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GAO: Comprehensive Approach Needed To Combat Prescription Drug Abuse
GAO: 'Comprehensive Approach' Needed To Combat Prescription Drug Abuse Abuse of legally marketed controlled prescription drugs may not get the attention devoted to street drugs such as cocaine and heroin, yet their abuse is second only to that of marijuana/hashish and accounts for more drug-related deaths and emergency medical situations than all illegal drugs combined. So says an October 29 report to Congress from the General Accounting Office (GAO), which notes that the problem is further aggravated by the fact that-for a variety of reasons-prescription drug abuse is often beyond the scope of traditionallaw enforcement efforts. GAO investigated the extent of prescription drug abuse in this country and looked at ways to improve control over the sources of supply. Its report faults Drug Enforcement Administration efforts in this area and urges that additional resources be created by raising annual registration fees under the Controlled Substances Act . In addition, GAO says the best hope for controlling abuse of these drugs is "a comprehensive approach using law enforcement, reg~ ulation, education, and professional peer pressure." There is no escaping the magnitude of the problem, GAO found. Sta tistics from the Drug Abuse Warning Network, a nationwide program gathering data on drug abu se from hospital emergency rooms and medical examiners, show that prescription drugs dominate the figures on reported emergency medical situations and deaths involving controlled drugs (see table, p. 16). In 1980, for instance, prescription drugs were indentified in 74% (or 3,535) of the cases of controlled drugs involving deaths and in 75 % (or 71,431) of total emergency room cases involving con trolled drug use. While the major source of these prescription drugs was once at the Wholesale level, DEA regulations and new security procedures have closed American Pharmacy Vol. NS23, No.1 , January 1983/13
off much of this diversion. Instead, says GAO, 80-90% of abused prescription drugs now come from the retail level, where more than 616,000 physicians, dentists, pharmacists, veterinarians, and others are authorized to prescribe, administer or dispense con trolled drugs. The major law enforcement problem at this level, notes GAO, is that it is difficult to prove willful diversion. Even though pharmacists are required to keep detailed records on drugs acquired and dispensed, GAO found that establishing criminal intent by means of these records is rarely successful. Indeed, says the report, it was not until 1976 that a registrant, the owner of a pharmacy, was convicted under a criminal statute for the illegal sale of controlled drugs on the basis of results of a regulatory investigation. In the case of physicians, required to keep fewer and less detailed records, proof has been even harder to
come by, according to GAO. Adding to the problem is the fact that many abused prescription drugs are obtained legally. Prescription drugs most often involved in emergency room situations, for instance, are those from schedules III and IV . Obtained through legitimate channels, the drugs are often involved in suicide attempts, notes the report. GAO says the only effective strategy is "better coordination of law enforcement, regulatory and professional organization efforts." The report commends the efforts of the American Pharmaceutical Association and the National Association of Boards of Pharmacy in devising a better way of preventing and detecting prescription forgeries and alterations and sensitizing pharmacists to the seriousness of the problem. The report also cites actions by the American Medical Association, with whom APhA is working on a model plan, called Prescription Abuse Data Synthesis (PADS), to use existing federal, state and local statistics to determine the extent of drug diver-I sion at the state level. Representing the profession of pharmacy in the program, APhA's efforts will help create a more complete and accurate picture of the extent of prescription drug diversion. Under a recent amendment to the Controlled Substances Act, DEA is charged with providing states with analytical information to help locate sources of highly abused drugs . However, GAO found that the agency "has not allocated sufficient staff to adequately fulfill" this duty and urges that additional staff be assigned for this purpose. GAO was also dissatisfied with DEA's performance on Operation Script, its pilot program focusing on high-level retail violators. GAO says many of the program's targets did not meet DEA's own high-level violator criteria and that this aspect should be closely monitored in DEA's (continued on page 16) 13
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GAO REPORT
(con tinued from page 13) fo llow-u p effort, the Targeted Regis t ra nt Inves ti ga ti o n s P r og r a m (TRIP). GAO concludes that an obvious lim itin g factor to DEA' s efforts is its budget. Financial resources for DEA p rogram s could be significantly expanded by increasing annual fees charged registrants under the Controlled Substances Act, GAO says, pointing out that these fees, currently $5 p er year to community pharmacies and others at the retail level, have n ot been increased since they w ere established in 1971. In 1980, all CSA fees brought DEA $3.04 million, says the report. The agency's compliance and regulation exp enditures that year were $12.66 million. According to GAO, "if the existing fees had been five times greater (or $25 for retail practitioners) DEA's entire 1980 compliance and regulatory p rogram expenditures would have been more than covered."
