Epidemiology and Risk factors related to Medication errors in Moroccan children

 

Sara Jadda¹, Zakaria Abidli¹, Hinde Hami¹, Naima Rhalem² Houda Sefiani²,

Abdelmajid Soulaymani¹, Abdelrhani Mokhtari¹, Rachida Soulaymani-Bencheikh^2,3

¹PPR-B-Mokhtari-FS-UIT-Kenitra, Laboratory of Genetics and Biometry, Faculty of Sciences,

Ibn Tofail University, Kenitra, Morocco.

²Anti Poison and Pharmacovigilance Center, Rabat, Morocco.

³Faculty of Medicine, Mohammed V University, Rabat, Morocco.

 

ABSTRACT:

Objective: the present study aims to desribe the characteristics of medication errors occuring in Moroccan children and to analyze the risk factors associated with the hospitalization of cases. Methods: This is a retrospective study of medication errors occurring in children under the age of 15 and declared via the telephone response to the toxicological information unit of the Anti Poison and Pharmacovigilance Center of Morocco during the period from the 1st January 2014 until December 31, 2017. Results: During the study period, 295 medication errors in children were reported to the Anti Poison and Pharmacovigilance Center of Morocco. The average age was 4.2±3.3 years with extremes ranging from 2 days to 14 years. In order to highlight the factors influencing the hospitalization of patients, we studied the effect of the following variables: dose error, drug error, posology error, error related to the patient’s entourage, error related to the patient, symptomatology. Among the 46 cases with known symptoms, 33 children presented hepato-digestive disorders. Medication errors due to patients represent 3.5 times the risk of hospitalization (RR=3.5; 95% CI : [6.5-37.9]), the same risk for symptomatic cases with (RR = 3.5; 95% CI: [12.4- 46.8], while the dose and administration errors represent respectively 1.4 (RR = 1.4; 95% CI: [33-70.7]) and 1.1 1 (RR = 1.1; 95% CI: [1.4-28.2]) of the hospitalization risk. Conclusion: Medication erros can cause very considerable damage, sometimes even resulting in the death of the child. For this, future research is needed to put in place effective prevention strategies that can reduce the risk of errors in children. However, awareness campaigns can also be useful for health professionals and the general public.

 

 

 

INTRODUCTION:

Medication errors are a major public health problem worldwilde¹. They cause significant mortality and morbidity, especially in children^2-3. This risk continues to worsen given the lack of awereness, training and information of health professionals and the global population on the damage that can be caused by drug misuse, and due to the lack of studies carried out in this direction.

 

Medication errors can affect all age groups without exception, at different stages of treatment^4-5. However, children are at high risk because such mistakes are potentially more dangerous for them than for adults. Until now, interventions to minimize medication errors in children have led to only limited improvements⁶.

 

Drug safety is paramount in pediatric patients, owing to an alarming number of drugs errors. Each year, in the United States alone, 7000 to 9000 people die as a result of medication error⁷. It is estimated that 5.7% of medication errors concern the pediatric population⁸. U.S. poison-control centers handle more than 200.000 cases of out-of-hospital medication errors annually, and children under 6 years old constitute approximately 30% of these cases⁹. In addition, a French study has shown that the number of medication errors is 2 times higher in neonatology and that there is 3 times more risk of SAE (Serious Adverse Event) than in adult unit¹⁰.

 

There are a host of factors from which medication errors can derive to children. Illegible prescriptions, abbreviations in prescriptions, language barriers, lack of communication skills, and multiple drug combinations are some of the major factors leading to medication errors. Children with multiple prescriptions are at risk for preventable adverse drug events. Dosing errors, such as incorrect dosage or frequency of administration and either underdosing or overdosing, are common medication errors. Other errors include inappropriate medication selection for the indication, incorrect route of administration, failure to screen drug interactions or monitor side effects, and lack of communication between members of the healthcare team¹¹.

 

Medication errors in pediatric patients can lead to unwanted adverse events and reactions. It is important for physicians, pharmacists, and other healthcare providers to be aware that children need special dosing considerations and careful monitoring because their bodies are in different stages of development compared with adults. Pharmacists are in the position to counsel parents and caretakers about proper medication administration and storage. Communication between all persons involved in the care of pediatric patients will yield a better outcome.

 

At the national level, very little research has been done in this sense. Therefore, the present study aims to desribe the characteristics of medication errors occuring in Moroccan children and to analyze the risk factors associated with the hospitalization of cases.

 

METHODS:

This is a retrospective study of medication errors occurring in children under the age of 15 and declared via the telephone response to the toxicological information unit of the Anti-Poison and Pharmacovigilance Center of Morocco during the period from the 1st January 2014 until December 31, 2017.

 

The statistical methodology was based on two axes: descriptive statistics and analytical statistics. Descriptive analysis is done using IBM SPSS Statistics (v21) software. It concerns the characteristics linked to the patient (sex, age, area, place of intoxication), the characteristics of the drug in question (therapeutic class, route of administration), as well as the characteristics linked to the error (stage, type and responsible of the medication error, symptomatology, clinical signs, gradation, hospitalization, evolution), which allowed us to draw up the epidemiological profile of all the cases notified. Age was analyzed according to the distribution of the IPCS (WHO).

 

The contingency test (Chi-square) allowed us to study the associations between the studied variables and the outcome. Furthermore, the association between the variables and the hospitalization of cases was highlighted by calculating the Odds ratio.

 

RESULTS:

During the study period, 295 medication errors in children were reported to the Anti Poison and Pharmacovigilance Center of Morocco. The average age was 4.2 ± 3.3 years with extremes ranging from 2 days to 14 years. The most exposed age group was toddler with 49.2% of reports (Figure 1).

