An Analysis of Ethical Issues in Prescribing and Dispensing Syringes to Injection Drug Users

Zita Lazzarini, JD, MPH
Director, Program in Medical Humanities, Health Law, and Ethics
University of Connecticut Health Center
263 Farmington Ave. MC- 6325
Farmington, CT 06030-6325
phone: 860-679-5494
fax:860-679-5464
e-mail: lazzarini@nso.uchc.edu

June 30, 2000

I. Introduction

Physicians caring for patients at risk of HIV infection or those already infected face many complex decisions. Perhaps one of the most contentious is the physicians' and health agencies' roles in HIV prevention among active injection drug users (IDUs). Specifically whether health care providers or the government should endorse and support efforts to provide sterile syringes to drug users. Considerable attention, both public and scholarly, has focused on the appropriate use syringe exchange programs. Less debate has centered on efforts to deregulate syringes (remove prescription requirements or limits on possession) and the practice of physicians prescribing syringes to IDUs. This article considers two questions: whether it is ethical for physicians to prescribe and pharmacists to dispense syringes to IDUs, and whether physicians and pharmacists have an affirmative ethical duty to do so. The article begins by describing the dilemma, then discusses the ethical framework of the physician-patient and pharmacist-patient relationship. Next, it considers several roles law plays in relation to these questions. In conclusion it suggests that the weight of ethical reasoning supports physicians' choice to prescribe and pharmacists' to dispense.

The Problem

An estimated 1.1-1.5 million persons in the United States use injection drugs. Injection drug users (IDUs) risk contracting viral diseases such as hepatitis B and C, and HIV, parasitic infections, including malaria, and bacterial illnesses such as endocarditis from using contaminated injection equipment. Injection drug use may cause as many as half of all new HIV infections nationwide. (Holmberg, 1996) In the Northeast injection drug use has been the leading risk factor associated with new AIDS cases since 1988. As a consequence, public health officials, clinicians and policy makers have sought effective means to reduce injection drug use, get active IDUs into treatment, and reduce the risk that IDUs not in treatment will contract HIV or transmit it to their sexual partners, children, and other IDUs. Active IDUs can take relatively simple steps to avoid bloodborne infections by using a sterile syringe for each injection, not sharing drug preparation equipment with other IDUs, and not mixing drugs with other IDUs.

Structural impediments in most states (laws, regulations, and policies), however, make it dangerous or impossible for IDUs to obtain and carry sterile syringes, despite the fact that these syringes might save their lives. Many health officials and activists support syringe exchange programs (SEPs) as one means to provide sterile syringes to IDUs who cannot otherwise obtain them legally. Some jurisdictions have modified existing laws to permit IDUs either to possess syringes (e.g., Oregon) or to purchase syringes without a prescription (e.g., Connecticut and Maine). (MMWR 1998)

Despite exhaustive empirical studies showing the overall beneficial impact of SEPs and syringe deregulation, (Normand, 1995) heated public debate continues to focus on whether government should ever actively participate in providing syringes to IDUs. In the year 2000, after nearly twenty years of the AIDS epidemic, the U.S. remains without a national policy to support increased access to sterile syringes as part of a comprehensive HIV control policy, and with many state and local laws that continue to discourage safe injection behavior by IDUs.

Physicians caring for IDU patients have limited options for HIV prevention. They know their patients risk contracting HIV and other bloodborne diseases from contaminated injection equipment and they risk transmitting these diseases to others once infected. Many also know that IDUs cannot legally obtain syringes on their own. Physicians have limited choices to protect their patients and the public's health. They may be able to refer their patients to legal SEPs, or even, in a few states, to advise them to purchase syringes over the counter in local drug stores. But the majority of physicians caring for IDUs have no legal source of sterile syringes to offer IDUs, except the same source they would offer their diabetic patients, a prescription. Some physicians would like to be able to prescribe sterile syringes, but fear possible legal and professional consequences. Even where syringes may be purchased legally without a prescription, state law or regulation may demand that customers demonstrate a "legitimate medical purpose" for their use. Most pharmacists find a doctor's prescriptionprima facie evidence of medical legitimacy. Pharmacists may also be aware of, and feel constrained by drug paraphernalia laws that prohibit sales of paraphernalia, including syringes, where the seller knows that the user intends to use it to ingest or inject illegal drugs. (Gostin & Lazzarini, 1997) In either case, pharmacists may demand customers produce a prescription even where laws actually do not require one.

In confronting this problem, physicians and pharmacist ought to ask: whether it is ethical for physicians to prescribe and pharmacists to dispense syringes to IDUs, and whether physicians and pharmacists have an affirmative ethical duty to do so. In considering this dilemma, three terms, "law," "ethics," and "morals" may cause confusion. For the purposes of clarity the terms are defined as follows: "law" consists of "norms formally promulgated by a political authority and more or less enforced through a legal process based on adjudication;" "ethics," of "norms shared by a group on a basis of mutual and usually reciprocal recognition;" and "morals," of "notions of right and wrong that guide each of us individually and subjectively in our daily existence." (Hazard, 1995, p. 447-58) Legal parameters are more easily defined than ethical, since laws must be reduced to a single form for adoption and enforcement. Ethics and law, however, are inextricably intertwined since widely held views of what is "right" and "wrong" (ethics) often drive formal policy formation (laws). By examining ethical approaches and related legal theories I hope to shed light on how professionals or policy makers might approach these issues. Necessarily I will also consider the moral concerns that drive individuals. The debate over the "rightness" of providing sterile syringes to drug users may be founded on irreducible moral (as opposed to ethical) conflicts. The failure to reach perfect consensus should not, however, deter those interested in physicians' and pharmacists' obligations to their patients from seeking to make the most reasoned ethical evaluation of the problem. This article seeks to explore the contours of physicians' and pharmacists' obligations to their patients who are IDUs in the context of the HIV epidemic, recognizing that law, ethics and morals each play an important role in this debate.

The article does not address the "whole picture" of HIV prevention. We take it as given that increased access to syringes through SEPs, deregulation, or prescription, cannot be effective alone and must be part of a comprehensive HIV prevention and treatment policy as well as integrated programs to prevent drug use and provide timely access to drug treatment for IDUs. Ultimately, physician prescriptions for syringes may reach only a small proportion of IDUs, and therefore represent a small public health intervention. However, prescriptions can be a useful clinical tool for individual physicians and their patients. Prescribing also makes a powerful symbolic statement by physicians since it engages physicians directly in HIV prevention among active IDUs.

II. The Physician's and Pharmacist's Relationship to the Patient

A. The Ethics of the Physician-Patient Relationship

1. Fundamental ethical duties and goals

The doctor-patient relationship may be defined as a fiduciary relationship characterized by unequal knowledge and power in which one party exercises special skills to benefit the other. As part of this special relationship, physicians have a fundamental duty to act in their patients' best interest, to avoid harming their patients, and to act as their patients' advocates when necessary. (Beauchamp & Childress, 1994) A physician's duty traditionally arises during the first physician-patient encounter, concomitant with the beginning of the therapeutic relationship. A duty may arise, however, without the physician ever meeting the patient face to face, as when a consultant gives advice on treatment of a patient based on a long-distance consultation.

