Putting Policy into Practice: Contraception Care in San Francisco Pharmacies

Contraception Care in San Francisco Pharmacies

What makes some pharmacies more successful than others at implementing pharmacist-prescribed contraception care? To answer this question, we conducted a study to determine the extent of hormonal contraceptive prescribing, also referred to as furnishing in California, among San Francisco community pharmacies, and identify the factors that led to successful implementation.

Implementation in San Francisco pharmacies 

After calling all 113 community and independent pharmacies located in San Francisco, we identified 21 locations (19%) that furnished hormonal contraception. Only one of these was an independent pharmacy; the rest were chain community pharmacies. Half or more of Costco, CVS, and Safeway locations furnished hormonal contraception, while less than 5% of Walgreens and independent pharmacies did so. 

Factors associated with successful adoption

Within the control of pharmacies

We identified three main factors that led to successful implementation that were within pharmacy control. The first was a company protocol—respondents stated that having an established precedent and administrative support, and paying for pharmacists’ training, was crucial for successful implementation. The second was advertising, due to the community’s limited awareness of this service. Lastly, the accessibility of pharmacists played a role in increasing access to services and to hormonal contraception. 

Relating to the setting or larger community

We also identified factors leading to successful implementation outside the control of pharmacies. These included the location of the pharmacy and its patient population, as well as collaboration with local clinics. Pharmacies in proximity to students and other younger and short-term residents found there was more need for hormonal contraceptive furnishing services. One pharmacy had an existing collaboration with a local clinic and its providers that acted as a bridge to the service. 

Barriers to service adoption 

Respondents also reported several barriers to successful implementation. The cost of consultation for patients was a widespread concern. Lack of time was another barrier reported by many pharmacists, which could be resolved through scheduled appointments or more overlaps of pharmacist shifts. The last identified barrier was patient privacy. Many respondents expressed a need for a private consultation room in order to provide a confidential service, and those that had a private consultation room acknowledged this as a benefit. 

Effect of COVID-19 on furnishing 

Our data collection began in April 2020, shortly after the introduction of San Francisco’s shelter-in-place order. We asked study participants to comment on whether practices or demand for hormonal contraception had changed under the shelter-in-place order and responses were mixed. While some pharmacies reported an increase in demand for hormonal contraceptive furnishing, others reposted a decrease. 

Implications for the future

We found an increase in participation among pharmacies in San Francisco that were furnishing hormonal contraception than previously reported in California overall; 19% in San Francisco in 2020 versus 11% statewide in 2017. This finding could reflect either pharmacies adding this service gradually over time or a local phenomenon. However, CVS pharmacists reported that a new corporate protocol was initiated in 2020, suggesting the higher rate of furnishing we identified could be reflected statewide. Our results detailed successful strategies used by San Francisco community pharmacies that could serve as a model for expanding this service to other pharmacies. In the words of one respondent:

“The pharmacist is the most overtrained and underutilized health care professional we have.”

With more widespread implementation of this service, community pharmacists can increase their scope of practice, improve quality and continuity of care for patients, and expand access to hormonal contraception to improve reproductive health.

Link to the full paper.

References

  1. California Board of Pharmacy 1746.1: Protocol for pharmacists furnishing self- administered hormonal contraception. Link.
  2. Chen L, Lim J, Jeong A, & Apollonio D. Implementation of hormonal contraceptive furnishing in San Francisco community pharmacies, 2020. Journal of American Pharmacists Association. doi:https://doi.org/10.1016/j.japh.2020.07.019
  3. Gomez AM. Availability of pharmacist-prescribed contraception in California, 2017. JAMA. 2017;318(22):2253e2254. 

Chen Lim Jeong ApollonioAbout the Authors

Lauren Chen, Julie Lim, and Asher Jeong are third-year doctoral students at the University of California San Francisco (UCSF) School of Pharmacy. Dorie Apollonio is a professor in the UCSF Department of Clinical Pharmacy.

Reducing Maternal Mortality in the United States through Collaboration

Maternal Mortality Blog Post - Birth Control Pharmacist

Healthy childbirth requires education and action prior to conception and should continue throughout the gestation period to monitor for any changes that require immediate medical attention. Approximately 60% of maternal deaths are preventable and family planning has shown to decrease the number of maternal deaths related to pregnancy.1,2 Addressing the heightened rates in the United States requires the collaboration of medical expertise to maximize the health of mothers and their offspring.

