Updated Report on State Policy Efforts to Expand Access to Contraception in Pharmacies

Free 22-page report describing the current landscape of direct pharmacy access to contraception in pharmacies, state policy approaches and experiences, as well as implementation.

The 2020 report includes information for policy efforts in 2020, along with emphasis on definitions of reimbursement vs. payment and a new appendix with model bill elements. 

Outreach Initiative to Expand Access to Depot Medroxyprogesterone Acetate (DMPA)

DMPA Outreach Study Infographic

Why Expand Access to DMPA

The novel coronavirus 2019 (COVID-19) presented many downstream challenges in healthcare throughout 2020. An area of particular interest was the impact COVID-19 had on access to hormonal contraception, specifically DMPA intramuscular (DMPA-IM). Prior to the pandemic, patients who used DMPA-IM would attend approximately four clinic visits per year (every 12 weeks) to obtain their injection from a medical professional.

As public health risks continued to be a primary concern and shelter-in-place orders were issued, the Centers for Medicare & Medicaid Services (CMS) issued waivers under section 1135 of the Social Security Act, which permitted state governments to adjust their public health responses to the pandemic as they deemed fit. One way Medi-Cal used this waiver was to cover self-administered DMPA subcutaneous (DMPA-SC) without a prior authorization so patients could continue using their preferred method of hormonal contraception while decreasing exposure to COVID-19 until further notice.

Our study explored interest in at-home, self-administered DMPA-SC among patients who had been on DMPA-IM at an urban, hospital-based safety-net primary care clinic in San Francisco. 

Approach to Patient Outreach 

Our team consisted of medical and pharmacy students, pharmacists, and medical doctors. We identified patients who had been on DMPA-IM within the last nine months (August 2019-May 2020) by searching the clinic’s electronic medical records. Through this process, we identified 90 patients and successfully reached 70 patients (78%) by telephone. Our patients were all on Medi-Cal or Family PACT. Additionally, our patient base was largely non-English speaking, so interpretative services were utilized for effective, patient-preferred communication. Once each patient’s identity was confirmed, we explained self-administered DMPA-SC and answered any questions posed by the patient. If the patient expressed interest in DMPA-SC, we ordered a prescription to their community pharmacy and offered telehealth appointments to answer any further questions, demonstrate how to self-inject, and/or observe the patient as they self-administered. Of the 70 patients reached, 26 patients (37%) were interested in learning more about DMPA-SC. By the end of our study, 15 patients (21%) successfully self-administered DMPA-SC or had a family member or friend do it for them.  

Clinical Implications

Feedback received from patients previously utilizing DMPA-IM suggests at-home administration of DMPA-SC is a viable option when selecting a hormonal contraceptive. By continuing to advocate for at-home administration, the medical community can help expand access to hormonal contraception for all patients.  

 

Check out the full study here

References

  1. Depo-SubQ Provera 104 prescribing information. Pfizer, December 2020. Link. Accessed February 25, 2021. 
  2. Katz M, Newmark RL, Aronstam A, O’Grady N, Strome S, Rafie S, et al. An implementation project to expand access to self-administered depot medroxyprogesterone acetate (DMPA). Contraception. 2020;102(6):392-5. DOI

Birth Control Pharmacist Sara Strome Headshot
About the Author

Sara Strome, PharmD Candidate is a pharmacy student in the Class of 2022 at the University of California San Francisco School of Pharmacy.

Webinar Introduces Pharmacists to New Hormonal Contraceptives

New drugs are constantly being approved by the FDA, and it is important for practicing pharmacists to stay up to date on new contraceptives. There are now over 50 unique contraceptives available, and pharmacists need to be aware of these and incorporate them into their practices. Birth Control Pharmacist recently hosted a webinar that aimed to educate pharmacists, pharmacy staff members, and other healthcare providers to feel more comfortable with the new contraceptive options they could prescribe or dispense.

The faculty speaker, Shareen El-Ibiary, PharmD, BCPS, FCCP, is a professor and chair of the Department of Pharmacy Practice at Midwestern University, College of Pharmacy. She is also a consultant for Birth Control Pharmacist.

The program focused on three new hormonal contraceptives – Annovera, Twirla, and Slynd – along with one new nonhormonal contraceptive – Phexxi.

What is Annovera?

Annovera is a new contraceptive vaginal ring that contains segesterone and ethinyl estradiol. It is different from NuvaRing because it is used for 13 consecutive cycles, as opposed to just one cycle. It is not refrigerated.

