Report 2 Of The Council On Scientific Affairs (I-97) Full Text

AMA Report 2 of the Council on Scientific Affairs (I-97) Full Text

Recycling of Nursing Home Drugs

Substitute Resolution 503, adopted at the 1996 Interim Meeting, directed the American Medical Association (AMA) to study the feasibility of nursing homes (long-term care facilities, LTCFs) returning unused, sealed, and dated drugs to their vendor for credit and resale. Presently, there is no AMA policy on this subject. This report briefly reviews the limited literature on medication waste in LTCFs, describes the policy statement of the American Society of Consultant Pharmacists and the views of the American Medical Directors Association on the return and reuse of medications in LTCFs, and provides the Council on Scientific Affairs' (CSA) recommendations on the subject.

Medication Waste in Long-Term Care Facilities

Medication waste in LTCFs can be defined as any medication that has been dispensed and paid for, but not consumed, by a particular LTC patient.1 In 1987 Kidder2 reviewed 13 studies that addressed the magnitude of drug waste in LTCFs. Despite differences in methodology among the studies, Kidder concluded that from a total of 66,123 months of patient care a reasonable estimate for the ingredient costs of drug waste in LTCFs ranged from $1.52 per patient per month to $5.67 per patient per month with an unweighted average of $3.12 per patient per month (in 1984 dollars). However, documenting the cost of drug discards as a percentage of the total cost of drugs dispensed was not determined.

Searching the MEDLINE database using the search phrase "medication or drug and waste or wastage and nursing home or long term care" resulted in only three references and all were included in the review article by Kidder. Searching the indices of International Pharmaceutical Abstracts from 1992 through May 15, 1997, under the term "wastage" resulted in two more recent references that are relevant to this subject.

Shinavier and Kirk3 assessed medication waste in selected central Texas LTCFs under the same corporate ownership. For each of 8 facilities, 30 to 40 medication profiles of residents were randomly selected and followed for 90 to 180 days to obtain data on drug disposition, including discarded medications. Of 999 prescriptions analyzed, 77 (7.7%) had some quantity wasted. The total ingredient cost of the prescriptions was $20,889, of which $780 (3.7%) was wasted.

Paone et al conducted a 2-year (1992-1994) prospective study that evaluated the scope and costs of medication waste in Massachusetts LTCFs.4 They determined the quantity of medications wasted, expense of medications wasted, and reasons for medication waste for 2,360 residents of 17 LTCFs using a data-collection form that was completed by nurses at each facility and collected by consultant pharmacists at monthly intervals. Data were collected for 12 months from each participating LTCF. Collectively, 198 months of data representing 852,300 patient days were obtained from the 17 LTCFs. Costs of medications destroyed were estimated as the ingredient costs. The cost of medication waste was calculated to be $0.15 per patient day ($4.50 per patient per month); allowing for an average of 8% inflation in the cost of medication, the average cost of medication waste in Kidder's review would be $6.74 (in 1993 dollars). From an estimated total medication ingredient cost of $1,934,721, medication waste accounted for $129,854. Thus, the percentage of medication wasted for the 17 LTCFs in this study was 6.7% of the cost of the medications dispensed (range among individual LTCFs, 1.77% to 11.39%). Over 90% of wasted medication was due to patient death; medication discontinued; medication changed; and patient hospitalized, transferred, or discharged.

Policy Statement of the American Society of Consultant Pharmacists

The American Society of Consultant Pharmacists (ASCP) represents approximately 6,000 registered pharmacists and educators who largely are concerned with pharmaceutical procedures within nursing homes and related health facilities. In July 1996, the Board of Directors of the ASCP adopted an ASCP Statement on the Return and Reuse of Medications in Long-Term Care Facilities.5 Based primarily on the study by Paone et al,4 the ASCP noted that the cost associated with unused medications in LTCFs was approximately 6.7% of the total costs of the medications dispensed, and resulted from order changes and death or discharge of residents. The ASCP noted that under appropriate circumstances, health care costs could be reduced through the return and reuse of unused prescription medications. Thus, the ASCP adopted a statement that addressed the legitimate return and reuse of medications in LTCFs when federal and state laws and regulations and facility policies and procedures are met, and when reasonable mechanisms (for both the payer and the dispensing LTC pharmacy) are in place for billing only the number of doses used and crediting the number of doses returned.5

The ASCP position is as follows:

"ASCP supports the return and reuse of medications to the dispensing pharmacy to reduce waste associated with unused medications in LTCFs and to offer substantial cost savings to the health care system, provided specific drug product safeguards and appropriate billing policies are in place.