California is one of the first states to take an initiative in the common complications that arise during childbirth. The California Maternal Quality Care Collaborative (CMQCC) has backed initiatives surrounding two common complications in childbirth: hemorrhaging and blood pressure. Since early prevention of these two serves as a crucial factor in the mother’s health, the team has created standard procedures through practicing these events through simulation, formulating a method for the measurement of blood loss, and creating an accessible toolkit to treat such events when they arise. The Pomona Valley Hospital Medical Center is laying the foundation for protocols that will save a woman’s life during childbirth. Utilizing this expertise has shown benefit based on efforts by the CMQCC and can further be supported by preventative care measures employed by the pharmacist.3

The Pharmacist’s Role in Reducing Maternal Mortality

The pharmacist’s scope of practice can have a significant impact on the rates of maternal mortality in the United States, ranging from preconception care, interventions during pregnancy, and patient education.2 The relationship between unintended pregnancies and maternal mortality suggests that reducing rates of unintended pregnancy would be beneficial in, too, reducing rates of maternal mortality. Pharmacists could also aid in the development of a reproductive life plan (RLP) with patients to firstly aid in pregnancy planning. RLPs involve both partners and “includes goals patients make personally about having or not having children and encourages intentional pregnancy planning.”4 Initiating a conversation about a RLP also serves as an opportunity to address a patient’s health needs. For people who are looking to prevent pregnancy, a pharmacist can aid a patient in choosing a contraceptive method that suits the patient’s lifestyle and preferences. For those who do have intentions to become pregnant in the near future, pharmacists can provide education and counseling on health behaviors that could be harmful to a potential pregnancy.4

The Significance of Collaboration

The role of the pharmacist is continually evolving. In collaboration with other healthcare professionals, pharmacists can lay the groundwork needed to reduce maternal morbidity in the United States. Pregnancy planning and education could allow for the formation of RLPs and reduce the number of unintended pregnancies as well as increase awareness for behaviors that could hinder or advance maternal-infant outcomes. Pharmacists’ intervention in conjunction with the initiatives such as the CMQCC could provide for significant breakthroughs in health and wellness before, during, and after parturition.

References

  1. “Maternal Mortality.” Centers for Disease Control and Prevention, 13 Aug 2020. Available at: http://www.cdc.gov/reproductivehealth/maternal-mortality/index.html.
  2. Tsui AO, McDonald-Mosley R, Burke A. Family Planning and the Burden of Unintended Pregnancies. Epidemiologic Reviews. 2010;32(1):152-174.
  3. Montagne, Renee. “To Keep Women from Dying in Childbirth, Look to California.” NPR, 29 July 2018. Available at: https://www.npr.org/2018/07/29/632702896/to-keep-women-from-dying-in-childbirth-look-to-california.
  4. Peters LM, DiPietro Mager NA. Pharmacists’ Provision of Contraception: Established and Emerging Roles. Innov Pharm. 2016;7(3):15.

About the Author

Courtney Smith Headshot
Courtney Smith, PharmD Candidate
is a pharmacy student in the Class of 2024 at Ohio Northern University.

Reviewed by Natalie DiPietro Mager, PharmD, PhD, MPH.

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.

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

Can Contraceptives be Vegan? Important Considerations for Vegan Patients

The Vegan Society defines veganism as “a way of living which seeks to exclude, as far as is possible and practicable, all forms of exploitation of, and cruelty to, animals for food, clothing or any other purpose”. Since veganism extends beyond just a diet for avoiding animal products, awareness of medication ingredients is also a component of this lifestyle, and patients may be curious at to where their contraceptives fit in.

Potential Uncertainties in Contraceptives

Two inactive ingredients commonly found in hormonal contraceptives which could be considered problematic for vegans are lactose and magnesium stearate. Lactose can act as a filler, a diligent powder, or as an acid in medications and magnesium stearate acts as a lubricant during tablet processing and improves medication solubility. The source of these ingredients, and the status of whether they are vegan can be cloudy. Traditionally, lactose is derived from cow’s milk via bovine rennet extraction, but it can also be produced synthetically. Similarly, magnesium stearate is typically rendered from the fat of cows, pigs, and sheep, however it can now be produced from vegetable matter. Although these ingredients can be found on the medication label, their source is not stated.

Authors of The BMJ article, Why Can’t All Drugs Be Vegetarian? found that differentiation between vegetarian and non-vegetarian lactose was poor as materials involved and the process of manufacturing was often not available. Upon contacting manufactures of lactose-containing products, they found there was uncertainty as to whether medications were suitable for vegetarians or vegans. Because of this, the authors point to clearer labeling requirements as a necessity for understanding animal content in medications.

