Economic Consequences of Unused Medications in Houston,Texas

Methods

This pilot study was conducted over a 6-month period (April-September 2002). The study investigated the quantity and types of medications returned to a community pharmacy during a “Medicine Cabinet Cleanup Campaign” promoted by the pharmacy. The University of Houston Institutional Review Board approved the study protocol.

The Medicine Cabinet Cleanup Campaign was established so that individuals could drop off partially used, expired, or unwanted drugs from their home to a local, community grocery-store pharmacy. Prescription and over-the-counter (OTC) agents, and samples provided by pharmaceutical representatives (samples) were collected. Participants were notified of the campaign by advertisements placed within the pharmacy, 2 articles in a neighborhood newsletter, and leaflets placed in prescription bags dispensed by the pharmacy. The advertisements requested participants to bring unused medications to the pharmacy for proper disposal. Participation was encouraged through a monthly $50 raffle drawing of a gift certificate for grocery purchases within the store. Participants submitted unused medications to a pharmacy staff member who exchanged them for a raffle ticket. The drugs were stored behind the pharmacy counter in large, tamper-proof biohazard containers. Medications were transported to the University of Houston College of Pharmacy for data entry and cataloging on a weekly or biweekly basis. Schedule drugs were sorted independently and stored in a secure, locked cabinet of the principle investigator. At the end of the study, all returned medications and containers were incinerated.

Data collected for the unused medications included drug name, dosage form, original quantity, estimated percent remaining from prescription rounded down to the nearest quartile (0, 25%, 50%, 75%, or 100%), prescription classification (prescription, sample, or OTC), and original fill or discard dates. No patient identifiers were recorded. Drugs were coded by pharmaceutical class using the classification scheme obtained from the American Health Formulary Service. ⁶ Medication costs were estimated using the 2001 Red Book median wholesale drug cost estimates. ⁷ Costs were determined by multiplying the cost per pill to the estimated number of pills remaining in the container. Costs were calculated only for solid prescription medications due to the difficulty in calculating the amount remaining for liquid preparations. Samples and OTC medications were also excluded from the cost analysis due to the difficulty in determining accurate pricing information. The population living within 3 miles surrounding the community pharmacy was obtained from the US Census Bureau Census 2000.

Results

Discussion

Similar to studies performed in other countries, this investigation revealed that a massive amount of unused medications is present in an urban neighborhood in the US. As this study was a voluntary effort by the community, it is likely that this is an underestimate of the amount of unused medications present in the community. Extrapolating our results to the US population (estimated 291 000 000) would represent >34 500 000 unused pills with an estimated cost burden of $53 million. As this assumes that 100% of unused drugs were collected from the community, these numbers likely represent an underestimate of the true value. This is supported by findings from a cross-sectional study that estimated over $1 billion in unused medications are present in the US senior citizen population. ⁵

Community pharmacies may be an ideal venue to establish programs to collect this reservoir of unused or outdated medications. It is estimated that 250 000 000 people enter a community pharmacy each week. ⁸ Community pharmacies would have the necessary personnel, expertise, and storage area to collect and store unused drugs. Large incentives would also likely not be required for community participation in a collection program. In our study, the potential to exchange unused medications for something else (in this case, a raffle ticket) was enough incentive to encourage participation for many people. However, 2 major obstacles must be overcome to allow large-scale incorporation of these programs. First, community pharmacists would likely require compensation to establish and maintain this program, and patients or customers may be more interested in bringing in their unused medications if an incentive is offered. This could be achieved in a number of ways. Recently, many states have adopted policies that allow pharmacists to bill Medicare for immunization delivery services. ⁹ A similar program could be adopted for collection of unused medications to help offset the costs of the program. However, this study demonstrated that these costs were minimal. Customers or patients could also be offered a rebate plan through the community pharmacy or the pharmaceutical manufacturers. As part of an advertising campaign, pharmacies could offer a rebate on new prescriptions for persons returning unused medications. Anecdotally, our study generated positive advertising for the pharmacy. Participants were generally pleased to have the ability to safely discard their unused drugs as well as the potential for a raffle prize. Although we did not measure this impact, it is possible that the increased business to the store and pharmacy could offset the costs of a rebate or raffle system.

Second, proper disposal of these medications will require a coordinated effort either by community pharmacies or by governmental organizations such as the Centers for Disease Control and Prevention or the Department of Public Health. The medications collected in this study were incinerated using the biological safety system of a major teaching university. Obviously, this system is not available for the majority of community pharmacies. Alternative systems or a coordinated approach to dispose of these drugs would be required.

Recycling of these unused medications is another potential option. In France, a structured, industry-funded organization is responsible for the recollection and potential recycling of unused drugs. ¹⁰ Any returned medications that are deemed recyclable are donated to charity. To be recyclable, there must be evidence that the drug has not been adulterated. The common use of blister packs and other single-dose packaging in France allows many returned medications to meet this definition. In the US, grass-root efforts to recycle unused medications from long-term care facilities have received support by the Food and Drug Administration. However, none of the drugs that were collected from our project would satisfy World Health Organization or American Medical Association guidelines for medication recycling due to the containers being returned. A number of issues, including proper packaging and assurances against tampering, will have to be overcome before recycling of these medications can become commonplace. Until that time, efforts to decrease the amount of unused drugs or proper disposal should be undertaken.

This study has several limitations. First, we did not attempt to assess the percentage of unused medications present in the community that were returned to the pharmacy. Second, the costs of the drugs that were returned were based on wholesale costs obtained from the 2001 Red Book. Many of these medications were much older; thus, the price does not represent their original wholesale price. Third, we did not attempt to quantify the costs of liquid preparations due to the difficulty in determining the amount remaining. For oral pills, the amount remaining in the container was rounded down to the nearest quartile to avoid overestimating the number of pills remaining. Thus, even our calculation of the number of pills collected and their monetary value is an underestimate. Lastly, as this pilot project involved the collection of unused drugs from a community in Houston, the generalizability of these findings is unknown. Other areas around the country likely have a higher prevalence of drug wastage. For example, almost 10 000 postal employees have received antibiotics for anthrax prophylaxis in New York City and Washington, DC.^11,12 Up to 63% of these antibiotics were discontinued prematurely due to adverse events or other reasons. No coordinated efforts have been made to collect these medications, and it is likely that many remain in the medicine cabinets of these households. Safety concerns and drug misadventures related to these unused medications should become a focus for future inquiry.

Summary

This study demonstrated that an enormous amount of unused medications are present in a community in the US. Community pharmacies may be an ideal venue to coordinate programs to collect this information.