The content of that duty, what physicians can or ought to do, is more difficult to define. Professional codes, the common goals of the profession and application of ethical standards support certain broad principles of conduct, yet thoughtful professionals and ethicists can disagree about the details of specific cases.

Physicians as professionals commit themselves to professional codes of conduct and ethics which have their roots in the Hippocratic tradition of ancient Greece, but continue to be adapted to meet modern dilemmas. Professional codes are not usually binding as a matter of law, but they represent important current expressions of professional and societal norms.

Leading professional organizations define the goals of medicine broadly as: to prevent disease, to restore or preserve health or function, and to alleviate suffering. Physicians may also work with patients to achieve other, patient centered goals, which are compatible with the goals of medicine, including patients' social and spiritual goals as they cope with illness and death. (Faber-Langendoen, 1998)

2. Ethical theories

No single ethical theory or approach has achieved universal acceptance as the best or right way to resolve ethical dilemmas in medicine. Several approaches justify attention in this case - - consequentialist (teleological ), nonconsequentialist (deontological), and the principled approach. These theories, as well as the concept of "virtue," provide a theoretical basis for parts of the professional codes of ethics and can be used both to describe how individuals actually behave (descriptive ethics) and how they should behave (normative ethics).

Consequentialism determines what is right based on the what results an action brings. For example, in a utilitarian-consequentialist theory the proper action is the one that achieves the greatest benefit for the most people. Consequentialists need to know or estimate the outcomes of acts and must use some system to determine what is a "benefit" or which is the greater "benefit." (Beauchamp & Childress, 1994)

By contrast, the deontological approach maintains that the correctness of an action must be determined independently of its results. According to deontologists, maintaining other universally important ideals, including truth-telling, confidentiality, non-discrimination, and obedience to the law are more important than the actual outcomes of an act. Therefore, deontologists will not favor arguments based on the benefits or harms the action will bring about. (Beauchamp & Childress, 1994)

Proponents of "virtue" ethics argue that physicians should embody the character or virtues of a good physician: truth, integrity, loyalty, courage, and compassion, among others. Also described as "character" ethics, this reasoning stresses the motivations of moral agents, both physicians and patients. Virtue ethics emphasizes that neither rules nor principles will guarantee ethical choices if the motivations of agents are improper. In determining the proper course of action physicians should ask: 1) how would I act if I was motivated by truthfulness, loyalty, compassion, and integrity (or other professional virtues)? and 2) is my chosen action "appropriately gauged to bring about the desired [result] and [is it] morally justified in conformity with relevant principles?" (Beauchamp & Childress, 1994, p.56-62).

The principled approach to biomedical ethics, arguably the most common approach used in clinical ethics, holds that physicians must strive to respect four basic principles in making choices: respect for persons (or autonomy), beneficence, nonmaleficence, and justice. Thus, the principled approach encompasses aspects of both consequentialism and non-consequentialism. The results of actions remain important (helping rather than harming your patient), but the duty to respect individuals' autonomous choices relies more on the rightness of the action itself, often independent of its consequences. Ethical dilemmas arise when an action (or inaction) creates tension between principles. Critics of the principled approach note that it contains no formal means to resolve conflicts between principles.

Considering distinct ethical theories elucidates the different possible approaches to the questions: whether it is ethical for a physician to prescribe (or a pharmacist to dispense) syringes to IDUs to prevent bloodborne diseases; and whether the physician or pharmacist has an affirmative duty to do so. Key issues that reappear throughout the review of differing ethical approaches include: 1) the significance of empirical data on access to syringes and disease prevention; 2) defining the physician's role in caring for IDU-patients; and 3) the symbolic import of providing syringes versus recommending treatment or abstinence.

3. Defining ethical duties in new situations - Should physicians prescribe syringes for IDUs?

Defining a physician's obligations to her IDU patient demands consideration of the nature of the physician's obligation, available alternatives, and often, practical implications such as the impact of illegal actions on the physician.

IDU patients often experience a number of serious health and social risks. Continued use of illegal drugs poses risks of morbidity and mortality from many causes. (Friedman, 1996) Use of injection drugs also places an IDU at high risk for bloodborne diseases (hepatitis B, C, HIV), infections caused by non-sterile injections (endocarditis, local abscesses), overdoses, dependence on other drugs, and many other infectious diseases related only indirectly to injection drug use (TB). IDUs are also disproportionately more likely to be homeless, mentally ill, unemployed and have fragmented families. Thus IDU-patients have substantial social service needs as well as medical needs.

Ideally, the physician would like to help IDUs stop using drugs completely. However, not all IDUs will be able or willing to stop immediately. The demand for treatment often outstrips supply. Drug treatment programs may have waiting lists or prohibitive entry criteria. Absence of childcare or provision for treating pregnant women has curtailed access by women IDUs. Even after entering treatment, relapses are common, "[c]ycling one or more times from recovery back through relapse to dependence or abuse . . . is so common that it must be seen as an intrinsic feature of the natural history of individual drug behavior." (Gerstein & Harwoods, 1990, p.72-76) IDUs not in treatment, for whatever reason, risk deadly infections if they lack access to sterile syringes or do not practice safe injection practices.

From a practical perspective physicians must grapple with the needs of his or her patient who lacks access to treatment, has attempted treatment and relapsed, or who remains unready for treatment. Despite the government's war on drugs, including its efforts to restrict access to drugs and syringes, injection drug use has continued. (Stryker, 1989) If physicians can take measures to protect patients from contracting a deadly disease in the short-term, their long-term prospects for drug treatment and eventual return to productive living are much more significant.

The physician's basic ethical obligations - to help, not to harm and to advocate for patients - supports both protecting patients from bloodborne diseases and discouraging drug use. Providing competent, compassionate medical care for IDU-patients requires physicians to help their patients reduce their risk of bloodborne diseases and to stop using drugs or enter treatment. Physicians should also provide patients with timely, accurate scientific information regarding their conditions and treatments. (Doxiadis, 1987)

From a consequentialist perspective, the physician examines the effects of his/her actions including the harms and benefits associated with that action. Substantial scientific evidence exists suggesting that increasing access to syringes can reduce HIV infections and does not increase drug use or related crime. (Normands, 1995) Also, legal restrictions on access to syringes have not been shown to reduce drug use or have any direct public health benefit. Reliance on empirical data to "prove" the benefit of a policy practice appeals to scientists, physicians and public health officials but does not address the larger questions integral to the consequentialist approach, which is the highest good? What if "benefits" conflict?

