Unintended Consequences: A Case of Metoclopramide and Paracetamol Packaging Confusion in an Infant

Ambika Nand Jha and Varsha Ratan Gaikwad

Published on: 2024-12-12

Abstract

Background: Adverse drug reactions (ADRs) pose a major challenge to global health, contributing to significant rates of illness and death. With the complexity of modern healthcare systems vigilant pharmacovigilance systems are essential to detect and manage these risks, thereby safeguarding patients and ensuring the rational use of medications. ADRs may arise from factors such as drug interactions, genetic predispositions, organ dysfunction, or inappropriate medication use. On the other hand, medication errors, which differ from ADRs, are preventable mistakes made during drug prescribing, dispensing, or administration, and can lead to adverse drug events (ADEs). Both ADRs and medication errors underscore the importance of careful monitoring, ongoing professional education, and a patient-centered approach to enhance treatment outcomes and minimize harm. Tackling these challenges is critical to improving the safety and quality of healthcare delivery.

Clinical Scenario: A 9-month-old male infant, initially managed for an upper respiratory tract infection with paracetamol, Cefixime, and Ofloxacin ear drops, developed symptoms of dizziness, weakness, and atypical oral sensations following inadvertent administration of metoclopramide suppositories due to packaging similarity. After referral to a tertiary care facility, comprehensive neurological and laboratory assessments, including brain imaging, revealed no significant abnormalities. The patient received intravenous hydration and a dose of paracetamol, with marked clinical improvement observed over a 24-hour period. He was discharged in stable condition, without any lasting sequelae.

Conclusion: This case underscores the risks of medication errors in pediatric care, particularly when medications have similar packaging. It highlights the need for clearer labelling, thorough medication reviews, and heightened awareness among healthcare providers and caregivers. Prompt intervention and proper monitoring are crucial in managing ADEs, and improving safety protocols and education can help prevent such incidents in the future. This emphasizes the need for vigilance in medication management to ensure patient safety, especially in vulnerable populations like infants.

Keywords

Clinical monitoring; Drug packaging confusion; Medication errors; Medication safety; Pediatric care; Supportive care

Introduction

Medication errors remain one of the most prevalent and preventable causes of patient harm in healthcare settings. These errors can occur in a variety of ways, such as administering the incorrect drug or dosage, using the wrong route of administration, or giving medication to an unintended patient [1, 2]. The scope of medical errors has gained significant attention in recent years due to their profound impact on public health [2]. Common types of medical errors include surgical mistakes, misdiagnoses, medication errors, equipment malfunctions, patient falls, hospital-acquired infections, and breakdowns in communication [3]. Identifying the underlying factors, failures, and risk points that contribute to these adverse events is critical in developing strategies to prevent similar incidents in the future [4]. To mitigate the occurrence of medical errors, it is crucial to foster an environment where individuals at every level of the healthcare system—from healthcare providers to patients—are encouraged to report errors transparently. The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as "any preventable event that may lead to inappropriate medication use or harm." This encompasses errors across various stages, such as prescribing, compounding, dispensing, distributing, and administering medications [5, 6]. Historically, studies on medication errors have predominantly concentrated on those committed by healthcare professionals. However, an emerging body of research has highlighted that patients themselves often contribute to medication errors during self-administration [7]. A Medication Self-administration Error (MSE) can occur when a patient inadvertently takes their prescribed medication at the wrong time, in the wrong dose, confuses it with another medication, or stores it improperly. Medication errors represent a significant challenge to health systems globally, as they not only undermine the effectiveness of treatments but also elevate healthcare costs [8]. While many medication errors do not result in immediate harm, they can sometimes lead to severe consequences, including hospitalization, long-term complications, or even death [9, 10]. The prevalence of these errors underscores the urgent need for comprehensive strategies aimed at reducing medication-related risks and enhancing patient safety. By addressing the root causes and promoting better practices, it is possible to minimize the occurrence of medication errors and ultimately improve patient outcomes [11].

In this case, summery in table 1 the medication error occurred due to the similar packaging of two different drugs, which led to a mix-up during administration. The infant was mistakenly given metoclopramide suppositories instead of the prescribed paracetamol suppositories. Both medications had similar color packaging, which caused confusion, particularly since the parents, who were illiterate, relied on the color to identify the drugs. This highlights the critical issue of medication labelling and packaging, as even small similarities can lead to serious errors, especially in settings where patients or caregivers are unable to read or differentiate between the medications. The packaging design plays a crucial role in preventing such mistakes, and this case emphasizes the need for more distinct and user-friendly labelling to ensure safety and reduce the risk of medication errors.

Clinical Scenario

A 9-month-old full-term male infant, delivered via elective cesarean section due to breech presentation, presented to a private clinic with fever and symptoms consistent with an Upper Respiratory Tract Infection (URTI). These symptoms included sore throat, nasal congestion, cough, and difficulty breathing. The fever was intermittent, typically elevated in the evening and accompanied by chills. On clinical examination, the throat appeared erythematous and inflamed. The patient also reported chest tightness, rhinorrhoea, and occasional sneezing. The attending physician prescribed paracetamol suppositories, along with Cefixime and Ofloxacin ear drops. Paracetamol was administered at 7:00 am, 1:00 pm, and 8:00 pm on the first day of treatment. However, after the final dose, the infant developed increasing dizziness, weakness, and significant loss of strength. Additionally, the child exhibited an unusual oral sensation, which prompted concern for a potential adverse drug reaction. The parents, worried about these new symptoms, sought care at a nearby private hospital, where the child received intravenous fluids and was subsequently referred to a tertiary care hospital for further evaluation, with meningitis or encephalitis as potential differential diagnoses. Upon review of the medications in the emergency department, it was discovered that the infant had been mistakenly administered metoclopramide 5 mg suppositories instead of the intended paracetamol. The confusion arose due to the similar packaging of the two medications, which led to an error, as the parents, who are illiterate, rely on the color of the medication for identification.

