Contraception Options at Midlife

As a pharmacist, you’ve probably been asked “until what age should I use birth control?”  Regardless of age, women have reproductive potential until they have reached menopause. Therefore, to prevent unplanned pregnancies, it is important to continue using contraception in the meantime (1). Pharmacists can play a vital role in helping women decide between the different birth control options as well as educating on how long contraception should be continued.

Birth Control Pharmacist - Contraception Age Menopause

When does fertility end?

Menopause is defined as 12 consecutive months of amenorrhea. The onset of menopause can vary between 40 to 60 years of age, though the median age in North America is approximately 51 years (2). While patients should continue contraception methods until menopause, it is often difficult to accurately assess the onset when using hormonal birth control. If presence or absence of menses is not a reliable indicator for a particular patient, the measurement of follicle-stimulating hormone (FSH) may be used for evaluation. Alternatively, rather than assessing menopausal status, women may choose to continue contraception until the age of 55 (1). By this point, approximately 95% of women have reached menopause and it is presumptively established (3).

 

What are the birth control options at midlife (mid-40s to mid-50s)?

Combined Hormonal Contraceptives

Combined hormonal contraceptives (CHCs) are an option that are especially beneficial for women entering the perimenopause phase, as these options help with decreasing vasomotor symptoms (VMS) and symptoms associated with genitourinary syndrome of menopause (GSM) commonly experienced during this transition. Examples of VMS include hot flashes, night sweats, and sleep disturbances.  Examples of GSM include vaginal atrophy, irritation, dryness, dyspareunia (pain with sex) and urinary incontinence. Women may continue this option until age 55 if free of contraindications. Alternatively, they may choose to stop CHC for 1 to 2 months to allow for resumption of their menses to assess menopausal status. If this option is chosen, women should utilize another short-term, non-hormonal contraceptive method to prevent pregnancy. Once CHC is stopped, your patient may be a candidate to switch to menopausal hormone therapy (HT) to treat VMS and GSM (1). There are many options for HT and they contain similar hormones in lower doses compared to CHC. However, unlike CHC, HT will not prevent pregnancy if your patient is at risk of unintended pregnancy. Thus, it is important to ensure your patient is no longer at risk of unintended pregnancy (e.g. has reached menopause) before making the switch. The choice to continue HT after CHC should be a shared decision between a patient and her provider after a full evaluation of the risks and benefits of therapy, including an assessment of the severity of symptoms and impact on quality of life.

Progestin-Only Contraceptives

Aside from CHCs, there are several progestin-only contraception methods that women may choose to use. Options include progestin-only pills, the hormonal implant (Nexplanon), depot medroxyprogesterone, and hormonal intrauterine devices (IUDs). These options may cause amenorrhea, therefore similarly to CHCs, it can be difficult to assess the onset of menopause. These options may also be used until the age of 55 if no contraindications exist. For women who choose to start menopausal HT following this, they may use their long-acting IUD in place of other progesterone formulations for endometrial protection — which is required for patients who have an intact uterus (1).

Nonhormonal Contraceptives

Although many hormonal contraception options exist, one non-hormonal option that women can consider is the copper IUD, ParaGard. Unlike others, ParaGard tends to increase menstrual flow in the first 3 to 6 months, then normalize thereafter. Therefore, identifying the onset of menopause may be easier in women using this option. ParaGard may be safely continued until menopause is reached (1).

 

In conclusion, patients who wish to avoid an unintended pregnancy should use contraception until menopause. Pharmacists can educate patients on the risk of unintended pregnancy in midlife and determine eligibility for the various methods of contraception. While hormonal options may make it difficult to assess the onset of menopause, these options can safely be continued until the age of 55, if there are no contraindications. At age 55, menopause is presumptively established. Non-hormonal options like ParaGard may be continued until menopause is reached. Once post-menopausal, women may discontinue contraception methods completely, or switch to hormone therapy since lower doses can then be used to effectively treat menopausal symptoms after a full assessment of the risks and benefits. Hormone therapy does not prevent pregnancy.

 

References:

  1. Miller TA, Allen RH, Kaunitz AM, Cwiak CA. Contraception for midlife women: a review. Menopause 2018;25(7):817-827.
  2. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep 2016;65:1-66.
  3. Long ME, Faubion SS, MacLaughlin KL, Pruthi S, Casey PM. Contraception and hormonal management in the perimenopause. J Womens Health (Larchmt) 2015;24(1):3-10.

About the Author:

Linli Fung, PharmD is a PGY1 acute care pharmacy practice resident at UC San Diego Health in San Diego, California.

FDA Updates on Birth Control

There have been some notable changes with birth control products, including three new product approvals and one product exiting the market.

