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A 30-year-old patient who refuses to be drug tested.

CASE DESCRIPTION

A 30-year-old African American man with sickle cell disease (SCD) [3] presented with diffuse joint pain, shortness of breath, nonproductive cough, and chest pain. Chest x-ray and computed tomography scan revealed cavitary lesions in the lungs. In addition, transthoracic echocardiogram showed moderate tricuspid value regurgitation and a 3 X 2.8 cm mass at the base of the posterior tricuspid valve consistent with vegetation. Blood cultures were positive for viridans streptococci. The patient was diagnosed with right-sided infective endocarditis and started on intravenous (IV) antibiotics.

While hospitalized, the patient was confrontational, left the hospital frequently, and sometimes refused vital sign monitoring. During his stay, 2 subsequent blood cultures were positive for Pseudomonas aeruginosa and Candida albicans. Given his presentation and history of polysubstance abuse, concern for drug abuse through the IV catheter was raised. The patient refused to submit a urine sample for drug screening; however, blood was drawn with no objections. A serum screen for drugs of abuse was ordered. At our institution, this test requires approval by a laboratory medicine resident and is generally approved only in cases of anuria. On discussing the case with the clinical team, we discovered that the patient had refused urine drug screening and was unaware that serum drug screening was ordered.

DISCUSSION

MEDICAL PERSPECTIVE

The relationship between pain and substance abuse in patients with SCD is complicated, and providers rate encounters with this group as extremely challenging (1). The rate of substance abuse in patients with SCD is believed to be higher than in the general population. Infective endocarditis is one of the most severe complications of IV drug abuse, causing 5%-20% of IV drug abuse-related admissions and 5%-10% of deaths (2). It is suspected when the right heart valves are infected or sepsis is caused by organisms such as P. aeruginosa or C. albicans. Confirmation of IV drug use can omit the need to search for other causes of symptoms. Confirmation can also affect treatment. For example, naloxone can be given to reverse the effects of opioids in the acute setting. Oral antibiotics could be considered if continued IV access is more harmful than helpful. Harm-reduction strategies could also be explored, such as medication assistance therapy or other forms of substance use treatment.

On the other hand, studies have shown that drug screening in trauma victims in the emergency setting rarely changes management (3, 4). Bast et al. (3) retrospectively reviewed 3312 trauma victims' charts. Urine drug screen was performed on 2678 patients, of whom 414 tested positive. Interestingly, the management did not change in any of these patients. Similarly, Kellermann et al. (4) showed that management changed in only 4.4% of patients with clinically suspected drug overdose after drug screening was performed.

LABORATORY PERSPECTIVE

Several factors affect the detection of drugs of abuse. These include the dose administered, chronicity of abuse, route of administration, analytical technique, and type of specimen tested (5). Urine, serum, and saliva can be used for drug testing. Urine testing is the preferred method because it is both noninvasive and more sensitive. Generally, the detection time for drugs of abuse in urine is longer than in serum. For example, morphine can be detected in serum for 20 h after intravenous administration of 12 mg of heroin, and in urine for 35.3 h (5).

LEGAL PERSPECTIVE

In general, informed consent is legally required for all procedures and testing, with few exceptions. Informed consent is a process of communication between the provider and patient. The informed consent document is only a record of the process. Informed consents are required in clinical and research settings. Both include basic information about the procedure as well as the risks, benefits, and alternatives. Research informed consents are typically more comprehensive and often written. Potential consequences of laboratory testing are risks that should be discussed. In practice, however, this is often not done. Failure to obtain consent is civil battery (unconsented touching) and also the basis for malpractice actions in most states (6). Emergencies are the primary exception for consent. Consent for lower-risk testing and care may be implied through the patient's actions or as part of a general consent as part of hospital admission. Nonetheless, most patients wish to participate in decisions while hospitalized (7). Our patient had previously objected to drug testing in urine and therefore required a careful consideration of whether he had revoked his general or implied consent.

