The chemically dependent patient should be given the same rights and conscientious care as a patient treated for any other physical ailment.
Addicted persons should be assured that their care will be comprehensive and nonjudgmental and their rights to privacy and decision making respected.
Without this ethical basis and assurance of protection, it would be very difficult for addicts to voluntarily seek treatment without fear of being discriminated against for doing so or being treated with substandard care.
Federal regulations (42 CFR, § Part 2) are in place to protect and enforce a patient's fundamental rights to privacy and nondiscrimination.
Addiction treatment professionals should also be cognizant of the principles of respect and beneficence that are not mandated by any law.
In designing programs and providing services, agencies and individual providers must adhere to Federal and State laws.
Because these laws are subject to change, programs and services need to be reviewed periodically by the provider's legal counsel.
Any federally assisted alcohol or drug abuse program, hospital, clinic, and/or referral center must follow Federal regulations concerning the confidentiality of alcohol and drug abuse patient information (42 CFR, § Part 2).
While State laws may be more stringent than Federal regulations, they may not negate any stipulation laid out in the Federal regulations.
Hospitals, clinics, and treatment program staff must be aware of their State's laws, regulations, and reporting requirements (e.g., with respect to mental health, HIV, and child protection).
Likewise, patients in treatment programs should be told what confidentiality protection their program offers and when these protections may be suspended.
For instance, a program can be subpoenaed to release confidential treatment records.
However, the program has the right to present its case for nonrelease prior to release of any information if a valid legal defense is presented.
Confidentiality and reporting laws and regulations significantly affect service providers.
The challenge is to design a treatment program that complies with Federal and State laws and regulations, while providing services responsive to patients' special needs.
Treatment program staff must be trained to deal with the conflicts between confidentiality and reporting issues and to recognize how these conflicts affect their ability to deliver services (CSAT 1994a).
The Federal regulations on confidentiality and reporting are set forth in 42 CFR, § Part 2.
In many instances, they restrict the treatment provider from releasing information about drug abuse patients to a greater degree than doctors or attorneys are restricted in releasing information about their clients.
Violating the regulations is punishable by a fine of up to $500 for a first offense and up to $5,000 for each subsequent offense.
Any program that specializes, in whole or in part, in providing treatment, counseling or assessment, and referral services to patients with alcohol or other drug problems, must comply with the Federal regulations.
These Federal regulations apply to all programs that receive Federal assistance; this includes indirect forms of Federal aid such as tax-exempt status or State or local government funding coming in whole or in part from the Federal Government.
The regulations and the exceptions to them are specific; for more indepth information regarding confidentiality, disclosure, and reporting, refer to Confidentiality: A Guide to the New Federal Regulations(Legal Action Center 1988).
Each MTP may write a bill of patients' rights and responsibilities tailored to the specific requirements of the program.
Service providers can establish a basis of trust and respect by discussing these rights and responsibilities with the patient upon admission.
In addition, all staff should understand them.
The State Methadone Treatment Guidelines (Chapter 4-Admissions Policies and Procedures) outlines the crucial items to be included in a patient's rights statement (CSAT 1993b).
To initiate treatment, Federal regulations require that the patient sign an informed consent (FDA Form 2635) regarding participation in methadone maintenance (21 CFR § 291.505(d)(1)(ii)).
All patients are entitled to be advised of their rights and responsibilities regarding confidentiality, program policies and procedures, and treatment services provided.
Many programs obtain other consents at this time to facilitate admission and improve treatment.
Consent to obtain records from other treatment programs or hospitals or both will allow the medical team to better assess the patient.
Consent to notify a central registry (to preclude enrollment in more than one MTP) and consent to allow the program to bill insurers for services rendered should also be obtained.
Some MTPs include written agreements for the patient to sign concerning program policies regarding patient fees, prevention of diversion or loitering, community incidents, proper storage of medication in the home, and other important issues.
Programs should be aware that many applicants are extremely anxious during the admissions process.
It may, therefore, be necessary to review the many forms and consents with the patient after a few weeks when he or she is more stable and able to clearly understand these documents.
Methadone treatment program staff should be concerned with how they communicate with patients regarding confidentiality and reporting, and how they share information about a patient with other programs or individuals.
Patients should receive the following information:
Information about the various Federal, State, and local laws and how such laws affect individuals receiving services.
Information about their right to confidentiality; patients should be informed about laws related to reporting and court involvement.
A copy of the written informed consent document.