What is Twirla?

Twirla is a new contraceptive patch that contains levonorgestrel and ethinyl estradiol. It is very similar to Xulane in terms of application, but Twirla has lower rates of headache, nausea, and breast tenderness.

What is Slynd?

Slynd is a new progestin-only oral contraceptive that contains drospirenone. In each pack of 28 tablets, there are 24 active tablets and four inactive tablets. The main benefit of Slynd over norethindrone is less opportunity for missed doses. Unlike norethindrone’s 3-hour window to take a dose, patients on Slynd have up to a 24-hour window to take a dose before it is considered a missed dose. Pharmacists need to be aware of the unique drug interactions associated with Slynd.

What is Phexxi?

Phexxi is a new prescription-only contraceptive gel that does not contain nonoxynol-9. Instead, it contains lactic acid, citric acid, and potassium bitartrate. Phexxi should be applied vaginally within one hour before each episode of intercourse. It should not be used by patients who have recurrent urinary tract infections or urinary tract abnormalities.

Dr. El-Ibiary wrapped up the program by reviewing patient cases, and she even demonstrated a patient interaction within a pharmacy. This helped bring the concepts from the lecture portion to life and allowed participants to practice incorporating these new hormonal contraceptive into their counseling and other practices.

Fortunately, if you missed the webinar, the video recording and materials are available for home study online at https://birthcontrolpharmacist.com/newhc/. The course material is available to all, with pharmacists having the opportunity to obtain Continuing Pharmacy Education credit. This material provides education to participants to increase their comfort in prescribing, dispensing, or counseling patients on the new contraceptive options available.

Participants provided feedback at the conclusion. Keep reading to see their positive reviews and gain a better idea of what to expect from the online course:

 “As a P1, I appreciate how Dr. El-Ibiary explained everything clearly. It helped me better understand the content and I now have a much better understanding of contraceptives.”

“Very practical, real-life patient case scenarios were used as effective teaching points.”

“Amazing presentation. Very informative and easy to follow.”

“Thank you for providing this CE! It was both helpful & thorough.”

New Hormonal Contraceptives Home Study CPE


Katie HoodAbout the Author

Katie Hood, PharmD Candidate is a pharmacy student in the Class of 2021 at Shenandoah University Bernard J. Dunn School of Pharmacy and Pharmaceutical Sciences. Katie completed an elective APPE rotation with Birth Control Pharmacist.

Webinar Equips Pharmacists to Provide Contraception Care During COVID-19

During the COVID-19 worldwide pandemic it has been quite the adjustment to deliver safe and quality patient care. Specifically, for contraception care, pharmacists have been working extra hard to continue their direct patient care with how accessible they are. Birth Control Pharmacist recently hosted a webinar that facilitated an educational program and discussion for pharmacy staff members to feel more equipped to deliver contraception and emergency contraception services during COVID-19.

We had multiple speakers of diverse backgrounds in order to give different perspectives on the effects of COVID-19 on contraception care and how pharmacists can best help their patients. The panel speakers were Jennifer Karlin, MD, PhD an attending physician in Family & Community Medicine at UC Davis and Sonya Frausto, PharmD who is the pharmacist-in-charge at Ten Acres Pharmacy, an independent community pharmacy.

What is the healthcare landscape during the COVID-19 pandemic?

Laying out the landscape during the COVID-19 pandemic helped paint a picture to participants about the extensive effects on contraception care. Whether that be loss of insurance or fear of infection from going to healthcare facilities, it highlighted how important it can be for pharmacists to assist their patients with contraception while following national guidelines.

How can pharmacists prescribe birth control safely?

National guidelines covered prescribing birth control and also social distancing to reduce the risk of spreading the virus. Telehealth has been a useful service in adhering to social distancing, while also maintaining face-to-face encounters. This helps patients maintain a personal relationship with their pharmacist.

What are some best practices within the pharmacy?

There are many useful suggestions throughout the webinar, but a useful tool they referenced is the Contraceptive Care Best Practices During COVID-19 best practices guide for pharmacies created by Birth Control Pharmacist.

Dr. Frausto wrapped up the program by reviewing useful tools and resources to use while in the pharmacy. Then she demonstrated a patient interaction within a pharmacy. This helped really bring the whole webinar together with a real-world example and solidified that this webinar is well worth the watch.