Every competent person also has a common-law right to self-determination, which includes a right to refuse treatment. In the US, this is also a constitutional right under the 14th Amendment due-process clause if state action is involved (such as a state hospital or state law). If the testing is done for any law enforcement purpose, it may also be a violation of the Fourth Amendment's prohibition against unreasonable search and seizures. In this case, state action was not involved, and therefore these constitutional issues did not arise.

ETHICAL PERSPECTIVE

Providers have a fiduciary duty to enhance the well-being of the patient. The ability of providers to do so depends on relational trust, in which patients feel safe to disclose personal information. Disclosure of substance abuse is particularly difficult because it is both stigmatizing and literally criminal.

Nonetheless, patients retain the right not to disclose information or refuse a test that would reveal the truth. This right is embodied in the ethical and legal obligation of informed consent: the right to consent necessarily has a corollary right to refuse. This right is grounded in respect for autonomy, one of the principles of biomedical ethics (Table 1) (8). Ethical dilemmas in health care occur when these principles conflict. In this case, the desire to tailor therapy based on knowledge of drug use conflicted with the desire to respect the patient's autonomy.

CONFLICTING PRINCIPLES

Respect for autonomy requires that providers honor the right of competent patients to self-determination in medical decision-making. It also obligates providers to disclose information required for the patient to make in formed decisions. Patient decisions must be voluntary; therefore, coercion or deceit by providers is ethically unacceptable. One of the most common ethical dilemmas is when patients refuse treatments or tests that providers believe honor their obligations of beneficence and nonmaleficence (e.g., Jehovah's Witness refusal to receive blood products); these principles overlap and obligate providers to (a) maximize benefit for patients as well as (b) do no harm or prevent and minimize harm to patients. In this case, respect for autonomy might result in higher costs and wasted resources because of the inability to tailor care. In cases of drug abuse, patients are typically not acting in their own best interests; however, competent patients have a right to make autonomous decisions that are not in their own best interests. Patients actively under the influence of drugs may have fluctuating capacity that must be carefully assessed. Drug testing may help improve treatment or help initiate appropriate referrals, but doing so over a patient's objection will damage the trust that is the foundation of the provider-patient relationship.

Resolving ethical dilemmas requires examination of the conflicting principles and justifying the ultimate decision. Positive results may have employment and legal consequences. In addition, testing done for purely medical reasons can sometimes be used as evidence in criminal cases. Providers should also consider the actual changes to treatment and whether those changes justify the damage to trust attendant to overriding the patient's autonomy. Although existing studies indicate little change in emergency-setting treatment (3, 4), ongoing inpatient treatment may be different. They should also consider whether there are alternatives, such as additional communication with the patient or social work consultations, that could facilitate voluntary disclosure.

Justifying actions that infringe on principles requires consideration of whether (a) the proposed action is likely to achieve the underlying goal; (b) the proposed action presents the lowest degree of infringement; (c) the negative consequences of the action are minimized; (d) no morally preferable options exist; and (e) the proposed action was arrived at through the proper process (8). There are no universal guidelines on obtaining informed consent for inpatient drug testing; instead, individual institutional policies govern the practices. For example, Veterans Affairs hospitals mandate specific informed consent, but do not mandate a process. Other hospitals do not require informed consent or do not have specific policies about drug testing (9). It may be ethically acceptable to override the patient's refusal if (a) serum screening accurately informs the provider whether the patient is an IV drug abuser; (b) that information will substantively change treatment decisions; (c) other less intrusive options have been attempted without success; and (d) hospital policies and careful deliberations were followed.

CASE FOLLOW-UP

In our institution, general treatment consents are obtained on hospital admission. The consent legally allowed serum drug screening even without a specific informed consent. The clinical team was faced with an ethical dilemma of choosing between the patient's autonomy and maximizing his well-being. Testing proceeded and was positive for morphine and tetrahydrocannabinol. A 24-h attendant was provided to prevent further IV drug abuse during the hospitalization.