When informed consent is obtained, it must be time limited, content specific, person-to-person, signed, and witnessed, in keeping with the requirements of Federal drug treatment confidentiality laws.
Service providers and patients should be concerned with how courts handle patient records, and under what circumstances courts can order medical or psychiatric evaluations or both.
Once records go to adult court they become public record.
Individuals concerned about court records and subpoenas need to understand State laws.
It should be noted that in most States, but not all, juvenile records are confidential.
Courts can order an evaluation to determine if a patient needs treatment for substance abuse, to make a diagnosis, and to make a referral for treatment or services.
If the court orders the evaluation, the information cannot be kept from the court because of confidentiality regulations.
However, the information is still confidential to all other individuals and institutions outside the criminal justice system.
Patients should also receive information regarding confidentiality of records on entering treatment.
Assurance of confidentiality in HIV counseling and testing is imperative if the desired outcome is routine consent to testing.
Persons will be more likely to participate in counseling and testing programs if they believe that they will not experience negative consequences in areas such as medical services, housing, employment, and school admission.
Most States require that patients who agree to counseling and testing sign an informed consent specific to HIV testing.
This consent should describe what the HIV antibody test does and does not indicate, State practices regarding the reporting of test results, and confidentiality guidelines followed by the program and the State.
The program should stress to patients that having specific clinic staff know their HIV status can be integral to providing comprehensive substance abuse treatment.
Individual MTPs should define their criteria for "need to know" in light of the need for confidentiality.
The patient's signed informed consent indicates those staff who need to know HIV test results in an emergency situation.
On the other hand, patients should have the option of anonymous, off-site HIV counseling and testing if they so choose.
Requiring individuals to be tested for HIV and other infectious diseases as a condition of admission to treatment, refusing to admit otherwise eligible individuals, or providing differential treatment to such patients are practices that are likely to violate Federal and State nondiscrimination laws.
However, to protect the safety and health of the patients and staff, an individual seeking treatment who is thought to have active TB or any other highly contagious disease may be denied admission until it has been medically determined if the patient needs treatment prior to being admitted to the program.
Undoubtedly, testing for infectious diseases can benefit patients in treatment as well as the community at large.
Testing for HIV, hepatitis B, TB, syphilis,4 and other sexually transmitted diseases is strongly advocated for treatment populations as it can lead patients to seek appropriate medical care, initiate preventive actions, and interrupt the transmission of the disease to others.
Despite these benefits, some patients may choose not to undergo testing.
Treatment providers need to be respectful of these choices.
Certain infectious diseases must be reported to health authorities under State statutes and regulations.
Many variations exist among States concerning conditions and diseases to be reported, timeframes for reporting, agencies that should receive reports, persons required to report, conditions under which reports are required, and penalties for not reporting.
In most States, local health departments rather than State departments receive infectious disease reports.
The patient needs to be made aware of these State regulations while at the same time being reassured that this information is confidential and will not be released inappropriately.
Treatment providers should seek information about the requirements of their State and develop protocols and training programs to ensure compliance (CSAT 1994a).
Programs can fulfill both State reporting and Federal confidentiality requirements in the following ways:
The program can obtain the patient's consent for disclosure of information.
Programs that are part of a general hospital or larger health care facility can make disclosures that do not identify an individual as a drug or alcohol patient.
A program can enter into a Qualified Service Organization Agreement (QSOA) with a laboratory or medical care provider that conducts HIV testing or other diagnostic services for the program.
Under this agreement, the program gives the names of individuals with reportable conditions to the service provider, which in turn discloses the information without disclosing the person's status as an alcohol or substance abuse patient.
Programs can disclose information under the research exception if the purpose of the State's reporting law is solely to collect data about the incidence of HIV and AIDS so that the State can comply with the requirements of the law.
Public health statutes in States usually authorize or require contact tracing for sexually transmitted diseases.
Most States currently do not classify HIV infection as a sexually transmitted disease, although some States have specifically authorized or required such tracing.
The informed consent of the patient must be sought for contact tracing and partner notification in circumstances where statutes are silent.
All notifications accomplished by persons other than the patient, regardless of the reporting requirement, are performed without revealing the identity of the patient (CSAT 1994a).
Although the name of the infected person is not revealed during partner notification and contact tracing, it may be inferred by the partner in some situations.
These notifications may place patients in treatment at risk for negative consequences, such as physical abuse or abandonment.
