Int J Pharm Pharm Sci, Vol 11, Issue 3, 48-53Original Article
DRUG UTILIZATION PATTERN IN PAEDIATRIC PATIENTS IN A SECONDARY CARE HOSPITAL
R. SENTHILSELVI1*, M. BOOPANA1, LINTA SATHYAN1, PRIYA VISUVASAM2, V. GANESAN1
1Department of Pharmacy Practice, The Erode College of Pharmacy, Erode, 638112, Tamilnadu, India, 2Govt. Head Quarters Hospital, Tiruppur, Tamilnadu, India
Email: Senthilselvi65@gmail.com
Received: 12 Nov 2018 Revised and Accepted: 22 Feb 2019
ABSTRACT
Objective: The study was carried out to generate research on drug utilization pattern in paediatric patients in government headquarters hospital, Tiruppur, Tamilnadu, India using world health organization (WHO) and international network for rational use of drugs (INRUD) core indicator.
Methods: The core prescribing indicators of the world health organization was used to assess the appropriate use of drugs. Index of rational drug prescribing (IRDP) developed by Zhang and Zhi was also used to find out the performance of a health care system in terms of drug utilization.
Results: Out of 859 drugs in 200 cases the highest prescribed drug class is antibiotics 304(35.39%) and the majority of drugs were administered in injectable form 412(47.94%). It was analysed that a majority of prescriptions 117(58.5%) were discharged in between 4-7 d. 161(80.5%) patients were dismissed after completion of treatment. On analysing world health organization (WHO) prescribing core indicators, the average number of drugs per prescription was 4.29 which is higher than double the average number (i.e., 2). This indicates poly-pharmacy practice. 97.78% of drugs were prescribed were the generic name and percentage of encounters with antibiotic prescribed was 90.5% which is thrice greater than world health organization (WHO) standard<30%. Prescribing of injections is not within the world health organization (WHO) recommended range<20% and it was far higher showing 97.5% which is essential for paediatric inpatients. The prescribing practice in paediatric ward is in complete adherence to national essential drug list (EDL) or formulary. The mean value of the index of rational drug prescribing (IRDP) obtained was 3.09 which is very similar to that of optimal value world health organization (WHO).
Conclusion: Prescription by generic name, prescribing drugs from essential drug list (EDL) and free government supply are encouraging findings in this hospital. The result shows poly-pharmacy and overuse of antibiotics are the areas to be concerned. The better clinical outcome shows rational prescribing is practised well.
Keywords: Core indicators, an International network for rational use of drugs (INRUD), Index of Rational Drug Prescribing (IRDP), Poly-pharmacy, Essential drug list (EDL), Antibiotics
© 2019 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
DOI: http://dx.doi.org/10.22159/ijpps.2019v11i4.30746
INTRODUCTION
World Health Organization (WHO) defined drug utilization research as ‘studies on the marketing, distribution, prescription and the use of drugs in a society, with special emphasis on the resulting medical, social and economic consequences [1, 2]. Drug utilization studies are important in order to evaluate the appropriate and judicious use of drug therapy [3]. Appropriate drug utilization studies are properly utilized to evaluate the efficacy, safety, convenience and economic aspects at all levels in the chain of drug use.
Various drug utilization reviews have been conducted all over the world but only limited studies are conducted addressing the drug use pattern in paediatric population especially in India [4]. 20 to 25% of total world population comprise paediatric, which are more prone to acute and chronic infectious disease. The incomplete development of paediatric physiological conditions and their rapid growth and development need some accurate diagnosis and evidence-based medical treatment [5].
Infants and children are the most vulnerable population groups. They are particularly sensitive to contract illness and harmful effects of drugs because of their difference in pharmacokinetics and pharmacodynamics to that of adults [6]. Also, drug use in paediatric is not extensively researched and the dosage form of licensed drugs is limited [7].
Monitoring the safety of medical use in children is of paramount importance because only a limited data can be generated through clinical trials of drug development [8]. Infants and children constitute a large population in a developing country like India. Promotion of appropriate and safe drugs for children is hour globally essential [9].
Doses for children often derived from adult dosages after adjusting the body weight. But even within the paediatric population especially preterm neonate doses varies from the calculated weight-adjusted doses [10]. There are likewise various drug-related problems in children such as heterogeneous nature of paediatric population, off-label and unlicensed drug use, lack of familiarity between adult and paediatric guidelines, inability to swallow solid dosage form etc [11]. Prescription auditing, a type of vigilance activity, which is beneficial in clinical practice for reducing the burden of disease and to ensure irrational prescribing is hence indispensable [9].
