|Year : 2021 | Volume
| Issue : 2 | Page : 82-88
Drug prescribing trends and safety profile in pediatric care: Observations from a tertiary care center
Farangipet Fathima1, Princy Louis Palatty1, Jayachandran Mamatha2, Chennakeshava Thunga3, Nizam Mithotti4, Faizan Kalekhan5, Manjeshwar Shrinath Baliga5
1 Department of Pharmacology, Father Muller Medical College, Mangalore, Karnataka, India
2 Department of Pharmacology, Amrita Institute of Medical Sciences, Kochi, Kerala, India
3 Department of Pediatrics, Kasturba Medical College, Manipal, Karnataka, India
4 Department of Pharmacology, Shree Devi College of Pharmacy, Mangalore, Karnataka, India
5 Father Muller Research Centre, Mangalore, Karnataka, India
|Date of Submission||28-Nov-2020|
|Date of Decision||12-Dec-2020|
|Date of Acceptance||26-Dec-2020|
|Date of Web Publication||30-Mar-2021|
Dr. Princy Louis Palatty
Department of Pharmacology, Amrita Institute of Medical Sciences, Kochi - 682 041, Kerala
Source of Support: None, Conflict of Interest: None
Background: Globally, pharmacovigilance, rationality of drug prescription studies, and adverse drug reaction (ADR) in children affected with ailments are an understudied topic. Children are a vulnerable age group and reports suggest that over 10% of hospitalized have adverse reactions to therapy and up to 2.9% of all hospital admissions are the consequence of ADRs. In lieu of these observations, the present study was undertaken in a tertiary care hospital to ascertain the bad prescribing habits and ADR in children. Methodology: This was a prospective study and was carried out in the department of pediatrics at a tertiary care hospital for 6 months. The prescription orders of the children on medical treatment for various common ailments were analyzed. The drug prescribing pattern, safety profile of the drug/s alone and in combination was analyzed in accordance with the standard pharmacovigilance method. Results: In the study, a total number of 212 drugs were prescribed for 646 study participants. Most of the study participants were male child, and respiratory infection was the prevalent ailment affecting the children during the study period. With regard to the drug prescription, the average number of drugs per prescription was 3.96. Drugs prescribed by generic name were 6.9%, while 97.21% of the drugs prescribed were observed to be essential for the medical condition. Among the classes of drugs prescribed, antipyretics and antibiotics were the major classes of drugs administered in children admitted in inpatients facility, while among the outpatients (OPs), respiratory drugs and antipyretics were the most common prescribed drugs. Most importantly, polypharmacy was common in inpatients compared to OPs and also that 5.1% had some form of ADR. Conclusion: The present study showed rational prescribing pattern but poor standard pharmacovigilance technique.
Keywords: Adverse drug reactions, essential drugs, focused pharmacovigilance, generic names, pediatrics, prescription auditing
|How to cite this article:|
Fathima F, Palatty PL, Mamatha J, Thunga C, Mithotti N, Kalekhan F, Baliga MS. Drug prescribing trends and safety profile in pediatric care: Observations from a tertiary care center. Indian J Med Spec 2021;12:82-8
|How to cite this URL:|
Fathima F, Palatty PL, Mamatha J, Thunga C, Mithotti N, Kalekhan F, Baliga MS. Drug prescribing trends and safety profile in pediatric care: Observations from a tertiary care center. Indian J Med Spec [serial online] 2021 [cited 2021 Aug 2];12:82-8. Available from: http://www.ijms.in/text.asp?2021/12/2/82/312677
| Introduction|| |
The prescription order is an important document; the doctor plans after having completed a detailed investigative and clinical evaluation and is a vital document for both treatment records and for the patient to adhere for recovery. From a clinical viewpoint, reports indicate that the prescribing pattern and behavior depends on the regulations put forth by the government; the medical literatures, especially the standard books, journal, drug information gazettes, and commercial company pamphlets; opinion and personal experiences of professional colleagues., However, various prescribing errors do result as a result of ineffective use of these inputs and are common with the rational use of drugs being regarded to be a common problem.
Terminologically, rational use of drugs is using the right drug at appropriate concentration, schedule, and time period and this is beautifully summed up by the definition put forth by the World Health Organization (WHO)” Rational use of drugs requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, at the lowest cost to them and their community.” From a clinical perspective, the rationality of drug prescribing pattern is of cardinal importance in children, a vulnerable age group to treat because bad prescription can result in adverse drug reaction (ADR), which when severe can cause irreparable damage and may be life threatening.
Physiologically and pharmacologically, children are deviant from the adults as age and size; organ function and developmental state contribute to variation in drug pharmacokinetics and dynamics and the assumption of scaling down drug dosing from the prescribed dose for adults can be deleterious. In addition, the measly available reports on pharmacovigilance in children do suggest that, when compared to adults, ADRs can be more severe and can trigger significant morbidity in the children and that irrational use of medicines, poly-pharmacy, inadequate dosage, excessive use of injections over oral forms, and prolonged use of antimicrobials even after the eradication of infections. To further substantiate, historical reports do suggest that over 10% of hospitalized children have ADR to therapy and also that nearly 2.9% of all hospital admissions result due to it. In lieu of all these observations, an active drug surveillance system is required to understand the risk and causes for ADR in children.
