ABSTRACT
Introduction
The monitoring system
The reporting system
Information provided by the system
The effective monitoring of the movement of drugs
Author:D. W. MURDOCH
Pages: 47 to 53
Creation Date: 1983/01/01
For the past 13 years the Commonwealth Department of Health has operated a computerized monitoring system which records the movements throughout Australia of selected legal drugs with abuse potential. The Drugs of Dependence Monitoring System is designed to prevent diversion to the illicit market. From the moment of import or manufacture, every movement of the selected drug is monitored until the drug reaches the final distributor, in most cases a pharmacy, a veterinarian or a hospital. Approximately 300,000 movements are checked each year. All drugs used in Australia, which are covered by the Single Convention on Narcotic Drugs, 1961, and the 1971 Convention on Psychotropic Substances are included in the system. Reports are generated on quantities imported, exported, locally produced, used in manufacture and distributed. The result is that the risk of diversion has been reduced to a minimum. Information obtained from the system has proved of considerable assistance in fulfilling Australia's international treaty obligations.
The Commonwealth of Australia is a Federation of six states and two territories. Responsibilities for drug control are divided between the Commonwealth and state or territory governments. The Commonwealth-, under its external affairs powers, is responsible for control over the import and export of drugs as well as the manufacture of narcotic drugs. The states and territories are responsible for the control of drugs distributed within their boundaries.
During the late 1960s, concern was expressed in Australia about the diversion of legal drugs with abuse potential to the illicit market. At that time no effective check existed on the movement of such drugs across state borders or within the states.
The Commonwealth and state governments agreed that a system was required to collect, collate and disseminate information on both inter- and intra-state transactions involving drugs included in the Single Convention on Narcotic Drugs, 1961 [ 1] , and drugs to be included in the l 971 Convention on Psychotropic Substances [ 2] , when it became operative.
The Commonwealth Department of Health untertook responsibility for designing and implementing such a system, which was introduced in January I 970. The system was designed to monitor the movement of legal drugs, provide relevant information to the Commonwealth and state governments and assemble statistical data for use in formulating appropriate policies for d rug control. The system was adapted for computerized data processing.
At present the monitoring system of dependence-producing drugs involves 147 reporting authorities, all of them companies licensed to import, export, manufacture, formulate or distribute the specified drugs on a wholesale basis. Reports generated relate to purchases by some 6,000 pharmacies and l ,500 hospitals.
The drugs monitored by the system are : cocaine, codeine, dextromoramide, diethylthiambutene, dihydrocodeine, diphenoxylate, ethylmorphine, etorphine, fentanyl, hydrocodone, hydromorphone, levorphanol, methadone, morphine, normethadone, opium, oxycodone, oxymorphone, pethidine, phenazocine, phenoperidine, pholcodine, piritramide, pentazocine, phencyclidine, difenoxin, amphetamine, methylamphetamine, methylphenidate, phenmetrazine, methaqualone, amylobarbitone, amylobarbitone sodium, quinalbarbitone, quinalbarbitone sodium.
Any new or unusual trend in the use of dependence-producing drugs is quickly detected. The movement of the drug is monitored from the moment of its import or manufacture until it reaches the final distributor.
The system shows what quantity of a given drug is imported, exported, locally produced and used in manufacturing processes, the amount distributed, by whom, to whom and in what form and quantity. All these data are recorded and cross-checked. A total of 392,996 transactions were monitored in this way during I 982.
The system requires all reporting authorities to report their transactions each week. They provide basic data which is routinely gathered for individual record-keeping and invoicing.
In introducing the system, the Commonwealth asked companies to provide details of their invoicing systems and customers' accounts and to any changes as they occurred. This information was computerized and linking numbers were assigned so that the various codes used by the 147 reporting authorities could be cross-matched in producing reports.
The system evolved required no change on the part of a reporting authority in its record-keeping system and it was readily supported by the Australian pharmaceutical industry.
