News Briefs

Fentanyl (Duragesic) recall is expanded

Janssen Pharmaceutica Products has expanded its recall of fentanyl transdermal system (Duragesic) CII 75 mcg/hr, NDC #50458-035-05 from one lot to five. The control numbers are 0327192 (exp. 10/05), 0327193 (exp. 10/05), 0327294 (exp. 11/05), 0327295 (exp. 11/05), and 0330362 (exp. 12/05).

The company recalled one lot of Duragesic 75 mcg/hr patches (control number 0327192) in February 2004 after determining that a small percentage of patches in this lot might leak medication along one edge. Since then, a small number of patches with the same problem have been identified in one additional lot. As a precaution, the company is recalling four additional lots of 75 mcg/hr patches that were produced on the same manufacturing line during the same period.

Exposure to the leaked medication could result in inadvertent ingestion or increased transdermal absorption of the opiate component fentanyl, leading to potentially life-threatening complications. Conversely, leakage of medication could lead to inadequate dosing, resulting in treatment failure, and/or opiate withdrawal.

Anyone who comes in contact with the leaked medication is advised to rinse exposed skin thoroughly with water only; soap should not be used.

For more information about the recall, see www.fda.gov/cder/drug/shortages/duragesic-Letter.pdf.


Most hospital pharmacists monitor medication therapy

Almost all pharmacists in United States hospitals regularly monitor patients’ medication therapy in some capacity, according to results of the 2003 ASHP (America Society of Health-System Pharmacists) National Survey of Pharmacy Practice in Hospital Settings. The survey, which was published in the March 1 issue of the American Journal of Health-System Pharmacy, focuses on the role pharmacists play in managing and improving the medication-use process.

The survey found that in the last three years, most hospitals have increased the amount of time pharmacists devote to monitoring patients’ medication therapy. To facilitate pharmacists’ involvement in medication monitoring, hospitals have undertaken a variety of activities, including:

  • Hiring more clinical pharmacy staff.
  • Granting pharmacists better access to computerized patient data.
  • Implementing computerized prescriber order entry systems.
  • Redeploying pharmacists to patient-care units.
  • Expanding the responsibilities of pharmacy technicians.
  • Implementing automated dispensing systems.
  • Educating administrators on the impact of clinical pharmacy services on patient care.

Large hospitals were most likely to have increased pharmacist hiring and implemented technological advances to promote pharmacist patient-care involvement, but small hospitals were equally likely to have expanded technician responsibilities and pharmacist access to patient data to accomplish these same goals.

High-risk patients are most often the beneficiaries of pharmacists’ medication-monitoring services. Patients in the intensive care unit were most likely to be monitored (81.6%), followed by patients being treated in the medical-surgical service (62.5%), nutrition service (46.8%), and pediatric service (38%).

In general, more than three-fourths of hospitals had pharmacists routinely monitor blood levels or other patient responses to medication. For example, nearly all hospitals had pharmacists monitor aminoglycosides and vancomycin (94.2% and 92.8%, respectively). Additionally:

  • Just over 76% of hospitals had pharmacists monitor patient response to warfarin.
  • 66.9% monitor response to heparin.
  • 52.6% monitor phenytoin levels.
  • 47.1% monitor theophylline levels.


Study: Early treatment with thrombolytic t-PA for stroke

A study in the March 6 issue of The Lancet confirms the benefits of getting stroke patients to the hospital quickly for rapid thrombolytic treatment, according to the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health (NIH).

Stroke patients who were treated within 90 minutes of the onset of their symptoms showed the most improvement. The study suggests that t-PA given up to four hours after the onset of symptoms may be of benefit. As time passes, the effect of treatment seems to diminish. The researchers estimate there almost is no benefit when treatment is administered at six hours.

Another significant finding reported by the authors is that severe stroke patients tend to present to the hospital earlier than patients with milder strokes, and those who were treated had much better recoveries than patients who were given a placebo. This means that the greatest effect of early treatment was seen in the group with the most to gain in terms of reducing long-term disability.

The pooled data from the trials — two were sponsored by pharmaceutical companies and one was funded by NIH — represent the work of 16 teams of researchers and several statisticians around the world. Although the data in The Lancet paper suggest that the beneficial effect of t-PA may extend beyond three hours (from 181 to 270 minutes), the authors caution that large prospective randomized trials would be required to confirm this finding and that this does not justify any delays in treatment.


Sponsors announced for Medicare drug discount card

Health and Human Services (HHS) Secretary Tommy G. Thompson has announced the approval of 28 private sponsors to provide seniors and people with disabilities savings on their prescription drugs, beginning June 1. With the new cards, Medicare beneficiaries will receive discounts on prescription drugs, and low-income beneficiaries may receive an additional $600 to pay for their prescription medicines in both 2004 and 2005.

All Medicare beneficiaries, except those who already receive outpatient drugs through Medicaid, will be able to enroll in a discount card program starting in May. HHS says that the sponsors are planning to offer 48 general drug discount cards, 27 available nationally to all eligible Medicare beneficiaries. Thirty-six of the general cards will charge a fee of less than $30 to enroll in a card, including five that will not charge a fee. There is no enrollment fee for people who qualify for the $600 credit.

Medicare-approved cards will be marketed to seniors by organizations offering the cards. Seniors will sign up for the cards directly with the organization offering the card they choose. HHS will provide seniors help in selecting a card.

Under the prescription drug card program, approved cards must offer discounts on prescription drugs for all of their Medicare enrollees. At least some of these savings must come from manufacturer rebates. Card sponsors also must publish prices for the prescription drugs their cards will cover, provide access to an extensive retail pharmacy network, operate call centers, and have a process to respond to beneficiary concerns.

A list of Medicare-approved card sponsors is available at www.hhs.gov/news/press.