1. New yearly birth control vaginal ring approved. This birth control ring is very different from the existing vaginal ring product since it works for 1 year. It is a combined hormonal product and contains ethinyl estradiol and a new progestin — segesterone acetate. The ring is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year. The brand name is Annovera. One advantage of this product is that it does not require refrigeration. It is expected to be available in 2019. For more info, FDA News Release and Manufacturer Press Release.

Blog Post Images (4)

2.  First direct-to-consumer birth control digital app approved. This is the first app approved by the FDA as a safe and effective method of contraception.  It is indicated for use by adults aged 18 years and older. The app must be used with a thermometer — a two decimal basal thermometer, which is not the same as a normal fever thermometer.

Users will measure their temperature first thing in the morning before they get up and out of bed (at least five mornings a week) and enter it into the app.  For the algorithm to calculate daily fertility, users will also need to add their period data each month. The Natural Cycles algorithm analyses the information entered into the app to detect ovulation, thereby identifying green days, when no protection is needed, or red days, when you should use condoms or abstain from sex to prevent a pregnancy. For more info, FDA News Release and Company Website.

Natural Cycles Birth Control App

3. Another generic levonorgestrel emergency contraceptive pill approved. New generic emergency contraception (EC) pill approved. Preventeza is the brand name and it is made by the makers of Vagisil. This is another Levonorgestrel 1.5 mg single-pill EC product that may be sold without a prescription to consumers of all ages — women and men. It is available online only from the manufacturer’s website.

Preventeza Emergency Contraception

4. Essure to be discontinued. Essure is a permanent birth control method that doesn’t requires surgery and is placed in an office-based procedure. In this procedure, a soft, flexible insert is delivered through the vagina and uterus and permanently placed in each fallopian tube. No incision is required to deliver or place the inserts and general anesthesia is not required. Over time, a natural barrier forms around the inserts and prevents sperm from reaching the eggs by occluding the fallopian tubes. During this time, the patient must continue using another form of birth control to prevent pregnancy until the confirmation test at 3 months post-procedure.

The manufacturer is discontinuing production and it will no longer be available at the end of 2018.  This may be due to complaints from users due to adverse effects, restrictions by the FDA in April of this year, and/or low utilization. For more info, FDA Press Announcement.

Blog Post Images (3)

This has been a busy time for birth control product changes. We always welcome new birth control options to fit patient needs, given they are safe and effective.

5 Things Pharmacists Need to Know About Preconception Health

Pharmacists have great potential to improve preconception health. As they become increasingly aware and involved in providing preconception care, pharmacists can help close the gaps in such care by being advocates for the expansion of their role in preconception health.

Here are 5 things pharmacists should know about preconception health:

Preconception Pharmacists Birth Control1. We have a big problem with adverse pregnancy outcomes in the United States
The United States has high rates of infant mortality, maternal mortality, and other adverse pregnancy outcomes compared to other developed countries.1 Almost half of all pregnancies (45%) in the United States are unintended.2 In a society with such poor outcomes, health care professionals should provide preconception care within their scope of practice as part of routine health care to women and men of reproductive potential, regardless of pregnancy intention.2,3,4
 
2. Preconception health is all about optimizing the health of people with reproductive potential to ensure any pregnancies are healthy ones.
What is preconception care? Preconception care is the recognition and management of biomedical or behavioral issues that should be addressed before pregnancy to optimize health.3,4 For women of reproductive potential, recommended preconception care interventions can be broadly organized into four categories: counseling, maternal assessment, screening, and vaccinations.5 While preconception health may be more readily associated with women’s health, preconception health in men of reproductive potential is also important. Preconception care for men can help ensure pregnancies are intended, improve pregnancy outcomes, reduce the transmission of sexually transmitted diseases (STDs), and improve men’s health.6
 
3.  Pharmacists have the potential to deliver preconception care services.
Pharmacists are one of the most accessible health care providers and are well positioned to meet patients’ needs in preconception care, and improve health outcomes in the United States.5,7 Pharmacists can provide preconception care in areas such as disease state, and medication management; immunizations, folic acid supplementation, substance use counseling, smoking cessation, and contraceptive counseling.
 
4. Pharmacists want to provide some preconception services more than others.
So what do pharmacists think about providing preconception care to patients? We recently conducted a cross-sectional study of 332 pharmacists, and student pharmacists across the United States and its territories to assess pharmacist experiences, interest, and comfort with preconception care comprehensively.8 Pharmacists, and student pharmacists were already most involved with routine immunizations (54%), diabetes management (53%), and smoking cessation (52%), showing the consistent role pharmacists play in providing these preconception care services.

Pharmacists, and student pharmacists also expressed strong interest in providing STD/HIV screening and management (68%), and medication management services (62%). Examples of STD/HIV screening and management services that could be developed include community pharmacy clinics that provide screening and/or treatment, as well as patient counseling when over-the-counter screening tests are bought.9 In addition, because more than 80% of pregnant women take over-the-counter or prescription medications, pharmacists are well positioned to provide counseling to reduce risk of medication teratogenicity prior to pregnancy.10 These services may be considered initially for implementation to advance the role of pharmacists in providing preconception care.

