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ORIGINAL ARTICLE
Year : 2012  |  Volume : 2  |  Issue : 3  |  Page : 258-265

Drug utilization pattern among geriatric patients assessed with the anatomical therapeutic chemical classification / defined daily dose system in a rural tertiary care teaching hospital


1 Department of Pharmacology, SBKS Medical Institute and Research Center, Piparia, Dist. Vadodara, India
2 Pramukhswami Medical College, Karamsad, Dist. Anand, Gujarat, India

Date of Web Publication8-Aug-2012

Correspondence Address:
Rima B Shah
Department of Pharmacology, SBKS Medical Institute and Research Center, Piparia, District: Vadodara, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2231-0738.99480

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   Abstract 

Aim: To use the ATC/DDD system to study the drug utilization pattern among geriatric patients in a rural tertiary care teaching hospital. Materials and Methods: A cross-sectional prospective observational study involving 400 geriatric patients was carried out from August 2007 to October 2009. Relevant information was obtained by personal interview and from perusal of case files. Results: The majority of the patients (72%) were in age group of 65-74 years. There was a male preponderance (60.03%). Of the total 1026 disease conditions, cardiovascular diseases were the most common (86.75%), followed by musculoskeletal conditions (32.25%); psychiatric diseases (0.5%) had the lowest prevalence. Comorbid conditions were present in 315 (78.75%) patients. A total of 2924 drug formulations, containing 3254 active ingredients, were prescribed, of which 339 (11.59%) were fixed-dose combinations (FDCs). The mean number of drug formulations per prescriptions was 7.31±4.39. Polypharmacy and high polypharmacy were prevalent in 52% and 23.25% of patients, respectively. Only 15.6% formulations were prescribed by their generic names and only 51.7% were drugs that were included in the World Health Organization's Essential Medicines List (WHO-EML) Drugs acting on the cardiovascular system (22.81%) were the most frequently prescribed drugs, followed by antimicrobials (16.89%) and drugs acting on the gastrointestinal system (13.61%). Ranitidine (A02BA02) 150 mg was most frequently prescribed drug having DDD of 162, followed by aspirin (B01AC06) 75 mg, diclofenac sodium (M01AB05) 50 mg, and amlodipine (C08CA01) 5 mg with numbers of DDD 118UD, 94, and 88, respectively. Conclusion: Drug utilization data can help in assessing the quality of care given to the geriatric patients and promote rational use of medicines.

Keywords: Anatomical therapeutic chemical classification / Defined daily dose system, drug utilization pattern, geriatric patients


How to cite this article:
Shah RB, Gajjar BM, Desai SV. Drug utilization pattern among geriatric patients assessed with the anatomical therapeutic chemical classification / defined daily dose system in a rural tertiary care teaching hospital. Int J Nutr Pharmacol Neurol Dis 2012;2:258-65

How to cite this URL:
Shah RB, Gajjar BM, Desai SV. Drug utilization pattern among geriatric patients assessed with the anatomical therapeutic chemical classification / defined daily dose system in a rural tertiary care teaching hospital. Int J Nutr Pharmacol Neurol Dis [serial online] 2012 [cited 2019 May 19];2:258-65. Available from: http://www.ijnpnd.com/text.asp?2012/2/3/258/99480


   Introduction Top


Drug utilization research has been defined by the World Health Organization (WHO) in 1977 as 'study of marketing, distribution, prescription, and use of drugs in society, with special emphasis on the resulting medical, social, and economic consequences.' [1] Drug utilization research may provide insights into different aspects of drug use and drug prescribing, such as pattern of use, quality of use, determinants of use, and outcome of drug use. Drug utilization is an important component of many research initiatives that examine the clinical and economic effectiveness of pharmacotherapy. Monitoring medication use and knowledge of prescription habits are some of the strategies recommended for containing and controlling medication cost and its effect on the national budget.