From a deontological perspective, the physician looks to the norms of society "[b]ecause normative principles are integral to the kind of society that is desirable, [therefore] society may choose to forgo the benefits of a policy that is thought to undermine the moral values which the community holds dear." (Gostin & Lazzarini, 1997, p.645) Our society highly values individual's freedom to control their lives. Thus, one approach to evaluating the proper role of physicians in treating IDUs turns upon on an evaluation of whether IDUs can exercise freedom of choice - whether they are "autonomous." If addiction or heavy drug use completely negates an IDU's free will, then physicians should not take any action that permits continued drug use as that would be tantamount to facilitating slavery. (Mills, 1994) If, however, as I have argued, even IDUs exercise autonomy, albeit compromised autonomy, then physicians can work to "enhance" their patients autonomy by offering them support for stopping drug use, but also giving them the means to protect themselves from deadly diseases. Restricting access to syringes denies individuals the opportunity to take measures to protect their health and to make a decision affecting their bodies. By allowing individuals the opportunity to make choices that have significant public health benefits, prescribing syringes could prevent disease and preserve health of individuals until they can stop using drugs.

Adopting a principled approach, whether or not to prescribe syringes to IDUs appears, at first, to bring beneficence andrespect for persons into conflict. A physician might argue that continued drug use clearly harms the patient and therefore any action on the physician's part that is "beneficent," seeking to promote the good of the patient, should discourage and not promote drug use. In contrast, respect for persons suggests several important considerations. First, in the sense of "autonomy," respect for persons requires that the physician respect the autonomous choices of competent patients. If drug users continue to inject yet want to use sterile syringes to reduce their risk of infection, then they should be able to exercise independent choice to do so. Second, respect for persons suggests that physicians should strive to respect the humanity and dignity of each patient, and to refrain from demonizing patients for socially unacceptable or illegal behaviors including drug use.

Most physicians would not think of refusing to treat or ignoring the medical needs of their patients who smoke or drink alcohol, even to excess. By contrast, many doctors do not want IDUs as patients. Those who do treat IDUs and patients with a record of injection drug use, may not treat their pain adequately, even when severe pain could be expected (cancer or other terminal condition), and may be reluctant to provide them with other interventions out of fear that it will increase their drug using behavior. (Brennan, 1991) When physicians focus exclusively on avoiding any action that could exacerbate IDU-patients' drug use, they may actually deny them necessary or useful care. For many patients who inject drugs, merely being engaged in the medical system in a positive way is a benefit. In this context, adopting and enforcing a government preference against any action that might appear to condone drug use, should not occur at the cost of exposing IDUs to HIV. The government should not inflict harm on an individual as a means of persuasion.

Upon closer examination, however, the apparent conflict between the principles of beneficence and respect for personsdisappears in most cases. The physician's claim to beneficence can and should result in efforts to persuade IDUs to stop using drugs, enter treatment, or stop injecting. Given the scarcity of drug treatment and the reality that many patients will relapse before successfully ending their drug use, physicians inevitably will have patients who cannot or will not stop using drugs, successfully complete treatment, or stop injecting. Physicians owe a duty of beneficence to these patients too. For these patients, beneficence requires education about safer alternatives and access to sterile syringes. Prescribing syringes to patients who are IDUs provides access and permits patients to reduce the risk of contracting or transmitting HIV.

Finally, any discussion of HIV and drug use today must consider the principle of justice. African-Americans and Hispanics bear a disproportionate burden of both epidemics in the United States. Adding socio-economic status to the picture reveals a concentration of all three among society's most vulnerable communities. Consequently, the policies we as a society adopt to deal with drug use and HIV will disproportionately affect these communities.

Communities of color may already feel they have been ill-served by state and federal policies for HIV/AIDS prevention, education, medicines, drug treatment and other social services arguably. (Normands, 1995) Among their most important critiques has been the poor access many minority and poor people have to regular medical care for routine care, health promotion, diagnosis and treatment of chronic conditions. A policy that promoted increased access by IDUs to regular medical care, that could improve their chances of entering drug treatment and of avoiding infection with HIV and other bloodborne diseases, would also promote the principle of justice.

Some would argue that despite its potential to prevent bloodborne disease, providing IDUs with syringes, via any mechanism, but particularly from the prescription of a physician, violates the principle of nonmaleficence, the duty to do no harm. For example, by arguing that "but for" the prescription for a needle, a drug user would not have overdosed and died, or would not have injured others in a motor vehicle accident. This argument fails because ample evidence has demonstrated that in the absence of sterile syringes, IDUs will use whatever is available. Denying IDUs access to syringes is unlikely to prevent specific harms such as those listed above.

Also noteworthy in this context are the virtues of medicine. Compassionate physicians will recognize all their IDU-patients' needs - both access to drug treatment, and to ways to prevent bloodborne infections while they remain addicted. Faithful physicians will not abandon their patient easily, even when that means facing the legal and ethical challenge of whether or not to prescribe syringes. Honest physicians will freely share with their IDU-patients everything they know about ways to prevent bloodborne disease transmission, including safer injection practices and how/where to obtain sterile syringes. Courageous physicians will be willing to incur potential personal risks to promote their patients' best interests.

The physician has an ethical duty to care for his IDU-patients. This can take several forms - education and counseling, referrals to drug treatment, or aiding patients in obtaining sterile syringes. If the physician fails to act and the patient contracts HIV, no future act can undo the harm. By taking action, the physician can help prevent further injury to the patient and preserve the chance to treat the patient for drug addiction at a later time. A variety of ethical approaches support physicians ethical option to prescribe syringes. Finding an affirmative duty applicable to all situations would be more difficult.

B. The Ethics of the Pharmacist-Patient Relationship

To varying degrees, pharmacists act independently of physicians. They may do so in order to fulfill their independent ethical obligations, to protect the health of "their" patients, or because they fear violating the law as they understand it. Increasingly pharmacists strive to define pharmacy as a profession independent of medicine with its own national professional bodies, a code of ethics, and often professional practice guidelines. (Anderson & Berridge, 2000) Thus, some discussion of pharmacists' ethical duties is relevant to efforts to promote access to syringes through either over-the-counter sale or expanded prescribing.

Many factors effect pharmacists' decisions about for whom to fill prescriptions and to whom to sell syringes over the counter. Pharmacists are aware of, and feel constrained by, laws and regulations restricting syringes. In many states syringe prescription laws or regulations explicitly require pharmacists to sell syringes only upon proof of legitimate medical need. Other states have "voluntary" prescription requirements recognized by pharmacists (no legal provisions requires a prescription, but pharmacists voluntarily choose to enforce one). In other jurisdictions pharmacists are expressly permitted to refuse to sell syringes which they believe may be intended for illegal use. (Gostin & Lazzarini, 1997) Even where sale is legal, the decision to sell syringes without a prescription is often left to the pharmacist's discretion. Pharmacists can refuse to sell syringes based on the idea of conscientious objection. A pharmacist who is unsure if it is proper to sell to a specific individual may balk at selling syringes without a prescription.

Pharmacists exercise discretion even where customers present a prescription, perhaps by questioning the validity of the prescription. A pharmacists might also feel bound to report physicians they know or suspect prescribe to IDUs to the Drug Enforcement Administration (DEA) or local licensing and disciplinary authority. Pharmacists might, therefore, derail efforts by individual physicians to expand IDUs' access to syringes through prescriptions.