Reports are forwarded to the Commonwealth Department of Health each week and provide detailed information on all movements to and from reporting authorities, imports and exports, loss, larceny , and controlled and accidental destruction. They also show the use of controlled substances in the manufacturing and formulating processes, including the quantity of drugs processed and the yield obtained.
Reporting authorities are required to record details of each transaction on a form provided, and at the end of each week the completed forms are forwarded to the Commonwealth Department of Health for key-punching and computer processing. Where appropriate, reports are also required, even if no transactions have taken place, to ensure that every authority has reported. Most reports are compiled manually. However, a number of authorities with computer facilities provide movement reports direct from their automated systems. These reports are produced with a similar layout to the normal report form and, being compatible with the manual form, are treated in the same manner.
Information required on the form includes the name and address of the reporting authority, the week and year of the report, a drug code, the number of units involved in the transaction, a movement code and an identifying customer account number.
The drug code is a four- or five-digit number allocated to each drug and preparation according to the form, strength, brand and package. Approximately 2,200 codes have been allocated. Reporting authorities are supplied with code books which are continually updated.
The movement code is a single alphabetical character and is used to describe the movement being reported. An extract from a typical report is shown below. The letter R in the table denotes an inward movement ;
S indicates an outward movement ; F means the drug used in a manufacturing or formulating process ; M denotes the drug obtained from a manufacturing or formulating process ; D means destruction of a drug under official supervision or expended in a quality control process ; and L would indicate lost, stolen or destroyed drug under circumstances other than those officially supervised.
The identifying customer's account number is allocated by the individual reporting authority. The Commonwealth Department of Health is kept informed of any changes in, or addition to, these numbers. The number allocated to the customers varies with different authorities. This problem is, however, overcome by the use of an internal linking number within the computer which converts a single customer's varying account number into a unique identifier.
An extract from a typical report reads as follows :
Entry number |
Drug code |
No. of units |
Move code |
Account number |
---|---|---|---|---|
1 | 2560 | 10 | R | 105 |
2 | 0700 | 1 | S | 40132 |
3 | 8733 | 750 | F | BN042 |
4 | 0661 | 142000 | M | BN042 |
5 | 0661 | 300 | D |
Key:
Entry 1. Receipt by a reporting authority of 10 packs each containing 5 ampoules of 15 mg morphine sulphate from a supplier with account number 105.
Entry 2. Sale of 1 pack of 100 5-mg tablets of dexamphetamine sulphate to a customer with account number 40132.
Entry 3. Use in a formulating process of 750 grams of dexamphetamine sulphate in processing batch number BN042.
Entry 4. Yield of 142,000 5-mg tablets of dexamphetamine sulphate from processing batch number BN042.
Entry 5. Expenditure of 300 5-mg tablets of dexamphetamine sulphate in a quality control process.
Based on information derived from the monitoring of transactions, regular reports are prepared for the Commonwealth and State health departments as well as other interested bodies. One result has been the prompt indication of unusual trends developing in drug use.
A profile can be created .for a particular drug, geographical area or recipient. For instance, if an unusually high usage of drugs is observed in a particular area, the State Health Department can request a report on all movements of drugs to that area. Any significant increase in the purchase of such drugs is investigated. Inspection pharmacists employed by the government health authorities have also found the system useful. Prior to a routine inspection they can request a report on a particular pharmacy's trading, and this can be checked against entries in the drug register.
A valuable additional effect of the system is that persons involved in the industry or handling dependence-producing drugs have become increasingly aware of the need for accurate record-keeping.
A number of reports are generated to assist in the control of legal transactions, to determine stock balances and to enable import quotas to be prepared.
A basic monthly movement report provides details of all inter- and intra-state movements which includes movements between reporting authorities, such as wholesalers, and non-reporting authorities, such as retail pharmacies, hospitals, medical practitioners and veterinarians. Also shown are imports and exports, loss, larceny, controlled and uncontrolled destruction, manufacturing and formulating processes, as well as information on an opening stock balance, the number of movements and quantities involved and a closing stock balance for each drug or preparation for the four weeks under review.