Considering the physiological changes that occur with aging and its impact on the pharmacokinetics and pharmacodynamics of drugs, it is essential to monitor drug effects, especially adverse drug reactions (ADR) and drug interactions, vis-a-vis clinical outcome in geriatric patients. [2] To understand these processes better and in order to make the drug use rational and safer, it is necessary to study the pattern of drug use in geriatric patients. As the number of medicines taken by geriatric patients and the incidence of ADR is more in this age-group, it becomes increasingly important to study patterns of drug use. Very few studies on drug utilization in geriatric patients are available and, to the best of our knowledge, no such study has been conducted in India so far. For these reasons we undertook the present study with the broad aim of understanding the pattern of drug use in geriatric patients and the influence of factors like age, gender, education status, socioeconomic status, etc. on drug prescribing in geriatric patients.

The anatomical therapeutic chemical classification (ATC) / defined daily dose (DDD) system is a tool for presenting drug utilization research in order to improve quality of drug use and is recommended by the WHO as the international standard for drug utilization studies. [1] One component of this system is presentation and comparison of drug consumption statistics at international and other levels. The DDD is an artificially and arbitrarily created statistical measurement used for research purposes when comparing the utilization of drugs. The formal definition of the DDD is 'the assumedaverage maintenance dose per day for a drug used for its main indication in adults.' DDD are assigned only to drugs that have already been provided with an ATC code. The DDD methodology was developed in response to the need for converting and harmonizing readily available volume data (bulk costs and prescriptions) from supply statistics of pharmacy inventory data into medically meaningful units; it allows us to make crude estimates of the number of persons exposed to a particular drug or class of drugs. [3],[4],[5]

The aim of this descriptive study was to analyze general medication utilization patterns in geriatric patients in a rural tertiary care teaching hospital.


   Materials and Methods Top


A prospective observational study was undertaken from August 2007 to October 2009 in Shree Krishna Hospital and Medical Research Center, a rural 550-bed tertiary care teaching hospital attached to Pramukhswami Medical College, Karamsad, India. The study protocol was approved by the human research ethics committee of the institute prior to commencement of the study (approval letter no PSMC/HREC/477 dated 18/12/07).

Sample size

Four hundred patients in the geriatric age-group (≥65 years), 200 each from the inpatient and outpatient departments of Shree Krishna Hospital (SKH), were included in the study.

Criteria for inclusion of participants

Patients of either gender who had completed 65 years of age on 31 st July, 2007, or earlier and who attended outpatient department or were admitted to the wards of different departments like medicine, surgery, obstetrics and gynecology, orthopedics, psychiatry, skin, TB and chest, ophthalmology, ENT, oncology, and dentistry were included in the study.

Criteria for exclusion of participants

Patients unable to communicate, i.e., patients on ventilators or seriously ill patients requiring ICU admission as well as those unwilling to participate were excluded from the study.

For recruiting study subjects, 2 months each was spent in the departments of general medicine, surgery, obstetrics and gynecology, and orthopedics and 15 days each in the departments of psychiatry, skin, TB and chest diseases, ophthalmology, ENT, oncology, and dentistry. Patients were recruited into the study on a pro rata basis in the stipulated time period and all the patients participating in the study were given clear explanations about the purpose and nature of the study in a language they understood. Written informed consent was obtained before inclusion in the study. All inpatients were visited daily in their respective departments during their hospital stay and interviewed. Every inpatient was followed up till he/she was discharged and their case record sheets were reviewed for gathering the necessary information and entered in a prestructured case record form. All outpatients, new as well as old, meeting the inclusion criteria were interviewed once only and their case sheets were reviewed to gather necessary information - as on that day - to fill up the case record forms.

The data was analyzed for patient-related details and drug use as follows:

Analysis of patients' details

We examined the age- and gender-wise distribution of the patients, literacy status, living status, socioeconomic status [6] , and main diseases suffered from as well as comorbid conditions.