From an ethical standpoint, The American Pharmaceutical Association Code of Ethics states that "A pharmacist places concern for the well-being of the patient at the center of professional practice." It also states that "A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner." Finally, while the pharmacist serves the individual, the Code also states that "A pharmacist serves individual, community and societal needs." (Am. Pharm. Ass'n, 1995, p.2131) Pharmacists' precise role in promoting the good of the patient, however, has changed over time. Both the concept of pharmacists' duties and the definition of "practice" have grown in recent years. Cost control pressures continue to reduce physicians' time with patients and thus their ability to educate patients on the correct use of medication or devices. Expanded database collection by pharmacies often produce a "record" for individual patients that includes much of the information usually contained in the medical record. As a consequence pharmacists have taken on some of the screening, counseling, and education duties previously performed by doctors.

Traditionally, the duty of the pharmacist was fairly simple. A pharmacist was required to correctly fill the prescriptions given by a doctor to his patients. The duty was limited primarily because of physicians' dominant position in health care during this century. Pharmacists questioning the prescribing practices of a physician, might interfere with the physician-patient relationship. This approach relied on the "learned intermediary doctrine" in which a physician (the learned intermediary), not the pharmacist, had the duty to warn patients about the potential side effects of drugs. (Fleischer, 1999) The role of pharmacist was little more than that of a dispenser. The 1952 Code of Ethics went so far as to explicitly deter pharmacists from giving advice to a customer. In this traditional setting, a pharmacist was only liable if he/she did not correctly fill the prescription that the doctor prescribed. Thus, a pharmacist was not responsible for advising customers regarding proper dosage (under this traditional view, the customer was not considered a patient of the pharmacist) or warning them of potential dangerous side-effects of drugs. These responsibilities remained with the physician.

Pharmacists' expanded role now encompasses greater practice, discretion, and duty. In addition to screening out "invalid" prescriptions, pharmacists are held responsible for either notifying a physician or directly warning a patient of an inadequate instruction in a prescription. (Riff v. Morgan, 1986) A pharmacist may also be held liable for failing to meet certain "minimum standards" of prescription review, including, on occasion, a duty to refuse to fill a valid prescription. When interpreted most broadly, that is to hold a pharmacist liable even though she followed a valid prescription, suggests a relationship, and therefore a duty between the pharmacist and customer is independent of that between the physician and the patient.

The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) expanded pharmacists' duties. OBRA-90 requires pharmacists to screen prescriptions, keep a history of patient records, and make an offer to discuss proper drug use with Medicaid patients. Following the mandate of OBRA, many states applied those duties to all pharmacist-patient encounters. (Fleicscher, 1999)

The Commission to Implement Change in Pharmaceutical Education [CICPE] articulated pharmacists' increased responsibilities in the following terms, "the mission of pharmacy practice is to render pharmaceutical care. Pharmaceutical care focuses pharmacists' attitudes, behaviors, commitments, concerns, ethics, functions, knowledge, responsibilities and skills on the provision of drug therapy with a goal of achieving definite outcomes toward the improvement of a patient's quality of life." (Commission to Implement Change in Pharm. Educ., 1993) "Pharmaceutical care directs that this [achieving desired outcomes] responsibility is to be a shared obligation between the prescriber and the pharmacist." (McCarthy, 1998, p.361)

Pharmacists' duties exist in the context of the respective responsibilities of physicians and pharmacists. Legal interpretations have tended to divide these responsibilities into two broad categories, risk assessment and risk management. The responsibility for risk assessment falls primarily to the physician. Physicians must assess the risks and benefits in prescribing a drug to a patient during each visit and determine the most appropriate drug treatment. Pharmacists remain primarily responsible for risk management. "Risk management relates to the proper drug use rather than correct drug choice." (Abood & Brushwood, 1994, p.212)

The difference between risk management and assessment is fairly simple. Risk assessment involves a decision by a doctor about the proper treatment for a patient based on that patient's individual needs and history. By contrast, risk management concerns the drug in general and the risks that the drug presents to any user. Generally, pharmacists are not responsible for an incorrect risk assessment.

The role of the pharmacist continues to change. Both the law (common law and statutory law) and pharmacy practice shape this change. Although drug choice ultimately remains with the physician, the pharmacist plays a growing role. Increasingly, clinical pharmacists help develop drug therapy programs for patients and act as therapeutic consultants. (McCarthy, 1998) Pharmacists counsel patients with diabetes, hypertension, and asthma. They may instruct patients on function and use of devices associated with their prescribed treatments. For example, pharmacists can review proper inhaler use for patients with asthma or syringe use and disposal for diabetics. As pharmacists take on greater responsibilities, the duty of the pharmacist will also continue to change. In this period of change, however, little consensus exists across geographic areas as to the scope of pharmacists' legal duties.

Under the pharmacist's traditional role, a pharmacist would merely have to fill the prescription as given. As the role of the pharmacist has changed, so too the ethical and legal obligations have become more complex. Pharmacists exercise a greater degree of control and bear a greater responsibility than ever before. Yet, although the majority of pharmacists in various surveys have expressed support for over-the-counter sales of syringes in general, far fewer are enthusiastic about selling to IDUs. (Jones & Taussig, 1999) In areas of first impression (such as syringe prescribing), where no clear definition exists as to the pharmacist's duty, examination of official statements of professional organizations as well as existing codes of ethics, and legal concepts of duty and liability help define the pharmacists' ethical and legal duties.

In late 1999, leaders of the American Medical Association (AMA), American Pharmaceutical Association (APhA), Association of State and Territorial Health Officials (ASTHO), and the National Alliance of State an Territorial AIDS Directors (NASTAD) issued a joint statement calling for the coordinated efforts of state leaders in pharmacy, public health, and medicine to address access to sterile syringes as a means of preventing further transmission of bloodborne infections. Specifically, "APhA encourages state legislatures and boards of pharmacy to revise laws and regulations to permit the unrestricted sale or distribution of syringes and needles by or with the knowledge of a pharmacist in a effort to decrease the transmission of blood-borne diseases." (joinstatementsyringe <WWW document>) Where the law permits sales of syringes without a prescription or can be interpreted to allow sales to IDUs with prescriptions, APhA's position supports pharmacists dispensing syringes.

Pharmacists professional codes also provide relevant guidance. This code obliges pharmacists to put the health needs of their patients first. (Am. Pharm. Ass'n, 1995) Medical decisions, including the potential benefits of access to sterile syringes, should be made based on objective scientific criteria. Thus, if the preponderance of the evidence from well-designed scientific studies indicates probable health benefits and low risks, pharmacists ought to honor prescriptions for syringes.

The risk assessment / risk management model is somewhat outdated in the era of expanding pharmaceutical practice and duties. Using it, however, would not contradict the result suggested by either of the earlier approaches. Applying the risk assessment / risk management model, the pharmacists' role would be limited to complete and accurate instruction in how to use the prescribed treatment, in this case syringes. Pharmacists could provide information on safe injection practices, disposal of needles, and means to access drug treatment. The risk assessment / risk management approach, suggests pharmacists should sell syringes. Where they are validly prescribed and there are no absolute risk management contraindications to their use, the pharmacist would assume a physician has already assessed the situation and determined that the benefits of prescribing syringes in this situation outweigh the risks. In that context, the pharmacist's duty is to sell the syringes, and manage their proper use through patient education.

