Category: Pharmacy

Finding Gluten-Free Oral Contraceptive Options for Your Patients

Patients with celiac disease or who otherwise follow a gluten-free diet need to be aware of potential sources of gluten, especially in medications such as oral contraceptives. The FDA defines gluten as “proteins that naturally occur in [wheat, barley, and rye or their crossbred hybrids] and that may cause adverse health effects in persons with celiac disease”. Potential sources of gluten can come from excipient ingredients, which are used to bind pills. Starches used in excipients are typically derived from corn, potato, rice or tapioca which don’t contain gluten, but some starches may also be derived from wheat.

Besides the type of starch, the amount of starch in a pill can vary. While the FDA strictly regulates the active ingredients of drug products, drug manufacturers are allowed to use any quantity and type of FDA-approved excipient. Another factor to consider is that generic products only require the active ingredient to be identical to the brand and do not have to use the same excipient or inactive ingredients. So while a brand name medication may be gluten-free, the generic formulation isn’t guaranteed to also be gluten-free.

Determining if a Medication is Gluten-Free

If you’re looking for what ingredients are included in a medication, you can find them listed on the package insert, also known as the prescribing information. If the ingredients listed on the package insert don’t include what source they are derived from, such as ‘starch’ instead of ‘cornstarch’, then you should call the manufacturer to confirm the source.

Examples of both gluten-free and gluten-containing excipient ingredients include:

  • Pregelatinized starch, sodium starch glycolate: derived from corn, potato, rice, or wheat but chemically processed so gluten remaining is unlikely
  • Dextrans, dextrose: derived from corn and potato starch so they do not contain gluten
  • Dextrates, dextrins: derived from any starch source so you would have to call the manufacturer to confirm if gluten is included
  • Starch alcohols (xylitol, maltitol, and mannitol): some are derived from wheat but they are purified to no longer contain gluten

Another issue that can arise is cross-contamination. The FDA has stated that although they don’t collect data in regards to contamination with gluten, “the amount of gluten would be well below the levels we have estimated an inactive ingredient, such as wheat starch, could potentially contribute to an oral drug product”. If wheat happens to be an impurity in a drug listed as gluten-free, the FDA estimates that it could contain no more than 0.5 mg of gluten per pill (for reference, a slice of bread labeled ‘gluten-free’ may contain up to 0.57 mg of gluten and still meet FDA criteria for being considered gluten-free).

Drug Information Resources

DailyMed (https://dailymed.nlm.nih.gov/dailymed/) is a reputable online resource for pharmacists to use as you are able to see the active and inactive ingredients in each geneic formulation of a drug. This may be a complicated resource for patients, so make sure to limit this resource to your own education.

Currently, there are several oral contraceptive options available that are gluten-free. To be 100% certain, it is best to consult either DailyMed or the package insert for the ingredient lists.

Patient Counseling

Ultimately, it is up to the patient to decide if they feel comfortable taking their particular oral contraceptive. If there is any uncertainty about a medication’s gluten-free status, contacting the manufacturer directly is the best way to clarify. Other birth control methods that don’t include gluten are non-oral options such as the Depo-Provera® shot, Nexplanon® implant, vaginal rings, condoms (depending on lubricant used), diaphragms, IUDs, transdermal patches and more.

As pharmacists, it is important to make note of patient allergies on their profiles as well as counsel patients on the inactive ingredients in their medications so that patients can feel more confident and at ease while taking their medications. You can apply your skills when caring for patients by keeping track if generic manufacturers change and informing patients if they are able to continue taking their medications.

References

  1. United States, Congress, Food and Drug Administration. “Gluten in Drug Products and Associated Labeling Recommendations: Draft Guidance for Industry .” Gluten in Drug Products and Associated Labeling Recommendations: Draft Guidance for Industry, 2017, pp. 1–12.
  2. Parrish, Carol. “Medications and Celiac Disease- Tips from a Pharmacist.” Celiac.org, Jan. 2007, celiac.org/main/wp-content/uploads/2009/11/Medications_and_Celiac_Disease.pdf.

About the Author

birth control pharmacist headshots (2)Niamh O’Grady, PharmD Candidate, is a pharmacy student in the Class of 2021 at the University of California San Francisco School of Pharmacy.

