Should pharmacists prescribe birth control?

In its recent segment on Oregon’s new law allowing pharmacists to prescribe and dispense contraceptives, Good Morning America portrayed pharmacists as ill-equipped to fill this need without input from a physician, notably an OB/GYN.¹ During the segment, medical contributor Dr. Jennifer Ashton contended that pharmacists do not have the training or expertise to care for patients using contraceptives.

Said Ashton, “Last night I spoke to the president of ACOG [American Congress of Obstetricians and Gynecologists], and they are all for more access to contraception for women, but they do not think the pharmacist is the right person there, because it in fact puts another person, another barrier in between women and the birth control.¹”

Is that statement scientifically supported? Might it be revenue-driven? We see a clear conflict in this criticism of the value and expertise of pharmacist clinicians.

When Good Morning America co-anchor Robin Roberts asked Dr. Ashton, “Should pharmacists be the best person to handle this situation?” Ashton’s response was “This comes down to risk vs. benefits, and low risk does not mean no risk. The pill does have a slightly increased risk for blood clots; it in fact has an 8% failure rate in preventing pregnancy with typical use, and to state the obvious, a pharmacist is not a physician.”¹

Later, Dr. Ashton tweeted, “But 2 think that ocps [oral contraceptive pills] don’t have significant medical issues attached & that PharmD can manage that is laughable.”

See also: Should pharmacists be allowed to prescribe oral contraceptives?

First things first

Let’s start by correcting the segment’s title: “Over-the-Counter Birth Control Available in Oregon, California to Follow,” with its suggestion that contraceptives will be available over the counter (OTC) in pharmacies.¹

OTC medications are available without a prescription, and patients can purchase them without medical evaluation. In Oregon and California, contraceptives will be prescribed by a pharmacist and dispensed only after a health screening is completed. This is not synonymous with OTC, and clearly birth control pills will not be available like cough drops or antacids.

According to Oregon’s House Bill 2879 Section 2(B), it will be necessary to “[p]rovide a self-screening risk assessment tool that the patient must use prior to the pharmacist’s prescribing the hormonal contraceptive patch or self-administered oral hormonal contraceptive.”

See also: California pharmacists soon able to prescribe birth control

The real problem: Access to care

• It is estimated that within the next 10 years, there will be a 27% shortage of primary care providers (PCPs) in the United States, approximately 90,000 less than the U.S. health system requires.³

• At present, the United States has 300,000 pharmacists, and the number continues to increase.⁴

• More than two-thirds of Californians live in areas with shortages of healthcare providers, according to Senator Ed Hernandez, an optometrist, who is sponsor of the birth-control-pill bill.⁵

• A study published in year 2011 states that in 2006, 49% of pregnancies were unintended - a slight increase from 48% in 2001. Among women aged 19 years and younger, more than four out of five pregnancies were unintended.⁶

According to ACOG, access and cost issues are common reasons why women do not use contraceptives.

An obvious alternative

Pharmacists are the most accessible healthcare providers and are in a unique position to alleviate these issues.⁷ They offer the advantage of convenient locations and extended hours of operations that many physicians do not provide. In the case of urgent care facilities or emergency departments, while patients might find them open, it is unlikely that they would receive contraceptive prescriptions there, and if they did, the pharmacist would be likely to question their intent prior to filling them.

Approximately 250 million people walk into a pharmacy every week. Pharmacists have the opportunity to educate up to 250 million people about unintended pregnancies, to counsel them on pregnancy, and to promote access, as well as to prescribe hormonal contraceptives to women, if so indicated.

It is no secret that pharmacists have expertise in the area of comprehensive contraception counseling. This dates back at least 20 years, to the key role pharmacists played in preventing fetal exposure to teratogenic drugs such a thalidomide and isotretinoin. ^8-12

The benefits speak for themselves

There is strong evidence supporting the beneficial effects pharmacists have on therapeutic outcomes and improved adherence.

A meta-analysis of 298 studies by Marie A. Chisholm-Burns et al. showed favorable impact of pharmacist-provided patient care on therapeutic, safety, and humanistic outcomes.¹³ Another systematic review of community pharmacists’ interventions in chronic disease management showed significant improvements in patient adherence.¹⁴

Consider the effect of pharmacists on immunization rates. In 2004, Steyer TE et al. demonstrated that individuals ages 18 to 64 years and individuals aged 65 years and older are more likely to receive influenza vaccines in states where pharmacists can provide vaccinations.¹⁵ This led to expansion of pharmacy-based immunization to all 50 states. To ensure appropriate vaccine administration, pharmacists conduct health screenings - as they could do to ensure appropriate prescription of contraceptives.

The question of expertise

Good Morning America labeled pharmacists as “a drug resource.” Pharmacists are trained to do far more than that label suggests.

• Pharmacists are highly qualified medical professionals with extensive educational and clinical training in pharmacology, therapeutics, medicinal chemistry, pharmacokinetics, and other related pharmaceutical, clinical, and biological sciences.

• They are trained in disease-state management, including patient monitoring and medication adjustment.