Pharmacists, and student pharmacists were most comfortable providing services to female adults (88%), and female adolescents (65%) compared to male adults (61%) or male adolescents (32%). Implementing training sessions, and workshops may be beneficial to encourage the provision of preconception care services to male patients, especially male adolescents.
 
5. We need more work to prepare our pharmacists to provide these services.
Pharmacists and student pharmacists alike were interested in receiving more training about preconception care topics, particularly STD/HIV screening and management, minimizing risk of medication teratogenicity, and phenylketonuria management. Developing new and improved education and training programs could expand pharmacists’ knowledge on these preconception care services. In addition to education and training programs, access to patient medical records, patient education materials, and clinical guidelines would be useful resources to facilitate the provision of preconception care.

This article was co-written by Cydnee Ng, a student pharmacist at the University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.

References

  1. MacDorman MF, Matthews TJ, Mohangoo AD, Zeitlin J. International comparisons of infant mortality and related factors: United States and Europe, 2010. Natl Vital Stat Rep. 2014;63(5):1-6.
  2. Guttmacher Institute. Unintended pregnancy in the United States. Guttmacher Institute website. http://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states. Published September 2016. Accessed April 24, 2017.
  3. Johnson K, Posner SF, Biermann J, et al. Recommendations to improve preconception health and health care – United States: a report of the CDC/ATSDR preconception care work group and the select panel on preconception care. MMWR Recomm Rep. 2006;55(RR-6):1-23.
  4. Kent H, Johnson K, Curtis M, et al. Proceedings of the preconception health and health care clinical, public health, and consumer workgroup meetings. CDC website. www.cdc.gov/preconception/documents/WorkgroupProceedingsJune06.pdf. Created June 27-28, 2006. Accessed April 24, 2017.
  5. DiPietro Mager NA. Fulfilling an unmet need: roles for clinical pharmacists in preconception care. Pharmacotherapy. 2016;36(2):141-151.
  6. Frey KA, Navarro SM, Kotelchuck M, Lu MC. The clinical content of preconception care: preconception care for men. Am J Obstet Gynecol. 2008;199(6):S389-S395.
  7. El-Ibiary SY, Raney EC, Moos MK. The pharmacist’s role in promoting preconception health. J Am Pharm Assoc (2003). 2014;54(5):e288-e303.
  8. Ng C, Najjar R, DiPietro Mager N, Rafie S. Pharmacist and student pharmacist perspectives on providing preconception care in the United States. J Am Pharm Assoc (2003). 2018. doi: 10.1016/j.japh.2018.04.020.
  9. Dugdale C, Zaller N, Bratberg J, et al. Missed opportunities for HIV screening in pharmacies and retail clinics. J Manag Care Spec Pharm. 2014;20(4):339-345.
  10. Lassi ZS, Imam AM, Dean SV, Bhutta ZA. Preconception care: screening and management of chronic disease and promoting psychological health. Reprod Health.2014;11(suppl 3):S5.

This article was originally published in Pharmacy Times.

Pharmacists Provide Contraception for Zika Preparedness

A recent CDC report highlighted that Zika infections are of increasing concern, particularly in the summer travel months. To allow women and families to plan childbearing in the face of this threat, access to contraception is critical.

ZIka Contraception Pharmacists
One evidence-based strategy to increase access to contraception in the United States is pharmacist prescribing, wherein patients can go directly to a pharmacy for contraceptive supplies. Pharmacists are well qualified to assess patient eligibility for contraceptive methods following review of patient-reported medical history, and measuring blood pressure. This may greatly increase access to prescription-only contraceptives, such as pills, patch, ring, and injection, while maintaining product coverage for insured patients. While 33-50% of United States residents do not have a medical home, nearly all live within 5 miles of a community pharmacy. 

Prescriptive authority is granted at the state level. Eight states thus far (California, Colorado, Hawaii, Maryland, New Mexico, Oregon, Tennessee, and Utah), as well as Washington D.C., have passed legislation allowing pharmacist prescribing of contraception via statewide protocol. Other states allow this under collaborative practice agreements (i.e., Washington), and 9 states allow pharmacists to prescribe emergency contraception pills, which has important implications for access and reimbursement for these products. Pharmacists in California, Colorado, Hawaii, New Mexico, Oregon, Tennessee, and Washington are able to prescribe birth control and provide direct access to women—thanks to implementation of the state laws—and it will be happening soon in Washington D.C., Maryland, and Utah. That doesn’t mean every pharmacy in those states is participating though. These are all relatively new laws, so patients should check with their pharmacy or check Birth Control Pharmacies to find a participating pharmacy near them.
 
