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Is NASPER Safe and Effective?

Is NASPER Safe and Effective?
By David B. Brushwood, R.Ph., J.D.
University of Florida
October 2002

The National All Schedules Prescription Electronic Reporting Act of 2002 (NASPER) has been introduced as House Bill 5503 in the 107^th Congress. If passed, this legislation would establish a national electronic system for practitioner monitoring of the dispensing of any Schedule II, III or IV controlled substance.

Under this proposed law, every dispenser of controlled substances would be required to report to the Secretary of Health and Human Services specific information about controlled substances dispensed, including:

• Patient indentifier
• Drug dispensed
• Date of dispensing
• Qauntity dispensed
• Number of refills ordered
• Practitioner who signed the prescription
• Dispenser

The Secretary would be permitted to provide compilations of this information to practitioners (physicians, pharmacists, and other licensed persons permitted by federal or state law to distribute, dispense or administer controlled substances) who certify that they need this information to provide care to a bona fide current patient. The Secretary would also be permitted to provide compilations of this information to any local, state or federal law enforcement, narcotics control, licensure or disciplinary authority that requests the information as part of an ongoing drug diversion investigation.

This proposed national electronic prescription monitoring program (ePMP) is similar to surveillance systems already established in 18 states, although the state systems vary widely in their design and operation.

The stated purpose of NASPER is to develop "a national electronic databank, supported by state databanks where they are established under state law, to allow providers to access the information necessary to ascertain that a particular prescription may be unnecessary or the subject of abuse." The language of NASPER states that this information must be provided to practitioners because they would otherwise be "unaware of all prescriptions a patient is receiving, including abuse, improper use, and illegal distribution."

NASPER is a proposed new drug surveillance system with significant implications for patient care and for the public health. Just as new drugs must be studied for safety and efficacy prior to their widespread use, I suggest that a new drug surveillance system should be studied for safety and efficacy before it is adopted. As is the case with new drugs, the sponsor of a new drug surveillance system should bear the burden of demonstrating safety and efficacy.

To suggest that drug systems should be treated the same as drug products is not as far-fetched as it may initially seem. The IOM report, To Err Is Human: Building a Safer Health System, supports the widely held belief that failures of quality in health care are related to system problems and not to product or personnel inadequacies. The FDA has begun to employ risk management strategies to focus on systems as the cause of medication-related problems.

There currently is insufficient evidence to conclude that NASPER proposes a safe and effective drug surveillance system. NASPER should not be adopted until its sponsors provide empirical evidence that a national ePMP can be expected to achieve its goals without having serious adverse effects. The sponsors of NASPER should provide data to support their implicit assertion that the system's benefits justify its risks, in light of the potentially safer and more effective alternatives that are already available. The public demands this level of evidence for new drugs, and the public deserves this level of evidence for new drug surveillance systems also.

To show system efficacy, the sponsors of NASPER must provide data to support their contention that the system will reduce substance abuse. If the system merely changes the character of substance abuse, or simply leads drug diverters to adopt more creative ways of continuing their illegal conduct, then the system is not an effective one. Increased comfort level of practitioners may result from the implementation of NASPER, but this is not a valid efficacy outcome if the level of substance abuse remains constant (or increases) and the practitioners are enjoying a false feeling of security. Anecdotes and case studies are insufficient. To justify widespread use of such a comprehensive system, the sponsors of NASPER must show that ePMPs have reduced substance abuse in the places that have used them.

An unsafe ePMP is one that decreases appropriate prescribing of opioids for the treatment of pain. A reduction in appropriate opioid prescribing leads to human suffering, exacerbation of medical conditions, reduced productivity, and diminished quality of life. There is a potential for ePMPs to reduce appropriate prescribing in two ways. First, there is the "chilling" effect of regulatory oversight. Second, there is the possibility that reports of acquisition of opioids from multiple sources will be viewed by practitioners as evidence of "addiction" when in fact it is "pseudoaddiction." Sponsors of NASPER should show, through empirical evidence, that these two deterrent effects on prescribing and dispensing are unlikely to occur. An ePMP is also unsafe if it does not adequately protect the confidentiality of private patient records. With extensive medication use records being made available to any clinic or pharmacy that requests them, there is the possibility of unauthorized release of information. Sponsors of NASPER should provide evidence that the safeguards in place to protect patient privacy will be effective.

An alternative to NASPER would be to use data that are currently available to identify "hot spots" of potential drug diversion, and to refer these concerns to local law enforcement authorities. The existing data include ARCOS (Automation of Reports and Consolidated Orders System), DAWN (Drug Abuse Warning Network), state SURS (Surveillance and Utilization Review System) programs, DEA reports of theft or loss of controlled substances, and local arrest records. These data are currently available but they are not being used in a coordinated way. It makes more sense to better use existing data than to create an entirely new system of data collection, aggregation and reporting.

Practitioners their part to improve their prescribing and dispensing practices without a national ePMP. They can make better use of techniques designed to distinguish between legitimate pain patients and drug diverters. These techniques include the acquisition of prior medical records, insistence on photo identification, pain management agreements, and urine drug testing.

There may be a need for NASPER, or for another form of national ePMP. Yet, the creation of a costly new federal surveillance system cannot be justified until empirical data support its safety and efficacy. If a stronger commitment to using existing systems will be equally as effective, and less risky, then recommitment to existing programs should be the goal; not new system development.

Any new program directed at substance abuse reduction from the supply side will face serious obstacles and should be thoroughly studied before it is implemented. Substance abuse programs that fail to address demand are notoriously ineffective. Drugs don't cause drug abuse, people cause drug abuse. Only if there is empirical evidence to indicate that NASPER will buck the trend and succeed as a supply side program, should the health care community risk the adverse consequences that this new surveillance system may bring with it.

David Brushwood is Professor of Pharmacy Health Care Administration at the University of Florida in Gainesville. He is a Mayday Scholar with the American Society of Law, Medicine and Ethics (ASLME). For information about ASLME pain policy projects, go to ASLME.org.