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Pharmaceutical Diversion
Pharmaceutical Diversion A Problem For the 1980s
By RONALD BUZZEO and ROBERT C. WILLIAMSON
I llicit trafficking in pharmaceutical controlled substances is commonplace today. Changing abuse patterns have resulted in a burgeoning underworld market for hydromorphone, methaqualone, barbiturates, and amphetamines. Street prices for hydromorphone and methaqualone range from $25 to $50 per dosage unit. Many other controlled pharmaceuticals sell illicitly in the $10-$15 range. The manufacture and distribution of these substances are regulated by the U.S. Government in accordance with the provisions of the Controlled Substances Act of 1970 (CSA). This law provides for a "closed system of distribution. " Registered drug handlers must secure adequate facilities for the storage of their controlled substances. Additionally, the legitimate distribution of these substances is restricted to authorized users, and all transfers of drugs . are sufficiently documented. The Justice Department's Drug Enforcement Administration is responsible for the identification and prosecution of individuals who vio-
Ronald Buzzeo, BS Pharm, is chief of the Compliance Division, Office of Compliance and Regulatory Affairs, Drug Enforcement Administration, Washington , DC 20537. Robert C. Williamson is a staff assistant in the division's investigations section . 10
American Pharmacy Vol. NS20, No. 12, December 1980/682
late the Controlled Substances Act. DEA's primary enforcement activities are conducted by some 2,000 special agents stationed throughout the world. Approximately 200 compliance investigators monitor the legitimate manufacture and distribution of controlled substances through a regulatory investigation program designed to identify instances of diversion and other illegal activities. Currently, there are more than 600,000 DEA registrants who manufacture, distribute, or dispense some 20,000 brand name products controlled by the CSA. Diversion of these products for illegal purposes has de~lined significantly since the passage of the Act. Still, we estimate that some 300 million dosage units are diverted annually from legitimate sources. Most of the diversion now occurs at the points of dispensing-practitioners, pharmacies, hospitals, and clinics. These registrants are most vulnerable to illegal drug activities. They must deal with drug thefts, indiscriminate prescribing, and forged prescriptions. A few-a very small percentage-have been implicated in illegal drug sales. To deal with drug diversion at this level, DEA has created four separate programs: • The Pharmacy Theft Prevention program, which calls on state and local pharmaceutical associations for their help in developing
methods to discourage pharmacy crime; • The Voluntary Compliance program, aimed at minimizing illegal prescription use and indiscriminate prescribing; • "Operation Script," a sophisticated computerized tracking system designed to identify DEA registrants iI)volved in drug trafficking; • The Diversion Investigative Unit program, primarily a grant program to support state regulatory boards and enforcement agencies. Pharmacy Theft Prevention
Pharmacists are more likely to experience a drug theft than any other legitimate drug handler. This is not surprising. Most pharmacies are ill equipped to provide expensive security devices that would effectively deter criminal elements. Moreover, pharmacies are plentiful, and they all stock controlled substances. In 1979, retail pharmacies accounted for 71 % of the 11,400 drug thefts reported to DEA. In 1975 DEA conducted two major studies of pharmacy theft. These studies disclosed that there were many inexpensive methods pharmacists could use to make their pharmacies less attractive to a potential burglar. For example, proper lighting and layout can discourage illegal entry. Most pharmacy thefts are committed by inexperienced burglars who are likely to respond to a favorable opportunity. Locking
American Pharmacy Vol. NS20, No. 12, December 1980/683
devices that can be upgraded at a modest price will easily persuade these individuals that a potential breaking-and-entering charge is not worth the effort. Police visibility also is a crucial factor in reducing all types of pharmacy crime. Local police departments must be responsive to the needs of pharmacists, as well as other small business owners. Following this study the DEA developed its Pharmacy Theft Prevention program. Designed as a community action approach to pharmacy theft, the PTP program was initiated in 1977 following a pilot project in St. Louis, MO, which reduced pharmacy burglaries by 55% and pharmacy armed robberies by 46%. Today there are 14 active PTP cities and two statewide programs (Utah and Rhode Island). Statistical analysis of pharmacy thefts in these areas varies from city to city but in 1979, DEA determined that theft in PTP areas, overall, was approximately 9% less than for pharmacies as a whole. The nucleus of a PTP program is the leadership in a community. Usually, city or county pharmaceutical associations initiate the program. These leaders form an executive committee that includes representatives from the police department and a DEA compliance investigator. Without the full support and participation of the local police depart11
