Drugs Advisory Research Articles

A review of the characteristics and treatment progress of 45 pregnant opiate addicts attending the Irish National Drug Advisory and Treatment Centre over a two year period.

The increase in the number of patients presenting to the National Drug Advisory and Treatment Centre addicted to opiates has been accompanied by an increase in the number of pregnant opiate addicts attending for treatment. Studies published in January 1982 referred to the emergence of maternal addiction as a serious problem in Ireland. Since then the escalation of this specific problem has continued and a programme designed to meet the needs of the pregnant addict was initiated at the clinic. This paper reviews the characteristics and treatment progress of 45 opiate addicts who were referred to the clinic over a two year period.

Vaginal Spermicides and Congenital Disorders: The Validity of a Study

To the Editor.— In April 1981, an article by Jick et al, 1 of which I was a coauthor, suggested that a mother's exposure to spermicide the time of conception might cause certain birth defects. Our article was not corroborated by subsequent studies. 2 An expert panel assembled by the Food and Drug Administration found our study unpersuasive because of poor design and unsupported by well-designed studies ( Proceedings of the Fertility and Maternal Health Drugs Advisory Committee , unpublished transcript. Food and Drug Administration, Dec 15, 1983). It is the purpose of this letter to allay further long-persisting concern generated by our article by showing that it was based on an inaccurate presumption of exposure to spermicide near the time of conception. In our study, a mother was presumed to have used vaginal spermicides near the time of conception if she had received a prescription for spermicides within 600 days

The Outcome of Occupational Referrals

Abstract: A follow‐up study was undertaken of all clients referred to the Hunter Drug Advisory Service from their place of employment during the period 1978‐82. Data are presented describing the age, sex, principal drug problem(s) and the period of follow‐up of the clients. In addition the amount and type of treatment received by each client is briefly discussed. At follow‐up 12 of the 24 clients (50%) were judged to have been successfully rehabilitated in terms of their work performance. Successful clients were on average 14 years younger than those judged unsuccessful. The degree of treatment received including involvement in Alcoholics Anonymous did not appear to influence the quality of outcome.

THE HUNTER DRUG ADVISORY SERVICE APPROACH TO PROBLEM DRINKERS

ABSTRACTThe role of the Hunter Drug Advisory Service (HDAS) is briefly described. The background of problem drinking clients is outlined and their sources of referral listed. HDAS' approach to counselling problem drinkers is discussed with emphasis placed on the first interview and its importance. The rationale for largely avoiding the use of the alcoholism concept in HDAS counselling is examined. Finally, the issue of client treatment after the first interview is described with particular reference to the role of Alcoholics Anonymous.

The Pill, Breast and Cervical Cancer, and the Role of Progestogen in Arterial Disease

Various findings on a relationship between the pill breast and cervical cancer and the role of progestogens in cardiovascular disease were debated at the recent hearings of the USFDAs Fertility and Maternal Health Drugs Advisory Committee. The committees actions on the topics addressed include recommendations for changes in oral contraceptive (OC) package inserts which warned of increased risk of breast cancer with OC use as available research does not support such an association. The committee made an additional recommendation that women take pills with low doses of estrogen and progestogen. Current trends in pill use presented at the hearing show a decline in the estrogen and progestogen potencies of most availabel brands of OC. In addition to variations over time in the number of women taking the pill and in the formulations taken there has been a sharp decrease in the proportion of older women taking the pill. An overview of the state of research on a possible association between breast cancer and pill use as presented at the hearing indicates that the major epidemiologic studies have found no overall increased risk of the disease for pill users. Whereas case control studies during the 1970s suggested that long-term use by some subgroups of women namely those with benign breast disease those with a family history of breast cancer and those who had not had a full-term pregnancy put them at increased risk more recent and larger studies do not confirm such results. Nonetheless more research is still needed before final conclusions can be reached; close clinical supervision for all women taking OCs is still essential. Most recent studies have also failed to confirm any overall increase in the risk of cervical cancer with pill use but that there might be an increased risk among very long-term users especially women who initiate sex early and have multiple sex partners. Considerable controversy surrounds the conflicting findings of various studies involving the pill and cervical cancer due to such confounding variables as sexual history. In addition most studies have been of cervical dysplasia and carcinoma in situ rather than of invasive cervical cancer itself. Evidence concerning an association between progestogens and the increased risk of arterial disease is more impressive and shows that there is a persistent and cumulative effect of progestogens on reducing the levels of high-density lipoproteins and thereby on increasing the risk of arterial disease. Progestogens with androgenic properties seem to be especially involved in such increased risk. The committees recommendations on breast cancer and cervical are similar to those made by Britains Committee on Safety of Medicines.