The existing state protocols vary, particularly with respect to contraceptive methods allowed, and age restrictions. We strongly recommend that additional states adopt similar legislation to increase access to contraception via pharmacists prescribing. The legislation and protocols should be evidence-based, and include all contraceptive methods that are safe to use when self-administered or administered by a pharmacist, and exclude age and duration restrictions. In addition, states should consider reimbursement and implementation at the outset to facilitate widespread uptake by patients and pharmacies alike.

Community pharmacies are often available, and accessible for vulnerable, hard-to-reach populations. Pharmacies have expanded hours of operation on evenings, and weekends, are visited frequently, and would allow for a single visit for the clinical visit, and contraceptive supplies. In order to protect more women from unintended pregnancy during the Zika crisis, pharmacists should be fully engaged and enabled to provide much-needed contraceptive services.

There will be a podium presentation on this topic at the American Public Health Association meeting on November 13, 2018 in San Diego, California. 

This article was co-written by Natalie DiPietro Mager, RPh, an associate professor of pharmacy practice at Ohio Northern University.

References

  1. Bonner L. Pharmacists in New Mexico can prescribe hormonal contraceptives. American Public Health Association. www.pharmacist.com/article/pharmacists-new-mexico-can-prescribe-hormonal-contraceptives. Created June 12, 2018. Accessed June 21, 2018.
  2. Illnesses from mosquito, tick and flea bites increasing in the US. [news release]. Altanta, GA: May 1, 2018; CDC. www.cdc.gov/media/releases/2018/p0501-vs-vector-borne.html. Accessed June 21, 2018.
  3. Darney BG, Aiken AR, Küng S. Access to Contraception in the Context of Zika: Health System Challenges and Responses. Obstet Gynecol. 2017;129(4):638-642.
  4. Dresser M. Assembly gives OK for Maryland pharmacists to write birth control pill prescriptions. Baltimore Sun. www.baltimoresun.com/news/maryland/politics/bs-md-pharmacists-pill-20170408-story.html. Published April 8, 2017. Accessed June 21, 2018.
  5. National Association of County & City Health Officials, 2014. Local Health Department and Pharmacy Partnerships for Enhancing Medication Dispensing during Emergencies. http://naccho.org/advocacy/positions/upload/14-03-LHD-Pharmacy-partnerships-for-emergency-response.pdf
  6. National Conference of State Legislatures. Emergency contraception state laws. NCSL website. www.ncsl.org/research/health/emergencycontraception-state-laws.aspx. Accessed June 21, 2018.
  7. Rafie S. Colorado is third state allowing pharmacists to prescribe birth control. Pharmacy Times. www.pharmacytimes.com/contributor/sally-rafie-pharmd/2017/02/colorado-is-third-state-allowing-pharmacists-to-prescribe-birth-control. Published February 27, 2017. Accessed June 21, 2018.
  8. Rafie S, Stone RH, Wilkinson TA, Borgelt LM, El-Ibiary SY, Ragland D. Role of the community pharmacist in emergency contraception counseling and delivery in the United States: current trends and future prospects. Integrated Pharmacy Research and Practice. 2017;6:99-108

This article was originally published in Pharmacy Times.

Responding to Patient Questions About Taking the Wrong Pill in the Pack

We want you to be prepared to answer your patient questions.  One common mishap that may lead patients to call or consult with you is what to do if the wrong day’s pill is taken on accident?

wrongbirthcontrolpill

Before you can answer this question, you need to know what birth control pill formulation the patient is taking.  If it’s a progestin-only pill, the answer is much simpler since all the pills in the pill pack are the exact same (norethindrone 0.35 mg) and there are no inactive pills.  In the case of a progestin-only pill, the patient should continue taking one pill daily at the regular scheduled time.  Since there were no missed doses, there are no additional instructions.

For combination birth control pills, where there is a combination of both estrogen and progestin hormones, there are many different formulations. Some pills have different doses of hormones every week or sometimes the dose changes after just a couple days.  Let’s start with a monophasic formulation.  For example, Yaz has 24 “active” pills, all with the same doses of both hormones, and 4 hormone-free or “placebo” pills at the end of the pack.  Any two active pills are the exact same (ethinyl estradiol 20 mcg and drospirenone 3 mg).  So in this case, the fact that the wrong day was punched out and taken would not make any difference.  It’s just important to reassure the patient and have her continue taking one active pill a day until she is back on track.  For a biphasic, triphasic or quadriphasic formulation, any two active pills can be treated as equivalent and the same instructions followed.  However, any pills with estrogen only (for example, two pills before the inactive pills in Mircette or LoLoestrinFe), should be treated as inactive pills.  If the patient took an inactive pill, it should be treated as a missed dose.  Refer to the CDC Guidelines for Missed Doses of Combined Oral Contraceptives, Patch or Vaginal Ring.

