International Journal of Pharmaceutical Studies and Research E-ISSN

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1 Research Article UNUSED MEDICATIONS: HOW COST AND HOW DISPOSAL OF IN CAIRO, EGYPT Manal El-Hamamsy Ph.D., Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Egypt. Address for Correspondence Ass. Prof. Manal El-Hamamsy,Ain Shams University, Faculty of Pharmacy, Abasia, Cairo,Egypt ABSTRACT Back ground: Patients may not use all the medications dispensed to them due to side effect intolerance, dosage changes, discontinuation of the medication, or medications reaching the expiration date. Therefore, it is not uncommon for patients to be in possession of unused or expired medications. Unused and expired medications are likely managed in a wide variety of ways. Objectives: 1- To determine the amount, types, and costs of unused medications. 2- To identify and assess the different pathways of disposal of dispensed drugs. Methods: 1. All drugs returned unused to 20 community pharmacies located in Cairo, Egypt were documented during April A total of 316 patients completed a survey about medication disposal practices Results: 1-Of 541 returned items, 20.15% were antibiotics The most important reasons for returning drugs were the patient felt better (16.29%). The total wholesale price of returned drugs was ( U$) Egyptian pounds. 2-Of 316 people interviewed, 97% had some type of pharmaceutical in their house. Responses indicate that (15.50%) finish their medication, (22.78%) keeps them until the expiration date, and (26.27%) discard them in household waste. Conclusion: This study demonstrated that an enormous amount of unused medications are present in the community in Egypt. The total wholesale price of returned drugs in one month was calculated at Egyptian pounds ( U$) which confirm the substantial economic value of unused drugs. Household waste was the most popular disposal method for all types of drugs. KEY WORDS: economics, unused drugs, disposal of drugs, Egypt. INTRODUCTION discarded each year in disposal programs Patients may not use all the medications provided by community pharmacies (3). Due dispensed to them due to side effect to the amount of medication consumption in intolerance, dosage changes, discontinuation of the medication, or medications reaching the expiration date. Therefore, it is not uncommon for patients to be in possession of unused or expired medications (1). Massive quantities of unused drugs in the community have been documented. For example, >204 tons of unused medicines have been collected in disposal programs in Alberta, Canada, over 8 years (2).A study conducted in England estimated that 37.6 million ( $62.4 million US) of drugs were the US, the potential for wastage is significant. This problem is complicated by the tremendous increase in pharmaceutical consumption, as evidenced by the increase of prescriptions sold in the United States (from 2.9 billion in 2000 to 3.4 billion in 2005) and the increase of pharmaceutical sales (from $79 billion in 2000 to $116 billion in 2005)(4). A cross-sectional study of people >65 years old estimated that drug wastage accounted for 2.3% of all drug costs. This would represent over $1 billion

2 in drug wastage in the elderly population in the US (5). A study by Braybrook et al., designed to examine ways to streamline the prescription process in order to reduce costs, looked at some of the reasons people gave for returning unused pharmaceuticals to the pharmacy. The most common reason was a change of medication. Most items (80%) were returned within a year of their prescription date, but some people returned the medicines only after the infrequent removal of unwanted items that have built up over time, with some products being returned 13 years after they were dispensed (6). Unused and expired medications are likely managed in a wide variety of ways. Hoarding expired medications in the home or giving them to friends and family may increase the risk of accidental or inappropriate ingestion. Disposal of unwanted medications by rinsing them down a sink, flushing them down a toilet, or throwing them in the trash may also be common (7).Although a few pharmacies will take unused and expired medications back to facilitate proper disposal of them, the majority will not (8). Numerous medications have been found in trace amounts in groundwater, surface bodies of water, and drinking water (9), and in recent years, the existence of pharmaceuticals and their metabolites in water has been recognized as potentially dangerous. Acetaminophen, verapamil, and estradiol are just a few of the chemical routinely found in American waterways (10). Unfortunately, current water treatment systems do not remove many pharmaceuticals from drinking water.usually the concentration of these medications is negligible; however, longterm exposure to even low levels of multiple medications could be hazardous (10,11). Aim of the work: The objectives of this pilot study were to: 1- Determines the amount, types, and costs of unused medications present in community pharmacies located in Cairo, Egypt. 2- Identify and assess the different pathways of disposal of dispensed drugs. Main outcome measures: number of returned drugs, economic value of returned drugs, reasons for returning drugs and other methods of disposal of drugs. Method: The study was carried out in Cairo, Egypt during April This study was carried out in two parts. In the first part all drugs returned unused to 20 community pharmacies located in Cairo were documented during a period of one month (April 2009). The drugs were counted and classified according to the British National Formulary (BNF 2006) (12). We targeted 12 therapeutic groups in this study. 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. Costs were determined by multiplying the cost per pill to the estimated number of pills remaining in the container according to the list of drug prices provided by the Egyptian's Ministry of Health. 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 (13). In the second part of the study 316 respondents were asked whether they ever had any of the types of medicines and when and how they disposed of them. Information about the age, sex, education, profession, and postal code of the respondent in order to assess socioeconomic

