A drug utilization study to provide background data for bringing amendments in the drug dispensing...

ORIGINAL REPORT

A drug utilization study to provide background data for bringingamendments in the drug dispensing policy of a pediatricreferral centery

Inderjeet Singh MBBS, MD1, Rajan Mittal MBBS, MD, DM1, Nusrat Shafiq MBBS, MD, DM1,Bhavneet Bharati2, Ramesh Kumar Nigah MPharma3, P. Pandhi MBBS, MD, DM1,Ranjeet Roy Chaudhary MD, PhD4 and Samir Malhotra MBBS, MD, DM1*

1Department of Pharmacology, PGIMER, Chandigarh, India2Department of Paediatrics, PGIMER, Chandigarh, India3Central Drug Store, PGIMER, Chandigarh, India4Apollo Hospitals Educational and Research Foundation, Task Force for Research, New Delhi, India

SUMMARY

Objectives The purpose of this study was to generate data regarding the drug utilization pattern in pediatric population of our tertiary carehospital so that we could generate an essential medicine list (EML).Background Drug therapy accounts for a major portion of expenditure toward health care. Reduction in health care cost for an individualcan be achieved by lowering the cost of drug treatment.Methods This was an observational study conducted in the Advanced Pediatric Centre of our hospital, during which prescriptions and caserecords were reviewed.Results During the study a total of 891 prescriptions were reviewed. Antibiotics and nutritional supplements were the major drugsprescribed. A large percentage of drugs were prescribed as trade names. Eighty three per cent of the drugs were prescribed from the NationalList Of Essential Medicine 2003 (India). Antibiotics accounted for the major bulk of cost of drugs, most of which were purchased by thepatients.Conclusions Restricted use of newer antibiotics, branded drugs and prescribing from the EML could be considered as targets for reductionof cost of therapy. Copyright # 2009 John Wiley & Sons, Ltd.

key words—drug; utilization; pediatric; India

Received 20 November 2008; Revised 10 February 2009; Accepted 20 July 2009

INTRODUCTION

India is a developing country with population of over1 billion. Although the annual per capita income is$3800, a large number of people (34.3%) live belowpoverty line (per capita income for those below povertyline is $1 per month). The Indian government spendsabout 5% of the Gross Domestic Product (GDP) onhealth care.1

Further, health care in the government institutes ishighly subsidized as far as consultation fees, hospitalstay, and investigations are concerned. However, evenin these setups a large number of patients have to makeout of pocket payments for medicines. National HealthAccounts reveal that about 72% of all healthexpenditure burden is borne by the patients.2 AnIndian household spends 5% of total expenditure onhealth.3 A national sample survey reported that about3.7% of total population was impoverished in the year1999 due to health care costs.4 Other studies haveshown that 17–34% of hospitalized Indian patients getimpoverished due to health care costs burden.5 Thesestatistical data show that health expenditure is asignificant issue for an Indian household.

pharmacoepidemiology and drug safety 2010; 19: 393–399Published online 17 December 2009 in Wiley InterScience (www.interscience.wiley.com) DOI: 10.1002/pds.1832

*Correspondence to: S. Malhotra, Department of Pharmacology, PGIMER,4001, Research Block B, Chandigarh 160012, India.E-mail: [email protected] authors declare no conflict of interest.

Copyright # 2009 John Wiley & Sons, Ltd.

In order to take care of this medication burden in thestate of Delhi, a comprehensive drug policy was imple-mented that had a major impact on drug prescribingpattern in various health care centers in Delhi.According to this model, a centralized procurementof medicines across all the public sector hospitals wasinitiated, which allowed the government to bargainwith drug manufacturers and obtain medicines at costmuch lower than the market price. After implementa-tion of Delhi model6 percentage of drugs dispensed onprescription increased from 16.5% in the year 1997 to84% in the year 2002. This considerably brought downthe out of pocket payment by the patients. Bulkpurchasing of selected drugs during the policy periodled to an estimated saving of nearly 30% in the annualdrugs bill for the government of Delhi.6

Keeping in mind the huge financial burden borne bythe patients and the success of Delhi model in bringingdown the prices of essential medicines we conductedthe study with the aim of generating drug utilizationdata in the pediatric population visiting a tertiary carehospital. The study results would be taken as a basis foridentification of potential targets for changes in drugpolicy, purchase, and procurement in our city.

