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10/29/2012

The Meningitis Tragedy – More Regulation is Not the Answer

By Dr. Daniel A. Hussar is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

Twenty-four deaths and 317 people ill with meningitis at the time I prepare this commentary.  And the story is far from complete. Meningitis, Deaths, Compounding Pharmacies, New England Compounding Center (NECC) have dominated the media headlines in recent weeks.  Most of the deaths and illness from meningitis are considered to be attributable to a heretofore obscure fungal organism (Exserohilum rostratum) that was a contaminant in presumably sterile formulations of methylprednisolone that were administered by epidural injection for the treatment of back pain.  The product was prepared by the New England Compounding Center in Massachusetts and distributed to physicians and hospitals in numerous state.

Tragedy
I do not use the word “tragedy” lightly.  It is the strongest word that I think of to describe the consequences of the situation that has occurred.  It is an appropriate description for one death that was preventable, but this situation is multiplied many times over.  In addition, hundreds of patients have been diagnosed with meningitis, and thousands of others have received injections from the same lots of medication and not experienced complications but are fearful that they will. There are many components of this experience that will continue to be examined and discussed in depth.  However, none of them should be allowed to diminish the concern and compassion for the families of those who died, and the efforts to accomplish the recovery of those who are ill with meningitis.

The New England Compounding Center
Information provided by the Food and Drug Administration and other agencies, as well as news reports, strongly suggest that there were multiple failures on the part of the NECC with respect to compliance with standards, procedures, and safeguards that are applicable to the preparation of sterile products.  I can’t explain the reasons for these failures and will not attempt to defend them.  Extensive discussion has centered around the questions as to whether NECC should be considered a compounding pharmacy or a pharmaceutical manufacturer, and which regulatory agency is responsible for monitoring its operations.

Compounding pharmacies
At one time all pharmacies compounded prescriptions but, at present, most pharmacies do little or no compounding.  However, in recent years there has been an increased awareness that the health needs of many patients can be best served by combinations of medications and inactive ingredients and/or special dosage forms that are not commercially available.  Compounded prescriptions can be considered to be the original personalized medicines.  Accordingly, many pharmacists have emphasized compounding as an important component of their practice and the practices of some pharmacists are entirely committed to the compounding of prescriptions and related services.  In addition to being licensed by a state board of pharmacy, there is a voluntary accreditation process in which many of these pharmacies participate and are evaluated.

Some pharmacists limit the extent of their compounding to non-sterile formulations whereas others have the facilities, equipment, and procedures to also prepare sterile products and other specialized formulations.  The number of prescriptions dispensed by most compounding pharmacies is relatively small when compared with the number of prescriptions dispensed in traditional pharmacies, and the patients served are in the local community.  A smaller number of compounding pharmacies prepare a much larger number of prescriptions for patients in a larger geographical area.  However, regardless of whether the number of compounded prescriptions is small or large, a central tenet of a compounding pharmacy practice is that each prescription is prepared for a particular patient.

Manufacturing
The manufacturing of pharmaceutical products has been the responsibility of pharmaceutical companies that then provide the products to pharmacies, physicians, or others that are authorized to provide the medications to patients.  The Food and Drug Administration (FDA) is the agency that has the authority to regulate pharmaceutical manufacturers.  However, the FDA does not have the authority to regulate the practice of pharmacy or the practice of medicine.  This is the responsibility of the state licensing boards.

An important question that has emerged in the tragedy resulting from the use of contaminated injections is whether the NECC functioned as a compounding pharmacy and supplied medications for individual patients, or whether it functioned as a manufacturer that supplied products for subsequent use in individuals for whom it did not have names or records.  Three lots of methylprednisolone injection, representing a total of 17,676 vials, have been implicated in the occurrence of meningitis that has been attributed to contamination of the product.  This large number of vials coupled with the apparent lack of patient names on the labels of vials, as well as additional information derived from the multiple investigations that are underway, give every appearance that NECC was engaged in manufacturing.         


More regulation is not the answer!
State Boards of Pharmacy have regulations that are applicable to the practice of pharmacy and the operation of pharmacies, and the FDA has regulations that are applicable to the companies that manufacture pharmaceutical products.  Some of the news reports of the meningitis tragedy have made reference to the “loosely-regulated” area of compounding pharmacy, and some legislators and others are calling for tighter regulations for these pharmacies.  However, I would contend that the current regulations are sufficient and provide appropriate authority for the regulatory agencies.

News reports indicate that both the FDA and the Massachusetts Board of Pharmacy had communicated concerns to NECC on previous occasions.  Apparently there was an awareness of existing problems or the potential for such.  In my opinion, the problem in the current situation is that existing regulations were not adequately monitored and enforced with appropriate actions.  I feel that the FDA and boards of pharmacy do not have adequate resources and staffing to appropriately fulfill their responsibilities and this situation must be addressed.  More regulation is not the answer – instead, we must direct our efforts to increase the monitoring and effective utilization and enforcement of regulations we have now.

In an area such as compounding pharmacy, it is unlikely that the officials and investigators of the FDA or a board of pharmacy will have significant experience and expertise in the operations and responsibilities being evaluated.  I recommend that these agencies appoint advisory panels of pharmacists, and others as appropriate, with pertinent experience and expertise who can provide objective recommendations that will be of value to the agencies in making the most appropriate decisions.  The current use of advisory committees by the FDA to make recommendations regarding the approval of new drugs provides a model that can be considered.

Daniel A. Hussar

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