conditions of Daniel Grossman, MD

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1 Oral contraceptives and conditions of safe over-the-counter use Daniel Grossman, MD March ac 23, 2012

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

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

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

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

6 Global OC prescription requirements

7 Women s interest in accessing OCs without t a prescription 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 at risk of unintended pregnancy (n=2,046) 2 37% said they were likely to use an OTC OC 59% of current users 30% of women using no method or less effective method 1. Landau, et al, Grossman, et al, unpublished data

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

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

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

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

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

13 Pharmacist interest in providing hormonal contraception National survey sent to random sample of APhA pharmacist members N=2,725 (19% response rate) 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 Barriers: lack of reimbursement mechanisms (66%), liability issues (57%), time constraints (56%), lack of private counseling area (44%) Landau et al, 2009

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

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

16 Insurance and cost Women s current out-of-pocket expenditures for 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 Liang et al., 2011

17 Thank you!