Even where legislatures have modified laws to permit over-the-counter sale of syringes, pharmacies (and pharmacists) still have the option whether to sell syringes without a prescription. After Connecticut changed its law to permit limited sale of syringes over-the-counter, a questionnaire to 15 pharmacies in New Haven found that four had policies against the sale of syringes without a prescription. Thirteen of 18 pharmacies in Hartford allowed the sale of syringes without a prescription. By contrast, in pharmacies on the periphery of Hartford, only five of nine pharmacies allowed the sale of syringes without a prescription. One pharmacist responded that he suspected that most, if not all of the pharmacists that work the day shift only sell syringes with a prescription. (Singer, 1998) Thus, deregulation alone does not necessarily guarantee that IDUs will have access to syringes without a physician's prescription. Conversely, even where the law does not require a prescription, pharmacists may be more willing to sell an IDU syringes with a prescription (which implies a physician's endorsement of a legitimate medical purpose) than to sell over-the-counter.

Pharmacists dispensing syringes based on prescriptions have ample support for their actions in the position statements of their national professional body, ethical codes, and even a relatively conservative interpretation of the pharmacist's role. Some might even suggest these materials create an obligation to dispense syringes to prescription-holding IDUs in the absence of specific reasons to believe the prescription would be harmful.

C. Why some physicians and pharmacists might refuse to treat IDUs

Physicians may feel ill-prepared for treating IDUs and perceive few positive reasons for involvement with them. IDU-patients can be difficult and demanding. Their medical problems are complicated by their need for social services, which many include drug treatment, housing, counseling, assistance with parenting, child care and ultimately job training. Most regular physicians offices are not equipped to provide this level of intensive intervention and support, so IDUs who are patients may not ever get the support they need to quit using. Additionally IDU-patients present interpersonal challenges. (Selwyn, 1997)

When physicians do treat IDUs they may be so wry of encouraging drug use that they may not provide care the patient needs to treat an underlying illness. Physicians are particularly hesitant to prescribe narcotics to IDUs or former IDUs even when such treatment is warranted by conditions known to cause pain. Physicians may also refuse to provide other forms of treatment due to fears that the treatment will facilitate continued drug use. (Troyen, 1991)

Pharmacists may avoid selling to IDUs for reasons of safety or fear of harming their business. Common concerns expressed by pharmacists are that having IDUs as customers will drive away other customers, that IDUs will commit crimes in an around the pharmacy, or that they will discard their used needles and syringes nearby. (Wright-De Aguero & Weinstein 1998) Reluctance of physicians and pharmacists' to engage with IDUs results in reduced access to health care and pharmacy services for IDUs who already receive less care than the majority population.

Additionally, physicians or pharmacists may morally oppose an IDU's drug use or other illegal activities, or be personally repelled by IDUs affect or their daily lives. Separating professional ethical duties from personal responses may be necessary for some professionals to care for IDUs regularly.

III. The Roles of Law in the Debate over Prescribing/Dispensing Syringes

A. The relationship between law and ethics

"Ethical values and legal principles are usually closely related, but ethical obligations typically exceed legal duties. In some cases, the law mandates unethical conduct. In general, when physicians believe a law is unjust, they should work to change the law. In exceptional circumstances of unjust laws, ethical responsibilities should supersede legal obligations." (Council on Ethical and Jud. Affairs, 1998, p.1)

Law influences ethical analysis in at least two ways. First, in many situations, legal analysis of physician liability establishes physicians' legal duty in a particular case. Although legal duties are not always dispositive of ethical duties in a particular situation, law usually establishes the minimum quality of action acceptable to society. In these cases law may provide the floor, while ethics describes the normative goal or ideal.

Second, however, law may pose a structural barrier to ethical conduct. In these cases the tension between law and ethics may create an ethical dilemma for physicians, whether to fulfill their duties to patients and break the law, or to obey the law and leave some obligations unfulfilled. Both of these issues, standard of care and physicians' options, when faced with legal barriers, will be covered below.

Law plays a significant role in discussions of duty, which also occupies much of the dialog about ethics. This section reviews three ways in which law affects determinations of physicians' and pharmacists' ethical duty, establishment of a standard of care, duty to third parties, and law as a barrier to actions which physicians or pharmacists feel are ethically justified.

B. The Standard of Care

A legal determination of the standard of care often frames the discussion about the physician's and pharmacist's obligation with respect to his/her patients and provides a minimum threshold for ethical duties. Yet, the standard of care continuously evolves and may be difficult to determine in new situations. Ultimately, only a court or jury determines whether physicians' and pharmacists' actions comply with the standard of care. Nonetheless, we can examine factors that are used in establishing the standard of care in order to determine how a court might analyze a situation. These include: the reasonable practitioner standard, customary practice, practice guidelines, a respectable minority position, new developments in the field (scientific, medical, technical), the limitations of self-regulation, and whether a professional or ordinary standard of care applies.

1. A professional standard of care

As a general rule, physicians must exercise reasonable care as expected of other physicians of similar skill, training, and education. (Cristoffel, 1982) Expert witnesses testify in court as to what a reasonable physician would do. Although community standards have historically played an important role in establishing the applicable standard of care, increasingly, courts rely on a national standard. Ultimately, a jury determines the standard of care based on the evidence introduced.

Health care professionals make decisions everyday based on multiple factors, including the facts of the particular case, the care givers' perceived duties, the patient's perceived needs, personal preferences for treatment, knowledge of new scientific evidence, and willingness to act. In much of medical care, when there are different treatments available, "the choice between them is usually based on value judgments, not medical judgments." (Capron & Michel, 1993, p.25) Some patterns of choices become codified as part of "customary practice," which helps establish the standard of care. While the customary practice is not

determinative, it plays an important role in establishing the reasonableness of the physician's actions.

Physicians have a duty to keep up to date with progress in their fields and to use their "best judgment" in making decisions. This includes knowing the latest research regarding drugs, techniques, and procedures in their specialty. In these cases, custom does not protect a physician from liability.

Practice guidelines also play a role in the formation of the standard of care. The admission of a guideline into evidence does not compel the court to accept the guideline as the appropriate standard of care. (Rheingold & Valet, 1993) Courts still depend on expert testimony to establish the relevance of the practice guideline. Ultimately, courts may find other evidence more persuasive of the standard of care.

However, even where customary practice or practice guidelines exist, there are times a physician could utilize more than one treatment option. Courts allow for a "respectable minority" rule which permits physicians to choose between acceptable treatments without fear of facing liability if the treatment chosen does not work.