QUESTIONS

1. Why is a urine drug screen important in this case?

2. Should informed consent be obtained to test the blood in this case?

3. How can providers select clinical care that may infringe on ethical principles?

POINTS TO REMEMBER

* Confirming recent drug use may change patient care as well as allow for appropriate referrals and strategies for treating substance use disorders.

* Urine is the preferred sample for drugs of abuse screening because it is noninvasive and the detection time for drugs of abuse in urine is longer than in serum.

* There are no universal guidelines on obtaining informed consent for drugs of abuse screening in the inpatient setting, but specific informed consent is the most ethically defensible method.

* Consideration of the principles of biomedical ethics and provider obligations may assist decision-making.

References

(1.) Freiermuth CE, Haywood C Jr, Silva S, Cline DM, Kayle M, Sullivan D, et al. Attitudes toward patients with sickle cell disease in a multicenter sample of emergency department providers. Adva Emerg Nurs J 2014; 36:335- 47.

(2.) Miro JM, Moreno A, Mestres CA. Infective endocarditis in intravenous drug abusers. Curr Infect Dis Rep 2003; 5:307-16.

(3.) Bast RP, Helmer SD, Henson SR, Rogers MA, Shapiro WM, Smith RS. Limited utility of routine drug screening in trauma patients. So Med J 2000; 93:397-9.

(4.) Kellermann AL, Fihn SD, LoGerfo JP, Copass MK. Impact of drug screening in suspected overdose. Ann Emerg Med 1987; 16:1206 -16.

(5.) Verstraete AG. Detection times of drugs of abuse in blood, urine, and oral fluid. Ther Drug Monit 2004; 26:200 -5.

(6.) Alper J; Roundtable on Health Literacy; Board on Population Health and Public Health Practice; Institute of Medicine. Informed consent and health literacy: workshop summary (2015). http://www.nap.edu/catalog/19019/informed-consent-and-health-literacy-workshop-summary (Accessed January 2016).

(7.) Upadhyay S, Beck A, Rishi A, Amoateng-Adjepong Y, Manthous CA. Patients' predilections regarding informed consent for hospital treatments. J Hosp Med 2008; 3:6-11.

(8.) Beauchamp TL, Childress JF. Principles of biomedical ethics. Oxford, UK: Oxford University Press; 2013.

(9.) Warner EA, Walker RM, Friedmann PD. Should informed consent be required for laboratory testing for drugs of abuse in medical settings? Am J Med 2003; 115:54-8.

Jalal B. Jalaly, [1] Kelly K. Dineen, [2] and Ann M. Gronowski [1] *

[1] Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, [2] School of Law, Albert Gnaegi Center for Health Care Ethics and Bander Center for Medical Business Ethics, Saint Louis University, St. Louis, MO.

* Address correspondence to this author at: Department of Pathology and Immunology, Washington University School of Medicine, Box 8118, 660S Euclid, St. Louis, MO 63110. Fax 314-362-1461; e-mail gronowski@wustl.edu.

Received July 9,2015; accepted August 31,2015.

DOI: 10.1373/clinchem.2015.246033

[3] Nonstandard abbreviations: SCD, sickle cell disease; IV, intravenous.

Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article.

Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest:

Employment or Leadership: A.M. Gronowski, Clinical Chemistry, AACC, IFCC.

Consultant or Advisory Role: None declared.

Stock Ownership: None declared.

Honoraria: None declared.

Research Funding: None declared.

Expert Testimony: None declared.

Patents: None declared.
Table 1. Summary of ethical principles.

Principle              Definition

Respect for autonomy   Duty to respect a patient's right
                         of governance
Nonmaleficence         Duty to avoid causing harm
                         and to minimize harm to the
                         patient
Beneficence            Duty to maximize benefits and
                         to enhance patient's well-being
Justice                Duty to treat patients fairly and
                         equitability
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Title Annotation:Clinical Case Study
Author:Jalaly, Jalal B.; Dineen, Kelly K.; Gronowski, Ann M.
Publication:Clinical Chemistry
Article Type:Clinical report
Date:Jun 1, 2016
Words:2146
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