3 status was collected. Respondents gave their written informed consent to this information being used anonymously in our study. Only closed-ended questions were used, with the questioner specifying possible answers. These questions have the advantages of being quick to administer, easy to answer, and easier to analyze and interpret than are open-ended questions (14). Where list questions were employed, no limit was placed on the number of answers that could be given, so that respondents were not required to choose a single answer when it did not wholly represent their attitude or behavior. Statistic The statistical package SAS Version 8.1 (SAS Institute, Cary, NC) was used for statistical analysis. Summary statistics were calculated for the amount of medications collected, their types and classes, and costs. RESULT RESULT OF THE FIRST PART: In 20 community pharmacies 541 returned items were collected during one month most of the drugs were antibiotics (20.15%), gastrointestinal (16.27%), cardiovascular system (10.72%), respiratory system (8.13%) and nervous system (7.20%) (table 1).most important reasons for returning drugs were the patient felt better (16.29%),reaching the expiration date(14.46%),patient died (12.02),unknown reasons(14.87%) and the prescriber change the treatment(9.98%)(table 2).The total wholesale price of returned drugs was calculated at Egyptian pounds ( U$). RESULT OF THE SECOND PART: The sample size was 316 people interviewed (54.8% female, 45.2% male).almost everyone (97%) had some type of pharmaceutical in their house. Responses indicate that (15.50%) finish their medication and hence have none to dispose of, (22.78%) keeps them until the expiration date, (11.39% ) don't dispose of them,(26.27%) discard them in household waste, with the remainder returning them to a pharmacist (12%) or flushed medications down the toilet (11.39%). Household waste was the most popular disposal method for all types of drugs (table 3). Table 1: Number and economic value of returned drugs Classification Number % Pound % Gastrointestinal Blood and blood forming organs Cardiovascular system Respiratory system Genito-urinary system Systemic hormonal preparations,sex hormones and insulin's antibiotics Antineoplastic and imunomodulating agents Analgesics and antiinflamatory Nervous system Antiparasitic prouducts,insecticides and repellents Dermatologicals Various others Total ( U$)