METHODS

This drug utilization study was conducted at theAdvanced Pediatric Centre of Postgraduate Institute ofMedical Education and Research, Chandigarh, India.The study was an observational study completed over aperiod of 6 months, from January 2007 to June 2007.Medical records and the outpatient cards of patientsvisiting the hospital were reviewed. Records from thespecialty clinics, including, rheumatology, endocrin-ology, asthma, nephrology, diabetes, and gastroenter-ology clinics were evaluated. Additionally, recordsfrom the general outpatient clinics and inpatients werealso reviewed for the analysis. All the records werereviewed by two investigators independently.Patient characteristics such as age, sex, demographic

data, diagnosis, and the prescription were recorded in aproforma applicable for the drug utilization studies.The following WHO core drug prescribing indicatorswere evaluated: (a) average number of drugs perencounter, (b) percentage of drugs prescribed bygeneric names, (c) percentage of encounters with anantibiotic, (d) percentage of encounters with aninjection, and (e) percentage of drugs prescribed fromthe essential drugs list or formulary. Adherence to theWHO Defined Daily Dose (DDD) for each drug usedcould not be evaluated as there is no specified DDD for

pediatric age group. Intravenous fluids and nutritionalpreparations were also included in the study. Drug data,including name of the drug, dosage schedule (form,route, and frequency) and duration of treatment wererecorded. All drugs were coded as per the WHOAnatomical Therapeutic and Chemical Classification(ATC) coding system. The diseases were classifiedaccording to the WHO ICD 10 classification. NationalList of Essential Medicine 20037 of India was used forassessing the number of drugs prescribed from theessential list. All information was transcribed onto anMS Access 2007 version database and subsequentlystatistically analyzed using the same.Statistical analysis—continuous data are expressed

as mean� S.D. Additionally median with rangewas alsocalculated for such data. Nominal data were expressed aspercentages. No statistical hypothesis was tested.

RESULTS

A total of 891 prescriptions comprising of 20.5%inpatient and 79.5% outpatient prescriptions werereviewed during the study period. Chronic diseases likeasthma (14.3%), epilepsy (12.9%), renal diseases(11.6%), and musculoskeletal disorders (13.8%)accounted for maximum number of outpatient pre-scriptions while systemic infectious diseases (80%)accounted for maximum inpatient prescriptions.Anti-infective agents were the main class of drugs

prescribed [692 (28.3%)]. Other classes of commonlyprescribed drugs were anti-inflammatory agents,cardiovascular drugs, drugs acting on the centralnervous system and hormonal agents (Table 1).Prescriptions were made to patients from diverse

socio-economic background. The mean age of patientsfor whom the prescriptions were written was 59.8months [Median-48, Range (1–204)]. Neonates accountedfor only 2% of the total prescriptions (Figure 1a).Majority, 74.6%, of the recipients were males. 36.7%and 29.5% of total prescriptions were made to childrenof age 1–5 years and 5–10 years, respectively. About41% of total antibiotic prescriptions were made tochildren of age group 1–5 years (Figure 1b). Similarwas the percentage of respiratory drugs prescribed tothis age group.The mean� SD [median (range)] number of drugs

prescribed per prescription (DPP) was 2.7� 1.5[2(1–10)]. Average DPP for inpatient and outpatientswas 3.8� 1.8 [4(1–9)] and 2.47� 1.36 [2(1–10)],respectively. In the outpatient setting, specialty wiseaverage DPP was: endocrinology 3.5� 1.01[1.5(1–6)];nephrology 3.4� 1.7 [3(1–9)]; rheumatology 3.0� 1.7[3(1–10)]; pulmonology 2.5� 1.2 [2,1–6].

