Methadone Treatment in Narcotic Addiction. Chapter 8

Introduction

This chapter discusses the NYC MMTP procedures with respect to:

• Informing patients of their dosage
• The use of solid versus dissolved medication
• Methadone dosage manipulation and the prescribing of nonopiate, mood-altering drugs
• Services for patients following voluntary detoxification

Informing Patients of their Dosage

The NYC MMTP initially attempted to keep dosages secret from patients, assuming that this policy would allay patient concern regarding the amount of methadone prescribed, that there would be less manipulation of the staff, and that a better staff-patient relationship would be established. Many patients, however, viewed the policy as paternalistic, and staff members soon began to question the premise underlying the "blind" dosage approach. It was apparent that patients did not stop thinking and worrying about the dosage level, and there was an almost universal expression of concern that the dose being administered was inappropriate (xlviii). Six months after the Program began, an unexpected opportunity arose which permitted a comparison of the existing procedures with a clinical situation in which all patients were informed of their dosage.

In June, 1971, several thousand methadone patients were left without care when a private program in New York City was abruptly closed by Federal authorities. In order to provide continuity of treatment for these individuals, emergency referrals were arranged to other private and public programs, and approximately 400 were sent to the NYC MMTP. To accommodate these transfers, the Program converted a decommissioned Staten Island ferry boat into a clinic facility. Since medication was initially administered and dispensed by Public Health nurses with no prior experience in addiction treatment, and without the availability of pharmacist support, the Program was obliged to use "Diskets" (xlix) which the nurses could dissolve on the spot for consumption in the clinic; take-home doses were dispensed undissolved.

Obviously, patients receiving a given number of 40-mg Diskets immediately knew their precise dosage. To the surprise of many staff members, arguments over methadone dosages very rarely occurred, even though dosage levels varied widely, and patients could quite easily determine by observation the amount of medication being administered to others. In view of this experience, the procedures of the NYC MMTP were changed in the fall of 1971, and all patients were subsequently told the exact amount of medication ordered for them. The feeling of both the staff and the patients has continued to be overwhelmingly in favor of this open policy (l).

Solid versus Dissolved Medication

As noted above, the NYC MMTP initially dissolved all medication in order to keep patients from knowing their dosages. Once the need for secrecy was no longer a factor, the many advantages of dispensing medication for take- home in solid form became apparent (li). From the patient's perspective, it was far easier to carry one small bottle with several days' tablets than a separate bottle for each day's medication. (This was especially relevant for those patients who visited the clinic on the way to work.) The need for "locked boxes," previously employed by the Program to lessen the likelihood of accidental ingestion by children in the patients' homes, became obsolete, to the relief of many patients who claimed the conspicuous boxes made them targets for thieves. The inconvenience of having to refrigerate medication dissolved in Tang or Kool-Aid was also eliminated.

The economic and logistical advantages for the Program of solid medication were numerous. The required number of "child-proof" bottles was drastically reduced, as was the need for medication labels; several days' medication could be dispensed in one bottle for take-home consumption, with instructions regarding the number of tablets to take each day. Depending on the quality of the bottles and caps purchased, they could generally be used on more than one occasion. It was also considerably easier for the nursing staff to place a specified number of tablets in a bottle than to have to dissolve each day's supply separately.

In March, 1972, an official of the Food and Drug Administration told a meeting of all metropolitan-area methadone program directors in New York that the F.D.A. had decided to prohibit the dispensing of liquid methadone. In explaining the rationale for this decision, it was argued that dissolved medication lent itself to "skimming" on a large scale at the pharmacy and clinic level. Most programs that dispensed liquid methadone used stock solutions prepared ahead of time from powdered methadone which, if diverted for illicit use, could be readily dissolved and injected. In a relatively large facility diversion of as little as 5% of the medication could represent a large quantity, and yet even if the discrepancy were detected, it would probably be attributed to an acceptable degree of pharmacist error (lii). Subsequently, however, the F.D.A. did an about-face and within a year had mandated that all programs dispense dissolved medication only (113).

Ironically, the F.D.A.'s rationale for insisting upon dissolved methadone was identical to its earlier endorsement of solid medication: there would be less likelihood of illicit diversion. Street addicts, if given a choice, were known to prefer purchasing tablets since the dose could be determined with certainty, while dissolved methadone represented a danger either of being cheated or of unknowingly taking an overdose. Therefore, it was hypothesized that the demand for the drug on the illicit market would disappear if methadone were available in liquid form only. Predictably, black market methadone continued to be in demand, and the incidence of methadone overdose deaths among nonpatients in New York City increased sharply in the 6 months following implementation of the F.D.A. regulation in July, 1973: from 50 during the first half of the year to 131 in the last half (114).

After arguing in vain against this new ruling, the NYC MMTP had no choice but to comply. Nevertheless, the Program maintained its policy of advising patients of their dosage, and nurses have continued to prepare all medication by dissolving Diskets, rather than relying on stock solutions provided by hospital pharmacists (liii).

Discouraging Excessive Dosage Manipulation and
Prescribing of Nonopiate Mood-Altering Drugs

The futility of seeking to resolve all patient problems through the manipulation of methadone dosage and the use of other drugs has been recognized since the Program's inception. In this regard, the Program's Policy and Procedures Manual stresses the following precautions:

The physician, the entire unit staff, and the patient must recognize that few individuals who have been receiving widely varying amounts of illicit narcotics will be able to change abruptly to regulated doses of methadone with absolutely no side effects. This is true regardless of the care which is exercised in determining appropriate medication schedules. Attempts to adjust dosages to the point where there are no complaints whatever are likely to produce constant frustration and cynicism among both staff and patients.... Patients should be encouraged to advise the staff of their response to medication. Physicians are urged to respond to patients' complaints firmly but not inflexibly; confidently, but not disinterestedly.

