New strategies are being developed in various states to catch offenders
New strategies are being developed in various states to catch offenders
Noelle Bush didn't commit a crime by driving to a Walgreen's pharmacy in Tallahassee, Fla., in January 2002. Her crime was posing as a physician to order a prescription for the antidepressant Xanax (alprazolam, Pharmacia) by telephone. An alert pharmacist caught the bogus script and called police when Bush arrived. The daughter of Florida's Gov. Jeb Bush was arrested and sent to a court-ordered residential drug rehabilitation program.
Noelle's arrest attracted international attention because of her family connections, but she is hardly unique. Patients gone badwriting their own Rxs, duping prescribers and pharmacists, stealing drugs from friends or familyare major sources of drug diversion. Most diversion by patients is for their own use, say drug abuse experts. But patients are also important suppliers of Rx drugs sold on the street.
Diversion by patients is nothing new if you work in the field," said Dana Drooz, pharmacist, lawyer, and manager of drug enforcement for the Kentucky Department for Public Health. Drooz heads Kentucky's prescription drug moni-toring program (PDMP), widely hailed as one of the best in the country.
"But diversion by patients is new to the broader world," said Drooz. "Nobody recognized that prescription drugs are abused until OxyContin [oxycodone, Purdue Pharma] hit the scene. Now everyone knows about doctor shopping and forged scripts."
Doctor shopping involves a patient who either lies about pain, anxiety, or some other condition to a physician in order to obtain medication, or takes the same problem to multiple physicians to obtain and fill multiple Rxs. When Nevada began its PDMP in 1997, the typical doctor shopper was seeing 22 different prescribers, visiting 16 different pharmacies to fill 159 scripts, and receiving 9,351 doses of controlled substances yearly.
Law enforcement barely blinked. "For years, pharmacists and doctors would call us, and nobody responded," said Kevin Bernard, San Diego Police Department detective and head of RxNet, the countywide Pharmaceutical Abuse Task Force founded earlier this year. RxNet links local law enforcement, the Drug Enforcement Administration, Federal Bureau of Investigation, state board of pharmacy, and other enforcement groups concerned with Rx diversion and abuse. RxNet also alerts area pharmacies to potential doctor shoppers and fraudulent prescription patterns.
"If you take your typical police dispatcher, even your typical beat cop, they just didn't know that prescription drug use could be a violation," Bernard explained. "When a known doctor shopper came into a pharmacy, the pharmacist had to convince the dispatcher that the police had to get involved. By the time you got through all that, even if you got a response, the shopper was off to the next pharmacy to fill another prescription."
But while some jurisdictions take a keen interest in Rx drugs, other locales continue to ignore the problem. "Law enforcement wants to catch somebody with a drawer full of crack cocaine," Keith Macdonald, executive secretary of the Nevada State Board of Pharmacy, said. "Rx drug abuse is too complicated. They're interested in street drugs that are easier to understand, easier to quantify, and easier to prosecute."
One of the biggest issues in Rx drug abuse is defining the scope of the problem, especially with analgesics. "Even many pharmacists don't understand the long-term use of opioids," said Susan Winckler, v.p. and staff counsel for the American Pharmaceutical Association. "What looks like dramatic overuse may simply be a patient with chronic pain who is highly tolerant. You need to be aware of the uses of pain management before you make a judgment."
At the same time, prescription drug abuse and diversion are very real problems. According to a May 2002 report on state-run PDMPs from the General Accounting Office, hydrocodone, diazepam, methylphenidate, and oxycodone are the most frequently diverted Rx drugs.
The National Institute on Drug Abuse (NIDA) reports a number of commonly prescribed opioids, central nervous system depressants, and stimulants have become favorites for abuse. The most commonly abused opioids include oxycodone, propoxyphene, hydrocodone, hydromorphone, meperidine, and diphenoxylate.
In the CNS depressant category, abuse favorites include mephobarbital, pentobarbital, diazepam, chlordiazepoxide hydrochloride, alprazolam, triazolam, and estazolam. Among stimulants, dextroamphetamine, methylphenidate, and sibutramine hydrochloride monohydrate are the most commonly abused Rx products.