4 Table 2: Reasons for returning drugs Reasons Number % Expiry date due Patient felt better Patient died Unknown Physician changed order No effect or insufficient effect Adverse drug reactions Hospital admission Patient non-compliance or error Others Inconvenient to use Oversupply Changed dosage Empty package Contra-indication or interaction Prescription error Dispensing error Table 3: Method of disposal of medication Method of disposal Number of patients utilizing the method % Returned to a pharmacy Disposed of medication in the garbage Flushed medications down the toilet Disposed of drugs at another time (when drug expired) Use all medications before expiation Don't dispose of medications DISCUSSION The number of times a drug is returned gives an indication of the frequency of prescribing and the level of medication noncompliance. Antibiotics (16.32%) was the high amount of medication returned, followed by gastrointestinal (14.01%), blood forming organs (10.22%), geneto-urinary system (10.16%) and cardiovascular system (9.18%).This result consistent with Kevin et al who found that, the drug classes collected most frequently were nonsteroidal antiinflammatory drugs/pain (25%), cough/cold/allergy (15%), antiinfectives (11%), cardiac (10%), respiratory (9%), neurologic (8%), dermatologic (7%), and gastrointestinal (7%) (13). Many prescriptions are frequently switched or simply stopped in midstream by prescribers, 9.98% of patients returned their medication due to the physician change the order (table 2). This is agreeing with Leslie and Rosenheck who documented the switching phenomenon in a recent article tracking the prescription of antipsychotic medications within the Department of Veterans Affairs. Of the 21,873 patients with schizophrenia who were on stable 3-month prescriptions of any antipsychotic medication, 25% had their medications switched during the next year (15). Patients are also likely to stop medication on their own, 16.29% of patients

5 returned their medications due to they felt better or due to noncompliance (2.65%). Not more than 50% of patients adhere to a chronically prescribed antipsychotic medication, typical or atypical in type, for one year (16). Antidepressants, another costly and widely used medication class, are discontinued even more frequently (17). As we move away from the mental health arena, adherence is still a major problem. The cholesterol-lowering statins, which, like atypical antipsychotic medications and antidepressants, are prescribed most often for chronic use, show a similar pattern of premature discontinuation, leaving much unused, expensive medicine in consumer hands (18).Adherence rates for all medications prescribed for asthma range from 30% to 70% (19). Proper medication disposal is still an emerging environmental issue. Recently, pharmaceuticals have been detected in surface water, ground water, and drinking water. Furthermore, resistant bacteria may be selected in the aeration tanks of sewage treatment plants by the antibiotic substances present (11). As shown in table 3, 12% of respondents returned unused medications to pharmacies,the more typical methods were disposal of medication in the garbage (26.27%) followed by 22.78% disposed of drugs at another time i.e. when drug expired,15.50% use all medication before expiration,11.39% flushed medication down the toilet and 11.39% not disposing of them. Kuspis and Krenzelok surveyed 500 callers to a US poison information center, finding that only 1.4% reported returning expired medications to a pharmacy. The more typical disposal methods were throwing out in the trash (54%), flushing down a toilet or rinsing down a toilet or sink (35.4%), and not disposing of them (7.2%). A more recent study of 392 patients in southeastern England, where legal obstacles are much fewer, found that 21.8% of respondents returned unwanted medications to pharmacies (7, 20). Traditionally, disposal advice to consumers has been limited to flushing down the toilet or, in some cases, burning or grinding and discarding in household waste, but emerging environmental concerns mean that this is sometimes modified (21). People are first advised to check whether local pharmacies or doctors are able to receive returns or whether hazardous waste facilities exist in the area. As a last resort, disposal in household waste is deemed to be less harmful than disposal via the sewage system (22). Of important note, FDA currently recommends disposal by flushing for select medications, mainly Schedule II controlled substances.the federal guidelines are summarized here (23): Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so. If no instructions are given, throw the drugs in the household trash, but first: Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash. Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag.