MATERIALS AND METHODS
Study site
The study was conducted in the department of child health on Government district headquarters Hospital, Tiruppur, a 500 bedded hospital.
Study design
This is a prospective observational study and was carried out in the department of child health unit of Government Headquarters Hospital, Tiruppur.
Study period
The study was undertaken during a period of 6 mo from March 2018 to August 2018.
Study population
The study population includes the patients of Govt. Headquarters Hospital, Tiruppur. A total of 200 numbers of admitted cases were chosen from paediatric ward.
Ethical approval
Research protocol, data collection form and informed consent form (Tamil/English) was approved by the Institutional Human Ethics Committee (IHEC) of the Government Headquarters Hospital, Tiruppur, Tamilnadu (IHEC NO: IHEC/GH-Tiruppur/ECP/PD-002). The approval was obtained before the study was commenced.
Patient selection
Patients selection was based on the inclusion criteria. The inclusion criteria included newborn of 1 mo to 12 y, considered both male and female patients who stayed in the hospital for more than 24 h. Exclusion criteria included all adult patients, outpatients, intensive care unit emergency patients, immuno-compromised patients and the patients not willing to participate in the study.
Prescribing core indicators
The prescribing core indicators of WHO was an average number of medicines per encounter, percentage of medicines prescribed by generic name, percentage of encounters with an antibiotic prescribed, percentage of encounters with an injection prescribed and percentage of medicines prescribed from the essential drug list formulary.
Index of rational drug prescribing (IRDP) was also performed.
Statistical analysis
Data were entered and analysed using Microsoft Excel (windows 8; version 2007). Graphical representation is used for visual interpretation of the analysed data.
RESULTS
Out of 200 prescriptions analyzed, a total of 859 drugs were prescribed.
Table 1: Age-wise classification
| Age group | Frequency | Percentage (%) |
| 1-23 Mo | 58 | 29 |
| 2-11 Y | 134 | 67 |
| 12 Y | 8 | 4 |
Table 2: Gender wise distribution
| Age | % of male | % of female |
| 1-23 Mo | 29 | 29 |
| 2-11 Y | 65 | 69 |
| 12 Y | 6 | 2 |
Table 3: Distribution of diseases in paediatric patients
| Distribution of diseases | No. of diseases | Percentage (%) |
| Seizure disorder | 27 | 13.5 |
| GI disorder | 35 | 17.5 |
| Fever | 54 | 27 |
| Respiratory disease | 46 | 23 |
| UTI | 4 | 2 |
| Anaemia/Malnutrition | 4 | 2 |
| Poison cases | 14 | 7 |
| Genetic disorders | 2 | 1 |
| Autoimmune disease | 1 | 0.5 |
| Others | 13 | 6.5 |
Table 4: Medicines prescribed to paediatric patients
| Medicines category | No. of drugs | Percentage (%) |
| Anti-asthmatics | 57 | 6.64 |
| Anti allergics | 43 | 5.0 |
| NSAIDS | 159 | 18.5 |
| Anti-emetics | 41 | 4.77 |
| Corticosteroids | 5 | 0.58 |
| Anti-epileptics | 42 | 4.88 |
| Antiulcer agents | 82 | 9.54 |
| Antispasmodics | 4 | 0.47 |
| Vaccines | 3 | 0.34 |
| Anti-amoebic agents | 14 | 1.63 |
| Vitamin supplements | 10 | 1.16 |
| Antibiotics | 304 | 35.39 |
| Others | 95 | 11.1 |
Table 5: Antibiotics prescribed to paediatrics
| Antibiotic classification | No. of antibiotics | Percentage (%) |
| Aminoglycosides | 83 | 27 |
| Cephalosporins | 167 | 55 |
| Penicillin | 22 | 7 |
| Penicillin combinations | 11 | 3 |
| Macrolides | 15 | 5 |
| Tetracyclines | 2 | 1 |
| Sulphonamide combinations | 2 | 1 |
| Carbapenem | 2 | 1 |
Table 6: Route of administration
| ROA | Sub-class | Frequency | Percentage (%) |
| Injectables | Intravenous | 409 | 47.6 |
| Intramuscular | 2 | 0.23 | |
| Subcutaneous | 1 | 0.11 | |
| Oral | - | 384 | 44.7 |
| Inhale | - | 62 | 7.21 |
| Topical | - | 1 | 0.11 |
Table 7: Drug-drug interaction per encounter
| Drug interaction | No. of prescriptions | Percentage (%) |
| Cases with DI | 126 | 63 |
| Cases without DI | 74 | 37 |
Table 8: Duration of hospital stay
| Duration | No. of prescriptions | Percentage (%) |
| 1-3 d | 58 | 29 |
| 4-7 d | 117 | 58.5 |
| 8-11 d | 22 | 11 |
| 12 or above | 3 | 1.5 |
Table 9: Patient outcomes
