3/25/2017
Expanding Access to
Birth Control
Kathleen Besinque, PharmD, MSEd.
Sarah McBane, PharmD, CDE, BCPS, FCCP
Disclosures
Dr. Besinque – nothing to disclose
•
Target Audience: Pharmacists
•
ACPE#: 0202-0000-17-039-L04-P
•
Activity Type: Application-based
Dr. McBane – spouse employed by Amgen
The American Pharmacists Association is accredited by the Accreditation
Council for Pharmacy Education as a provider of continuing pharmacy
education.
Learning Objectives
1. Discuss the evolving roles of community pharmacists in
managing contraceptive care for female patients.
2. Recommend contraceptive products on the basis of patientspecific information.
3. Formulate a plan to educate patients regarding
contraceptives and their method of use.
4. Identify resources of additional information for patients
receiving oral hormonal contraceptives and for health care
providers.
5. Discuss the significance of recent standardized protocols that
allow pharmacists to furnish hormonal contraceptives.
Pharmacists’ Role in Contraception Care
• A resource for information
and advice
• Manage side effects
• Provide advice re: drug
interactions and missed pills
• Source of information regarding
new methods
• Provide contraceptives within
the scope of practice
• Pursuant to a statewide
protocol or pursuant to a
collaborative practice
agreement
1
3/25/2017
Collaborative Practice Agreement v Protocol
• Collaborative practice agreement
What best describes your practice setting?
• Protocol
• An agreement between a pharmacist/pharmacy and a prescriber that provides for collaborative practice as defined by the state board
Adapted from NABP Report of the Task Force on Pharmacist Prescriptive Authority • System or procedure to follow in specific situations
• Plan for medical treatment Chain community
Independent community Health department Adapted from Merriam Webster
Office‐based Does your state have a specific protocol or
agreement for hormonal contraception?
Are you currently furnishing/prescribing hormonal
contraception?
Yes
Yes
No
No
Not sure One is being developed California
Oregon
Washington
Age limits
None
18 and older unless woman can show has previous prescription
None Formulary Pills, patch, ring, injection only
Oral self‐administered contraceptives and patches only
None
MEC Limits
Category 1 and Category 2
Category 1 and Category 2
None‐ generally Category 1 only is
the practice standard
Standard Protocol
Yes
Yes. Maximum duration is 3 years.
No. Must file CDTA with Department of Health.
Training for pharmacist
Course option open‐ requires
one hour specific to self administered hormonal contraception, application of the USMEC, and other CDC guidance on contraception
Must have Board approved course (cost $250.00)
None required (most pharmacists do seek training)
Under development. AB1114 requires MediCal to provide 85% of physician payment for services.
Established billing codes and structure
Payment as a provider
Health‐systems pharmacists have been paid since 1/1/2016, all other pharmacists will begin receiving compensation on 1/1/2017 as long as they are a network provider on the patient’s health plan.
New Mexico
Missouri
HB 233
South Carolina H 3064
Age limits
None
18 and older unless woman
can show has previous prescription
18 and older unless woman
can show has previous prescription
Formulary Pills, patch, ring, injection only
Oral self‐administered contraceptives and patches only
Oral self‐administered contraceptives and patches only
MEC Limits
Category 1 and Category 2
TBD
TBD Standard Protocol
Yes
TBD – bill states “add to practice of pharmacy” Yes. Maximum duration is 3 years.
Training for pharmacist
Must have Board approved course TBD
Must have Board approved course TBD
Dispensing reimbursement included in bill TBD
Payment as a TBD
provider
2
3/25/2017
Barriers Affect
Consistent Contraceptive Use
Other
20.7%
(n=173)
What’s going on in your state? Side Effects
33.8%
(n=283)
Access
45.5%
(n=381)
Reasons for Discontinuing OCs
Westhoff CL. Am J Obstet Gynecol. 2007.