Copyright # 2009 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, 2010; 19: 393–399DOI: 10.1002/pds

394 i. singh ET AL.

Analysis of WHO core indicators is summarized inresults (Table 2).Injectables used in inpatient and outpatient settings

were 81% and 21%, respectively. Antibiotics were themost common (77%) drugs prescribed as injectables.From among the antibiotics, beta-lactam group of

antibiotics were prescribed most commonly (78%).The other drugs prescribed as injectables were insulin(10%), immunological agents (6.5%), inotropes 2%,and the rest were parenteral antiepileptic and vitaminpreparations etc.Overall 83% of the total drugs prescribed were from

the National List of Essential Medicine 2003.Adherence to the list was most commonly seen withantiepileptic drugs (95%) and least with drugs used forgastrointestinal diseases (35%).In total 2443 drugs were prescribed in various clinics

in the study population. Of these 71% were prescribedby trade names. Only 28% of drugs were prescribed bytheir generic names (Figure 2).Antibiotics were prescribed in 392 out of 891

prescriptions. 218(55.8%) of these had a singleantibiotic prescribed, 74(18%) and 73(18%) had two

Table 1. Table showing various classes of drugs prescribed

Major group Classes of drugs Numberprescribed(percentage)

Anti-infectives 692(28.3%)Beta lactams 278(40.17%)Anti tubercular drugs 149(21.53%)Aminoglycosides 55(7.95%)Others 51(7.37%)Antiprotozoal and Anthelmintics 46(6.65%)Tetracyclines 31(4.48%)Antivirals 28(4.05%)Antifungals 24(3.47%)Quinolones 16(2.31%)Macrolides 14(2.02%)

Anti-inflammatory 301(12.32%)Non steroidal anti-inflammatorydrugs

107(35.55%)

Corticosteroids 146(48.5%)Immunosuppressants 34(11.3%)Others 14(4.65%)

Hormonal agents 110(4.5%)Thyroid hormones 39(35.45%)Insulin 29(26.36%)Vit D preparations 25(22.73%)Steroidal agents 11(10%)Pituitary hormones 6(5.45%)

Cardiovascular drugs 139(5.69%)Beta blockers 34(24.46%)ACE inhibitors 31(22.30%)Diuretics 24(17.27%)Inotropes 22(15.83%)Calcium channel blockers 14(10.07%)Others 11(7.91%)Alpha blockers 3(2.16%)

Drugs acting on central nervous system 290(11.87%)Antiepileptics 267(92.1%)Anticholinergics 14(4.83%)Muscle relaxants 3(1.03%)Others 5(1.72%)Antipsychotics 1(0.34%)

Drugs acting on gastrointestinal system 92(3.67%)Proton pump inhibitors 31(33.7%)Prokinetic agents 20(21.74%)Laxatives 15(16.30%)Antiemetic 13(14.13%)Antacids 6(6.52%)Others 4(4.35%)H2 blockers 3(3.26%)

Drugs acting on respiratory system 247(10.11%)Bronchodilators 119(48.18%)Anti-inflammatory 92(37.25%)Antihistamines 28(11.3%)Others 8(3.23%)

Nutritional supplements 572(23.41%)Total 2443

Figure 1. (a) Pie chart showing age distribution of prescriptions. (b) Barchart showing age wise drug usage pattern (CVS, cardiovascular drugs;CNS, central nervous system drugs; GIT, gastrointestinal drugs)

Table 2. Table showing WHO core indicators assessing drug prescription

WHO Core indicators N(%)

Encounters with injectables 244(27.4%)Encounters with antibiotics 393(44.1%)Drug prescribed from the essential medicine list 2044(83.67%)Average number of drugs per prescription 2.7Drug prescribed as generic 692 (28.3%)


drug dispensing policy of a pediatric poulation 395

and three antibiotics prescribed per prescription,respectively.Drugs prescribed in various clinics are shown in

