The problem of barbiturates in the United States of America

Abstract

Barbiturates are not included in the group of substances under international control. However, in certain respects they present problems analogous to those arising in narcotics control, and the international bodies have on several occasions given attention to the question whether elements of that control, more particularly of a national character, were needed.

Details

Pages: 15 to 19
Creation Date: 1957/01/01

The problem of barbiturates in the United States of America

Barbiturates are not included in the group of substances under international control. However, in certain respects they present problems analogous to those arising in narcotics control, and the international bodies have on several occasions given attention to the question whether elements of that control, more particularly of a national character, were needed.

At its third session, in 1952, the Expert Committee on Addiction producing Drugs of the World Health Organization reviewed the situation with respect to the use and abuse of barbiturates in the world and the effects of chronic intoxication from these substances,[1] and it recorded its opinion that it was advisable to take measures to strengthen the control over barbiturates on the national level. Such measures might include the following: (1) barbiturates should be dispensed only on prescription; (2) each prescription should specify the number of times it may be refilled or repeated; (3) a careful record should be kept of each prescription.

At its seventh session, in 1956,[2] the Committee noted that according to the evidence at its disposal the consumption of barbiturates continued to increase; the situation with respect to them had not improved. In its opinion, barbiturates were habit-forming, and there was a critical dosage[3] at which they could produce a drug addiction dangerous to public health, although differentiation amongst them with respect to the intensity of this liability could not yet be made. The Committee continued to be of the opinion that control measures at the national level were sufficient, but needed close attention, and in some instances definite strengthening. The measures suggested by the Committee were the same as those indicated at its third session.

The Commission on Narcotic Drugs, on the proposal of the representative of Egypt, decided to consider the problem of barbiturates at its twelfth session which will meet in New York at the end of April 1957. A good deal of material on the question has recently become available, in connexion with official inquiries in the United States, which throws much light on the problems involved.

In the United States, the problem of barbiturates has lately been studied on the national level by several committees: the President of the United States appointed, in 1954, an Interdepartmental Committee composed of representatives of the Departments of State, Treasury, Defence, Justice and Health, Education and Welfare, with the aim of making a comprehensive, up-to-date survey on the extent of narcotic addiction, and to expedite a systematic review and improvement of the narcotics programmes, local, national and international. The Committee in its report [4] submitted recommendations, the last of which - No. 14 - dealt in the following terms with the problem of barbiturates:

The Committee noted striking similarities between the individual and social problems raised by the abuse of narcotic drugs, and such substances as marihuana, barbiturates, amphetamines, and others which affected emotional behaviour. It had been observed that the circumstances and attitudes underlying excessive habitual use of such depressants and stimulants frequently paralleled or preceded those associated with the narcotics. It was recommended that a similar study of the extent and effects of the improper use of such drugs be undertaken, with a view to determining the appropriate scope of federal state and local regulatory controls.

In addition to the President's Committee there were two committees of the United States Congress dealing with the problem of narcotic drugs. The Committee on Ways and Means of the House of Representatives directed, at the close of the first session of the 84th Congress, the appointment of a sub-committee for the purpose of making an investigation and study of illicit trafficking in narcotics, barbiturates and amphetamines in the United States. This sub-committee conducted public hearings in different cities. The Committee gave its findings in a special report,[5] and made inter alia, the following recommendations:

  1. Legislation based on the inter-state commerce clause should be enacted immediately to provide more stringent federal controls with respect to barbiturates and amphetamines so as to prevent their continued abuse.

  2. Legislation should be enacted immediately to control the importation and exportation of barbiturates and amphetamines.

  3. Possession through other than authorized sources should be made subject to proper penalties.

  4. The Food and Drug Administration should be provided with additional appropriations to permit an increase in their enforcement personnel to cope with the illicit traffic in barbiturates and amphetamines.

  5. State and local governments should be urged to increase their enforcement activities to combat the abuse of barbiturates and amphetamines.

  6. The states should be urged to adopt uniform legislation to control barbiturates and amphetamines and provide adequate penalties for violation.

  7. The states and local communities should establish a programme for the treatment and rehabilitation of barbiturate addicts and chronic users of amphetamines.

