Enhancing the reporting of adverse drug reactions in medical journals. Part 2

In recent years, the quantity of biomedical articles written by scientists worldwide has grown significantly. Healthcare professionals are eager to publish their scientific discoveries, particularly new, rare, or unexpected adverse drug reactions (ADRs), in certain journals within the scientific community. An initial publication of a well-documented ADR report can inspire other readers to report similar cases. Published case reports can also aid in managing complex cases in a clinical setting. Consequently, enhancing the reporting of adverse drug reactions in the medical literature is essential. In the first part of the overview created by experts from the DrugCard, you learned about the requirements for article titles and patient information. This overview section will familiarise you with the requirements for drugs and adverse reaction information and a discussion section.

Drug Information Requirements

Identifying the suspected drug(s) generic name (or the trade name) together with the manufacturer, strength, or dosage units is extremely important. Authors should provide the exact or approximate dose of the suspected drug and other drugs used for multidrug therapy. Mention the treatment period (start, end) and the restart date if the suspect drug rechallenge took place. Indicate the route of drug administration, such as oral or intravenous. Provide information about the duration of therapy before the event onset, including the intervals between the first dose-event and the last dose-event. A good example is from a case report of Vancomycin-induced organizing pneumonia:

“The patient was prescribed the intravenous vancomycin (1.6 g per day) for 41 days and meropenem (3 g per day) on the first day of hospitalization. The treatment with meropenem was stopped on the 28th hospital day”.

Concomitant therapy in the reporting of adverse drug reactions in medical journals

When reviewing the history of drug therapy concerning an adverse event, it is crucial to look beyond the immediate treatment preceding the event. Evaluate the potential impact of concomitant therapies (including non-prescription, herbal drugs etc.) in cases involving multiple drug therapies. For example, a case report of severe hypotension, asystole, and cardiac arrest after Sugammadex administration:

“The patient is an 80-year-old male … in polytherapy with 50 mg Levothyroxine, 300 mg Allopurinol, 500 mg Metformin and 322 µg Aclidinium Bromide inhalation… The patient went into surgery after premedication with 2 mg of Midazolam intravenously. Antibiotic prophylaxis was performed with 1 g of Cefotaxime. General anesthesia was induced with Propofol and a total of 30 mg Rocuronium and, after tracheal intubation, was maintained with 2% Sevoflurane and Fentanyl”.

Description of adverse drug reaction

A comprehensive depiction of the adverse drug reaction is necessary, which should include a detailed account of the event and its severity. Additionally, it is essential to provide the onset date and duration of the adverse event. An example from the Sugammadex case report:

“At the surgery end, the Sevoflurane administration was stopped and, after 5 min, 200 mg Sugammadex was administered to the patient: one minute later, he developed severe bradycardia with heart rate below 35 beats/min and systolic blood pressure decreased to below 50 mmHg, and was promptly treated with a total of 10 mg Ephedrine and 1 mg Atropine i.v. to restore normal heart rate and systolic blood pressure. However, the patient’s clinical condition rapidly worsened with the onset of severe hypotension, asystole, and cardiac arrest.”

Causality assessment in the medical literature

If an adverse event concerns a medication with an established causality, the author(s) should include their causality assessment in the manuscript. Nevertheless, in most scientific publications, the authors do not explicitly state a causal relationship between a medicinal product and an adverse event. However, they may use tools like the Naranjo scale for causality assessment, like in the case report of Sugammadex:

“Using the Naranjo nomogram, a 7 point-score (probable) was set to this report…“.

The Naranjo ADR Probability Scale aims to provide a standardized approach to causality assessment for all adverse drug reactions. Therefore, it is recommended to use this scale for reporting adverse events in publications. There is even an online calculator available for this purpose.

Discussion section

The ADR report’s discussion section must comprehensively assess the causal relationship between the suspected drug and the event. Authors should mention diagnostic procedures utilized to confirm the final diagnosis. Plausible explanations for the adverse event’s pharmacology or biology should be discussed. Also, researchers should review previous reports in biomedical journals or product labeling to identify ADR trends. The discussion should evaluate the ADR’s implications for patient care and future research.

Summary for authors on improving reporting of adverse drug reactions in medical journals

Authors can improve ADR reporting in literature by providing complete and accurate drug information, including dose and patient characteristics. A detailed description of the adverse reaction, including timing, severity, and outcome, is necessary. Researchers should use appropriate causality assessment tools to evaluate the causal relationship between the drug and adverse reaction. Authors should provide plausible pharmacological or biological explanations based on available evidence. Following these guidelines improves the quality of ADR reporting and contributes to safe and effective medication use.