Typical Effectiveness of Contraceptive Methods
Contraceptive Methods in US
•
Hormonal methods
•
•
•
•
•
•
Most effective
< 1 pregnancy/
100 women in 1 year
Combined hormonal contraceptives
Progestin‐only contraceptives
Progestin Intrauterine devices
Implants
Emergency contraceptive pills
6−12 pregnancies/
100 women in 1 year
Implant
Injectable
Vasectomy
Pills
Female
Sterilization
Patch
IUC
Ring
Diaphragm
Non‐hormonal methods
•
•
•
•
•
•
Barrier contraceptive methods
Fertility Awareness‐Based Methods
Coitus Interruptus Copper Intrauterine device
Female and Male Sterilization
Lactational Amenorrhea Method
Least effective
>17 pregnancies/
100 women in 1 year
Male Condoms
Female
Condoms
Spermicides
Sponge
Withdrawal
Fertility Awareness–
Based Methods
Trussell J, et al. In: Hatcher RA, et al., eds. Contraceptive Technology. 2011. Chart adapted from WHO 2007.
Hormonal Contraceptive Options
• Method of Administration
• Pill (oral)
• Vaginal ring
• Patch
• Injection
• Implant
• IUD
Oral Regimen options
• Type of regimen
• Monphasic
• Triphasic
• Multi‐phasic
• Hormone options
• estrogen/progestin • progestin only
• Dosing options
• Daily
• Weekly
• Monthly
• Quarterly
• 3‐10 years
17
3
3/25/2017
US Medical Eligibility Criteria 2016
• Criteria are organized according to:
–
Contraceptive method
–
Patient characteristics (age, smoking
status, etc.)
–
Preexisting conditions (hypertension,
epilepsy, etc.)
• Criteria use a numeric scheme to provide the
recommendations for contraceptives being
used for contraceptive purposes only, not for
treatment of medical conditions.
•Separate columns if recommendations differ for:
•Initiation criteria (preexisting conditions)
•Continuation criteria (condition develops or
worsens)
Safety/Risk Categories
1
Method can be used without restriction
2
Advantages generally outweigh theoretical or proven risk
3
Method usually not recommended unless other, more appropriate methods are not available or not acceptable 4
Method not to be used
19
US Medical Eligibility Criteria 2016
Pap smears must be performed prior to
prescribing hormonal contraception?
True
False
Cu‐IUD: copper‐containing intrauterine device
LNG – IUD: levonorgestrel‐releasing intrauterine device
DMPA: depot medroxyprogesterone acetate POP: progestin‐only pill
CHC: combined hormonal contraceptives Only before the first prescription
Not sure/don’t know
21
Required for Hormonal Contraception?
Pregnancy test
Not required
Pelvic exam
Not required
Pap smear
Not required
STI screening
Not required
Leeman L. Obstet Gynecol Clin N Am. 2007
MMWR U.S. Selected Practice Recommendations for Contraceptive Use 2016
Required to Furnish Hormonal Contraception
Medical history or Self-screening
tool
REQUIRED
Blood pressure
MMWR U.S. Selected Practice Recommendations for Contraceptive Use 2016
4
3/25/2017
Angela
Angela
more…
Screen* for precautions or contraindications Collect other pertinent information
Measure blood pressure
more…
Smoke?
No
Breastfeeding?
No
Delivered within 6 weeks?
No
Diabetes?
No
Migraines?
No
Heart disease?
No
DVT/PE?
Angela
No
Breast Cancer?
No
Hepatic disease?
No
Recent surgery?
No
Interacting medications?
No
Auto‐immune disease?
No
more…
*Usually on the patient self‐screening form Condit ion
Cu-IUD
LNG-IUD
Implant
DMPA
POP
CHC
Age
Menarche to
< 20 years
2
≥ 20 years
1
Condit ion
Menarche to Menarche to Menarche Menarche Menarche to
to < 18yr to < 18yr < 40 years
< 18yr
< 20 years
1
1
2
1
2
≥ 20 years
18 – 45
18 – 45 18 – 45
≥ 40 years
1
years
years
years
2
1
1
1
>45 years >45 years >45 years
1
2
1
Cu-IUD
LNG-IUD
Implant
DMPA
POP
CHC
1
1
Drug Interactions
SSRI’s
1
1
1
1
5
3/25/2017
Should the pharmacist provide hormonal
contraception to Angela?