ment, no program can realize its potential. The committee puts the program together, monitors the progress of each part, and supplies the impetus to keep it going. It provides a collective voice to deal with local government officials, the media, and others whose assistance is necessary to the program. It also serves to pass information to the rank-and-file pharmacists through seminars, mailers, and press releases. Perhaps the most important service the committee can render is to tell local pharmacists of the multitude of options available to them in their fight to suppress pharmacy crime. One very effective method of accomplishing this objective is to hold seminars for interested pharmacists at a time chosen to be conducive to maximum attendance. These seminars need not last more than a few hours, which makes them more attractive to the busy pharmacist. Topics should include the level of police participation and assistance to be expected, a discus-
PTP Programs Philadelphia Nashville Johnson County, KS Dallas Denver Seattle San Diego San Juan Clark County, NC Jefferson County, KY Pittsburgh Wyandotte County, KS Lawrence, KS Independence, MO sion of the pharmacy theft problem in the local area, available security devices and their relative merits, burglary prevention techniques, and the appropriate response to an armed robbery. Pharmacists also must understand the need for security improvements in all pharmacies instead of piecemeal efforts by only a few. PTP programs are limited only by the imagination of the committee and the nature of local problems. Many PTP programs have con12
50 r------------------------------------------------, 40
All Pharmacies
10
o ----- ---- ----------------,- --- ----------------10 Q) (J)
~ 20
U Q)
PTP Cities
o 30 ;;f.
40 50~----------------------------
______________________- J
4th Qtr
1st Qtr
2nd Qtr
3rd Qtr
4th Qtr
1st Qtr
1978
1979
1979
1979
1979
1980
ducted security surveys to establish minimum security standards. Pharmacies are then inspected and given decals indicating that they meet these standards. Other programs have established "hot lines" to forewarn an entire pharmaceutical community of forged or bogus prescriptions. PTP programs also have explored group rates for alarm systems and discounted insurance rates for security improvement. Voluntary Compliance Program
Physicians frequently act as unwitting sources of supply for drug abusers. This occurs when a drug user feigns an illness which is generally treated with a controlled substance. For example, pain associated with a back strain might be treated with a narcotic analgesic. Stimulants are often prescribed where patients are overweight. Sedative-type drugs are routinely pre~cribed for anxiety. Undeniably, some physicians are more casual in their prescribing practices than others. Seasoned drug dealers quickly identify the "easy" physicians and routinely
visit them to maintain their supply. Illicit drug profits are large enough to support transportation costs among several metropolitan areas. Thus the active dealer may make this a full-time profession. DEA field offices also report sophisticated practitioner-directed drug rings. Typically, a male will transport a group of females to several physicians' offices on the same day. These women will request prescriptions for stimulant and/or depressant controlled substances. These rings can secure 500-700 dosage units in a day. If the prescriptions can be refilled, the diversion is multiplied. This m'e thod of operation is frequently associated with organized prostitution. Drugs secured in this fashion are controlled by pimps, who give a portion to their prostitutes and sell the remainder. Another common method of diversion is to alter or forge prescriptions. The theft of blank prescription pads from physicians' offices is a frequent occurrence. Drug users quickly become adept at filling out prescriptions that look like the real thing. In one instance the DEA
American Pharmacy Vol. NS20, No. 12, December 1980/684
Johnson County Program One of the most successful PTP programs is in Johnson County, KS, where every pharmacy in the county belongs to the program. Started in 1978, the program originally directed its efforts at upgrading pharmacy security. Pharmacists were first instructed in viable security precautions and were then each visited by a detective from the city/ county investigative squad who made general security recommendations. Every pharmacy owner upgraded security and received a decal indicating that certain precautions against theft had been taken. In 1980, there have only been four burglaries in Johnson County and no armed robberies. The Johnson County program then turned its attention to stopping forged prescription orders through a community system called Pharm-Alert which works on a pyramid basis. When a pharmacist discovers a forged prescription order, he notifies the participating detective who assures a quick response to the crime. The pharmacist then contacts a number of other pharmacists, giving them a description of the suspect and the method of operation. These pharmacists in turn call other pharmacists, who pass the word on until the entire community knows about the problem. The PTP program was also instrumental in the passage of a state law making the acquisition of controlled substances through fraud and deceit a felony. This was accomplished through the efforts of two PTP program executive committee members: Joseph Shalinsky, secretary of the Kansas State Board of Pharmacy, and Detective Richard A. Darnell, intelligence analyst for the city/ county investigative squad.
