Meet Slynd: A Novel Progestin-Only Pill

What’s this new pill?

Slynd® is the new progestin-only oral contraceptive approved by the FDA in May 2019. This novel progestin-only pill (POP) contains drospirenone 4 mg in each active tablet, which is a higher dose than what is found in drospirenone-containing combined oral contraceptives (COCs). 

Table 1. Products with drospirenone.

Product Name

Medication Doses

Regimen

Yasmin, Zarah, Syeda, Ocella

Drospirenone 3 mg, ethinyl estradiol 30 mcg

21/7

Safyral

Drospirenone 3 mg, ethinyl estradiol 30 mcg, levomefolate calcium 451 mcg

21/7

Yaz, Gianvi, Loryna

Drospirenone 3 mg, ethinyl estradiol 20 mcg

24/4

Beyaz

Drospirenone 3 mg, ethinyl estradiol 20 mcg, levomefolate calcium 451 mcg

24/4

Slynd

Drospirenone 4 mg

24/4

This will be the second POP formulation available, in addition to the many norethindrone 0.35 mg products currently available.

What are the features of this new pill?

This pill provides pregnancy prevention with a 24/4 dose regimen. In the ongoing evolution of contraception, the goal has always been to improve efficacy as well as minimizing adverse events. Estrogen dose reduction and shortening of hormone-free intervals have been helpful to meet these goals. As a result, Slynd was developed with a 24/4 dose regimen which provides a more stable hormonal timeframe compared to traditional 21/7 dose regimens, achieving greater pituitary and ovarian suppression. For this reason, the 24/4 regimen has less hormone withdrawal effect and improves pelvic pain, headaches, breast tenderness, and bloating symptoms that are reported during the hormone-free days with 21/7 regimens.  

Slynd pill pack

Figure 1. Slynd pill pack containing 24 active pills and 4 inactive pills.

(Image credit: slynd.com)

Slynd also allows a 24-hour missed pill window which improves reliability and bleeding profiles in the event of a missed dose. One study compared two arms — one with four missed doses (four 24-hour delays) and the other with no missed dose during the cycle. Even with four missed doses in the cycle, there was adequate ovarian suppression and the same follicular size was observed in both arms.

Drospirenone inhibits ovulation by suppressing luteinizing hormone (LH) secretion. Additionally, by modifying cervical mucus, it reduces sperm transport and thus prevents fertilization. Unlike other conventional synthetic progestins, drospirenone has a similar profile to endogenous progesterone. As an analogue of 17-alpha spironolactone, drospirenone has anti-mineralocorticoid and anti-androgenic activity. Due to the anti-mineralocorticoid activity, it increases urinary sodium and serum aldosterone. Therefore, compared to other COCs causing fluid retention and edema, drospirenone has an ability to reduce blood pressure. 

 

Should we be worried about blood clots with drospirenone?

Drospirenone was first introduced to the market in combination with low dose ethinyl estradiol as a contraceptive well suited for women with premenstrual dysphoric disorder (PMDD), moderate acne, polycystic ovarian syndrome and hirsutism. 

While the FDA is concerned about the potential correlation between contraceptives containing drospirenone and blood clots, the overall result of two prospective multicenter phase III studies reported no single case of venous thromboembolism (VTE) in patients who used POP. FDA has funded a study to investigate the correlation, and still is reviewing other clinical trials. In 2011, the FDA reported that “preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.” 

Other studies have shown use of drospirenone-containing COCs was not associated with increased risk of thromboembolic events compared to other COCs containing other progestins. Due to data limitations, the causality is still unclear, and FDA will provide updates once available. 

While there is an increase in the relative risk of this rare adverse event with COCs containing drospirenone, the incidence is still very low and much lower than pregnancy and postpartum periods. ACOG’s Committee on Gynecologic Practice has concluded that the risk of thromboembolism in patients who use drospirenone-containing COCs is very low.  

It is unknown whether Slynd increases the risk of VTEs, however, any potential risk with this POP is expected to be lower than COCs containing drospirenone. 

 

Which patients should not use this pill?

