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.

file-feb-28-10-30-02-am

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.

An OTC Birth Control Pill Could Become a Reality

An over-the-counter (OTC) birth control pill is finally on the horizon. HRA Pharma, a French pharmaceutical company, has recently formed a partnership with the nonprofit research organization Ibis Reproductive Health to conduct the research needed to prepare and submit a new drug application for an OTC progestin-only pill to the FDA. While the approval may be several years away, at least we are on the way. More than 70% of women support OTC access to birth control.1

This is an exciting prospect that could make birth control pills more widely available and easier for people to access and use. Ultimately, it may make a dent in our high rate of unintended pregnancies (45% of all pregnancies in the United States).2

All birth control pills – combined and progestin-only – are currently available by prescription only. Some states, such as California and Oregon, have enacted state laws allowing pharmacists to prescribe hormonal birth control. The more resources and options people have to obtain their birth control, the more likely they are to use it to effectively control if and when they have a pregnancy.

The birth control options currently available OTC are spermicides, condoms, and levonorgestrel emergency contraception. Progestin-only pills are much more effective at preventing pregnancy than any of these other methods. The pill—including progestin-only and combined—is one of the most effective birth control methods available. Both pill types are about 99% effective when used exactly as directed and 91% effective with typical use.3 Progestin- only pills have about the same effectiveness as combination estrogen and progestin pills, rings, and patches.

While combined hormonal birth control pills are generally more popular, the estrogen component results in some serious contraindications and precautions.3 Women with high blood pressure, migraines with aura, and other medical conditions should be avoiding estrogen. On the other hand, the progestin-only pill does not have the same concerns and can be safely used by most women. An OTC progestin-only pill is expected to follow in the footsteps of levonorgestrel – a progestin-only emergency contraceptive pill.

Many professional medical associations have expressed support for OTC birth control pills, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, and the American College of Clinical Pharmacy Women’s Health Practice and Research Network.4-7 It’s even a bipartisan issue, although there are disagreements on who should pay for an OTC birth control pill among different political parties.

Pharmacists and other providers have expressed concerns about expanding access to birth control and how that might impact other necessary health services.8,9 We must trust women to continue to seek and obtain related preventive health care and health maintenance from their primary care physicians, obstetricians/gynecologists, or other health care providers. There is no evidence to suggest that birth control pills should be held hostage to make women go to the doctor. Pap smears and other preventive health care procedures are important, and access to birth control pills is important, but the 2 are independents and do not need to be linked.3

For more information, see the Oral Contraceptives Over-the-Counter (OCs OTC) Working Group websites: http://ocsotc.org/ and http://freethepill.org/.

References:

  1. Grossman D, Grindlay K, Li R, Potter JE, et al. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013;88(4):544-52.
  2. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016; 374(9): 843-52
  3. US Centers for Disease Control and Prevention. US selected practice recommendations for contraceptive use, 2016. MMWR. 2016;65(4):1-66.
  4. American Academy of Family Physicians (AAFP) Resolution No 501: Endorse access without age restriction to over-the-counter oral contraceptive pills. April 2016.
  5. American College of Obstetricians and Gynecologists Committee Opinion No 615: Access to contraception. Obstetrics and Gynecology. 2015; 125(1):250–5.
  6. American Medical Association Resolution D-75.995 (Sub. Res. 507, A-13): Over-the-counter access to oral contraceptives. American Medical Association. 2013.
  7. McIntosh J, Rafie S, Wasik M, McBane S, Lodise NM, El-Ibiary SY, et al. Changing oral contraceptives from prescription to over-the-counter status: An opinion statement of the Women’s Health Practice and Research Network of the American College of Clinical Pharmacy. Pharmacotherapy. 2011;31(4):424-37.
  8. Rafie S, Kelly S, Gray EK, et al. Provider opinions regarding expanding access to hormonal contraception in pharmacies. Womens Health Issues. 2016;26(2):153-60.
  9. Rafie S, Haycock M, Rafie S, Yen S, Harper CC. Direct pharmacy access to hormonal contraception: California physician and advanced practice clinician views. Contraception. 2012;86(6):687-93.

This article was originally published in Pharmacy Times.

MPR Ask the Experts Interview

mpr-cover

A few months ago, I was interviewed by the team at Monthly Prescribing Reference (MPR) regarding pharmacist prescribing of oral contraceptives. The newsletter has just been published and I want to share with you all as it is a great reference if you are interested in prescribing oral contraceptives.

In the 16-page newsletter dedicated to this topic, you will see both my responses as well as responses from Dr. Lorinda Anderson of Oregon to the following questions:

In your opinion, what are the implications of legislation allowing qualified pharmacists in California and Oregon to prescribe and dispense certain types of contraceptives? What is your take on how women perceive these new laws?

Under the Affordable Care Act, insurance plans are permitted to use cost sharing to encourage or discourage use of specific contraceptive products. In your opinion, how much does cost sharing influence the decision of which OC to prescribe? Are there any concerns that cost sharing could prevent a patient from receiving the OC that is optimal for her?

When choosing from among the many combination OCs available, how do the doses of estrogen factor into your decision (if at all) regarding which OC to prescribe?

For which patients and under what circumstances might one opt to prescribe a progestin-only OC or a combination OC?

What questions/concerns should pharmacists expect to address when counseling a patient who is being prescribed an OC?

In your experience, what are some common side effects that may occur with OC use? In the event that a patient finds specific side effects persistent and/or bothersome, what do you recommend in terms of next steps?

In what type of situation should a pharmacist refer patients to a women’s healthcare professional or other healthcare provider for contraception?

What would you like to communicate to your colleagues regarding the appropriate training and knowledge that should be acquired in order to begin prescribing contraceptives? Can you recommend any relevant resources that your colleagues could consult if needed?

Do you have any concluding remarks that you would like to share with our readers?

Please see the full newsletter here.

Thank you to MPR and Teva Generics for supporting this important content for pharmacists.