  8. The current programmes for education of physicians, pharmacists, nurses, and all other persons handling barbiturates and amphetamines concerning the dangers inherent in these drugs should be intensified. The Federal Government, through its qualified agencies, should co-ordinate its endeavours in this field with the associations and groups representing the manufacturers, physicians, pharmacists and others in the drug field.

  9. The Federal Government, in co-operation with state and local authorities should maintain appropriate surveillance and records so as to be able to determine the adequacy of applicable laws and enforcement procedures relating to barbiturates and amphetamine abuse.

The Hon. Hale Boggs introduced a bill amending the federal Food, Drug and Cosmetic Act (as amended), which provided, inter alia, for prohibition of the manufacture, compounding, processing, sale, delivery, other disposition or possession of any barbiturates except by persons, enterprises or institutions authorized under the terms of the bill;[6] and for the keeping of records of stocks and of all transactions in barbiturates.

5

See Bulletin on Narcotics, Volume VIII, No. 3.

6

See Bulletin on Narcotics, Volume VIII, No. 3, pp. 23- 24. The bill was introduced in the House of Representatives at the 84th Congress, but did not reach consideration. It has been reintroduced at the 85th Congress.

Finally, by resolution of 18 March 1955 the Senate of the United States authorized a nation-wide investigation of the illicit narcotic traffic. The inquiry was undertaken to find "ways and means of improving the Federal Criminal Code and other laws and enforcement procedures dealing with the possession, sale and transportation of narcotics, marihuana and similar drugs". A special aim was to establish methods for more effective treatment and rehabilitation of addicts. The task was carried out by the Sub-Committee on the Improvement in the Federal Criminal Code which conducted hearings and obtained other evidence. This sub-committee presented first a preliminary report[7] and then a final report.[8] These reports did not make recommendations regarding the problem of barbiturates but the Committee heard witnesses and received exhibits on this subject.[9]

Testimony on barbiturates was given by Dr. Haverlock F. Fraser, Assistant Director, Addiction Research Centre, National Institute of Mental Health, Public Health Service Hospital, Lexington, Kentucky. He pointed out first that barbiturates - which are synthetically prepared derivatives of veronal or barbituric acid, used in medicine for their central nervous system depressant or sedative effects - were first prepared in Germany in 1903 and have increased enormously in production since then: production of barbiturates in the United States had increased 400% since 1933. In 1948, over 300 tons of these drugs were manufactured, and currently the production was at such a rate that it could provide 24 capsules of 0.1 g per year for every person in the United States.[10] These figures were confirmed later on in a table presented to the Committee by Thomas Jefferson Scott, Commodity Specialist, United States Tariff Commission.[11] According to that table, the total production of barbiturate acid derivatives in 1954 was 798,000 lb (the highest production shown was 900,000 lb in 1947). The actual sales value was $3,204,000 in 1954

There was also an increase in the rate of accidental death or suicides due to barbiturates: per 100,000,000 population, from 171 in 1933 to a peak of 764 in 1949 to 597 (preliminary figure) in 1953. These figures were given to the Committee by George P. Larrick, Commissioner of Food and Drugs, Department of Health, Education and Welfare.[12] Dr. Fraser explained the danger of the drugs: "The abuse of barbiturates assumes two forms: (1) acute intoxication or the taking of such large doses that the individual is poisoned-and (2) chronic intoxication or the continuous taking of large doses, and this results in addiction to the drug ".[13]

The evidence thus given was confirmed throughout the hearings. Dr. Fraser summed up the effects of barbiturates as follows : [14]

  1. Barbiturates are very useful drugs, however their use may be abused and a definite addiction to them may ensue.

  2. The danger of addiction to barbiturates is considerably less than is the danger of addiction to narcotic drugs.

  3. The medical problems involved in the prevention and treatment of chronic barbiturate intoxication resemble those of chronic alcoholism rather than those of narcotic addiction.

7

See Bulletin on Narcotics, Volume VIII, No. 2, p. 11.

8

See Bulletin on Narcotics, Volume VIII, No 3, p. 3.