In 2001, licit medications were mentioned in 43% of drug abuse-related emergency department visits according to DAWN, the Drug Abuse Warning Network. Nearly all drug-related emergency department admissions mentioned psychotherapeutic agents (19%) or CNS agents (18%). DAWN statistics do not include accidental overdoses or other misadventures by patients for whom the drug was prescribed unless there is evidence of abuse.
According to DEA, about nine million Americans aged 12 or older reported using prescription drugs for nonmedical purposes in 2000, the latest year for which data are available. That's about 37.5% of the more than 24 million individuals who reported using any illicit drug during the year. Both estimates are based on the National Household Survey on Drug Abuse, conducted by the Department of Health & Human Services.
DEA combines the annual survey with DAWN and Rx drug abuse indicators such as drugstore thefts. The overall message is that illicit use of prescription products is growing. "Doctor shopping is probably the most prevalent means favored by individuals using prescription products illicitly," said Stacy Marko, staff coordinator at the DEA Office of Diversion Control. "The vast majority of patients and physicians are legitimate. The problem is that these doctor shoppers are real professionals at duping physicians."
There are no national data on how many physicians are duped into writing scripts for patients who abuse or sell the drugs, said Dale Austin, deputy executive v.p. of the Federation of State Medical Boards. But anecdotes abound. "Most physicians have had some exposure to doctor shoppers," he said. "And they don't want any further experiences. It's a real challenge." The challenge is balancing the demands of appropriate medical care, drug abuse, and law enforcement. That leaves a broad window for uncertainty and misuse.
There are three types of doctor shoppers at work: intentional diverters, accidental shoppers, and productive shoppers. Intentional diverters either feign illness or take the same illness to multiple physicians, Winckler explained. The goal is to obtain multiple scripts, either for abuse or resale. The resale market is lucrative. According to DEA, a single 40-mg tablet of OxyContin that sells for about $4 to cash patients in most pharmacies fetches $40 on the street.
Accidental shoppers simply don't know any better, Winckler said. They go to one physician for back pain, another for an on-the-job injury, and another for cancer pain. None of the physicians knows about the others; none asks the patient about other pain medications. And because each script was written by a legitimate prescriber for a legitimate problem, no one recognizes the potential for overmedication, dependence, or abuse.
Productive shoppers are patients whose physician underprescribes analgesics. The patient visits another physician, then another, until the combination of scripts finally relieves the pain. Their behavior is often called pseudoaddiction, addictive-type drug-seeking activities that continue until the underlying pain is finally resolved.
"You have to remember that few prescribers ever got into trouble for underprescribing pain meds," noted David Brushwood, professor of healthcare administration at the University of Florida. "Some patients genuinely need multiple physicians because no single doc is willing to write an effective analgesic script for fear of attracting attention from law enforcement. That's a real challenge to pharmacists."
Another challenge to pharmacists: Doctor shoppers look like patients. The typical Nevada doctor shopper is a 38-year-old female with children in the family, Macdonald noted. "Shoppers look and act like typical patients," he said. "They usually want to pay cash, which can be a clue at the pharmacy, and they know exactly what drug it's going to take to relieve their pain, which should ring bells in the physician's office."
Pharmacy is the traditional defense against doctor shopping. Many local pharmacy groups use fax networks to alert nearby stores about known doctor shoppers or a spike in scripts from a particular physician.
"If a local physician is willing to write Vicodin [acetaminophen/ hydrocodone, Knoll Pharmaceuticals] for all comers or a patient keeps appearing with multiple scripts, pharmacists will recognize it in a hurry," said John Tilley, president of Zweber Pharmacy in Los Angeles and member of the California Board of Pharmacy. "But stores in the next community over aren't aware of the problem. A fax alert network keeps us all in the loop."
Law enforcement sometimes takes the initiative. In Dalton, Ga., the Whitfield County sheriff's department collects reports of attempted Rx fraud from pharmacists and physicians. If a specific patient, physician, or abuse pattern appears, pharmacies across Whitfield and surrounding counties in Georgia and Tennessee are notified by fax.
