Keeping scheduled drugs secure in the nursing home.

Guidelines for securing one of the more "sensitive" units in the facility

It is a fact of life, albeit a grim one, that where there are drugs, there is the potential for pilferage and diversion. The nursing home is not immune from such activity. Scheduled drug requirements are encountered commonly in hospital and office-based settings. But they are equally important in the nursing home setting and require the attention of all professional staff involved in ordering, prescribing and administering medications.

Keeping scheduled drugs secure is a multifaceted, ongoing process that begins with proper ordering and dispensing, and extends to careful monitoring, accountability and a heightened level of awareness.

Scheduled Drug Ordering and Dispensing

Efficient and legal prescribing and accountability for scheduled drugs has recently been facilitated by the proposed Drug Enforcement Agency (DEA) rule change regarding the transmission of controlled substance prescriptions between the prescriber and dispenser via facsimile (or FAX), as per 21 CFR Part 1306, Fed Regis 58 (no. 183); 49453-5. This change is especially important to expedite the delivery of Schedule II medications in time-sensitive cases, where the medications need to be started or changed rapidly in response to patient need.

Formerly, the only way a schedule II drug could be dispensed was on receipt of a written prescription, except in "emergency" cases where a pharmacy could dispense a 72-hour supply based on an oral prescription, provided the prescriber forwarded a written prescription (Rx) to the dispensing pharmacist within a three-day period.

Pending final posting of the proposed change, the DEA will require that the original Rx be presented and verified against the FAXed Rx at the time the substances are actually dispensed. However, two exceptions to this requirement will be granted:

1) Home infusion pharmacies providing intravenous (IV) pain therapy may receive and dispense from a FAXed schedule II Rx and have that FAXed Rx considered the original Rx as required by the current law;

2) Nursing home pharmacies may also receive and dispense any controlled substance in schedule II via the same process.

In both exceptions, all FAXed Rxs must have complete information as required by 21 CFR 1306.05(a), including the date issued, full name and address of the patient (in the case of the nursing home, that address is used), and name, address, DEA registration number, and signature of the prescribing practitioner. Further, the FAX must be kept on file for verification against inventory.

The dispensing pharmacist is still, however, held accountable for RX forgeries, and must know and verify the prescribing practitioner's FAX number against the telephone number of the originating FAX machine, and otherwise verify that the Rx was both written and transmitted by the prescriber.

Significantly, these two exceptions to the DEA rule also allow for greater than a 72-hour supply to be dispensed in the home and nursing home settings, thereby allowing the Rx to cover as long a period of time as is medically indicated.

Avoiding Pilferage and Diversion

Chemical substance-related impairment among health care professionals, including physicians, pharmacists and nurses, is perhaps the most common occupational hazard faced by this group. Its prevalence among health care professionals may be between 10-15%. An even higher percentage of health care professionals may be occasional abusers of both legal and illicit drugs.

The administrator, directors of medical and nursing staff, and pharmacy provider and consultant share the responsibility for the accountability for controlled substance prescribing, dispensing and administration records within the facility and for monitoring for potential staff dependence or abuse.

It is helpful to keep in mind that substance dependence may be defined as the occurrence of three or more of the following:

1) frequent preoccupation with the substance;

2) taking the substance in larger amounts or for longer than intended, especially if the substance is a legitimate drug, e.g. benzodiazepine or narcotic analgesic;

3) tolerance, leading to higher and higher doses;

4) withdrawal syndrome;

5) taking the substance to avoid withdrawal;

6) repeated desire/attempts to curb or control usage;

7) frequent intoxication or impairment by substance use when expected to fulfill social or occupational responsibilities, or engaged in hazardous activity (e.g. driving);

8) avoidance of important family, social, occupational or recreational activities in order to seek or take substance;

9) continued use, despite significant family, social, occupational or legal problems or chronic exacerbation of a physical disorder.

Cost-effective Usage of Scheduled Drugs

The choice of drugs used for pain management in the nursing home will, of course, greatly impact the number and type of drugs available for illicit use. There is no need to deny a resident in pain sufficiently potent analgesia to restore reasonable comfort. But sustained-release morphine tablets, suppositories and reservoir systems, and fentanyl patches are a viable alternative to analgesia administered via injection.

Further, attention should be paid to stepped-care approaches to pain management: beginning with less potent peripherally-acting agents, progressing to antidepressants and finally to sustained-release morphine, when appropriate.

Many states do not allow a floor-stock system of scheduled drugs in the nursing home similar to that found in an acute care hospital. This excessive duplication of stock produces a very high inventory of individually prescribed drags to be checked on each shift change for each resident. Fortunately, when a scheduled drug is discontinued for a resident, there is a DEA-approved method for disposal, available through each state board of pharmacy office, to avoid excessive accumulation of scheduled drugs no longer needed for therapy.

Nevertheless, pilferage and diversion must be watched for continually. The following "red flags" should heighten your level of suspicion:

* New orders are made for any controlled substance for use on only one shift.

* A resident requires repeated doses of a controlled substance when one dose had sufficed previously, or dosage is escalated after a prolonged period of dosage stability.

* A heretofore pleasant employee displays aberrant behavior that may be indicative of intoxication, withdrawal or dependence.

Conclusion

Use and abuse of scheduled drugs in the nursing home everyone's concern. Appropriate attention will avoid many professional, personal and legal pitfalls. To that end, the following guidelines will prove useful.

1. Work closely with your medical staff, consultant pharmacist and director of nursing to pinpoint suspected problems of diversion; notify the state drag inspector (as required in some states) if your suspicions are confirmed.

2. Keep meticulous records of scheduled drug prescribing, dispensing, receipt on the nursing station, change of shift and administration, and reconcile any discrepancies immediately when they are detected.

3. Attempt to help any person with suspected substance abuse problems by referral to an appropriate treatment program; the state boards will mandate such treatment following due process and conviction.

4. In hiring or reviewing staff for hire, be alert for signs or history of substance abuse.

Suggested Reading

1. Cooper JW. Community and Nursing Home Practice Drug Therapy OBRA Monitoring and Patient Education Guidelines-1993. Consultant Press, 1200 Colliers Creek Rd., Watkinsville, GA 30677.

2. Aronheim JC. Handbook for Prescribing Medications for Geriatric Patients. Boston, Little, Brown, 1992.

James W. Cooper, Pharm. PhD., FASCP, FASHP, is Professor and Assistant Dean for External Relations, University of Georgia College of Pharmacy, Athens, GA.