|Year : 2018 | Volume
| Issue : 2 | Page : 62-67
Pharmacovigilance for pediatric outpatient prescriptions in tripoli children hospital
Yousef A Taher1, Sawsan F Faraj1, Awatef M Samud2, Fathy E El-Taher3, Fathi M Sherif1
1 Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya
2 Department of Anaesthesia and Intensive Care, Faculty of Medical Technology, University of Tripoli, Tripoli, Libya
3 Department of Orthodontic, Faculty of Dentistry, University of Tripoli, Tripoli, Libya
|Date of Web Publication||29-Jun-2018|
Prof. Yousef A Taher
Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, University of Tripoli, Tripoli
Source of Support: None, Conflict of Interest: None
Background: Pharmacovigilance for pediatric drug therapy is lacking among Libyan patients. Hence, pediatric patients are at risk of unpredictable drug effects as a result of prescription fault. Therefore, this study was aimed to determine the drug prescribing errors for children attending the pediatric outpatient clinic at Tripoli Children Hospital, Libya. Materials and Methods: A retrospective study was carried out using the given prescription for patients who attended the hospital between July 2 and November 30, 2012. Patients aged below 13 years were included in the study. Drug use indicators were assessed using the British National Formulary guidelines. Results: There were 600 prescriptions (75.9%) collected for both, female patients (303 prescriptions, 50.5%) and male patients (297 prescriptions, 49.5%) with a total of 1167 prescribed drugs (on average 1.9 ± 1.2 items/prescription). Five hundred and eighty-six prescriptions are found which had at least one type of error, and this correlated with increased number of drugs per prescription. The error rate was 97.7%. Prescribing by inadequately dosing was done in 3.3% of all the prescribed medications, while 3.8% had inadequate durations. Furthermore, diagnosis, dosage, frequency, duration, and instruction were omitted in 96.5%, 5.7%, 10.2%, 42.8%, and 89.6% overall prescribed drugs, respectively. Drug–drug interactions were found in 63 prescriptions (10.5%) and involved mostly antiepileptic medications. Conclusion: Our study demonstrates that pediatric patients are at high risk of both, treatment failure, and adverse drug reactions. Hence, pharmacovigilance for pediatric prescriptions is critically needed. As well, a continuous medical education, in particular rational drug prescription, with much focus on the pediatric doctors, is strongly recommended.
Keywords: Drug use, Libya, medication errors, pediatricians' prescriptions, pharmacovigilance, rational
|How to cite this article:|
Taher YA, Faraj SF, Samud AM, El-Taher FE, Sherif FM. Pharmacovigilance for pediatric outpatient prescriptions in tripoli children hospital. Libyan J Med Sci 2018;2:62-7
|How to cite this URL:|
Taher YA, Faraj SF, Samud AM, El-Taher FE, Sherif FM. Pharmacovigilance for pediatric outpatient prescriptions in tripoli children hospital. Libyan J Med Sci [serial online] 2018 [cited 2018 Jul 18];2:62-7. Available from: http://www.ljmsonline.com/text.asp?2018/2/2/62/235694
| Introduction|| |
Pharmacovigilance is a science dealing with assessment and detection of any drug-related problems. Accordingly, drug prescribing errors is considered as an important phenomenon for medical errors. The concept of medical error is a term outlines all errors that arise within the treatment including diagnosis, instructions, and prescribing and dispensing errors. It can be established at all health-care systems including hospitals, clinics, emergency rooms, Intensive Care Units, outpatient centers, pharmacies, patients' homes, and laboratories. Over the world, drugs prescribing errors is one of the major global health problems at all the levels of health-care providers.
Drugs prescribing errors is one of the most common types of medical errors as medication is the major health-care intervention. It has been reported that more than 6000 deaths per year occur due to medication errors in the United States alone. In England, it has been shown that drug prescribing errors occur in 1.5% of the total prescriptions, and 3%–8% of administration errors were found in the doses given. In addition, the use of wrong drug names, wrong dosage forms, incorrect dosage calculation, and dosage frequency were the main factors associated with errors in prescribing medication. So far, there is no guide to rational drug prescribing in Libya or drug information center dealing with basic pharmacological information considering drug prescription and their doses for children.