"Prescription drugs are the most abused drugs on the street in our area," said narcotics unit detective Paul Woods. "You get an idea there's a problem when you get 10 pharmacies and 11 doctors all reporting the same suspicious- acting person." The unit makes about five arrests each month for prescription fraud, he said. One of their highest profile cases was a Whitfield County sheriff's captain and his wife. Both were sentenced to state prison earlier this year.
Does working with law enforcement help? Absolutely, said Joel Zive, owner of Zive Pharmacy and Surgical Supply in the Bronx, N.Y. An undercover policeman arrested a persistent doctor shopper after Zive called for help earlier this year. "Word spreads in an instant on the street," he said. "If you fill just one prescription, you have everybody and their uncle coming in off the street. If you take a stand, doctor shoppers leave you alone."
But they don't stop shopping. Doctor shoppers just take their business to the next town or the next county. Fifteen states are using PDMPs to cast a wider net to stop doctor shoppers and other Rx diversion. Half a dozen other states are establishing PDMPs.
"Pharmacies and physicians along the border with Kentucky have been screaming for a monitoring program for years," said William T. Winsley, executive director of the Ohio State Board of Pharmacy. The board's PDMP proposal has been approved by the state house and could be approved by the state senate later this year. "They're getting inundated by doctor shoppers fleeing the Kentucky monitoring program," he said. "Nobody on the house side opposed the bill. The major drug companies are behind it, the associations are behind it, and law enforcement is behind it. The only concern is finding $1 million to get it up and running."
Virginia is also creating a PDMP. But the commonwealth is starting with a small pilot project in the southwest corner adjoining Kentucky. Rebecca Snead, executive director of the Virginia Pharmacists Association, isn't convinced that PDMPs actually reduce doctor shopping and Rx drug diversion. In Kentucky, for example, law enforcement investigation time on doctor shopper cases has dropped from an average of 156 days to 16 days. But a drop in case investigation time does not imply a drop in the incidence of doctor shopping, she noted. She also heard PDMP doubters pointing to a potential chilling effect on prescribers.
"There are a whole host of studies showing that physicians, nurse practitioners, and pharmacists underprescribe opioids for fear of involvement by law enforcement," said John Giglio, executive director of the American Pain Foundation. He cited a 1998 study in which 54% of Wisconsin physicians admit to underprescribing opioids specifically to avoid investigation by law enforcement.
A 2001 article in the Journal of the American Pharmaceutical Association revealed that 68% of Wisconsin pharmacists believed that patients with undertreated pain were "drug seekers" because they asked for additional medication.
Snead doesn't dispute the underprescribing or the overreaction to inadequate pain treatment, but a state PDMP isn't the problemWisconsin doesn't have one. "I looked very hard for data on both sides of the issue," she said. "There are people who care passionately on both sides, and I have them all as members. I could not find data to substantiate either assertion."
Arguments about prescription monitoring could heat up after the election. That's when Congress is likely to look at NASPER, the National All Schedule Prescription Electronic Reporting Act of 2002. The act, introduced in both the House and the Senate at the end of September, would establish a national PDMP. "We have seen just how easy it is for people to jump across the border to another state to escape monitoring," said a spokesman for Rep. Ed Whitfield (R, Ky.), who introduced NASPER in the House. "Kentucky has a model program, which is pushing the problem onto our neighbors. A broader approach is needed."
Or maybe not. DEA backs Rx drug monitoring, but Marko cautioned that a national program may not be the answer. She suggested that a state-by-state approach, tailored to the distinct needs of each state, would be more effective than a federal program.
State regulators seem to agree. Macdonald said a federal PDMP is a fine concept, but the actual program would be too big, too cumbersome, and too intrusive. He favors a national mandate for state-designed and state-administered PDMPs. Now that Kentucky and Nevada have developed a workable software product, program start-up and maintenance costs should fall, he said.
"We haven't absolutely been able to stop doctor shopping, but we've cut it back significantly," Macdonald said. "There's no reason other states can't do it, too."
Each of the 15 state prescription drug monitoring programs (PDMPs) is different, but they have common features.
Most states have abandoned paper reporting as too intimidating to use and too difficult to search. Electronic reporting is standard, with pharmacy reporting required monthly or biweekly. Newer programs monitor all controlled substances, not just Schedule II products.
