Twirla: A New Contraceptive Patch

What is Twirla?

Twirla is a new contraceptive patch designed for patients who want freedom from the daily pill without committing to a longer acting method. This transdermal patch delivers 120mcg of levonorgestrel and 30mcg of ethinyl estradiol through Agile’s Skinfusion® patch, which consists of five layers and serve as the reservoir for the active and inactive ingredients, as well as a barrier to prevent accumulation of debris from daily wear. Twirla is designed to be applied once weekly for three weeks, followed by one patch free week for menstruation.

Currently there is only one hormonal contraceptive patch available for consumer use called Xulane (norelgestromin 150mcg/ethinyl estradiol 35mcg). Women who use this patch have higher blood serum concentrations of estrogen compared to oral methods (AUC0-∞ 37.7±5.6 vs. 22.7±2.8), which is associated with health concerns such as increased risk of blood clots in the legs and lungs. Agile Therapeutics, the women’s healthcare company behind Twirla, saw an unmet need in the market for a low-dose hormonal contraceptive patch. This market gap lead to the development of their newly formulated contraceptive patch, Twirla.

 

What are the pros and cons of Twirla?

This patch provides another option for women who desire an alternative from a daily pill, without the constraints of a longer acting method. Twirla is applied once weekly, meaning women only have to remember their birth control about three times a month rather than every day. With various daily activities and responsibilities, a weekly patch liberates women from one of those daily routines. There are other birth control options such as the Depo-Provera injection, IUDs, or implants that serve as alternatives to the pill but some women perceive these methods as more invasive compared to the patch. Additionally, given the lower dose of estrogen, Twirla appears to have a lower risk of blood clots as shown in comparator studies but remains equally effective in regulating menstrual cycles and preventing pregnancies as compared to the existing patch option.

Although the convenience of a patch is desirable, there are several noteworthy considerations with this product. As previously mentioned, Twirla’s formulation lowers the risk of blood clots, but there remains a risk of blood clots with hormonal patches compared to oral methods.  Additional side effects reported with Twirla include unscheduled vaginal bleeding, weight gain, headache, and abdominal cramps.  Women have also reported skin irritation when applying and removing the patch. Regarding size, Twirla is round and slightly larger (28cm2) than the Xulane (14 cm²) patch. Additionally, both Twirla and Xulane are currently only produced in one neutral shade of beige. For many women, this prevents the possibility of a discrete form of birth control which may make this a less desirable option.

 

Are there different considerations with a patch compared to other contraceptive methods?

Given the hormones in Twirla, the patch works just like the pill in terms of preventing pregnancy by delaying ovulation.  It can be applied on the upper arm, buttocks, back, or lower abdomen. The patch is designed to withstand activities such as exercising, swimming, showering, etc. If the patch does happen to fall off during the week, it can be reapplied or a new patch may be used in its place. If the patch has been off more than 24 hours, a back up method such as condoms should be used for the next seven days of the new patch cycle. Although it’s rare (<2% of the time), healthcare providers recommend daily checks to ensure the patch has not accidentally fallen off. Patches should not be worn longer than the week they are intended and consequences of doing so include bleeding, spotting, and increased risk for unintended pregnancy. If a patient is more than 48 hours late transitioning from the existing patch to a new patch, then a back up should be used for seven days. Like all other birth control methods, Twirla does not protect against sexually transmitted diseases or HIV.

 

Is Twirla a good option for everyone?

There is no one-size fits all method that is right for all women. Some women might be at greater risk for adverse effects with the patch. Agile reported reduced efficacy in preventing pregnancy for women who weigh 202 pounds (92kg) or more, or who have a BMI of 30 kg/m2 or greater. As a result, the drug company initially issued a Limitation of Usestatement in their product labeling that documented this clinical outcome.  Since gaining FDA approval, this limitation has transitioned to a listed contraindication. Xulane’s package insert lists the same contraindication, yet is regularly prescribed in women with a BMI >30 kg/m2. Studies have shown that the decrease in efficacy does not preclude the use of these patches in obese women. To combat the associated risks, additional counseling to emphasize the importance of strict compliance with the patch for optimal protection is necessary. Studies have also shown an increased risk in blood clots in women who are overweight and those who smoke. Additional contraindications for using Twirla include women with a high risk of thrombotic disease, who experience migraine with aura, who have liver disease, or who have undiagnosed abnormal uterine bleeding.