Fortunately, if you missed the webinar, the video recording and materials are available for home study online at https://birthcontrolpharmacist.com/careduringcovid/. The course material is available to all, with pharmacists having an opportunity to obtain Continuing Pharmacy Education credit. This material provides education to participants to increase their comfort in providing contraception care, including prescribing hormonal contraception, in community pharmacies during the COVID-19 public health emergency.

Participants provided feedback at the conclusion. Keep reading to see their positive reviews and gain a better idea of what to expect from the online course:

“I loved this CE. Very informative, the speakers were great and passionate about the topic!

“As a newer pharmacist, this type of information helps me to feel better prepared to provide these kinds of services to patients.

“Loved the topic, very timely for COVID.”

“I was coming from a state where pharmacists did not prescribe birth control so this was a new perspective for me.”

pharmacy-based-contraception-care-during-covid-19-online-cpe-program-1


About the Author

Samantha ThompsonSamantha Thompson, PharmD Candidate is a pharmacy student in the Class of 2023 at University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. Samantha completed a summer internship with Birth Control Pharmacist.

New Webinar Prepares Pharmacists to Provide Reproductive Health Services and Referrals

Pharmacists play a key role in providing health care to patients. Their scope is currently expanding into women’s health, specifically in prescribing birth control. As more states pass legislation to allow pharmacists to prescribe birth control, we are preparing pharmacy staff members with the appropriate knowledge and tools to best assist their patients.

We hosted an exciting webinar, “Meeting Reproductive Health Needs at the Pharmacy” with Provide. Provide is a nonprofit organization with a goal to provide healthcare and social services to patients without bias or judgement. They understand the lack of care for patients experiencing an unintended pregnancy and seek to provide a comfortable environment for people to explore their options. This webinar shed light and helped to educate pharmacists, student pharmacists, and pharmacy technicians about family planning services including birth control access, emergency contraception, and abortion. The program included myths and facts about reproductive health, best practices to combat stigma, and how to connect patients with local resources.

Anna Pfaff and Dr. Sally Rafie led the discussion. Each touching on different subject material and bringing some diverse perspectives to the topic, Dr. Rafie as a pharmacist who also runs Birth Control Pharmacist and Anna as a patient educator who coordinates Provide’s Referrals Program. There are many barriers for different populations, further magnified during the COVID-19 pandemic and Title X restrictions, to obtain family planning services.

One very important objective of the program was preparing pharmacists and pharmacy teams to combat stigma surrounding these services. Pharmacy best practices were provided to address individual, environmental, and structural stigmas. The presenters raised awareness around these issues and shared new practical pharmacy communication guides that pharmacists and pharmacy team members can use in their everyday practices. As an example, Dr. Rafie and Monica Sliwa (a UCSD pharmacy student intern with Birth Control Pharmacist) performed a role play activity to show different approaches to assisting a patient find an emergency contraception method in the pharmacy. They also demonstrated the steps to refer patients for other services using online directories.

Fortunately, if you missed the webinar, the video recording and materials are available for on-demand home study online at https://birthcontrolpharmacist.com/referrals/. The course material is available to all, with pharmacists and pharmacy technicians having an opportunity to obtain Continuing Pharmacy Education credit. This material provides education to pharmacy staff members in reducing stigma in access to reproductive health services.

Participants provided feedback at the conclusion. Keep reading to see their positive reviews and gain a better idea of what to expect from the Newonline course:

“Though not having a place of practice due to being in my 4th year of pharmacy school, I appreciated having these materials that can be utilized in whatever area of practice I’m in. I am interested in a career in women’s health and know that these resources will be valuable to me when transitioning into my career.”

“I love the handout provided, and I learned more about abortion clinics. I feel so much more comfortable about discussing options with patients now.”

“I plan on promoting this initiative and educating my colleagues on reproductive health competencies so that patients in my practicing state will have more options for accessibility.”

Meeting Reproductive Health Needs at the Pharmacy On-Demand Webinar


About the Author

Samantha ThompsonSamantha Thompson, PharmD Candidate is a pharmacy student in the Class of 2023 at University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. Samantha completed a summer internship with Birth Control Pharmacist.

