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Rx: Clean Needles

With dirty syringes contributing to nearly one-quarter of the state's AIDS cases, a new report argues that clean needles by prescription may be the answer.

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The use of dirty needles to shoot drugs presents a serious public-health threat for North Carolina. In fact, the practice is directly responsible for some 1,900 of the state's more than 8,100 AIDS cases and may have played a role in hundreds of others, according to statistics from the Centers for Disease Control and Prevention. In the United States as a whole, tainted needles accounted for 22 percent of the 46,400 AIDS cases reported last year, and they have also been linked to the spread of other infectious diseases such as hepatitis.

The Institute of Medicine, a quasi-public national think tank, took up the dirty needle issue in a recent report titled "No Time to Lose: Getting More from HIV Prevention." The institute found that needle-exchange programs that allow drug users to trade used needles for clean ones could reduce transmission of HIV significantly. About 100 such programs operate in the United States, including one in Asheville. But the programs--which are based on a public-health philosophy known as the "harm reduction" approach--are technically illegal under drug paraphernalia laws, and they are at risk for being shut down by law enforcement authorities.

There have been attempts to change North Carolina law to allow the exchanges, but they have proved unpopular in the General Assembly. In 1997, Sen. Jeanne Lucas (D-Durham), and Rep. Thomas Wright (D-Wilmington), sponsored bills that would have established a pilot needle-exchange program in the state, but they went nowhere. Wright reintroduced a similar measure last session, but it died in committee. Many lawmakers fear that endorsing the bills could be viewed as supporting illicit drug use--political suicide in a socially conservative state.

But a new study by a law professor at Philadelphia's Temple University proposes a simple solution to the complex problem of halting needle-transmitted diseases: It calls on doctors to prescribe clean needles for addicts.

"In the past, physicians who wished to prescribe sterile syringes to drug addicts did not do so in part because of the perception that it would violate state and federal laws aimed at combating drug abuse or result in a malpractice claim," said Scott Burris, the study's author, at a Washington, D.C., press conference unveiling the study. "Our analysis shows that, in most places, these concerns are unfounded. It's legal."

Burris' Project on Harm Reduction in the Health Care System examined needle laws across the country. His research, published recently in the Annals of Internal Medicine, found that physicians can prescribe sterile needles legally in every state except Delaware and Kansas, and that pharmacists can legally fill those prescriptions in 25 states. Burris says, though, that pharmacists have a "reasonable claim to legality" in another 21 states--among them North Carolina.

Doctors in North Carolina are governed by the state's Medical Practice Act, which gives regulatory authority to the N.C. Medical Board. State medical licensure law says nothing about the physician's general authority to prescribe devices. Aside from limitations imposed by other laws, doctors in North Carolina are free to prescribe any device they believe will benefit their patients if the prescription is consistent with proper professional conduct as determined by the board.

Prescribing powers for certain drugs are defined in the N.C. Controlled Substances Act, which forbids prescription of a controlled substance except for a legitimate medical purpose. This law does not govern syringes, though, which are not defined as controlled substances. In addition, North Carolina has a drug paraphernalia law, which defines paraphernalia generally as "all equipment, products and materials of any kind that are used to facilitate, or intended or designed to facilitate, violations of the Controlled Substances Act, including ... injecting ... or otherwise introducing controlled substances into the human body." It lists 12 types of items as examples of paraphernalia, including hypodermic syringes.

According to Burris' analysis, the only "articulated standard" for a prescription lies within the Controlled Substances Act, which holds that a prescription must be written with a valid medical purpose and in the course of professional practice. He assumes that this is the standard that would be applied to assess the validity of a prescription for sterile needles.

"Such a prescription, issued to a patient who cannot or will not enter drug treatment, for the purpose of preventing the transmission of a serious communicable disease during injection, would seem to be well within the parameters of allowable discretion set by this standard," Burris writes in a memorandum about North Carolina law.

He acknowledges that some physicians might disagree with the practice. But he notes that prescribing sterile needles falls in line with treatment principles accepted by a "responsible segment" of the medical profession and is well-supported by medical and public health research.

When determining whether the prescription arose within the usual course of professional practice, the court would probably consider whether a bona fide doctor-patient relationship existed and whether other care was provided. Burris says a doctor prescribing syringes to regular patients in his or her office or clinic, keeping records and providing other treatment services would not fail this test.

That leaves the paraphernalia law to consider. This statute makes it a crime to "deliver, possess with intent to deliver, or manufacture with intent to deliver" drug paraphernalia--the key word being "deliver."

"A physician who writes a prescription for an item is not actually transferring possession of that item to the patient, but merely providing the patient with instructions and authorization for the pharmacist who will transfer possession by dispensing the prescription at the time of sale," Burris writes.

But that raises the question: Can a pharmacist legally fill such a prescription?

A pharmacist who fills a prescription for syringes is clearly transferring the syringe. Therefore, if a syringe is drug paraphernalia, the transfer is illegal. But is a syringe dispensed by a valid prescription, for legitimate medical reasons, "drug paraphernalia" under North Carolina law?

Burris says no.

"Dispensing sterile injection equipment to an [injection drug user] does not violate North Carolina law where the pharmacist does not and reasonably should not know that the patient intends to use the equipment to illegally inject drugs," he writes.

Burris says that although a cautious reading of the paraphernalia law would be that such dispensation is illegal, it doesn't follow that the cautious reading is necessarily the correct reading.

North Carolina adopted its paraphernalia law in 1981 as part of a national effort by the federal government to end what had become an enormous retail trade in drug-related equipment. The law was never intended to interfere with medical care. The paraphernalia law lists several factors to help determine whether an item is paraphernalia. The fact that a pharmacist is a legitimate supplier of syringes to the community and that the syringes have legitimate uses supports the position that the items do not necessarily constitute paraphernalia under the law. Moreover, a contrary interpretation would lead to absurd results, Burris argues.

"For example, a pharmacist who sells needles to a diabetic knowing that he is a drug user who will probably use some of the needles for heroin as well as insulin would be violating the law, were it construed to apply to health-care providers in this way," he writes.

Of course, physicians and pharmacists concerned about keeping their license amidst the current drug-war paranoia may not be consoled by Burris' analysis. So he offers several suggestions of what can be done to ensure medical professionals are not prosecuted for trying to protect public health:

The General Assembly could amend the Drug Paraphernalia Act to clearly deregulate the sale of injection equipment.

The medical and pharmacy boards could issue regulations explicitly stating that providing sterile injection equipment to drug-using patients to prevent disease transmission is an acceptable medical practice. They could also require training in the theory and practice of harm reduction.

A practitioner wishing to prescribe or dispense injection equipment could bring an action for declaratory judgment to test the legality of the action.

The General Assembly, governor or other state officer could request an attorney general's opinion on the matter.

Practitioners can consult with local law enforcement officials to ensure they are not interested in prosecuting doctors or pharmacists. "Many needle exchange programs operate successfully for long periods under such informal dispensations," Burris notes.

There's growing support in the medical community for the harm-reduction approach to drug addiction that Burris advocates. At its June meeting, the American Medical Association adopted a resolution that supported "the ability of physicians to prescribe syringes and needles to patients with injection drug addiction in conjunction with addiction counseling in order to help prevent the transmission of contagious diseases."

Materials from Burris' project are available on the World Wide Web at www.temple.edu/lawschool/aidspolicy/ default.htm. EndBlock

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