Drug Firms Battle Rule on Prescription Forms

Printed on bank note quality paper, they measure about 8 by 5 inches. Each bears a number. Doctors and dentists are required to sign them. Copies go to the state. They are called “triplicate” prescription forms, and never has a pad of paper so small ignited so much political heat. Law enforcement officials contend that triplicates help them track pill-pushing doctors, deter prescription forgery and put a dent in drug abuse.

Physicians call the forms an intimidating intrusion into their practices and into the privacy of their patients, possibly inhibiting some doctors from providing needed medications.

Pharmaceutical companies, meanwhile, see triplicates as a threat not only to patients but to profits because of the precipitous drop in sales of drugs once triplicates are required.

For years these powerful forces have collided in state after state. Along the way, both the rhetoric and campaign contributions have flowed.

“Triplicates have been the single most divisive element in the attempt to deal with prescription drug abuse,” said Bonnie B. Wilford, director of the Pharmaceutical Policy Project at George Washington University in Washington. “The divisions are so deep I know people who won’t even talk to each other over the issue anymore.”

Wilford said she watched 10 years of work unravel as the triplicate controversy plowed a rift in the National Steering Committee on Prescription Drug Abuse. The panel, which was organized after a White House conference in 1980, had dissolved by 1990.

“The American Medical Assn. opposed them. Law enforcement wanted them,” she said. “It was the 500-pound gorilla that sat in the middle of all our discussions. It drew the energy right out of the committee.”

Triplicate prescriptions are used for Schedule II drugs, a ranking under state and federal law for medications with a high potential for abuse. The category includes amphetamines, barbiturates, codeine, morphine, methadone, methylphenidate or Ritalin, and synthetic opiates, such as Dilaudid and Demerol.

When a triplicate is issued, a copy goes to the doctor, the pharmacy and the state agency that monitors controlled substances. By looking for odd sales patterns, regulators say they can ferret out drug dealing professionals, prescription thefts and people who trick physicians and pharmacists into prescribing them drugs.

Today, no more than 10 of the 50 states have triplicate programs because of intense political opposition from medical societies, drug companies and patient advocates.

Opponents offer a variety of criticisms--all countered with equal fervor by advocates. Among the most enduring and potent complaints is that doctors will prescribe weaker, less effective drugs to avoid having state authorities looking over their shoulders.

“The head of the AMA once said the war on drugs should not become a war on patients and their doctors. I’m afraid it has become just that,” said Harvey L. Rose, a Sacramento-area physician at the forefront of the effort to change state policy related to prescribing narcotics.

The California Medical Board prosecuted Rose in 1981, alleging gross negligence and incompetence in prescribing powerful pain relievers. Though the charges were sustained, the case was dismissed on appeal because the state lost his trial transcripts.

Rose likes to point to the case of Tracy Temp, a 29-year-old athlete and college student from Contra Costa County who committed suicide after pain from an immune system disorder rendered her an invalid. In her note, she complained about her doctor.

“I only wish you knew how horrible it was to hear your detached voice going on about doses and the federal drug people,” Temp wrote. “I can’t stand to live with this constant replay on pain, and you’re worried about someone. . . . I think you want me to go to another office so you won’t look bad.”

Research from Brandeis University in Massachusetts shows that where triplicates are mandated, doctors have, in fact, shied away from using the most powerful narcotics for broken bones, muscle or joint injuries and ill-defined pain. According to the study--an analysis of 40,000 office visits to 1,500 doctors--prescriptions for cancer patients were unaffected.

Researcher Linda Wastila cautioned that she did not try to gauge the quality of care.

Other studies indicate that, after triplicates are required, states generally experience a 30% to 50% drop in the prescribing of Schedule II drugs. Though the research does not prove that the quality of care suffers, triplicate opponents say they believe patients are not getting the most appropriate medication.

“Triplicates result in the use of less effective and more risky drugs,” insisted David E. Joranson, a research director at the University of Wisconsin-Madison Medical School. “Many doctors say they don’t even keep the forms in the office.”