6 Pharmacy take-back programs are another solution allowing patients to return unused or expired medications for proper disposal.although pharmacists play an important role in educating the public about proper medication disposal, the efforts of other health care professionals are also essential in helping to reduce water contamination with pharmaceuticals. Physicians, physician assistants, nurse practitioners, and dentists can also educate their patients and be more cognizant about overprescribing medications. Health care providers can also provide education and petition for hospitals to develop policies and procedures regarding proper medication disposal (24). CONCLUSION: This study demonstrated that an enormous amount of unused medications are present in the community in Egypt. The total wholesale price of returned drugs in one month was calculated at Egyptian pounds ( U$) which confirm the substantial economic value of unused drugs. Household waste was the most popular disposal method for all types of drugs. RECOMMENDATION: Community pharmacies would have the necessary personnel, expertise, and storage area to collect and store unused drugs. An investment in proper patient and health-care provider education is an appropriate first step in reducing medication waste. Proper disposal of these medications will require a coordinated effort either by community pharmacies or by governmental organizations. Recycling of these unused medications is another potential option. ACKNOWLEDGMENT: This study was self-funded by the investigator. We acknowledge the clinical pharmacy diploma students academic year for their participation in running the survey. REFERENCES 1. New Hampshire Department of Environmental Services. Environmental Fact Sheet. Emptying the medicine cabinet. Disposal guidelines for pharmaceuticals and personal care products. WMD- SW-33. Accessed 27 July Cameron S. Study by Alberta pharmacists indicates drug wastage a "mammoth" problem CMAJ 1996; 155: Huge waste of medicines claimed (editorial). Pharmaceut J 2000; 264: U.S. Census Bureau economic census. Accessed econ/census07, October 9, Morgan M. The economic impact of wasted prescription medication in an outpatient population of older adults. J Fam Pract 2001; 50: Braybrook S, John N, Leong K. A survey of why medicines are returned to pharmacies. Pharm J 1999; 263: R Kuspis A, Krenzelok P. What happens to expired medications? A survey of community medicine disposal. Vet Hum Toxicol 1996; 38: Smith A. Managing pharmaceutical waste: what pharmacists should know. J Pharm Society Wisconsin; Nov/Dec 2002; Heberer T. Occurrence, fate, and removal of pharmaceutical residues in the aquatic environment: a review of recent research data. Toxicol Lett 2002; 131: Woodhouse B. Pharmaceuticals and other wastewater products in our waters: a new can of worms? Southwest Hydrology; Nov/Dec 2003; 12 13, 30, 11. Stackelberg E, Furlong T, Meyer T. Persistence of pharmaceutical compounds and other organic

7 wastewater contaminants in a conventional drinking water treatment plant. Sci Total Environ 2004; 329: British National Formulary, ed. London: British Medical Association and Royal Pharmaceutical Society of Great Britain. 13. Kevin G, Mikki J, Kathy B, Melinda N. Economic Consequences of Unused Medications in Houston, Texas. The Annals of Pharmacotherapy 2004; Vol. 38, No. 7, pp Peterson A. Constructing Effective Questionnaires. Thousand Oaks, CA:Sage Publications, Leslie L, Rosenheck A. From conventional to atypical antipsychotics and back: dynamic processes in the diffusion of new medications. Am J Psychiatry 2002; 159: Cooper E, Hanrahan P, Luchins J. Compliance with typical versus atypical antipsychotic medications. Drug Benefit Trends 2003; 15: Tierney R, Melfi A, Signa W, Croghan W. Antidepressant use and use patterns in naturalistic settings. Drug Benefit Trends 2000; 6: Avorn J, Monette J, Lacour A, et al. Persistence of use of lipid-lowering medications. JAMA 1998; 279: Bender B, Milgrom H, Rand C. Nonadherence in asthmatic patients: is there a solution to the problem? Ann Allergy Asthma Immunol 1997; 79: Boehringer K. What s the best way to dispose of medications? Pharmacist s Letter. 2004; 20. Accessed 25 December Daughton G. Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human health. II. Drug disposal, waste reduction, and future directions. Environ Health Perspect 2003b; 111: Boehringer K. What's the best way to dispose of medications? Pharm Lett 2004; U.S. Food and Drug Administration. Disposal by flushing of certain unused medicines: what you should know. Accessed at ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/Ensuring SafeUseofMedicine/Safe- DisposalofMedicines/ucm htm# MEDICINES, February 25, Julie Ehret Leal; Amy N. Thompson; Walter A. Brzezinski. Pharmaceuticals in Drinking Water: Local Analysis of the Problem and Finding a Solution through Awareness. J Am Pharm Assoc. 2010; 50(5):