOR: C, expert opinion).
Evidence summary
There is very little patient-oriented research to help answer this question. Virtually all of the literature is based on bench research and expert opinion.
Wait at least 6 weeks to follow up after starting therapy
Serial serum TSH measurements are adequate to follow adults with newly diagnosed, uncomplicated primary hypothyroidism. However, serum thyroid hormone levels normalize before serum TSH. Serum thyroid hormone concentrations increase first, then the TSH secretion falls because of the negative feedback action of levothyroxine on the pituitary and hypothalamus. Levothyroxine has a 1-week plasma half-life; a steady state is achieved about 6 weeks (6 half-lives) after the start of treatment or a change in dose. The TSH level should, therefore, be evaluated no earlier than 6 weeks after initiating therapy or adjusting levothyroxine dosage.1,2 The full effects of thyroid hormone replacement on the TSH level may not become apparent until 8 weeks of therapy.3
Check TSH 4 to 6 months after initial follow-up
If the initial dose doesn’t require adjustment, reevaluate the patient and measure serum TSH again in 4 to 6 months because levothyroxine clearance can increase after the euthyroid state is established.4 If a dosage change is needed, make adjustments every 6 weeks, based on serum TSH values, until TSH values return to the reference range. Successful treatment reverses all the signs and symptoms of hypothyroidism, although some neuropsychologic and biochemical abnormalities, such as depressed mood and lipid abnormalities, may persist for several months.3
Monitor stable patients annually, especially the elderly
Examine the patient and measure serum TSH annually after identifying the proper maintenance dose, more often if an abnormal result or a change in the patient’s status occurs.2 Certain situations such as pregnancy, initiation of new medications, or liver or kidney disease may require more frequent monitoring.
Generally, once a stable maintenance dosage of levothyroxine is achieved, the dosage will remain adequate until the patient has a significant weight change or reaches his or her seventh or eighth decade.1 Although monitoring less often than once a year can be justified in younger adult patients whose weight is stable, patients older than 65 years must be monitored annually to avoid overreplacement. With age, thyroid binding may decrease, and the serum albumin level may decline. This can result in a 20% reduction in the dose of levothyroxine required.5,6
Recommendations
The American Association of Clinical Endocrinologists (AACE) recommends reassessment and repeat lab work at least 6 weeks after any change in levothyroxine brand or dose. The AACE practice guidelines suggest follow-up with appropriate interim history, physical exam, and pertinent lab studies at 6 months, and then annually after the TSH level has normalized.7
1. Hueston WJ. Treatment of hypothyroidism. Am Fam Physician. 2001;64:1717-1724.
2. Singer PA, Cooper DS, Levy EG, et al. For the Standards of Care Committee, American Thyroid Association. Treatment guidelines for patients with hyperthyroidism and hypothyroidism. JAMA. 1995;273:808-812.
3. Felig P, Baxter JD, Frohman LA. Endocrinology and Metabolism. 3rd ed. New York: McGraw-Hill, Inc.; 1995:504-505.
4. Braverman LE, Utiger RD. Werner and Ingbar’s The Thyroid: A Fundamental and Clinical Text. 7th ed. Philadelphia: Lippincott-Raven; 1996:884-885.
5. Rosenbaum RL, Barzel US. Levothyroxine replacement dose for primary hypothyroidism decreases with age. Ann Intern Med. 1982;96:53-55.
6. Sawin CT, Geller A, Hershman JM, et al. The aging thyroid. The use of thyroid hormone in older persons. JAMA. 1989;261:2653-2655.
7. American Association of Clinical Endocrinologists Medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002;8:457469.
Six to 8 weeks after the start of levothyroxine therapy you should reexamine patients and measure their serum thyroid-stimulating hormone (TSH) (strength of recommendation [SOR]: C, common practice and expert opinion). If thyroid function is normal at that time, examine the patient and measure serum TSH again in 4 to 6 months because clearance of levothyroxine increases in the euthyroid (normal) state (SOR: C, expert opinion).
