News Briefs

APhA awarded contract to establish Support Center

The American Pharmaceutical Association in Washington, DC, has been awarded a contract by the U.S. Department of Health and Human Services to establish the Pharmacy Services Support Center (PSSC) under the direction of the Office of Pharmacy Affairs within the Health Resources and Services Administration (HRSA).

The purpose of the PSSC is to streamline national support and expertise in the delivery of pharmacy advice and technical assistance for community health centers, HIV/AIDS drug assistance programs, hemophilia treatment centers, and other eligible HRSA grantees.

Some components of the project include: assisting the agency in determining its role in the pharmacy benefit under Medicare, assessing state pharmaceutical assistance programs, providing networking opportunities with key pharmacy groups, and developing educational materials to measure improved quality outcomes and reduce medication errors. Diane Goyette, RPh, JD, has been named the senior director of the center.


Wyeth stops producing two vaccines

Wyeth announced in November that it was ceasing production of two of its vaccine products: FluShield, an injectable influenza virus vaccine, and Pnu-Imune, an injectable polysaccharide pneumococcal vaccine for adults.

Wyeth says adequate supplies of injectable flu vaccine are now available in the United States as a result of recent capacity increases provided by other manufacturers. Aventis Pasteur’s Swiftwater, PA, facility, which currently produces about half the influenza vaccine used in the United States, has voiced its commitment to meeting U.S. demand. PowderJect Pharmaceuticals in England also supplies the flu vaccine.

The company says it has chosen to pursue new flu immunization technologies, such as its intranasal influenza vaccine. Ending production of the vaccines will allow it to reallocate resources to resolving the nine-month shortage of Prevnar, its pneumonia vaccine for young children, and winning regulatory approval for the nasal flu vaccine, a Wyeth spokesman told the Associated Press.


Pharmacist participation in rounds cuts errors

A recent study found that including a clinical pharmacist on daily patient rounds cut medication errors by about 50%. The article, published in the Nov. 1, 2002, issue of the American Journal of Health-System Pharmacy, also found that pharmacists’ interventions decreased the duration of errors.

In the study, a clinical pharmacist participated in daily rounds on one of the 19 medical services in an academic medical center for one month. The pharmacist investigated allergy information, monitored trends in laboratory test values, and reviewed medication orders for appropriate medication selection and dose. The pharmacist also reviewed drug indications; patient age, weight, and organ function; and the medication administration record.

At the same time, a team of three reviewers examined all patients’ medical charts for errors, including variances in medication selection, dosing, and monitoring from recommendations published in the institution’s clinical staff manual. Reviewers classified the errors as prescribing, administration, pharmacy, or discharge errors. Overall, 46 errors occurred in the intervention group, while 94 errors occurred in the control group.

The number of patients without a medication error during their hospital stays also increased to 40%. In addition, the interventions affected how long an error continued after it occurred. An error persisted less than one day and with less than one dose of medication in the study group, compared with 2.4 days and two doses of medication for patients in the control group.

To read more about the study, go to www.ashp.com.


Warnings strengthened on three medications

The Food and Drug Administration and Novartis have strengthened the labeling for Cafergot, a combination of ergotamine and caffeine. Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of Cafergot with potent CYP3A4 inhibitors, including protease inhibitors and macrolide antibiotics.

The revised label includes a new boxed warning and updates to the contraindications, warnings, precautions, and clinical pharmacology sections of the prescribing information. To read the full MedWatch 2002 safety summary, go to www.fda.gov/medwatch/SAFETY/2002/safety02.htm#caferg.

In addition, the FDA and Pharmacia/Pfizer have strengthened the contraindications, warnings, and adverse reactions sections of the prescribing information for valdecoxib (Bextra). In post-marketing experience, rare reports of hypersensitivity reactions (such as anaphylactic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme, have been received. These cases, some of which were serious/life-threatening, have occurred in patients with and without a history of allergic-type reactions to sulfonamides. To read the MedWatch 2002 Bextra safety alert, go to: www.fda.gov/medwatch/SAFETY/2002/safety02.htm#bextra.

Finally, the FDA and MedImmune have revised the warnings, overdosage, and post-marketing experience sections of the palivizumab (Synagis) label to provide clarification on the risk of anaphylaxis based on worldwide post-marketing experience. The labeling was revised to reflect that adverse events after a sixth or subsequent dose of palivizumab are similar in character and frequency to those reported after the initial five doses. To read the full safety summary, see: www.fda.gov.


Certain medication errors more likely to be harmful

Certain types of medication errors are more likely to cause harm or death to patients, according to a data report released in December by the United States Pharmacopeia’s (USP) Center for the Advancement of Patient Safety (CAPS) in Rockville, MD.

"Summary of Information Submitted to MedmarxSM in the Year 2001: A Human Factors Approach to Medication Errors" is the third annual analysis of medication error reports by Medmarx, the national reporting database operated by USP. Medmarx is an Internet-accessible, anonymous medication error reporting program and quality improvement tool used to track medication errors.

Though the Medmarx data report relatively few errors (2,539/105,603 or 2.4%) resulted in harm in 2001, the report found that more cases of patient harm ensued when hospital staff applied incorrect administration techniques with medication and administered incorrect dosages of drugs. In addition, medication errors frequently involved high-alert medications. The report indicates that the top five products involved in harmful errors are the high-alert medications insulin, morphine, heparin, warfarin, and potassium chloride.

"Our data indicate that the wrong administration technique, such as the improper dilution of IV products, was almost four times more likely to cause harm in hospital patients," says Diane Cousins, RPh, vice president of CAPS at USP.

Of the 2,539 harmful errors, 353 required initial or prolonged hospitalization, 70 required intervention to sustain life, and 14 resulted in death. Patients involved in these harmful errors received intensive patient care, which triggered longer hospital stays, extensive testing, additional patient monitoring, and increased drug therapy.

For more information, visit the USP web site at www.usp.org.