OVER-THE-COUNTER AVAILABILITY OF HORMONAL CONTRACEPTIVES

To advocate that hormonal contraceptives be available over the counter (OTC) without age restriction only under conditions that ensure safe use, including the availability of pharmacist consultation to ensure appropriate self-screening and product selection, and that maintain patient confidentiality; further,

To encourage the Food and Drug Administration to require manufacturers to include all patients of childbearing age, including adolescents, in studies to determine the safety and effectiveness of OTC hormonal contraceptives; further,

To advocate that all insurers and manufacturers maintain coverage and limits on out-of-pocket expenditure so that patient access is not compromised.

Rationale

There have been repeated calls to make hormonal contraceptive products more widely available, with the intent of expanding access to women’s reproductive health therapies and reducing unintended pregnancies. The American College of Obstetricians and Gynecologists (ACOG) advocates over-the-counter (OTC) access to hormonal contraception, including oral contraceptive pills, the contraceptive patch, contraceptive vaginal rings, and depot medroxyprogesterone acetate injections, without age restrictions. The American Medical Association (AMA), and the American Academy of Family Physicians (AAFP) support OTC access to oral contraceptives. ASHP agrees with ACOG and AMA that there is no clinical justification to restrict access to hormonal contraceptives by adolescents past menarche.

As with other OTC medications, there is recognition that both progestin-only and combined oral contraceptive use carries a very small amount of risk of adverse events and should be determined to be safe and effective for self-use. Progestin-only hormonal methods are generally safe and carry no or minimal risk of venous thromboembolism (VTE), and the VTE risk with combined oral contraceptive use is small compared with the increased risk of VTE during pregnancy and the postpartum period. ASHP advocates that OTC hormonal contraceptives should therefore be available where a patient has access to a pharmacist. Patient self-screening and product selection would be improved through pharmacist-provided consultation that assists patients in identifying absolute and relative contraindications (e.g., hypertension, heart or kidney disease), assessing other patient-specific factors (e.g., adherence practices), and determining when to recommend a referral to seek a higher level of care through the use of counseling and clinical decision-making tools. This process would guide the determination of which contraceptive product would be most safe and effective for an individual patient. ASHP does not believe that the current model for behind-the-counter access to some drug products (e.g., pseudoephedrine, emergency contraception) is appropriate for hormonal contraceptives because such a model would place the pharmacist in a gatekeeping rather than the clinical role that is necessary to ensure safe and effective use of these therapies.

Manufacturers will need to submit a supplemental new drug application for conversion from prescription to OTC status, including post-marketing surveillance reports and studies of consumer behaviors. It is critical that adolescents be included in these studies to assess their label comprehension, aptitude to self-select, and ability to effectively use the OTC hormonal contraceptives.

Given the intent to expand access to these therapies, ASHP advocates along with ACOG and AAFP that the proposed reclassification to OTC should not result in increased costs to patients and should include full insurance coverage without cost sharing. Modifications to national, regional, and local drug coverage decisions may be needed to ensure that payer policies do not unintentionally restrict or prevent access to OTC oral contraceptives.