Should We Offer Preconception Services in Community Pharmacies?

Why is preconception care important?

Roughly 4 million pregnancies occur in the United States annually.1 A common misconception is that preconception care is only a health care need when there is an intention to become pregnant. However, because nearly half of all pregnancies in the United States are unplanned, most birth defects occur within the first 3 months of pregnancy, and nearly one-fifth of pregnant women in in the United States receive no prenatal care before the end of their first trimester, preconception care is a serious population health issue deserving of attention.2-4

Why should pharmacists consider being involved?

Although preconception care is recommended to be routinely provided to all women of reproductive potential, gaps exist. With an estimated 90% of Americans living within 5 miles of a community pharmacy, community pharmacists have been proposed as an ideal provider of selected preconception care services to help fill these gaps and support preconception care initiatives.5,6

Where do we even start?

My PGY-1 community pharmacy residency was an incredible year filled with many great experiences that truly helped sculpt my professional practice during my first year as a pharmacist. One of the requirements was to develop and implement a research project; the topic chosen was preconception care. In full disclosure, I did not know much about it when I started the project and quickly found I had more questions than answers. However, I rapidly realized how deserving it is of continued attention.

Our primary objective was to perform a needs assessment using modified evidence-based core indicators:

Preconception Services in the Pharmacy

The above parameters were assessed with the use of a 1-page patient survey, retrospective chart review, and vaccine database review.3,7

Of the 110 patients who were asked to complete the survey, 99 patients took the survey and were included in the study for analysis. More than 75% of the patient population reported being sexually active and only about 50% of participants indicated they used some form of contraception, highlighting a large proportion of the population with the potential to become pregnant, as well as for unplanned pregnancy.

96% of study participants were found to have at least one health concern that could adversely affect a pregnancy if she were to become pregnant. The majority of study participants reported at least one of the following:

  • Abnormal BMI
  • Missing documentation of at least one assessed vaccination
  • No form of daily multivitamin that contained folic acid

Additionally, roughly half of survey participants were on at least one medication with potentially teratogenic effects.

Not only was preconception care need established across the majority of survey participants, but needs were found to span multiple preconception care parameters as well as differing demographics. However, despite the demonstrated need, 78.8% of the survey participants indicated they were not interested in receiving more information on preconception care. Therefore, pharmacists must play an active role in identifying and educating eligible patients.

Are you ready to begin implementing preconception care services within the community pharmacy setting?

If the answer is yes — and I hope it is — what are the next steps?

In identifying these concerns, we hoped that the results could be used in developing new clinical services to support preconception care needs.

Pharmacists already provide non-dispensing services via multiple service models, therefore preconception care services may be built within existing frameworks.6,8,9,10 This support can include:

  • Screening for preconception parameters
  • Optimizing pharmaceutical care plans for adequate disease state management
  • Counseling for prescription and over-the-counter (OTC) products to assist in family planning
  • Prescription contraception via statewide protocol or collaborative practice agreement (depending on state/scope of practice)

As we continue to learn more about the need for and how preconception care fits into community pharmacy practice, I leave you with one final question:

Where might preconception care services fit within your pharmacy workflow and how might you implement these types of services to better the health of the patients you serve?

References

For the original research article, please visit: https://www.ncbi.nlm.nih.gov/pubmed/31010784

  1. Centers for Disease Control and Prevention. Births and natality. Available at: https://www.cdc.gov/nchs/fastats/births.htm; March 31, 2017. 
  2. Centers for Disease Control and Prevention. Preconception health and healthcare. Available at: https://www.cdc.gov/preconception/index.html; February 13, 2017. 
  3. Johnson K, Posner SF, Biermann J, et al. Recommendations to improve preconception health and health caredUnited States. A report of the CDC/ATSDR Preconception Care Work Group and Select Panel on Preconception Care. MMWR Morb Mortal Wkly Rep. 2006;55(RR06):1e23.
  4. Korenbrot CC, Steinberg A, Bender C, Newberry S. Preconception care: a systematic review. Matern Child Health J. 2002;6(2):75e88.
  5. Frederick J. By the numbers: how community pharmacists measure up. Drugstore News;March 13, 2015. Available from:http://www.drugstorenews. com/article/numbers-how-community-pharmacists-measure. 
  6. DiPietro NA, Bright DR. Medication therapy management and preconception care: opportunities for pharmacist intervention. Inov Pharm. 2014;5(1):141.
  7. Frayne DJ, Verbiest SV, Chelmow D, et al. Health system measures to advance preconception wellness: consensus recommendations of the Clinical Workgroup of the National Preconception Health and Health Care initiative. Obstet Gynecol. 2016;127:863e872.
  8. DiPietro Mager NA. Fulfilling an unmet need: roles for clinical pharmacists in preconception care. Pharmacotherapy. 2016;36(2): 141e151.
  9. El-Ibiary SY, Raney EC, Moos MK. The pharmacist’s role in promoting preconception health. J Am Pharm Assoc. 2014;54:e288ee303.