identified a group that actually printed its own prescriptions and hired an answering service for a phony office. Pharmacists who called to verify a prescription's authenticity invariably received a call back to corroborate the "patient's" medical need for the substance. A much simpler, and more common, method is simply to alter a legitimate prescription. The addition of a zero can make a prescription for 30 one for 300. The number three can easily be converted to an eight. Large amounts can frequently be explained by vacation or extended travel. It is surprising how often this ploy has been successful. The importance of prudent prescription practices cannot be overemphasized. DE A' s Voluntary Compliance program has been established as a vehicle for the transmission of relevant information to all DEA registrants. Through the Practitioners Working Committee the agency disseminates important information to professionals in the fields of medicine, dentistry, and pharmacy. The committee has developed prescribing guidelines that provide for acceptable professional responses to guard against diversion through indiscrimina te prescribing. The guidelines establish procedural techniques that greatly reduce instances of unwitting diversion. Additionally, medical practitioners are instructed to make their prescriptions alteration proof and to take proper precautions to avoid theft of prescription blanks. 'Operation Script' The number of registrants involved in illegal activities is actually quite small when compared to the total number authorized to receive and dispense controlled substances. DEA estimates that only 2% of all practitioner-type registrants (about 12,000) are actively engaged in illegal activities. Nevertheless, these registrants have become significant sources of diversion, representing billions of dollars of illegal sales annually. Registrant violators are assured of a continuous supply of drugs, since they can purchase them from within the legitimate pipeline. For example, in one DEA practi-
American Pharmacy Vol. NS20", No. 12, December 1980/685
tioner case a physician in Connersville, IN, was indicted for illegal sale, conspiracy, continuing criminal enterprise, and tax fraud. During the two-year period of active investigation, law enforcement officials expended $21,000 in official government funds for the purchase of drug evidence (amphetamines, cocaine, methaqualone, and secobarbital). DEA field offices estimate that this physician accounted for the diversion of more than 1 million dosage units of Schedule II controlled substances. This doctor was convicted and is currently serving a 10-year prison sentence. In response to this type of diversion the DEA designed a sophisticated pilot program that would use scarce resources to identify and investigate registrants involved in high-level drug trafficking. The project was initiated in October 1979 under the name "Operation Script." Tentative investigative targets were developed using purchase information available in the DEA's Automated Reports and Consolidated Orders System (ARCOS) . This information was evaluated by DEA field offices, which also provided potential targets based on local enforcement intelligence. After a careful analysis of all existing intelligence information, 94 DEA registrants in 22 states were selected for investigation. Practitioner-type investigations are time consuming and difficult. Typically, a drug user will ask for drugs, and a physician will perform a perfunctory examination. Successful undercover purchases must elicit testimony from the practitioner that clearly shows that the suspect is willingly and knowingly preparing a prescription for nonmedical purposes. Additionally, in jury proceedings, physicians as a rule make very sympathetic defendants. Convicted practitioners generally receive very light sentences. A sentence of more than three years is considered significant in a practitioner case. The DEA's "Operation Script" is still under evaluation. To date, the project has resulted in 10 convictions. Six more of the targets are under indictment, and 20 have been referred to U.S. attorneys for prosecution. 13
Diversion Investigative Units "Operation Script" was designed to target only the most egregious violators. The investigation and regulation of physicians and pharmacists must ultimately fall to state regulatory boards and enforcement agencies. In 1972 DEA initiated the Diversion Investigative Unit program to stimulate the <;levelopment of state agencies that could respond adequately to registrant diversion. This is primarily a grant program for the establishment of special task forces called Diversion Investigation Units consisting of state police, state regulatory investigators, and a DEA special agent or compliance investigator.