Analysis of drugs used

Data were analyzed for total number of drugs prescribed (taking into consideration the number of ingredients in a multidrug formulation), average number of drugs per prescription, average number of drugs per prescription in the various departments, use of fixed-dose drug combinations (FDC), drugs prescribed by generic name or brand name, whether the drug was included in the WHO-EML (15 th edition, March 2007), and category-wise distribution of drugs prescribed. Depending on the number of drugs prescribed per day, patients were divided in three categories: those taking <5 medicines per day, 5-10 medicines per day, and > 10 medicines per day. For this study, 5-10 medicines per day was considered as 'polypharmacy' and >10 medicines per day was considered as 'high polypharmacy'. The ten most frequently prescribed drugs were identified and were given ATC codes. [7] The DDD of these drugs was calculated according to the WHO's ATC/ DDD system. [7]

Statistical analysis

All data were analyzed with the help of SPSS® version 14 software.


   Results Top


The demographic data [Table 1] shows that the majority of the patients were in the age-group of 65-74 years (288/400; 72%), followed by age-group of 75-84 years (85/400; 21.3%); the lowest number of patients (27/400; 6.8%) were in the age-group of >85 years. The age distribution among inpatients and outpatients was similar. Out of the total 400 patients, 60.03% (241/400) were male and 39.8% (159/400) were females. The majority of patients, (182/400; 45.5%) had studied only up to the 10 th standard; 3% (12/400) had completed postgraduate education. Only a small proportion of the patients (47/400; 11.8%) were living alone, and the majority (353/400; 88.3%) were living with their families. Most of the patients belonged to category of middle (174/400; 43.55%) and lower (172/400; 43%) socioeconomic classes and very few (54/400; 13.5%) belonged to higher socioeconomic class.
Table 1: Demographic data of patients

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A total of 1026 disease conditions were found to be prevalent among these patients. Diseases related to the cardiovascular system (347; 86.75%) were the most common cause for attending the hospital, followed by musculoskeletal conditions (129; 32.25%). Psychiatric diseases (2, 0.5%) were the least frequently encountered [Table 2]. Only 85 of the 400 patients (21.25%) had just one disease; the remaining patients (315; 78.75%) had comorbid conditions, ranging from two to seven [Table 3].
Table 2: Disease conditions prevalent in geriatrics patients

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Table 3: Distribution of comorbidities in the patients Number of diseases patient simultaneously suffering from

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The department-wise distribution of patients and drug use is shown in [Table 4]. The minimum number of drugs per prescription was one and the maximum number of drugs per prescription was 27. The average number of drugs per prescription was 7.31±4.39. The highest number of drugs per prescription was seen in the TB and Chest Department (10.64±5.42) and lowest number of drugs per prescription was in the Ophthalmology Department (5.51±2.83). Of these 400 patients, 99 (24.75%) were taking less than five medicines per day. Polypharmacy and high polypharmacy were found in 208 (52%) and 93 (23.25%) patients, respectively.
Table 4: Department-wise distribution of patients and drug use among them

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A total of 2924 drug formulations containing 3254 active ingredients were prescribed to the study population. Of the 2924 formulations, 2585 (88.41%) contained only one active ingredient, while 339 (11.59%) were FDCs. A large number (2468; 84.4%) of drugs were prescribed by their brand names and only 456 (15.6%) were prescribed by their generic names. A little more than half (1513; 51.7%) of the prescribed drugs were those included in the WHO-EML.

The category-wise distribution of drugs prescribed is shown in [Table 5]. Drugs acting on the cardiovascular system (667; 22.81%) were the most frequently prescribed drugs, followed by antimicrobials (494; 16.89%), drugs acting on the gastrointestinal system (398; 13.61%), and vitamins and minerals (317; 10.84%). Together these drugs accounted for nearly two-thirds (64.15%) of the total drugs in this study.
Table 5: Category-wise distributions of drugs

