AMA Journal of Ethics^®

Case

Dr. Eptor is facing Nick, an adolescent in the community emergency department (ED). Nick is 16, has been sexually active for about a year, has had three partners in the last six months, and has now noticed green penile discharge for about a week. Nick is otherwise healthy and has no other symptoms. Embarrassed about his symptoms, he drove alone for over two hours to Dr. Eptor’s ED out of fear of being recognized. Based on Nick’s clinical symptoms, Dr. Eptor is fairly confident of a diagnosis of Neisseria gonorrhea urethritis and prescribes 250 mg intramuscular (IM) ceftriaxone plus 1g azithromycin by mouth. He sends off Nick’s specimen for Gram stain and culture.

Dr. Eptor is also concerned about Nick’s partners. He recently overheard fellow physicians talk about prescribing a double dose of an antibiotic to cover a potential infection in a partner, something they called “expedited partner therapy.” Dr. Eptor practices in a rural area and mostly deals with members of the local farming community. He has not seen an adolescent with a sexually transmitted infection (STI) in almost five years and generally feels uncomfortable working with this population of patients. Coincidentally, he is currently being sued for misdiagnosing acute coronary syndrome (ACS) as gastric reflux three months ago, so he is feeling uneasy and on edge about making a misstep.

Dr. Eptor struggles as he thinks about Nick and his three female partners. “How could I prescribe something to a person I have never met? What if one has an adverse reaction or doesn’t respond to the medication? Is it ethically justifiable for me to prescribe ceftriaxone, an IM medication?” Dr. Eptor knows that resistance to gonorrhea treatment has been increasing but he doesn’t know the specific resistance profile for the area where Nick lives.

After some reflection, Dr. Eptor also becomes concerned that if he doesn’t provide Nick with additional prescriptions, Nick’s potentially asymptomatic partners might not ever seek care and could develop complications. Dr. Eptor doesn’t want to be responsible for missing an opportunity to treat a subclinical infection in a young woman and risk her developing pelvic inflammatory disease (PID), which could compromise her fertility. He wonders about the scope of his public health role in this case and isn’t sure whether the decision he makes will be compliant with his state’s regulations and institution’s guidelines and protected from a legal standpoint.

Commentary 2

In this case, Dr. Eptor is faced with the decision of how best to treat a probable sexually transmitted infection (STI) in his adolescent patient, Nick, and whether to prescribe for Nick’s asymptomatic partners. This case thus pertains to expedited partner therapy (EPT) and partner-delivered patient therapy (PDPT). EPT involves a clinician treating an STI patient’s sex partners without actually seeing them in person [1]; PDPT happens when a clinician writes additional prescriptions for the patient’s sex partners that are delivered to those partners by the patient. In other words, EPT and PDPT constitute a kind of proxy health care delivery that work best when the clinician’s actual in-person patient serves as a reliable messenger. Currently, the Centers for Disease Control and Prevention (CDC) advises that EPT only be used to treat suspected chlamydia and gonorrhea in patients with opposite-sex partners [2]. Multiple ethical and legal questions arise about EPT and PDPT, which are discussed here.

EPT and “Nontraditional” Clinician-Patient Relationships

Several considerations favor the use of EPT. One source of ethical complexity in this case, from the clinician’s point of view, is the high probability that Nick has infected his sex partners. When one patient is treated and his sex partners are not, infection recurrence for the initially treated patient is possible. In response to this risk for this particular patient, Dr. Eptor could recommend to Nick that he abstain from all sexual relations with any partners until they are all treated and, if need be, cured. There is also a public health risk that the clinician must consider—that others in the community might be infected.

Another ethically relevant consideration has to do with whether the particular STI in question needs to be reported to a state or federal health official. (Clinicians are required, for example, to report confirmed cases of the following to the CDC: chlamydia, gonorrhea, chancroid, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and primary and secondary syphilis.) In this case, Nick’s sex partners are identifiable third parties, so Nick could encourage them to see Dr. Eptor in person for examination, testing, and possible treatment. However, since this kind of “traditional” method of outreach only leads to about 20 percent of sex partners being treated [3], the physician should consider EPT as an ethical means of treating those his patient has put at risk.

Years ago, physicians began employing PDPT in an effort to reach more people potentially infected with STIs and thereby improve both individual patients’ health and the health of the public [4]. Since the CDC’s release of a white paper on the review and guidance for the use of EPT in 2006 [1], more research has been done. EPT has been shown to be efficacious for chlamydia and gonorrhea in heterosexual sex partners through multiple randomized clinical trials [5] and might also be safe to use in cases of Trichomonas vaginalis [6]. Repeat trials have shown EPT to increase the number of sex partners treated and to lower recurrence and persistence of infections [7-10]. Because of this strong clinical evidence, EPT can be said to benefit both patients and the public. EPT requires that both the original patient’s partners and clinicians be willing to interact with each other through an intermediary; this lack of intimacy and connection changes the physician-patient relationship.

