Reproductive Health During COVID: Eliminating FDA’s Burdensome Barriers to Mifepristone

What is Mifepristone? 

Mifepristone is the primary component in the FDA-approved regimen taken to terminate pregnancies through 10 weeks gestation and is seen as an alternative to a surgical procedure.1 Many patients view this as less invasive, allowing for more privacy and control over a personal situation. The standard oral regimen includes mifepristone 200mg followed by misoprostol 800mcg 24-48 hours later. There are alternative doses available depending on medication availability and gestational window.2 mifepristone and misoprostol work in tandem to halt the pregnancy from developing and induce cramping to evacuate the contents of the uterus. Following the administration of these medications, women typically report back to their healthcare provider one to two weeks later to ensure the medications were fully effective and that the pregnancy has been terminated. Women can expect heavy bleeding and strong abdominal cramps that are most severe during the first few hours post-treatment but typically subside over the next day or two.1,3

Current Practice of Mifepristone Prescribing

The protocol for women pursuing medication abortion counseling and treatment often begins in a doctor’s office. Patients undergo a series of health screenings including laboratory testing, an ultrasound assessment to determine gestational age, and contraindication evaluations.2,4 

Additionally, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) prior to prescribing mifepristone, stating this is necessary to ensure safe use of the medication by patients.1,4 REMS programs are typically employed when prescribing medications with major safety concerns or the potential for serious adverse effects. Beyond this program, there are numerous stipulations to prescribing and dispensing mifepristone. Patient agreement forms, healthcare provider supervision and policies that restrict dispensing this medication anywhere outside of clinics, medical offices, and hospitals, make mifepristone unnecessarily difficult for patients to obtain.

How Has the Pandemic Impacted this Process? 

Cue the COVID-19 pandemic and reproductive health becomes infinitely harder. Once the country began shutting down in March, schools, businesses, and many other public entities were at a standstill as nonessential services. While many healthcare facilities were faced with overwhelming numbers of potential patients with coronavirus, other health related surgeries and appointments were postponed to mitigate infection risk in the general population. Access to abortion is time-sensitive, so when it is unavailable it leaves many women without fundamental choices for their family planning and reproductive outcomes. 

Reproductive care, including abortion, has been regarded as nonessential in many states across the United States, barring women from access to vital medical services. Governors in Texas, Louisiana, Mississippi, Alabama, and Oklahoma have made efforts towards ending both medical and surgical abortions.5 These states, among others, have aimed to restrict access to reproductive health processes by deeming them elective rather than essential procedures. As of April 8th 2020, Temporary Restraining Orders (TROs) have impeded certain state bans on abortions while litigation remains ongoing in Ohio, Alabama, and Oklahoma.5 While certain states continue to debate reproductive health legislation, congressional lawmakers contested the FDA on behalf of their constituents earlier this month. On June 16th 2020, the FDA received a letter on behalf of over 100 members of congress urging them to ease restrictions surrounding reproductive care during the pandemic.

ACOG’s Efforts to Ease Reproductive Care Restrictions 

In response to certain states’ stringent limitations and the overdue revisions to modern reproductive care, the American College of Obstetricians and Gynecologists (ACOG) filed a lawsuit petitioning the FDA to remove restrictive barriers to obtaining mifepristone during the COVID pandemic. The civil rights action was officially filed May 27th, 2020 to challenge the FDA to alter the multitude of requirements to prescribing mifepristone as nationwide efforts shift towards telemedicine.7,8 Both the CDC and the FDA have encouraged the use of telehealth to allow flexibility for doctors to safely meet with their patients while foregoing unnecessary in-person appointments. Thus far, women seeking mifepristone to end an early pregnancy or manage a miscarriage have been an exception to the highly enforced transition to telemedicine.7 Likewise, women are still required to travel to their doctor’s medical office or hospital to pick up the medication rather than a contactless option like mail order. ACOG pointed out the incongruence of the FDA’s standards which require patients to be seen in person to obtain mifepristone, yet allows them to take it in their homes without medical supervision. To emphasize their point, ACOG continues by noting that out of more than 20,000 drugs regulated by the FDA, mifepristone is the only medication that has such specifications, while allowing patients to self-administer in a location of their choosing.7 

When utilized for reasons other than abortion or miscarriage, the FDA allows mailing mifepristone to patients’ homes without the barriers imposed upon women pursuing reproductive care.7 This caveat exclusively hinders women in need of reproductive care from easily obtaining the required medications without bearing the unnecessary risk of COVID-19 infection from visiting a medical clinic. Many women who refuse this option are left with less effective options which may necessitate consequential procedures, thereby increasing exposure risk for patients and healthcare workers; the very circumstance all facets of medicine are trying to avoid.7