Meet Phexxi – A New Non-Hormonal Contraceptive Gel

Image from https://hcp-phexxi.com

About the Product

Lactic acid, citric acid, and potassium bitartrate (Phexxi, Evofem Biosciences) is a prescription combination, non-hormonal contraceptive gel approved by the FDA in May 2020. The vaginal gel was found to be 86.3% effective with typical use when inserted up to 1 hour before vaginal intercourse.1

The gel acts as a contraceptive by maintaining the vaginal pH within its normal range of 3.5 to 4.5, an environment too acidic for sperm to survive. This pH regulating mechanism decreases sperm viability and supports bacteria integral to the vaginal microbiome.1

The gel is supplied in a package of twelve, single dose (5 grams), pre-filled applicators with an attachable plunger. The applicator should be inserted into the vagina immediately before or up to 1 hour before vaginal intercourse, with a new dose needing to be administered prior to each act of intercourse.2

What Patients Can Expect

The most common adverse events (AEs) were vulvovaginal burning (20%) and vulvovaginal itching (11.2%). Of local AEs, 23.9% were mild, 18.7% were moderate, and 2.3% were severe. Rates of these reactions mostly decreased over time.1

Women with a history of recurrent urinary tract infections or urinary tract abnormalities should not use the gel due to the 0.36% incidence of cystitis or pyelonephritis in clinical trials.2

Male partners of women using the gel might also experience local AEs such as burning, itching, and pain. However, the local AEs experienced by male partners were generally mild (74.7%), while 21.4% were moderate and 3.9% were severe.2

Offering This New Option to Patients

The contraceptive gel is an option for women who are seeking a non-hormonal or on-demand method of birth control. Women preferring to use multiple methods of contraception can combine the gel with diaphragms and latex, polyurethane, and polyisoprene condoms. However, it should not be used with vaginal rings.2

Spermicide is also available as a vaginal gel, but it is only about 72% effective with typical use.3 Like the non-hormonal contraceptive gel, it can be used on-demand. Nonoxynol-9, the active ingredient in most spermicides, can cause vaginal irritation and increase the risk of HIV transmission.4 In a clinical trial comparing nonoxynol-9 to the , incidences of vulvovaginal itching, burning, and irritation were similar, with the non-hormonal contraceptive gel having a slightly higher incidence of vulvovaginal burning.5

The contraceptive gel’s novel pH modulating mechanism is currently being studied for prevention of gonorrhea and chlamydia in the phase 2B clinical trial AMPREVENCE. Preliminary results from the 4-month study period showed a 50% relative risk reduction of chlamydia and a 78% relative risk reduction of gonorrhea. The clinical trial will move on to phase 3 later in 2020.6

Although the gel will be available as a prescription only treatment in September 2020, patients may face barriers to accessing the gel during COVID-19. Evofem Biosciences plans to launch a telemedicine program to support patient and provider access to the contraceptive gel.7 Additionally, barriers to contraception access could be further mitigated by enabling pharmacists to prescribe birth control.

REFERENCES

  1. Thomas MA, Chappel BT, Maximos B, Culwell KR, Dart C, Howard B. A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial. Contraception: X.2020; vol. 2 100031.
  2. Phexxi. Prescribing information. Evofem Biosciences; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208352s000lbl.pdf. Accessed June 17, 2020.
  3. HHS. Spermicide. https://www.hhs.gov/opa/pregnancy-prevention/birth-control-methods/spermicide/index.html. Accessed June 17, 2020.
  4. FDA. Code of Federal Regulations Title 21; April 1, 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.325. Accessed August 3, 2020.
  5. Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel; March 11, 2020. https://clinicaltrials.gov/ct2/show/results/NCT01306331. Accessed August 30, 2020.
  6. Evofem Biosciences Reports Positive Top-Line Results from Phase 2b Study of Amphora® for Prevention of Chlamydia and Gonorrhea in Women. Evofem Biosciences; December 2, 2020. https://evofem.investorroom.com/2019-12-02-Evofem-Biosciences-Reports-Positive-Top-Line-Results-from-Phase-2b-Study-of-Amphora-R-for-Prevention-of-Chlamydia-and-Gonorrhea-in-Women. Accessed August 3, 2020.
  7. U.S. FDA Approves Evofem Biosciences’ Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy. Evofem Biosciences; May 22, 2020. https://evofem.investorroom.com/2020-05-22-U-S-FDA-Approves-Evofem-Biosciences-Phexxi-TM-lactic-acid-citric-acid-and-potassium-bitartrate-the-First-and-Only-Non-Hormonal-Prescription-Gel-for-the-Prevention-of-Pregnancy. Accessed August 3, 2020.

About the Author

This article was co-written by Whitney Russell, a student pharmacist at University of Kentucky College of Pharmacy.

This article was originally published in Pharmacy Times.

Measuring Blood Pressure: An Important Prerequisite to Prescribing Hormonal Contraception

Why is it important to measure blood pressure before prescribing hormonal contraception?

