Campaign For Safe Medication Dispensing

Main Category: Caregivers / Homecare
Article Date: 24 Oct 2004 - 0:00 PDT

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Efforts Based on Reported Errors Between REMINYL® and AMARYL®

Janssen Pharmaceutica Products announced today that it has learned of several reports of errors in prescribing and dispensing of the medication REMINYL® (galantamine hydrobromide) for mild to moderate Alzheimer's disease. These errors were due to confusion between REMINYL® and the diabetes drug AMARYL® (glimepiride), which is marketed by Aventis Pharmaceuticals. The administration of AMARYL® to patients with Alzheimer's disease and without diabetes mellitus has resulted in serious adverse events, including severe hypoglycemia and death.

In order to raise awareness and to educate prescribers and pharmacists about these medication errors, Janssen Pharmaceutica Products, L.P., is launching a campaign to help prevent medication prescribing and dispensing errors. The program includes outreach to pharmacists, physicians and consumers through a variety of targeted communications.

According to reports submitted to the U.S. Food and Drug Administration (U.S. FDA) and the U.S. Pharmacopoeia, since REMINYL® was introduced in the United States in 2001, 10 prescriptions for REMINYL® have been incorrectly written, interpreted, labeled or filled, due to confusion between REMINYL® and AMARYL®. In two cases, death occurred subsequent to the medication error.

The products both have a 4 mg strength dose, and both are available in tablet form. The generic name for REMINYL® is galantamine, and the generic name for AMARYL® is glimepiride.

"Patient safety is our first priority, and we are working with the U.S. FDA to launch a comprehensive professional and public information effort to raise awareness about this issue and to help prevent future occurrences," said Scott Reines, M.D., Ph.D., therapeutic area head, Central Nervous System, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "We have issued letters to 120,000 physicians who prescribe medicines for patients with Alzheimer's disease and to 96,000 pharmacists in the United States, and we are reaching out to patients and caregivers with alerts and tips regarding safe medicine practices."

In addition to sending letters to physicians and pharmacists, Janssen Pharmaceutica Products, L.P., is:

-- Issuing a photo fact sheet that depicts specific characteristics of REMINYL® tablets for use by its sales force.

-- Placing advertising in medical and pharmacy journals about the differences between AMARYL® and REMINYL®.

-- Collaborating with professional medical societies to ensure widespread dissemination of the messages among their memberships.

-- Working with software companies to explore the opportunity to include pop-up alerts when either product name is entered into pharmacy computer systems.

-- Providing tags for pharmacy shelves to help alert pharmacists to take special note when they fill REMINYL® prescriptions to assure accurate dispensing.

-- Contacting Alzheimer's disease-related consumer advocacy organizations to request that they disseminate information on this issue to their constituents.

-- Issuing new patient instructions and a brochure for caregivers of patients with Alzheimer's disease to advise them to take notice of the medications being dispensed. Called "An All Around Guide: When Your Doctor Prescribes REMINYL®," the brochure contains the following advice for patients and caregivers:

- Ask your physician to repeat the name of any medicine he or she prescribes.

- Ask your physician or nurse to clearly write down the name of the medication so that you have it when you go to the pharmacy.

- Request a product brochure for the medication from your physician.

- Ask your pharmacist to double-check that you have received the right medication. - Read the package inserts that accompany your prescriptions.

- Seek immediate attention for the signs and symptoms of low blood sugar.

Patients, caregivers and health care professionals with questions, concerns or reports of medication errors related to REMINYL® and AMARYL® should contact Janssen Pharmaceutica Products, L.P., directly at 1-800-JANSSEN (1-800-526-7736). Additional information is available on the Web sites http://www.SharingCare.com and http://www.reminyl.com.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., developed REMINYL® under a codevelopment and licensing agreement with UK-based Shire Pharmaceuticals Group plc.

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