9

See Hearings before the Subcommittee on Improvements in the Federal Criminal Code of the Committee on the Judiciary United States Senate, Eighty-fourth Congress, First Session, on Illicit Narcotics Traffic pursuant to S.R. es.67, United States Government Printing Office, Washington 1956, 10 volumes, 4,896 pages, hereinafter referred to as Committee Hearings.

The following excerpts from articles included in the Committee's records also show this basic difference between the problem of barbiturates and narcotic drugs.

Drs. H. F. Fraser, M.D., & James A. Grider, Jr., M.D., in an article entitled "Treatment of Drug Addiction ", published in the May 1953 issue of the American Journal of Medicine, write as follows:

When barbiturates are administered in the usual therapeutic doses under supervision of a physician, addiction does not occur even though the drugs may be taken for many months. However, chronic consumption of large amounts of barbiturates results in true addiction. Abrupt withdrawal of barbiturates from persons who have been consuming 0.8 gram or more of these drugs daily may provoke a serious abstinence syndrome characterized by convulsions and delirium.[15]

Similarly, Harris Isbell, M.D. & Walter M. White, M.D. write in an article entitled "Clinical Characteristics of Addictions", published in the same issue of the same magazine:

Barbiturate addiction. - Barbiturate addiction can be used as the prototype of addiction to hypnotics. It is wise to reiterate that barbiturate addiction implies habitual consumption of amounts of barbiturates far in excess of those used therapeutically. There is no evidence that significant physical and emotional dependence occur in patients who consume only the usual therapeutic doses of these drugs. Addiction ordinarily does not occur unless the patient is consuming 0.8 gram or more of one of the potent, quickly acting barbiturates daily.[16]

Even if the witnesses were not always in agreement with each other on points of detail, they agreed that barbiturates were dangerous and that strict state or federal control should be exercised over them. Some of the witnesses believed that the use of barbiturates might lead directly to addiction to narcotics; others thought that many addicts used barbiturates as substitutes for heroin and morphine when these became unavailable. Some cases of miscellaneous misuse of opiates and barbiturates were also reported. John Gutknecht, State's Attorney of Cook County, Illinois, was concerned about the danger of the abuse of barbiturates leading to addiction to stronger drugs. He declared : [17]

With reference to the problem of barbiturates and amphetamines, we wish to say that we get relatively few cases involving them in our courts. Their problem to date in this area is as yet more social than criminal, though undoubtedly it will lead sooner or later to the use of stronger drugs in many cases. We feel that the immediate need there is closer control of the outlet, both in connection with the physician and the pharmacist. Our drug laws today are not of much value, because mixtures are excluded, and since the control of the outlet to-day is pretty weak anyway there is need not only for the strengthening of the law to include mixtures, but there is the need for more personnel for both state and federal enforcement agencies to check on sales, amounts, and customers.

Finally, the Committee was presented with evidence concerning the treatment of barbiturate addicts. It included in its records the article, "Treatment of Drug Addiction" by H. F. Fraser, M.D., & James A. Grider, Jr., M.D., Lexington, Kentucky, referred to above. This article reads in part : [18]

... Institutional treatment of barbiturate addiction is just as necessary as it is in narcotic addiction. The physician should refuse to prescribe barbiturates for a person he believes is addicted to them, until the patient agrees to institutional treatment, and he should not continue to prescribe these drugs if the patient procrastinates and does not promptly complete arrangements for institutional treatment ...

Patients being withdrawn from barbiturates must be kept under close observation. Their beds should be provided with sideboards or else their bed should be a mattress on the floor so that if convulsions occur they will not fall to the floor. Patients should not attempt to walk, bathe, or go to the bathroom unattended. Diet should be light during the first few days but subsequently no restrictions are necessary ...

Delirious patients must be under continuous observation, rectal temperature checked three times daily and adequate fluid and food intake maintained. Fever of more than 104°F. is a serious sign and should be combated by measures which favour body heat loss, such as keeping the room cool, the patient uncovered and administration of antipyretics. "Cold packs" should be avoided since these place undue strain on an already impaired circulatory mechanism. Once improvement is noted withdrawal is accomplished by gradual reduction of barbiturates.