Top
20.,Controlled Drugs Abused 'Calendar Year 1980 (Source: Drug Abuse Warning Network) CSA
Drug Diazepam Heroin Methaqualo~e
scheduLe
Nu mbers reported by: Emergency Medical examiners rooms
Flura.z;~paIt\{
Marijuana PCB
- Je
Pharmacists Oppose Direct Promotion of Rx Drugs A join t survey of pharmacists and physician s on the question of advertising prescription products directly to the public found that a sizable m ajority of both groups are against it. More than two thirds (68. 7%) of the pharmacists said they opposed direct promotion, as did 63 .8% of physician s. But w hile both groups w ere in agreement on that question, the survey pointed up some interesting differences as w ell. For instance, 38%
of the pharmacists polled said consumers had mentioned such promotional messages to them, while 15.2% of physicians said they had been similarly questioned. In addition, a larger number of pharmacists (38.1 % )-compared with 29% of the physicians-said they had seen or heard such advertising. The survey was undertaken by the American Medical Association's American Medical News and by American Druggist magazine.
Drug to Treat Back Problems The Food and Drug Administration has approved an injectable drug to be used as an alternative to surgery in the treatment of some back problems. The drug, chymopapain
(Chymodiactin-Smith Laboratories, Inc .) is for use in treating hernia ted lower back discs when more conservative measures-such as bed rest 16
and traction-fail. Derived from the extract of the papaya plant, the drug's active substance is an enzyme; it is intended to be injected into the disc in a hospital setting. In a clinical study of the drug involving 108 patients, the success rate in relieving disabling pain was 75 %.
According to the AMA publication, other findings were: • More than two thirds (68 .5%) of the responding pharmacists said they thought such promotional activities by drug companies would increase prescription drug costs; • One third of pharmacists (32.3 %) said if the ad trend became widespread it would affect their decisions regarding inventory; • Pharmacists underestimated the degree of physician opposition to such ads. Pharmacists guessed that half (54.1 %) would object; actually, 63.8% objected. • Six of ten pharmacists (58.9%) said they thought the direct ad approach would affect physicians' prescribing patterns. Some 16% disagreed with that, while 24% said they did not know. Of those who thought the ads would alter physicians' prescribing patterns, 63.3% of the pharmacists said they thought physicians would be "likely to prescribe" an advertised product.
American Pharmacy Vol. NS23, No. 1, January 1983/16
off much of this diversion. Instead, says GAO, 80-90% of abused prescription drugs now come from the retail level, where more than 616,000 physicians, dentists, pharmacists, veterinarians, and others are authorized to prescribe, administer or dispense con trolled drugs. The major law enforcement problem at this level, notes GAO, is that it is difficult to prove willful diversion. Even though pharmacists are required to keep detailed records on drugs acquired and dispensed, GAO found that establishing criminal intent by means of these records is rarely successful. Indeed, says the report, it was not until 1976 that a registrant, the owner of a pharmacy, was convicted under a criminal statute for the illegal sale of controlled drugs on the basis of results of a regulatory investigation. In the case of physicians, required to keep fewer and less detailed records, proof has been even harder to
come by, according to GAO. Adding to the problem is the fact that many abused prescription drugs are obtained legally. Prescription drugs most often involved in emergency room situations, for instance, are those from schedules III and IV . Obtained through legitimate channels, the drugs are often involved in suicide attempts, notes the report. GAO says the only effective strategy is "better coordination of law enforcement, regulatory and professional organization efforts." The report commends the efforts of the American Pharmaceutical Association and the National Association of Boards of Pharmacy in devising a better way of preventing and detecting prescription forgeries and alterations and sensitizing pharmacists to the seriousness of the problem. The report also cites actions by the American Medical Association, with whom APhA is working on a model plan, called Prescription Abuse Data Synthesis (PADS), to use existing federal, state and local statistics to determine the extent of drug diver-I sion at the state level. Representing the profession of pharmacy in the program, APhA's efforts will help create a more complete and accurate picture of the extent of prescription drug diversion. Under a recent amendment to the Controlled Substances Act, DEA is charged with providing states with analytical information to help locate sources of highly abused drugs . However, GAO found that the agency "has not allocated sufficient staff to adequately fulfill" this duty and urges that additional staff be assigned for this purpose. GAO was also dissatisfied with DEA's performance on Operation Script, its pilot program focusing on high-level retail violators. GAO says many of the program's targets did not meet DEA's own high-level violator criteria and that this aspect should be closely monitored in DEA's (continued on page 16) 13
........