"ASCP supports the return to the dispensing pharmacy and reuse of medications only if:

 The returned medications are not controlled substances.  The medications are dispensed in tamper-evident packaging and returned with packaging intact.  In the professional judgment of the pharmacist, the medications meet all federal and state standards for product integrity.  Policies and procedures are followed for the appropriate storage and handling of medications at the long-term care facility and for the transfer, receipt, and security of medications returned to the dispensing pharmacy.  A system is in place to track re-stocking and reuse to allow medications to be recalled if required.  A mechanism (reasonable for both the payer and the dispensing LTC pharmacy) is in place for billing only the number of doses used or crediting the number of doses returned, regardless of payer source."5

The ASCP clarified three points in its policy statement. First, because LTCFs are not Drug Enforcement Administration (DEA) registrants, pharmacies may not accept controlled substances returned from such facilities. Second, the statement uses the term "tamper- evident" instead of "unit dose" to convey that other types of packaging are acceptable for reuse as long as the tamper-evident seal is intact and drug product integrity is assured. Finally, the amount of credit issued for returned and reused medications should include the ingredient cost less the cost of processing these returns. Processing costs may include, but not be limited to: delivery and pickup expense; packaging, unpacking, and repackaging costs; labor costs; record keeping costs including data processing; and overhead expenses.5

Views of the American Medical Directors Association

The American Medical Directors Association (AMDA) was asked to review Substitute Resolution 503 and to share its views with the CSA regarding the recycling of nursing home drugs. The AMDA lacks official policy on this subject. The following views of the AMDA were presented in a letter from the AMDA delegate to the AMA (Eric G. Tangalos, MD. Personal communication, April 1997).

The AMDA's physicians are acutely aware of the cost of medications in LTCFs and believe that medication waste may be between 5% and 10% of the costs of medications dispensed in LTCFs. The AMDA has closely followed the development of compliance packaging, which can significantly reduce medication errors and provide an appropriate level of safety with regard to returning and recycling unused medications.

The AMDA noted that Substitute Resolution 503 and the recommendations in the article by Paone et al4 are similar in that they recommend accepting return of unused, sealed, and dated drugs that are dispensed in the original manufacturer packaging (bulk or unit dose). The AMDA believes that Bingo card packaging and unit dose would also apply. The AMDA further notes that the ASCP policy statement is somewhat more expansive, allowing for medications to be returned if they are in tamper-evident packaging and returned with packaging intact.

The AMDA states that it has worked closely with ASCP over the past 7 years. With regard to a study of the feasibility of returning unused, sealed, and dated medications to the vendor for credit and resale, the AMDA accepts ASCP's data. The AMDA concludes by stating it supports the findings of ASCP and except for semantic clarification, accepts the ASCP policy statement regarding the return of unused medications.

Summary

Based on limited studies, it appears that the cost associated with unused medications in LTCFs is between 4% and 10% of the total costs of the medications dispensed. More than 90% of the wasted medication is due to discontinuation or change in medication or death, transfer, or hospitalization of the resident. The ASCP has adopted a policy statement that supports the return and reuse of medications to the dispensing pharmacy to reduce waste associated with unused medications in LTCFs and to offer substantial cost savings to the health care system, provided specific drug product safeguards and appropriate billing practices are in place. The AMDA supports the findings of ASCP and generally accepts the ASCP policy statement regarding the return of unused medications from LTCFs.

RECOMMENDATIONS

The following statements, recommended by the Council on Scientific Affairs, were adopted as AMA Policy at the 1997 AMA Interim Meeting.

1. The American Medical Association (AMA), consistent with the policy of the American Society of Consultant Pharmacists (ASCP), supports the return and reuse of medications to the dispensing pharmacy to reduce waste associated with unused medications in long-term care facilities (LTCFs) and to offer substantial savings to the health care system, provided the following conditions are satisfied: (a) The returned medications are not controlled substances.

(b) The medications are dispensed in tamper-evident packaging and returned with packaging intact (e.g., unit dose, unused injectable vials and ampules).

(c) In the professional judgment of the pharmacist, the medications meet all federal and state standards for product integrity.

(d) Policies and procedures are followed for the appropriate storage and handling of medications at the LTCF and for the transfer, receipt, and security of medications returned to the dispensing pharmacy.

(e) A system is in place to track re-stocking and reuse to allow medications to be recalled if required. (f) A mechanism (reasonable for both the payer and the dispensing LTC pharmacy) is in place for billing only the number of doses used or crediting the number of doses returned, regardless of payer source. 2. The AMA will communicate this policy to the federal and state governments and other organizations, as appropriate. References

1. Mathieson DR, Rawlings JL. Evaluation of a unit dose system in nursing homes as implemented by a community pharmacy. Am J Hosp Pharm. 1971;28:254-259.

2. Kidder SW. Review of drug waste in long-term care facilities 1976-1983. J Geriatr Drug Ther. 1987;1(3):35-47.

3. Shinavier BD, Kirk KW. Medication waste in selected central Texas long-term care facilities under the same corporate ownership. Consult Pharm. 1992;7:415- 422.

4. Paone RP, Vogenberg FR, Caporello E, et al. Medication destruction and waste measurement and management in long-term care facilities. Consult Pharm. 1996;11:32-40.

5. ASCP Statement on the Return and Reuse of Medications in Long-Term Care Facilities. Alexandria, VA; American Society of Consultant Pharmacists; July 1996.