Drospirenone is contraindicated in women with positive or unknown antiphospholipid antibodies, ischemic heart disease, stroke, current or history of breast cancer, hepatocellular adenoma, malignant hepatoma, and severe hepatitis. Clinicians should use this medication with caution in patients who are taking other medications that can predispose them to hyperkalemia, or monitor potassium level.

The drug interaction profile is similar to drospirenone-containing COCs. Although drospirenone is metabolized independently of P450 enzymes, it is a minor substrate of CYP3A4. It is recommended to avoid use in patients taking strong 3A4 inhibitors to prevent hyperkalemia. Strong P450 and P-glycoprotein transporter inhibitors and inducers can affect the serum concentration, efficacy, and adverse effects. 

 

What’s the bottom line for place in therapy?

In conclusion, Slynd can be used in most patients and will be an important option for patients with contraindications to estrogen — including history of high blood pressure or smoking above age 35 — PMDD, as well as patients desiring contraception without androgenic effects, such as those with acne or polycystic ovary syndrome (PCOS).

 

References:

  1. Mishell DR. “YAZ and the Novel Progestin Drospirenone.” The Journal of Reproductive Medicine 2008.
  2. Machado RB, et al. “Drospirenone/Ethinylestradiol: A Review on Efficacy and Noncontraceptive Benefits.” Womens Health 2011;7(1)19–30.
  3. Bachmann G, Kopacz S. “Drospirenone/Ethinyl Estradiol 3 Mg/20 Mug (24/4 Day Regimen): Hormonal Contraceptive Choices – Use of a Fourth-Generation Progestin.” Patient Preference and Adherence, 2009 
  4. Palacios S, et al. “Multicenter, Phase III Trials on the Contraceptive Efficacy, Tolerability and Safety of a New Drospirenone‐Only Pill.” Acta Obstetricia Et Gynecologica Scandinavica 2019.
  5. Center for Drug Evaluation and Research. “Risk of Blood Clots with Birth Control Pills Containing Drospirenone.” FDA Website Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-possible-increased-risk-blood-clots-birth-control.
  6. American College of Obstetricians and Gynecologists. Risk of venous thromboembolism among users of drospirenone-containing oral contraceptive pills. Committee Opinion No. 540. Obstet Gynecol 2012;120:1239–42. Available at: https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Risk-of-Venous-Thromboembolism.
  7. Drugs.com. Exeltis USA, Inc. Announces the Approval of Slynd (drospirenone), the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window. 2019. [online]
  8. Slynd (drospirenone) [prescribing information]. Florham Park, NJ; Exeltis USA, Inc.; May 2019.
  9. Duijkers IJ, Heger-Mahn D, Drouin D, Colli E, Skouby S. Maintenance of ovulation inhibition with a new progestogen-only pill containing drospirenone after scheduled 24-h delays in pill intake. Contraception 2016;93(4):303–309.
  10. CDC. US Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep 2016;65Available at: https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/appendixc_tableC1.html

Lida Binesheian - Slynd Article on Birth Control Pharmacist

About the Author:

Lida Binesheian, PharmD, CACP is a Clinical Pharmacist and Certified Anticoagulation Care Provider based in Austin, Texas.

Interactions Between Emergency Contraception and Other Hormonal Contraceptives

The American Society for Emergency Contraception (ASEC) recently held their annual EC Jamboree in Washington, DC. Participants included health care providers, researchers, reproductive health advocates, and pharmaceutical stakeholders.

One highlight was the key clinical discussions centered on drug interactions between emergency and other hormonal contraceptives, including ulipristal acetate (ella, Afaxys Pharma).

A selective progesterone receptor modulator, ulipristal acetate binds the progesterone receptor, and has both antagonistic and partial agonistic effects. When ulipristal acetate is in the picture, along with another progestin hormone, there will be competition for the progesterone receptors. For this reason, the patient’s use of another progestin-containing hormonal contraceptive either before or after may impact its effectiveness [1]

This theory is based on the pharmacology of the drugs and was supported by a European study. The study looked at the impact of starting a desogestrel progestin-only pill the day after taking ulipristal acetate, compared to starting the same progestin-only pill without ulipristal acetate beforehand. The group that had taken ulipristal acetate showed a slower onset of action of the progestin-only pill in preventing ovulation and thickening the cervical mucus. This particular progestin-only pill is not available in the United States [1]

