August 2007 Vol 7 copy.indd SULTAN QABOOS UNIVERSITY MEDICAL JOURNAL AUGUST 2007 VOL 7, NO. 2, P. 109-115 SULTAN QABOOS UNIVERSITY© SUBMITTED - 27ND JANUARY 2007 1Pharmacy Department, Sultan Qaboos University Hospital P. O. Box 35, Al-Khod 123, Sultanate of Oman; 2Oman Medical College, P. O. Box 620, Azaiba 130, Muscat, Sultanate of Oman *To whom correspondence should be addressed. Email: alsiyabi@dal.ca Value and Types of Medicines Returned by Patients to Sultan Qaboos University Hospital Pharmacy, Oman Khalid Al-Siyabi,1 Kassim Al-Riyami2 C L I N I C A L & B A S I C R E S E A R C H ABSTRACT Objectives: Frequent physician visits, improper therapeutic adherence and treatment modification after hospitalisation could result in unused medicine accumulating at home. This study aims to examine the value and types of medicines returned by patients at a tertiary care unit in Oman. Method: All medicines voluntarily returned to Sultan Qaboos University Hospital main phar- macy between February and June 2003 were reviewed. The cost of these medicines and potential cost saving, if some were returned to the hospital distribution cycle, were computed. A method of determining by physical observation whether they can be recycled was developed based on institutional-based guidelines and criteria. Results: Three hundred and eighty one patients returned their medicines (69% female). The patients returned a total of 07 drugs (mean per patient 3. per month) corresponding to a total cost of Omani Rials (OR) 20,40 (mean per patient OR 0.6) ( OR = 2.58 US dollar). Potential cost saving was OR 5,550 (mean per patient OR 2.9). Medicines of the cardiovascular group were returned in greatest number (24%) while anti-infective drugs had the highest share of the total cost (6%). Conclusion: The study identified values and types of medicines returned by patients at tertiary care unit in Oman. Medications used for cardiovascular and infectious diseases appeared as the most frequent and the most expensive returned medicines. It suggests that health care providers in Oman should devise health education programmes to improve proper utilization of medicine. Keywords: Drugs, supply and distribution; Prescriptions, drug; Health care economics; Oman. مستشفى صيدلية إلى املرضى طريق عن املعادة قيمة وأنواع األدوية –عمان قابوس السلطان جامعة الريامي السيابي، قاسم خالد تراكم إلى باملستشفى الترقيد بعد العالج طرق وتعديل العالجية باخلطة وقلة االلتزام لألطباء الزيارات تكرار يؤدي أن املمكن امللخص: الهدف: من الطريقة: بعمان. الثالثية العناية إلى وحده املرضى طريق عن املعادة األدوية وأنواع قيمة معرفة إلى تهدف الدراسة البيوت.هذه في كميات من األدوية ومت 2003م ويونيو فبراير بني قابوس ــلطان الس جامعة ــفى مبستش ــية الرئيس الصيدلية إلى املرضى طريق عن طوعا املعادة األدوية كل مراجعة متت ــب حس ــر املباش الفحص طريقة مت إتباع . التوزيع حلقة إلى أعيدت األدوية هذه أن ــو ل توفيرها املفترض واملبالغ ــا بأنواعه األدوية هذه ــة قيم ــاء إحص بترجيع أدويتهم قاموا مريضا وثمانون النتيجة: ثالثمائة وواحد ال. أم ــتخدام لالس صاحلة األدوية هذه كانت إذا فيما ملعرفة املعروفة واألنظمة اللوائح مريض لكل (املتوسط 20140 رياال وقدرة إجماليا مبلغا يعادل والذي الشهر) 3.1 في مريض لكل (املتوسط 1071 دواءا استرجاع مت (%69 إناث). أكثر الدموية واألوعية القلب لعالج ــتخدمة األدوية املس كانت 2.9 رياال). املريض ــط (متوس 5550 رياال مبلغا قدره توفير ميكن وبهذا 10.6 رياال) اخلالصة: بينت هذه .(61% التكاليف مجموع من النسب بأعلى عالج العدوى املستخدمة في األدوية ساهمت بينما (24%) بلغت حيث إعادة األدوية واألمراض القلب لعالج ــتخدمة املس األدوية عمان.تعتبر الثالثية في العناية وحدات إحدى إلى بإعادتها يقوم املرضى التي األدوية وأنواع قيم ــة الدراس املثلى للطرق صحية توعية ــتحداث اس في الصحية بالرعاية واملهتمون القرار أصحاب يقوم بأن ــعرا.نقترح س وأغالها املعادة األدوية أكثر من املعدية األدوية. استعمال في عمان. اقتصاد الرعاية الصحية، األدوية، وصف وتوزيع، إمداد الكلمات: أدوية، مفتاح Advances in Knowledge This is the first study in Oman to review the value and types of unused returned medicines. It has identified possible areas where there is a need to monitor drug therapy: cardiovascular and infectious diseases. The study stimulates the need to conduct a country-wide, sustained campaign for returning unused medicines to pharmacies. This may K H A L I D A L -S I YA B I A N D K A S S I M A L - R I YA M I 110 A MAJOR HEALTH BENEFIT TO THE GENERAL public in the Sultanate of Oman is the pro-vision of health services at all government hospitals and health centres free of charge including free medications. The health care services in Oman are provided by the Ministry of Health (MOH). They are divided into primary, secondary (regional), tertiary levels. The MOH manages tertiary hospitals (4 hospi- tals), all located in the capital Muscat.1 Sultan Qaboos University Hospital (SQUH) is a tertiary teaching hos- pital independent of yet working closely with MOH health care services. It accepts referred patients from and refers patients back to MOH managed services. SQUH and all government owned health care institu- tions dispense the free prescribed medicines from the pharmacies located within the respective health care facilities. SQUH, a 350-bed tertiary teaching hospital, pro- vides both general medical care and specialized treat- ment. In 2001, the hospital budget for the purchase of medicines