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FACT SHEET ON THE NEED FOR
A FEDERAL PRESCRIPTION DRUG MONITORING DATABASE
This memorandum explains the reasons Congress should pass the National All Schedules Prescription Electronic Reporting Act (NASPER) as advocated by the
American Society of Interventional Pain Physicians (ASIPP) that establishes a national electronic data bank for practitioner monitoring of Schedule II, III
and IV controlled substances. This bill incorporates multiple aspects of the state programs proposed by Representative Charles Norwood. H.R.3015 passed
the House unanimously and has been passed on to the Health, Education, Labor, and Pensions Committee in the Senate. We are awaiting for unanimous consent
in the Senate during this legislative session in order to avoid the costly delays of starting all over again during the 109th Congress.
- Public Health Issues: Health care practitioners and pharmacists desperately need a national electronic monitoring system to ensure that they are prescribing and dispensing Schedule II, III, and IV controlled substances that are medically necessary. Without such a databank, practitioners and pharmacists have no way of knowing whether a particular patient is receiving the same medication from other practitioners. Patients may be receiving Schedule II, III and IV prescriptions from multiple practitioners who are unaware of the potential for drug interactions or of the potential for abuse and trafficking of certain medications. All of these situations pose serious public health issues. A national electronic databank would allow physicians to access the information necessary to ascertain that a particular prescription is unnecessary. This proposal means good patient care and good medical practice.
- States' Recognition of the Need for Such Databanks: The need for an electronic monitoring system is evident from the fact that 15 states, including California, Hawaii, Idaho, Illinois, Indiana, Kentucky, Michigan, Nevada, Oklahoma, Texas and Utah, have created such systems. Multiple other states are enacting such programs. The state programs vary with respect to the schedules of substances for which reporting is required. Most states, like California, capture data only for Schedule II prescriptions, while a few, like Kentucky, capture data for Schedule II - V prescriptions. The NASPER that ASIPP is proposing would require reporting Schedule II, III and IV prescriptions. Systems that only target Schedule II drugs fail to track many of the moderately abused drugs.
- U.S. GAO Suggests Further Action Needed Than That Taken through the State Databases: In May 2002, the GAO reviewed existing state monitoring programs and concluded that they indeed provide an efficient tool for stemming the growing problem of illegal diversion of prescription drugs. They offer quick access to comprehensive information on drugs most likely to be abused and deter abusers from doctor shopping within the state. Further, only a few programs operate proactively, while most operate reactively. Incidents of drug diversion, however, are on the rise in neighboring states, indicating the problem is proliferating or shifting to states without monitoring programs. This underscores the interstate nature of the problem and the need for a national database.
- The Need for a Databank with Nationwide Access: Most states unfortunately, do not have electronic monitoring systems in place. The GAO explains this as a problem of awareness about the magnitude of the problem. GAO explains that with a highly effective KASPER program in Kentucky, which shares boundaries with seven states, only two of which have prescription monitoring programs, drug diverters have moved their diversion activities to nearby non-monitored states. Consequently, OxyContin diversion problems have worsened in Tennessee, West Virginia, and Virginia – all contiguous non-monitoring states – because of the presence of Kentucky’s KASPER program, according to a joint federal, state, and local drug diversion report. The GAO report also stated that one challenge faced by states attempting to control diversion and abuse of controlled substances, is a lack of awareness of the seriousness of this public health and law enforcement problem. Nationally, prescription drug abuse involves a multibillion-dollar illegal diversion market, resulting in deaths of abusers, and is as significant a problem as abuse of illegal drugs. Multiple states also have created controlled substance task forces and OxyContin task forces. The first prescription drug monitoring program was established in California in 1940. The number of states with prescription drug monitoring programs has grown only slightly over the past decade, from 10 in 1992 to 15 in 2002. In addition, state programs that are in place are neither uniform nor integrated. Patients moving from one jurisdiction to another (as in cases involving Virginia, the District of Columbia, and Maryland) will typically be able to obtain multiple prescriptions by merely crossing state lines. The conscious and more prevalent unconscious misuse of Schedule II, III and IV controlled substances are a national problem that cannot be effectively addressed on a state-by-state basis.
NASPER allows states to have their own systems so long as they share data with other states to deal with cross-borders.
- Prescription Drug Monitoring: Strategies to promote treatment and deter prescription drug use: In a hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, 108th Congress, Second Session, on March 4, 2004 (Serial No. 108-73), many experts and congressional leaders testified to the fact of high prevalence of controlled substance abuse and strategies to prevent such abuse.