Overemphasis on medication, especially methadone, sleeping pills and tranquilizers, will tend to reinforce an orientation which many addicts have prior to entering the Program that most, if not all, problems are solved by drugs. The Clinic staff must recognize that complaints related to sleep, sexual function and most other causes of anxiety (in the population at large no less than among our patients) usually are neither due to nor cured by medication (115).

The problem of overprescribing of psychotropic drugs is a problem which faces the medical profession at large; the fact that Valium is the most widely prescribed drug in America, and Librium the third most prevalent, is evidence of the extent of the problem (116). Although the NYC MMTP has been successful in keeping at a minimum the prescribing of mood-altering drugs by its own physicians, some patients continue to obtain such drugs from other sources.

Services for Patients Following Voluntary Detoxification

Recognizing that coercing patients to remain in treatment would be medically and morally unconscionable, and diametrically opposed to the principle that all patients must be voluntary, the Program has a firm commitment to provide every assistance to patients who opt for detoxification. Accordingly, overt or subtle pressure to dissuade patients wishing to withdraw from methadone has been avoided, and former patients are assured top priority should they seek readmission following voluntary termination; in such cases there is no minimum interval between discharge and readmission, and relapse to narcotic use is not a prerequisite.

Some staff members, however, felt that detoxified individuals should not be discharged at all. The argument was advanced that in order to avoid applying pressure on patients to continue taking methadone, the provision of medical, vocational, legal, and all other ancillary services should not be made contingent upon the administration of medication; in other words, it was suggested that patients should be offered the option of remaining indefinitely "active" even after detoxification.

This argument was initially rejected due to the extraordinary demand by many thousands of addicts who were forced to wait months for admission because of limited capacity. Every patient who remained on the active census following detoxification would, in fact, deny admission to a heroin addict who desperately wanted methadone treatment. If the Program had viewed its therapeutic regimen as a continuum leading to a state of total abstinence (as is true of almost all programs today), then it clearly would have been paradoxical to discontinue services when a patient achieved the final "phase" of treatment. This, however, was not the objective of the Program. Rather, the NYC MMTP was designed to provide methadone maintenance; supportive services were viewed as an essential adjunct to treatment with methadone. The clinic staffing was barely adequate to provide ancillary services to the caseload of patients receiving methadone; obviously, it could not provide such services to nonmethadone clients as well.

Nevertheless, the policy that all patients be promptly discharged following detoxification generated increasing concern among clinic staff, and in the middle of 1973 a compromise was reached between the opposing viewpoints. Voluntarily detoxified patients were thereafter permitted to remain in active status, and have continued access to all the services of the Program, for a period not to exceed 3 months following the last dose of methadone (liv). Subsequent experience with the 3-month "grace period" revealed that only a very small proportion of patients returned to the clinics following detoxification unless they had decided to request resumption of methadone treatment (lv).

Notes

xlviii. The program in Palo Alto, California, while maintaining a double-blind dosage protocol, found that "...a majority of patients in all [dosage] groups regard their dose as too low" (110). The experience of the NYC MMTP, and others, was that patients were concerned about being given too much as well as too little medication: "Patients are not supposed to know their dosage of methadone, and they resent this. One girl [sic!], for example, complained that she was feeling high and suspected that the nurse had increased her dose. She felt that her dose was her business and that at the very least she would be informed so as to know what to expect.... [P]atients continued to negotiate for more or less methadone on the basis of perceived side effects" (111).

xlix. "Disket" is the trade name of an Eli Lilly methadone preparation, a scored 40-mg tablet which can readily be broken by hand into four 10-mg quarters.

l. The same experience was reported by the Palo Alto program: in the course of a research project, patients were not only advised of the precise amount of methadone being prescribed, but permitted (within limits) to make adjustments at will. With the uncertainty removed, very few patients availed themselves of the opportunity to change dose, despite their previous conviction that the dosage was inadequate (112).

li. The NYC MMTP has always administered medication in solution for consumption in the clinics. In addition to ensuring that patients actually drink the methadone given to them, the Disket used by the Program was known to cause gastric irritation if taken without prior dissolving.

lii. Just prior to the conversion to Diskets, the NYC MMTP arranged for samples of medication prepared by pharmacists in the various contract hospitals to be quantitatively analyzed; discrepancies were found to be the rule rather than the exception, and in some cases amounted to as much as 30%. This generated considerable concern not only with respect to possible diversion of the drug, but on grounds of clinical safety and efficacy; these findings added to the urgency with which the NYC MMTP changed to tablet methadone.

liii. The Program's experience is that maximum control of methadone supplies can be assured only through the use of tablet-form medication, which permits an exact accounting of how many milligrams are received, administered and dispensed by the individual clinics.

liv. To ensure that analysis of patient retention in the Program would be meaningful, the NYC MMTP continued to define the "official termination date" as the date of last medication.

lv. This experience has been reported by other methadone maintenance programs as well, and is reflected in the difficulty of obtaining follow-up information on patients after detoxification (117-119).