was approximately three million OR. The hospital pharmacy spent 40% and 60% of its medicines budget for inpatients and outpatients respectively.2 During that year, the pharmacy was dispensing an av- erage of 300 prescriptions per day.2 The number of prescribed pharmaceutical items per prescription is continually rising and contribut- ing to increase health care cost world wide. In England during 2001, there was 6.4% increase in prescription numbers and a total ingredient cost of £6.1 billion rep- resenting an expenditure rise of 6.9% from 2000.3 The proportion of unused prescribed medicines is also in- creasing. In the year ending March 2001, 584.6 tons of unwanted medicines were returned to community pharmacies in England for destruction under Disposal of Old Pharmaceuticals (DOOP) scheme.4 This repre- sented an increase in s of 65% over the preceding four years compared with a rise of only 14% in prescription numbers during the same periods.3 There have been a number of similar large and detailed studies undertak- en in countries such as the USA, Canada and Sweden.5, 6, 7 For example, the US study conducted by Morgan et al. found that the mean individual annual cost of wasted medication s was $30.47. Waste represented 2.3% of total medication costs in their study. The study concluded that the individual costs were modest, but if $30 per person represents a low estimate of aver- age annual waste, the US total national cost for adults older than 65 years would top $1 billion per year.7 The availability of unused medicines in the home may unfortunately constitute a source of material for intentional or accidental poisonings. In the United Kingdom, in excess of 90,000 cases of poisoning as- sociated with pharmaceutical products are treated in hospital each year.8 Moreover, it is unclear how many medicines are disposed of through normal household refuse and the domestic sewerage system. The environmental impact of inappropriate medi- cine disposal by patients is a serious environmental issue.8, 9 One of the phenomena associated with the provi- sion of free medications, in countries such as Oman, is frequent switching by the patient from one hospital to another or multiple visits to one hospital.10 Added to this is the medication dispensing policy of SQUH, by which most patients with chronic disease are pre- lead to better understanding of why medicines remain unused by patients. Physio-chemical analysis of returned medicines should be looked into; this may help policy makers to review the issue of recycling of unused medicines. This study forms the basis for future research in this very important area of patient compliance with their prescribed medication. It also provides more data related to returned medication in Oman in particular and the Gulf region overall. Application to Patient Care Little was known about patients’ adherence to their therapy or about over prescribing by attending physicians in Oman. This study indicated areas where increased interaction between physicians and their patients is needed. This study has identified that patients with cardiovascular disorders are more likely to require additional attention and monitoring of their therapy. If this were done, patient care could be improved. The study suggests the presence of large amount of unused medicines kept at patients’ homes. There is a potential risk of accidental dosing and/or unintentional overdosing which could adversely affect patient care. Patient with chronic diseases should be encour- aged to bring their medications every time they attend their clinics. This study has identified the need for policy makers to review the 3-months supply prescribing policy for outpatients. 111 VA L U E A N D T Y P E S O F M E D I C I N E S R E T U R N E D B Y PAT I E N T S T O S U LTA N Q A B O O S U N I V E R S I T Y H O S P I TA L P H A R M A C Y, O M A N scribed a three-month supply. In an attempt to tackle medicine waste, SQUH Pharmacy has awareness campaigns. In an effort to improve compliance, notices were posted in strate- gic patient waiting areas requesting patients to return unused medicines to the pharmacy department for disposal. This is a passive ongoing campaign. The re- turned medicines are sorted and disposed by incinera- tion at the SQUH facility. These returned medicines represent financial loss, possible treatment failure and/or over prescription. This study was initiated to address some of these issues. The goals of the study were to compute the types and values of unused medicines; assess the po- tential cost saving if medicines were returned to the distribution cycle and develop criteria aimed at recy- cling some of the returned medicines based only on a physical examination of them. M E T H O D The study was performed in the SQUH Department of Pharmacy between February and June 2003 when co-author, Khaid Al-Siyabi, was a third year pharmacy student at Dalhousie University, Canada and doing ex- perimental learning at SQUH Pharmacy. Returned medicines received by pharmacy staff, were used for the study. The patient name, drug name, strength, dosage form, date of dispensing and quan- tity returned were all documented. Medicines were included if they had SQUH patients’ labels. This proc- ess was to