Article reviewed by Breanna Failla, PharmD Candidate and Brooke Griffin PharmD, BCACP

Contraception During COVID-19: Pharmacy Best Practices

Pharmacists should not allow postponed or cancelled appointments to keep patients from accessing birth control. It’s important that patients understand how their pharmacy can continue to meet their contraceptive needs during the coronavirus disease 2019 (COVID-19) pandemic.

Pharmacists should inform patients that even though clinics and providers’ offices might be closed, their pharmacy is still able to facilitate refills, provide emergency contraception, and, in some states, prescribe hormonal contraception.

The following tips can help ensure your pharmacy is meeting patients’ contraceptive needs during COVID-19, while keeping your patients and pharmacy staff safe.

1. Encourage Contactless Communications and Dispensing 

Prevent patients from missing doses or going without contraception by preemptively contacting them via texts, emails, and calls to assess their needs. Encourage patients to utilize contactless communication to get in touch with the pharmacy for prescriptions or other items they want to order.

Pharmacies can provide contactless contraceptive care during COVID-19 by encouraging patients to obtain birth control prescriptions and products via mail, drive-through, or curbside pick-up services.1 


2. Promote and Supply Over-the-Counter Products

Visits to the pharmacy may be very limited for patients because of stay-at-home orders, social distancing, and other COVID-19-related barriers. Preemptively supplying prescriptions for emergency contraception can avert out of pocket costs while mitigating stress for patients that experience method failure and are unable to access the pharmacy in a timely manner.2 Encourage patients to have a pregnancy test on hand, in addition to over-the-counter contraceptive options, to ensure that patients’ contraceptive needs are met when routine visits to the pharmacy are not feasible.


3. Optimize Prescriptions and Anticipate Patient Needs

To maintain social distancing and the health of patients and employees, encourage providers to transmit new prescriptions electronically or via telephone.1 

Prescriptions for birth control should include maximum quantities and refills for a full year’s supply.2 Some states require health plans to cover dispensing a 12-month supply of birth control.3 Dispense the maximum amount allowed by the patient’s insurance and share the cash price if a patient desires paying out-of-pocket to limit visits to the pharmacy or clinic.

Pharmacy staff can proactively review patients’ profiles to anticipate upcoming refills and ensure the pharmacy’s birth control inventory is adequate to fulfill patient needs.2 

Check with your state’s COVID-19 pharmacy executive orders to ensure permitted emergency refills are being authorized.


4. Adapt Pharmacist Prescribing

Utilize Telehealth for Birth Control Visits

Patients are turning to telehealth services to access contraception during COVID-19. Transitioning your contraception service to telehealth wherever possible will ensure continuity of care while protecting the health and safety of patients and employees. Pharmacists can utilize telehealth to initiate contraception, assess and switch current methods, and adjust therapy as needed.

Due to COVID-19, some telehealth HIPAA regulations have loosened and health insurance plans are beginning to cover telehealth services.4 

Offer Methods that Don’t Require Blood Pressure Screening

Encourage patients to consider a progestin-only contraceptive if they’re unable to visit the pharmacy for a blood pressure screening.

Progestin-only contraceptive methods do not require a blood pressure screening in order to be safely prescribed, making them a feasible option when prescribing birth control via telehealth. Progestin-only options that can be prescribed by pharmacists and dispensed at the pharmacy include progestin-only pills (containing norethindrone or drospirenone) and depot medroxyprogesterone acetate injections (subcutaneous or intramuscular formulations).

Blood pressure measurement is required prior to initiating combined hormonal contraceptives—containing both estrogen and progestin hormones—due to the increased risk of stroke and myocardial infarction in patients with hypertension or without blood pressure measurements.

This article was co-written by Whitney Russell, a student pharmacist at University of Kentucky College of Pharmacy, and Kailey Hifumi, a student pharmacist at the Pacific University School of Pharmacy.

This article was originally published in Pharmacy Times.

Click image to view and download our COVID guide.

Find out more about providing contraceptive care during COVID-19 on our COVID resource page

References

  1. CDC. Guidance for pharmacies during COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html; Published April 14, 2020. Accessed May 15, 2020.
  2. Family Planning National Training Center. What family planning providers can do to meet client needs during COVID-19. https://www.fpntc.org/resources/what-family-planning-providers-can-do-meet-client-needs-during-covid-19. Accessed May 15, 2020.
  3. Kaiser Family Foundation. Oral contraceptive pills. Available at: https://www.kff.org/womens-health-policy/fact-sheet/oral-contraceptive-pills/. Published May 23, 2019. Accessed May 15, 2020.
  4. Beyond the Pill. Contraceptive care during COVID-19. https://beyondthepill.ucsf.edu/contraceptive-care-during-covid-19. Accessed May 15, 2020.