Patient Considerations

If a patient feels that their personal definition of veganism involves avoiding ingredients such as lactose in their hormonal contraceptives, there are alternatives contraceptive options such as condoms (look for non-latex brands such as Glyde and Sir Richard’s), IUDs, the Ortho Evra patch, vaginal rings, the implant, or the Depo-Provera injection. However, it is important to note that hormones themselves are also often derived from animals. Additionally, all products, even the ones made without animal-sourced ingredients, are tested on animal subjects before they can progress to human testing and make it to market.

So, can a patient use contraceptives and still be considered vegan? The Vegan Society recommends avoiding medications that contain animal products but also re-emphasizes the ‘as far as practical and possible’ portion of their definition for what it means to be vegan. Since all oral contraceptives currently available contain lactose, most would agree that taking them falls under that category as there is no practical way that they can be completely vegan. “Sometimes, you may have no alternative to taking prescribed medication. Looking after yourself and other people enables you to be an effective advocate for veganism,” says The Vegan Society.

The Pharmacist’s Role

Lastly, the Vegan Society also reminds patients to “open up a conversation with your pharmacist or doctor” in regard to discussing the intersection of medications and veganism, and providers need to be prepared to have these conversations too. Initiating dialogue with patients about their dietary and lifestyle preferences can help with understanding what contraceptive methods they feel most comfortable and confident using and fitting into their vegan lifestyle. Pharmacists are in an optimal position to discuss the options relevant to veganism with patients by being knowledgeable about animal testing as well as active and inactive ingredients and their sources. Being proactive and having these conversations could prevent patients from stopping or changing medications that they feel do not align with their lifestyle, while helping improve adherence and satisfaction.

References:

  1. Tatham , Kate, and Kinesh Patel. “Why Can’t All Drugs Be Vegetarian?” BMJ, vol. 348, 8 Feb. 2014, pp. 18–20., (link).
  2. McKie, Joshua, and Sue Gough . “Is There a Lactose-Free Oral Contraceptive?” UK Medicines Information, 3 Aug. 2016, (link).
  3. Fry, Samantha. “Is My Medication Vegan?” The Vegan Society, 13 Oct. 2017, (link).
  4. “List of Animal-Free Medications.” The Vegan Society, (link).
  5. “Definition of Veganism.” The Vegan Society, (link).
  6. Barclay, Eliza. “Is Your Medicine Vegan? Probably Not.” NPR, NPR, 15 Mar. 2013, (link).

About the Author

Niamh O’Grady, PharmD Candidate, is a pharmacy student in the Class of 2021 at the University of California San Francisco School of Pharmacy

Reviewed by Breanna Failla, PharmD Candidate and Brooke Griffin, PharmD, BCACP

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

No Taxation for Menstruation: The Importance of Student Pharmacist Advocates

Pictured: Policy Postcards sent to Michigan Legislators from an event called “Galentine’s Day”

At the University of Michigan College of Pharmacy, the APhA-ASP chapter’s inaugural Women’s Health Campaign hosted multiple events to educate and engage student pharmacists and the Ann Arbor community. While our Campaign focused on topics directly related to pharmacy, such as contraception and HPV vaccination, we have also taken the initiative to advocate for a crucial area of women’s health: menstruation.

Our American Pharmacists Association-Academy of Student Pharmacists (APhA-ASP) chapter, in collaboration with Student National Pharmaceutical Association (SNPhA), hosted an event called “Galentine’s Day” in February. This event gave student pharmacists the opportunity to purchase women’s health-related buttons to raise money for Ozone House, a shelter in Ann Arbor, MI for homeless adolescents. Our profits went toward the purchase of menstruation products for this vulnerable population, many of whom are just beginning their period. Additionally, student pharmacists wrote to their state representatives to support abolishing the “Tampon Tax” in Michigan and throughout the United States.

Pictured: Buttons from Fundraiser

With this in mind, let’s take some time to educate ourselves…

What is a “Tampon Tax”?

Currently, states have the authority to determine which products have sales tax and which are exempted. Products such as lip balm and prescription drugs, are defined as “medically necessary items” and are therefore not imposed with a sales tax. Unfortunately, feminine hygiene products are categorized as “luxury items” and taxed (for reference, Michigan sales tax is 6%). Hence the name “Tampon Tax”. This is an example of women being disproportionately affected within health care.