Indeed, although a large number of medications are prescribed in pediatric outpatients in Tripoli, little is known regarding frequency and type of medication errors that occur. Furthermore, the clinical importance of these errors and effective approaches for reducing them has not been previously informed. Although several studies , seeing at medication errors have been performed in health-care setting, such information for children is scarce. Therefore, the present study was aimed to investigate the type of prescribing errors in the pediatric outpatients' prescriptions and to provide useful suggestions and helpful strategies to minimize these errors.
| Materials and Methods|| |
The present retrospective study was conducted using pediatric outpatient prescriptions at Tripoli Children Hospital in Tripoli, the capital of Libya. This children hospital is ranking number one and covering all patients' residents in Tripoli and the nearby cities at the West of Libya. The clinic diagnosis timetable is 24 h/day even during public holidays. The general outpatients' clinic is run by medical officers with 3 years and above work experience. Prescriptions written for children aged ≤13 years by physicians for a 5-month period (July 2–November 30, 2012) were collected from the main pharmacy by the researcher and then were analyzed carefully. The inclusion criterion includes only the outpatient prescriptions whereas, in patients' prescriptions, prescriptions for children above 13 years old or when the ages are omission were excluded from the study. Furthermore, prescriptions were considered illegible when it could not be clearly read and these were mainly carbon paper duplicates of the original prescriptions. During the study period, prescriptions were collected daily from the pharmacy main plastic box where all the prescriptions coming from hospital outpatients' clinic are kept. At the end of study period, 790 prescriptions were gathered. The information obtained from these prescription papers were age, sex, and the drug prescription proper. All prescribed drugs were checked if they were written by generic names, brand names, or abbreviation. The doses, frequency, duration of use, adequacy of the dose prescribed, potential interactions of drug-drugs and/or food, or disease of the prescribed drugs were all precisely revised. The prescription errors were evaluated according to the British National Formulary guidelines.
In addition, the doses of syrups and suspensions were checked in milligrams or milliliters; for tablets, doses were further checked if it is in unit numbers. Moreover, the study was explored looking for prescribing banned drugs "contraindicated drugs in children." The patients' weights were estimated using the standard formulae according to the Libyan Medical File Book Notes for approximate weight of normal infants and children. The estimated weight was used to determine the adequacy of the prescribed doses of the drugs.
For ethical considerations, the study was ethically approved by the Department of Pharmacology and Clinical Pharmacy, University of Tripoli. Further, it was done under permission from the Tripoli Children Hospital Administration Office.
Data collected from prescriptions were analyzed with GraphPad Prism statistical software (GraphPad Software Inc., San Diego, California, USA). Descriptive statistics including frequencies and percentage of the total were used to present the data. To determine if there is a linear association between appropriation of errors (as independent factor) and number of prescribing drugs (as dependent factor) per a prescription, a Pearson correlation coefficient was used. In the analysis of dosage writing manner (unit/dose, mg/dose or ml/dose), comparisons between groups were made using Chi-square test. The level of significance was set at 5%.
| Results|| |
Of the 790 (100%) prescriptions collected, 190 prescriptions (24.1%) were found illegible and excluded from the study due to different reasons; 75 prescriptions (39.5%) included ages above 13 years old; ages were missed in 103 prescriptions (54.2%); and 12 prescriptions (6.3%) were carbon paper duplicates copies. Hence, 600 prescriptions (75.9%) who met the inclusion criteria were analyzed and used for the study. All the prescriptions showed that the patients' gender was indicated. Two hundred and ninety-seven prescriptions (49.5%) were written for males and 303 prescriptions (50.5%) were written for female patients.
The mean age (±standard deviation) of the pediatric patients was 5.4 ± 0.2 years. In 585 prescriptions (97.5%), the age of patients was expressed by years, whereas in 15 prescriptions (2.5%), it was expressed by date of births. Approximately two-thirds of patients (64.4%) were between the ages of 1–5 years old. Overall, the total number of prescribed drugs was 1167 items. The most common 20 prescribed drugs are illustrated in [Figure 1]. Our data show that antiepileptics, antibiotics, and analgesics and antipyretics are the most frequently prescribed drugs. The significant findings of this study were that there are no banned drugs which have been prescribed for children. More than four-fifths of the prescribed drugs (973 drugs; 83.4%) were for oral administrations, 5.7% for parental use, while around 10% were prescribed by other routes. Overall, we found that only 14 prescriptions were entirely free of errors, thus giving a 97.7% error rate.
|Figure 1: The most frequently prescribed drug categories for pediatric outpatients during the study period (n = 600)|
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The number of drugs prescribed for a patient per a visit was found 1–7 drugs per prescription, with a mean of 1.9 ± 1.2 items. The distributions of the number of prescribed drugs, per prescription, are shown in [Figure 2]. While 1–2 drugs per prescription were the most common, seven drugs per prescription was the least. In line, our results show that there is a significant positive correlation between appropriation of error and increased number of prescribed drugs per prescription [r = 0.98; P < 0.0001, [Figure 2].