Recent Updates to Gaining Mifepristone Access

After deliberation in federal court, ACOG accomplished what they sought out to do when issuing their lawsuit to the FDA. On July 13th 2020,  a federal district court ruled in favor of a temporary suspension of the restrictions imposed upon obtaining mifepristone.9 The ruling sided with the notion that the barriers around  mifepristone subjected countless women to the unnecessary health risks of public exposure during the COVID-19 pandemic. While the preliminary qualifications and REMS testing still applies, the court’s order allows clinicians to mail mifepristone to eligible patients seeking abortion care under the U.S. Department of Health and Human Services’ COVID-19 Public Health Emergency. Although this has the potential to vastly expand access to mifepristone, ACOG continues to encourage clinicians to practice within their state’s laws which take precedence over this ruling.10 In response to the lifted restrictions, the president of ACOG, Eva Chalas, M.D., FACOG, FACS, hailed this decision as a “necessary step forward in our collective work toward health equity”.9  

How Pharmacists Can Play a Role

As the nation strives to adapt to telemedicine, pharmacists are becoming the sole in-person healthcare provider for many Americans. Pharmacists are often conveniently positioned in stores housing groceries or necessary supplies that people continued visiting during the pandemic. As one of few essential businesses that never closed, pharmacy dispensing of mifepristone would enable women to have more timely access to mifepristone and avoid the added risks of visiting additional clinic locations. In light of telemedicine, health disparities would be reduced for patients that have difficulty accessing medical abortions in their communities. Pharmacists may be able to help fill this gap and ensure safe use of mifepristone by counseling patients on how to take it and by answering questions that may arise.4 This shift in responsibility would continue to prioritize patient safety while employing trained healthcare professionals to aid in convenience, education and accessibility to a time-sensitive medication. 

References

  1. Center for Drug Evaluation and Research. (n.d.). Mifeprex (mifepristone) Information. Retrieved June 24, 2020, (link)
  2. (n.d.). Retrieved June 27, 2020, from (link)
  3. Center for Drug Evaluation and Research. (n.d.). Questions and Answers on Mifeprex. Retrieved June 24, 2020, (link)
  4. Raifman, S., Orlando, M., Rafie, S., & Grossman, D. (2018). Medication abortion: Potential for improved patient access through pharmacies. Journal of the American Pharmacists Association, 58(4), 377-381. doi:10.1016/j.japh.2018.04.011
  5. Bayefsky, M. J., Bartz, D., & Watson, K. L. (2020). Abortion during the Covid-19 Pandemic — Ensuring Access to an Essential Health Service. New England Journal of Medicine, 382(19). doi:10.1056/nejmp2008006
  6. Congress of the United States – degette.house.gov. (2020, June 16). Retrieved June 24, 2020, from (link)
  7. ACOG V. FDA Complaint Mifepristone COVID-19, retrieved June 24, 2020 (link).
  8. ACOG Suit Petitions Court to Remove FDA’s Burdensome Barriers to Reproductive Care During COVID-19. (2020, May 27). Retrieved June 24, 2020 (link)
  9. Federal Court Blocks FDA Restriction That Unnecessarily Imposes COVID-19 Risks on Patients Seeking Abortion Care. 27 May 2020, (link)
  10. “Court’s Order Lifting Burdensome FDA Restriction: What You Need to Know.” ACOG, 15 July 2020, http://www.acog.org/news/news-articles/2020/07/courts-order-lifting-burdensome-fda-restriction-what-you-need-to-know.

About the Author

Savannah Gross, PharmD Candidate, is a third-year pharmacy student at University of Georgia College of Pharmacy

Article Reviewed by: Sally Rafie, PharmD, BCPS, APH, NCMP, FCCP

Effectiveness of Hormonal Contraceptives in Patients with Higher Weights

Introduction

Obesity is becoming more prevalent every year and as pharmacists, it is important to revisit current contraceptive options for these patients. Overweight patients are defined as having a BMI ranging from >25-29.9 kg/m2 and obese patients a BMI >30 kg/m2. Currently there are no safety contraindications in patients with a BMI > 25 kg/m2 alone when initiating oral contraceptives according to the current CDC guidelines; however, efficacy with these agents raises a valid question. We will address efficacy of both hormonal contraceptives as well as other modes of contraception.

Currently, there are several theories on how obesity can affect the efficacy of contraceptives. One theory is that the absorption of contraceptives may be increased due to the higher cardiac output that leads to increased blood flow, thus causing a faster gastric emptying of the drug meaning that the drug has less opportunity to be absorbed. Another thought is that higher levels of lipoprotein found in obese people may compete with drugs for binding sites on albumin, causing there to be more unbound drug. Furthermore, some studies revealed that there may be an association between obesity and a lower concentration of sex hormone-binding globulin. Hepatic metabolism and excretion of drugs may also be affected by obesity. While there isn’t one clear indication that may cause these discrepancies, there have been many studies conducted to test effectiveness in various types of contraceptives.