insure that all items were SQUH items and were in the SQUH formulary. Those items without SQUH patients’ labels were excluded. Due to the lack of clear international defini- tions and guidelines on which medicines could be considered reusable and safe in an outpatient setting,11, 12, 13 the Department developed its own guide- lines and criteria taking patient safety into account. Medicines were qualitatively assessed to determine if they could be theoretically recycled based on dosage form, physical and chemical features [Table1]. Two licensed pharmacists confirmed the selection process carried out by the investigator. The drugs were classified according to the classification index of the British National Formulary.14 All data were entered into a Microsoft Excel programme for analysis and drug costs were computed using the acquisition cost in OR, provided by the Pharmacy Department during the time of the study.15 Figure 1: Distribution of most returned medications by pharmacological class. Cardio: cardiovascular system, CNS: central nervous system, Endo: endocrine, GI: gastrointestinal, Immuno: immunosuppressant, Resp: respiratory system, Musclar: musculoskeletal K H A L I D A L -S I YA B I A N D K A S S I M A L - R I YA M I 112 R E S U L T S Three hundred and eighty one patients, of whom 263(69%) were female, voluntarily returned their med- ications. A total of 1,171 items were returned to the pharmacy, an average of 3.1 medications per patient. Among these, 99 drugs were excluded. Cardiovascular drugs were the most common pharmacological group of returned drugs represent- ing 24% of the total returned medications. Central nervous system drugs were the second most returned medications with 14% [Figure1]. The remaining 1,072 drugs represented a total cost of OR 20,140, an average of OR 10.6 per patient per month during the time of the study. The anti-infective drugs represented the highest share of the total cost (61%), followed by cardiovascular (7%) and central nervous system (CNS) drugs (7%) [Figure 2]. The total cost of potentially reusable medications was OR 5,550 (27.6% of the returned medicines cost), an average of OR 2.9 per patient per month. D I S C U S S I O N This was an observational study, the first of its kind to be reported in Oman. In Arabian Gulf countries, there have been similar studies addressing the economic impact of unused medicines and patients’ percep- tion of safe medicine disposal.16, 17 Hisham et al. found that families in Saudi Arabia and other Gulf countries spent a total of US$ 150 million on medications that were never consumed. These results came from a pre- dominantly Saudi based questionnaire study.16 Our study found that, on average, each of the 381 patients returned three medicines at an average total cost of OR 10.6. This was a passive and voluntary ex- ercise carried out in a tertiary teaching hospital. There are 15 government run hospitals available in Oman and patients have access to all of them as well as ac- cess to all other health centres. Patients may have been dispensed medicines whenever they had contacts with physicians. Hence, we consider this study reveals only the tip of an iceberg. The study identified both possible therapeutic fail- ure and/or over prescription. Nearly one in five of the returned medicines were for cardiovascular therapy. It Figure 2: Percentage cost of most returned groups of medications (OR) Cardio: cardiovascular system, CNS: central nervous system, Endo: endocrine, GI: gastrointestinal, Immuno: immunosuppressant, Resp: respiratory system, Musclar: musculoskeletal 113 VA L U E A N D T Y P E S O F M E D I C I N E S R E T U R N E D B Y PAT I E N T S T O S U LTA N Q A B O O S U N I V E R S I T Y H O S P I TA L P H A R M A C Y, O M A N is not clear if this result reflected a pure treatment fail- ure, therapy modification or that this class of medica- tion was prescribed more frequently than other classes hence the higher percentage of returns. Cost wise, the anti-infective group of returned drugs was the highest (61%). One patient returned an anti-viral drug (Valciclovir) costing OR 800. This item increased the overall total cost of anti-infective drugs. From the clinical perspective, this study identifies the disease conditions to which health care providers need to pay more attention before repeat prescribing/ dispensing. Large amounts of unused medicines in patients’ homes increase the risk of self-medication, the sharing of medications amongst those with similar symptoms, the use of expired medicines and the use of different brand of similar drugs leading to accidental over dosage.18, 19 The study emphasizes the need for a detailed dia- logue prior to prescription so that patients and their physicians are in agreement and also the need to mon- itor the use of medicines, especially when modifying regimens. It is important to give clear and appropriate directions during patient counselling. The best way is to insist that patients bring all of their medicines with them whenever they visit a health care facility. Equally, from the economic perspective, the study provided a quantitative estimate of wasted resources due to medicines voluntarily returned and unused. In- terestingly, while part of this waste was