Category: pharmacy

Meet Slynd: A Novel Progestin-Only Pill

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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.

New APhA-ASP Women’s Health Campaign

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In 2018, APhA-ASP launched its new Women’s Health Campaign to address the health educational needs of women across the country. One area of focus for ASP chapters is to “provide education on the pharmacist role in reproductive health, including hormonal contraceptive options and access to hormonal contraceptives.”

This year at the University of Michigan – College of Pharmacy, our APhA-ASP chapter is working to promote women’s health at our college and within the university.  Since women’s health pharmacy is a niche area within the profession, we wanted to provide a career development event for pharmacy students to be exposed to “The Pharmacist Role in Rxeproductive Health”.

On Monday, November 11th, our chapter hosted its first “Rxeproductive Health”  event focusing on pharmacist involvement in a variety of fields within reproductive health. We invited Dr. Lauren Leader, PharmD, BCPS of Michigan Medicine and Dr. Brooke Griffin, PharmD, BCACP of Midwestern University and Birth Control Pharmacist to educate our students on topics of peripartum health, pharmacist prescribing of hormonal contraception, and policy to expand the pharmacist profession in women’s health. The event began with phast phacts (“fast facts”) on women’s health and where in the United States pharmacists have prescribing authority for hormonal contraceptives, followed by a question and answer between our panelists and audience. The program ended with a collaborative reflection with our guest speakers on a policy brainstorming session, asking ourselves: “What role or roles do we want to see pharmacists to have in women’s health and reproductive health?” Despite an all-day snow storm in Michigan that day, we had a lot of students attend and participate, making for a memorable and meaningful event.

As I reflect on my first three years of pharmacy school and as my interests in women’s health continues to grow, I have started to notice the lack of women’s health events outside of the lecture room. APhA-ASP launching their campaign last year has given our organization the opportunity to advocate for women’s health to the community and to our college of pharmacy. “The Pharmacist Role in Rxeproductive Health” was our first focused women’s health event for ASP, providing our students with the knowledge and networking to advocate for this population in health care. Given the success of our first event, I am excited to see where our ASP chapter will go from here.

For more information about the APhA-ASP Women’s Health campaign, visit: https://www.pharmacist.com/apha-asp-womens-health-campaign 

Rxeproductive Health Event.PNG

Photo 1 from L to R: Dr. Lauren Leader and Dr. Brooke Griffin

Photo 2 from L to R: Tina Bednarz (APhA Policy Vice President), Dr. Brooke Griffin, Dr. Lauren Leader, Andy Van Waardhuizen (SNPhA Women’s Health Committee Chair), Lana Alhashimi (APhA Policy Liaison), Jacqueline Muscat (APhA Women’s Health Liaison)

 

About the Author:

Tina Bednarz, PharmD Candidate is a third-year pharmacy student at the University of Michigan – College of Pharmacy where she is the Policy Vice President of the chapter’s APhA-ASP organization.

5 Pearls from the States Forum on Pharmacist Birth Control Services

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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.

5 Things Pharmacists Need to Know About Preconception Health

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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

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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

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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?

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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.