On average, a woman will menstruate over 2,500 days in her lifetime. This equates to almost seven years of using around 17,000 tampons and sanitary napkins. With a 6% sales tax in Michigan, costs greatly add up, especially for something that is a naturally occurring part of many women and should be considered medically necessary.

The topic of menstruation is historically taboo within society, but more recently has lessened over the years. Now, we have seen governments in the U.S. and worldwide start to legislate around this idea of “period equity”, by ensuring proper menstrual education and equal access to hygiene products. Currently, ten states have legislation explicitly exempting feminine hygiene products from the state sales tax: Connecticut, Florida, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, and Nevada*.

*Note: Oregon, Montana, Delaware, New Hampshire, and Alaska do not have a sales tax on any product.

Why should we abolish the “Tampon Tax”?

Feminine hygiene products are not luxury items. These products are used monthly and women should not have unfair financial burdens imposed upon them to purchase what are considered a medical necessity. This is especially true for women with lower socioeconomic status and those without homes.

The main argument against abolishing the “Tampon Tax” is the yearly tax revenue from these products. Menstrual products contribute around $5 million dollars annually to the state of Michigan to be used in various social programs and school aid funds. While loss of revenue could be detrimental to these programs, legislators can creatively think of other ways to ensure that these state programs continue to have funding. Additionally, legislators in Michigan have stated this to be a smaller matter in comparison to other policy topics. But, with a tax affecting millions of women, this legislative act should be at the forefront. The important part to keep in mind is that these products should not have been taxed in the first place as they are medically necessary to such a large portion of the population.

The importance of student pharmacist advocacy!

With managing coursework, student organizations, internships, and self-care, it can be difficult for student pharmacists to stay up to date on legislative pharmacy updates. Though it may seem overwhelming, advocacy is anything that showcases pharmacy. This can range from hosting a “Pharmacy Day at the Capitol” to providing a blood pressure screening to a community member. These acts promote pharmacy practice. We are a generation of new future pharmacists where our profession is constantly innovating and expanding; we want to practice our license to its fullest potential. And we have the power to achieve these goals through pharmacy advocacy.

Menstruation and period products do not directly correlate with pharmacy. However, as health care professionals, it is important that we advocate for all of patient care!

Coming back to our “Galentine’s Day” event, students had the opportunity to write to their state and federal legislators supporting the abolition of the “Tampon Tax”. Overall, we raised around $200 for the Ozone House and were able to mail out 41 of our policy postcards to the following:

  • Eight Michigan State Senators
  • Eleven Michigan State House of Representatives
  • Two Michigan U.S. Senators
  • Two Michigan U.S. House of Representatives

Just two weeks after mailing out our postcards, I received a letter from Senator Jim Runestead (MI-15), who not only thanked me for sharing my thoughts and concerns of abolishing the “Tampon Tax”, but as chair of the Senate Finance Committee, was going to meet to discuss the involved senate bills (currently SB123 and SB124) and finding resolutions for the women of Michigan.

Participation matters! Your voice matters! And most importantly…student advocacy is successful.

How do I get involved?

Whether you’re a pharmacist or student pharmacist, there are multiple ways to lend your voice to abolish the “Tampon Tax” and help others in need. Below are some resources to get started:

  • For student pharmacists, get involved with organizations like APhA-ASP that have committees dedicated to policy and women’s health!
  • Keep up to date with where Michigan’s SB123 and 124 are in the legislative process.
  • PERIOD. – A non-profit organization working to de-stigmatize periods, have accessible period products in public institutions, and abolish the “Tampon Tax”.
  • Helping Women Period – A non-profit organization based in Lansing, Michigan bringing free feminine hygiene products to homeless and at-risk women.
  • Ozone House – Continue our collaboration by helping those in need of menstruation products.

Together, we collectively say “No Taxation for Menstruation”!

References

  1. Censky, A. Legislators Try Again To Dismantle Michigan’s ‘Tampon Tax’ (2019). Accessed 3/18/2020: (link)
  2. Klawiter, J. Michigan Tampon Tax (2017). Accessed 3/18/2020: (link)
  3. Bryan, W. Bill introduced to remove Michigan’s ‘Tampon Tax’ (2019). Accessed 3/18/2020: (link)
  4. Zraick, K. It’s Not Just the Tampon Tax: Why Periods Are Political (2018). Accessed 3/18/2020: (link)
  5. Sagner, E. More States Move To End ‘Tampon Tax’ That’s Seen As Discriminating Against Women (2018). Accessed 3/18/2020: (link)

About the Author

Tina Bednarz, PharmD Candidate is a student at the University of Michigan College of Pharmacy

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