Magazine article Drug Topics

Gene Therapy Is Coming: Is Your Pharmacy Ready?

Magazine article Drug Topics

Gene Therapy Is Coming: Is Your Pharmacy Ready?

Article excerpt

With medical science hurtling toward gene therapy, it may not be long before these vts land in your pharmacy's lap. Do you have a formal system set up to prepare your department for this new technology?

Speaking at the recent ASHP annual meeting in Philadelphia, Karen Hale, M.P H., R.Ph., senior research specialist at Ohio State University Medical Center in Columbus, warned that one concern you must deal with is employees' "latent worry" about preparing these virusbased products. Gene therapy could involve hepatitis B or retroviruses as gene transfer vectors, and these organisms tend to inspire fear. Having guidelines set up for gene therapy and training employees on how to protect themselves against possible hazards will go a long way in allaying their fears, she stressed.

The first step to participating in gene therapy is risk assessment. This involves assessing employees' potential for acquiring an infection on the job resulting from exposure to these agents. Hale said her hospital uses the National Institutes of Health's guidelines on research involving recombinant DNA molecules for its risk-assessment program. These guidelines can be found on NIH's Web site (www.nih.org).

There are four basic risk groups, Hale told the audience. They range from being the least serious in terms of exposure to being the most serious and likely to cause disease. Most hospitals engage in activities that fall in the middle, she said. Risk groups two and three require the use of biological safety cabinets; protective equipment to minimize release of the agents to the environment, while protecting the integrity of the products; and biosafety signs to warn visitors of the presence of the agents.

Many pharmacists may not fully understand how many regulations apply to gene therapy. Besides adhering to standards from the Occupational Safety and Health Administration, you may have to follow rules from the Environmental Protection Agency, Department of Transportation, postal service, and others, she said. For instance, if your hospital serves another facility, and you have to move the agent by ground or air to that site, there are at least five agencies that govern transport outside an institution, she cautioned. She added that many agents are temperature sensitive and have to be transported on ice, creating an additional challenge.

Also, pharmacists may not be used to dealing with the different containers and delivery systems gene therapy entails. Rather than using a vial with sterile closure, rubber stopper, and needles, you may be handling open containers with screw-top lids, liquid vessels that are easy to knock over, and even micropipettes. …

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