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Biomedical subjects

G A Faich

Publications and source records attributed to G A Faich.

At least 37 records · Page 2Linked to original sources
PubMed1990

International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group.

A method for standardized postapproval adverse drug reaction (ADR) reporting has been developed and implemented by seven multinational pharmaceutical manufacturers and six regulatory authorities. This is based on a set of uniform definitions, procedures and a single reporting form, and has been demonstrated to be useful and effective. When regulators and manufacturers develop requirements and systems for ADR reporting they should consider adapting this method.

Drug Industry↗
PubMed1989

Morbidity and mortality among low birth weight infants exposed to an intravenous vitamin E product, E-Ferol.

In April 1984, the US FDA was notified of an unusual clinical syndrome consisting of ascites, liver and renal failure, thrombocytopenia, and death among low birth weight infants exposed to an intravenous vitamin E preparation, E-Ferol. The product, which had not been tested for safety prior to marketing, was voluntarily withdrawn from the market in early April. To further investigate the reported associations, the FDA conducted a retrospective cohort study among seven neonatal intensive care units where the product had been used. Standardized abstraction forms were completed for infants admitted to a unit between Nov 1, 1983, and April 30, 1984. Included in the study were 379 infants weighing 2,000 g or less and surviving at least two days; 148 (39%) had been exposed to E-Ferol. Compared with the unexposed infants, the exposed infants were more likely to die and to have ascites, hepatomegaly, thrombocytopenia, and a combination of clinical events similar to the syndrome initially reported. We conclude that the use of E-Ferol in these neonatal intensive care units was associated with increased morbidity and mortality among exposed infants.

Acute Kidney Injury↗
PubMed1988

The importance of adverse reaction reporting by physicians. Suprofen and the flank pain syndrome.

The role of spontaneous reporting in detecting the suprofen-associated flank pain syndrome was examined, including the specific effect of the "Dear Doctor" letter in accelerating the information-gathering process once the initial signal was generated. We believe this to be a noteworthy example of the ability of spontaneous reporting to produce a timely and unequivocal signal of drug-related risk. It also serves to demonstrate the need for vigilant postmarketing surveillance for all newly marketed drugs in the United States, even though considerable premarketing and postmarketing drug experience may exist from use in countries outside of the United States.

Acute Kidney Injury↗
PubMed1988

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 +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.

Adult↗
PubMed1988

National adverse drug reaction surveillance. 1986.

The collection of adverse drug reaction (ADR) reports by the Food and Drug Administration serves to provide additional information on the toxic reactions of drugs that often cannot be known before a drug is marketed. In 1986, a total of 53,547 ADR reports were received; 56% of these were made by US health care professionals based on observations made during usual clinical practice. The 1986 total represents an increase of 14% in ADR reporting over 1985, continuing a trend begun in 1981. While these increases are encouraging, US reporting rates are far below many other countries, and further encouragement of reporting must be done. Of these ADR reports, 24% involved serious reactions and 20% involved new drugs. An ADR report should be seen as a professional responsibility; reports are carefully analyzed and used.

Adolescent↗
PubMed1987

National adverse drug reaction surveillance: 1985.

The Food and Drug Administration received about 37,000 adverse drug reaction reports in 1985. Seventy-one percent of the reports involved toxic reactions to usual doses of drugs and were sent by medical care professionals directly to the Food and Drug Administration or to pharmaceutical manufacturers. In terms of severity, 2% of reports involved death while 21% involved hospitalization. The highest proportions of hospitalization or death were found for reports describing cardiovascular, hematologic, or respiratory effects. Nearly half of the reported deaths were in patients more than 59 years of age. The majority of reports described an adverse drug reaction occurring within two weeks of initial exposure to the suspected drug. Adverse drug reaction reporting by physicians is crucial to ensuring that pharmaceutical products are used appropriately.

Adult↗
PubMed1987

Ulcerogenicity of piroxicam: an analysis of spontaneously reported data.

Previous reports have suggested that piroxicam may be more ulcerogenic than other non-steroidal anti-inflammatory drugs (NSAIDs) in use. Critics have attributed this putative relation to flawed comparisons of spontaneously reported data. In this study cases of upper gastrointestinal bleeding, perforation, and ulcer reported to the Food and Drug Administration's spontaneous reporting system over 12 years were examined. Reporting rates for eight NSAIDs were compared over identical periods of their marketing life cycles. After adjustments were made for the heterogeneity in the underlying reporting rates the difference in rates between piroxicam and the other drugs was considerably reduced but piroxicam retained its top ranking among the drugs; however, large and clinically important differences in the frequency of cases of upper gastrointestinal bleeding, perforation, and ulcer between piroxicam and the rest of the NSAIDs compared probably do not exist.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1987

National patterns of aspirin use and Reye syndrome reporting, United States, 1980 to 1985.