You are an excellent resource for patients dealing with a contraceptive mishap.

Please share any common questions with us and we’re happy to provide guidance in a future blog post!  We look forward to answering many more questions!

Can the NuvaRing be used for 4 weeks instead of the usual 3 weeks?

nuvaring birth control pharmacistNuvaRing was named one of the best healthcare inventions of the year by TIME Magazine in 2001. It was a new birth control option that allowed women to avoid taking daily pills, receiving injections, or inserting a hormonal implant. The first contraceptive vaginal ring (CVR) approved in the U.S., NuvaRing is a flexible, self-administered, transparent ring that contains progestin (etonogestrel) and estrogen (ethinyl estradiol). These hormones are released continuously (average 0.12 mg/day etonogestrel and 0.015 mg/day ethinyl estradiol) when inserted in the vagina. NuvaRing remains a popular method of hormonal contraception today.

After being on the market for almost 2 decades, vaginal ring use has increased and use can be tailored to fit patients’ needs, such as skipping the monthly withdrawal bleed. According to the manufacturer’s prescribing information, maximum effectiveness is achieved when the ring is inserted in the vagina continuously for 3 weeks and then removed for one week to allow for a monthly withdrawal bleed — mimicking the natural menstrual cycle. However, prescribers may write prescriptions with different instructions for use. Continuous use regimens may be prescribed to insert a new vaginal ring every 3 or 4 weeks without a ring-free week. Patients that use a continuous use regimen (omitting a ring-free week) will likely not experience a withdrawal bleed. However, breakthrough spotting or unscheduled bleeding may be experienced with continuous use regimens.

What is the evidence behind using the vaginal ring for four weeks instead of the usual three weeks?

The manufacturer states NuvaRing is still an effective hormonal contraception if inserted for 4 weeks (instead of the usual three weeks), but the manufacturer recommends removing it for a ring-free week before inserting a new ring for maximum contraceptive effectiveness. Ovulation inhibition to prevent pregnancy is maintained with insertion of the CVR for up to 4 weeks. However, the manufacturer recommends ruling out pregnancy for placements longer than 4 weeks before inserting a new ring.

Some systemic side effects of the CVR are comparable to oral contraceptives with similar incidence of headaches and weight gain. However, CVRs have an increased risk for local vaginal side effects like vaginitis (12.2% in CVR versus 6.8% in oral contraceptives) and vaginal discharge (4.8% in CVR versus 1.6% in oral contraceptives). Patients using CVR report less nausea and breast tenderness when compared with patients using oral contraceptives. Side effects may be related to the serum level differences between CVRs and oral contraceptives. Bioavailability of ethinyl estradiol are similar between CVR versus oral contraceptives at 55.6% versus 43% to 55%, respectively. However, the bioavailability of the progestin in CVRs are almost double at 100%, compared to 64% in oral contraceptives. The NuvaRing package insert includes precautions for carbohydrate and lipid metabolic effects, high blood pressure, headaches, uterine bleeding, vascular risks, liver disease, and Toxic Shock Syndrome.

While a potential risk, Toxic Shock Syndrome has rarely been reported with CVR use. The table below summarizes the evidence found in clinical studies of extended CVR use.

Table 1. Summary of clinical studies of extended regimens of the contraceptive vaginal ring (CVR).

Study Title

(PubMed ID, Year)

Purpose Design (Study size) Results Conclusion
Extended regimens of the combined contraceptive vaginal ring containing etonogestrel and ethinyl estradiol: effects on lipid metabolism

21757057 (2011)

To evaluate lipid changes with continuous CVR use for one year Prospective cohort (n=75) of continuous use for 3 months, followed by one ring-free week Significant increase in total triglycerides Extended CVR use may cause lipid changes, but this side effect is similar to oral or parenteral estrogen use
Extended regimens of the combined contraceptive vaginal ring: evaluation of clinical aspects

20159178 (2010)

To evaluate symptoms, body weight, and blood pressure changes with continuous CVR use for one year Prospective cohort (n=75) of continuous use for 3 months, followed by one ring-free week Less irritability, less dysmenorrhea, increased body weight (within an expected range), no changes in blood pressure Extended CVR use is well-tolerated with some non-contraceptive benefits (mood, less painful menstruation)
Extended regimens of the combined contraceptive vaginal ring: cycle control

19835716 (2009)

To compare menstrual patterns of women using extended CVR or oral contraceptives Prospective cohort (n=75 on CVR, 75 on oral) of continuous use for 3 months, followed by one contraceptive-free week Significant decrease in total days of bleeding and spotting for both methods, slightly lower for oral route Continuous oral use may result in less menstruation, but CVR offers more predictable menstrual cycle control with less unscheduled bleeding
Frequency and management of breakthrough bleeding with continuous use of the transvaginal contraceptive ring: a randomized controlled trial