John Walters, Director of the White House Office of National Drug Control Policy, said, "The non-medical use of prescription drugs has become an
increasingly widespread and serious problem in this country, one that calls for immediate action."
Emergency room visits resulting from the abuse of narcotic pain relievers have jumped 163% since 1995.
The proposed 2005 budget from the White House for prescription drug diversion control will increase by $20 million to $138 million. Most of the funds will be directed at reducing the non-medical use of prescription drugs, mainly opioids.
Results from the 2002 national survey on drug use and health showed the following:
- An estimated 6.2 million persons, or 2.6% of the population, aged 12 or older, were current users of prescription-controlled drugs taken non-medically, with 4.4 million using pain relievers for non-medical purposes. This survey reflected increased use of opioids from 2001 from 3.5 million to 4.4 million.
- In 2002, approximately 1.9 million persons aged 12 or older had used OxyContin non-medically at least once in their lifetime. This is a significant increase as OxyContin use was less than a million in 2001.
- In 2002, among adults who used an illicit drug in the past year, 17.1% had serious mental illness in that year, while the rate was 6.9% among adults who did not use an illicit drug.
In interventional pain management settings, it was shown that 18% to 24% of patients were abusing controlled substances.
- Integration with HIPAA: The NASPER is consistent with the privacy rules set forth in the Privacy Standards promulgated under the Health Insurance Portability and Accountability Act (HIPAA). HIPAA permits disclosures of protected health information (PHI) whenever required by law. The NASPER would create a legal requirement for disclosure and would, therefore, fit squarely into the existing HIPAA regulatory scheme that became effective on April 14, 2003. If the NASPER were enacted, there would be no need to amend HIPAA or the Privacy Standards.
- Privacy Concerns: Under the NASPER, only a practitioner or pharmacist who is currently treating a patient may request information. Each request must be certified by the treating practitioner or pharmacist that the information is necessary for the purpose of providing medical or pharmaceutical treatment or to evaluate the need for such treatment for a bona fide current patient. Thus, the NASPER provides for limited disclosure to the patient’s treating physician or pharmacist after the physician or pharmacist has certified that the information is necessary for treatment purposes. With these safeguards, the NASPER is narrowly tailored to serve its purpose. Law enforcement agencies may obtain information, but only when the request is based on a legitimate need and evidence for cause.
All states, regardless of whether there is state prescription drug monitoring program, have the authority under their laws to conduct investigations of the records of individuals alleged to be involved in prescription drug diversion and abuse, including the records of prescribing physicians and dispensing pharmacies.
- Costs: Data from the various states suggests that the costs would be modest and, in any event, outweighed by savings from the public health benefits of implementing such a system. The annual data collection costs for the Kentucky program, which requires reporting of Schedule II - V prescriptions are $500,000 annually. This figure includes equipment costs, operating expenses and contract services as well as salaries, fringe benefits, and travel expenses for certain personnel. Significant cost savings will be realized by having an integrated system covering all jurisdictions. Based on the costs of the various state programs, we believe that the costs of data collection and maintenance to the national program would be modest. Generally, the state programs do not assess fees for practitioners or pharmacists. ASIPP strongly opposes funding a federal databank from fees assessed to practitioners and pharmacists who would access the information. The costs for NASPER are estimated to be $20 million initially and $10 million each year.
CBO has estimated the total cost this program for 10 year would be $ 65 million.
- Definitions: Schedule II substances are drugs that have a “currently accepted medical use” and “high potential for abuse… that may lead to severe psychological or physical dependence.” 21 U.S.C. § 812(b)(2). Schedule III substances are drugs that have a “currently accepted medical use” and potential for abuse and dependence that is slightly less than that of Schedule II substances. Id. § 812(b)(3). Schedule IV substances are drugs have a “currently accepted medical use” and potential for abuse and dependence that is slightly less than that of Schedule III substances. Id. § 812(b)(4).
For more information, please contact the ASIPP Government Affairs Counsel Tim Hutchinson (HutchinsonT@dsmo.com)
or Randi Hutchinson at Dickstein Shapiro Morin & Oshinsky, LLP at (202 955-6600 or HutchinsonR@dsmo.com)
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American Society of Interventional Pain Physicians
81 Lakeview Dr, Paducah, KY 42001. Phone: 270-554-9412, Fax: 270-554-5394 | Email: asipp@asipp.org | Internet: http://www.asipp.org
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