US Pharm. 2018;43(5):22-25.
ABSTRACT: Minors are regarded as being under their parents’ or legal guardians’ care until they reach the age of legal adulthood. As a result, parental consent is generally needed for medical care. Many states have conferred on minors the right to consent to their own treatment for certain conditions, including obtaining hormonal contraceptives. Along with the legal right to consent to contraceptives, the confidentiality and privacy of the minor must be considered. Pharmacists may find themselves in the situation of dispensing or prescribing prescriptions for minors who consent to hormonal contraceptives. Compliance with consent laws for minors requesting hormonal contraceptives should be incorporated into practice by pharmacists.
Society has long determined the age at which a person has matured sufficiently to leave the supervision of his or her parents. In the United States, individual states define when minors attain adulthood (known legally as the age of majority), usually at age 18 years. Until that point, unless a minor is emancipated or has other unique circumstances, he or she is under the control of a parent. Once a person reaches the specified age, he or she is granted the privilege of decision making, which often includes his or her personal healthcare. Parental consent for healthcare issues is generally desirable when a minor is too young or is not capable of making an appropriate decision given the complexity of the disease state and adherence to treatment. However, through legislation, many states have determined that certain aspects of healthcare do not require parental consent and minors are granted the freedom of seeking such care on their own. Examples of such healthcare services include prenatal care, treatment for sexually transmitted diseases, drug or alcohol abuse treatment, and contraceptive services.1 Because pharmacists commonly dispense contraceptives or may provide contraceptive services, it is important to understand how current laws grant minors the ability to give consent for these products.
Consent Requirements for Minors
At the federal level, the Title X Family Planning Program issues grants to clinics across the country that provide family planning and related preventive health services.2 Adolescents who receive care at one of these federally funded facilities are not required to have their parents’ or guardians’ consent to obtain hormonal contraceptives or other preconception healthcare services.3 The clinic is not permitted to notify the minor’s parents or guardians about the services received.3 Additionally, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) contains provisions addressing the issue of minors and the privacy of their health information.
Whether minors can or cannot consent to medical treatment is not within the scope of the HIPAA Privacy Rule, which “addresses access to, and disclosure of, health information, not the underlying treatment.”4 Although the Privacy Rule allows parents access to their child’s healthcare records “when such access is not inconsistent with State or other law,” there is a notable exception wherein disclosure of the minor’s records is not permitted.5 The parent or legal guardian should not be given access “when the minor is the one who consents to care and the consent of the parent is not required under State or other applicable law.”5 As a result, laws on the state level provide important insight into the rights of minors consenting to hormonal contraceptives.
Almost every state has passed laws or policies that permit minors to consent to contraceptive services.6 States may allow all minors to consent to hormonal contraceptives or just minors meeting specified characteristics, such as being married or attaining a certain age.6 Along with the ability to consent to contraceptives, state laws usually include privacy or confidentiality regulations with regard to parental notification.1 An example of minor-consent laws and confidentiality may be found in the North Carolina statutes: “Any minor may give effective consent to a physician licensed to practice medicine in North Carolina for medical health services for the prevention, diagnosis and treatment of… (ii) pregnancy,”7 and “The physician shall not notify a parent, legal guardian, person standing in loco parentis, or a legal custodian other than a parent when granted specific authority in a custody order to consent to medical or psychiatric treatment, without the permission of the minor.”8 Pharmacists should always remember to follow the stricter law when federal and state laws conflict.
Considerations in Dispensing Contraception to Minors
State laws and court decisions can impact how pharmacists dispense hormonal contraceptives for minors. Although the state law may not specifically identify pharmacists, efforts should be made to maintain privacy and confidentiality for minors who present with prescriptions for hormonal contraceptives. This could include asking the patient at the time of drop-off whether the prescription information should be kept confidential from a parent or guardian and whether the patient will personally pick up the dispensed prescription or designate another person. Attaching the minor’s filled prescription to another family member’s prescription waiting to be dispensed could result in the unauthorized viewing of the minor’s hormonal contraceptive. Therefore, it is imperative for the pharmacy to ensure that this documentation is made in the patient’s medication profile. Finally, privacy issues may arise if a parent or guardian requests the minor’s prescription history, such as a yearly dispensing record for tax purposes. Although a parent or guardian may insist that he or she has a right to view the child’s medication history, instances in which a minor can consent to medical treatment generally presume the right to confidentiality.5,9 Creating sound policies at the pharmacy and training all personnel can help reduce breaches when minors wish to keep their contraceptive prescriptions confidential from parents or guardians.