Each prescription report identifies patient, prescriber, pharmacy, drug, and formulation.
Prescribers and pharmacies can request data to verify that a specific patient is not filling scripts from multiple physicians or that a prescriber is not writing unlikely numbers of controlled substance scripts. Law enforcement access requires probable cause. Data requests are usually filled within four to 24 hours.
Some programs generate alerts when activity thresholds are crossed. In Nevada, for example, patients who see more than 10 physicians, use more than 10 pharmacies, or receive more than 500 oral doses of controlled substances within a six-month period trigger an alert. A pharmacist reviews the alert and, if it seems appropriate, sends a report to each of the prescribers and pharmacies the patient has used. It is up to the physicians and pharmacists to take appropriate action.
Physicians aren't always the victims. Doctors go bad, too. In Florida, pain specialist James Graves, M.D., was convicted of manslaughter in February 2002 in the deaths of four patients from overdoses of OxyContin (oxycodone, Purdue Pharma). Graves, reportedly the top OxyContin prescriber in Florida, was the nation's first physician to be convicted of manslaughter or murder in an OxyContin-related death. Physicians in California and Florida face similar murder or manslaughter charges.
Key testimony came from two dozen area pharmacists who had stopped filling what they called "Graves cocktails." His typical script combined OxyContin, Soma (carisoprodol, Wallace Pharmaceuticals), Xanax (alprazolam, Pharmacia), and Lortab (hydrocodone/acetaminophen, UCB Pharma).
Graves was sentenced to 64 years in prison for four counts of manslaughter, five counts of unlawful delivery of a controlled substance, and one racketeering charge. He also faces Medicaid fraud charges. A state investigator said Florida paid pharmacies $385,000 for bogus scripts written by the physician.
Pain management experts blame outmoded ideas about drug addiction for much of the confusion and concern over treating patients in pain. Even many pharmacists and physicians fail to recognize the difference among tolerance, dependence, and addiction. Tolerance and dependence are normal physiological consequences of extended opioid therapy, according to the Federation of State Medical Boards. In its model guidelines on the use of controlled substances for the treatment of pain, FSMB said flatly that neither physical dependence nor tolerance should be considered addiction.
Analgesic tolerance is the need to increase the dose of opioids to achieve the same level of analgesia. Tolerance does not equate with addiction.
Physical dependence is a physiological state of neuro-adaptation characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence does not equate with addiction.
Addiction is a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on a substance for its psychic effects. Addiction is characterized by compulsive use despite harm. Addiction is sometimes referred to as "drug dependence" and "psychological dependence."
Pseudoaddiction is a pattern of drug-seeking behavior by patients who are not receiving adequate pain relief. Once adequate pain management is provided, what looks like addictive behavior disappears.
Prescription monitoring treads a twisting path between appropriate care and Rx drug abuse. "There is a problem with the abuse of prescription meds," said Matt Bromley, policy and communications director for the American Alliance of Cancer Pain Initiatives (AACPI). "There has been for years. But if prescription monitoring is not done in a balanced manner, it has an adverse impact on access to care and adequate pain relief."
No state PDMP is perfect, Bromley said, but the most successful meet most of the criteria on AACPI's wish list:
The program is designed and run by a healthcare agency, not law enforcement.
Reporting is electronic, not based on multiple copy or serialized prescription forms.
All controlled substances, Schedules II, III, IV, and V, are monitored.
The program is overseen by a multidisciplinary medical review group that is conversant with the most current practices and protocols in pain management.
Patient confidentiality is protected.
Individual practitioners can access PDMP data to evaluate their own patients.
Law enforcement can access PDMP data only after showing probable cause based on other sources.
Healthcare education programs address practitioner concerns about the potential chilling effect of regulatory scrutiny.
Practitioners are encouraged to communicate concerns and questions to their PDMP administrator.
Responsible agencies conduct research to evaluate the impact of the PDMP on patients, providers, and the actual incidence of drug diversion and abuse in the community.
Fred Gebhart. DOCTOR SHOPPING. Drug Topics 2002;22:38.