Birth Control Pharmacist HeadshotsAbout the Author

Mollie Reidenbach, PharmD is a clinical care coordinator with SpartanNash, a chain community pharmacy primarily based in Michigan, embedded within a physician group to provide medication therapy support for both their patients and providers.

Teratogenic Medications and Contraception Management

Teratogenic Medications and Contraception

The use of prescription medications by pregnant women has increased over the past 30 years and with the usage comes an increased associated risk of exposing the fetus to the drugs. These medications can cause fetal abnormalities during a pregnancy. Often, for unique reasons, women are not concomitantly prescribed contraception or are not educated regarding the importance of using contraception while taking these high risk medications. Although, the use of teratogenic medications may be necessary for a woman’s health it is important to use birth control while on these drugs to prevent exposure during a pregnancy. 

What are teratogenic medications?

Teratogens are agents that interfere with fetal development when exposed during pregnancy and cause abnormalities. Examples of these teratogens include, but are not limited to alcohol, smoking, and various prescription medications. 

The thalidomide tragedy is an unfortunate example of what teratogenic drugs can do to the development of fetuses. In the late 1950s and early 1960s, thalidomide was widely used for the treatment of nausea in pregnant women soon after, it became apparent that the treatment caused malformations of the arms and legs. Currently, the drug is limited to use for the treatment for various conditions such as skin lesions caused by leprosy and multiple myeloma.

Why is it important to take contraception while on these medications?

Many women take potentially teratogenic medications for health conditions such as hypertension, diabetes, cholesterol, etc. and taking these medications while pregnant increases the risk of fetal malformations and spontaneous abortions. The use of contraception while taking these medications reduces the risk of having pregnancies with abnormalities. 

A study was conducted to evaluate teratogenic medications and associated prescription of contraception in the primary care setting. They found that 25% of the patients that participated in the study were prescribed at least 1 high risk medication from Table 1 and of those patients over half did not have contraceptive management. Ondansetron, often used for nausea in pregnancy, was excluded from the second analysis resulting in 10% of the patients on a high-risk medication and 61.9% of those patients were found to be without any use of contraception management.

The table below summarizes the medications that were used in a study and the teratogenic risks associated with them.

Table 1. Common teratogenic medications and related potential fetal effects

Medication Name Potential Fetal Effects
Atorvastatin, Simvastatin, Pravastatin Congenital abnormalities in infants and skeletal malformations in rats and mice
Topiramate Cleft lip/palate and hypospadias
Valproic Acid Facial dysmorphology, congenital heart defects, spina bifida, cleft lip/palate, development delays
Ondansetron Cardiac malformations
Paroxetine Cardiac malformations and pulmonary hypertension
Lisinopril Spontaneous abortion, oligohydramnios, newborn renal dysfunction

Who is at risk? 

Women who were less than 25 years of age had a low probability of receiving contraception when prescribed a teratogenic medication compared to patients who were of advanced maternal age (over 35 years old). Demographically, among all women who participated in the study, 60% belonged to a minority group compared to the 40% who were not in a minority group which suggests that minorities may be prescribed teratogenic medications more frequently compared to their non-minority counterparts.

Why is this a problem?

The study did not explore why this trend was seen. There are multiple challenges that family physicians face regarding contraception and teratogenic medication management. The first is that physicians may not be able to identify their patients’ family planning intentions, making appropriate counseling challenging. Second, they may experience difficulty finding clinically relevant information on the teratogenic medications. Additionally, while some medications are monitored strictly such as isotretinoin (Accutane), most are not, which makes it difficult for the provider to regularly re-evaluate reproductive plans when patients do not make frequent office visits. Lastly, specialists might prescribe these medications and fail to communicate with the primary care physician leaving the management of contraception up to the patient.

What can pharmacists do? 

It is important to practice interprofessional collaboration which results in safer prescribing practices. Pharmacists are now able to prescribe birth control in some states and can educate patients about contraception use while on teratogenic medications and directly provide contraception if needed and document it.

References

  1. Panchal, BD, Cash, R, Moreno, C, et al. (2019). High-Risk Medication Prescriptions in Primary Care for Women Without Documented Contraception. The Journal of the American Board of Family Medicine 2019;32(4):474–480.
  2. Kim, JH, Scialli, AR. “Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease.” Toxicological Sciences 2011;122(1):1–6.
  3. “Thalidomide: Research Advances in Cancer and More.” Mayo Clinic, Mayo Foundation for Medical Education and Research, 25 May 2019. Available at: https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/thalidomide/art-20046534

About the Author

Sara Shaikh, PharmD Candidate is a pharmacy student at the University of California San Francisco School of Pharmacy in San Francisco, California.

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.

New APhA-ASP Women’s Health Campaign

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.

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.

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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.

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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.