Pharmacists Prescribing Contraceptives to Minors
Several states have successfully advanced the pharmacy profession by allowing pharmacists to prescribe contraceptives to patients (TABLE 1), a task previously restricted to other healthcare practitioners (i.e., physicians, nurse practitioners, physician assistants). Results from the landmark Direct Access study demonstrated community pharmacists’ ability to screen and safely prescribe hormonal contraceptives based on a collaborative drug-therapy protocol, with very high patient satisfaction.10 State law specifies the type of training a pharmacist must complete before being granted permission to prescribe contraceptives.11
In general, an encounter begins with completion of a standardized self-screening questionnaire by the patient.11 The pharmacist then reviews the patient’s responses and follows a protocol or algorithm to determine whether hormonal contraceptives are safe for use; after this, a contraceptive product is selected.11 The pharmacist also provides important counseling to the patient, including the need for backup methods of contraception at initiation of therapy, adherence, and potential adverse effects.12 The types of hormonal contraceptives a pharmacist is permitted to prescribe vary by state and may include oral, patch, ring, or injectable dosage forms.12-14 Although it will improve access to hormonal contraceptives, the expansion of pharmacy practice to permit the prescribing of hormonal contraceptives does nothing to change their FDA classification to OTC products.
Although minor-consent laws are important for pharmacists to be aware of, there may be specific age restrictions that preclude pharmacists from prescribing contraceptives to minors in general. For example, pharmacists in Colorado may use a statewide protocol to prescribe contraceptives only “to a person who is at least 18 years of age.”12 Pharmacists in Oregon are also subject to age requirements; however, in addition to prescribing a contraceptive to a person who is aged at least 18 years, pharmacists may also prescribe contraceptives to persons under 18 years of age “only if the person has evidence of a previous prescription from a primary care practitioner or women’s health care practitioner for a hormonal contraceptive patch or self-administered oral hormonal contraceptive.”13 Finally, there is no age restriction in California for patients who are prescribed contraceptives by a pharmacist pursuant to a statewide protocol.14
The Colorado State Board of Pharmacy published a “frequently asked questions” document regarding pharmacists’ prescribing of hormonal contraceptives.15 The document explained the rationale for prohibiting pharmacists from prescribing contraceptives to women aged younger than 18 years. “There are several studies that have demonstrated the safety and effectiveness of over the counter hormonal contraceptives. Unfortunately, these studies involved women over 18 years of age.”15 The studies, which sought to determine the safety of “OTC” oral contraceptives, analyzed the ability of women to self-identify contraindications to therapy by filling out a questionnaire or checklist and then comparing their responses to the assessment of a healthcare provider.16-18 Although two studies included patients aged older than 18 years,17,18 it is important to note that one study included patients as young as 15 years old.16 Regardless, the “OTC” studies for oral contraceptives do not accurately reflect pharmacy practice because the study participants determined the safety of hormonal contraceptives before a healthcare provider intervened.
The Colorado State Board of Pharmacy also cited the American Academy of Pediatrics’ (AAP) policy statement, “Contraception for Adolescents,” as justification to allow pharmacists to prescribe contraceptives only for women aged 18 years and older.19 In this publication, the AAP cites typical use-failure rates of 9% for combined oral contraceptive pills in adults—and possibly higher rates in adolescents—as reason to use other forms of contraception in adolescents.19 The policy statement lists progestin implants, intrauterine devices, and progestin-only injectables as the preferred contraceptives for adolescents, followed by oral contraceptives.19 The Colorado State Board of Pharmacy noted, “According to their review, these alternative contraceptives are much more effective and safe for adolescents. An initial clinical visit with a medical provider will allow adolescents to review these options.”15 Although pharmacists are well positioned to discuss with patients the most effective contraceptive methods, an approach similar to that used by Oregon—in which pharmacists may prescribe hormonal contraceptives to minors using a previous prescription—may be a desirable compromise.