Treatment providers should exercise care to protect patient confidentiality when counseling about, assisting with, or performing partner notifications and contact tracing.
Public health statutes in all States require the Public Health Service to be notified of cases of known or suspected active TB.
Laws mandate appropriate followup and treatment of anyone who may have acquired TB from a known exposure to an individual with active TB.
Despite strict ethical codes and legal requirements for the confidentiality of patient information, some treatment providers may find themselves under a "duty to warn" statute that may require a breach of confidentiality.
Treatment providers may be faced with and should be prepared to resolve the conflicting obligations to protect the patient's right to confidentiality and the duty to warn a third party of a threat to harm (CSAT 1994a).
A trend in the law has developed to require psychiatrists and other therapists to take "reasonable steps" to protect an intended victim when they learn that a patient presents a "serious danger of violence to another." This trend started with the case of Tarasoff v. Regents of the University of California, 17 Cal3d 425 (1976).
In this case, the California Supreme Court held a psychologist liable for monetary damages because he failed to warn a potential victim whom his client killed after first threatening to do so.
The court ruled that a psychologist has a duty to warn the intended victim or others likely to notify the victim of the danger, to inform the police, or to take other steps reasonably necessary under the circumstances.
While the Tarasoff ruling, strictly speaking, applies only in California, courts in a number of other States have followed Tarasoff in finding therapists liable for monetary damages when they failed to warn someone threatened by a client.
Most of these cases are limited to situations in which patients threaten a specific identifiable victim, and they do not usually apply where a patient makes a general threat without identifying the intended target.
States that have enacted laws on this question of a threat to a specific victim have similarly limited the duty to warn to such situations.
There is, however, another problem: The apparent conflict between the Federal confidentiality requirements and the Tarasoff case.
The Federal confidentiality regulations prohibit the type of disclosure that Tarasoff and similar cases require, unless the disclosure is made pursuant to a court order or is made without identifying the individual who threatens to commit the crime as a patient.
Moreover, Federal regulations make it clear that Federal law overrides any State law that conflicts with the regulations.
In the only case, as of this writing, that addresses this conflict between Federal and State law (Hensenie v. United States, 541 F.
Supp. 999 [D.
Md. 1982]), the court ruled that the Federal confidentiality law prohibited any report.
A program that learns a patient is threatening violence to a particular person or persons may be well advised to seek a court order permitting a report or to make a report without revealing client-identifying information.
If a staff person believes that a particular person is in clear and imminent danger, it is probably wiser to err on the side of reporting the danger to the authorities or to the threatened individual.
This guideline is especially important in States that already follow the Tarasoff rule.
While each case presents different questions, it is doubtful that any prosecution (or successful civil lawsuit) under the confidentiality regulations would be brought against a staff member who warned about potential violence when he or she believed in good faith that a particular individual was in real danger.
On the other hand, a civil lawsuit for failure to warn may well result if the threat is actually carried out.
In any event, the counselor should at least try to issue the warning in a way that does not identify the individual as a substance abuse patient.
Nonconsensual and unauthorized release of confidential information may harm the patient and may subject the health care and social services provider to civil or criminal liability.
To avoid this possibility, the MTP administrative staff should develop protocols and procedures governing the release of information and train employees in their use.
Access to counsel knowledgeable in the area of confidentiality should also be provided to employees.
At a minimum, the following information should be covered in protocols and training:
Elements of and procedures for obtaining informed consent
Situations in which consent to release information is not necessary (e.g., if the patient is in an emergency room and unable to communicate adequately, communication with medical personnel is justified on the basis of the medical emergency clause)
Whether to notify patients when information is released without their consent (e.g., court order or medical emergency)
How to respond to a request for information (e.g., in denying a request, making sure that the denial does not itself confirm the existence of a medical or substance abuse condition)
How to limit disclosures to information necessary and relevant for the provision of services to the patient or how to satisfy legal grounds for nonconsensual disclosure
While the Federal regulations were set up to protect the confidentiality rights of drug and alcohol patients, the law can pose difficulties for addiction treatment professionals when confidentiality seems at odds with a person's duty to warn.
The following section discusses a few of the difficult and controversial topics specific to methadone patients concurrently dependent on opioids and cocaine.
Some issues remain in contention among the Consensus Panel; however, some essential ethical guidelines are put forth based on sound clinical judgment.
Continued cocaine use by concurrently dependent methadone patients poses particular challenges to program staff in providing comprehensive services.