The Counterattack

Supporters of triplicates say such strident opposition is often nothing more than an attempt by organized medicine and the drug industry to protect their earnings and sidestep regulations they find inconvenient.

“Triplicates can result in massive financial losses for the drug industry,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, founded by consumer advocate Ralph Nader. “Because of political pressure from doctors and the drug companies, triplicates are not happening around the country.”

On the enforcement level, states adopting triplicates say prescription forgeries and falsifications have been virtually eliminated. Michigan officials say they used to have almost 104,000 forged or falsified prescriptions a year for Schedule II drugs. New York estimated that it had more than 125,000.

Aside from unconfirmed anecdotes from physicians and patient groups, researchers also say there is no conclusive evidence that triplicates breach patient confidentiality or hamper necessary treatment.

A 1992 study by the federal General Accounting Office found no proof that physicians withheld proper care because they feared oversight. The study also uncovered no breaches of patient confidentiality or lawsuits alleging invasions of privacy.

“All these complaints have been greatly inflated by the drug industry and the American Medical Assn. in their effort to obstruct the passage of triplicate laws,” said Dr. Peter Lurie, an assistant professor of medicine at the University of California, San Francisco, who has studied drug monitoring programs.

Countering arguments that triplicates are detrimental to proper medication, DEA officials say that the sale of morphine used for acute pain has risen almost 400% in the United States over the last decade.

Studies suggest that triplicate forms may play only a minor part in why some doctors do not prescribe powerful pain medications. Perhaps more significant are poor assessments of pain by physicians and a reluctance by patients to take drugs or reveal the severity of their pain.

“Regulation is a legitimate barrier to adequate pain treatment, but it is not the most important barrier. The real crux of the undertreatment problem is that the medical profession is not trained to treat and manage it properly,” said Kimberly Calder, director of Cancer Care, the largest agency in the nation providing support for cancer patients.

As for the expressed fears of grueling investigations and unwarranted prosecutions, authorities say these, too, are exaggerated. For example, there are about 75,000 licensed physicians practicing in California. About 120 were disciplined by the Medical Board from 1990 to 1995 for prescription-related violations. About one in nine lost their licenses.

Also, no more than 20 doctors, dentists and pharmacists a year are ever criminally prosecuted in the state for prescription drug offenses.

New York Experience

Perhaps nowhere has the triplicate fight been fought more fiercely--and with such profound results--as in New York. There, the drug industry and the 30,000-member medical society teamed up in an effort to repeal restrictions that had been placed on tranquilizers, hypnotics and sedatives, which are known as benzodiazepines.

Laurie T. Cohen, a government affairs counsel for the society, summed up the opposition view: “Regulators are constantly in your face. It is an attitude we don’t think is necessary. We have always been vehemently opposed to these triplicate programs.”

Sold under such names as Valium, Librium, Halcion and Xanax, the benzodiazepines are used to treat severe anxiety, panic attacks and sleep disorders. They are some of the most widely prescribed drugs in the United States and some of the most controversial.

Researchers and drug industry executives contend that benzodiazepines have a low rate of abuse and are more effective and safer than barbiturates, the drugs they replaced. However, there is mounting evidence that they are often misused, that people have been kept on them far too long and that benzodiazepines can cause withdrawal symptoms worse than heroin.

After 18 months in court and a failed bid by opponents to have New York legislators intervene, the triplicate requirement went into effect. Within a year, benzodiazepine prescriptions plummeted from 5.3 million to 2.9 million.

Emergency room admissions related to the drugs dropped 48% in New York City and Buffalo, according to the Drug Abuse Warning Network, which surveys emergency rooms across the country.

State officials say triplicates staunched the flow of benzodiazepines to 3,400 people suspected of getting as many as 250,000 illegal prescriptions a year for the drugs. Also, sales of benzodiazepines reportedly dropped 76% at pharmacies thought to be pill mills.

Although state officials point proudly to these numbers, pharmaceutical industry executives say they are misleading.

