FDA approves new labels for hormone therapy

The Food and Drug Administration (FDA) is advising women and health care professionals about new safety changes to labeling of all estrogen and estrogen with progestin products for use by postmenopausal women.

The FDA says these changes reflect its analysis of data from the Women’s Health Initiative study (WHI), a landmark study sponsored by the National Institutes of Health that raised concern about risks of using these products. The Prempro (a combination of estrogens plus a progestin) arm of the WHI was halted early in July 2002 because the overall health risks, particularly the risks of invasive breast cancer and cardiovascular disease, exceeded the benefits of the drug.

The revisions for the labels of hormones Premarin (containing estrogens), Prempro, and Premphase (containing estrogens with a progestin) build on revisions to the labeling that Wyeth Pharmaceuticals, the products’ manufacturer, made in August 2002, shortly after the release of the findings from WHI.

The new boxed warning, the highest level of warning information in labeling, highlights the increased risks for heart disease, heart attacks, strokes, and breast cancer. This warning also emphasizes that these products are not approved for heart disease prevention. FDA also has modified the approved indications for Premarin, Prempro, and Premphase to clarify that these drugs should be used only when the benefits clearly outweigh risks. To minimize the potential risks and to accomplish the desired treatment goals, the new labeling also advises health care providers to prescribe estrogen and combined estrogen with progestin drug products at the lowest dose and for the shortest duration for the individual woman.

USP gives tips to prevent drug errors in children

Medication errors can be especially devastating for children. That’s why the United States Pharmacopeia (USP) in Rockville, MD, has announced recommendations for preventing medication errors in children.

USP’s Center for the Advancement of Patient Safety created the recommendations after analyzing medication error data from its databases. Before administering the medication, health care providers must consider a child’s age, weight, medication dosing frequencies, and a number of other factors to help ensure the safety of young patients.

The recommendations include the following:

  • Dosage forms and/or preparations that are compounded, prepared in serial dilutions, and/or extensively manipulated should be prepared in the pharmacy and verified by a pharmacist. Where possible, a second health care professional familiar with dilutions and compounding should verify the product preparation and labeling.
  • Policies and procedures should be developed and implemented when automated dispensing machines are being used for pediatric medications, including double independent verification of medications loaded into the machines and the inability to override system safeguards.
  • When possible, medications should be prepared and dispensed as "unit-dose" containers for all pediatric medications in all health care facilities.
  • The patient’s weight, age, and other appropriate dose indicator(s) should be available and clearly identified on all prescriptions and orders before the dose is dispensed and administered.
  • Wherever possible, a validated computer algorithm should calculate pediatric dosages as part of an integrated medication order entry system. Calculations, whether computerized or manual, should be independently double-checked by a pharmacist and signed off by at least one other licensed health care professional to confirm accuracy.
  • Abbreviations, acronyms, and symbols used throughout an organization should be standardized and readily available. A list of abbreviations, acronyms, and symbols that should not be used also should be available.
  • To prevent 10-fold overdoses, a terminal or trailing zero should never be used after a decimal. A leading zero should always precede a decimal expression of less than one.

For a complete list of the recommendations, see www.usp.org.

American Pharmaceutical Association changes name

Members of the American Pharmaceutical Association (APhA) in Washington, DC, have voted overwhelmingly to change the association’s name to the American Pharmacists Association.

A name-change amendment to APhA’s bylaws required 75% of the votes cast by Dec. 2, 2002. The amendment passed with nearly 90% approval from APhA members. The name change will formally take effect March 29, 2003, at the APhA Annual Meeting in New Orleans. At the opening session on that date, outgoing president Janet P. Engle, PharmD, will conclude her address by proclaiming the name change and unveiling a new association logo. The association will retain its current abbreviation, APhA.

Consumers still taking risks with OTC painkillers

The ongoing abuse and misuse of over-the-counter (OTC) pain relievers such as ibuprofen and naproxen is a very real problem in the United States, according to the National Consumers League (NCL) in New York.

A Harris Interactive survey of 4,263 adults reveals that many Americans take OTC medications for pain relief, but often they do so without regard for their safety. Of the 84% of survey respondents who have taken an OTC pain reliever within the last year, 44% admitted to exceeding the recommended dose. Many also ignore critical label information. NCL says it released the survey to help educate consumers who take non-steroidal anti-inflammatory drugs about the possible dangers of improper use.

According to the survey, 50% of respondents who reported taking an OTC pain reliever within the last year were not concerned about potential side effects. Almost half (45%) agreed that it is more important to control pain regardless of risk. And only 16% (unprompted) reported reading the entire product label.

The survey also shows that consumers overlook the risks of mixing OTC pain medications with other drugs, especially cold remedies with multiple active ingredients, prescription drugs, and alcohol:

• Forty-five percent of the people who reported taking an OTC pain reliever agreed that it is safe to take an OTC pain reliever while also taking another OTC cold or flu medication.

• One-third (34%) agreed it is safe to take an OTC pain reliever while taking a prescription medication.

• Almost 20% agreed it is safe to take an OTC pain reliever while drinking some alcohol.

• An overwhelming majority (80%) have not discussed some of the key risks associated with misusing these products — stomach bleeding or ulcers — with a physician or pharmacist.

Survey results and a free brochure, "OTC Pain Meds: What Helps, What Hurts," are available at www.nclnet.org. The brochure also is available by calling toll-free (866) 216-2316.