Figure 3. Antibiotics and nutritional agents were themost common drugs prescribed to the inpatients.Mean cost per prescription was $13.7� 41.54

[Median $3.8, Range (0.06–409.2)]. Anti-infectiveagents accounted for the major cost (70% of total cost)of prescribed drugs. Among the anti-infective agents,the newer antibiotics like vancomycin, meropenam,piperacillin plus tazobactam accounted for the majority

of the cost. The percentage cost of other drugs isdepicted in the results (Figure 4). The total cost ofprescriptions was $12 135.04.

DISCUSSION

Our study is the first drug utilization study reporting thedrug usage pattern among pediatric population in bothinpatient and outpatient settings at a tertiary care levelin India. Some authors have previously conducted drugutilization studies in this age group, but those studieswere done in specific settings such as the neonatalemergency patients8 or outpatient department of areferral care teaching hospital.9

Ours is a tertiary care referral center which conducts,besides general pediatric outpatient department,several specialty clinics. Inpatient setting constitutesboth general wards and intensive care units. However alarge proportion of patient visits are primary visits.Therefore our sample is fairly representative of all thepublic sector hospitals in the city. Drug prescriptionsare written by the treating physicians, while the drugsare to be procured by the patients themselves.The drugs which accounted for over 50% of

prescriptions included the anti-infectives and nutri-tional supplements (includes vitamins and mineralsupplements). The anti-infective agents were mainlyused in the inpatient settings. Of the anti-infectiveagents, antibiotics were most commonly prescribed.These agents also accounted for a larger percentage ofinjectables. The diseases commonly responsible forhospital admissions in the pediatric age groupespecially the children of 1–5 years, in our settingsare infectious in etiology. This may have accounted fora higher usage of these compounds. Though we couldnot gather complete information about the indicationfor their use, inappropriate use of antibiotics cannot beruled out. The present finding has brought forth theneed to investigate the rational use of antibiotics inpediatric age group. Similar high use of anti-infectiveagents has been noted by other authors.8,9 In a studydone by Bharathiraja et al.10 about 79.4% of childrenwere prescribed antibiotics for common childhoodillnesses 96% of which were prescribed for acuterespiratory infections (ARI). Antonio da Cuna et al.,11

reported that 28% of antibiotic prescriptions forchildren in Brazil with ARI were inappropriate.Inappropriate antibiotic prescription is more prevalentin the outpatient settings and at primary care level inchildren. However, in the inpatient settings and theintensive care settings of tertiary care centers the dataregarding this issue is scarce.

Figure 2. Bar chart showing the generic and trade name drug prescriptionpattern (CVS, cardiovascular drugs; CNS, central nervous system drugs;GIT, gastrointestinal drugs)

Figure 3. Pie chart showing cost of various drug classes (CVS, cardiovas-cular drugs; CNS, central nervous system drugs; GIT, gastrointestinal drugs)


396 i. singh ET AL.

The other group which was commonly prescribedwas of nutritional supplements. A variety of agentswere classified as nutritional supplements. A largenumber of these patients needed iron supplementation,which may be accounted by high incidence of anemiain this age group. Malnutrition continues to be asignificant problem for children and adults in India.12

The use of multivitamins may not be entirely rationaland needs to be investigated. In a study done by Shaikhet al.,13 it was observed that large number of childrenand adolescents use vitamin and mineral supplements,which for most may not be medically indicated. Use ofnutritional supplements is another area which needscloser scrutiny.In total, 27.3% of the prescriptions had a drug

prescribed as an injectable. Most of the injectableswere prescribed to the patients admitted to the hospital.Prescribing of drugs as injectables can be associatedwith medication errors and involves the problemsassociatedwith their administration.14 From the evalua-tion of the data sources majority of the injectables werefound to be indicated. However, there is a need toemphasize the need to switch over to other routes ofadministration as soon as possible. A systematic reviewconcluded that oral therapy appears to be an effective