• They learn how to conduct physical exams, point-of-care testing, and health-and-wellness instruction.

• After they receive their doctorate (PharmD), many pharmacists complete postgraduate general residency training, followed by specialty residency.

• Pharmacists can become board-certified in several specialties, among them ambulatory care, critical care, nutrition, pharmacotherapy, oncology, and psychiatry.¹⁶

Government recognition

The federal government has recognized the value of pharmacists for years.

Within the Department of Veterans Affairs, the Department of Defense, and the Public Health Service, pharmacists see patients in primary care and specialty clinics regularly. In collaboration with physicians and other clinicians, they treat diabetes, hypertension, hepatitis, heart disease, infectious disease, cancer, psychiatric disorders, pain, and many other disease states.

They do not diagnose, and they do not wish to.  But given a diagnosis, they prescribe medication, generally selecting the more cost-effective choices; order appropriate laboratory analysis; and triage new problems where immediate medical attention is required. ¹⁷

Who’s watching for interactions?

As Dr. Ashton mentioned, hormonal contraceptives do not come without risk. Furthermore, hormonal contraceptives carry several drug-drug, drug-food, drug-natural supplement interactions where their efficacy is reduced by CYP3A4 inducers, including phenytoin, phenobarbital, St. John’s Wart, carbamazepine, and some antibiotics, such as those in the rifamycin class. Conversely, certain drugs such as macrolide antibiotics could elevate toxicity as a result of diminished metabolism.

Many of these interactions require additional counseling and backup contraception. Often these cases are not brought to the attention of those who prescribe the birth-control pills, a consideration that Dr. Ashton did not address.

Furthermore, various estrogen-based contraceptives induce CYP1A2, leading to potential interactions with commonly prescribed medications such as ciprofloxacin, tizanidine, and olanzapine, all of which do not generally fall within the bailiwick or expertise of any conventional prescribers.

Even if such prescribers were proficient in evaluating these pharmacokinetic issues, they would be far less likely to be aware of the drug combinations, particularly if, for example, an antibiotic or antifungal were prescribed by a dermatologist and the hormonal therapy by an OB/GYN.

Having the pharmacist prescribe hormonal contraceptive will not only increase access; it will also help ensure that selection of these medications is safe and appropriately effective, and will mitigate several risks, including drug interactions.

Study findings

A study in Washington State evaluated the impact of pharmacists who prescribed hormonal contraceptives.¹⁸

The study evaluated 26 community pharmacists and 214 women enrollees. Pharmacists identified women at risk of unintended pregnancy and offered to evaluate them to determine whether they could safely use oral contraceptives, contraceptive patches, or the contraceptive vaginal ring. Interested women self-administered medical and contraceptive history questionnaires.

Pharmacists measured weight and blood pressure, and were allowed to provide hormonal contraception, including oral contraceptives, the contraceptive patch, and the contraceptive vaginal ring.

Study interviewers followed up with women by telephone at 1-, 6-, and 12-month intervals. Of the study participants, 195 women (91%) were prescribed hormonal contraceptives by participating pharmacists. After 12 months, 70% of women responding to an interview reported continued use of hormonal contraceptives.

This study demonstrated that pharmacists can efficiently and safely screen women for hormonal contraceptive therapy and select appropriate products. In addition, almost all respondents expressed willingness to continue to see pharmacist prescribers and to receive other services from them.

The healthcare team

When pharmacists are members of healthcare teams, they improve patient health and decrease costs.¹³

The Community Preventive Services Task Force also found strong evidence that when a pharmacist is included on the team, team-based care can improve blood pressure control.^{19, 20}

Additional research has shown that when physicians and pharmacists work together using medication therapy management (MTM), patients’ chronic conditions improve.^21-23

A clear need

It is evident that there is a clear need for interprofessional collaboration to optimize patient care.

Pharmacists will not replace physicians. Pharmacists work with patients to manage medications and triage them for required physician intervention.

As stated in Oregon’s House Bill 2879 Section C, pharmacists will “[r]efer the patient to the patient’s primary care practitioner or women’s health care practitioner upon prescribing and dispensing the hormonal contraceptive patch or self-administered oral hormonal contraceptive.”

Through team-based care and collaboration, physicians and pharmacists can and should work together toward the common goal of improved patient outcomes by the provision of quality pharmaceutical care.

Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP is a clinical pharmacy specialist, Stratton V.A. Medical Center, Albany N.Y., and adjunct associate professor, Western New England University College of Pharmacy and Albany College of Pharmacy and health Sciences. He is an adjunct assistant professor, University of Connecticut School of Pharmacy. He is owner and managing editor of PainDr.com. He has no relevant disclosures for this topic. Contact him at jeff@paindr.com.

Lisa L. Dragic is a 2016 PharmD candidate at Temple University School of Pharmacy, Philadelphia Penn.

Mena Raouf is a 2016 PharmD candidate at Albany College of Pharmacy and Health Sciences, Albany, N.Y.