| Patient outcomes | No. of patients | Percentage (%) |
| Discharged | 161 | 80.5 |
| Referred | 8 | 4 |
| Discharged at request | 21 | 10.5 |
| Absconded/leave against medical advice (LAMA) | 10 | 0.5 |
Fig. 1: Age wise classification
Fig. 2: Gender wise distribution
Fig. 3: Distribution of diseases
Table 10: Assessment of prescribing indicators
| Prescribing indicators assessed | Average/percentage | WHO standard |
| Average number of drugs per encounter | 4.29 | ≤2 |
| Percentage of drugs prescribed by generic name | 97.78% | 100% |
| Percentage of encounters with antibiotics | 90.5% | <30% |
| Percentage of encounters with injections | 97.5% | <20% |
| Percentage of drugs from essential drug list | 100% | 100% |
Fig. 4: Medicines prescribed to paediatrics
Fig. 5: Antibiotics prescribed
Fig. 6: Route of administration
Fig. 7: Drug-drug interaction
Fig. 8: Duration of hospital stay
Fig. 9: Patient outcomes
Fig. 10: WHO prescribing indicators
DISCUSSION
The paediatrics were considered to be infants and toddlers (1 mo-23 mo), children (2-11 y) and adolescents (12 y) according to age group and also by considering inclusion criteria of this study. Adolescent patients are 8 (4%), found to be significantly less when compared to infants and toddlers 58 (29%) and children 134 (67%).
The number of male patients (65%) and female patients (69%) was found to be significantly high in the age group 2-11 y (children) when compared to the number of male patients (6%) and female patients (2%) in the age group of 12 y (adolescents). An equal number of male and female patients (29%) was observed in the age group 1 mo — 23 mo (infants and toddlers).
The majority of paediatric patients were taken to the hospital due to fever and it was 54 (27%). Second comes respiratory disease 46 (23%). Gastrointestinal disorder was found to be 35 (17.5%) and then comes seizure disorder 27 (13.5%). Paediatric patients admitted with poisoning cases were 14 (7%) and with genetic disorder is 1 (0.5%). Paediatrics admitted due to urinary tract infection and anaemia/malnutrition were found to be equal 4 (2%). Only 1 (0.5%) is admitted due to autoimmune disease and 13 (6.5%) belong to other diseases. An earlier study reported that respiratory system disease (25.6%), was most commonly seen, followed by fever (19.2%), GIT (18.4%) and hepatitis (8.8%) disorders [6].
The highest prescribed drug class is antibiotics 304 (35.39%). Second commonly prescribed drugs belong to nonsteroidal anti-inflammatory drugs (NSAIDs) 159 (18.5%). 57 (6.64%) number of drugs prescribed are anti-asthmatics, 43 (5%) are anti-allergic, 41 (4.77%) are antiemetic, 5 (0.58%) are corticosteroids, 42 (4.88%) number of drugs belong to anti-epileptic, 82 (9.54%) are anti-ulcer agents, 14 (1.63%) are anti-amoebic agents, 10 (1.16%) are vitamin supplements and 4 (0.47%) are antispasmodic. The least prescribed drugs are vaccines 3 (0.34%). The rest of drugs 95 (11.1%) are categorized as others. A previous study reported that analgesic drugs were the most frequently prescribed therapeutic class of drugs (26.9%) [12].
Among antibiotics, cephalosporin 167(55%) are the most prescribed and then comes aminoglycosides 83 (27%). 22 (7%) number of drugs is penicillin, 15 (5%) are macrolides and 11 (3%) are penicillin combinations. Equal number of drugs 2 (1%) are prescribed as tetracyclines, carbapenem and sulphonamide combinations. In a study, it was found that the most frequently prescribed group of antibacterial were cephalosporin (62%) followed by penicillin [13].
The majority of drugs were administered in injectable form 412 (47.94%), in which the intravenous route is most commonly administered 409 (47.6%). Only 2 (0.23%) of drugs are administered via intramuscular route and 1 (0.11%) is given via subcutaneous route. Oral route is contributing around 384 (44.7%). Inhalation route contributes around 62 (7.21%) and topical was only 1 (0.11%). In another study it was found that 85.6% of medications are oral medications, 4.4% of cases consist of inhalational drugs, 8.6% of cases are topical drugs and 1.3% are suppositories or pessesaries [14].