Regarding to omission errors, our data show that cases' file number was not denoted in all patients' prescriptions. In addition, 579 prescriptions (96.5%) do not include diagnosis of the disease. [Table 3] shows that the dose was 87.2% adequately written; 3.3% wrongly written and was omitted in 5.7% of the total prescribed drugs. Most of these faults are concerned with drugs acting on gastrointestinal tract (GIT), followed by analgesic and antipyretic medications. Crucially, [Table 2] shows that although the duration of drug use was 44 times (3.8%) inadequately prescribed, the duration of use was not indicated for 500 (42.8%) prescribed drugs. Importantly, our results show that the duration of use of more than 50% of the prescribed antibiotics was inadequately illustrated [Table 2]. Furthermore, frequency and instruction for drug intake were omitted, respectively, for 119 (10.2%) and 1046 (89.6%) prescribed drugs. Paracetamol (prescribed 48 times; 4.1%), diazepam (4/0.3%), drugs acting on GIT "in particular antacid (2/0.2%), domperidone (2/0.2%), glycerin suppositories 'as laxative' (1/0.1%), and hyoscine N-butyl bromide (2/0.2%)," glucagon (1/0.1%), salbutamol (1/0.1%), and normal saline "used as nasal decongestant" (5/0.4%) were falsely instructed deeming of their frequencies of dosing. These medications were occasionally recommended as once daily, "i.e., when necessary or as SOS," instead of using them in separated doses. In addition, of the 600 prescriptions, doctors' names and signatures and the date of writing prescription were omitted in 37 (6.2%) and 8 (1.3%) prescriptions, respectively.
The present study considered that any drug written by an alternative name or a part from the generic name is an error. It has been found that, of the 1167 times drugs written over the study period, drugs were 541 times (46.4%) written by generic names, 567 times (48.6%) by brand names, and 59 times (5.1%) were prescribed in abbreviation.
Concerning dosing errors, herein, the written of under- and/or overdosing of prescribed drugs is counted as an inappropriate dosing. Our data show that prescribing by inadequate dosing was done in 38 times (3.3%) of all the prescribed medications. Indeed, the majority of dosing errors were found in prescriptions for kids <4 years old. Among the prescribed antibiotics, the results show a significant error difference [P< 0.0001, [Table 3] between prescribing of antibiotics in tablet form in unit number and in mg/kg (χ2 = 18.8) and between their prescribing in syrup or suspension form in ml and in mg/kg (χ2 = 23.6). Moreover, of the total examined prescriptions, 63 prescriptions (10.5%) have found to include serious drug interactions. Most drugs combined errors were found linked to prescribed antiepileptic drugs. A number of drug incompatibilities are shown in [Table 4]. In addition, a drug–food interaction was realized associated with the anthelminthic medication. It has been observed that no written instructions are provided on taking the anthelminthic drugs with meals (data not shown).
| Discussion|| |
Writing a prescription is an important aspect of medical practice. Prescriptions can be misinterpreted by the health-care provider, in particular pharmacist, and indeed will result in dispensing errors. The counseled strategy meant with downgrade prescription errors is that doctors should write their prescription very clearly. Omissions of file number and gender of the patients can be considered as risk-free errors and are not likely to be factors for medication errors. However, this is not true when the age of patients is used to estimate the body weight required to adjust drug dosage in mg/body weight. In the present study, calculation of doses according to the age cannot be totally excluded as a risk factor since a small number of patients with their ages stated found experience inadequate drug dosing. The omission of duration of use of certain drugs observed in this study; such as omission of duration of use of antiepileptic drugs and antibiotics is a serious error since failure of treatment could be expected from such omission if patient stop use of drug after few days of treatment. Likewise, ineffective treatment could be happening due to written of under-dose therapeutic level for certain drugs, analgesic/antipyretic, antibiotics and drugs used for GIT, included. Inappropriate dose use of antibiotics has been detailed to rush up resistance development. Furthermore, analgesics and antibiotics have been previously documented as two classes of drugs commonly involved in medication errors., The most common errors connected with these drugs include wrong dosing and omission errors. Unfortunately, the omission of doctor's name and signature and the date of writing prescription make it difficult to find the real source of the prescribing error and hence make it hard to avoid future occurrence.