Combined hormonal contraceptives (CHCs) are a relatively safe and effective method for your patients in preventing pregnancy and treating other disease states such as menorrhagia, endometriosis, PCOS and more. However, CHCs may increase the risk for a few serious cardiovascular events. This risk is increased if a patient has hypertension.

Screening for hypertension prior to staring CHCs is a class A recommendation for safe use according to the U.S. Selected Practice Recommendations for Contraceptive Use (SRC). In a systemic review, women who did not have their blood pressure checked prior to starting hormonal contraception had higher odds of having an acute myocardial infarction and ischemic stroke.

Also, in a small percentage of patients, CHCs can cause life-threatening hypertension, which can lead to irreversible damage to the kidneys and cause renal failure. This effect can last after the medication is discontinued.

Due to these severe adverse effects, all patients are screened for hypertension prior to starting CHCs. If a patient is hypertensive, they should be treated appropriately and have blood pressure well controlled prior to starting a hormonal contraceptive method.  

How do CHCs raise blood pressure?

The mechanism by which CHCs increase blood pressure is unknown. Regardless, CHCs can cause small increases in blood pressure in both normotensive patients and patients with hypertension which is significant enough to be recognized as a risk for hypertensive patients.

Who is at risk of complications from CHCs?

It is not advised to use CHCs in patients with severe hypertension (defined as systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg). However, in people with controlled and monitored hypertension and who are also under 35 years of age, CHCs may be appropriate as long as they are otherwise healthy and do not smoke (U.S. MEC 3). It is important to mention that even if a patient has hypertension that is under control, there is still a risk present for cardiovascular events and that other contraceptive options should be considered before initiating a CHC.

Patients are at a higher risk of cardiovascular complications if they are older than 35 years of age, have a familial history of hypertension, cardiovascular disease or preexisting occult renal disease, and if the patient is obese. Providers should use discretion in patients with these preexisting conditions before starting CHCs or consider more appropriate contraceptive options.

What other options are there for patients with hypertension?

Patients with uncontrolled hypertension, or who are at risk of malignant hypertension have other options for contraception. Progestin only contraceptives such as progestin only pills (POPS), the shot, or levonorgestrel-containing IUDs are recommended over CHCs according to the CDC MEC for women with hypertension. Non-hormonal options include the copper-containing IUD, condoms, or spermicides.

References

  1. Tepper NK, Curtis KM, Steenland MW, Marchbanks PA. Blood pressure measurement prior to initiating hormonal contraception: a systematic review. Contraception 2013;87:631–8.
  2. CDC. U.S. medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep (No. RR-X);2016.
  3. Development, updates, and future directions of the World Health Organization Selected Practice Recommendations for Contraceptive Use. Int J Gynecol Obstet 2017;136: 113–119 – 04 January 2017
  4. Armstrong, Carrie. Hormonal Contraceptives in Women with Coexisting Medical Conditions. Am Fam Physician. 2007 Apr 15;75(8):1252-1258.
  5. El-Ibiary SY, Shrader SP, Ragucci KR. Contraception. In: DiPiro JT, Yee GC, Posey L, Haines ST, Nolin TD, Ellingrod V. eds. Pharmacotherapy: A Pathophysiologic Approach, 11e. McGraw-Hill; Accessed July 22, 2020. https://accesspharmacy-mhmedical-com.mwu.idm.oclc.org/content.aspx?bookid=2577&sectionid=227710658

About the Author

Elizabeth Duxbury Pharm.D. is a recent graduate of University of California, San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences in 2019.

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

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

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

Updates in Male Contraceptive Agents

white round capsules

Male contraceptive agents have been highly anticipated as the next step in contraception innovation. To date, several hormonal agents have been developed and tested for safety and efficacy, with three products: Nesterone with Testosterone gel (NES/T), 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MTNDC), and dimethandrolone undecanoate (DMAU). Currently, NES/T is leading in development and contraceptive ability.[1,2]

NES/T has been formulated as a gel containing Nesterone, also known as segesterone acetate (a “pure” progestin presently found in Annovera) in combination with testosterone. This product has passed phase I and phase IIa trials, and is currently in phase IIb trials with a predicted conclusion date for February 2021.[2] NES/T is formulated as a topical gel that can be applied to the shoulders daily with the drug action of sperm count/development suppression to thresholds that should translate to effective contraception with normal hormonal function.[2]