Controversy exists among expert clinicians about when and whether to discharge a patient from a methadone program for continued use of illicit drugs and alcohol.
The Consensus Panel agrees that patients should be given every chance to continue in and try to benefit from treatment and that treatment should last as long as it is appropriate and effective.
Staff should make every effort to rework treatment plans and provide help and counseling for continued use of other drugs.
A policy of administrative discharge of patients from treatment for continued addict behavior, such as discharge for cocaine-positive urines, may sometimes be self-defeating.
Treatment providers have worked on ways to discourage continued drug use while patients are in treatment (see chapter 4). If a methadone-maintained patient continues to use heroin, the physician should look carefully at dosage and blood plasma levels to see if there is a problem with metabolism, absorption, or excretion that might influence adequacy of dosage.
There is controversy over where to draw the line with concurrently dependent patients.
Those favoring a harm-reduction approach stress that no matter how extensively patients on methadone use illicit drugs, they are better off than they would be without methadone.
Particularly, their risk of acquiring or spreading HIV infection while on methadone is reduced.
On the other hand, failure to set limits increases the likelihood of a particular patient's continued use of drugs and of increased overall use in the clinic, thereby defeating the harm-reduction goal.
Because of the scarcity of treatment slots and waiting lists for methadone treatment in many locations, an individual who occupies a treatment slot while continuing to inject may prevent another patient from receiving treatment who wants it and might benefit more.
This issue would not be as important if treatment were promptly available to all who need it.
Given the scarcity of treatment resources, programs may need to consider administrative discharge for patients in noncompliance and develop their own policies based on the unique characteristics of the clinic and the patient population served.
Pregnant patients who continue to use drugs, including alcohol, also pose special difficulties.
Every effort should be made to counsel these patients about the dangers of continued substance use.
Practices and procedures such as warning, extra counseling, urine screens, loss of take-home privileges, and probation should be used.
It is also essential to retain pregnant patients in treatment, where they may benefit from supportive and medical services.
Discharge exposes them to potential relapse to needle use and life on the street.
Although withdrawal from methadone is rarely recommended for pregnant patients, when it is attempted it must be done with special care under the supervision of a physician experienced in perinatal addiction (see chapter 4).
There will, nevertheless, be situations when an administrative or disciplinary discharge is necessary.
When a patient endangers staff, other patients, or program existence with violent, threatening, or criminal behavior, he or she should be discharged after adequate warning.
The Consensus Panel recommends establishing ethical criteria for discharge that include a suitable dosage protocol for withdrawal from methadone and a readmit procedure that includes a behavioral contract.
If a private clinic has to discharge for nonpayment, one way to ensure that a patient is not abruptly cut off from medication is to require payment upon admission for the first and last months to establish a buffer zone for gradually tapering off medication.
The Consensus Panel agrees that blind withdrawal is unethical unless requested by the patient to aid in the withdrawal process.
Withdrawal and discharge should be a last resort in light of the strong probability of relapse and the subsequent dangers of infectious disease that jeopardize the patient's health.
In addition, withdrawal can lead to potentially serious medical complications.
Withdrawal should not be considered as a punitive action but can be a measured response to program ineffectiveness for that patient.
Treatment providers will be confronted at times with difficult situations involving patients with children and their local child protective services agencies.
Some patients may have already worked out agreements about what must be done to keep their children before they enter a drug treatment program.
Programs should not discriminate against patients on the basis of such agreements or their involvement with child protective services.
All Federal and State laws regarding confidentiality should be adhered to.
If a child is judged to be at imminent risk of harm and all intervention services have failed, a child protective services worker may be involved.
Alcohol and other drug use alone, however, should not be the sole criteria for court intervention (CSAT 1993a).
Reporting can cause dilemmas as hospitals, programs, and physicians must also adhere to the Federal confidentiality laws on alcohol and drug abuse information.
Programs need to be cognizant of the reporting requirements in their State, and patients should also be advised about certain situations in which their confidentiality protections may be suspended.
For example, a physician treating a mother who abuses cocaine and leaves her young children alone may be required to report the situation to a child protective services agency despite the confidentiality agreement between the physician and patient.
Reporting laws on maternal substance abuse and fetal exposure have an impact on pregnant patients and patients who are mothers.
A report on a substance-abusing mother could lead to removal of children from her care and placement of them in protective custody or foster care.
A woman might forego getting prenatal care, followup care, or even treatment for fear of losing her child.
4TB and syphilis testing is required by 21 CFR § 291.505.
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