Following this study, Afaxys revised the ulipristal acetate label in March 2015 to include: “Hormonal contraceptives: Progestin-containing contraceptives may impair the ability of ella to delay ovulation … Avoid co-administration of ella and hormonal contraceptives. If a woman wishes to start or resume hormonal contraception after the intake of ella, she should do so no sooner than 5 days afterwards, and she should use a reliable barrier method until the next menstrual period.“ [2]

Last year, another study found that combined oral contraceptives containing estrogen and progestin hormones are expected to reduce efficacy of ulipristal acetate, as well. In this United States study, researchers evaluated the impact of initiating an ethinyl estradiol/levonorgestrel combined pill 2 days after ulipristal acetate use [3]. More participants experienced ovulation when the combined pill was initiated compared to those who did not initiate any hormones after ulipristal acetate.

Pharmacists and pharmacy staff can refer to a 1-page guide created by ASEC, available on the organization’s website at americansocietyforec.org, for additional information on FDA-approved emergency contraceptives.

References

  1. Brache V, Cochon L, Duijkers IJ, et al. A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception. Hum Reprod. 2015;30(12):2785-2793.
  2. Ulipristal acetate (ella) prescribing information. May 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=052bfe45-c485-49e5-8fc4-51990b2efba4
  3. Edelman AB, Jensen JT, McCrimmon S, Messele-Forbes M, O’Donnell A, Hennebold JD. Combined oral contraceptive interference with the ability of ulipristal acetate to delay ovulation: A prospective cohort study. Contraception 2018;98(6):463-466.

This article was originally published in Pharmacy Times.

5 Pearls from the States Forum on Pharmacist Birth Control Services

States Forum on Pharmacist Birth Control Services

The inaugural States Forum on Pharmacist Birth Control Services was recently held in conjunction with the American Pharmacists Association (APhA) 2019 Annual Meeting in Seattle, Washington. This session was hosted by Birth Control Pharmacist. Most states were represented at the forum with over 60 participants, and there was meaningful discussion on how to make this service not only possible, but also impactful.

Sally Rafie, PharmD kicked off the program with a review of the current landscape. Sharon Landau MPH followed by facilitating brief updates from the states, including those that have implemented pharmacist birth control services, are in progress, and are considering this action. State representatives shared successes, challenges, and lessons learned. Don Downing, BSPharm then led a focused discussion on payment for pharmacist services.

Here are 5 pearls to take away from the States Forum:

1. Even states that tend to be conservative, particularly with women’s health, should consider pursuing policy. 
Legislation to allow pharmacist birth control services is a nonpartisan effort. While some of the early states had Democratic lawmakers sponsoring bills, more than half of those passed and under consideration are sponsored by Republican lawmakers.

2. Avoid certification because this is standard practice for pharmacists. 
Payment for pharmacist services is critical to success. Multiple states cited this as the biggest challenge they are currently facing. Health plans may look for “certification” to credential a pharmacist as a provider or pharmacists assessing a body system to determine the service is eligible for payment. Washington has had success with payment for pharmacist services by recognizing pharmacists as medical providers and using legislation to mandate payment for pharmacist services by all government and private health plans.

3. Provide education for pharmacists and identify pharmacist and physician champions in advance of proposed legislation.
Pharmacists are not the only stakeholders who champion initiatives for pharmacist birth control services in the states; legislation has even moved forward without necessarily engaging the state pharmacist associations or other pharmacists. In some states, pharmacists have more concerns than other stakeholders and may even testify in opposition of proposed legislation. Many of these concerns may be due to knowledge gaps and can be addressed with education opportunities in advance of legislation. Identifying physician champions is important, particularly for testifying in support of any proposed legislation. Check with local teaching hospitals for family planning fellows who will likely be enthusiastic about engaging in this work.

4. We need to promote our birth control services as a profession, as well as individual pharmacists and pharmacies that offer the service.
While pharmacists are getting trained and geared up to provide this service, the public remains largely unaware. Some pharmacies are seeing low patient demand for their birth control services. With over 1100 participating pharmacies on the birthcontrolpharmacies.com map, there is an opportunity to have a greater impact in serving communities.