and safe alternative to parenteral antibiotics inhospitalized children with severe pneumonia who donot have any serious signs or symptoms.15 It needs tobe investigated if the practice of switching fromparenteral to oral drug administration when the clinicalcondition permits would reduce the cost associatedwith drug therapy.Interesting to note was a high percentage of drugs

prescribed from essential list. Eighty-three per cent ofdrugs prescribed were prescribed from the IndianNational List of Essential Medicines, 2003. This listdiffers from the recent WHO Essential Medicine List(EML)16 drugs which were compiled keeping theunderdeveloped nations in mind. Essential drugs areaimed at achieving accessibility to quality assured andaffordable medicines to larger sections of the society. Itneeds to be seen, however, if the concept of essentialmedicines is used to its maximum potential in variousother clinical settings. The ‘Delhi model’ for devel-oping a comprehensive drug policy could serve as atemplate for furthering this practice.6 The mainobjective of the policy was to improve the availabilityand accessibility of quality essential drugs for all thosein need. The steps taken to implement the policy were:(1) selection of EML, (2) establishment of pooled

Figure 4. Bar chart showing drug usage pattern in various speciality clinics (CVS, cardiovascular drugs; CNS, central nervous system drugs; GIT,gastrointestinal drugs)



procurement systems, (3) preparation of a formulary,(4) introduction of quality assurance system, (5) trainingin rational prescribing, (6) provision of drug information,(7) development of standard treatment guidelines,(8) research, and (9) monitoring and evaluation andcontents of drug advertising and promotions.The practice of prescribing drugs by brand names is

prevalent in most of the clinical settings of India. Ourstudy results comply with the results of other studiesand generic name prescribing was seen in 28% ofdrugs. Generic prescribing has been shown to haveseveral benefits such as increased patient adherence totherapy and lowered cost of drug therapy in terms ofsaving.17,18 American Academy of Family Physiciansrecommends prescribing drugs in generic forms as astrategy to avoid high cost of drug therapy.19

The average cost per prescription approximated$13.7. This amount is a substantial burden for thepatients, as they largely belong to the lower socio-economic strata and receive no reimbursement formedical expenditure. The high cost per prescriptionwas largely driven by antibiotic prescriptions whichaccounted for nearly 70 per cent of the total cost. Thisfinding is similar to the results of a previous study doneby us in the adult emergency unit of our tertiary carecenter.20 In that study we had observed that antibioticsusage accounted for more than 50% of drug costexpenditure. Though, we did not investigate if this highcost per prescription could be brought down if genericswere prescribed in place of branded drugs, the roleplayed by prescription of branded drugs cannot beruled out. The overall cost projections carried out overto the entire population from which the sample wasderive approximates to 40 crore INR for a period of1 year. This has been obtained by taking into con-sideration the cost burden of individual groups of drugsand summing them up.Most of the drugs prescribed were purchased by the

patients, which accounted for a large percentage of outof pocket drugs. This indicates that patients share alarge amount of burden toward health care. This issignificantly large amount for patients belonging to lowsocio-economic groups.4,5

Some of the limitations of our study are a lowpercentage of neonates (2% of total prescriptions),reliance on one time analysis of prescriptions, inabilityto assess the rationality of use of antibiotics in varioussettings. Data needs to be generated regarding theannualized cost projections for our hospital and thesavings possible based on Delhi experience. Practice ofprescribing newer antibiotics and nutritional supple-ments could be considered as potential targets forreducing the cost of drug treatment.

CONCLUSIONS

From this study, it is apparent that there is need forestablishment of a system for provision of medicines ata subsidized rate in the government setup in a countrylike India since a large proportion of the populationbelongs to low socio-economic status. Establishmentof such a system needs generation of drug utilizationpattern. Our study is a first step in this direction.

