HHS proposes smallpox vaccination compensation

The Department of Health and Human Services (HHS) has proposed a plan to create a smallpox vaccination compensation program to provide benefits to public health and medical response team members who are injured as a result of receiving the smallpox vaccine. This plan is in response to public health and medical response teams being vaccinated voluntarily against smallpox as part of an overall effort to better prepare the nation against terrorism.

The proposed compensation program includes elements similar to the benefits package currently available to police officers and firefighters. Under the Public Safety Officers Benefit program administered by the U.S. Department of Justice, the federal government currently pays a $262,100 death benefit and a $262,100 permanent and total disability benefit to police officers and firefighters. State and local governments provide short-term disability benefits and health care benefits.

The benefits package would be administered by HHS and would be retroactive to cover those who already have been vaccinated under the program. Besides the permanent and total disability benefit and the death benefit, the plan offers these two elements:

  • Temporary or partial disability benefit. HHS would compensate individuals for two-thirds of lost wages after the fifth day away from work, up to a maximum of $50,000. This benefit would be secondary to any workers’ compensation or disability insurance benefits that might be available to the individual.
  • Health care benefit. HHS would compensate individuals for their reasonable out-of-pocket medical expenses for other than minor injuries. This benefit would be secondary to any health insurance benefit that might be available to the individual.

In addition, HHS would provide compensation to third parties who contract vaccinia from public health and medical response team workers who have been vaccinated.

In other smallpox news, the Centers for Disease Control and Prevention (CDC) in Atlanta reports that all states have submitted smallpox response plans, and smallpox vaccine was administered to 12,690 civilian health care and public health workers in 45 jurisdictions between Jan. 24 and Feb. 28. In February, the Department of Defense reported that two soldiers had experienced severe adverse reactions to the vaccine; both are now doing well. The CDC also emphasized the importance of proper vaccine site care after two women experienced probable cases of ocular vaccinia after they were exposed to the vaccination sites of military personnel.

Counterfeit epoetin alfa presents hazard to patients

The U.S. Food and Drug Administration’s (FDA’s) Office of Criminal Investigation has uncovered the existence of contaminated counterfeit epoetin alfa (Procrit). Epoetin alfa is used to stimulate the production of red blood cells in humans to treat severe anemia.

As a result of investigative review and laboratory testing performed by the FDA, and in cooperation with Ortho Biotech Products, LP, Bridgewater, NJ, health care providers and consumers are being alerted to the existence of three lots of counterfeit product labeled as Procrit:

  • P007645 — 40,000 units/mL, Expiration 10-2004
  • P004677 — 40,000 units/mL, Expiration 02-2004
  • P004839 — 40,000 units/mL, Expiration 02-2004

Ortho is issuing the warning to health care providers and others in a letter (also posted on its web site: www.orthobiotech.com/counterfeit/letter.html) because counterfeit epoetin alfa has been found to be contaminated with bacteria and therefore represents a significant potential hazard to consumers. In addition, FDA testing has demonstrated that some counterfeit product contains no active ingredient.

The FDA urges both health care providers and patients to check the packaging and vials very carefully before using this product. Anyone finding counterfeit product should not use it, should quarantine it, and should immediately contact FDA’s Center for Biologics Evaluation and Research at (800) 835-4709, prompt #1, then prompt #5; and Ortho Biotech at (800) 325-7504, prompt #2.

More details concerning the counterfeit product are available on Ortho’s web site at www.procrit.com/counterfeit/letter.html.

The FDA’s investigation into this matter is continuing.

Adverse events associated with sirolimus (Rapamune)

Wyeth has received post-marketing reports of bronchial anastomotic dehiscence, including fatal cases, in patients treated with sirolimus in combination with tacrolimus and corticosteroids.

Two centers have reported this serious adverse event in lung transplant recipients in whom this immunosuppressive regimen was initiated at the time of transplantation. At one center, four of 15 patients enrolled in an investigator-sponsored study developed bronchial anastomotic dehiscence; a fatal outcome was identified in three of these four patients. Further information regarding these patients will be published in Transplantation in 2003. The second center reported two cases of bronchial anastomotic dehiscence, one of which was fatal.

In its "Dear Health Care Provider" letter, Wyeth states that "the safety and efficacy of Rapamune as immunosuppressive therapy has not been established in lung transplant patients, and, therefore, such use is not recommended." The prescribing information for sirolimus has been updated to include new information in the boxed warnings section.

To read the MedWatch 2003 safety summary, including a link to the "Dear Healthcare Professional" letter, go to: www.fda.gov/medwatch/SAFETY/2003/safety03.htm#rapamu.

FDA proposes standards for dietary supplements

The U.S. Food and Drug Administration (FDA) has proposed a new regulation to require current good manufacturing practices (CGMPs) in dietary supplements’ manufacturing, packing, and holding. The proposed rule would establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled to reflect the active ingredients and other ingredients in the product.

This proposed rule includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints related to CGMPs.

This proposal is intended to cover all types of dietary supplements. However, to limit any disruption for dietary supplements produced by small businesses, the FDA is proposing a three-year phase-in of a final rule for small businesses. The proposal includes flexible standards that can evolve with improvements in the state of science, such as validating tests for identity, purity, quality, strength, and composition of dietary ingredients.

APhA releases patient, pharmacist publications

The American Pharmacists Association (APhA) in Washington, DC, recently released several publications that are of benefit to patients and pharmacists. They include:

  • 2003 series of Patient Education Brochures. These newly designed brochures provide consumer-friendly information on important health topics and help patients understand their medications. For more information, call APhA at (202) 429-7537.
  • Allen’s Compounded Formulations: The Complete U.S. Pharmacist Collection. This publication is a collection of the monthly column, "Contemporary Compounding," from the national pharmacy journal U.S. Pharmacist. The 168 preparations presented in the collection span the 15-year existence (1988-2002) of the column. Written by Lloyd V. Allen, Jr., PhD, RPh, the collection includes basic formulas that provide for some uniformity of preparation as well as a starting point for further modification for specific patients. For more information, call (800) 878-0729.
  • Pharmacist Disease Management Credentialing: Diabetes, 2nd ed. This review book is designed to help pharmacists who are preparing for the National Institute for Standards in Pharmacist Credentialing Disease State Management Examination. Consisting of three self-study modules, the book will help pharmacists integrate diabetes education and management into their practice and become comfortable with their role in the care of patients with diabetes. For more information, call (800) 878-0729.