 

Is Twirla available now?

Twirla was approved by the FDA earlier this month on February 14, 2020. As part of the approval process, the FDA is requiring Agile to conduct a long term, observational post-marketing study to further evaluate the risks of blood clots in new users of Twirla. With its recent approval, the manufacturer is now focusing their attention on commercializing Twirla for consumer use. They hope to complete the manufacturing process and expect to ship the initial product to wholesalers as early as the end of this year.

With patient needs and safety in mind, the approval of this medication further expands the range of contraceptive options available for women. Given that there have only been three non-daily combined hormonal contraceptive methods made available since 2001, this is a valuable and timely option for women who seek alternative methods.

References

  1. FDA Approves Agile Therapeutics, Inc.’s Twirla® (levonorgestrel and ethinyl estradiol) Transdermal System – A New Weekly Contraceptive Patch Delivering a 30 mcg Daily Dose of Estrogen and 120 mcg Daily Dose of Progestin. (2020, February 14). Retrieved February 23, 2020, from https://ir.agiletherapeutics.com/news-releases/news-release-details/fda-approves-agile-therapeutics-incs-twirlar-levonorgestrel-and
  2. Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System – Full Text View. (2017, September 25). Retrieved from https://clinicaltrials.gov/ct2/show/NCT02158572?term=AG200-15&draw=2&rank=1
  3. Therapeutics, A. (n.d.). Results From the SECURE Trial, a Phase 3 Study of the… : Obstetrics & Gynecology. Retrieved from https://journals.lww.com/greenjournal/Abstract/2017/05001/Results_From_the_SECURE_Trial,_a_Phase_3_Study_of.46.aspx
  4. Hatcher, R. A. et. al (2018). Contraceptive technology. New York, NY: Ayer Company Publishers, Inc.
  5. Van den Heuvel et. al, M. W. (2005). Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception72(3). Retrieved from https://www-sciencedirect-com.proxy-remote.galib.uga.edu/science/article/pii/S0010782405000971 

About the AuthorBirth Control Pharmacist Headshots

Savannah Gross is a third-year pharmacy student at the University of Georgia College of Pharmacy. 

Article reviewed by Rebecca Stone, PharmD, BCPS, BCACP

Endometriosis Basics and How Contraception Can Help

What is endometriosis?

Endometriosis is characterized as a condition in which endometrial tissue, which normally lines the uterus, develops outside of the uterine cavity in abnormal locations such as the ovaries, fallopian tubes and abdominal cavity.1 Endometriosis is a common cause of chronic pelvic pain in women and can sometimes be associated with infertility.2 It is estimated that 1 in 10 women suffer from endometriosis (with percentages even higher in women with chronic pelvic pain and infertility).  On average, it takes anywhere from 3 to 11 years from the onset of pain symptoms for women to be accurately diagnosed with endometriosis.3

As pharmacists, it is important to establish our role in patient care and to be aware of this underdiagnosed condition and the role of hormonal contraception in managing symptoms and the disease. We can assist patients with endometriosis by having confidence in the medication they were prescribed and keeping in mind the individual treatment goals in each patient. While there is no definitive cure for endometriosis, there are pharmacological approaches in the management of the associated pain. While there are many different options available for women with endometriosis, this article will be focusing on the use of hormonal contraceptives in endometriosis pain management. Additionally, it is important to keep in mind that no hormones are free of side effects and severity and tolerability can vary significantly; not all types of endometrial pain respond equally to hormonal treatment.4

 

What is the role of hormonal contraceptives in endometriosis treatment?  

