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GW Expert Discusses Meningitis Outbreak
SPHHS Visiting Professor Ruth Lopert talks about the deadly cases of meningitis and what can be done to safeguard against a future outbreak.
October 17, 2012
Ruth Lopert, visiting professor of health policy at the George Washington University School of Public Health and Health Services and an expert in pharmaceutical regulation and policy, answers questions on the current outbreak of meningitis that has been linked to a contaminated steroid drug.
Q: Why did this fatal outbreak of meningitis happen, and what needs to be done on the regulatory front to ensure that it doesn’t happen again?
A: The situation is extremely alarming because of the nature, severity and scale of the problem. To date the Centers for Disease Control and Prevention has identified 233 cases of meningitis and 15 deaths in 15 states. These cases highlight the need for a serious review in the way that compounding is regulated.
Q: What is compounding and what seems to have gone wrong in this case?
A: The purpose of pharmaceutical compounding is to enable the creation of products that meet the specific needs of individual or small numbers of patients. For example, compounding pharmacists can tailor drugs for individual patients to avoid preservatives that can trigger allergy in sensitive patients. But recently compounding companies, like the New England Compounding Center, have been mixing up large amounts of drugs and shipping them across state lines. In this case, the New England Compounding Center allegedly shipped drug vials that were contaminated with a fungus to 23 states and 76 medical facilities. They, like other compounding companies, didn’t have to meet the Food and Drug Administration’s quality standards for manufacturing because they are not technically considered manufacturers. However, this outbreak highlights flaws in that system: That kind of large-scale production of a drug should fall within the regulatory oversight of the FDA.
Q: In your opinion, are there other "outbreaks waiting to happen" due to lack of federal or regulatory oversight?
A: It's difficult to know. However, if large-scale compounding of sterile injectable preparations in environments not subject to manufacturing quality controls by the FDA is permitted to continue we might face similar problems in the future.
Q: Is there anything that providers and consumers can or should be able to do in the current environment to make sure they are getting safe and effective drugs?
A: Providers should know where drugs are coming from and if they’re using drugs from a compounding pharmacy they should tell patients they are planning to administer an unapproved product. They should also explain any potential risks to the patient and obtain explicit written consent any time they prescribe such a drug. Consumers should ask for an approved drug if they are uncomfortable with the risks associated with a compounded drug.