DIUs Alabama Arkansas California DC Georgia Hawaii Illinois Indiana Maine Massachusetts Michigan Nevada New Hampshire New Jersey New Mexico North Carolina Oklahoma Pennsylvania Texas Utah Washington
The units are directed totally by the state. However, there is a broad spectrum of expertise to develop appropriate investigative and regulatory procedures. DEA provides 1824 months' seed funding, regulatory training, and investigative support. After the initial funding period, participants must pay for continuation of the units. To date, all participating states except Florida have continued funding. There are currently 21 states with active Diversion Investigation Units. Since the program's incep14
tion, DIUs have accounted for approximately 3,000 arrests and 15 million dosage units. In the last fiscal year alone these units made some 500 arrests and removed approximately 1 million dosage units of controlled substances from the illicit market. On the Horizon Considerations are under way to modify existing investigative programs to allow for a greater concentration of resources in the area of drug diversion. DEA's targeting ability is being examined and improved. Depending on the results of "Operation Script," the agency may initiate a continuing program to identify and investigate registrant violators who are appropriate for federal investigation. DEA also is exploring drugspecific investigations at the manufacturer and distributor levels. A concentrated inquiry into the legitimate production of highly abused substances will provide information regarding areas of abuse and investigative leads from excessive purchase information. These investigations also may give rise to changes in production quotas. The Pharmacy Theft Prevention program, the Voluntary Compliance program, and the Diversion Investigative Unit program are here to stay. These programs are worthwhile and appropriate. They incorporate mutual efforts from differing parties and are very inexpensive relative to most government initiatives. Pharmaceutical diversion can be reduced significantly through selective federal efforts working in a partnership with appropriate state and local agencies. DEA intends to be responsive to changing trends in drug abuse and drug trafficking. Scarce resources must be used prudently to effectively disturb trafficking patterns and techniques. This is a problem for the 1980s and a challenge for pharmacists and other health practitioners as well as DEA.D
Pharmacist's Manual A new edition of the DEA's
Pharmacist's Manual is expected by the end of 1980. Sections of the manual that were included in the last edition will remain substantially unchanged. Several new sections are being added, however: • Central record keeping-although a central record keeping permit is no longer necessary, the procedure for such record keeping is outlined; • Power of attorney-gives procedures for the pharmacist to give someone the power of attorney to sign order forms for Schedule II drugs; • Excessive purchases of controlled drugs-puts the pharmacist on notice that a manufacturer or distributor has the responsibility to notify DEA if a registrant is making unusual or excessive purchases of controlled drugs; • U.S. Postal Service mailing requirements--outlines the postal service's procedures for mailing controlled substances (procedures may change as the requirements are revised); • Forged prescriptions-tells the pharmacist how to handle them; • Narcotics treatment programs-discusses procedures necessary for the establishment of narcotic treatment programs. Also included is a complete list of U.S. regional, district, and resident DEA offices that have compliance officers. The DEA is planning to distribute the manual through regional and local DEA offices rather than sending it directly to individual registrants. Pharmacists who wish to obtain a copy should contact their local DEA office. -PAM
American Pharmacy Vol. NS20, No. 12, December 1980/686
By RONALD BUZZEO and ROBERT C. WILLIAMSON
I llicit trafficking in pharmaceutical controlled substances is commonplace today. Changing abuse patterns have resulted in a burgeoning underworld market for hydromorphone, methaqualone, barbiturates, and amphetamines. Street prices for hydromorphone and methaqualone range from $25 to $50 per dosage unit. Many other controlled pharmaceuticals sell illicitly in the $10-$15 range. The manufacture and distribution of these substances are regulated by the U.S. Government in accordance with the provisions of the Controlled Substances Act of 1970 (CSA). This law provides for a "closed system of distribution. " Registered drug handlers must secure adequate facilities for the storage of their controlled substances. Additionally, the legitimate distribution of these substances is restricted to authorized users, and all transfers of drugs . are sufficiently documented. The Justice Department's Drug Enforcement Administration is responsible for the identification and prosecution of individuals who vio-