Combined hormonal contraceptives (CHCs) and progesterone only pills (POPs) have been used for pain management associated with endometriosis. Hormonal contraceptives help to slow the growth of new endometrial tissue and may prevent formation of new adhesions which can help decrease the pain patients have. However, hormonal contraceptives will not eradicate any endometrial tissue that currently exists in the patient.5

There are a few differences in tolerability and the level of evidence for each treatment. For assessing the different types of contraceptive treatment for endometriosis, the European Society of Human Reproduction and Embryology (ESHRE) has created a grading scale as part of their justification for treatment:

Grading Scale

Grade A: treatment has been backed by meta-analysis, systemic review or multiple RCTs (high quality). 

Grade B: treatment has been backed by a meta-analysis, systemic review or multiple RCTs (moderate quality), single RCT, large non-randomized trial, case-control or cohort studies (high quality). 

Grade C: treatment has been backed by a single RCT, large non-randomized trial, case-control or cohort studies (moderate quality).4

CHCs may considered as it can reduce endometriosis-associated dyspareunia, dysmenorrhea and non-menstrual pain.4 Oral CHCs are considered “Grade B”.4 It is important to note that endometriosis is considered to be a predominantly estrogen-dependent disease. It is possible that the estrogen component of CHCs may mask the effect of the progestin by possibly activating the disease. However, it has been argued that ethinylestradiol doses are too low to reach an activating threshold.4 According to the American College of Obstetricians and Gynecologists (ACOG) guidelines, CHCs showed significant decrease in pain in patients and if that therapy is not tolerated patient could move on to progestins. Unlike the ESHRE, they did not differentiate between types of contraceptives and their related effectiveness.5 

Among the CHCs, it is important to recognize that different dosage forms have different grades of evidence of efficacy in the ESHRE guidelines. Continuous CHCs (active tablets only) were given a “Grade C”.  Vaginal contraceptive rings and transdermal patches were also given a “C”.4

Progestin-only pills are considered “Grade A” by the ESHRE guidelines because they have the most evidence to date in reducing endometriosis-related pain. Additionally, while Levonorgestrel-containing IUDs are not FDA approved as treatment for endometriosis, they are given a “Grade B” as an option to reduce pain related to the disease.4 Additionally, the ACOG guidelines recognize the use of levonogersterol-containing IUDs to reduce endometriosis related pelvic pain, but emphasized that potential side effects like irregular bleeding and weight gain are common.5  

Another type of progestin contraceptive that can be used for endometriosis-associated pain is Depot medroxyprogesterone (DMPA). DMPA works to prevent follicular growth preventing ovulation.6 ACOG recognizes DMPA as a suitable treatment as it has been approved by the FDA for treatment of endometriosis-associated pain.5 Furthermore, ESHRE gave DMPA a “Grade A” as an option to reduce endometriosis-related pain.4

As pharmacists, we serve a vital role in the patient care plan and can be there to help patients recognize the types of treatment options available to them. As a patient, it may be hard navigating through the different contraceptive options that they have for endometriosis pain management. Pharmacists can help patients navigate these options in order to help improve their quality of life.

References

    1. Noncontraceptive benefits of birth control pills: fact sheet. ASRM (American Society for Reproductive Medicine). Available from: https://www.reproductivefacts.org/globalassets/rf/news-and-publications/bookletsfact-sheets/english-fact-sheets-and-info-booklets/noncontraceptive_benefits_of_bcp_factsheet.pdf. Accessed January 16, 2020
    2. Leyland N, Casper R, Laberge P, Singh SS, SOGC. Endometriosis: diagnosis and management. J Obstet Gynaecol Can 2010;7 (Suppl 2):S1–32.
    3. Husby GK, Haugen RS, Moen MH. Diagnostic delay in women with pain and endometriosis. Acta Obstet Gynecol Scand. 2003;82(7):649–53. 
    4. Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D’Hooghe T, De Bie B, et, al. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014;29(3):400-12.
    5. Committee on Gynecologic Practice. ACOG Practice Bulletin No. 114: Management of endometriosis. Obstet Gynecol. 2010;116(1):223–36.
    6. Depo-Provera CI (medroxyprogesterone acetate) [package insert]. U.S Food and Drug Administration website. Revised October 2010. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020246s036lbl.pdf. Accessed February 10, 2020

About the Author

Breanna HeadshotBreanna Failla, PharmD Candidate is in her second year of pharmacy school at Midwestern University Chicago College of Pharmacy. She serves as APhA-ASP Chapter President and Midyear Regional Meeting Coordinator for Region 4. 