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Ranitidine 150 mg was most frequently prescribed drug (162 cases), followed by aspirin 75 mg (118 cases), diclofenac sodium 50 mg (94 cases), amlodipine 5 mg (86 cases), vitamin B complex (85 cases), salbutamol MDI (100 mcg/puff, 200 puffs in one container) (69 cases), calcium + vitamin D 3 (500 mg+ 250 IU) (66 cases), ciprofloxacin 500 mg (65 cases), atorvastatin 10 mg (65 cases), and paracetamol 500 mg (64 cases). These ten drugs were given the ATC code and their number of DDDs was calculated [Table 6].
Table 6: Ten most frequently prescribed drugs and ATC/DDD codes

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   Discussion Top


The geriatric population is on the rise worldwide. This population is vulnerable to many diseases and drug-related problems. Limited data are available in general, and in India in particular, on drug utilization in this population. We undertook this study in order to understand the pattern of drug use and related issues in geriatric patients.

In this study, male subjects (60.3%) predominated; 65.5% of the patients had had basic education (10 th standard and above); 88.3% were living with their families; and 86.5% were from the lower and middle socioeconomic strata. The majority of these patients had retired from work and hence was dependent on family member(s) for income and support.

The morbidity pattern in these patients was quite similar to what is commonly found in Indian geriatric patients. The common morbidities included cardiovascular conditions like hypertension, coronary artery disease, and congestive cardiac failure, and disorders of the musculoskeletal system such as osteoarthritis and new fractures due to fall. The notable feature was that psychiatric conditions were very uncommon (0.5%). This is in sharp contrast to the findings from western countries, where psychiatric conditions are among the most common. [8] This low prevalence of psychiatric conditions in our study could be due to poor awareness regarding psychiatric illness among patients and family members . On the other hand, it is also possible that as most of the elderly persons in this study were living with their families (and not in old age homes), they had the advantage of family support and care, which may have helped in avoiding psychiatric conditions. The majority of patients in our study had comorbid conditions. The prevalent comorbidities in our study are very similar to the ones reported in another Indian study. [9] Loss of functional reserve with aging makes geriatric patients vulnerable to the development of multiple diseases affecting different body systems. The presence of comorbidities means that multiple and complex drug therapy is required and thus the chances of ADRs and drug interactions are greater.

In this study, a total of 2924 drug formulations were prescribed to a total 400 patients for different diseases. Of these drug formulations only 11.59% were FDCs. FDCs increase the risk of drug interactions and ADRs. Moreover, they cause difficulty in titrating the dose of a particular drug as it is not possible to increase or decrease the dose of an individual ingredient alone. The use of FDCs can improve compliance with therapy by decreasing the number of formulations to be taken, but their benefit/risk ratio should be assessed before they are prescribed. However, considering that the number of FDCs in India, which is around 60% of all available formulations, [10] the use of FDCs in our institution is relatively low, reflecting rational use of medicines. Partly, this may also be because our hospital pharmacy does not stock many FDCs.

We found that the average number of drugs prescribed per prescription was 7.3±4.39, as against five drugs per prescription reported by studies from Brazil [11] and South India [12] in geriatric patients. Considering the types of patients visiting a tertiary care hospital and the tendency for comorbidities in the elderly, this high number of medicines per prescription is not unexpected. The average number of medicines in our study is more than that in the other two studies mentioned, and fall in the category of polypharmacy. However, it may be mentioned that while computing the number of medicines taken by our patients we have counted each ingredient in multidrug formulations. In our study, 75.25% of patients were prescribed more than five medicines per day which, by definition, amounts to polypharmacy. In similar studies from Germany [13] and Singapore [14] polypharmacy was found in 26.7% and 60% of patients, respectively. The magnitude of polypharmacy in our study is significantly more (P<.05) than that in both other studies. It is noteworthy that the scale of polypharmacy is more in Singapore than in Germany though Singapore can be rated to be as well developed as Germany. It seems likely that polypharmacy is a common practice in South Asian counties. Considering the adverse outcomes associated with polypharmacy, including adverse drug events, drug-drug interactions (often very complex), increased cost of medications and/or treatment, increased risk of hospitalization, patient non-adherence with treatment (which increases with complex regimens), and various medication errors, we need to take appropriate measures for minimizing the extent of polypharmacy.