Ronald Buzzeo, BS Pharm, is chief of the Compliance Division, Office of Compliance and Regulatory Affairs, Drug Enforcement Administration, Washington , DC 20537. Robert C. Williamson is a staff assistant in the division's investigations section . 10
American Pharmacy Vol. NS20, No. 12, December 1980/682
late the Controlled Substances Act. DEA's primary enforcement activities are conducted by some 2,000 special agents stationed throughout the world. Approximately 200 compliance investigators monitor the legitimate manufacture and distribution of controlled substances through a regulatory investigation program designed to identify instances of diversion and other illegal activities. Currently, there are more than 600,000 DEA registrants who manufacture, distribute, or dispense some 20,000 brand name products controlled by the CSA. Diversion of these products for illegal purposes has de~lined significantly since the passage of the Act. Still, we estimate that some 300 million dosage units are diverted annually from legitimate sources. Most of the diversion now occurs at the points of dispensing-practitioners, pharmacies, hospitals, and clinics. These registrants are most vulnerable to illegal drug activities. They must deal with drug thefts, indiscriminate prescribing, and forged prescriptions. A few-a very small percentage-have been implicated in illegal drug sales. To deal with drug diversion at this level, DEA has created four separate programs: • The Pharmacy Theft Prevention program, which calls on state and local pharmaceutical associations for their help in developing
methods to discourage pharmacy crime; • The Voluntary Compliance program, aimed at minimizing illegal prescription use and indiscriminate prescribing; • "Operation Script," a sophisticated computerized tracking system designed to identify DEA registrants iI)volved in drug trafficking; • The Diversion Investigative Unit program, primarily a grant program to support state regulatory boards and enforcement agencies. Pharmacy Theft Prevention
Pharmacists are more likely to experience a drug theft than any other legitimate drug handler. This is not surprising. Most pharmacies are ill equipped to provide expensive security devices that would effectively deter criminal elements. Moreover, pharmacies are plentiful, and they all stock controlled substances. In 1979, retail pharmacies accounted for 71 % of the 11,400 drug thefts reported to DEA. In 1975 DEA conducted two major studies of pharmacy theft. These studies disclosed that there were many inexpensive methods pharmacists could use to make their pharmacies less attractive to a potential burglar. For example, proper lighting and layout can discourage illegal entry. Most pharmacy thefts are committed by inexperienced burglars who are likely to respond to a favorable opportunity. Locking
American Pharmacy Vol. NS20, No. 12, December 1980/683
devices that can be upgraded at a modest price will easily persuade these individuals that a potential breaking-and-entering charge is not worth the effort. Police visibility also is a crucial factor in reducing all types of pharmacy crime. Local police departments must be responsive to the needs of pharmacists, as well as other small business owners. Following this study the DEA developed its Pharmacy Theft Prevention program. Designed as a community action approach to pharmacy theft, the PTP program was initiated in 1977 following a pilot project in St. Louis, MO, which reduced pharmacy burglaries by 55% and pharmacy armed robberies by 46%. Today there are 14 active PTP cities and two statewide programs (Utah and Rhode Island). Statistical analysis of pharmacy thefts in these areas varies from city to city but in 1979, DEA determined that theft in PTP areas, overall, was approximately 9% less than for pharmacies as a whole. The nucleus of a PTP program is the leadership in a community. Usually, city or county pharmaceutical associations initiate the program. These leaders form an executive committee that includes representatives from the police department and a DEA compliance investigator. Without the full support and participation of the local police depart11
ment, no program can realize its potential. The committee puts the program together, monitors the progress of each part, and supplies the impetus to keep it going. It provides a collective voice to deal with local government officials, the media, and others whose assistance is necessary to the program. It also serves to pass information to the rank-and-file pharmacists through seminars, mailers, and press releases. Perhaps the most important service the committee can render is to tell local pharmacists of the multitude of options available to them in their fight to suppress pharmacy crime. One very effective method of accomplishing this objective is to hold seminars for interested pharmacists at a time chosen to be conducive to maximum attendance. These seminars need not last more than a few hours, which makes them more attractive to the busy pharmacist. Topics should include the level of police participation and assistance to be expected, a discus-
