The effects of prescription orders on the control of narcotic drugs
Author: Helmut E. EHRHARDT, Oskar SCHRÖDER
Pages: 1 to 7
Creation Date: 1977/01/01
Institute for Legal and Social Psychiatry, University of Marburg (Federal Republic of Germany)Jur.D., Ministerialrat Oskar SCHRÖDER
Federal Ministry of Youth, Family and Health, Bonn.
Control of the use and, more particularly, the abuse of narcotics and other potentially habit-forming drugs is a many-sided problem, from the lawyer's, no less than the doctor's, standpoint. Up to about 10 years ago the practical significance of this whole set of questions was relatively modest in the Federal Republic of Germany, and little interest was taken in it. The average of one drug-dependent person per 10,000 inhabitants of the Reich, arrived at as long ago as 1927, remained fairly constant for many years and even fell slightly between 1950 and 1965. In 1964 4,357 such persons were registered at health offices in the Federal Republic of Germany. As reported in this Bulletin(vol. XI, No. 1) in 1959, most of these were doctors and other members of medical professions. We were able to establish that drug dependence in Germany at that time was for the most part a problem of doctors prescribing narcotic drugs and doctors addicted to them.
This situation has changed radically over the past decade. Our "drug scene" today is much the same as that in other European countries; its manifestations and spread are undergoing the same change, which is clearly dependent on availabilities. The remarkable similarity of trends on the drug scene in different countries gives impressive confirmation of the internationalization and regionalization of the illicit drug market. It has become clear that the intensity of control measures, particularly as applied by the police, plays a decisive role. The realization that control of the drug market can no longer be treated as a purely national affair appears to be making only slow headway in some countries. The liberalization of control in one country inevitably has adverse effects, first in neighbouring countries but subsequently in the international market too. Hence the significance and purpose of international conventions such as the 1961 Single Convention are emphatically confirmed by the development of the drug scene in European countries.
Control of the licit and control of the illicit market in drugs represent two different but by no means independent levels of action. Any loosening of the legal availability of narcotic drugs almost inevitably serves to enrich the illicit market. The prime responsibility of the national legislator, therefore, is to ensure adequate control of the licit traffic in such drugs. In the Federal Republic of Germany, the Opium Act of 1929 and the Prescription Order of 1930 proved inadequate in the face of the changed structure and, particularly, the alarming proportions of the new drug wave. The Narcotic Drugs Act of 10 January 1972 ( Bundesgesetzblatt( BGB1.) I,2; III, 2121) 1 is intended to achieve better control of licit dealings in narcotic drugs. In particular the campaign against dependence is to be intensified through a new system of criminal penalties for violations of the Act. Provisions of importance to doctors and pharmacists on the implementation of the Narcotic Drugs Act are laid down in the 1974 Narcotic Drugs Prescription Order, which has improved the control machinery available to them. Among the most important innovations is prescription of narcotic drugs exclusively on special prescription forms, a measure which doctors had been demanding for decades and which had been practised in one Federal Land - the Saarland - with demonstrable success ever since 1952.
The Order as a whole conforms extensively to the international conventions and presents a conception of narcotic drug control that has some novel features. The following description of the content and first results of the Order should afford a basis for comparison and criticism.
An order concerning the prescription, dispensing and recording of the whereabouts of narcotic drugs (hereinafter called "the Order") came into force in the Federal Republic of Germany on 1 April 1974, replacing the old Order of 1930. 2 The key provision of the Order - the introduction of special prescription forms for narcotic drugs - is primarily the outcome of the recommendation made in article 30, paragraph 2( b)(ii), of the Single Convention on Narcotic Drugs, 1961; it is at the same time the implementation of an important item in the Federal Government's programme of 12 November 1970 for the campaign against the misuse of narcotics and other drugs.
It had long been evident that the old Order of 1930 was in need of overhaul, because the many exceptions had made it difficult to follow and it was in any case outmoded in structure. The control system of the Order was full of loopholes and no longer measured up to the requirements of the campaign against the misuse of narcotics, which had increased to a frightening degree. An attempt was therefore made to write the new Order in a form as concise, well organized and easy to grasp as possible, so that it would be handy to use without missing its main purpose, which is to restrict the legal use of narcotic drugs in medicine, to bring it more into the open, and to make it more amenable to supervision.
The new Order is in seven sections and has been cut down to 20 articles (from the previous 30). Section I deals with the material field of application of the Order, and, in particular, excludes from it medicaments which can be prescribed on the normal form. Section II deals with the prescription of narcotic drugs by medical practitioners, dentists and veterinary surgeons, while section III covers the dispensing of narcotic drugs by pharmacies. Section IV contains a special set of rules on the prescription and dispensing of narcotic drugs for the fitting-out of merchant vessels; this is of importance only for ports and coastal areas. Recording of the whereabouts of narcotic drugs is governed by the provisions of section V. Section VI contains the provisions concerning fines and other penalties, and section VII gives the final provisions, in particular the date of entry into force of the Order.1
The text of the Act is reproduced in the United Nations series of Laws and Regulations, document E/NL.1972/51 of 5 October 1973, pages 8-15.2
The text of the Order is reproduced in the United Nations series of Laws and Regulations, document E/NL.1974/20-23 of 2 July 1975, pages 6-22.