Article reviewed by Brooke Griffin, PharmD, BCACP

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.

Pharmacists Provide Contraception for Zika Preparedness

A recent CDC report highlighted that Zika infections are of increasing concern, particularly in the summer travel months. To allow women and families to plan childbearing in the face of this threat, access to contraception is critical.

ZIka Contraception Pharmacists
One evidence-based strategy to increase access to contraception in the United States is pharmacist prescribing, wherein patients can go directly to a pharmacy for contraceptive supplies. Pharmacists are well qualified to assess patient eligibility for contraceptive methods following review of patient-reported medical history, and measuring blood pressure. This may greatly increase access to prescription-only contraceptives, such as pills, patch, ring, and injection, while maintaining product coverage for insured patients. While 33-50% of United States residents do not have a medical home, nearly all live within 5 miles of a community pharmacy. 

Prescriptive authority is granted at the state level. Eight states thus far (California, Colorado, Hawaii, Maryland, New Mexico, Oregon, Tennessee, and Utah), as well as Washington D.C., have passed legislation allowing pharmacist prescribing of contraception via statewide protocol. Other states allow this under collaborative practice agreements (i.e., Washington), and 9 states allow pharmacists to prescribe emergency contraception pills, which has important implications for access and reimbursement for these products. Pharmacists in California, Colorado, Hawaii, New Mexico, Oregon, Tennessee, and Washington are able to prescribe birth control and provide direct access to women—thanks to implementation of the state laws—and it will be happening soon in Washington D.C., Maryland, and Utah. That doesn’t mean every pharmacy in those states is participating though. These are all relatively new laws, so patients should check with their pharmacy or check Birth Control Pharmacies to find a participating pharmacy near them.
 
The existing state protocols vary, particularly with respect to contraceptive methods allowed, and age restrictions. We strongly recommend that additional states adopt similar legislation to increase access to contraception via pharmacists prescribing. The legislation and protocols should be evidence-based, and include all contraceptive methods that are safe to use when self-administered or administered by a pharmacist, and exclude age and duration restrictions. In addition, states should consider reimbursement and implementation at the outset to facilitate widespread uptake by patients and pharmacies alike.

Community pharmacies are often available, and accessible for vulnerable, hard-to-reach populations. Pharmacies have expanded hours of operation on evenings, and weekends, are visited frequently, and would allow for a single visit for the clinical visit, and contraceptive supplies. In order to protect more women from unintended pregnancy during the Zika crisis, pharmacists should be fully engaged and enabled to provide much-needed contraceptive services.

There will be a podium presentation on this topic at the American Public Health Association meeting on November 13, 2018 in San Diego, California. 

This article was co-written by Natalie DiPietro Mager, RPh, an associate professor of pharmacy practice at Ohio Northern University.