In the present study, the average number of drugs per prescription was found within the WHO recommended limit of two  and is slightly lower than that reported in other studies from developing countries such as Nigeria, Gambia, Saudi Arabia, the United Arab Emirates (UAE), and India. Nonetheless, as the number of prescribed drugs, per prescription, is increased, the frequency of error is increased too. Incidentally, prescribing by generic name is considered as the accurate way of counseling medications as it promotes improved access. In Tripoli Children Hospital, generic names were observed at high rates than that reported in Sudanese, the UAE, and Nigerian  studies. However, a Tanzanian study  was reported as having a higher pattern of use generic names, 87% versus our 46.4%. Indeed, the use of trade names and/or abbreviations can be accepted in Tripoli Children Hospital as to minimize patients waiting time. Indeed, use of abbreviation and trade names for prescribed drugs are common in developing countries as a large number of patients'do visit outpatient's clinic per day. However, these abbreviation "names" should be standardized and be informed all over the hospital staff, in particular those at hospital's pharmacy. Our study indicates that about two-fifths of the prescribed drugs were associated with dose errors in the form of overdosing and underdosing. Doses errors observed, herein, are equally distributed between overdosing and underdosing. A majority of patients on antiepileptic drugs and on drugs acting on GIT are receiving drugs with potential for side effect complications once overdosed. The present study demonstrated, in particular, that the under- and overdose errors are associated with drugs for oral use, involved prescription of tablets in a unit number, and syrup formulations in milliliters. Furthermore, the most serious things are that these under- and overdose errors are concomitant with writing tablets for children under 4 years old as it is problematic for them to swallow. Hence, in this case, parents, at home, are often manipulating the adult dosage formulations. These manipulation processes include cutting and grinding up the tablets and mixing them with food or drinks before administration. Indeed, this kind of manipulations is associated with a great risk of errors since the bioavailability of drugs used will be, in the best situation, unpredictable.
Ascorbic acid was not prescribed with subscription to be not used at night (data not shown). Furthermore, mebendazole as an anthelminthic drug was not recommended with a subscription to be used with meals. Although these drugs are not within the most frequently prescribed drugs, shown in [Figure 1], it has been indicated that the use of ascorbic acid at night increases GIT distressing, whereas the administration of mebendazole with fatty meals increases its bioavailability and decreases patients' acute abdominal pain once taken on empty stomach. A number of studies have indicated that prescribing medication errors should be attributed to different reasons and these include that (1) attending of too many patients at the same time and a low number of doctors are available per pediatric hospital a day; (2) distractions from patients, parents, and nurses could make physicians exhausted and be faced with an extraordinary workload; and (3) a personal error, this linked by doctors' memory as it cannot be always depended on it when writing many drugs at a time, in particular similar drug names. Hence, taking care of these incidents is highly recommended in a way of decreasing prescription errors.
Our retrospective study has its limitation during interpretation of the results. First, all prescriptions were collected from one hospital in Tripoli city and this may not reflect the real story. Second, the present study concentrates mostly on prescribing errors and was not planned to detect either dispensing errors in outpatients' pharmacy or administration errors by parents. In fact, however, our findings may be used as a representative of daily pediatric outpatients' prescription behavior. Moreover, although the results we analyzed are few years old, we do not consider this is a major limitation. The outcome would not differ greatly when more recent data would have been available.
The present study illustrates several medication errors among the examined prescriptions. The majority of prescribing errors that occur in Tripoli Children Hospital are use of nongeneric names, incorrect doses, frequencies and durations of treatment, and negatively interactive drugs. These errors had similarly been quantified in numerous studies., In this study, we found that the error rate, at Tripoli Children Hospital, is extremely higher compared to others. Error rate in a Nigerian study was reported less frequently, with 62.2%; error rate was reported by 15% of American study, compared to 97.7% in the present prescriptions. Hence, as the guarantee of the efficacy and safety of some prescribed drugs used in this study is at low range, the error that occurs in pediatric prescription is difficult to be considered benign. Therefore, reviewing of all pediatric prescriptions, by a monitoring committee, for adequacy, appropriateness, and doses accuracy according to patient's weight is seriously needed. In addition, it is advised to establish a national program dealing with continuous medical educations, monthly or yearly, with much focus on rational drug prescription.
