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.

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.