GAO REPORT
(con tinued from page 13) fo llow-u p effort, the Targeted Regis t ra nt Inves ti ga ti o n s P r og r a m (TRIP). GAO concludes that an obvious lim itin g factor to DEA' s efforts is its budget. Financial resources for DEA p rogram s could be significantly expanded by increasing annual fees charged registrants under the Controlled Substances Act, GAO says, pointing out that these fees, currently $5 p er year to community pharmacies and others at the retail level, have n ot been increased since they w ere established in 1971. In 1980, all CSA fees brought DEA $3.04 million, says the report. The agency's compliance and regulation exp enditures that year were $12.66 million. According to GAO, "if the existing fees had been five times greater (or $25 for retail practitioners) DEA's entire 1980 compliance and regulatory p rogram expenditures would have been more than covered."
Top
20.,Controlled Drugs Abused 'Calendar Year 1980 (Source: Drug Abuse Warning Network) CSA
Drug Diazepam Heroin Methaqualo~e
scheduLe
Nu mbers reported by: Emergency Medical examiners rooms
Flura.z;~paIt\{
Marijuana PCB
- Je
Pharmacists Oppose Direct Promotion of Rx Drugs A join t survey of pharmacists and physician s on the question of advertising prescription products directly to the public found that a sizable m ajority of both groups are against it. More than two thirds (68. 7%) of the pharmacists said they opposed direct promotion, as did 63 .8% of physician s. But w hile both groups w ere in agreement on that question, the survey pointed up some interesting differences as w ell. For instance, 38%
of the pharmacists polled said consumers had mentioned such promotional messages to them, while 15.2% of physicians said they had been similarly questioned. In addition, a larger number of pharmacists (38.1 % )-compared with 29% of the physicians-said they had seen or heard such advertising. The survey was undertaken by the American Medical Association's American Medical News and by American Druggist magazine.
Drug to Treat Back Problems The Food and Drug Administration has approved an injectable drug to be used as an alternative to surgery in the treatment of some back problems. The drug, chymopapain
(Chymodiactin-Smith Laboratories, Inc .) is for use in treating hernia ted lower back discs when more conservative measures-such as bed rest 16
and traction-fail. Derived from the extract of the papaya plant, the drug's active substance is an enzyme; it is intended to be injected into the disc in a hospital setting. In a clinical study of the drug involving 108 patients, the success rate in relieving disabling pain was 75 %.
According to the AMA publication, other findings were: • More than two thirds (68 .5%) of the responding pharmacists said they thought such promotional activities by drug companies would increase prescription drug costs; • One third of pharmacists (32.3 %) said if the ad trend became widespread it would affect their decisions regarding inventory; • Pharmacists underestimated the degree of physician opposition to such ads. Pharmacists guessed that half (54.1 %) would object; actually, 63.8% objected. • Six of ten pharmacists (58.9%) said they thought the direct ad approach would affect physicians' prescribing patterns. Some 16% disagreed with that, while 24% said they did not know. Of those who thought the ads would alter physicians' prescribing patterns, 63.3% of the pharmacists said they thought physicians would be "likely to prescribe" an advertised product.
American Pharmacy Vol. NS23, No. 1, January 1983/16