Yes
No
Maybe
Can the pharmacist provide hormonal
contraception to Jess?
Jess
Yes
No
Maybe, depending on state law
Only if her parents approve
Condit ion
Cu-IUD
LNG-IUD
Implant
DMPA
POP
CHC
Age
Menarche to
< 20 years
2
≥ 20 years
1
Menarche to < Menarche to < Menarche Menarche Menarche to <
20 years
18yr
to < 18yr to < 18yr
40 years
2
1
2
1
1
≥ 20 years
1
18 – 45 years
1
>45 years
1
18 – 45
years
1
18 – 45
years
1
≥ 40 years
2
Health care rights for persons under 18
• Vary by state
• Typically the age to consent for family planning services differs from age of consent for other medical services
• Confidentiality issues
• Mandated reporting?
>45 years >45 years
2
1
6
3/25/2017
Brandie
Smoke?
Screen* for precautions or contraindications No
Breastfeeding?
No
Delivered within 6 weeks?
No
Diabetes?
Collect other pertinent information
Measure blood pressure
No
Migraines?
No
Heart disease?
No
DVT/PE?
No
Breast Cancer?
No
Hepatic disease?
No
Recent surgery?
No
Interacting medications?
No
Auto‐immune disease?
No
*Usually on the patient self‐screening form Condit ion
Cu-IUD
LNG-IUD
Implant
DMPA
POP
CHC
Is Brandie an appropriate candidate for hormonal
contraceptives?
Age
Menarche to
< 20 years
2
≥ 20 years
1
Yes
Menarche to < Menarche to < Menarche Menarche Menarche to <
20 years
18yr
to < 18yr to < 18yr
40 years
2
1
2
1
1
≥ 20 years
1
18 – 45 years
1
>45 years
1
18 – 45
years
1
18 – 45
years
1
No
≥ 40 years
2
>45 years >45 years
2
1
Possibly but Brandie needs a referral Yes and EC should be provided
Recommended Actions After Late/Missed HC
• Take the most recent missed pill as soon as possible (any other missed pills
should be discarded).
If 2 or more consecutive • Continue taking the remaining pills at the usual time (even if it means taking
pills have been missed
two pills on the same day).
(≥ 48 hours since a pill
• Use back-up contraception (e.g., condoms) or avoid sexual intercourse until
should have been
hormonal pills have been taken for 7 consecutive days.
taken)
• If pills were missed in the last week of hormonal pills (e.g., days 15-21 for
28-day pill packs): Omit the hormone-free interval by finishing the hormonal
pills in the current pack and starting a new pack the next day.
• If unable to start a new pack immediately, use back-up contraception (e.g.,
condoms) or avoid sexual intercourse until hormonal pills from a new pack
have been taken for 7 consecutive days.
• Emergency contraception should be considered if hormonal pills were
missed during the first week and unprotected sexual intercourse occurred in
the previous 5 days.
• Emergency contraception may also be considered at other times as
appropriate.
Providing Combined Hormonal Contraception and ECPs
For women who
Need EC because of missed OCs
Offer this ECP
LNG
Need EC and want UPA
to start OCs, Patch
or Ring
LNG
Are obese and need EC (BMI> 30 UPA
kg/m2
For ongoing contraception
Use backup method for
Give EC now. Continue pill pack or start new pack if on last week of pills
Give EC now. Wait to start HC for 5 days after unprotected sex
7 days
May be used May be preferred
7 days
14 days
14 days
7
3/25/2017
Suzanne
Smoke?
Screen* for precautions or contraindications No
Delivered within 6 weeks?
No
Diabetes?
Collect other pertinent information
Measure blood pressure
No
Breastfeeding?
No
Migraines?
Yes
Heart disease?
No
DVT/PE?
No
Breast Cancer?
No
Hepatic disease?
No
Recent surgery?
No
Interacting medications?
No
Auto‐immune disease?