It should be remembered that acute barbiturate intoxication may be superimposed on chronic barbiturate intoxication. Patients who are chronically intoxicated with barbiturates may become confused and ingest such large amounts of barbiturates that serious acute poisoning develops. Whenever a patient who has been acutely poisoned with barbiturates recovers from coma, every effort should be made to ascertain if he has been taking large doses of barbiturates daily and, if so, he should be mildly reintoxicated with barbiturates and then gradual reduction begun. ...

Combined barbiturate and opiate addiction has become quite common. Withdrawal of both drugs can proceed concurrently with more time usually being required to withdraw barbiturates than opiates.19 The authors of the article also emphasize the importance of psychiatric and rehabilitative treatments. Such rehabilitative measures are mentioned as dietary, vocational, recreational and social procedures.

Model State Barbiturate Act

The Drafting Committee of the Council on State Governments of the United States of America offered to the several states of that country a model state barbiturate Act. The suggested legislation is preceded by an explanatory statement. This was part of its report, Suggested State Legislation (programme for 1955). At its meeting in September 1955 the Drafting Committee reviewed certain provisions of the Act having to do with the regulation of retail and wholesale practices in handling drugs of this category and developed the text of two amendments which have been incorporated in the suggested legislation which follows. These amendments are printed in italics.

HYPNOTIC OR SOMNIFACIENT (SLEEP-PRODUCING) DRUGS

Explanatory Statement

The safeguarding, dispensing, and use of sleep-producing drugs-notably the barbiturates--present a special problem for state legislation and enforcement, since they do not fall within the legal classification of narcotic drugs, nor are they regulated under the provisions of federal and state narcotic drug Acts. The sleep-producing drugs include (1) the barbiturates, which are herein defined as" the salts and derivatives of barbituric acid or compounds, preparations or mixtures thereof"; and (2) other drugs of hypnotic or somnifacient (sleep-producing) effect on humans and animals-such drugs as paraldehyde, chlorahydrate, and compounds under various trade names.

Federal and state authorities, as well as representatives of pharmaceutical groups, appear agreed that the properties and characteristics of these sleep-producing drugs, as well as the results of their abusive use, are sufficiently different from narcotic drugs such as morphine and cocaine to make it necessary that their control and regulation should reflect these differences. There is considerable evidence, however, that the barbiturates and other like drugs are potentially harmful, that their misuse in the form of "sleeping-pill" addiction has become a serious problem, and that there is need for action to bring this area of drugs under effective regulation as a measure essential to the public health and for the protection of individuals. A New Jersey Legislative Commission to Study Narcotics, in this connexion, stated in its 1952 report that "... vital statistics show that more people in the United States die of barbiturate poisoning than from any other kind of poisoning ".

The following proposal is based partly on a model state barbiturate Act developed by various pharmaceutical organizations, and partly on an Ohio enactment of 1949; it reflects various features of federal legislation in this field; and it has been reviewed carefully over a two-year period by federal officials concerned with regulation of drugs, as well as by the Drafting Committee. The proposal is recommended for consideration of states which may require new legislation in this field, or which may wish to broaden or strengthen the coverage of existing legislation. The attention of states which have comparable laws confined to control of barbiturates is specifically called to the wider coverage of this proposal. States which have administrative procedures acts may wish to expand section 6 of this act to provide that regulations issued pursuant hereto shall be in conformity with the provisions of such administrative procedures legislation.

Suggested Legislation

[Title should conform to state requirements. The following is a suggestion: "An Act to regulate the handling, sale and distribution of hypnotic or somnifacient drugs ".]

( Be it enacted, etc.)

Section 1.-Definitions

As used in this Act

  1. The term "drug" means (A) the salts and derivatives of barbituric acid or compounds, preparations or mixtures thereof, and (B) other drugs or compounds, preparations or mixtures thereof which the [State Commissioner of Health or other competent state officer or agency] shall find and declare by rule or regulation duly promulgated [ after reasonable public notice and opportunity for hearing][20] to have a hypnotic or somnifacient effect on the body of a human or animal; except that the term" drug" shall not include any drug the manufacture or delivery of which is regulated by the narcotic drug laws of this state.

