Wins and Losses in Pain Control

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1993 Angarola RT, Joranson DE. Wins and losses in pain control. APS Bulletin 1993;3(4):8-9.

Wins and Losses in Pain Control

Robert T. Angarola, Esq.; David E. Joranson, MSSW

The last few months have witnessed some extremely encouraging actions in the public policy area relating to pain control. Unfortunately, at the same time, some opportunities may have been missed and some new threats have emerged.

Texas

The Texas Board of Medical Examiners recently announced a new policy on pain control and the use of controlled substances. The board issued the following statement:

Quality medical practice dictates that those citizens of Texas who suffer pain and other distressing symptoms should be adequately relieved so that their quality of life is as optimum as can be...[T]he Texas Board of Medical Examiners recognizes that opioids (narcotics) and other scheduled controlled substances are indispensable for the treatment of pain and useful for relieving and controlling many other distressing symptoms that patients may suffer. It is the position of the Board that these drugs be prescribed for the treatment of these symptoms that patients may suffer. It is the position of the Board that these drugs be prescribed for the treatment of these symptoms in appropriate and adequate doses after an appropriate diagnosis is made. (Stasney & Hill, 1993, p. 1)

The board noted that controlled substances are subject to abuse and alerted practitioners to be diligent in preventing diversion to illegitimate use. The board advised Texas physicians as follows:

In determining the standard of practice for the use of [controlled substances] the Board will focus on their use for the targeted symptom diagnosed after a careful history, physical examination, and appropriate laboratory studies have been done. The Board recognizes that pain and many other symptoms are subjective complaints and appropriateness and adequacy of the drug and dose will vary from individual to individual. The standard will be determined largely by the treatment outcome...Quantity and chronicity of prescribing will be judged on the basis of the diagnosis and treatment of the targeted symptoms and neither of these factors are prima facie evidence of inappropriate or excessive prescribing. (Stasney & Hill, 1993, p. 1)

In 1982, Texas implemented a triplicate prescription program that reduced the prescribing of schedule II controlled substances, largely opioid analgesics, by more than 60% (Sigler et al., 1984). The enactment of the Intractable Pain Treatment Act of Texas in 1989 and the recent policy statement of the medical board should help to overcome regulatory impediments to the use of controlled substances in the management of pain. However, it is evident that requiring practitioners to use triplicate prescriptions for potent opioid analgesics will continue to limit the use of schedule II drugs and, thereby, negatively affect patient care.

Michigan

In 1988, the Michigan legislature enacted a triplicate prescription program (TPP) into law. It became effective the next year. The law had a "sunset" provision requiring the legislature to affirmatively reauthorize the program 5 years after enactment. In March 1993, the Michigan House held hearings on continuing the TPP. Witnesses from the agency that operates the program, the federal Drug Enforcement Administration, Medicaid officials, the Michigan State Police, county prosecutors, and the Michigan Pharmacists Association appeared to testify in favor of keeping the program. No one appeared representing the medical, nursing, or hospice communities or patient advocacy groups. Not surprisingly, the Michigan House approved reauthorization of the triplicate prescription program.

In April 1993, the "Michigan Triplicate Prescription Program Evaluation Report" was issued (Michigan Department of Commerce, Bureau of Occupational and Professional Regulation, Office of Health Services, & Michigan Controlled Substances Advisory Commission, 1993). Below is a listing of the principal findings of the evaluation report as stated in the executive summary and some comments on those findings:

The goal of the triplicate prescription program was to "reduce diversion of drugs in Schedule 2...A decrease in the number of prescriptions and units prescribed for the three most diverted Schedule 2 drugs [Percodan , Demerol , and Dilaudid ] is reported..." (p. v).

The authors imply that a reduction in the prescribing of opioid analgesics (which the Agency for Health Care Policy and Research and many others have found to be, underprescribed for patients in pain) means that there has been a similar reduction in diversion and abuse. This is not necessarily true. Diversion will continue if rogue physicians and pharmacists continue to divert controlled substances. There is no evidence presented that shows that the state agencies used the information obtained from the triplicate program to target and deal with those few diverters who probably do exist. To the contrary, the report states that "requests to access [triplicate prescription] data by law enforcement personnel have been minimal" (p. v).

Medicaid report "significant savings" since the institution of the triplicate program (p. v).

Medicaid officials may have saved a minimal amount of money by not paying for some opioid analgesic prescriptions, but at what cost to the patient and at what cost to the healthcare system if patients must now seek pain relief in costly emergency rooms or in inpatient settings? Collateral costs of triplicate programs have been reported (Collins & Zimmerman, 1992), but the Michigan report does not address these issues.