This commentary is the sole opinion of the authors and does not reflect the opinion of employers or employee affiliates. It was not prepared as part of Dr. Fudin’s official government duties as clinical pharmacy specialist.

References

1.     ABC News. Good Morning America. “Over-the-Counter Birth Control Available in Oregon, California to Follow.” January 2016. http://abcnews.go.com/GMA/video/counter-birth-control-oregon-california-follow-36077886. Accessed January 12, 2016.

2.     Olis.leg.state.or.us. 2015. https://olis.leg.state.or.us/liz/2015r1/downloads/measuredocument/hb2879. Accessed January 12, 2016.

3.     Colwill JM, Cultice JM, Kruse RI. “Will Generalist Physician Supply Meet Demands of an Increasing and Aging Population?” Health Affairs 27, no. 3 (2008):w232–w241.

4.     Department of Professional Employees. “Pharmacists and Pharmacy Technicians: Facts and Figures.” 2014. http://dpeaflcio.org/programs-publications/issue-fact-sheets/pharmacists-and-pharmacy-technicians-facts-and-figures/. Accessed January 12, 2016.

5.     Healthline News. “California to Let Pharmacists Prescribe Birth Control Pills.” June 2015. http://www.healthline.com/health-news/california-to-let-pharmacists-prescribe-birth-control-pills-062615. Accessed January 12, 2016.

6.     Cdc.gov. Unintended Pregnancy Prevention | Unintended Pregnancy | Reproductive Health | CDC. 2016. http://www.cdc.gov/reproductivehealth/unintendedpregnancy/. Accessed January 12, 2016. Accessed January 12, 2016.

7.      Acog.org. Over-the-Counter Access to Oral Contraceptives - ACOG. 2016. http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Over-the-Counter-Access-to-Oral-Contraceptives. Accessed January 12, 2016.

8.     Zeldis JB., et al. "STEPS: A comprehensive program for controlling and monitoring access to thalidomide." Clin Ther 21.2(1999):319–330.

9.     Uhl K, Trontell A, Kennedy D. "Risk minimization practices for pregnancy prevention: understanding risk, selecting tools." Pharmacoepidemiology and Drug Safety. 16.3(2007):337–348.

10.  Honein MA, Lindstrom JA, and Kweder SL. "Can We Ensure the Safe Use of Known Human Teratogens?" Drug Safety. 30.1(2007):5–15.

11.  Cragan JD, et al. "Ensuring the safe and effective use of medications during pregnancy: Planning and prevention through preconception care." Maternal and Child Health Journal. 10.1(2006):129–135.

12.  Di Pietro NA, Bright DR. "Medication therapy management and preconception care: opportunities for pharmacist intervention." Innovations in Pharmacy. 2014, Vol. 5, No. 1, Article 141. http://z.umn.edu/INNOVATIONS.

13.  Chisholm-Burns MA, Kim Lee J, Spivey CA et al. “US pharmacists' effect as team members on patient care: systematic review and meta-analyses.” Med Care. 2010 Oct;48(10):923-33.

14.  Van Wijk BL, Klungel OH, Heerdink ER, et al. “Effectiveness of interventions by community pharmacists to improve patient adherence to chronic medication: A systematic review.” Annals of Pharmacotherapy. 2005;39:319−28.

15.  Steyer TE, Ragucci KR, Pearson WS et al. “The role of pharmacists in the delivery of influenza vaccinations.” (2004) Vaccine, 22(8),1001-1006.doi:10.1016/j.vaccine.2003.08.045.

16.  Bpsweb.org. BPS Specialties | Board of Pharmacy Specialties. 2016. http://www.bpsweb.org/bps-specialties/. Accessed January 12, 2016.

17.  Fudin J. “Nobody Knows.” December 2015.  http://paindr.com/nobody-knows/. Accessed January 12, 2016.

18.  Gardner JS, Miller L, Downing DF, et al. “Pharmacist prescribing of hormonal contraceptives: Results of the Direct Access study.” J Am Pharm Assoc. (2003) 2008;48:212–26.

19.  Community Preventive Services Task Force. “Team-Based Care to Improve Blood Pressure Control.” July 2014. http://www.thecommunityguide.org/cvd/cvd-AJPM-recs-team-based-care.pdf

20.  Carter BL, Rogers M, Daly J, et al. “The potency of team-based care interventions for hypertension: A meta-analysis.” Archives of Internal Medicine. 2009;169:1748−55.

21.  Odum L, Whaley-Connell A. “The role of team-based care involving pharmacists to improve cardiovascular and renal outcomes.” Cardiorenal Medicine. 2012;2:243−50.

22.  Centers for Disease Control and Prevention. Collaborative Practice Agreements and Pharmacists’ Patient Care Services: A Resource for Pharmacists. Atlanta, Ga.: US Dept. of Health and Human Services, Centers for Disease Control and Prevention; 2013.

23.  Carter BL, Ardery G, Dawson JD et al. “Physician and pharmacist collaboration to improve blood pressure control.” Arch Int Med. 2009;169:1996−2002.