| Conclusion|| |
We have clearly demonstrated that pediatric outpatients are at real risk of unpredictable drug effects as a result of prescription fault. The continued existence of medication error among pediatric patients is due, in part, to the absence of education programs, after graduations, and national guidelines. Hence, since pediatric outpatients' prescriptions contain a variety of medical errors, pharmacovigilance for pediatric prescriptions is greatly necessitated. Therefore, continuous medical education, in particular rational drug prescription, with a much focus on the pediatric doctors, is strongly recommended.
We are grateful to all pharmacists working at outpatients' pharmacy unit of the hospital for their great cooperation.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
WHO. The Importance of Pharmacovigilance (Safety Monitoring of Medicinal Products). Geneva: WHO Library Cataloguing-in-Publication Data; 2002. p. 4-8.
Ghaleb MA, Wong IC. Medication errors in children. Arch Dis Child Educ Pract Ed 2006;91:ep20-ep24.
Joss S, Dean JC. A schinzel-giedion-like syndrome – A milder version or a separate condition? Clin Dysmorphol 2002;11:271-5.
Sherif FM. An evaluation of the prescribing patterns of rugs in Libya. JMJ 2008;8:203-6.
Efnan M, Abdulla Z, Sheta A, Efreia H. Evaluation of health services in Nalut region through partial evaluation of the prescriptions. Al Qalam J 2016;2:193-203.
British National Formulary. Joint Formulary Committee. London: BMJ Group and Pharmaceutical Press; 2012.
Hersh AL, Jackson MA, Hicks LA; American Academy of Pediatrics Committee on Infectious Diseases. Principles of judicious antibiotic prescribing for upper respiratory tract infections in pediatrics. Pediatrics 2013;132:1146-54.
Hicks RW, Becker SC, Cousins DD. Harmful medication errors in children: A 5-year analysis of data from the USP's MEDMARX program. J Pediatr Nurs 2006;21:290-8.
Wolf ZR, Hicks R, Serembus JF. Characteristics of medication errors made by students during the administration phase: A descriptive study. J Prof Nurs 2006;22:39-51.
Quick JD, Hogerzeil HV, Velasquez G, Rago L. Twenty-five years of essential medicines. Bull World Health Organ 2002;80:913-4.
Fadare J, Olatunya O, Oluwayemi O, Ogundare O. Drug prescribing pattern for under-fives in a paediatric clinic in South-Western Nigeria. Ethiop J Health Sci 2015;25:73-8.
Risk R, Naismith H, Burnett A, Moore SE, Cham M, Unger S, et al.
Rational prescribing in paediatrics in a resource-limited setting. Arch Dis Child 2013;98:503-9.
Gupta N, Safhi M, Sumaily J, Agarrwal M. Drug prescribing patterns in children regestered in the department of pediatric of Jizan General Hospital of Jizan, KSA. Int J Pharm Pharm Sci 2013;5:397-9.
Sharif SI, Al-Shaqra M, Hajjar H, Shamout A, Wess L. Patterns of drug prescribing in a hospital in Dubai, United Arab Emirates. Libyan J Med. 2008;3:10-12.
Karande S, Sankhe P, Kulkarni M. Patterns of prescription and drug dispensing. Indian J Pediatr 2005;72:117-21.
Ahmed AM, Awad AI. Drug use practices at pediatric hospitals of Khartoum state, Sudan. Ann Pharmacother 2010;44:1986-93.
Oshikoya KA, Ojo OI. Medication errors in paediatric outpatient prescriptions of a teaching hospital in Nigeria. Nig Q J Hosp Med 2007;17:74-8.
Nsimba SE. Assessing prescribing and patient care indicators for children under five years old with malaria and other disease conditions in public primary health care facilities. Southeast Asian J Trop Med Public Health 2006;37:206-14.
Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 11th
ed. Ohio: Lexi-Comp Inc.; 2004.
Ferner RE, Coleman J. Anticipating, preventing and investigating medication errors. Clin Med (Lond) 2005;5:12-5.
McPhillips HA, Stille CJ, Smith D, Hecht J, Pearson J, Stull J, et al.
Potential medication dosing errors in outpatient pediatrics. J Pediatr 2005;147:761-7.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]