Once the proper maintenance dose of levothyroxine is achieved, evaluate the patient and obtain a serum TSH at least annually, or as clinically indicated (SOR: C, expert opinion).
Evidence summary
There is very little patient-oriented research to help answer this question. Virtually all of the literature is based on bench research and expert opinion.
Wait at least 6 weeks to follow up after starting therapy
Serial serum TSH measurements are adequate to follow adults with newly diagnosed, uncomplicated primary hypothyroidism. However, serum thyroid hormone levels normalize before serum TSH. Serum thyroid hormone concentrations increase first, then the TSH secretion falls because of the negative feedback action of levothyroxine on the pituitary and hypothalamus. Levothyroxine has a 1-week plasma half-life; a steady state is achieved about 6 weeks (6 half-lives) after the start of treatment or a change in dose. The TSH level should, therefore, be evaluated no earlier than 6 weeks after initiating therapy or adjusting levothyroxine dosage.1,2 The full effects of thyroid hormone replacement on the TSH level may not become apparent until 8 weeks of therapy.3
Check TSH 4 to 6 months after initial follow-up
If the initial dose doesn’t require adjustment, reevaluate the patient and measure serum TSH again in 4 to 6 months because levothyroxine clearance can increase after the euthyroid state is established.4 If a dosage change is needed, make adjustments every 6 weeks, based on serum TSH values, until TSH values return to the reference range. Successful treatment reverses all the signs and symptoms of hypothyroidism, although some neuropsychologic and biochemical abnormalities, such as depressed mood and lipid abnormalities, may persist for several months.3
Monitor stable patients annually, especially the elderly
Examine the patient and measure serum TSH annually after identifying the proper maintenance dose, more often if an abnormal result or a change in the patient’s status occurs.2 Certain situations such as pregnancy, initiation of new medications, or liver or kidney disease may require more frequent monitoring.
Generally, once a stable maintenance dosage of levothyroxine is achieved, the dosage will remain adequate until the patient has a significant weight change or reaches his or her seventh or eighth decade.1 Although monitoring less often than once a year can be justified in younger adult patients whose weight is stable, patients older than 65 years must be monitored annually to avoid overreplacement. With age, thyroid binding may decrease, and the serum albumin level may decline. This can result in a 20% reduction in the dose of levothyroxine required.5,6
Recommendations
The American Association of Clinical Endocrinologists (AACE) recommends reassessment and repeat lab work at least 6 weeks after any change in levothyroxine brand or dose. The AACE practice guidelines suggest follow-up with appropriate interim history, physical exam, and pertinent lab studies at 6 months, and then annually after the TSH level has normalized.7
Six to 8 weeks after the start of levothyroxine therapy you should reexamine patients and measure their serum thyroid-stimulating hormone (TSH) (strength of recommendation [SOR]: C, common practice and expert opinion). If thyroid function is normal at that time, examine the patient and measure serum TSH again in 4 to 6 months because clearance of levothyroxine increases in the euthyroid (normal) state (SOR: C, expert opinion).
Once the proper maintenance dose of levothyroxine is achieved, evaluate the patient and obtain a serum TSH at least annually, or as clinically indicated (SOR: C, expert opinion).
Evidence summary
There is very little patient-oriented research to help answer this question. Virtually all of the literature is based on bench research and expert opinion.