18757653 (2008)

To evaluate bleeding patterns with continuous CVR Prospective cohort (n=74) on CVR for continuous 6 months. Group 1 did not have ring-free days. Group 2 instructed to remove CVR for 4 days if bleeding occurs, and reinsert the same ring Group 2 experienced less days of bleeding compared to Group 1 A 4-day ring-free period helped resolve breakthrough bleeding better compared to continuous ring use without ring-free periods

 

References:

  1. Agile Therapeutics. Women’s Health Specialty Pharmaceutical Company [Internet]. Jefferies; 2016. Available from: Link
  2. Barreiros FA, Guazzelli CAF, Barbosa R, Torloni MR, Barbieri M, Araujo FF. Extended regimens of the combined contraceptive vaginal ring containing etonogestrel and ethinyl estradiol: effects on lipid metabolism. Contraception. 2011;84(2):155–9.
  3. Barreiros FA, Guazzelli CAF, Barbosa R, Assis FD, Araújo FFD. Extended regimens of the contraceptive vaginal ring: evaluation of clinical aspects. Contraception. 2010;81(3):223–5.
  4. Best Inventions of 2001 [Internet]. Time. Time Inc.; 2001. Available from: Link.
  5. Guazzelli CAF, Barreiros FA, Barbosa R, Araújo FFD, Moron AF. Extended regimens of the vaginal contraceptive ring: cycle control. Contraception. 2009;80(5):430–5.
  6. Kerns J, Darney P. Contraceptive Vaginal Ring. In: Schreiber C, editor. UpToDate. [Internet].: UpToDate; 2017. Available from Link.
  7. Merck & Co. NuvaRing: Highlights of Prescribing Information. 2018. Available from: Link.
  8. NuvaRing. DrugDex Evaluations. In: Micromedex 2.0 [Internet]. Ann Arbor, MI: Truven Health Analytics. c2018. Available from Link
  9. Sulak PJ, Smith V, Coffee A, Witt I, Kuehl AL, Kuehl TJ. Frequency and Management of Breakthrough Bleeding With Continuous Use of the Transvaginal Contraceptive Ring. Obstetrics & Gynecology. 2008;112(3):563–71.

Christine YuAbout the Author:

Christine Yu is a fourth-year pharmacy student at the University of California San Francisco School of Pharmacy in San Francisco, California.

Thanks, Birth Control Day

Join The National Campaign to Prevent Teen and Unplanned Pregnancy, Bedsider, and me in saying, “Thanks, Birth Control” today! Birth control is a wonderful tool that helps us help our patients with family planning and other health issues.

All the reasons I️ say “thanks, birth control” on this day every year:

  1. Thanks for fewer unplanned pregnancies (women using birth control carefully and consistently account for only 5% of all unplanned pregnancies).
  2. Thanks for giving people the freedom to plan a family on their own terms.
  3. Thanks for more economic opportunities for young women and men.
  4. Thanks for greater educational attainment.
  5. Thanks for improved maternal health.
  6. Thanks for being so amazingly awesome that it is used by 99% of women who have had sex.
  7. Thanks for helping build stronger families.
  8. Thanks for being one of the nation’s top 10 greatest public health achievements of the last 100 years, according to the CDC.
  9. Thanks for reduced public spending.
  10. Thanks for fewer abortions.
  11. Thanks for reminding us of something that has great bi-partisan support.
  12. Thanks for building stronger relationships.
  13. Thanks for fewer health disparities.
  14. Thanks for less child poverty.
  15. Thanks for helping countless individuals better plan for their future and realize their dreams.
  16. Thanks for fewer low birth weight babies.
  17. Thanks for being so darn cost effective (public funding for contraception saves nearly $6 in medical costs for every $1 spend on contraceptive services).
  18. Thanks for saving countless panties and other clothing items from being stained by unregulated periods.
  19. Thanks for helping women manage heavy and/or painful periods (and the resulting lost days from work, costs for feminine products, and treatment costs).
  20. Thanks for treating acne.
  21. Thanks for preventing cancer.
  22. Thanks for coming in lots of different forms to choose from.
  23. Thanks for helping women skip pesky periods.
  24. Thanks for treating prementrual syndrome and premenstrual disphoric disorder.
  25. Thanks for letting women and men choose control of whether/when they want to have children.
Why are YOU or YOUR PATIENTS thankful for birth control?  Tweet (#ThxBirthControl), post something on Facebook, share one of Bedsider’s clever digital postcards, or add a comment here.  Need some ideas?  The National Campaign has plenty.
Thank you and thanks birth control.

How to Set Your Birth Control Formulary and Inventory Levels

Inventory management can either make or break a pharmacy or clinic. It’s one of those things that you absolutely must keep a close eye on. Otherwise, things can go from good to bad and bad to worse very quickly.