5. Join us next year for the States Forum. 
Pharmacists valued sharing ideas, experiences, best practices, and strategies. Especially those in states who are considering legislation found the forum to be helpful. States that were farther along in implementing pharmacist birth control services were more than willing to share and help other states.

This article was originally published in Pharmacy Times.

Payment for Pharmacist Services in California

As of April 2019, California’s State Medicaid program, Medi-Cal, is providing payment for selected pharmacist services. This change is due to legislation (California Assembly Bill 1114) that was passed in 2016.

Medi-Cal Medicaid Payment Reimbursement Pharmacist Services

What is covered?

Pharmacist services are benefits for eligible fee-for-service Medi-Cal beneficiaries.

The following pharmacist services are now covered:

  1. Hormonal contraception
  2. Immunizations
  3. Tobacco cessation
  4. Travel health
  5. Naloxone

At this time, Medi-Cal is allowing pharmacists to bill for the following CPT codes:

  1. 99201 – New Patient (~10 minutes)
  2. 99212 – Established Patient (~10 minutes)
  3. 90471 – Immunization administration only

A new patient is one who has not received any pharmacist services at the same pharmacy in the last 3 years. An established patient has received pharmacist services at the same pharmacy within the last 3 years.

The rate of reimbursement for pharmacist services is 85% the physician rate. This is a change for reimbursement of the pharmacist service only. There is no change to the reimbursement for any medications that are furnished (prescribed and dispensed) — those have always been reimbursed at the same rate regardless of what provider type wrote the prescription. 

Pharmacist services must be billed by a Medi-Cal enrolled pharmacy. Since payment will be made to the pharmacy (and not any individual pharmacists), bills must be submitted by the pharmacy and include the rendering provider/pharmacist information.

How do pharmacists get started with billing?

Pharmacists must enroll as an Ordering, Referring, and Prescribing Provider (ORP Provider) with the California Department of Health Care Services (DHCS) in order to bill for these services. 

Before beginning the enrollment process, pharmacists will need:

  • A Type 1-Individual National Provider Identification (NPI) number. It is free to sign up for your NPI number online and only takes a few minutes.
  • A digital copy of their pharmacist (RPH) pocket license from the California Board of Pharmacy.
  • A digital copy of their California Drivers License.

To complete the ORP Provider enrollment process, follow these steps:

  1. Go to the PAVE Portal. If you are a pharmacy owner, you likely already have an account that you use to manage your pharmacy’s Business Profile account. You can invite your staff pharmacists as users for the pharmacy’s Business Profile, so that they may associate themselves with the pharmacy. 
  2. Select New Application.  
  3. Select “I’m new to Medi-Cal and I want to create a new application” and “I’m an individual licensed/certified healthcare practitioner. See screenshot below. PAVE 1
  4. For Business Structure, select “I’m an Ordering/Referring/Prescribing (ORP) provider. See screenshot below. pave-2.png
  5. For NPI number, enter your Type 1-Individual NPI number. This is your personal pharmacist NPI number, not the pharmacy’s NPI number. See screenshot below.pave-3-e1561883852442.png
  6. For Provider type, select Other and type “Pharmacist” in the box. See screenshot below.pave-4.png
  7. For the remaining steps, follow the instructions to complete your application.  TIP: When entering your professional license information, there should be no space between the alpha character and the license number. For example, enter your pharmacist license as RPH12345 without any spaces.

For technical support, call the PAVE Help Desk at (866)252-1949, Monday – Friday, 8:00 am – 6:00 pm Pacific time, excluding state holidays.

When can I start billing?

Visit dates on April 1, 2019 or after can be billed to Medi-Cal. Pharmacists will need to wait for their enrollment as an ORP provider to be approved before they can begin billing — you should expect this to take 3 months and may take up to 6 months.

How do I bill?

All claims must be submitted using CMS Form 1500.

For more information about billing procedures and documentation requirements, see the Medi-Cal Bulletin and follow the link under Item 1 to the provider manual.

 


References

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.

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.

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.