  2. The term "delivery" means sale, dispensing, giving away, or supplying in any other manner.

  3. The term "patient" means, as the case may be, (A) the individual for whom a drug is prescribed or to whom a drug is administered, or (B) the owner or the agent of the owner of the animal for which a drug is prescribed or to which a drug is administered, provided that the prescribing or administering referred to in (A) and (B) hereof is in good faith and in the course of professional practice only.

  4. The term "person" includes individual, corporation, partnership, and association.

  5. The term "practitioner" means a person licensed in this state to prescribe and administer drugs, as herein defined, in the course of his professional practice; "professional practice of a practitioner" means treatment of patients under a bona fide pratictioner/patient relationship.

  6. The term "pharmacist "means a person duly registered with the [state board of pharmacy] pursuant to [insert proper statutory reference].

  7. The term "prescription" means a written order, and in cases Of emergency, a telephonic order,[21] issued by a practitioner in good faith in the course of his professional practice to a pharmacist for a drug for a particular patient, which specifies the date of its issue, the name and address of such practitioner, the name and address of the patient (and, if such drug is prescribed for an animal, the species of such animal), the name and quantity of the drug prescribed, the directions for use of such drug, and the signature of such practitioner.

  8. The term "wholesaler" means a person engaged in the business of distributing drugs to persons included in any of the classes named in clauses ( a) to ( e), inclusive, of section 3 (1) (B) of this Act.

  9. The term "manufacturer" means a person who manufactures drugs, and includes persons who prepare such in dosage forms by mixing, compounding, encapsulating, entableting, or other process, but does not include pharmacists so preparing such drugs solely for dispensing on prescriptions received or to be received by them.

  10. The term "warehouseman" means a person who, in the usual course of business, stores drugs for others lawfully entitled to possess them and who has no control over the disposition of such drugs except for the purpose of such storage.

Section 2.-Prohibited Acts

It shall be unlawful

  1. To deliver any drugs unless:

    1. Such drug is delivered by a pharmacist in good faith upon prescription and there is affixed to the immediate container in which such drug is delivered a label bearing ( a) the name and address of the owner of the establishment from which such drug was delivered; ( b) the date on which the·prescription for such drug was filled; ( c) the number of such prescription as filed in the prescription files of the pharmacist who filled such prescription; ( d) the name of the practitioner who prescribed such drug; ( e) the name and address of the patient, and if such drug was prescribed for an animal, a statement showing the species of the animal, and ( f) the direction for use of the drug and cautionary statements, if any, as contained in the prescription; and

    2. In the event that such delivery is pursuant to telephonic order, such prescription shall be promptly reduced to writing and filed by the pharmacist; or

    3. Such drug is delivered by a practitioner in good faith and in the course of his professional practice only.

  2. To refill any prescription for a drug unless such refilling is specifically authorized on the prescription.

  3. To fail to keep the records required by section 4 of this act.

  4. For a practitioner to fail to confirm within 72 hours a telephonic order for a drug by giving to the pharmacist a written prescription therefor.

  5. For any person to possess a drug unless such person obtained suck drug on the prescription of a practitioner or in accordance with section 2 (1) (C) of this act or from a person licensed by the laws of any other state or the District of Columbia to prescribe or dispense drugs.

  6. To refuse to make available and to accord full opportunity to check any record, file, stock or inventory as required by section 5 of this Act.

  7. For any person to use to his own advantage, or to reveal other than to a public officer or employee charged with the duty of enforcing law relating to the handling, sale and distribution of drugs, or to a court when relevant in a judicial proceeding, any information acquired under the authority of section 5 of this act concerning any method or process which as a trade secret is entitled to protection.

  8. For any person to obtain or attempt to obtain a drug by fraud, deceit, misrepresentation or subterfuge; or by the forgery or alteration of a prescription; or by the use of a false name or the giving of a false address.