Narcotic drugs which are so dangerous that they must be prohibited or are not on sale in the Federal Republic of Germany may not be prescribed even on the special form; they are listed in an annex to the Order (102 drugs). The number of narcotic drugs which can now be prescribed on the special form has been reduced by the Order from the previous 69 to 24.
The possibilities of prescribing on the special form are, however, subject to two further basic restrictions: first, they may be prescribed only if their use is justified on medical, dental or veterinary grounds (article 4).
The second basic limitation is that, in the interests of security in trade in narcotic drugs and of avoiding the risk of addiction, even those drugs which are indeed medically necessary may be prescribed only as preparations and only up to a specified maximum content of the narcotic.
Where authorized narcotic drugs are to be prescribed, it is still necessary over and above these basic restrictions, to limit the quantity prescribed for any one day; to lay down, in particular cases, other limitations covering the purpose for which the drugs are to be used, the maximum content and the form in which they are dispensed; and, where appropriate, to state what further substances must be added.
The key provision of the Order is the introduction of special prescriptions in the shape of a serially numbered official form in three parts, with provision for carbon copies. 3 The introduction of the special forms is intended to lead to a reduction in the medical use of narcotic drugs and at the same time to afford better supervision of the way in which doctors, pharmacies and hospitals handle such drugs. The practical checks now begin at the point where the drug is prescribed instead of the point where it is dispensed. The special prescription form is intended to make medical practitioners, dentists and veterinary surgeons consider more closely than in the past whether the prescription of narcotic drug is really necessary.
The reason why the Federal Republic of Germany has opted for a prescription form in triplicate (article 9) in preference to the counterfoil books proposed in the Single Convention on Narcotic Drugs, 1961, is that it regards this system as safer for all concerned and less time-consuming for the physician. The prescription needs to be written out only once, and this ensures absolute concordance between all three parts. With other systems the same content must be written out more than once, with the consequent risk of errors in copying. The doctor keeps part III of the special form; parts I and II are handed by the patient to the pharmacist, who retains part I after he has supplied the medicament and, if need be, uses part II for settlement with the patient's sickness insurance fund. The doctor and the manager of the pharmacy have to keep their parts of the prescription on file and available for inspection for three years (instead of the five years previously specified in the case of the pharmacist). The Single Convention requires only that the prescription should be kept for two years (article 34, subparagraph ( b)); here, then, the Federal Republic of Germany has availed itself of article 39 of the Convention, which allows stricter control measures to be applied.3
See annexes Nos. 1-5.
The forms are published by the Federal Opium Office attached to the Federal Department of Health in Berlin (which is the "special administration" within the meaning of article 17 of the Single Convention of 1961); they are printed at the cost of the Federation, distributed to the Lander and issued to medical practitioners by the senior health authorities of the Land, either through the offices of the administrative district or through the health office or the local medical society. To this extent the implementation of the Order is in the hands of the Lander, and so is the relevant control. Since the form can be used for automatic data processing, the intention is that after five years the evaluation of the prescriptions and the major part of the supervision should be computerized under Federal Opium Office management (article 18). The special prescription forms have to be kept by the doctor under lock and key (article 9, para. 4). The doctor is not allowed to antedate prescriptions, and the pharmacist may not dispense narcotic drugs against a prescription made out more than seven days previously.
All persons and establishments that dispense or administer narcotic drugs to people who are to be treated - this means primarly pharmacies, medical practitioners and hospitals - are required to keep records showing the whereabouts of the drugs (article 15). The official forms for this purpose are also issued by the Federal Opium Office and, as before, paid for by the recipient. Like the special prescription forms, these too need now be kept for only three years, as compared with the previous five years and with the two years specified by article 34, subparagraph ( b), of the Single Convention. The provisions concerning fines and other penalties have now been brought directly into the Order (articles 16 and 17).
With the issue of this Order, the Federal Republic of Germany has organized legal domestic dealings in narcotic drugs, among medical practitioners, pharmacies, hospitals and patients requiring treatment, in a manner appropriate to the needs of a modern campaign against the misuse of narcotics and other drugs.
What success can be ascribed to the new Order so far? After the close of the year 1974 the Federal Opium Office polled nearly all the 13,383 pharmacies and hospital dispensaries concerning the number of prescriptions for narcotic drugs issued by medical practitioners, dentists and veterinary surgeons in the several quarters of that year. (The prescriptions made out by dentists and veterinary surgeons constitute less than 1 per cent of the total, and for simplicity's sake can be left out of consideration here.) The inquiry produced the following results:
The table shows that, in each category, prescriptions in the second, third and fourth quarters were s ome 40 per cent down on prescriptions in the first quarter. This can be considered a complete success so far as the aim of the new Order is concerned - namely, that even the legal use of narcotic drugs should be cut down as much as possible.