The number of cases of Reye syndrome reported annually to the Centers for Disease Control declined markedly between 1980 and 1985. In this article, we present pharmaceutical marketing research data that suggest sharp decreases in the use and purchase of children's aspirin between 1980 and 1985. These trends appear to correspond to the decrease in reporting of Reye syndrome cases. Additionally, analysis of physician mentions of aspiring and acetaminophen for treating flu and chickenpox showed statistically significant trends toward decreasing recommendations for the use of aspirin and significant trends toward increasing recommendations for use of acetaminophen. Trends in wholesale purchases of aspirin and acetaminophen by drug stores from 1979 through 1985 demonstrated a significant decline for the 81-mg children's aspirin tablet and an increase in purchases of children's acetaminophen products. Many factors may influence physician and parents' choice of analgesic/antipyretic medication, including information about Reye syndrome. Data suggest that a continuing decline in the use of aspirin for children may be accompanied by a continuing decline in the reported number of Reye syndrome cases.

Acetaminophen↗
PubMed1983

Streptococcal pharyngitis and acute rheumatic fever in Rhode Island.

A comprehensive survey of physicians, laboratories, and hospital records in Rhode Island showed that more than 157,000 throat cultures for a population of 930,000 people were done in 1980. Eighty-seven percent of primary care physicians prescribed antibiotic therapy before culture results were known, and almost 40% continued antibiotic therapy for ten days regardless of culture results. The throat culture positivity rate for beta-hemolytic Streptococcus was 17% statewide in 1980. Only three definite and seven possible cases of acute rheumatic fever were identified by hospital chart reviews and a physician survey covering the five years 1976 through 1980. Current throat culture practices probably have little influence on treatment of streptococcal pharyngitis and control of rheumatic fever in the state.

Acute Disease↗
PubMed1983

The epidemiology of diabetic acidosis: a population-based study.

A 12-month epidemiologic study in 1979 and 1980 of all diabetic acidosis admissions to all acute care hospitals in Rhode Island detected 152 episodes occurring in 137 persons. Eleven per cent of diabetic acidosis admissions presented in coma and the overall death-to-case ratio was 9%. Newly diagnosed diabetes accounted for 20% of these episodes, while persons having multiple episodes during the year accounted for 15% of the admissions. The annual rate of diabetic acidosis was 46 per 10,000 diabetics. Highest rates of diabetic acidosis were found for the elderly, those admitted from nursing homes and those residing in one geographic area of the state. For known diabetics with an admission for acidosis, 87% were on insulin prior to admission and 81% were nonobese. Patients seldom contacted physicians prior to admission. Insulin dose or frequency was often (40%) changed in the two weeks prior to admission. Most of the known diabetic cases of acidosis had emergency admissions for diabetes in the three-year period prior to admission and few had any structured diabetic outpatient education. Infection and noncompliance were the most frequently identified precipitants of diabetic acidosis occurring in known diabetics.

Adolescent↗
PubMed1983

An epidemiologic study of the risks associated with peripheral intravenous catheters.

As part of a standardized, multi-hospital prospective surveillance system for nosocomial infections in Rhode Island, an analysis was undertaken in March 1980-February 1982 to determine the interplay of factors that contribute to the risk of phlebitis in peripheral, non-steel, non-butterfly intravenous catheters. The authors studied 3094 patients with 5161 total episodes of peripheral intravenous catheters from day of admission until day of discharge. The overall rate of phlebitis was 2.3% (118 episodes), and the rate of intravenous catheter-associated bacteremia was 0.08% (1 definite episode, 3 possible episodes). Factors significantly associated with the occurrence of phlebitis were: underlying risk for any nosocomial infection, duration of the catheter episode, chronological order of the episode and an interaction between the latter two variables. Analysis of day-specific risk of phlebitis indicated that, for patients with low risk diagnoses, initial peripheral intravenous catheters might be left in place with relative safety for up to 96 hours. Over this time period, the day-specific risk for such patients ranged between 0.8% and 1.4%, exclusive of the first day. In all other circumstances, the current recommendation of 48-72 hours seems appropriate.

Adult↗