For the patient, their most basic expectation is to walk into the pharmacy with their shiny, new prescription and leave with their medications in hand. That’s why it is absolutely crucial to carefully set your birth control formulary and appropriately set your inventory levels.

Birth Control Pharmacist Formulary Inventory

Which birth control products should I keep in stock? 

If you are in a pharmacy that is already dispensing birth control prescriptions, you likely don’t need to make many changes at all! You can pick from the existing products that other birth control users are happy with when prescribing for your patients.

If you starting up and are a low volume clinic or pharmacy, simplicity is the key. Don’t stock your shelf full of 5 different equivalent generics that can be substituted for one another. Pick the one generic that is most cost effective or one that your patients most often request.

Choose medications to have on hand that can’t be substituted. Always keep Nuvaring, Xulane, and Depo-Provera or its generic on hand. These formulations are great options for people who have trouble adhering to a daily regimen or just don’t want to think about taking a pill every day.

Be sure to stock progestin only pills, extended cycle combination oral contraceptive (COC) pill packs, as well as emergency contraception because…well it’s in the name that it’s an emergency (Ella and Plan B One Step or generic). POPs are important to have stocked for your patients who may have contraindications to estrogen, such as migraines with aura or may be in the immediate postpartum period. There is only one progestin only pill formulation – norethindrone 0.35 mg.

When selecting the COCs to keep on hand, try to utilize the progestin’s class effects to your patient’s advantage. There are about 40 COC formulations on the market today. Narrow down the abundance of options when choosing your formulary by looking at how the progestins differ from one another. For instance, stock a COC that contains a progestin with low or no androgenic activity such as norgestimate or drospirenone respectively if your patient is concerned about or struggling with acne.

Other noncontraceptive benefits of hormonal pills that patients may request will be to suppress their menses. This is why we always want to have an extended regimen or even better a continuous regimen COC pack readily available. Yes, some of these are costly items that may not be your store’s “fast movers”, but having different formulations and the chance to get started on these right away will pay off in the end. The result being happy patients, happy pharmacy staff, and a larger base of pharmacy patrons.

Speaking of cost, inventory — if managed incorrectly — can come back to haunt you. Carefully controlling the inventory is how you will manage the potentially devastating high-cost of some medications. Like before, consider birth control options that cannot be substituted and limit your inventory on products that seem to have endless substitutions. Also, if you’ve noticed some insurances prefer certain products over others, keep that in mind as well.

How do I determine how much to keep on hand?

Once you’ve established what products you would like to keep on hand, look at your pharmacy’s dispensing history for each product. How many times do you dispense that product in a month’s time? Do you have a patron that comes in like clockwork every month for Yaz or LoLoestrin? Someone returning every three months for her 3-month supply? Here’s where utilizing a patient compliance tool to schedule refills, with the patient’s permission, can be extremely

Take all of these factors into account and utilize your inventory system’s options to set an order point or TIL (target inventory level). This will tell your computer to automatically order that medication once your BOH (balance on hand) drops below your pre-determined TIL. Most pharmacy systems have some version of this function and it can be a really helpful tool. The point here is to make sure you don’t have thousands of dollars in inventory sitting on your shelf gathering dust and worst case scenario expiring on the shelf. On the other side of that coin, you don’t want to turn patients away because you don’t stock the product that they are consistently picking up on a monthly It’s important to find a balance.

Patients in California and selected other states can now request up to an annual supply of their birth control to be dispensed and state law requires their health insurance company to cover this. Want to know more? Check out our recent article with more details.

Hopefully you find these tips useful in setting your birth control formulary and inventory.


About the Author:

Candace Stifflemire is a fourth-year pharmacy student at the University of the Incarnate Word Feik School of Pharmacy in San Antonio, Texas.

More Birth Control Supplies Leads to Longer Use

More frequent trips to the pharmacy to pick up refills are bad for patients when it comes to birth control. Studies have shown that when patients are given more supplies at a time, they stick to their birth control method for longer and have fewer unintended pregnancies.

Pharmacists are used to the barriers imposed by insurers on quantities we can dispense. But that does little to ease the frustrations of patients who have to come in every four weeks to obtain more birth control or are forced into a mail order pharmacy. And beyond frustrations, frequent trips lead to worse outcomes in this case.

Let’s start with the good that happens when the need to obtain refills goes away.

Birth Control Yay

More supplies leads to fewer unintended pregnancies and abortions. One study evaluated oral contraceptive supplies and pregnancy events among Medicaid users in California. Patients who were dispensed a one year supply of oral contraceptives experienced a 30% reduction in the odds of an unintended pregnancy compared to those patients who received supplies for one or three months. The one-year supply was also associated with a 46% reduction in the odds of an abortion.