Contraception During COVID: California’s Medi-Cal and FamilyPACT Programs Cover Depo-SubQ Provera

We recently wrote about the importance of offering patients subcutaneous depot medroxyprogesterone acetate (DMPA-SQ) as a contactless form of contraception during the COVID-19 public health emergency. California pharmacists can prescribe DMPA-SQ under statewide protocol upon completing the required training program and obtain payment for the visit for Medi-Cal patients.

As of April 9, 2020, California’s Medi-Cal, FamilyPACT, and managed Medi-Cal health plans are covering DMPA-SQ under pharmacy benefits.

To facilitate compliance with state and federal guidelines for sheltering in place and physical distancing, DHCS will temporarily allow for pharmacy dispensing of DMPA-SQ directly to patients for self-administration at home. This is in addition to current Medi-Cal policy that allows administration by a health care professional. Self-administration of DMPA-SQ would be at the option of the Medi-Cal recipient after individualized discussions and decision-making between the prescriber and the recipient. The prescribing provider is responsible for ensuring proper training of the recipient in administering the drug, potential side effects, and proper disposal of the pre-filled syringe.

The FamilyPACT system updates to allow for claim reimbursement of DMPA-SQ will not be implemented until May 15, 2020 for pharmacy dispensing, with a retro-effective date on or after April 9, 2020.  Pharmacies may re-process their denied claims after the implementation date and it should process successfully at that time. FamilyPACT always recommend that pharmacies validate eligibility, process the claim, get the denial, dispense the medication, and reprocess the claim after May 15 for payment. The reprocessed claim will show payment for the actual date of service as long as it is not before April 9.

Additionally, a reminder that a Medi-Cal beneficiary should not be required to pay for a covered medication until all avenues of successful processing have been explored and the department denies the service (for example the provider tries obtaining a TAR) and only if the patient requests to purchase the medication out of pocket. 

The full policy document is published on the COVID-19 webpage at: Direct-to-Patient Dispensing of Subcutaneous Depot Medroxyprogesterone Acetate – COVID-19 Emergency. This temporary policy change is effective immediately and remains in effect until further notice.

Clinical Considerations for Contraception During COVID: Patient Self-Administration

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During the COVID-19 pandemic and beyond, patients may desire a contactless method of contraception. The subcutaneous (SQ) formulation of depot medroxyprogesterone acetate (DMPA), Depo-SubQ Provera, is an important option to offer patients. This may be of particular interest among patients who currently come in to the pharmacy or go to a clinic for their intramuscular (IM) injection.

Formulation Differences

While patients are able to self-administer both subcutaneous and intramuscular injections for a variety of purposes (e.g., insulin, fertility medications), patients may prefer the SQ formulation of DMPA since it is associated with less pain and higher continuation rates than the IM formulation.

Differences between the two formulations are summarized in the table below.

Intramuscular (IM)Subcutaneous (SQ)
Dose150 mg104 mg
Duration13 weeks
(up to 15 weeks)		12-14 weeks
Generic AvailabilityYesNo
Cost at Pharmacy$70-100>$200

Another important consideration is insurance coverage of these products. Some health plans cover the IM formulation as a medical benefit but have not yet included it as a pharmacy benefit. Some health plans are now covering the SQ formulation as a pharmacy benefit due to COVID-19, while others cover it as a pharmacy benefit but require a prior authorization.

How to Initiate or Switch

There is no physical assessment or blood pressure measurement required for eligibility of DMPA.

If your patient is not currently using a method of hormonal contraception, they can begin using either the IM or SQ at any time during the menstrual cycle if it is reasonably certain that patient is not pregnant. A backup method of contraception should be used for 7 days.

If your patient is currently using IM DMPA, the SQ DMPA can be administered when she is due for her next injection. No backup contraception is needed.

If your patient is currently using any other hormonal contraception (i.e., progestin only-pill, hormonal IUD, combination hormonal pill, patch or ring) or a copper IUD, the DMPA should be administered 7 days before stopping the other method. No backup contraception is needed.

References

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.