Section 3.-Exemptions

  1. The provisions of paragraphs (1) and (5) of section 2 of this Act shall not be applicable (A) to the delivery of drugs for medical or scientific purposes only to persons included in any of the classes hereinafter named, or to the agents or employees of such persons, for use in the usual course of their business or practice or in the performance of their official duties, as the case may be; or (B) to the possession of drugs by such persons or their agents or employees for such use : ( a) Pharmacists; ( b) practitioners; ( c) persons who procure drugs (i)for disposition by or under the supervision of pharmacists or practitioners employed by them, or (ii) for the purpose of lawful research, teaching, or testing and not for resale; ( d) hospitals and other institutions which procure drugs for lawful administration by or under the supervision of practitioners; ( e) manufacturers and wholesalers; ( f) carriers and warehousemen.

  2. Nothing contained in section 2 of this Act shall make it unlawful for a public officer, agent or employee, or person aiding such public officer in performing his official duties, to possess, obtain, or attempt to obtain a drug for the purpose of enforcing the provisions of any law of this state or of the United States relating to the regulation of the handling, sale or distribution of drugs.

Section 4.-Records

  1. Persons (other than carriers) to whom the exemptions of section 3 of this Act are applicable shall (A) make a complete record of all stocks of drugs on hand on the effective date of this act and (B) maintain detailed, but not necessarily separate, records and inventories relating to drugs manufactured, purchased, sold, distributed and handled and retain all such records and inventories required by this subsection (1) for not less than two calendar years after the date of the transaction shown by such record and inventory

  2. Pharmacists shall, in addition to complying with the provisions of subsection (1) of this section, retain each prescription and written record of telephonic order for a drug filled by them, for not less than two calendar years immediately following the date of the filling or the date of the last refilling of such prescription whichever is the later date.

Section 5. - Access to Records: Inspection

Persons required by section 4 of this act to keep files, inventories or records relating to drugs shall, upon the written request of a public officer or employee charged with the duty of enforcing laws relating to the handling, sale and distribution of drugs, (A) make such fries, inventories or records available to such officer or employee, at all reasonable hours, for inspection and copying, and (B) accord to such officer or employee full opportunity to check the correctness of such files, inventories or records, including opportunity to make inventory of all stocks of drugs on hand.

Section 6. - Regulations

The [insert name of appropriate state agency] may pro-mulgate necessary regulations for the administration and enforcement of this act.

Section 7. - Penalties.

Any person violating any provision of this act shall be punished by a fine not exceeding [one thousand dollars], or by imprisonment for not more than [one year], or both; but if the violation is committed after a conviction of such person under this Act has become final, such subsequent conviction shall be punished by a fine not exceeding [ten thousand dollars], or by imprisonment for not more than [three years], or both.

Section 8. - Severability Clause

If any provision of this Act is declared unconstitutional or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the Act and the applicability thereof to other persons and circumstances shall not be affected thereby.

Section 9. - Repeal Clause

[If there is state legislation already in existence regarding barbiturates or other hypnotic or somnifacient drugs which this act will supplant, insert repeal clause here.]

Section 10

[Insert effective date.]

1

See Bulletin on Narcotics, Volume IV, No. 3.

2

See Bulletin on Narcotics, Volume IX, No. 1.

3

See, e.g., the view of Drs. Isbell and White cited below, according to which this dosage is "far in excess of those used therapeutically ".

4

See Bulletin on Narcotics, Volume VIII, No. 2.

10

Committee Hearings, p. 2150.

11

Committee Hearings, p. 2199.

12

Committee Hearings, p. 2217.

13

Committee Hearings, p. 2150.

14

Committee Hearings, p. 2157.

15

Committee Hearings, p. 2216.

16

Committee Hearings, p. 2312.

17

Committee. Hearings, p. 4312.

18

Committee Hearings, p. 2315.

19

Committee Hearings, p. 2318.

20

States which have basic administrative procedures legislation in effect may wish to insert reference to such legislation at this point in place of the words appearing here in brackets.

21

States which desire to eliminate the use of telephonic orders should omit the words" and in cases of emergency a telephonic order ". Corresponding changes should be made by deleting sections 2 (1) (B), section 2 (4), and by altering section 4 (2).