Oral contraceptives and Oral contraceptives and conditions of safe - PowerPoint PPT Presentation

Oral contraceptives and Oral contraceptives and conditions of safe over the counter use safe over-the-counter use D Daniel Grossman, MD i l G MD March 23, 2012 a c 3, 0

Oral contraceptives in the US Oral contraceptives in the US  Most popular Most popular contraceptive method  Used by 17% of US y women age 15-44  10.7 million women used the pill in 2006-2008  Two formulation groups  Combined oral contraceptives (COCs)  Progestin-only pills  Progestin-only pills (POPs) Mosher WD, Jones J, 2010

Factors contributing to non-use, discontinuation and gaps in use di ti ti d i  Side effects (feared and experienced) Side effects (feared and experienced)  Health concerns  Not liking (any) method N t liki ( ) th d  Personal/religious reasons  Access issues  Difficulty getting prescription/method Difficulty getting prescription/method  Cost Frost et al., 2007; Grossman et al., 2010; Potter et al. 2011

Obstacles to obtaining prescription contraception Among women who had used or wanted to use a prescription contraceptive (N=725) i ti t ti (N 725) % reporting it Obstacle as a problem p Long wait to get appointment 27% Doctor office hours not convenient Doctor office hours not convenient 23% 23% Doctor visit costs too much 20% No time off from work or school No time off from work or school 19% 19% Doctor visit takes a long time 17% Didn’t want pelvic exam 12% Landau et al., 2006

Could removing the prescription barrier Could removing the prescription barrier to oral contraceptives improve access to contraception? p Increase contraceptive uptake? Improve continuation? Reduce unintended pregnancy? Reduce unintended pregnancy? Reduce disparities in contraceptive use and unintended pregnancy?

Global OC prescription requirements Global OC prescription requirements www.OCsOTC.org

Women’s interest in accessing OCs without a prescription ith t i ti  Pharmacy Access Partnership survey (n=811) 1  41% of non-users reported they would start pill, patch or ring if directly available in pharmacy  Nationally representative survey of women age 18 44 at risk of unintended pregnancy 18-44 at risk of unintended pregnancy (n=2,046) 2  37% said they were likely to use an OTC OC 37% said they were likely to use an OTC OC  59% of current users  30% of women using no method or less effective method method 1. Landau, et al, 2006 2. Grossman, et al, unpublished data

FDA criteria for prescription-to-OTC switch i ti t OTC it h FDA criteria Oral contraceptives Drug has no significant toxicity if True overdosed Drug is not addictive True Users can self-diagnose conditions Women determine if they are at risk for appropriate use of unintended pregnancy Users can safely take the y Research suggests that women can gg medication without a physician’s self-screen for contraindications screening without involving a clinician Users can take the medication as Research suggests that continuation gg indicated without a doctor’s is similar/higher among women explanation obtaining pills OTC compared to in a clinic

Continuation of OCs obtained OTC Continuation of OCs obtained OTC Discontinuation 60% higher for those obtaining pills in bt i i ill i clinics Discontinuation 80% Discontinuation 80% higher for those who obtained 1-5 packs in a clinic in a clinic Potter et al., 2011 9

US MEC Category 3 & 4 Contraindications to use Contraindications to use Combined OCs Progestin ‐ only OCs • • Pregnancy Pregnancy • • MI/stroke MI/stroke • • MI/stroke while on OCs MI/stroke while on OCs • • Lupus with + Antiphospholipid antibodies Lupus with + Antiphospholipid antibodies • Breast cancer • Breast cancer • Severe cirrhosis/acute hepatitis • Severe cirrhosis • • Liver tumor Liver tumor • Certain drugs (TB, epilepsy, HIV) • Certain drugs (TB, epilepsy, HIV) • • History of malabsorptive bariatric surgery History of malabsorptive bariatric surgery • Allergy • Allergy • Breastfeeding < 1mo postpartum • < 21 days postpartum • Smoking at age ≥ 35 years • Hypertension • Complicated valvular heart disease • Peripartum cardiomyopathy Peripartum cardiomyopathy • Diabetes (severe) • DVT/PE (acute or history) 2010 US Medical Eligibility Criteria for • Major surgery with prolonged immobilization • Migraine with aura Contraceptive Use; Contraceptive Use; • Known hyperlipidemias Grossman et al., 2008; • Known thrombogenic mutations Grossman et al., 2011 ; White et al. 2012 • Gall bladder disease • Complicated solid organ transplant

Moving forward with an OTC switch f for oral contraceptives l t ti  Data strongly support safety of OTC Data strongly support safety of OTC provision of progestin-only pills (POPs)  Precedent of progestin only emergency  Precedent of progestin-only emergency contraception approved for OTC sale (with age restriction) makes it likely a POP age restriction) makes it likely a POP would be first OTC OC in US  But what about combined oral B t h t b t bi d l contraceptives (COCs)?

Pharmacy access to h hormonal contraception l t ti  Washington State Direct Access study g y  Collaborative drug therapy protocol to screen and counsel women for safe use of hormonal contraceptives prescribed by community contraceptives prescribed by community pharmacists  Found to be safe, effective and acceptable to women women  Unable to obtain insurance reimbursement for pharmacist services  Initiatives underway in District of Columbia I iti ti d i Di t i t f C l bi and other states to replicate Gardner et al, 2008

Pharmacist interest in providing hormonal contraception  National survey sent to random sample of APhA pharmacist members h i t b  N=2,725 (19% response rate)  85% interested in providing hormonal  85% interested in providing hormonal contraception  98%: important public health issue  88%: opportunity to increase business  88%: need additional training to help client select best hormonal contraceptive option p p  Barriers: lack of reimbursement mechanisms (66%), liability issues (57%), time constraints (56%) lack of private counseling area (44%) (56%), lack of private counseling area (44%) Landau et al, 2009

Initial use by Rx - Refills OTC Initial use by Rx Refills OTC  Women would be screened for Women would be screened for contraindications at initiation of the method  Unlikely to develop new contraindication in Unlikely to develop new contraindication in period of 1-3 years  Recognizes changing recommendations Recognizes changing recommendations for frequency of women’s preventive screening  Current users 3-fold more likely to report interest in OTC access

Use of a kiosk to screen for contraindications t i di ti  77% of El Paso OC users % reported being interested in using a kiosk to have their blood pressure their blood pressure checked before obtaining pills p  Kiosk could also screen for other contraindications t i di ti  Would require minimal or no involvement of no involvement of pharmacist

Insurance and cost Insurance and cost  Women’s current out-of-pocket expenditures for p p OCs approximately $15/month  Insurance usually does not cover OTC drugs  HHS Guidelines for Women’s Preventive Health Services require new private insurance plans to cover all FDA-approved contraceptives without cost-sharing  It will be critical that OCs provided OTC under conditions of safe use be covered by insurance or available at accessible price insurance or available at accessible price Liang et al., 2011

Thank you! Thank you! www OCsOTC org www.OCsOTC.org dgrossman@ibisreproductivehealth org dgrossman@ibisreproductivehealth.org