PTP Programs Philadelphia Nashville Johnson County, KS Dallas Denver Seattle San Diego San Juan Clark County, NC Jefferson County, KY Pittsburgh Wyandotte County, KS Lawrence, KS Independence, MO sion of the pharmacy theft problem in the local area, available security devices and their relative merits, burglary prevention techniques, and the appropriate response to an armed robbery. Pharmacists also must understand the need for security improvements in all pharmacies instead of piecemeal efforts by only a few. PTP programs are limited only by the imagination of the committee and the nature of local problems. Many PTP programs have con12
50 r------------------------------------------------, 40
All Pharmacies
10
o ----- ---- ----------------,- --- ----------------10 Q) (J)
~ 20
U Q)
PTP Cities
o 30 ;;f.
40 50~----------------------------
______________________- J
4th Qtr
1st Qtr
2nd Qtr
3rd Qtr
4th Qtr
1st Qtr
1978
1979
1979
1979
1979
1980
ducted security surveys to establish minimum security standards. Pharmacies are then inspected and given decals indicating that they meet these standards. Other programs have established "hot lines" to forewarn an entire pharmaceutical community of forged or bogus prescriptions. PTP programs also have explored group rates for alarm systems and discounted insurance rates for security improvement. Voluntary Compliance Program
Physicians frequently act as unwitting sources of supply for drug abusers. This occurs when a drug user feigns an illness which is generally treated with a controlled substance. For example, pain associated with a back strain might be treated with a narcotic analgesic. Stimulants are often prescribed where patients are overweight. Sedative-type drugs are routinely pre~cribed for anxiety. Undeniably, some physicians are more casual in their prescribing practices than others. Seasoned drug dealers quickly identify the "easy" physicians and routinely
visit them to maintain their supply. Illicit drug profits are large enough to support transportation costs among several metropolitan areas. Thus the active dealer may make this a full-time profession. DEA field offices also report sophisticated practitioner-directed drug rings. Typically, a male will transport a group of females to several physicians' offices on the same day. These women will request prescriptions for stimulant and/or depressant controlled substances. These rings can secure 500-700 dosage units in a day. If the prescriptions can be refilled, the diversion is multiplied. This m'e thod of operation is frequently associated with organized prostitution. Drugs secured in this fashion are controlled by pimps, who give a portion to their prostitutes and sell the remainder. Another common method of diversion is to alter or forge prescriptions. The theft of blank prescription pads from physicians' offices is a frequent occurrence. Drug users quickly become adept at filling out prescriptions that look like the real thing. In one instance the DEA
American Pharmacy Vol. NS20, No. 12, December 1980/684
Johnson County Program One of the most successful PTP programs is in Johnson County, KS, where every pharmacy in the county belongs to the program. Started in 1978, the program originally directed its efforts at upgrading pharmacy security. Pharmacists were first instructed in viable security precautions and were then each visited by a detective from the city/ county investigative squad who made general security recommendations. Every pharmacy owner upgraded security and received a decal indicating that certain precautions against theft had been taken. In 1980, there have only been four burglaries in Johnson County and no armed robberies. The Johnson County program then turned its attention to stopping forged prescription orders through a community system called Pharm-Alert which works on a pyramid basis. When a pharmacist discovers a forged prescription order, he notifies the participating detective who assures a quick response to the crime. The pharmacist then contacts a number of other pharmacists, giving them a description of the suspect and the method of operation. These pharmacists in turn call other pharmacists, who pass the word on until the entire community knows about the problem. The PTP program was also instrumental in the passage of a state law making the acquisition of controlled substances through fraud and deceit a felony. This was accomplished through the efforts of two PTP program executive committee members: Joseph Shalinsky, secretary of the Kansas State Board of Pharmacy, and Detective Richard A. Darnell, intelligence analyst for the city/ county investigative squad.