Unintended pregnancy is a costly outcome that can be mitigated in part by providing patients with a one-year supply of contraception. Contraception is generally cost effective and it would behoove health insurers and other payers to increase dispensing limits to allow for one-year supplies.

Six states have passed legislation requiring health plans to cover a 12-month supply of hormonal contraceptives. This applies to self-administered hormonal contraceptives including pills, patches, and rings. Patients may request these larger quantities to be dispensed from their pharmacy. Similar legislation has been introduced in 17 other states.

California’s legislation was passed in September 2016 and became effective January 2017, however it does not require health plans to adhere to the law until the plan renews. For many plans, the annual renewal period is in the fall or winter.

This has implications for pharmacies. Besides being aware of this law and honoring our patient requests for larger supplies, we also need to consider inventory adjustments to accommodate these requests. Keeping substantially larger quantities of birth control products will be challenging for many pharmacies as these come in bulky packaging and shelf space is limited. If this is a significant limitation for your pharmacy, consider dispensing an initial supply of about three months, ordering the remaining quantity, and mailing those supplies directly to the patient’s home when it arrives or whatever method the patient prefers.

All birth control methods dispensed at the pharmacy are stored at room temperature except for the vaginal ring (NuvaRing). Since the ring can only be stored at room temperature for up to four months, we will need to dispense appropriate quantities to ensure the medication remains effective. While patients may want to store their rings in their refrigerator at home, the temperature cannot be controlled and monitored as it is in the pharmacy. For this reason, it would be prudent to dispense up to four vaginal rings if the patient plans on inserting the first the same day or up to three vaginal rings in the patient plans on inserting the first within the next month. For patients to be satisfied with this plan, it will be critical to explain the storage requirements and concern for effectiveness with the patient.

This evidence-based change is good for patients. While it’s a change for pharmacies initially, hopefully they will benefit from improved patient satisfaction and outcomes.

 

References:

  • Foster DG, Hulett D, Bradsbetty M, Darney P, Policar M. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gyencol 2011;117:566-72.
  • Steenland MW Rodriguez M, Marchbanks PA, Curtis KM. How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other measures of consistent and correct use? A systematic review. Contraception 2013;605-10.
  • McMenamin SB, Charles SA, Tabatabaeepour N, Shigekawa E, Corbett G. Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study. Contraception 2017;449-51.

 

This article was originally published in Pharmacy Times.

The image was adapted with permission from Sarah Mirk via Flickr.

Colorado is Third State Allowing Pharmacists to Prescribe Birth Control

More good news about access to birth control is coming from the state level. Colorado has passed legislation authorizing pharmacists to prescribe birth control after obtaining additional training. They are the third state to follow California and Oregon with this statewide authority specific to birth control. There is a task force that is charged with implementing the new protocol in the coming months.

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Pharmacist Protocols

All state protocols to date require pharmacist training and patient screening with a questionnaire and blood pressure measurement. Colorado’s legislation most closely resembles Oregon’s in allowing initiation of birth control pills and patch to adult women for up to three years until she sees a physician. California’s protocol is more comprehensive in allowing initiation of birth control ring and injection as well, in addition to serving female patients of all ages without a duration limit.

Public Health Impact

In 2010, 45% of all pregnancies (43,000) in Colorado were unintended. This expanded pharmacist scope is great news for women in Colorado and affords them more choices in access points for birth control. Colorado pharmacists are also looking forward to providing this important public health service to their patients.

It is yet to be determined what types of patients utilize this service when offered by pharmacists. The service became available at participating pharmacies as of January 2016 in Oregon and April 2016 in California.

Colorado has had great success with other initiatives to address unintended pregnancies. The Colorado Department of Public Health and Environment Family Planning Initiative provided more than 30,000 intrauterine devices (IUDs) or implants at low or no cost to low-income women. This contributed to a 40% drop in the teen birth rate from 2009 through 2013. This project is among others in demonstrating that when cost and access barriers to long-acting, reversible contraceptive methods such as IUDs and implants are removed, women are likely to choose these more effective methods. By 2019, Colorado aims to reduce the unintended pregnancy rate to 30% or less as one of their “Winnable Battles.”

Safety

There have been concerns about the safety of providing hormonal contraception without physical exams and pap smears. Though hormonal contraceptives are not without risks, these are generally outweighed by the benefits and considered safe for most women. A pelvic examination and a pap smear are not necessary to initiate hormonal birth control.  They are important for other health reasons.  Women will need to complete a health history questionnaire and have their blood pressure taken at the pharmacy.  The pharmacist will use this information to determine which methods of birth control are safe.

This is another step forward in increasing access to birth control.  Hopefully more states will pass similar laws expanding access with pharmacist prescribing.

There is also growing support for over-the-counter birth control pills. That differs from pharmacist prescribing because consultation with a pharmacist would no longer be required.

This article was originally published in Pharmacy Times.