We found that only 15.6% of drugs were prescribed by their generic names. Other studies from India have reported generic prescribing to the extent of 38.85% [15] and 43.9%, [16] which is higher than that in our study. Very few studies have been conducted focusing on this aspect of drug prescribing. These findings clearly indicate that there is a need to encourage prescribing by generic names, particularly in hospitals attached to medical colleges. Medical students are taught only the generic names of drugs in pharmacology and generic prescribing is emphasized in teaching hospitals. In general, the world over, only the generic names of drugs are used in medical schools; similarly, in medical textbooks and scientific and research journals. Moreover, only generic names are accepted for legal and administrative purposes. However, due to aggressive marketing by pharmaceutical companies and a faulty drug policy doctors prefer to use brand names of the drugs in their prescribing in India. Commitment to prescribing drugs by generic names on the part of the doctor, and the political will to enforce drug production and prescribing only by generic names on the part of legislative and administrative bodies can certainly lead to decrease in irrational prescribing and increase in availability of essential drugs, thus ultimately promoting rational use of drugs at cheaper cost.

To best of our knowledge, ours is the first study where an effort has been made to determine the essentiality of medicines prescribed in geriatric patients by comparing the same with the WHO-EML (15 th edition, March 2007). We found that out of the total 2924 drugs prescribed, 1513 (51.7%) were those that were included in this list. First introduced in 1975, the concept of essential medicines is now widely accepted as a highly pragmatic approach to providing the best, evidenced-based and cost-effective drug therapy. [17] There is a need to educate and encourage the doctors to prescribe only essential medicines to the extent possible so as to ensure rational use of medicines in geriatric patients.

Nearly one-fourth of the drugs prescribed in this study were for cardiovascular conditions. This is not surprising as cardiovascular conditions topped the list of diseases in our patients. Following this, in descending order of frequency, the prescribed drugs included antimicrobial agents, drugs acting on the gastrointestinal system, vitamin supplements, and analgesic and anti-inflammatory drugs. Our findings correlate well with the observations from studies done in UK [18] and Brazil. [11]

We identified the ten most frequently prescribed drugs in this study. Ranitidine (A02BA02) was found to be the most frequently prescribed drug. This coincides with the findings of other studies from India, which have also shown highest use of group A (alimentary and metabolism) drugs according to the ATC classification system. [19] Though ranitidine was the most frequently prescribed drug, the prevalence of gastrointestinal diseases was very low in our study. Ranitidine was probably being prescribed for prophylaxis against non-steroidal anti-inflammatory drug (NSAID)-induced gastritis. However, prophylactic use of ranitidine is not needed with short-term NSAID therapy in patients without any history of ulcer disease. [20] Interestingly a Brazilian study [11] has also reported ranitidine as one of the most frequently prescribed medicines despite low prevalence of gastrointestinal conditions. This shows that irrational use of ranitidine is common.

The next most frequently used drugs, second and third in ranking in our study, were found to be aspirin (in antiplatelet doses, B01AC06) and diclofenac sodium, M01AB05 (94; 23.5%). Their large-scale use can be explained by the high prevalence of cardiovascular and musculoskeletal conditions, respectively. In the present study, vitamin B complex was used in 85 (21.25%) patients; this can perhaps be considered as nutritional supplement in geriatric patients; [21] very few indications exist for its therapeutic use. Though preparations of either vitamin B complex or multivitamins have not found place in the WHO-EML so far, multivitamin preparations are listed in the national list of essential medicines of India (2011). Among the cardiovascular drugs, amlodipine and atorvastatin were prescribed in 21.5% and 16.25% of patients, respectively. Their use corerelates with the high frequency of cardiovascular conditions (86.75%) in the patients included in this study. Calcium channel blocker drugs were the most frequently prescribed drug group for hypertension in our study as also in a similar study done in Ahmedabad, [22] though recent guidelines suggest that thiazide diuretics should be the drugs of first choice for treatment of hypertension in elderly (with calcium channel blockers being the drugs of second choice). [21]