identified a group that actually printed its own prescriptions and hired an answering service for a phony office. Pharmacists who called to verify a prescription's authenticity invariably received a call back to corroborate the "patient's" medical need for the substance. A much simpler, and more common, method is simply to alter a legitimate prescription. The addition of a zero can make a prescription for 30 one for 300. The number three can easily be converted to an eight. Large amounts can frequently be explained by vacation or extended travel. It is surprising how often this ploy has been successful. The importance of prudent prescription practices cannot be overemphasized. DE A' s Voluntary Compliance program has been established as a vehicle for the transmission of relevant information to all DEA registrants. Through the Practitioners Working Committee the agency disseminates important information to professionals in the fields of medicine, dentistry, and pharmacy. The committee has developed prescribing guidelines that provide for acceptable professional responses to guard against diversion through indiscrimina te prescribing. The guidelines establish procedural techniques that greatly reduce instances of unwitting diversion. Additionally, medical practitioners are instructed to make their prescriptions alteration proof and to take proper precautions to avoid theft of prescription blanks. 'Operation Script' The number of registrants involved in illegal activities is actually quite small when compared to the total number authorized to receive and dispense controlled substances. DEA estimates that only 2% of all practitioner-type registrants (about 12,000) are actively engaged in illegal activities. Nevertheless, these registrants have become significant sources of diversion, representing billions of dollars of illegal sales annually. Registrant violators are assured of a continuous supply of drugs, since they can purchase them from within the legitimate pipeline. For example, in one DEA practi-
American Pharmacy Vol. NS20", No. 12, December 1980/685
tioner case a physician in Connersville, IN, was indicted for illegal sale, conspiracy, continuing criminal enterprise, and tax fraud. During the two-year period of active investigation, law enforcement officials expended $21,000 in official government funds for the purchase of drug evidence (amphetamines, cocaine, methaqualone, and secobarbital). DEA field offices estimate that this physician accounted for the diversion of more than 1 million dosage units of Schedule II controlled substances. This doctor was convicted and is currently serving a 10-year prison sentence. In response to this type of diversion the DEA designed a sophisticated pilot program that would use scarce resources to identify and investigate registrants involved in high-level drug trafficking. The project was initiated in October 1979 under the name "Operation Script." Tentative investigative targets were developed using purchase information available in the DEA's Automated Reports and Consolidated Orders System (ARCOS) . This information was evaluated by DEA field offices, which also provided potential targets based on local enforcement intelligence. After a careful analysis of all existing intelligence information, 94 DEA registrants in 22 states were selected for investigation. Practitioner-type investigations are time consuming and difficult. Typically, a drug user will ask for drugs, and a physician will perform a perfunctory examination. Successful undercover purchases must elicit testimony from the practitioner that clearly shows that the suspect is willingly and knowingly preparing a prescription for nonmedical purposes. Additionally, in jury proceedings, physicians as a rule make very sympathetic defendants. Convicted practitioners generally receive very light sentences. A sentence of more than three years is considered significant in a practitioner case. The DEA's "Operation Script" is still under evaluation. To date, the project has resulted in 10 convictions. Six more of the targets are under indictment, and 20 have been referred to U.S. attorneys for prosecution. 13
Diversion Investigative Units "Operation Script" was designed to target only the most egregious violators. The investigation and regulation of physicians and pharmacists must ultimately fall to state regulatory boards and enforcement agencies. In 1972 DEA initiated the Diversion Investigative Unit program to stimulate the <;levelopment of state agencies that could respond adequately to registrant diversion. This is primarily a grant program for the establishment of special task forces called Diversion Investigation Units consisting of state police, state regulatory investigators, and a DEA special agent or compliance investigator.