A drug industry-funded study in 1992 suggested that doctors had simply begun prescribing less effective medications for needy patients. The increased use of alternative tranquilizers and sleeping aids totaled about 20% of the drop in benzodiazepine prescribing.

Triplicates are “a heavy-handed way to deal with the problem,” said Godfrey Grant, a spokesman for UpJohn Co., a pharmaceutical manufacturer opposed to the New York policy. “There are unanticipated, adverse effects that make it impossible for people to get the prescriptions they need.”

New York officials dismiss the shift to other drugs as insignificant, saying most were reasonable substitutes for benzodiazepines while the rest were prescribed in low numbers. “The medical society went around saying how the results of the regulation were going to be terrible, how the use of dangerous alternative drugs would dramatically increase, how it would drive up the use of alcohol,” said John L. Eadie, the former director of the state’s Public Health Protection Division. “None of this has occurred.”

The California Fight

Inspired by New York’s effort, California Assemblywoman Jackie Speier (D-Burlingame) tried to duplicate the program in California in 1990. But her legislation was defeated after intense lobbying by the drug industry and the California Medical Assn.

The original measure sought $6 million a year in funding to add benzodiazepines to the state’s triplicate program. At the time, about 8 million to 10 million prescriptions for the drugs were written annually in California.

After the bill’s introduction, members of the Assembly Health Committee removed the triplicate requirement and rewrote the measure so heavily that Speier hardly recognized it. She let the revised bill, which called for prescription limits, die in the state Senate.

“I thought we had a compelling case to place these drugs in Schedule II,” Speier said. “But the profit interests here were greater than logic. Who are we working for, the consumer or business?”

One of Speier’s supporters was Dr. Alex Stalcup, an addiction specialist from Walnut Creek, who contends that tranquilizers and sedatives are widely misused and should be regulated more.

“The politics start and end with money,” Stalcup said. “The chairs and presidents of local medical societies were escorted around in limos, going to their local representatives, and talking about how wrong it all was. . . . Boy, were we outclassed.”

In 1989 and 1990 alone, the main opponents of triplicates--drug companies, the Pharmaceutical Manufacturers Assn. and the California Medical Assn.--gave $149,000 in campaign donations to the 20 members of the Assembly Health Committee.

Speier herself received $8,306, almost all of it from the state medical association, which for years has been among the most generous campaign contributors in Sacramento.

Drug industry officials and the California Medical Assn. deny that campaign donations influenced the fate of Speier’s bill. They said they have a right to contribute money and to lobby on regulatory issues affecting them.

“Sometimes the people we contribute to agree with us, and sometimes they don’t,” said Danielle J. Walters, associate director of government relations for the California Medical Assn. “We were one of the original supporters of Jackie Speier. Did the donations influence her? Obviously not.”

In 1991, Speier tried again, proposing a bill to limit prescriptions of benzodiazepines to a 120-day supply unless the patient was reevaluated. The bill passed. Triplicates were not even mentioned.

Computer Monitoring

Academics such as Wilford of George Washington University predict that in the decades ahead, the triplicate controversy will fade as state regulators and law enforcement turn toward sophisticated computer networks to review millions of pharmacy records statewide.

Seven states have installed such monitoring systems. When fully operational, they can analyze prescription data much faster than the average triplicate program.

In California, Sandra K. Bauer, a member of the Board of Pharmacy, is pushing legislation to establish a computer network here. To help cut down on paperwork, prescribers would use one serialized form stored by the pharmacy.

Under the state’s current program, staff can scrutinize only 10% to 15% of the 1.5 million triplicates it receives a year because information must be typed into the unit’s computers entered by hand. “If they catch anything,” Bauer said, “its by accident.”

Today, the U.S. Drug Enforcement Administration and the National Assn. of State Controlled Substance Authorities recommend that every state adopt triplicate programs or move toward computer monitoring systems combined with numbered prescription forms.

“We need to increase controls over the categories of drugs with the most severe problems,” said Gene R. Haislip, a DEA administrator. “Until that is done, there won’t be any improvement.”