Fungal Meningitis Outbreak Calls Attention to the Role of Health Professionals in Medication Safety
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A multistate outbreak of fungal meningitis associated with epidural spinal injection of a contaminated corticosteroid solution has focused public attention on the practice of compounding pharmacy in the United States. Over 14,000 patients were exposed and over 300 contracted the disease with a fatality rate of nearly 10%. Many of the patients in this outbreak did not present with clinical manifestations of meningitis but instead presented with stroke syndromes. All had in common the risk factor of exposure to suspensions of methylprednisolone acetate prepared by the New England Compounding Center (NECC) since May 2012 which were contaminated with a strain of Aspergillus fumigatis, an organism normally found in soil and not usually a pathogen in immunocompetent adults. Possibly the immunosuppressive effect of the corticosteroid augmented the pathogenicity in this outbreak. There were several cases in which the suspension was used in intra-articular injection and septic arthritis from the fungus resulted.
The mortar and pestle, symbolic of the profession of pharmacy since ancient times, is a reminder that compounding (the preparation of doses of medication for individuals) remains an important function of the profession of pharmacy. The International Academy of Compounding Pharmacists (IACP) has developed an assesment questionnaire to assist prescribers and patients in selecting compounding pharmacies. In primary care, we commonly prescribe medication which is manufactured in standard dose forms and the prescription is transmitted to a registered pharmacist. The pharmacist dispenses it to patients with instructions on self administration, but most pharmacists practicing in the community setting are also trained in compounding and may be an important resource on the best method to provide individually customized medication to patients. Pharmaceutical manufacturing safety is regulated by the Federal Food and Drug Administration (FDA) and there is now Congressional discussion about extending the regulatory authority of FDA over pharmaceutical compounding. Currently compounding is regulated by individual state boards of pharmacy.
The NECC episode emphasizes the obligation of the professions of medicine, nursing, and pharmacy to perform our roles in medication safety and the necessity of intraprofessional communication and cooperation. Most of us in primary care do some in-office administration of medication regardless of the source from which it was obtained. Laws vary in each state about which health professions can administer which medications by which route but the basic principles of patient safety are common to all of them. Here’s how we use the “6 RIGHTS” of medication administration checklist in our practice:
- Be sure it is the RIGHT PATIENT by asking them to recite the full name and birthdate and check some identification if there is any question;
- Be sure it is the RIGHT MEDICATION and not expired by reading the name and expiration date silently from the container, recheck the order from the prescribing clinician, reread the name and expiration date and dose aloud to the patient and ask them if they are familiar with it and if they have a history of any adverse reaction to it;
- Be sure you are giving the RIGHT DOSE and don’t hesitate to question the prescriber or a reference source if you are not very familiar with the appropriate dosing;
- Be sure it is the RIGHT TIME considering interaction with food, drink, and other possibly interacting medication or recent doses of the same medication, likely effects (e.g. impaired ability to drive home, necessity of observation or follow-up labs, etc.);
- Be sure it is the RIGHT ROUTE of administration and is there any option (e.g. crushing and mixing a tablet or contents of a capsule with food or drink and what effect might that have on efficacy and safety);
- Be sure to record the RIGHT DOCUMENTATION with full information about the event.
The Federal Center for Disease Control (CDC) website has information for providers and patients on injectable medication safety. Recommendations to providers include:
- Never administer medications from the same syringe to more than one patient, even if the needle is changed.
- Do not enter a vial with a used syringe even if the needle is changed. Assign medications packaged as multi-use vials to a single patient whenever possible.
- Use bags or bottles of intravenous solution as a source of supply for only one patient.
- Maintain absolute adherence to proper infection control practices during the preparation and administration of injected medications.
- Wear a face mask in any spinal injection procedure.
- This webpage includes links to free provider lessons eligible for continuing education credit in medicine and nursing at this webpage.
Most of our patients have intact immune function and the settings in which we administer injections are generally clean, but I find the following checklist helpful for myself and my patient care team:
- Note the source of the injectables including the date of delivery to our practice and any other information necessary to trace a chain of evidence needed if there is a warning, recall, or adverse event.
- Maintain the injectable supplies according to the current recommendations of the manufacturer and of public health authorities.
- Use appropriate antiseptic technique in the preparation and administration of the injectable.
- Discuss with patients the risks and benefits of both the product and procedure and obtain informed consent before injection.
- Give adequate patient education about the expected result of the injection and what to do if adverse results occur.
- For some injectables (particularly vaccines covered by the National Vaccine Injury Compensation Program), there are standardized protocols and required forms for administration.
Charles Sneiderman MD PhD, DABFP
Family Physician and Medical Director
Culmore Clinic, Falls Church, VA
Published on November 13, 2012
Charles Sneiderman, MD PhD, retired in 2010 after a 31-year career in medical informatics at the Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health. His work included research and development in telemedicine, distance learning, and medical language and image processing. Since leaving federal service, he has developed a computerized clinical decision support system to assist primary healthcare practices in the recognition and management of post-traumatic stress syndromes with support from the NLM Disaster Information Management Research Center.
Dr. Sneiderman received a B.S. with high honors from the University of Maryland in 1969, and M.D. and Ph.D. degrees from Duke University in 1975. He completed residency training in family medicine at the Medical University of South Carolina in 1979. He has authored numerous scientific reports, book chapters, and medical educational media. He was a Clinical Assistant Professor of Family Practice at the Uniformed Services University of the Health Sciences. He maintains certification by the American Board of Family Medicine and has practiced family medicine part-time in the Washington, DC area since 1980. He has assisted wounded warriors with adaptive snowsports since 2005.
- Centers for Disease Control and Prevention (CDC). Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy – United States, 2012. MMWR Morb Mortal Wkly Rep. 2012;61:839-842. PubMed PMID: 23076093.
- International Academy of Compounding Pharmacists Compounding Pharmacy Assessment Questionnaire (CPAQ™). 2012.
- Schneider H. Report faults states’ oversight of specialty pharmacies. Washington Post. October 28, 2012.
- CDC webpage. Injection safety. July 12, 2012.
- CDC webpage. Vaccines. November 6, 2012.