DIUs Alabama Arkansas California DC Georgia Hawaii Illinois Indiana Maine Massachusetts Michigan Nevada New Hampshire New Jersey New Mexico North Carolina Oklahoma Pennsylvania Texas Utah Washington
The units are directed totally by the state. However, there is a broad spectrum of expertise to develop appropriate investigative and regulatory procedures. DEA provides 1824 months' seed funding, regulatory training, and investigative support. After the initial funding period, participants must pay for continuation of the units. To date, all participating states except Florida have continued funding. There are currently 21 states with active Diversion Investigation Units. Since the program's incep14
tion, DIUs have accounted for approximately 3,000 arrests and 15 million dosage units. In the last fiscal year alone these units made some 500 arrests and removed approximately 1 million dosage units of controlled substances from the illicit market. On the Horizon Considerations are under way to modify existing investigative programs to allow for a greater concentration of resources in the area of drug diversion. DEA's targeting ability is being examined and improved. Depending on the results of "Operation Script," the agency may initiate a continuing program to identify and investigate registrant violators who are appropriate for federal investigation. DEA also is exploring drugspecific investigations at the manufacturer and distributor levels. A concentrated inquiry into the legitimate production of highly abused substances will provide information regarding areas of abuse and investigative leads from excessive purchase information. These investigations also may give rise to changes in production quotas. The Pharmacy Theft Prevention program, the Voluntary Compliance program, and the Diversion Investigative Unit program are here to stay. These programs are worthwhile and appropriate. They incorporate mutual efforts from differing parties and are very inexpensive relative to most government initiatives. Pharmaceutical diversion can be reduced significantly through selective federal efforts working in a partnership with appropriate state and local agencies. DEA intends to be responsive to changing trends in drug abuse and drug trafficking. Scarce resources must be used prudently to effectively disturb trafficking patterns and techniques. This is a problem for the 1980s and a challenge for pharmacists and other health practitioners as well as DEA.D
Pharmacist's Manual A new edition of the DEA's
Pharmacist's Manual is expected by the end of 1980. Sections of the manual that were included in the last edition will remain substantially unchanged. Several new sections are being added, however: • Central record keeping-although a central record keeping permit is no longer necessary, the procedure for such record keeping is outlined; • Power of attorney-gives procedures for the pharmacist to give someone the power of attorney to sign order forms for Schedule II drugs; • Excessive purchases of controlled drugs-puts the pharmacist on notice that a manufacturer or distributor has the responsibility to notify DEA if a registrant is making unusual or excessive purchases of controlled drugs; • U.S. Postal Service mailing requirements--outlines the postal service's procedures for mailing controlled substances (procedures may change as the requirements are revised); • Forged prescriptions-tells the pharmacist how to handle them; • Narcotics treatment programs-discusses procedures necessary for the establishment of narcotic treatment programs. Also included is a complete list of U.S. regional, district, and resident DEA offices that have compliance officers. The DEA is planning to distribute the manual through regional and local DEA offices rather than sending it directly to individual registrants. Pharmacists who wish to obtain a copy should contact their local DEA office. -PAM
American Pharmacy Vol. NS20, No. 12, December 1980/686