No
*Usually on the patient self‐screening form Condit ion
Cu-IUD
Headaches a) Non-migraine (mild
or severe)
LNG-IUD
Implant
DMPA
POP
CHC
1
1
1
1
1
1*
1
1
1
1
1
2*
1
1
1
1
1
4*
Yes
b) Migraine
i) Without aura
(includes menstrual
migraine)
ii) With aura
Is Suzanne an appropriate candidate for
hormonal contraceptives?
No
Possibly but Suzanne needs a referral References and Resources
http://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6503.pdf
8
3/25/2017
http://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6504.pdf
Which of the following is the MOST appropriate recommendation to a woman seeking emergency contraception who has missed 2 doses of her hormonal contraceptive pills in the second week of her pack?
1. Levonorgestrel 1.5mg as soon as possible followed by 7 days of back‐up contraception.
2. Ulipristal 30mg as soon as possible followed by 7 days of back‐up contraception.
3. A woman who has missed 2 doses does not need emergency contraception and should continue taking her current contraceptive method.
Which of the following instructions correctly describe how to initiate a combined hormonal contraceptive ?
1. Using “Sunday start” means a woman should start the method on the first Sunday of the month and use of back‐up method of contraception for the first 7 days of use.
2. Using “First day start” means a woman should start the method on the first day of bleeding from her next menstrual cycle and does not require the use of a back‐up method.
3. “Quick start” means a woman should start the method immediately and use of back‐up method of contraception for the first 7 days of use.
You are counseling a 30 year old woman who is picking up her monthly supply of a combination hormonal contraceptive (CHC) pill. She has been taking the CHC pill for the past 8 months and has developed headaches without an aura during the last week of pills. The headaches are relieved by naproxen. She has normal blood pressure and does not smoke. Based on the MEC criteria, the woman should be advised to:
1. Continued on her current method.
2. Make an appointment with her primary care provider for evaluation of her headaches before continuing with her CHC.
3. Consider changing her method to a progestin only method.
9
3/25/2017
Smoking
Copper ‐ IUD
LNG – IUD Implant
Sub‐condition
Injection
Condition
Progestin‐only pill
1. Advise her to monitor her blood pressure and continue her contraceptive method.
2. Refer her to primary care provider for evaluation of her BP and to stop the contraceptive ring for now.
3. Refer her to primary care provider for evaluation of her BP and consider changing to a progestin only contraceptive.
A 31 year old woman who smokes a “couple” of cigarettes a day is requesting a combination hormonal contraceptive patch. Which of the following is the most appropriate advice from the pharmacist. Her BP is 110/68. The pharmacist should:
Combined pill, patch, ring
A 35 year old woman who has been using the contraceptive ring is picking up her refill. She asks if you can check her blood pressure. Her BP is 146/95. She tells you that her BP has never been high before and it must be a “defective cuff”. The most appropriate action for the pharmacist should be:
Age < 35
2
1
1
1
1
1
Age > 35, < 15 cigarettes/day
3
1
1
1
1
1
Age > 35, > 15 cigarettes/day
4
1
1
1
1
1
1. Advise her that she must stop smoking if she wants to use the contraceptive patch.
2. Advise her that the patch can be used until she is 35 or stops smoking.
3. Advise her that the patch can be used and inquire about her interest in smoking cessation. Based on the MEC criteria below, which methods are appropriate to recommend for a 30 year old woman with normal blood pressure who had a blood clot in her leg 5 years ago and is low risk for recurrence? Cu-IUD
Condit ion
LNG-IUD
Implant
Deep venous a) History of DVT/PE, not receiving anticoagulant therapy
thrombosis 1
2
2
I) Higher risk for
(DVT)/ recurrent DVT/PE
Pulmonary 1
2
2
II) Lower risk for
recurrent DVT/PE
embolism (PE)
b) Acute DVT/PE
2
2
2
DMPA
POP
CHC
2
2
4
2
2
3
2
2
4
c) DVT/PE and established anticoagulant therapy for the past 3 months
I) Higher risk for
recurrent DVT/PE
II) Lower risk for
recurrent DVT/PE
d) Family History (first
degree relatives)
2
2
2
2
2
4*
2
2
2
2
2
3*
1
1
1
1
1
2
1. LNG‐IUD 2. POP C. DMPA D. CHC 10