related to non- use of medications for treating chronic diseases (e.g. cardiovascular drugs), an important proportion of this waste was related to non-use of highly expensive drugs especially of the anti-infective class [Figure 3]. It could be very cost-effective to employ clinical pharmacists’ skills in specialized clinics, which are involved in pre- scribing these two pharmacological classes of drugs, in order to monitor the appropriate use of these medi- cations. Studies had proven the value of pharmacists in such specialized clinics.19-23 The current study also suggests that it could be economically viable to estab- lish physico-chemical analyses for returned medicines. The availability of a biochemical analytical facility in the College of Science on the Sultan Qaboos Univer- sity campus would enable this development. In this way, it could be confirmed whether returned medicine could be returned to the distribution cycle or not. Finally, from the health care perspective, the mag- nitude of the problem emphasizes the need for inter- Figure 3: Percentage distribution of pharmacological groups, both quantity returned and cost Cardio: cardiovascular system, CNS: central nervous system, Endo: endocrine, GI: gastrointestinal, Immuno: immunosuppressant, Resp: respiratory system, Muscle: musculoskeletal K H A L I D A L -S I YA B I A N D K A S S I M A L - R I YA M I 114 vention to avoid both health risks and waste of money. Different kinds of policies can be explored,23, 18 such as patient counselling by pharmacists at the time of dis- pensing and drug utilization reviews applied to outpa- tient or inpatient healthcare settings,25 may decrease drug prescription and consumption, improve medica- tion use and could save money.18 This study leads to some serious some important and serious recommendations for research and action: the need to explore similar exercises in other hospitals and health centres, carry out an active promotion of returning unused medicines to all pharmacy facilities, explore reasons for the return of medicines unused and the need to counsel patients before seeing a physi- cian and during the dispensing process. L I M I T A T I O N S This study has some major limitations. First, all drugs returned were considered to be SQUH’s items if the returned medicine had an SQUH patient’s label. Some of medications dispensed from other hospitals could have been mixed with SQUH items. This may have re- sulted in an overestimation, during the study, of the number of drugs returned to SQUH and their cost. We do not believe, however that the number was so high as to have a major effect on the overall estimate of the number and cost of items. This study did not investigate the reasons why patients were not using the medications. One study published by Anders, 26 studied the reasons and the relative importance of why medicines were returned unused to Swedish pharma- cies. He concluded that the four main reasons for returning unused medicines to pharmacies were (1) the medicines were too old, (2) the user had died, (3) there was no need for the medicine any more and (4) the therapy had changed. These reasons made up 75% of all reported reasons.26 Finally, the cost of returned Valciclovir in the anti-infective group represented an extreme in this group and skewed the total cost of this group. C O N C L U S I O N The study identified a substantial waste of medicines posing a danger to the family and the environment. The study also identified both possible therapeutic failure and/or over prescription. Patients with car- diovascular and anti-infective medications need to be targeted for the possible improvement in their medi- cation use. Pharmacist counselling and drug utiliza- tion reviews will improve patients’ compliance. Other cost-saving measures may also be found. Methods for analysing returned medicines should be adopted as this has the potential of making a substantial saving to this and other hospitals. Further studies, such as sur- vey of patients who have returned medications, should be carried out. This need for revision of the 3-months supply prescribing policy for outpatients is an impor- tant issue raised by this study. A K N OW L E D G ME N TS We would like to thank all those who helped in the successful completion of this study. Special thanks go to Elizabeth Worthing for her initial review of this ar- ticle and also to, Ahmed Al-Kindi, Ali Al-Ma’awali and Kamla Al-Rahbi who double checked the intial separa- tion process. Most importantly, all the thanks go to all SQUH Pharmacy Department staff for the provision of an appropriate and very friendly working environ- ment. Non-recyclable medications Recyclable medications 1. Compounded or reconstituted drugs 2. Drugs that require refrigeration 3. Drugs those are adulterated or misbranded 4. Drugs which have had their integrity, packaging or labelling compromised (e.g., through environmental damage such as water damage, crushing, a broken seal, a torn or marked label and originally dispensed 5. Expiry date of less than six months 6. Ampoules for parenteral medication in single-dose sealed containers 7. Suppositories and suspensions 1. Intact, solid oral dosage forms 2. 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