Leaving aside for now how courts might consider criminal provisions as they conflict with a possible standard of care, we can apply these various determinants of a professional standard of care to the issue of physicians prescribing syringes to IDUs. The most problematic aspect of an argument for prescribing syringes as the standard of care is customary practice. The vast majority of physicians currently caring for IDUs do not prescribe syringes. These physicians may not know their patients use injection drugs, or be unaware of HIV risk, or assume that such a prescription would be invalid or violate medical practice acts. Existing law provides little guidance here. Courts have interpreted medical practice acts to invalidate prescriptions for narcotics to IDUs for the purpose of maintaining their habits. (People v. Goldberg, 1975) Although no courts have addressed whether similar reasoning should be applied to prescription of syringes, decisions related to prescribing controlled substances have been used (perhaps erroneously) to suggest that a prescription for syringes for an IDU to prevent bloodborne diseases would be invalid. Although customary practice does not support prescribing, it should not be determinative in light of the substantial evidence regarding public health guidelines, new developments, and the views of the respectable minority which support a new or evolving standard of care.

Practice guidelines, the practices of a respectable minority, and new developments in the field provide the strongest evidence for prescribing as the standard of care. Public health and clinical authorities endorse physicians recommending that IDUs use sterile syringes for each injection. (U.S. Dept. of Health and Human Services, 1997) Where no legal access to syringes exists, these recommendations would seem to support physician prescribing to IDUs who fit all other criteria (have been counseled to stop using, enter treatment, or stop injecting, but cannot or will not currently).

Some physicians experienced in treating IDUs and persons with HIV want to prescribe syringes but fear legal consequences. Others have actually begun pilot programs for IDUs in states with syringe prescription laws. A respectable minority view, arguably already supports physician prescribing. Additionally, the overwhelming weight of empirical evidence collected and analyzed in recent years suggest a potential public health benefit from access to sterile syringes for IDUs to protect against HIV. (Normands, 1995)

Given the public health and clinical authorities endorse the idea that IDUs use sterile syringes for each injection (for clinical and public health reasons), an evolving standard of care that includes physicians prescribing syringes is a reasonable option that comports with scientific evidence.

2. An ordinary standard of care

Despite courts' marked deference to professional opinions regarding the standard of care, professional self-regulation cannot be completely unfettered. Complete professional discretion for setting the standard of care gives a profession the opportunity to shield itself (perhaps unfairly) from liability.

"A whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests, however persuasive be its usages. Courts in the end say what is required; there are precautions so imperative that even their universal disregard will not excuse their omission." (T.J. Hooper v. N. Barge Corp., 1932) Courts will also consider professional responsibility in the context of an ordinary standard of care.

A professional standard is not absolute, nor does it exist in a vacuum. The foundation of the ordinary standard of care is the duty to adopt reasonable behaviors and precautions that minimize resulting perils and dangers. Ordinary care mandates that persons of ordinary prudence utilize care to prevent injury to themselves or others under circumstances similar to those at issue. Defining the ordinary standard of care in any situation requires two steps: 1) calculating the risk; and 2) establishing what a reasonably prudent person would do. (Franklin & Rabin, 1996)

To calculate risk courts often turn to Judge Learned Hand's formula for an economic theory of negligence. Using this formula, BpL formula, the burden (B) of taking the necessary precautions is weighed against the injury (L) multiplied by the probability (p) that the injury will occur. (Posner, 1972) Where the cost of preventing the risk is less than the product of the cost of the injury and it probability, the defendant is liable.

Although Hand's formula functions well in theory, applying it to real world situations may be more problematic. Difficulties arise when courts or juries attempt to set monetary values on personal injuries and the costs of prevention. Juries may make judgments founded on reasonableness rather than by balancing costs.

The ordinary standard of care also demands evaluation of what a "reasonably prudent person" would do in like circumstances. This legal fiction compares the defendant's behavior to that of a reasonably prudent persons in order to determine negligence. A reasonable person is defined as one who adheres to the general standard of behavior in the community or who possesses the average level of moral judgment in the community.

In determining the standard of care for physicians treating IDUs at risk for contracting HIV and other bloodborne diseases, we can apply an ordinary negligence standard utilizing the cost-benefit analysis. Different variables contribute to this analysis: 1) the nature of the injury; 2) the probability of the injury; and 3) the costs of preventing the injury. The nature of the injury where IDUs are infected with bloodborne diseases remains serious. Although recent advances in anti-retroviral therapy have led to increased survival, HIV infection remains incurable, and finally fatal. Infections with hepatitis B or C, though less deadly, are more common and cause substantial illness and death in a proportion of patients. The probability of injury - in this case, the probability that an IDU will contract HIV or another blood-borne infection by sharing needles can be derived from national AIDS data. As of the end of June 1999, 36% of the 711,344 AIDS case reported from July 1998 to June 1999 were directly or indirectly associated with injection drug use. Furthermore, estimates indicate that up to 90% of IDUs are infected with hepatitis C. These numbers show that IDUs are at great risk of bloodborne diseases, and represent a significant proportion of those who contract HIV. Finally, a cost-benefit analysis must determine the burden of taking the necessary precautions to prevent the injury. Recommendations state that people who inject drugs should use sterile syringes to prevent the transmission of HIV and other blood-borne diseases. From an economic perspective, it costs approximately $195,188 to treat an HIV-infected person for a lifetime. In 1992, the median annual budget for running a SEP was $169,000. Using these data, it costs approximately $9,400 to prevent each new case of HIV infection among SEP clients, their sex partners, and children (where the government/private organization bears the cost of the SEP). (Lurie, 1993) Studies indicate that IDUs could bear much of the cost of this type of "prevention," most were willing to pay ten times the wholesale cost of syringes and none were unwilling to pay at all. (Junge, 1999)

Providing IDUs access to syringes costs relatively little compared with the cost of treating patients with HIV infection. Syringe exchange programs cost the most, but considerably less than the lifetime cost for HIV infection. Over-the-counter sale or prescription sale of syringes cost even less. The most direct means to prevent HIV among IDUs is to get them to stop using drugs. Persuading IDUs to stop using drugs may not always be possible, even when treatment is available. (Wiley & Samuel, 1989) As a consequence physicians may justifiably seek reasonable alternatives to protect IDUs and the public health. Thus, considering the B<pL formula (using the data on addiction, drug treatment and the probable benefits of access to sterile syringes), the ordinary standard of care analysis suggests that a relatively low burden intervention, such as prescribing syringes to IDUs under specific circumstances, ought to be an option, if not an obligation, of physicians.

3. Conclusions from a standard of care analysis

In summary, both ordinary and professional standards of care support prescribing syringes to IDUs to prevent bloodborne infections. Substantial evidence supports the argument that the standard of care should include educating patients on safe injection and access to syringes through either SEPs or prescription. (Normands, 1995) Where law provides no other legal access to syringes (SP and /or DP laws in force, and no SEPs), expert medical testimony could show that the proper standard of care is to prescribe needles to known IDUs. As discussed, practice guidelines are not dispositive, but can be introduced as evidence as to the proper standard of care. The AMA, the CDC, and the National Commission on AIDS have recommend the use of clean needles and syringes for IDUs. Some physicians may already participate in SEPs or even supply needles to their patients.