Systematic pharmacovigilance that addresses detection, assessment, understanding, and prevention of possible ADRs can be very useful in clinics as this will provide vital information on safety of the drug to be used in the children. Although deemed important on the contrary, there are no enough data on the efficacy and safety of many drugs in pediatrics. From a pharmacovigilance view point, one of the easiest and cost-effective methods is to undertake prescription audit using validated proforma and documentation methods. The outcome of such endeavors will help understand the proportion of rational drug use in the health facility under study. In the current study, attempt was made to understand the prescribing pattern, quantifying the ADRs, evaluating the safety profile, and determining factors contributing to ADR among children.
| Methodology|| |
This was a prospective, cross-sectional observational study and the data were collected from children seeking medical care in both outpatient and inpatient facilities of the Department of Pediatrics, at Father Muller Medical College Hospital, Mangalore, Karnataka, India after obtaining permission from the Institutional ethics committee (FMMC/FMIEC/1909/2015). Informed consent was obtained from one of the parents and assent from 6 to 18-year patients attending facility. All relevant details of history, examination, investigations, and drugs prescribed were included in the case record form. Severely debilitated, neonatal, and pediatric intensive care unit patients were excluded from the study. Telephonic contact was established periodically (every month) to look for the probable ADR. Study period was for 1 year with follow-up being done every 6 months. The Naranjo algorithm-probability scale for ADR and WHO UMC causality categories questionnaire was used to assess ADRs in the proforma questionnaire. Data were entered into excel and imported to SPSS (IBM version 16; Chicago, IL, USA). Statistical analysis was done, and data represented as frequency and percentage. Chi-square test was applied and P < 0.05 considered statistically significant.
| Results|| |
In the study, males were more in number in both inpatient (IP) and outpatient (OP) facilities [Table 1], majority in age group of 2 to 11 years [Table 1]. Most children admitted to IP facility were there for <5 days [Table 1]. Majority of the children who came to hospital had respiratory issues [Figure 1]. With regard to the ailment, respiratory infection was most common problem in both IP (32.3%) and OP (72.7%) patients [Figure 1]. Among IPs, the next common ailment was malaria (18.5%), followed by gastroenteritis (13.7%) [Figure 1].
|Figure 1: Details on the medical issues for which the pediatric patients came for treatment to the hospital|
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|Table 1: The age and gender details of the pediatric inpatients and outpatients|
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The total number of drugs in the 212 prescriptions analyzed was 646. Analysis showed that, on an average, 3.96 medicines were prescribed for IP, while it was 1.75 medicines for OP. In addition, it was observed that 57.2% of the IPs had more than four drugs being prescribed, while three patients were not treated with any drug. Oral route (74.4%) was the most common route, followed by injection (18.1%) and inhalation (7.1%) [Table 1]. The doctor's prescription analysis showed that, in IPs, 7.92% medicines were in generic names, whereas it was 0.6% for OPs [Table 1]. Overall, 6.19% of drugs prescribed in generic name. In our study, 97.21% (OP: 98.05% vs. IP: 96.95%) of the medicines were rated to be essential [Table 1].
With regard to the classes of drugs, antipyretics (64.5%) and antibiotics (50.8%) were major classes of drugs prescribed among IPs compared to OPs [Figure 2]. Cephalosporins (72.6%) were most commonly used, followed by penicillin (22.2%), aminoglycosides (11.3%), azithromycin (9.7%), and metronidazole (9.7%) [Figure 3]. The medications used for respiratory, gastrointestinal tract (GIT), and nutritional supplements are listed in [Figure 4], [Figure 5], [Figure 6]. In the study, 8.8% ADR was seen in the IP group during the study period, while there were none for the OP group [Table 1] and [Table 2]. Rashes were the most common adverse reaction, followed by bradycardia, chills and rigor, and diarrhea. The antibiotics amoxicillin and ceftriaxone were seen to be associated with ADR. The potential drug–drug interaction (DDI) observed is enlisted in [Table 3].
|Figure 2: Details on the medications prescribed to the pediatric patients who came for treatment in the hospital|
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|Figure 3: Details on the antibiotic prescribed to the pediatric patients who came for treatment in the hospital|
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|Figure 4: Details on the medications prescribed for the respiratory ailments to the pediatric patients who came for treatment in the hospital|
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|Figure 5: Details on the medications prescribed for the gastrointestinal ailments to the pediatric patients who came for treatment in the hospital|
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|Figure 6: Details on the nutritional medications prescribed for the pediatric patients who came for treatment in the hospital|
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|Table 2: Prescribing Indicators of the pediatric patients in inpatients and outpatients|
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|Table 3: List of the potential drug interactions observed in the pediatric inpatients|
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| Discussion|| |
The observations of the study have brought these aspects into focus; the predominance of male patients was 123 as compared to female which has 89. These observations are in agreement to a previous study carried out in North India where predominance of male child was more than the female child (65.89% vs. 34.11%). With regard to age stratification, majority of the students were in the age group of 2–11 years and is in deviation to the previous study where 29.8% of the pediatric patients were in the age group of 1 month to 12 months.
