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 i l G MD Daniel Grossman, MD

March 23, 2012 a c 3,

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, di ti ti d i discontinuation and gaps in use

• Side effects (feared and experienced)

Side effects (feared and experienced)

• Health concerns

N t liki ( ) th d

• Not liking (any) method
• 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 i ti t ti (N 725) prescription contraceptive (N=725)

Obstacle

% reporting it as a problem Doctor office hours not convenient Long wait to get appointment p 27% 23% Doctor visit costs too much No time off from work or school Doctor office hours not convenient 23% 20% 19% Doctor visit takes a long time No time off from work or school 17% 19% 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 ith t i ti without 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

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 i ti t OTC it h prescription-to-OTC switch

FDA criteria Oral contraceptives Drug has no significant toxicity if

• verdosed

True Drug is not addictive True Users can self-diagnose conditions for appropriate use Women determine if they are at risk

• f unintended pregnancy

Users can safely take the Research suggests that women can y medication without a physician’s screening gg self-screen for contraindications without involving a clinician Users can take the medication as Research suggests that continuation indicated without a doctor’s explanation gg is similar/higher among women

• btaining pills OTC compared to in a

clinic

Continuation of OCs obtained OTC Continuation of OCs obtained OTC

Discontinuation 60% higher for those bt i i ill i

• btaining pills in

clinics Discontinuation 80% Discontinuation 80% higher for those who

• btained 1-5 packs

in a clinic in a clinic

9 Potter et al., 2011

US MEC Category 3 & 4 Contraindications to use

• Pregnancy
• MI/stroke
• Pregnancy
• MI/stroke while on OCs

Contraindications to use

Combined OCs Progestin‐only OCs

• MI/stroke
• Lupus with + Antiphospholipid antibodies
• Breast cancer
• Severe cirrhosis/acute hepatitis
• Liver tumor
• 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
• Breastfeeding < 1mo postpartum
• Certain drugs (TB, epilepsy, HIV)
• History of malabsorptive bariatric surgery
• Allergy
• < 21 days postpartum
• Smoking at age ≥ 35 years
• Hypertension
• Complicated valvular heart disease
• Peripartum cardiomyopathy

Peripartum cardiomyopathy

• Diabetes (severe)
• DVT/PE (acute or history)
• Major surgery with prolonged immobilization
• Migraine with aura

2010 US Medical Eligibility Criteria for Contraceptive Use;

• Known hyperlipidemias
• Known thrombogenic mutations
• Gall bladder disease
• Complicated solid organ transplant

Contraceptive Use; Grossman et al., 2008; Grossman et al., 2011 ; White et al. 2012

Moving forward with an OTC switch f l t ti for oral contraceptives

• 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 B t h t b t bi d l

• But what about combined oral

contraceptives (COCs)?

Pharmacy access to h l t ti hormonal contraception

• 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

I iti ti d i Di t i t f C l bi

• Initiatives underway in District of Columbia

and other states to replicate

Gardner et al, 2008

Pharmacist interest in providing hormonal contraception

• National survey sent to random sample of APhA

h i t b pharmacist members

• 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 t i di ti contraindications

• 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 t i di ti contraindications

• 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