REFERENCES

1. World health statistics 2008 http://www.who.int/whosis/en/index.html.[accessed 1 January 2009].

2. Ministry of Health & Family Welfare: National Health Accounts, IndiaNew Delhi: Government of India; 2006.

3. Garg CC, Karan AK. Health and Millennium Development Goal 1:reducing out-of-pocket expenditures to reduce income poverty. Evi-dence from India Manila: Equitap, 2005.

4. Krishna A. Escaping poverty and becoming poor: who gains, who losesand why? World Dev 2004; 32: 121–136.

5. van Doorslaer E, O’Donnell O, Rannan-Eliya RP, et al. Effect ofpayments for health care on poverty estimates in 11 countries in Asia:an analysis of household survey data. Lancet 2006; 368: 1357–1361.

6. Chaudhury RR, Parameswar R, Gupta U, Sharma S, Tekur U, Bapna JS.Quality medicines for the poor experience of the Delhi programme onrational use of drugs. Health Policy Plan 2005; 20: 124–136.

7. National List of Essential Medicine 2003. http://www.cdsco.nic.in/nedl.pdf. [accessed 1 January 2009].

8. Chatterjee S, Mandal A, Lyle N, Mukherjee S, Singh AK. Drugutilization study in a neonatology unit of a tertiary care hospital ineastern India. Pharmacoepidemiol Drug Saf 2007; 16: 1141–1145.

9. Karande S, Sankhe P, Kulkarni M. Patterns of prescription and drugdispensing. Indian J Pediatr 2005; 72: 117–121.

10. Bharathiraja R, Sridharan S, Chelliah LR, Suresh S, Senguttuvan M.Factors affecting antibiotic prescription pattern in pediatric practice.Indian J Pediatr 2005; 72: 877–879.

11. da Cunha AJ, Amaral J, e Silva MA. Inappropriate antibiotic prescrip-tion to children with acute respiratory infection in Brazil. IndianPediatr 2003; 40: 7–12.

12. Final Report of National Family Health Survey. http://www.nfhsin-dia.org/NFHS-3%20Data/press-relesed.pdf. [accessed 1 January 2009].

13. Shaikh U, Byrd RS, Auinger P. Vitamin and mineral supplement useby children and adolescents in the 1999–2004 national health andnutrition examination survey. Arch Pediatr Adolesc Med. 2009; 163:150–157.

14. Taxis K, Barber N. Ethnographic study of incidence and severity ofintravenous drug errors. Br Med J 2003; 326(7391): 684.

KEY POINTS

� Our study results show that the prescription ofdrugs under brand names is a common practice ina country like India, which is in compliance withother studies of similar kind.

� It also points out that the prescription of newerantibiotics contributes to the majority of the costof drug therapy.

� Drug dispensing strategies are needed to improvethe prescription patterns thereby reducing theburden on the patients in terms of cost.


398 i. singh ET AL.

15. Rojas MX, Granados C. Oral antibiotics versus parenteral antibioticsfor severe pneumonia in children. Cochrane Database Syst Rev 2006;19(2): CD004979.

16. WHO Essential medicine list http://www.who.int/medicines/publi-cations/08_ENGLISH_indexFINAL_EML15.pdf [accessed 1 January2009].

17. Haas JS, Phillips KA, Gerstenberger EP, Seger AC. Potential savingsfrom substituting generic drugs for brand-name drugs: medical expen-diture panel survey, 1997–2000. Ann Intern Med 2005; 142: 891–897.

18. Shrank WH, Hoang T, Ettner SL, et al. The implications of choice:prescribing generic or preferred pharmaceuticals improves medicationadherence for chronic conditions. Arch Intern Med 2006; 166: 332–337.

19. Gardiner P, Dvorkin L. Promoting medication adherence in children.Am Fam Physician 2006; 74: 793–798.

20. Biswal S, Mishra P, Malhotra S, Puri GD, Pandhi P. Drug utilizationpattern in intensive care unit of a tertiary care hospital. J ClinicalPharmacology 2006; 46: 945–951.



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