In the present study, on an average, 3.96 medicines were prescribed and is in agreement to earlier reports.,, With regard to treatment details of pediatric patients who were treated on OP basis, the results suggest that 1.75 medicines were prescribed and numerically lesser than that reported in an earlier study. The most common route of drug administration was the oral (74.4%), followed by injection (18.1%) and inhalation (7.1%) and in agreement to earlier observations from Oman. Furthermore, with respect to drug prescription in generic terminology, it was observed that 7.92% of IPs and 0.6% in OP prescriptions followed the standard recommendations. Cumulatively, 6.19% prescriptions were in generic name and quite less when compared to previous studies.,,
With regard to data on ailments, respiratory infection was the most common in both IP (32.3%) and OP (72.7%) patients, with lower respiratory tract infection and pneumonia high among IP patients and upper respiratory tract infection among the OP patients. These results are in agreement to previous studies, while it is marginally less to another. The next most common ailment among IPs was malaria (18.5%), an infection common in the endemic region of Mangalore. Gastroenteritis and worm in stool was observed in 13.7% of the IPs and 13.6% of OPs and was less than reported in earlier studies.,
With regard to medications used, antipyretics (64.5%) and antibiotics (50.8%) were the major classes of drugs prescribed among IPs. The antibiotics, cephalosporins (72.6%), were the most commonly used, followed by penicillin (22.2%), aminoglycosides (11.3%), azithromycin (9.7%), and metronidazole (9.7%) and is not in agreement to earlier reports.,, Among the other group of drugs in IPs, nutritional preparations (62.9%) were the most commonly prescribed, followed by cough and cold preparations (45.2%), gastrointestinal drugs (36%), antimalarials (18.5%), and corticosteroids (6.5%) and similar to the observations of Akhtar et al. On the contrary, among OPs, the respiratory drugs (58%), antipyretics (52%), antibiotics (18%), GIT drugs (14.8%), and nutritional preparations (5.68%) were other category of drugs prescribed. These observations are not in agreement to the previous reports of Torvi and Dambal, who observed antimicrobials to be the most commonly prescribed drug.
In clinical practice, use of essential medicines and rationally is as per the stipulated guidelines and is always desired. In this study, 97.21% (OP 98.05% + IP 96.95%) of the medicines could be rated as essential, while lansoprazole that was prescribed for 3% patients may be considered as not an essential drug. On a comparative note, our results indicate that the adherence to prescription of essential medicines was higher than that indicated in previous studies.,,
Clinically, ADRs are important aspects, especially in vulnerable population such as children and reports from around the world indicate that every year, it is the cause for three deaths in the age group of newborn to 2 years. To substantiate, Priyadharsini et al. have reported thirty ADR over a study period of 3 months. In our study, we observed 8.8% ADR from the IP group, while there were none in the OP group. The most important ADRs were rashes, followed by bradycardia, chills and rigor, and diarrhea. Antibiotics were associated with the ADR, and use of amoxicillin and ceftriaxone was shown to cause them and in agreement to the earlier observations, where ADRs were reported on use antibiotics such as vancomycin, cloxacillin, amoxicillin, ampicillin, meropenem, ciprofloxacin, and cefixime.
The presence of drug interactions is a permanent risk in hospitals, especially in pediatric care. Significant drug interactions may result from changes in pharmaceutical, pharmacokinetic, or pharmacodynamic properties and can be life threatening. In our study, there were 28 potential drug interactions and no actual interactions were found. The IP group had potential 28 DDI, while the OP populations had none when ascertained by standard reference. The difference in the occurrence of probable DI and actual DI/ADR between the IP and OP populations can be easily reasoned. The IP groups were having higher tendency for polypharmacy; hence probable DI is increased. The OP patients were receiving fewer drugs that did not amount to polypharmacy. The drugs were given by the oral route for a short period. There was no DDI found in spite of thorough purposive check.
| Conclusion|| |
The present study was done to assess the prescribing trends and safety profile of drugs among pediatrics. A total of 212 prescriptions, including both OP and IPs, were analyzed using WHO prescribing indicators and safety profile using Naranjo Algorithm scale. The average number of drugs prescribed was 3.96 among IPs and 1.75 among OPs which is quite good compared to other studies. Drugs prescribed in generic name were 6.19% and 97.21% of the drugs prescribed were in essential drug list. We observed 5.18% ADR all of which can be considered mild and nonlethal. There was no actual drug interactions were found, indicating that the physicians adhered to good practice skills.
From pharmacology perspective, it can be concluded that these types of studies are required as it will help in promoting effective pharmacovigilance and surveillance of drug prescription, administration, and documentation of errors, help understand lacunae, and ADRs that can help in the betterment of the pharmacy practice and patient care. This will also add useful literature to the field of pediatric pharmacovigilance (a field less investigated) and will help the pharmacy and medical fraternity recognize the pattern of side effects, when known from literature and at times also document rare or unique side effects of importance. In the absence of structured clinical trials with children, these studies will be very useful for the pharmacy fraternity, the health-care sector, and society at large.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3]