Upon arrival at the emergency department, the patient was afebrile and alert, with a Glasgow Coma Scale (GCS) score of 15/15. He appeared well-hydrated, with stable vital signs, including a blood pressure of 123/76 mmHg, heart rate of 124 beats per minute, and oxygen saturation of 98% on room air. His temperature was 36.7°C, and his random blood glucose was 94 mg/dl. A comprehensive neurological examination yielded normal results, and cardiopulmonary and abdominal assessments were unremarkable. Laboratory investigations, including electrolytes, Complete Blood Count (CBC), liver function tests, Venous Blood Gas (VBG), and Electrocardiogram (ECG), all returned normal findings. Brain imaging was performed to exclude any acute intracranial pathology. The child was admitted for observation and supportive management, including intravenous fluids and a single dose of paracetamol. Following 24 hours of observation, during which the patient’s condition improved and laboratory results remained within normal limits, the infant was discharged in stable condition.

Discussion

Medication errors in pediatric care present a significant challenge due to the increased vulnerability of young patients and the potential for severe consequences. A recent case highlighted this issue when an infant was mistakenly administered metoclopramide suppositories instead of the prescribed paracetamol [12-14]. This error occurred due to the similarity in the packaging of the two medications, exacerbated by the parents' inability to read labels because of illiteracy. As a result, they relied on color coding, which ultimately contributed to the mistake. This case emphasizes the vital role of clear and distinguishable medication labelling and packaging, especially for populations with limited literacy or unfamiliarity with medical terminology [15, 16]. Medication errors can stem from various causes, including poor communication, cognitive biases, and insufficient labelling. These factors collectively increase the risk of harm in healthcare environments. In this particular situation, the prompt identification of the error and swift medical intervention led to a positive outcome for the infant, highlighting the importance of vigilant monitoring, precise labelling, and proactive management in preventing and addressing Adverse Drug Events (ADEs) [17-19].

The case also illustrates the need for healthcare systems to implement stronger safeguards, such as standardized labelling procedures and clearer visual distinctions in medication packaging, to mitigate the risk of mix-ups. Additionally, educating healthcare providers and caregivers about the risks of medication errors and the importance of proper drug identification is essential in preventing future incidents. By improving pharmacovigilance systems, enhancing packaging designs, and promoting a culture of safety, healthcare organizations can better protect patients and reduce the occurrence of medication errors.

Conclusion

This case emphasizes the critical need for medication safety in pediatric care, where errors can have significant consequences. The mix-up between metoclopramide and paracetamol suppositories, caused by their similar packaging, highlights the importance of distinct and clear labelling for medications. The added challenge of caregiver illiteracy further increases the risk of such mistakes, pointing to the need for medication packaging that is easily identifiable and not dependent on color or visual cues alone. The timely intervention and close monitoring in this case resulted in a favorable outcome for the infant, illustrating the importance of prompt medical management in mitigating the effects of adverse drug events. To prevent such errors in the future, healthcare systems should focus on improving pharmacovigilance, standardizing medication labelling, and providing better education for healthcare professionals and caregivers. Cultivating a safety-focused healthcare environment can significantly reduce risks and ensure the safe use of medications, especially for vulnerable patients.

Table1: Summery of the case.

Aspect

Details

Patient

9-month-old male infant, full-term, cesarean delivery due to breech presentation.

Initial Diagnosis

Upper respiratory tract infection (URTI) with fever, sore throat, nasal congestion, cough.

Prescribed Medications

Paracetamol suppositories, Cefixime, Ofloxacin ear drops.

Error

Mistaken administration of Metoclopramide suppositories instead of Paracetamol.

Cause of Error

Similar packaging of Metoclopramide and Paracetamol, reliance on color by illiterate parents.

Symptoms of Error

Dizziness, weakness, unusual oral sensation.

Intervention

IV fluids, single dose of paracetamol, neurological examination, brain imaging.

Outcome

No significant abnormalities found, clinical improvement in 24 hours, discharged stable.

Key Learning Points

Importance of clear labelling, distinct packaging, caregiver education, and vigilant monitoring.

Recommendations

Standardize medication labelling, improve packaging, and enhance education for caregivers and healthcare providers.

Acknowledgments

We would like to extend our heartfelt thanks to the patient and their family for their cooperation and trust, which were essential in completing this case report. Their willingness to participate in the study is greatly appreciated and played a crucial role in its success.

Ethical Declaration

The study was conducted following ethical guidelines, with informed consent obtained from the patient's guardian. The confidentiality of the patient’s personal information was strictly maintained throughout the research process, in adherence to privacy standards.

Conflict of Interest

The authors declare that there are no financial, personal, or professional conflicts of interest regarding this study.

Funding: None

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