Wait at least 6 weeks to follow up after starting therapy
Serial serum TSH measurements are adequate to follow adults with newly diagnosed, uncomplicated primary hypothyroidism. However, serum thyroid hormone levels normalize before serum TSH. Serum thyroid hormone concentrations increase first, then the TSH secretion falls because of the negative feedback action of levothyroxine on the pituitary and hypothalamus. Levothyroxine has a 1-week plasma half-life; a steady state is achieved about 6 weeks (6 half-lives) after the start of treatment or a change in dose. The TSH level should, therefore, be evaluated no earlier than 6 weeks after initiating therapy or adjusting levothyroxine dosage.1,2 The full effects of thyroid hormone replacement on the TSH level may not become apparent until 8 weeks of therapy.3
Check TSH 4 to 6 months after initial follow-up
If the initial dose doesn’t require adjustment, reevaluate the patient and measure serum TSH again in 4 to 6 months because levothyroxine clearance can increase after the euthyroid state is established.4 If a dosage change is needed, make adjustments every 6 weeks, based on serum TSH values, until TSH values return to the reference range. Successful treatment reverses all the signs and symptoms of hypothyroidism, although some neuropsychologic and biochemical abnormalities, such as depressed mood and lipid abnormalities, may persist for several months.3
Monitor stable patients annually, especially the elderly
Examine the patient and measure serum TSH annually after identifying the proper maintenance dose, more often if an abnormal result or a change in the patient’s status occurs.2 Certain situations such as pregnancy, initiation of new medications, or liver or kidney disease may require more frequent monitoring.
Generally, once a stable maintenance dosage of levothyroxine is achieved, the dosage will remain adequate until the patient has a significant weight change or reaches his or her seventh or eighth decade.1 Although monitoring less often than once a year can be justified in younger adult patients whose weight is stable, patients older than 65 years must be monitored annually to avoid overreplacement. With age, thyroid binding may decrease, and the serum albumin level may decline. This can result in a 20% reduction in the dose of levothyroxine required.5,6
Recommendations
The American Association of Clinical Endocrinologists (AACE) recommends reassessment and repeat lab work at least 6 weeks after any change in levothyroxine brand or dose. The AACE practice guidelines suggest follow-up with appropriate interim history, physical exam, and pertinent lab studies at 6 months, and then annually after the TSH level has normalized.7
1. Hueston WJ. Treatment of hypothyroidism. Am Fam Physician. 2001;64:1717-1724.
2. Singer PA, Cooper DS, Levy EG, et al. For the Standards of Care Committee, American Thyroid Association. Treatment guidelines for patients with hyperthyroidism and hypothyroidism. JAMA. 1995;273:808-812.
3. Felig P, Baxter JD, Frohman LA. Endocrinology and Metabolism. 3rd ed. New York: McGraw-Hill, Inc.; 1995:504-505.
4. Braverman LE, Utiger RD. Werner and Ingbar’s The Thyroid: A Fundamental and Clinical Text. 7th ed. Philadelphia: Lippincott-Raven; 1996:884-885.
5. Rosenbaum RL, Barzel US. Levothyroxine replacement dose for primary hypothyroidism decreases with age. Ann Intern Med. 1982;96:53-55.
6. Sawin CT, Geller A, Hershman JM, et al. The aging thyroid. The use of thyroid hormone in older persons. JAMA. 1989;261:2653-2655.
7. American Association of Clinical Endocrinologists Medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002;8:457469.
1. Hueston WJ. Treatment of hypothyroidism. Am Fam Physician. 2001;64:1717-1724.
2. Singer PA, Cooper DS, Levy EG, et al. For the Standards of Care Committee, American Thyroid Association. Treatment guidelines for patients with hyperthyroidism and hypothyroidism. JAMA. 1995;273:808-812.
3. Felig P, Baxter JD, Frohman LA. Endocrinology and Metabolism. 3rd ed. New York: McGraw-Hill, Inc.; 1995:504-505.
4. Braverman LE, Utiger RD. Werner and Ingbar’s The Thyroid: A Fundamental and Clinical Text. 7th ed. Philadelphia: Lippincott-Raven; 1996:884-885.
5. Rosenbaum RL, Barzel US. Levothyroxine replacement dose for primary hypothyroidism decreases with age. Ann Intern Med. 1982;96:53-55.
6. Sawin CT, Geller A, Hershman JM, et al. The aging thyroid. The use of thyroid hormone in older persons. JAMA. 1989;261:2653-2655.
7. American Association of Clinical Endocrinologists Medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002;8:457469.
Evidence-based answers from the Family Physicians Inquiries Network