Chronic active hepatitis in intravenous drug abusers may be delta agent infection associated.

Twenty-seven parenteral drug users had serum tested for delta aintigen and antidelta antibody and had liver biopsies performed. All patients has been referred from the Drug Advisory and Treatment Centre by its Medical Director. Of the thirteen delta positive patients four had chronic active hepatitis. All four patients with chronic active hepatitis were delta positive. This study suggests that delta agent infection increases the risk of progression of intravenous drug abuse associated liver disease to chronic active hepatitis.

A DRUG AND ALCOHOL SERVICE BASED IN A GENERAL HOSPITAL

AbstractThe development since 1976 of a treatment service for drugs and alcohol related problems at Royal Prince Alfred Hospital (RPAH) is described. The service, which was an initiative of the Division of Medicine is offered as a consultation, assessment and treatment service for in‐ and outpatients. The Unit acknowledges that a specific clinical intervention may not be important4, but that assessment and intervention of any sort may have a therapeutic importance. The organisation of Drug and Alcohol Services (DAS) in 1983 is headed by a General Physician with administrative responsibility to the Director of Medical Services and professional responsibility to the Division of Medicine, and the Department of Neurology. 376 new patient consultations were seen in 1983. A non medical detoxification unit on the hospital campus serviced 1700 admissions. There is a Liaison Nurse to assist with nursing management problems. The Unit has an education role in the Hospital for medical and nursing staff. Two project officers are completing a project on teaching guidelines and resource material for nurse education in N.S.W. A Regional Brain Damage Unit is investigating the prevalence of neurological disease due to alcohol and advising on special rehabilitiation needs of these patients. The overall success rate of the first 200 patients followed for at least six months in 1981 was 18%. There has been a satisfactory outcome in 15% of patients referred to community resources after alcohol detoxification. In 1983 5% of patients referred to the Service were using narcotics, 15% were using benzodiazepines or other sedatives. A methadone maintenance programme for heroin addicted mothers is run at King George V Hospital (RPAH) in conjunction with the Bourke Street Drug Advisory Service; referrals for opiate and other sedative dependence may be made to other special units in the region. The DAS Unit has become an integral part of the medical services offered at RPAH.

Contraceptive Development: Guidelines for the Clinical Testing of Male Contraceptive Drugs

Journal of AndrologyVolume 2, Issue 4 p. 225-228 Free Access Contraceptive Development: Guidelines for the Clinical Testing of Male Contraceptive Drugs C. A. SCHAFFENBURG, C. A. SCHAFFENBURG Division of Metabolism and Endocrine Drug Products, Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory CommitteeSearch for more papers by this authorT. A. GREGOIRE, T. A. GREGOIRE Division of Metabolism and Endocrine Drug Products, Food and Drug Administration Executive Secretary, Endocrinologic and Metabolic Drugs Advisory Committee.Search for more papers by this authorJ. L. GUERIGUIAN, J. L. GUERIGUIAN Division of Metabolism and Endocrine Drug Products, Food and Drug Administration Medical Officer and Group Leader, Division of Metabolism and Endocrine Drug Products, Food and Drug Administration.Search for more papers by this author C. A. SCHAFFENBURG, C. A. SCHAFFENBURG Division of Metabolism and Endocrine Drug Products, Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory CommitteeSearch for more papers by this authorT. A. GREGOIRE, T. A. GREGOIRE Division of Metabolism and Endocrine Drug Products, Food and Drug Administration Executive Secretary, Endocrinologic and Metabolic Drugs Advisory Committee.Search for more papers by this authorJ. L. GUERIGUIAN, J. L. GUERIGUIAN Division of Metabolism and Endocrine Drug Products, Food and Drug Administration Medical Officer and Group Leader, Division of Metabolism and Endocrine Drug Products, Food and Drug Administration.Search for more papers by this author First published: July‐August 1981 https://doi.org/10.1002/j.1939-4640.1981.tb00621.xCitations: 1 AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Citing Literature Volume2, Issue4July‐August 1981Pages 225-228 RelatedInformation

Over-the-counter hydrocortisone: boon or boon-doggle?