C. Duty to Third Parties

Issues of legal duty may extend to others beyond the doctor-patient or pharmacist patient relationship. Important questions about the physician's (or pharmacist's) potential duty include: 1) does the physician have a duty to protect those who share injection equipment with their IDU patients? 2) If so, how can the physician satisfy this duty (by educating patients on the correct use of sterile syringes, by providing prescriptions for sterile syringes, or by directly warning the third party of the potential risk)? 3) Does the physician have a duty to protect third parties by not providing syringes, thus not providing the instrumentality that could cause harm to others if used incorrectly?

Generally, an individual has no duty to control the conduct of another or to warn third parties who are in danger as a result of such conduct. Aside from a possible moral obligation, there is no legal duty to help another in danger.

A duty to prevent harm or to warn of the risk of harm may arise out of a special relationship, such as the physician-patient or therapist-patient-relationship described in Tarasoff v. Regents of the University of California. In Tarasoff, the court held that when a therapist is aware that a patient poses a danger to a foreseeable third party, she must take reasonable measures to warn or protect that third party. Preventing the danger the patient poses to others justifies the resulting breach of the confidential relationship between the therapist and patient. Tarasoff reaffirmed that the physician-patient relationship can create positive duties to third parties and established a common law duty to take steps to protect (to warn or warn others who might protect) an identifiable third party of dangers that a physician knew or should have known were posed by a particular patient. A duty to third parties may require disclosure of otherwise confidential information to third parties, or it may merely mandate the disclosure of information, about the risks, directly to the patient.

In the context of communicable diseases, some cases have imposed a positive duty on physicians to protect third parties from a patient's communicable disease particularly when the physician failed to warn the patient or the partner was a regular sex partner. (DiMarco v. Lynch Homes-Chester County, 1990) A physician may breach this duty by failing to inform the patient of exposure to or diagnosis of a communicable disease, by failing to warn the patient of the dangers associated with the communicable disease, or by giving erroneous advice to the patient. Inadequate care of the patient amounts to a breach of duty and causes a danger to third parties.

No cases have imposed a similar duty on physicians in relation to syringe-sharing partners of IDUs. Current public preventive care guidelines recommend that physicians should counsel IDU patients to stop using drugs or adopt safe injection practices. These guidelines suggest that the standard of care may soon include a duty to adequately inform IDU patients of risk of transmission via contaminated syringes and to counsel IDUs on how to avoid infection through safe injection practices. The guidelines present a weaker argument for an affirmative duty to assist IDUs to obtain sterile syringes. The guidelines provide no support for the proposition that physicians have a duty to protect third parties by refusing to prescribe. Physician refusal to prescribe is neither necessary nor sufficient to protect IDUs' partners and may actually increase their risk of harm by increasing the risk that IDUs will use contaminated syringes.

When caring for IDUs, physicians may satisfy any duty to third parties by informing the patient of the risk of transmission and reasonable means to avoid transmission (i.e., use of sterile syringes and condoms). When IDUs have no legal access to syringes physicians could ethically choose to prescribe syringes, in part, to protect the patient's sexual and needle-sharing partners and children from possible future infection.

D. Responses to Otherwise Prohibited Acts:

Civil Disobedience and Medical Necessity

"A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient." (Council on Ethical and Judicial Affairs, 1998)

A physician's duty extends beyond providing care for his/her patient. Physicians should work to change laws that are contrary to the best interests of their patients. "Professional ethical responsibilities exist beyond statute and may require defiance of the statute." (Sprinkle, 1994) Thus, not only should a physician assist IDUs in accessing sterile syringes, but they should also work to change the laws that restrict access.

When faced with an apparently unjust law or one that conflicts with their ethical obligations, public health goals, or personal morals physicians may quietly comply with the law, work to change it, or break the law in order to achieve some higher goal. When physicians opt to break the law and perform some legally prohibited act (e.g., providing syringes to IDU-patients in some settings)they may characterize their actions as civil disobedience or claim the defense of medical necessity.

1. Civil disobedience

The concept of civil disobedience has deep roots in American political, social and cultural history. (Loesch, 1991) Acts of civil disobedience highlight injustices in society. Civil disobedience is one means of taking action to bring about change. One hundred fifty years ago, Henry David Thoreau argued that people should refuse to follow laws that they believe are unjust:

"if it [the injustice] is of such a nature that it requires you to be the agent of injustice to another, then, I say, break the law…What I have to do is to see, at any rate, that I do not lend myself to the wrong which I condemn." (Thoreau, 1960)

Thoreau's words speak directly to the issue at hand. Physicians may face a conflict between their moral and ethical obligations to their patients and their legal obligations as a member of society. Medical evidence demonstrates the importance of sterile syringes for IDUs. In this context, physicians and pharmacists may conclude that the legal and structural obstacles are unjust. Where a physician or pharmacist believe her moral obligations outweigh her legal obligations, civil disobedience may result. (Loesch, 1991)

In order for an action to legally constitute as civil disobedience, there are four elements that need to be met: (1) the act must be illegal; (2) the act must be "predominantly nonviolent"; (3) the act must be intended to rouse the notice of the community to the illegal action; and (4) the actor must be willing to accept punishment for his action. (Deforrest, 1997) These elements comprise the framework in which physicians and pharmacists must act in order to legally utilize civil disobedience as a vehicle for social and political change.

Two other areas of medical practice illustrate instances in which some physicians have refused to obey what they perceive to be unjust laws.

Before Roe v. Wade was decided in 1973, establishing a woman's right to choose an abortion, many physicians challenged stew an federal abortion statutes. Some brought suits challenging the laws on their construction or impact on patient care. Others chose to act in their patient's best interest independent of legal constraints. For example, the federal law, the Therapeutic Abortion Act, permitted physicians to perform abortions only in cases where the procedure was necessary to preserve the life of his or her patient. This vague language allowed physicians to exercise discretion in determining when to perform an abortion. Although this resulted in more patients obtaining abortions, courts did not always endorse physicians' judgments. (People v. Belous, 1975) As a result, patients were able to obtain abortions through the help of their physicians acting in the best interests of their patients. Ultimately, the Supreme Court established the assumption that physicians had acted in the patient's best interest unless proven otherwise. (United States v. Vuitch, 1971)

In a more recent example, many physicians and professional associations emphatically signaled their intention to disobey the law after California adopted Proposition 187 in 1994. This proposition forced doctors, nurses, social workers, and teachers to report any patient, client, or student that they might suspect to be an illegal immigrant to authorities. (Iacopino & Crane, 1994, p.A22) Because of the health risks, physicians' ethics, and patient confidentiality involved in the proposition, the American Medical Association's policy-making body condemned Proposition 187. The AMA voted to oppose any federal regulations that required physicians to determine the immigration status of their patients before treating them. In addition, the 298,000 member AMA reaffirmed its position requesting Congress to provide adequate funds for the existing health-care programs for illegal aliens. The AMA's president-elect, Dr. Lonnie Bristow, said that California measure poses "a breach of physician ethics and patient confidentiality."