Since 1989, the state has collected $2.7 million in fees for controlled substances licenses to run the program, which will cost $800,000 a year (p. v).

Apparently, the state is using the funds raised not only to operate the TPP program but also to pay for other programs. This amounts to a tax on patients in pain. The state could have used these moneys to provide needed medications for pain relief or even to support more aggressive law enforcement efforts targeted at the few diverters who do exist. Such expenditures would not negatively affect cancer patients and others and would contribute to the public health.

A survey of 2,000 prescribers in Michigan indicates that at least a majority are satisfied with the program (p. vi).

It is well known that it is customary for physicians to avoid prescribing controlled substances, particularly opioid drugs. How many of the physicians polled actually used triplicate prescriptions? Furthermore, the report does not indicate the degree of support among physicians who do prescribe controlled substances or among those who manage pain.

The "findings" section reports great success for the triplicate program; however, the first "recommendation" is replacement of the triplicate form by a single-copy government-issued form (p. vi).

If the program was so effective, why not continue it in its present form? It certainly has not helped patients in pain. Moreover, a single government-issued form is likely to have the same negative effect on opioid prescribing as a triplicate prescription form (Angarola & Joranson, 1992b).

Methylphenidate (Ritalin (R)) is not being diverted or abused in Michigan. Therefore, there is no need to process or code prescriptions for this drug (p. vi).

These statements raise three questions: (a) Because no evidence exists that drug diversion and abuse are sufficiently greater for opioids than for methylphenidate, why should there be tighter prescription controls for opioids? (b) Why are patients who need analgesics subject to stricter monitoring than patients with attention deficit disorders and narcolepsy? Why should the state subject methylphenidate to a single-copy prescription program if it is not being abused?

As of August 1993, the Michigan legislature had not yet enacted a law that would continue operation of the triplicate prescription program. A few pain experts were trying to convey their views to key legislators and the governor. However, a lack of numbers and organized opposition have impeded their efforts. Proponents of regulatory programs that restrict access to pain medications in the name of the "war on drugs" are extremely effective in conveying their point of view. The groups that are dedicated to relieving pain must learn from law enforcement and regulatory officials how to present their message to legislators and executive branch policymakers.

Conclusion

The policy statement of the Texas Board of Medical Examiners is a welcome step in reassuring practitioners that they may prescribe controlled substances - even in extremely large quantities - in the proper treatment of patients in pain. On the other hand, we may have lost an opportunity in Michigan to eliminate a triplicate prescription program that has reduced opioid analgesic prescribing.

Michigan proposes to use an electronic data transfer system coupled with government-issued single-copy prescription forms to monitor the prescribing of controlled substances. Regulatory and law enforcement officials in Illinois, New York, Maryland, Oklahoma, and elsewhere have supported the use of single-copy prescriptions. The federal Drug Enforcement Administration has lobbied vigorously for such a program. Requiring the use of these prescription forms would send an unmistakable message to physicians that prescribing controlled substances could give them an unwanted high profile with the police or licensing authorities if they order more than a minimal amount for patients in pain or suffering from other disorders (Angarola & Joranson, 1992a). It would have the same chilling effect as a triplicate or duplicate prescription.

APS members should keep in contact with state regulators and legislators to let them have a well-informed view on the positive impact of actions such as those taken by the Texas Board of Medical Examiners and the harmful effects of prescription monitoring programs on patients.

References

Angarola, R.T., & Joranson, D.E. (1992a). Legislating proper pain management. APS Bulletin, 2(l) 13-15.

Angarola, R.T., & Joranson, D.E. (1992b). Single-copy serialized prescriptions: Old regulation in new clothing? APS Bulletin, 2(4) 14-15.

Collins, T.M., & Zimmerman, D.R. (1992). Programs for monitoring inappropriate prescribing of controlled drugs: Evaluation and recommendations. American Journal of Hospital Pharmacy, 49, 1765-1768.

Michigan Department of Commerce, Bureau of Occupational and Professional Regulation, Office of Health Services, & Michigan Controlled Substances Advisory Commission. (1993, April). Michigan triplicate prescription program evaluation report. Lansing, MI: Author.

Sigler, K.A., Guernsey, B.G., Ingrim, N.B., Buesing, A.S., Hokanson, J.A., Galvan, E., & Doutré, W.H. (1984). Effect of a triplicate prescription law on prescribing schedule II drugs. American Journal of Hospital Pharmacy, 41, 108-111.

Stasney, C.R., & Hill, C.S. (1993, Spring/ Summer). Pain control and the Texas State Board of Medical Examiners. The Board of Medical Examiners Newsletter, p. 1. Austin, TX.