The issue of whether the Food and Drug Administration (FDA) should or should not permit hydrocortisone-containing creams to be marketed on an over-the-counter (OTC) basis has been surfacing at intervals for approximately 15 years. The Academy appointed a committee in 1965 chaired by Dr. Clarence Livingood to develop recommendations, and again in 1975 a committee chaired by Dr. James B. Howell was appointed. In both instances, the recommendations to the FDA were that there was too much potential hazard and that there were too many opportunities for abuse to permit this. However, in recent years two separate OTC advisory panels of the FDA, the Topical Antimicrobial I[ Panel and the Sunburn and Topical Analgesic Panel, have recommended the release of hydrocortisone products for OTC sale. This issue was felt to be of such a controversial nature that it was referred by the FDA to the Dermatologic Drugs Subcommittee of the Antiinfective and Topical Drugs Advisory Committee of the FDA on July 24, 1979. This Subcommittee, at open hearing, approved the concept of releasing hydrocortisone products for OTC sale, but recommended that combination products of hydrocortisone with various antimicrobial or antifungal agents be prohibited for OTC sale. Testimony was submitted to the Subcommittee on behalf of the American Academy of Dermatology, which reaffirmed the Academy's previous position and concerns. In addition, the Academy witnesses pointed out that adverse effects of topical corticosteroid preparations were often subtle and could go unrecognized for many years, as witnessed by the inordinate delay before steroidinduced rosacea was appreciated as a serious con-

Moves beginning to approve new indications for aspirin use

Aspirin in daily doses of 1,300 mg is "safe and effective for reducing the risk of recurrent transient ischemic attacks in men who have had transient ischemia of the brain due to fibrin platelet emboli." With that pronouncement, a special advisory committee to the Food and Drug Administration has recommended that the official indications for aspirin be expanded to include therapy for certain types of transient ischemic attacks (TIAs) in men only. The recommendation of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee, if accepted by the agency, "may substantially alter the way medicine is practiced," according to Ron Kartzinel, MD, director of the FDA's Division of Neuropharmacological Drugs. The action may also represent the first official step in what some believe may become a rush to confirm new uses for the 80-year-old drug, now known to inhibit synthesis of certain prostaglandins. "The committee was very careful," says

Moves beginning to approve new indications for aspirin use

Aspirin in daily doses of 1,300 mg is "safe and effective for reducing the risk of recurrent transient ischemic attacks in men who have had transient ischemia of the brain due to fibrin platelet emboli." With that pronouncement, a special advisory committee to the Food and Drug Administration has recommended that the official indications for aspirin be expanded to include therapy for certain types of transient ischemic attacks (TIAs) in men only. The recommendation of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee, if accepted by the agency, "may substantially alter the way medicine is practiced," according to Ron Kartzinel, MD, director of the FDA's Division of Neuropharmacological Drugs. The action may also represent the first official step in what some believe may become a rush to confirm new uses for the 80-year-old drug, now known to inhibit synthesis of certain prostaglandins. "The committee was very careful," says

Medical News

<h3>Side effects of cimetidine use coming under scrutiny</h3> In a cruel twist of fate for the manufacturers of the peptic ulcer drug cimetidine, a recent federal hearing convened for the purpose of expanding the official clinical indications for cimetidine use to include long-term maintenance therapy was transformed into a veiled indictment of the agent. The hearing was conducted by the Food and Drug Administration's Gastrointestinal Drugs Advisory Committee at the request of Smith Kline &amp; French Laboratories, the principal manufacturers of cimetidine. Unfortunately for the company, recent articles in<i>The Lancet</i>(1:1005-1006, 1979), suggesting a link between cimetidine and gastric cancer, and in<i>The New England Journal of Medicine</i>(300:1012-1015, 1979), showing reductions in sperm counts after cimetidine therapy, altered the mood of the hearing from cooperation to interrogation. Nevertheless, the committee agreed that cimetidine is indicated in the long-term treatment of the most serious cases of duodenal ulcer.

The Saga of Encare Oval: An FDA Advisory Panel at Work

Editor’s note: in 1972 the FDA started a review of over-the-counter drugs. Seventeen OTC drug review panels were subsequently formed to look at the ingredients and labeling of various categories of OTC products. Approximately half of those panels have issued their final reports; a panel “self-destructs” once it has made its report to FDA. After an intricate process, including solicitation of public comments, a final monograph is published in the Federal Register. This article focuses on one of those panels, the OTC Contraceptive/Vaginal Drugs Advisory Panel, which is winding up its work this summer. Next month, American Pharmacy will highlight the research-gathering process which forms the basis for OTC drug panel members’ decisions.

Clinical pharmacology in Ireland.

Ireland has an effective National Drugs Advisory Board. Ethical considerations for human experimentation are unifonn throughout the country. The need for full‐time clinical pharmacology units has gained acceptance, but none has yet been established. Nonetheless, a contribution is being made to research in the field of clinical pharmacology.

Drug safety —establishment of a National drugs Advisory Board

Drug safety —establishment of a National drugs Advisory Board