 

Fig 1: Distribution of reports by patient age range.

 

The male sex represents 61.4% of cases. Almost all of the children were of urban origin with a percentage of 80.3%. The therapeutic classes involved in the study were varied and acted on different systems of the human body. According to the results, drugs acting on the nervous system were the most represented with a percentage of 39.7% (Table 1).

 

Table 1: Distribution of drugs involved in the study.

 

According to the study, medication errors occurred mainly during the administration stage in 65.1% of cases. The dose error of the drug administered was the type of 38.3% of the reported errors. The patient's entourage was responsible for the error in 71.2% of the cases. Home poisoning was the most recorded in 80% of children.

 

 

Of the reported errors, 24.1% were symptomatic with 6.8% requiring hospitalization or prolongation of hospitalization. Among 253 cases for whom the outcomes were known, 1 toddler aged 2 died following the administration of Sodium Valproate, an antiepileptic drug, instead of another drug.

 

Table 2: Distribution and outcome of medication errors according to the variables studied.

* Medication Error    ** Highly significant difference (p<0.05)    ^n.s No significant difference

 

 

Clinically, children presented various signs (Figure 2). Among the 46 cases with known symptoms, 33 children presented hepato-digestive disorders.

 

In order to highlight the factors influencing the hospitalization of patients, we studied the effect of the following variables: dose error, drug error, posology error, error related to the patient’s entourage, error related to the patient, symptomatology.

 

Fig 2: Distribution of clinical signs observed in children.

 

 

Medication errors due to patients represent 3.5 times the risk of hospitalization (RR=3.5; 95% CI : [6.5-37.9]), the same risk for symptomatic cases with (RR = 3.5; 95% CI: [12.4- 46.8], while the dose and administration errors represent respectively 1.4 (RR = 1.4; 95% CI: [33-70.7]) and 1.1 1 (RR = 1.1; 95% CI: [1.4-28.2]) of the hospitalization risk (Table 3).

 

Table 3: Effects of the factors studied on hospitalization.

RR, Relative Risk; CI, Confidence Interval

 

DISCUSSION:

Medication errors occur more frequently in children than in adults because of the need to prescribe a dosage based on the child’s weight and age, which make him sensitive to the slightest defect in administered dose^12-14. Medication errors in children are receiving considerable attention around the world. In our study, 295 medication errors in children were collected between 2014 and 2017 with the dose error in 113 cases. It is crucial for healthcare providers to ensure that the appropriate drug and dose are prescribed to children, especially neonates, because of their differences in response to drugs compared with adults. Understanding pediatric pharmacokinetics and stages of development can help providers more accurately prescribe medications for children and minimize dosing errors. Pharmacists can help prevent medication errors by checking dosing calculations, screening for drug-drug interactions, and counseling caregivers on proper administration and medication-storage safety tips. During 2008, a prospective study of drug errors occuring in children was conducted at the Poison Control and Pharmacovigilance Center of Morocco. The results showed that 62 cases were collected with the most common dose error in 34 children¹⁵. Moreover, a retrospective study at the Australian Children’s Hospital revealed that 2753 medication errors were reported over a 4-year period. Dose error (21%) and omission error (12.4%) were the most common types of event. The errors were mainly due to an incorrect reading of the medical prescriptions, thus leading to a poor therapeutic care of the child¹⁶. Based on data from the literature review, medication errors in children generally concern dose errors¹⁷. They are most often due to lack of attention or misunderstanding of the treatment regimen, or also to lack of communication between the different persons responsible¹⁸.

 

A study conducted in the United States showed that more than 63000 medication errors occured each year between 2002 and 2012 in children under 6 years. The most common errors occured at home or school¹⁹. In our study, home poisoning was the most observed in 80% of children with the most recorded administrative error (192 cases). According to the bibliography, 1571 administrative errors in children under 6 years have been reported to the Anti Poison Center of Quebec in 2005. These errors are very often due to a lack of understanding of the dose to be administered resulting in the absorption of super-therapeutic doses. They can also result from a lack of communication between the various persons responsible for the child, leading to the repetition of a dose already administered²⁰. Furthermore, the American Association of Poison Control Centers reported in 2013 that almost 80% of reported medication errors were in children under 12 years abd 85% of these errors were related to lack of communication between the responsible parties²¹.

 

Strategies to reduce the damage caused to children must concern all stages of the therapeutic circuit. Since drug administration is the most of time done at home, the involvement of parents and anyone caring for children will be essential to reduce the negative consequences of medication errors in this age group²².

 

 

CONCLUSION:

The concern with patient safety and care quality in health services mobilized the WHO in 2004 to reduce risks, organizing concepts and definitions on patient safety and recommending that countries pay greater attention to the theme. In that sense, children are particularly vulnerable to damage, mainly due to the peculiarities of their metabolism, such as age, weight and height. In addition, the lack of standardized drugs for pediatrics makes the medication process even more susceptible to errors.

 

Medication errors can cause very considerable damage, sometimes even resulting in the death of the child. For this, future research is needed to put in place effective prevention strategies that can reduce the risk of errors in children. However, awareness campaigns can also be useful for health professionals and the general public.

 

ACKNOWLEDGEMENT:

The authors are pleased to acknowledge the Anti Poison and Pharmacovigilance Center of Morocco for providing the facilities for the study, in addition to the entire research team of the Genetics and Biometry Laboratory at Ibn Tofail University. This study was carried out as a part of the PPR-B-Mokhtari-FS-UIT-Kenitra project.

 

CONFLICTS OF INTEREST:

None.

 

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Received on 10.02.2020           Modified on 26.03.2020

Accepted on 01.05.2020         © RJPT All right reserved