Carlene Baum

Prescription drug use before and during pregnancy in a Medicaid population

This study describes prescription drug use before and during pregnancy and is based on data obtained from the paid Medicaid claims of 18,886 Michigan women aged 15 to 44 years who were delivered of a live infant. Rates of exposure to drugs within 15 therapeutic categories are presented for each of five 90-day periods preceding delivery. Overall dispensed drug use (excluding vitamins) decreased during pregnancy; however, there was still substantial exposure to drugs including drugs that are contraindicated during pregnancy. During the gestational period, study mothers received an average of 3.1 prescriptions for nonvitamin drugs. Black mothers received more exposure to drugs other than vitamins than did white mothers. Black mothers had higher rates of exposure to analgesics, ampicillin, codeine, and vaginal preparations. Similarities between black and white mothers in the use of vitamins with and without other drugs suggest there is no racial difference in attaining prenatal care within the Medicaid system, but that black mothers may have more medical problems that warrant the use of other medications in addition to vitamins during pregnancy.

Prescription drug use in 1984 and changes over time.

More than 1.5 billion prescriptions were dispensed from retail pharmacies in 1984 at a consumer cost of

FACTORS AFFECTING PHYSICIAN REPORTING OF ADVERSE DRUG REACTIONS

18.4 billion. The number of prescriptions dispensed in 1984 equaled the previous record set in 1973. Over 40% of 1984 prescriptions were for four therapeutic classes: cardiovascular drugs, anti-infectives, psychotherapeutic drugs, and diuretics. Prescriptions for cardiovascular drugs and diuretics increased substantially from 1975 to 1984, while prescriptions for psychotherapeutic drugs decreased. Outpatient use of systemic antiinfectives remained fairly stable over the 10-year period. Trends in the use of specific drug categories within these broad therapeutic classes were variable, as were patient age and sex distributions.

Sedative-hypnotic drugs and the risk of hip fracture

A survey was performed to ascertain which factors influence physicians to directly report adverse drug reactions to the FDA. Eighty-two percent of the 190 physicians reporting reactions during an 11-week period responded to the survey. Reporters were disproportionately in primary care compared to all US physicians and tended to spend a larger amount of time in teaching and research than the average physician. More than half of the respondents were under 40 years of age. The major reporting influences found were the severity of the reaction and the newness of the drug. Patient attribution of the reaction to the drug was a strong influence on reporting of nonserious reactions. Concern for legal implications was a relatively infrequently (11%) noted influence on reporting physicians. No single reporting influence was unique to reporters of serious unlabeled reactions.

Trends in Use of Oral Hypoglycemic Agents 1964–1986

A retrospective cohort study was conducted in individuals 65 years of age and older using Medicaid-reimbursed claims to assess the risk of hip fracture in users of two sedative-hypnotic drugs, triazolam and temazepam. Using the triazolam cohort as the referent group, the rate ratio was 0.92 (95% confidence interval, 0.72 to 1.17) for hip fracture with temazepam. Stratifying by age, sex, race, residence, time enrolled in Medicaid, prescription number, combinations of these, and several other potential confounding variables did not materially change the results. Compared with the short-acting benzodiazepine hypnotic temazepam, use of triazolam, an ultra-short-acting benzodiazepine hypnotic, did not decrease the risk of hip fracture. This study did not determine that either drug, compared with no use in an insomniac control group, increases the risk of hip fracture. However, because sedative-hypnotic drugs have been found in other studies to increase the risk of falling and hip fracture, they should be used with caution, especially in the elderly.

Indices of Drug Misuse for Prescription Drugs

Oral hypoglycemic (OH) agents have been available in the United States for the treatment of non-insulindependent diabetes mellitus (NIDDM) for almost 30 yr. During this time they have been subject to considerable controversy. In this article, we present pharmaceutical marketing research data that provide a review of several facets of OH use. The number of OH prescriptions dispensed peaked in 1973, decreased through 1980, and has been increasing since that year. In 1986, OH agents accounted for 21.5 million prescriptions: 1% of all prescriptions dispensed that year. Chlorpropamide is currently the most frequently ingested OH agent; it is used by 33% of the market. The two OH agents introduced in 1984, glyburide and glipizide, had acquired 41% of the OH market by the end of 1986. The rate of OH use per 1000 diabetes mellitus visits increases with patients age. Patients aged 60 yr and older received OH prescriptions at a rate of 478 per 1000 diabetes mellitus visits in 1986. Data estimating both the number of patients diagnosed with diabetes and the number of diabetic patients taking OH agents indicate that the percentage receiving OH treatment has increased over the past 5 yr, with ∼35% of all diabetic patients taking OH agents in 1986.

Differences in Manufacturer Reporting of Adverse Drug Reactions to the FDA in 1984

Few studies of prescription-drug misuse have taken into account the numbers of prescriptions dispensed for specific drugs. Using data from the Drug Abuse Warning Network (DAWN) and the National Prescription Audit, we calculated indices of drug misuse for specific prescription drugs that are used mainly in outpatient settings and are either benzodiazepines, barbiturates, other sedative-hypnotics, analgesics, or CNS stimulants. In 1983-1985 the drugs associated with the highest numbers of DAWN medical examiner-reported drug-misuse deaths were codeine, diazepam, propoxyphene, phenobarbital, and secobarbital. However, the drugs with the highest indices of DAWN medical examiner-reported drug-misuse deaths/100,000 dispensed prescriptions were methamphetamine, methaqualone, amobarbital, secobarbital, and glutethimide. An index of fatality risk, calculated as 100 x DAWN medical examiner-reported drug-misuse deaths/DAWN emergency room-reported drug-misuse episodes, suggested that the risk of death from a glutethimide-associated drug-misuse episode had increased 92% from 1975-1979 to 1983-1983 and in 1983-1985 was the highest for the drugs studied. These indices might assist public health authorities attempting to design effective strategies to efficiently address the problem of prescription-drug misuse.

Sources of Spontaneous Adverse Drug Reaction Reports Received by Pharmaceutical Manufacturers

Pharmaceutical manufacturers were ranked by the number of adverse drug reaction reports that the FDA received from them in 1984. Twenty companies submitted 79% of all the manufacturer reports. These companies were assessed in terms of their total prescriptions, hospital and drug store sales, and detailing calls. All three variables were correlated with the number of ADR reports, but dollar sales were the best predictor of report volume. Reports from the top 20 manufacturers were no more likely to have serious outcomes than those from the other manufacturers, but they were more likely to have unknown outcomes. The top 20 companies submitted NCE reports at a rate almost twice that of other companies, and their NSAID reporting rate was eight times as great. They submitted 85% of the total NCE reports, while only 73% of the NCE reports sent directly to the FDA were for products manufactured by these companies.

Utilization of nonsteroidal antiinflammatory drugs

During the first quarter of 1986, 20 pharmaceutical manufacturers identified the original source for 5,744 domestic spontaneous postmarketing ADR reports. Overall, 27% of these reports originated with the field staff employed by the manufacturers and 34% originated with telephone calls made by health-care providers. The remaining 39% was derived from written provider reports, consumer reports, or the literature. Considerable variation in these percentages was found among manufacturers. Although some correlation was found between the number of field staff visits and the number of reports originating from field staff for some manufacturers, the frequency of field staff visits was not predictive of the number of reports obtained by most manufacturers.