EPT is widely practiced by physicians and endorsed by professional societies, with specific statements of support available from the American College of Obstetrics and Gynecology, the American Academy of Pediatrics, the Society for Adolescent Medicine, and the American Medical Association [11-14]. These endorsements suggest that the use of EPT and PDPT can be particularly helpful when patients’ sex partners are unlikely or unable to seek evaluation, testing, and treatment.

Principlism and EPT

Nonmaleficence, beneficence, respect for patient autonomy, and justice [15] are values that can be used to consider Nick’s case more from an ethics perspective.

Nonmaleficence is the “do no harm” principle of ethics, and beneficence means doing what is best for a patient. Although it is clear from the above discussion that EPT offers benefit to the patient, is there potential harm to the patients’ partners? Some physicians might be concerned that a partner could be given a medication to which he or she has an allergy [16], causing discomfort or even a potentially deadly reaction. While an important consideration, it should be noted that an adverse outcome has never been reported in the seven randomized clinical trials performed on thousands of EPT patients [7]. Another possible objection relates to the limited scope of EPT. Although sex partners might be treated for chlamydia and gonorrhea, they would not be treated or tested for other STIs such as HIV, syphilis, or Trichomonas vaginalis. Yet it is known that patients with one STI are at increased risk for co-infection with other STIs [17]. Recent research performed since the publication of the CDC’s white paper in 2006 has shown that it may be appropriate for trichomonas vaginalis to be included with chlamydia and gonorrhea as diseases that can be treated via EPT [6, 7]. Also, female patients infected with STIs are at risk for pelvic inflammatory disease (PID), infection extending beyond the cervix; of note, EPT is only prescribed to treat cervicitis. No research studies have been performed to determine the safety of EPT for PID. Due to the length of treatment required and the risks of infertility and systemic infection, a physician must still evaluate female patients with signs and symptoms of PID prior to initiating treatment.

EPT can also lead to a missed opportunity for patient care, and it could delay the identification and assessment of symptoms that might indicate diagnoses other than those for which the partner is being treated. Despite these concerns, the risk to patients who received EPT seems to be low [7]. Partners can be treated via EPT and then encouraged—presumably by the patient who is acting in the role of messenger—to extend, for lack of a better term, a physician’s invitation to be evaluated and assessed more fully. Physicians also cite concerns about the legality of EPT, specifically of prescribing a medication for a person they have never met or examined [18]. Currently, EPT is legal (explicitly allowed) or permissible (not explicitly illegal) in all but four states [19-23].

Respect for autonomy is a third principle to be considered, one expressing the importance of respect for a patient’s right to self-determination. This right is protected by two additional concepts of ethical importance: informed consent and confidentiality. Given the remote nature of health care delivery in EPT, is meaningful informed consent possible? While educational materials are available, such as those offered online by New York City’s PartnerCare [24] for a patient’s sex partners, the remote nature of health care delivery provided via EPT means that clinicians’ capacity to respond to patients’ questions and concerns is limited. Despite this limitation, as I’ve argued, the benefits of EPT seem to outweigh the risk that patients might not be fully informed about taking their prescribed medications.

For EPT to work, physicians must convince patients to disclose protected health information, including a diagnosis, to their partners. This is one way physicians can express respect for the autonomy of patients they don’t see directly. The Belmont Report states that patients, “to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them” [14]. Informed consent is abrogated by EPT, in that physicians never directly see or interact with the sex partners for whom they are writing prescriptions. It is impossible for full informed consent to be obtained without any sort of direct physician-patient interface. which is partially addressed by including prepared educational materials with the prescription for the sex partners of patients who will be receiving EPT [24]. The benefits of EPT seem to outweigh this very real negative ethical downfall of EPT.

Patient privacy is also violated in EPT, as it is typically necessary for patients to tell their sex partners about their diagnosis. Patient privacy is violated during most direct patient referral interactions as well, so this is not a particular weakness of EPT, but rather a factor of treating the partners of patients infected with sexually transmitted diseases.

Finally, we consider the principle of justice. Our current health care system, despite advances made in coverage by the Affordable Care Act, leaves many patients without access to care. As physicians operating in an imperfect system, it is important to remember that some patients will not be able to seek care due to financial constraints or lack of clinician availability. This might be particularly true for Dr. Eptor’s patients, as he practices in a rural area. EPT promotes access and therefore increases justice. EPT, and other forms of remote health care delivery (e.g., telemedicine), despite their drawbacks, increase the chances that persons not willing or able to visit a physician in person—due, perhaps, to a lack of insurance coverage, social or cultural factors, or immigration status, for example—can be treated.

When considered from a principlist perspective, EPT, despite the reservations noted above, is an ethical way to practice medicine. From a safety standpoint, research shows that EPT is safe for the limited STIs for which it is used. From a practical standpoint, treating patients remotely with an intramuscular injection of ceftriaxone is impossible, but a single 400-milligram dose of oral cefixime cures 96 percent of gonorrhea cases [25]. As long as the limitations of remote practice of health care are identified, considered, and responded to as fully as possible by clinicians practicing EPT, that can be called ethical medicine.