11β-MTNDC is a 28 day daily use oral tablet formulated to act as similarly to 28 day contraceptive regimens for females. The drug acts as a hormonal suppressant to impair spermatogenesis. It is currently in phase I trials, therefore its extent of efficacy and long term effects is still to be determined.[3]

DMAU is formulated as both a 28 day daily use oral tabletand a long acting injection (dosing frequency to be determined). DMAU has a similar action to 11β-MTNDC, and is also still under early investigation in phase I trials.[4]

Despite the difference in administration routes, these drugs have similar effects on male sex hormones. They suppress brain hormones called “gonadotropins,” which results in profound reduction of endogenous testosterone production. The low levels of testosterone thereby result in a reversible reduction in spermatogenesis within the testicles to the point of sperm development impairment, but not enough to cause lasting hormonal changes as of current trialing.[1] The drugs themselvesact as a supplement in place of the person’s own testosterone to maintain male hormonal functions. Current trialing has noted that each product does have the adverse of effect of minor acne at the beginning of treatment.[2,3,4] Participants also noted their concern with a lack of STI prevention.[5] However, with only low risk adverse effects demonstrated thus far in studies, and participants reporting these methods as “easy” treatment regimens to follow, these products appear acceptable for use in the eyes of the American male population.[2,3]

The utility of these products, if approved, is still being questioned. In one US survey participants stated that they would greatly consider the Nestorone topical gel as a first choice method of contraception. 6 However, based on previous contraceptive studies in the US and the United Arab Emirates, the percentages of men using methods of contraception is roughly 59% and 20% respectively.[7,8] According to a 2017 CDC study on contraception use in the U.S., approximately 42.5 million men (59% of the polled 72 million men in the study) engage in contraception practice.[7] With only just over half of the US male population reporting the use of contraception, it is understandable that drug marketing could be seen as risky to pharmaceutical companies if the products are still only in development.

The major obstacles to further drug development are marketing based support and acknowledgment. With only one major organization funding the research on these products, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, progress is very slow.[1] No major pharmaceutical marketing companies have made any public statements on male contraception as a new drug category, it may take longer than the full trialing time to hear more on product availability in the market.

These novel products, NES/T gel, oral DMAU and 11β-MNTDC, if proven to be effective contraceptive agents, would constitute a suitable alternative for couples that wish to participate in planned parenting, but wish to avoid or cannot use contraceptives indicated for females. Although the rate of progress is slow, it is substantial and the availability of male contraception agents may arrive within the next decade. For more information please follow the link to the Eunice Kennedy Shriver National Institute of Child Health and Human Development website (https://www.nichd.nih.gov/).

References

  1. Long JE, Lee MS, Blithe DL. Male Contraceptive Development: Update on Novel Hormonal and Nonhormonal Methods. Clin Chem 2019;65(1):153-160.
  2. Wang C, Page S, Nagia A, et al. Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception. https://clinicaltrials.gov/ct2/show/NCT03452111. Dec 11, 2019.
  3. Wu S, Yuen F, Swerdloff RS, et al. Safety and Pharmacokinetics of Single-Dose Novel Oral Androgen 11β-Methyl-19-Nortestosterone-17β-Dodecyl carbonate in Men. J Clin Endocrinol Med 2019; 104(3):629-638.
  4. Gava G, Meriggiola M. Update on male hormonal contraception. Ther Adv Endocrinol Metab. 2019;10.
  5. Glasier A. Acceptability of contraception for men: a review. Contraception 2010; 82(5):453-456.
  6. Roth M, Shih G, Ilani N, et al. Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial. Contraception 2014;90(4):407-412.
  7. Daniels K., Amba J. Current Contraceptive Status Among Women Aged 15–49: United States, 2015–2017. CDC. https://www.cdc.gov/nchs/products/databriefs/db327.htm. Accessed December 22 2019.
  8. Ghazal-Aswad S, Zaib-Un-Nisa S, Rizik DE, et al. A study on the knowledge and practice of contraception among men in the United Arab Emirates. J Fam Plann Reprod Health Care 2002; 28(4):196-200.
  9.  

Photo by Anna Shvets on Pexels.com


About the Author

Steven Gonzalez PharmD CandidateSteven Gonzalez, PharmD Candidate is a pharmacy student in the Chicago College of Pharmacy Class of 2022 at Midwestern University, with the dream of becoming a successful clinical pharmacist. In his time off, Steven enjoys spending time with his friends and family, going hiking, fishing, and watching classic movies.

Article reviewed by Brooke Griffin, PharmD, BCACP