In both these cases, pre- Roe v. Wade abortion laws and Proposition 187, physicians also protested government intrusion into the doctor patient relationship. This theme of seeking to preserve areas of medical decision-making from government interference could also be raised by physicians willing to prescribe syringes.

Physicians have broken the law in other contexts as well. Studies indicate that many physicians have lied to insurers and other third party-payers to ensure their patients receive the proper care and coverage. Others have lobbied for the use of illegal drugs for medicinal purposes, while some have prescribed fatal doses of medication for terminally ill patients who seek help in ending their own lives.

Presently, the existing laws in most states make it dangerous if not impossible for health care providers such as physicians and pharmacists to provide sterile syringes for IDUs. (Gostin & Lazzarini, 1997) Therefore, the actions taken by physicians and pharmacists to actively provide access for IDUs to sterile syringes would constitute an illegal action that satisfies the first requirement for civil disobedience. Physicians and pharmacists actions of prescribing or dispensing syringes are acts that take place every day in physicians's offices and pharmacies without any threat to the peace. In fact, their actions demonstrate that "they assume the responsibility of community membership and act with the best interests of the community in mind." (Loesch, 1991, p.1093) By prescribing in the regular course of medical practice or dispensing during the course of pharmacy business, physicians and pharmacists make a conscious and public statement about the injustice of the status quo. The degree of attention society give to such acts may vary but one purpose of civil disobedience is to demonstrate to society and the governing bodies that oversee it that the existing laws are unjust. In order for physicians and other health care providers to legally pursue civil disobedience, they must be willing to accept the consequences associated with their actions. (DeForrest, 1997) For professionals such as physicians and pharmacists, who may face loss or suspension of licensure or even criminal penalties, this represents a serious factor.

2. Medical necessity

However, breaking the law need not result in punishment if physicians successfully claim a defense such as medical necessity. The defense of necessity, generally is that there are times when individuals should be free some legal restraints in order to prevent imminent harm, or provide services that preserve life and health. (Bauer & Eckerstrom, 1987)

For a physician to invoke the medical necessity defense in general he or she must demonstrate four elements: (1) he or she acted to avoid or prevent an imminent harm; (2) there were no reasonable legal alternatives to violating the law; (3) the harm of the act was not disproportionate to the harm avoided; and (4) there was a reasonably anticipated causal relationship between the act and the harm avoided. It should be noted, however, that the defense of medical necessity has been raised in a number of cases after violating state laws by providing syringes to IDUs and produced mixed results.

A physician relying on the medical necessity defense needs to show that he/she was acting under a reasonable belief, supported by medical testimony and evidence, that it was necessary to break the law in order to avoid imminent injury. Ample medical and public health evidence demonstrates that giving IDUs access to sterile syringes to reduce HIV transmission does not increasing drug use or crime. (Normands, 1995) Given the rising numbers of patient-IDUs at risk of new infection or transmission to others, physicians can convincingly argue that providing sterile syringes will avoid imminent infections.

In addition to acting against an imminent harm, a physician should demonstrate that there was no reasonable legal alternative to prevent the spread of HIV besides providing sterile syringes. Although physicians have other options, when examined closely, they are neither as effective nor reasonable solutions. (Bauer & Eckerstrom, 1987) Physicians could counsel ID-patients to stop using drugs, stop injecting, or enter treatment. Unequivocally these options, if successful, would benefit the patient and reduce their HIV risk. Physicians should attempt to persuade IDUs to take one of these steps. However, many IDUs are unready to stop, or unable to enter treatment when they are ready. Additionally, physicians could counsel patient to use only sterile equipment obtained in pharmacies or SEPs. As demonstrated, however, the legal climate does not always permit IDUs to obtain syringes this way, however, this is not a viable option. Therefore, the only reasonable and effective means of preventing the transmission of deadly bloodborne diseases (for patients who are unable or unwilling to quit) by injection drug use is to ensure that the patients use sterile syringes when injecting drugs.

Coupled with the lack of reasonable legal alternatives, the action taken should not be disproportionate to the harm avoided. (United States v. Bailey, 1980) Specifically, the physician should show that his/her breaking of the law produces less harm than that resulting from the spread of HIV and other blood borne diseases. Beyond the arguments based on economic costs (See, Section III.B.2 above), compassion argues that IDUs should be permitted to avoid deadly infections where simple means of prevention exist. Additionally, protecting IDUs from HIV and hepatitis will also benefit the public health, both directly through fewer cases of disease among IDUs and indirectly through fewer cases among their sex partner and children.

Finally, the physician needs to show that there was a direct causal relationship between his/her action and the imminent harm avoided. While some courts have recognized availability of sterile syringes as a means to prevent imminent harm, others have not. Arguably, physicians providing IDUs access to sterile syringes fulfills this test. The problem of transmission and spread of HIV as well as other blood borne diseases is directly related to the use of contaminated syringes by IDUs. Substantial evidence suggest that providing IDUs with sterile syringes will reduce the risk of disease transmission.

Official state action to consider, accept, or reject various public health measures also may pose problems for those claiming medical necessity as a defense or seeking to challenge existing laws in other ways. Where defendants have violated the law, arguing medically necessity as a defense, courts have often looked at whether the legislature has already considered the health threat in question. Where the legislature has already acted, courts have tended to defer to its determinations. For example, in one case rejecting arguments of medical necessity where the legislature had defeated a proposal to liberalize access to syringes. (Commonwealth v. Leno, 1993)

IV. Conclusion

Although the topic of drug use and the correct stance of the government and private practitioners in dealing with IDUs continues to excite emotions and raise substantial debate, a careful analysis of ethical and legal duties suggests a more active positive role for physicians and pharmacists in preventing HIV infection among IDUs than has often been described. Physicians' primary responsibility to help their patients extends to protecting the health of their drug addicted patients who cannot or will not stop injecting drugs. Where no legal means exists for IDUs to access sterile syringes and therefore practice safe injection, physicians can easily argue that ethical imperatives support providing prescriptions to IDUs as part of a comprehensive HIV prevention and care strategy. Pharmacists, also ethically bound to "put the well-being of their patients at the center of their practice[s]," can argue that similar imperatives support their filling such prescriptions.

From a legal perspective, physicians could argue that prescribing syringes fits easily within an evolving standard of care based on new empirical evidence, practice guidelines, and the views of a respectable and qualified minority. Pharmacists can argue that the legal standard of risk management supports their filling prescriptions for syringes for IDUs and their active role in counseling IDUs on safe injection practices and disposal of syringes. The weight of arguments in this analysis of ethical and legal approaches to the question of prescribing syringes to IDUs suggests that prescribing/dispensing syringes is ethically permissible. Less evidence supports a general affirmative obligation to prescribe or dispense.

Laws do exist that might be invoked against physicians, pharmacists, or IDUs. Courts' approaches to such cases remain difficult to predict. At least theoretically, the defense of medical necessity provides an option for any of these parties, should criminal charges be brought against them.

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