Importantly, there is a specific term used throughout research studies to determine efficacy of different contraceptive methods called Pearl Index (PI). PI is a numerical value used to indicate the number of pregnancies that occur for every 100 women per years of use. Additionally, some trials looked at the minimum serum concentrations of hormones that were necessary to suppress ovulation thus preventing pregnancy (levonorgestrel 0.3 ng/mL).

Combined Hormonal Contraceptives (CHCs)

One study compared a CHC that contained 30 mcg of ethinyl estradiol (EE) and 150 mcg of levonorgestrel (LNG) in normal-weight versus obese women. Obese women were found to have a lower AUC and Cmax of both EE and LNG, but clinically speaking, LNG levels were above 0.3 ng/mL in each population which is clinically significant enough to suppress ovulation and prevent pregnancy.

Another study evaluated the efficacy of an extended-cycle CHC that contained 20 mcg of EE and 100 mcg of LNG for 84 days, followed by 10 mcg EE for 7 days. The study concluded that pregnancy rates were similar across weight and BMI and did not report any significant discrepancies amongst weight classes.

Vaginal Rings

For the vaginal ring containing 11.7 mg of etonogestrel and 2.7 mg of ethinyl estradiol (NuvaRing®), there was a study that evaluated normal-weight versus obese women. Like the combined oral contraceptive pill, the ring did cause lower serum concentrations of hormones in obese women, but clinically there were no differences in ovarian follicle development. This suggests that efficacy is not compromised in obese women.

DMPA Injection

In a study that looked at the efficacy of the depot medroxyprogesterone acetate (DMPA) injection in women stratified by BMI, the serum concentrations were significantly lower in obese individuals compared to normal weight women. Surprisingly, these serum concentrations were sufficient to suppress ovulation and efficacy was not compromised.

Intrauterine Device (IUD)

In a large trial conducted on levonorgestrel-containing IUDs (two strengths, 8 mcg/24h or 13 mcg/24h), PIs revealed IUDs were effective at preventing pregnancy regardless of the patient BMI.

Exception: The Patch (Ortho Evra)

It is significant to note that obese women have lower efficacy with the hormonal contraceptive patch compared to other methods. Ortho Evra or Xulane (containing 6 mg norelgestromin, 0.75 mg ethinyl estradiol per patch) package insert states that from results of clinical trials, this patch may be less effective in women weighing greater than 90 kg. In trials conducted, it was reported that out of 15 pregnancies reported during the study, 5 of them were from a patient weighing more than 90 kg. The package insert also noted that women with a body weight >90 kg accounted for less than 3% of the study population, so it may be beneficial to conduct additional trials to determine efficacy of the patch for overweight patients.

In Conclusion

While elevated BMI alone is not a contraindication when initiating some contraceptives, it is important to recognize that overweight women are at a higher risk of comorbidities such as diabetes, hypertension, and thromboembolism which may be contraindications. If an individual only has an elevated BMI, CHCs, vaginal rings, or the DMPA injection may be appropriate to use given no clinically significant differences in their efficacy. It is important to advise overweight patients against using the hormonal patch due to the higher risk of unplanned pregnancies. Lastly, it is important to counsel patients that no contraceptive option is going to be 100% effective regardless of weight.

References:

  1. Kerns J, Darney P. Vaginal ring contraception. Contraception. 2011;83(2):107–115
  2. Roumen FJ. The contraceptive vaginal ring compared to the combined oral contraceptive pill: a comprehensive review of randomized controlled trials. Contraception. 2007;75(6):420–429.
  3. Segall-Gutierrez P, Taylor D, Liu X, Stanzcyk F, Azen S, Mishell DR., Jr Follicular development and ovulation in extremely obese women receiving depo-medroxyprogesterone acetate subcutaneously. Contraception. 2010;81:487–495
  4. Westhoff CL, Hait HI, Reape KZ. Body weight does not impact pregnancy rates during use of a low-dose extended-regimen 91-day oral contraceptive. Contraception. 2012;85(3):235-239. doi:10.1016/j.contraception.2011.08.001
  5. Westhoff CL, Torgal AH, Mayeda ER, Pike MC, Stanczyk FZ. Pharmacokinetics of a combined oral contraceptive in obese and normal-weight women. Contraception. 2010;81:474–480
  6. Gemzell-Danielsson K, Apter D, Hauck B, et al. The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial. PLoS One. 2015;10(9):e0135309. Published 2015 Sep 17. doi:10.1371/journal.pone.0135309
  7. Janssen. Ortho Evra (norelgestromin/ethinyl estradiol) [package insert]. U.S Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf. Revised August 2012. Accessed July 3, 2020.
  8. Simmons KB, Edelman AB. Hormonal contraception and obesity. Fertil Steril. 2016;106(6):1282-1288. doi:10.1016/j.fertnstert.2016.07.1094

About the Author

Samantha Kim, PharmD is a recent graduate of University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.

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

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

5 Things Pharmacists Need to Know About Preconception Health

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

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
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  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.