27 (13.5%) number of prescriptions was found to be there with drug duplication and the remaining 173 (86.5%) were identified as cases without drug duplication as per drugs. com website. 126 (63%) prescriptions are cases with drug interaction and 73 (37%) number of prescriptions are found to be without drug interactions.141 (72.31) number of moderate drug interactions and 54(27.69%) number of minor drug interactions were found by analysing the prescription. Major drug interactions are not reported in case drug-food interaction 184 (92%) prescriptions have no drug-food interactions and only 16 (8%) number of prescriptions have reported drug-food interactions. Utilizing drugs. com website it was determined that 155 (77.5%) numbers are cases without contraindications and 45 (22.5%) are cases with contraindications.
While considering the comorbidity 69 (34.5%) prescriptions out of 200 are having 1 comorbidity, 9(4.5%) are prescriptions with 2 co morbidity and only 2 (1%) are prescriptions with ≥ 3 comorbidity. Majority of the prescriptions 117 (58.5%) show a duration of hospital stay for 4-7 d, 58 (29%) number of patients stayed in the hospital for 1-3 d, 22 (11%) number of patients were stayed for a period of 8-11 d and 3 (1.5%) patients were stayed for 12 or more days. 161 (80.5%) number of patients were discharged after completion of treatment and 8 (4%) were referred for better treatment. 21 (10.5%) were discharged at the request and 10 (5%) were absconded during the study.
An average number of drugs per prescription were 4.29 which is greater than double the average number (i.e., 2) recommended by the world health organisation (WHO). The increased value indicates the poly-pharmacy practice in this hospital. However, this cannot be considered irrational poly-pharmacy practice as there is need of empirical therapy till definitive diagnosis becomes clear and secondly for management of acute-life threatening conditions. Most of the patients require two or more drugs and here 52 (26%) patients have received 5 drugs during the hospital stay, which is the highest.
The percentage of drugs prescribed by generic (international non-proprietary) name is 97.78 in this study but according to WHO standards the optimal value is 100%. By using the generic name in the prescriptions, the chance of duplication of drug products can be avoided. Example: the prescribing of albuterol and duolin (levalbuterol/ipratropium) at a time.
Percentage of encounters with an antibiotic prescribed was 90.5% which is thrice greater than WHO standard<30%. This indicates an increased use of antibiotics in paediatric population. However, the increased use of antibiotics in paediatrics is caused by severe infections, prophylactic treatment for infections and for doubtful secondary bacterial infections in viral diseases. The lack of proper or definitive diagnosis is also a reason for increased antibiotic use.
Prescribing of injections is not within the WHO recommended range<20% and it was far higher showing 97.5%. However, this increased prescribing of injection is not irrational as the recommended range is for outpatients. Due to the severity of illness, unavailability of oral and other dosage forms for a particular drug and to increase medication adherence injection formulation may be prescribed more. Nevertheless, the overuse of injections may lead to economic cost and health hazards. In a previous study it was found that average number of drugs per prescription as 4 and percentage of drugs prescribed by generic name as 45%. The percentage of antibiotics prescribed was 33% and percentage of encounters with an injection in that study was 30.6% [6].
In this study, it was found that the prescribing practice in paediatric ward is in complete adherence to national essential drug list/formulary.
The mean value of Index of Rational Drug Prescribing (IRDP) was 3.09 which are very close to WHO optimal value of 5. The optimal index for all indicators was fixed at 1. Values closer to 1indicates the rational drug use.
CONCLUSION
This study demonstrates that prescription by generic name and prescribing drugs from EDL and free government supply of health care is encouraging findings. Poly-pharmacy and overuse of antibiotics are the areas to worry. Prescribing antibiotics to paediatric patients based on empirical therapy without culture sensitive test may lead to antibiotic resistance and health issues in the future.
It is rational to choose the intravenous route in the paediatric patient with age less than 14, who are admitted and who are in need of emergency care. Hence, prescribing of injections is not within the WHO recommend range<20%.
Sticking to state standard treatment guidelines in the light of WHO/INRUD for paediatrics and awareness among paediatricians will promote more rational prescribing.
LIMITATION OF THE STUDY
The study was conducted in a hospital in a rural area and only 200 paediatrics have participated in the study. As a result, we could not have a large sample size which could increase our work significance.
AUTHORS CONTRIBUTIONS
R. Senthilselvi and V. Ganesan designed and conceived the study. Priya Visuvasam and R. Senthilselvi analyzed, interpreted the data and drafted and revised the article while Linta Sathyan and M. Boopana participated in data collection and article revision.
CONFLICTS OF INTERESTS
All authors have none to declare
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