How is this sharp reduction in prescriptions to be explained? The reasons can only be surmised:
The necessity of using a special official form for the prescription of narcotic drugs instead of the normal form used hitherto reminds the medical practitioner every time he issues a prescription that it concerns a preparation which contains a narcotic drug; as long as he used one and the same form to prescribe all medicaments, the doctor was presumably not always conscious of this fact.
In addition, the doctor is now required to examine more closely than hitherto whether the use of a narcotic drug "on or in the human ... body is justified" (article 4, first sentence). The Order goes on to say that "Such use is not justified, in particular, where the intended purpose can be achieved in other ways" (article 4, second sentence). That is the case, for instance, where the intended purpose can be achieved by using a medicament which is available only on prescription on the normal form and which, by that token, is not a narcotic drug. A doctor who prescribes a narcotic drug even though its use is not medically justified risks up to three years' imprisonment or a fine under article 11, paragraph l(9 a), of the Narcotic Drugs Act.
Another complication for the doctor in using the new special prescription form is that he now has to state the narcotic drug content of the medicament in the form in which it is to be dispensed, giving the number of units in Arabic figures, and repeat it in words (article 10).
Lastly, the reduction in the number of narcotic drugs that may be prescribed (from 69 to 24) may have contributed to the fall in the total number of such prescriptions.
Whatever the real reasons for the sharp decline in prescriptions may be, the success obtained has unquestionably justified the introduction of the special form.
A fresh survey is to be made in the pharmacies at the end of 1977 in order to ascertain the further evolution of the number of prescriptions from 1975 onwards. These figures will also be helpful in preparing and facilitating the measures relating to the proposed computerized supervision of prescriptions.
If we assume that the positive result of the new Order - to the extent that it is discernible so far - in effecting a substantial reduction in the prescription of narcotic drugs by doctors is confirmed and maintained, this would seem to reflect at least a more critical attitude on the part of doctors in prescribing potent medicaments. However, this would be capable of proof only in the case of those medicaments which, as potentially dependence-producing drugs may be prescribed only on special prescription forms. The special form undoubtedly erects a psychological barrier, but this barrier can have its effect only on the medicaments covered by this provision. The illegal drug scene, inasmuch as it depends on narcotic drugs that are subject to general prohibition, obviously cannot be affected by such a Prescription Order. That, however, is no reason to forgo this form of regulation of medical practice with regard to prescription.
In addition to abuse of and dependence on narcotic drugs as such, we are faced today with a spreading "grey area" of abuse of a very wide range of medicaments, all too often leading to dependence on narcotic drugs. In particular it has proved difficult and sometimes impossible to draw a precise dividing line between actual and potential danger within the large and ever-growing group of psychotropic substances. To this extent, the need for effective control measures ranging beyond the narrower sphere of narcotic drugs is imperative. A first and important step in that direction is the Convention on Psychotropic Substances drawn up by the Economic and Social Council of the United Nations and signed by the participants in the Vienna Conference on 21 February 1971. This Convention is contested at some points in terms of its effects on the practice of pharmacotherapy, but must be welcomed in principle. A number of amendments, which under article 30 can be proposed by any Party to the Convention, will be needed to make it practicable.
Psychotropic substances in general, and narcotic drugs in particular, form only one sector in the field of drugs and drug law. However, abuse and harmful consequences are also known in many other groups of medicaments. The progress of the pharmacological and pharmaceutical sciences creates a need for legal and administrative regulations to protect primarily the patient but also the doctor. Regulation means more than just control measures, but it would be foolish to disregard the fact that pharmacotherapy, which has been steadily diversified, needs appropriate control. In the Federal Republic of Germany, the Act on Reorganization of the Drug Law, which was promulgated on 1 September 1976 ( BGB1. I, 2445) and whose main sections are to come into force on 1 January 1978, is intended to serve that purpose. The many-sided problems tackled by this Act cannot be discussed here. In the context of the Prescription Order, however, mention should be made of the procedure which has now been instituted for the approval of newly developed drugs. This replaces the registration procedure hitherto in force and signifies tighter control, for pharmacological, toxicological and clinical purposes, over new medicaments about to be introduced. In this connexion, the question whether a given new drug is narcotic or not will of course play a substantial role. It has long been the practice in German drug law to differentiate between medicaments that can be sold freely and medicaments subject to prescription, and to lay down stricter conditions for the prescription of narcotics. On the basis of experience so far, it is to be expected that some of the drugs developed in the future will be made subject to prescription, or to prescription on the special form for narcotic drugs, more quickly than hitherto, while others will be barred from trade and thus kept off the market altogether for the same reason. Hence, the practical significance of the new Prescription Order will probably increase still further. Whether such a development could also, in one way or another, have an adverse effect on the scope of pharmacotherapy cannot as yet be foreseen. In this sphere too, however, legal and administrative regulations can be corrected, as has been clearly shown in recent years.
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