Critical Shortages Of Narcotic Medications Pose Serious Health Risks

Main Category: Palliative Care / Hospice Care
Also Included In: Pharmacy / Pharmacist;  Pain / Anesthetics
Article Date: 16 Apr 2009 - 0:00 PDT

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The American Society of Consultant Pharmacists (ASCP) called for remedial action to alleviate the dire shortage of narcotic medications used regularly in the treatment of long-term care and hospice patients.

In a letter to Joshua M. Sharfstein, MD, Acting Commissioner of the US Food and Drug Administration (FDA), ASCP states concerns regarding a severe, nationwide shortage of appropriate narcotic pain medication for patients in nursing homes and in hospice care.

The drug formulation that is most at issue is morphine sulfate 20mg/ml oral concentrate. This drug, which has been on the market for decades, is used in long-term care because end-of life patients have trouble swallowing and the concentrated formulation is needed to avoid choking and to facilitate sublingual and buccal administration.

The Food and Drug Administration (FDA) recently notified the manufacturers of this product that manufacturing of this drug must be halted within 90 days because it was never approved. While there are two potential alternative, approved formulations, morphine 20mg/5ml and morphine 10mg/5ml, supplies are back ordered, and most longterm care pharmacies are reporting difficulty obtaining sufficient quantities.

"Even if adequate supplies of the approved alternatives could be secured, switching elderly and dying patients to the less concentrated formulations delays treatment and poses serious health risks," states ASCP Director of Policy and Advocacy Claudia Schlosberg in the letter. "Obtaining a prescription order for an alternative product may take a day or more given that most physicians treating nursing facility and hospice patients are not in the facility on a daily basis … and patients may unnecessarily endure pain and the facility can be cited by state survey agencies for ʻfailure to provide pharmaceutical services to meet the needs of each resident.1ʼ "

From a clinical standpoint, the less concentrated formulation of morphine poses a choking risk for patients with dysphagia, as it is necessitates a larger volume of liquid and cannot be as readily absorbed transmucosally. Another consideration is that this formulation of morphine is often used to treat dyspnea, particularly at the end of life. Most of the studies regarding the treatment of dyspnea evaluate morphine, not necessarily other narcotic medications. Therefore, there is little evidence or information for practitioners to use when selecting an appropriate and effective alternative medication and dose to treat dyspnea.

An additional concern is the cost. The approved alternative formulations are approximately 10 times more expensive than morphine 20mg/ml concentrated oral solution.

At a time when manufacturing issues and other enforcement actions have severely constrained the availability of many narcotic medications, ASCP urges FDA to reconsider its decision to require the manufacturer of 20mg/ml oral concentrate to cease production within 90 days. At the very least, FDA should ensure that this product remains available until other narcotic shortages are resolved and FDA has affirmatively established that there are sufficient supplies of approved alternatives to meet patientsʼ needs.

Reference:

1. 42 CFR 483.60, 483.60(a). Centers for Medicare & Medicaid Services, State Operations Manual, Appendix PP: Interpretive Guidelines for Long-Term Care Facilities, F-Tag 425 - accessed here, on April 8, 2009.

ASCPʼs letter to Acting Commissioner Sharfstein may be viewed here.

The American Society of Consultant Pharmacists, the recognized expert in geriatric pharmacotherapy, is the international professional society devoted to optimal medication management and improved health outcomes for all older persons. ASCPʼs 7,000 members serve individuals residing in a variety of environments, including nursing facilities, subacute care and assisted living facilities, psychiatric hospitals, and hospice programs, as well as in-home and community-based care. Visit ASCP's Web site at http://www.ascp.com.

Source
American Society of Consultant Pharmacists