CDC: Delay tetanus booster shots until 2002
Because one of two manufacturers discontinued production of tetanus toxoid-containing products, the Centers for Disease Control and Prevention (CDC) in Atlanta has recommended that health care providers delay administering routine booster doses of tetanus and diphtheria toxoids (Td) to adults and adolescents until 2002.
Aventis Pasteur in Swiftwater, PA, has increased production of Td to meet national needs, says the CDC in its publication Morbidity and Mortality Weekly Report, but since vaccine production takes 11 months, the shortage is expected to last throughout 2001. By seeking a delay in routine booster shots, the CDC hopes to ensure that health care providers have sufficient supplies of Td to vaccinate:
- people traveling to a country where the risk of diphtheria is high;
- people requiring tetanus vaccination for prophylaxis in wound management;
- people who have received less than three doses of any vaccine containing tetanus and diphtheria toxoids; and
- pregnant women who have not received Td within the past 10 years.
The CDC recommends that health care providers record the names of patients who are not able to receive routine booster doses through the rest of the year. When the supply of Td returns to normal, providers should contact these patients about receiving their dose. More information about the CDC’s recommendation is on-line at www.cdc.gov/mmwr/preview/mmwrhtml/mm5020a8.htm.
FDA moves antihistamines toward OTC use
Two advisory committees for the Food and Drug Administration (FDA) in Rockville, MD, voted that three prescription antihistamine drugs used to treat allergies are safe for over-the-counter (OTC) use, reports the American Pharmaceutical Association. The Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee voted 19-4 that loratadine (Claritin) and cetirizine (Zyrtec) can be used safely without the assistance of a learned intermediary such as a physician. The committees came to a similar conclusion for fexofenadine (Allegra) with a vote of 18-5.
The FDA organized the joint committee hearing after WellPoint Health Networks (formerly Blue Cross of California) filed a Citizens Petition in July 1998 requesting the conversion of Allegra/ Allegra-D, Claritin/Claritin-D, and Zyrtec to OTC status. The pharmaceutical manufacturers strongly oppose the switch of second-generation antihistamines from prescription-to- OTC status. This is the first time that the FDA has considered a prescription to OTC switch without the manufacturer’s support and at the request of an insurance company.
The FDA has traditionally followed advisory committees’ recommendations.
Faulty prescription drug use costs billions annually
A recent updated analysis estimates that prescription drug use problems in the United States costs the economy more than $177 billion each year. The analysis also estimates that the number of patient deaths has increased from 198,000 in 1995 to 218,000 in 2000.
The study, "Drug-related morbidity and mortality: Updating the cost-of-illness model," was released in the American Pharmaceutical Association’s March/April Journal of the American Pharmaceutical Association (JAPhA). Among the most significant drug-related problems identified in the JAPhA study are untreated indication, improper drug selection, subtherapeutic dosage, failure to receive drugs, overdosage, adverse drug reactions, drug interactions, and drug use without indication.
The new research updates a 1995 study, published in the Archives of Internal Medicine. That study estimated the annual cost of drug-related morbidity and mortality resulting from drug-related problems in the ambulatory setting at $76.6 billion.
Of the $177.4 billion in the new study, hospital admissions accounted for $121.5 billion (69%) per year, and long-term care admissions represented $32.8 billion (18%). Physician visits comprised $13.8 billion (8%), and emergency department visits and additional treatment cost more than $5.8 billion (3%) and $3.5 billion (2%), respectively.
The majority of cost increases appeared to result from the estimates of hospital and long-term care admission costs, which according to estimates in the literature, were more than twice the 1995 estimates.