References

  1. Bonner L. Pharmacists in New Mexico can prescribe hormonal contraceptives. American Public Health Association. www.pharmacist.com/article/pharmacists-new-mexico-can-prescribe-hormonal-contraceptives. Created June 12, 2018. Accessed June 21, 2018.
  2. Illnesses from mosquito, tick and flea bites increasing in the US. [news release]. Altanta, GA: May 1, 2018; CDC. www.cdc.gov/media/releases/2018/p0501-vs-vector-borne.html. Accessed June 21, 2018.
  3. Darney BG, Aiken AR, Küng S. Access to Contraception in the Context of Zika: Health System Challenges and Responses. Obstet Gynecol. 2017;129(4):638-642.
  4. Dresser M. Assembly gives OK for Maryland pharmacists to write birth control pill prescriptions. Baltimore Sun. www.baltimoresun.com/news/maryland/politics/bs-md-pharmacists-pill-20170408-story.html. Published April 8, 2017. Accessed June 21, 2018.
  5. National Association of County & City Health Officials, 2014. Local Health Department and Pharmacy Partnerships for Enhancing Medication Dispensing during Emergencies. http://naccho.org/advocacy/positions/upload/14-03-LHD-Pharmacy-partnerships-for-emergency-response.pdf
  6. National Conference of State Legislatures. Emergency contraception state laws. NCSL website. www.ncsl.org/research/health/emergencycontraception-state-laws.aspx. Accessed June 21, 2018.
  7. Rafie S. Colorado is third state allowing pharmacists to prescribe birth control. Pharmacy Times. www.pharmacytimes.com/contributor/sally-rafie-pharmd/2017/02/colorado-is-third-state-allowing-pharmacists-to-prescribe-birth-control. Published February 27, 2017. Accessed June 21, 2018.
  8. Rafie S, Stone RH, Wilkinson TA, Borgelt LM, El-Ibiary SY, Ragland D. Role of the community pharmacist in emergency contraception counseling and delivery in the United States: current trends and future prospects. Integrated Pharmacy Research and Practice. 2017;6:99-108

This article was originally published in Pharmacy Times.

Colorado is Third State Allowing Pharmacists to Prescribe Birth Control

More good news about access to birth control is coming from the state level. Colorado has passed legislation authorizing pharmacists to prescribe birth control after obtaining additional training. They are the third state to follow California and Oregon with this statewide authority specific to birth control. There is a task force that is charged with implementing the new protocol in the coming months.

file-feb-28-10-30-02-am

Pharmacist Protocols

All state protocols to date require pharmacist training and patient screening with a questionnaire and blood pressure measurement. Colorado’s legislation most closely resembles Oregon’s in allowing initiation of birth control pills and patch to adult women for up to three years until she sees a physician. California’s protocol is more comprehensive in allowing initiation of birth control ring and injection as well, in addition to serving female patients of all ages without a duration limit.

Public Health Impact

In 2010, 45% of all pregnancies (43,000) in Colorado were unintended. This expanded pharmacist scope is great news for women in Colorado and affords them more choices in access points for birth control. Colorado pharmacists are also looking forward to providing this important public health service to their patients.

It is yet to be determined what types of patients utilize this service when offered by pharmacists. The service became available at participating pharmacies as of January 2016 in Oregon and April 2016 in California.

Colorado has had great success with other initiatives to address unintended pregnancies. The Colorado Department of Public Health and Environment Family Planning Initiative provided more than 30,000 intrauterine devices (IUDs) or implants at low or no cost to low-income women. This contributed to a 40% drop in the teen birth rate from 2009 through 2013. This project is among others in demonstrating that when cost and access barriers to long-acting, reversible contraceptive methods such as IUDs and implants are removed, women are likely to choose these more effective methods. By 2019, Colorado aims to reduce the unintended pregnancy rate to 30% or less as one of their “Winnable Battles.”

Safety

There have been concerns about the safety of providing hormonal contraception without physical exams and pap smears. Though hormonal contraceptives are not without risks, these are generally outweighed by the benefits and considered safe for most women. A pelvic examination and a pap smear are not necessary to initiate hormonal birth control.  They are important for other health reasons.  Women will need to complete a health history questionnaire and have their blood pressure taken at the pharmacy.  The pharmacist will use this information to determine which methods of birth control are safe.

This is another step forward in increasing access to birth control.  Hopefully more states will pass similar laws expanding access with pharmacist prescribing.

There is also growing support for over-the-counter birth control pills. That differs from pharmacist prescribing because consultation with a pharmacist would no longer be required.

This article was originally published in Pharmacy Times.