The DDD system is most frequently used in academic articles and reports, and is a tool for national and international comparison of drug consumption. The number of DDDs for the ten most frequently used drugs in our study was calculated. This can serve as a baseline data for comparison with similar studies in future and can help identify any changes in the trend of drug consumption over time. In our study the number of DDD for ranitidine 150 mg tablets was 162, which indicates high consumption of ranitidine by patients in our setup. Yet another drug-utilization study from India, [23] wherein DDD of drugs was calculated (using a different method) showed results similar to ours with regard to frequently prescribed drugs; however, that study was not done exclusively in geriatric patients. In fact, to the best of our knowledge, ours is the first effort to calculate the DDD of commonly prescribed drugs in geriatric patients in India. Drug consumption data presented in DDD only give a rough estimate of consumption and not an exact picture of actual use. DDD provide a fixed unit of measurement independent of price, currency, package size, and strength, enabling the researcher to assess trends in drug consumption and to perform comparisons between population groups. The ATC/DDD system can also help in evaluation of long-term trends in drug use for assessing the impact of certain events on drug use and for providing denominator data in investigations of drug safety. [4]

Ideally, the DDD of the drugs in hospitalized patients should be calculated per thousand beds per year. We have not done so for our inpatient population since half of the patients included in the study were outpatients. The cost component of the drug therapy as part of DDD also could not be computed due to nonavailability of relevant data. Besides, the number of patients in the study is also relatively small. These can be considered as limitations of our study but, nevertheless, the study findings cannot be considered any less important. This study has generated data on the various diseases prevalent in Indian geriatric patients and given an overview of general drug utilization among them instead of focusing on one disease or a specific class of drugs only. As there has not been any similar earlier study in the Indian setting, we believe that our study is innovative in nature and that our findings provide baseline data for comparison with the findings of similar studies in future. Though this study has not focused on the morbidity pattern of a specific disease or the usage pattern of a particular category/class of drugs in Indian geriatric patients, it may pave the path for future larger-scale studies of a similar nature.

In conclusion, this study has shown the patterns of diseases prevalent in geriatric patients and drug use among them and has also provided useful baseline data. Drug utilization studies of this type may ultimately help in improving the quality of healthcare given to the geriatric patients.

 
   References Top

1.World Health Organisation. Introduction to drug utilization research. Geneva: World Health Organisation; 2003.  Back to cited text no. 1
    
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4.WHO Collaborating Centre for Drug Statistics Methodology, Guidelines for ATC classification and DDD assignment 2010. Oslo, 2009.  Back to cited text no. 4
    
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8.National institute of health. The number count: Mental disorders in America, 2008. [Last cited on 2009 Nov 22]. Available from: http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america/index.shtml. [Last accessed on 2011 Aug 12].  Back to cited text no. 8
    
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18.Kennerfalk A, Ruigómez A, Wallander MA, Wilhelmsen L, Johansson S. Geriatric drug therapy and health care utilization in the United Kingdom. Ann Pharmacother 2002;36:797-803.  Back to cited text no. 18
    
19.Zaveri H. Drug use in elderly: A prospective study in medicine outpatient department of tertiary care teaching hospital [dissertation]. Ahmedabad, Gujarat (India): The Gujarat University; 2008.  Back to cited text no. 19
    
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21.Satoshkar RS, Bhandarkar SD, Rege NN. Pharmacology and Pharmacotherpaeutics. 20 th ed. Mumbai: Popular Prakashan Private Limited; 2007.  Back to cited text no. 21
    
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23.Simpson GB, Das DG. Indian hospital drug use study shows need to improve prescribing. Essential Drugs Monitor No. 32; World Health Organisation;2003.  Back to cited text no. 23
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]


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