Firms engaged in formulation and manufacture are required to insert a batch or lot identification number on their weekly report form when reporting processing transactions. A comparison of the amounts of drugs used in the production of preparations with the amount of base drug contained in the subsequent yields provides a check on the efficiency of processing, and wastage can be determined with accuracy. The report serves as an aid in the detection of possible illicit diversion from manufacturers' premises.
In addition to the basic monthly report, an exception report lists all those hospitals and pharmacies whose purchases of any particular drug from all sources exceed a predetermined level during any given three-month period. This report highlights pharmacies in defined geographical areas whose purchases of a particular drug appear to have been abnormally high over prolonged periods.
Other monthly reports show estimated consumption figures during the previous six months on a state-by-state basis. Seasonal or unusual trends in drug consumption are readily identified, and, when used in conjunction with the exception report, possible problem areas are identified. These reports are also used to check on stocks of obsolete or out-of-production drugs held by wholesalers, which helps to obtain the co-operation of wholesalers in destroying all stocks detected in this way.
The monthly movement reports are supported by a variety of special reports which are available on request. One such report, which has proved of value to inspection pharmacists who carry out investigations or routine inspection, provides detailed information on purchases by nominated pharmacies, medical practitioners or hospitals from all wholesale sources for any period since the inception of the system. The scope of these special reports is virtually unlimited.
before the system was introduced no effective check on movements of drugs across state borders was possible. Now all such movements between reporting authorities are verified on a weekly basis ; the report of the supplying authority is checked against that made by the receiving authority. Any transactions that fail to match can be detected quickly. As a result, the system minimizes the risk of losses and thefts of drug consignments in transit to formulators, wholesale distributors and manufacturers.
All imports and exports of dangerous drugs are recorded and transactions checked against export and import licences issued by the Commonwealth Department of Health. Should, for example, a sale be made to an unlicensed buyer the transaction would be indicated by the computer and investigated.
During computer processing, all transactions are subject to a number of checks, and individual entries may be shown as an incorrect drug code, an unidentified customer account number and suspected incorrect movement details. Such errors are investigated by the Drugs of Dependence branch of the Department of Health and corrected, if they are obvious, or referred back to the reporting authority for clarification.
Of the 392,996 transactions monitored during 1982, 23,474 were sorted out because of coding errors or mismatching. Of these, 21,120 were resolved by the Drugs of Dependence branch. The remaining 2,354 mismatched transactions were referred to state health authorities for investigation. All were resolved.
Data are now readily available and have proved to be of considerable assistance in fulfilling Australia's international obligations under the Single Convention on Narcotic Drugs, 1961 , which requires that an annual report on consumption, imports, exports, stocks held and forward estimates be submitted to the United Nations. The information is also used to make estimates of requirements of some drugs covered by the 1971 Convention on Psychotropic Substances.
A recent example of the effectiveness of the system in highlighting trends was the detection of a steep rise in the consumption of methadone tablets. It was considered that this could be due to high usage in unauthorized methadone maintenance programmes. Investigation confirmed this assumption and the programmes were thereafter curtailed.
There is no doubt that the system is effective in preventing the diversion of drugs from legal sources to the illegal trade. Immediate attention is focused on events as they happen, and they can be speedily investigated.
The system helps to increase awareness of the need for accurate record keeping by persons who work with dangerous drugs. lt also helps to improve public relations between government authorities and the drug industry through the close co-operation required by the monitoring system and a common desire to contain the drug problem. before the introduction of the monitoring system, accurate data on Australia's consumption of dependence-producing drugs were unavailable. Data now available have proved of considerable assistance in controlling drug transactions and in fulfilling Australia's obligations under the international drug control treaties.
Single Convention on Narcotic Drugs, 1961(United Nations publication, Sales No. 62.XI. 1).
002Convention on Psychotropic Substances, 1971(United Nations publication, Sales No. E.78.XI.3).