As state pharmacy associations continue to advocate for pharmacist prescribing of contraceptives, a thorough knowledge of the pharmacy-practice and minor-consent laws for their state will help pharmacists determine whether it is permissible to prescribe contraceptives to minors without parental consent. Future research may be performed to determine pharmacists’ ability to prescribe hormonal contraceptives in this patient population.
Conclusion
The subject of minors obtaining hormonal contraceptives without parental consent may be perplexing to the pharmacist. Although some pharmacists may believe that parental consent is required for all medical treatment, many states do not have this restriction concerning contraceptives. As with dispensing prescriptions, pharmacists are expected to exercise professional judgment when prescribing hormonal contraceptives. Pharmacists should familiarize themselves with state regulations when it comes to minors’ right to consent to contraceptives and to comply with any privacy or confidentiality requirements in practice.
REFERENCES
1. English A, Bass L, Boyle AD, Eshragh F. State minor consent laws: a summary. 3rd ed. Chapel Hill, NC: Center for Adolescent Health & the Law; 2010.
2. HHS.gov. Funding history. www.hhs.gov/opa/title-x-family-planning/about-title-x-grants/funding-history/index.html. Accessed February 13, 2018.
3. HHS.gov. OPA Program Policy Notice 2014-01—confidential services to adolescents. www.hhs.gov/opa/title-x-family-planning/about-title-x-grants/program-policy-notices/confidential-services-adolescents.html. Accessed February 13, 2018.
4. HHS.gov. Does the HIPAA Privacy Rule provide rights for children to be treated without parental consent? www.hhs.gov/hipaa/for-professionals/faq/229/does-hipaa-privacy-rule-provide-rights-for-children/index.html. Accessed February 27, 2018.
5. HHS.gov. Does the HIPAA Privacy Rule allow parents the right to see their children’s medical records? www.hhs.gov/hipaa/for-professionals/faq/227/can-i-access-medical-record-if-i-have-power-of-attorney/index.html. Accessed February 27, 2018.
6. Guttmacher Institute. Minors’ access to contraceptive services. www.guttmacher.org/state-policy/explore/minors-access-contraceptive-services. Accessed February 13, 2018.
7. North Carolina G.S. § 90-21.5. Minor’s consent sufficient for certain medical health services.
8. North Carolina G.S. § 90-21.4. Responsibility, liability and immunity of physicians.
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10. 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;48:212-221.
11. Deja EN, Fink JL III. Pharmacists prescribing birth control: improving access and advancing the profession. Pharmacy Times. November 2016.
12. Colorado State Board of Pharmacy approved statewide protocol for prescribing hormonal contraceptive patches and oral contraceptives. www.colorado.gov/pacific/dora/ Pharmacy_Protocols. Accessed February 12, 2018.
13. OAR 855-019-0420. Contraceptive—delivery of care: age requirements.
14. Rafie S. California pharmacists can prescribe birth control. Pharmacy Times. April 2016.
15. Pharmacist-provided self-administered contraception frequently asked questions. https://drive.google.com/file/d/0B-K5DhxXxJZbOXpDQU4xdTAzSlk/view. Accessed February 15, 2018.
16. Shotorbani S, Miller L, Blough DK, Gardner J. Agreement between women’s and providers’ assessment of hormonal contraceptive risk factors. Contraception. 2006;73:501-506.
17. Grossman D, Fernandez L, Hopkins K, et al. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol. 2008;112:572-578.
18. Doshi JS, French RS, Evans HE, Wilkinson CL. Feasibility of a self-completed history questionnaire in women requesting repeat combined hormonal contraception. J Fam Plann Reprod Health Care. 2008;34:51-54.
19. Ott MA, Sucato GS; Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014;134:e1257-e1281.
20. Henry J Kaiser Family Foundation. Oral contraceptive pills. www.kff.org/womens-health-policy/fact-sheet/oral-contraceptive-pills/#footnote-228791-34. Accessed March 22, 2018.
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