Adverse Reaction (Drug/Product) Reporting Form    character size

  1. Information on Adverse Reaction Reporting

    • Adverse events include both adverse reactions and medication errors.
    • An adverse reaction is a harmful and unintended response to a health product. This includes any undesirable patient effect suspected to be associated with health product use. Unintended effect, health product abuse, overdose, interaction, and unusual lack of therapeutic efficacy are all considered to be reportable adverse reactions.
    • A medication error is any preventable event that may (but not necessarily) cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.
    • Medications errors are not reported using this form, but they may be the cause of adverse reactions as mentioned in section B of that form.
  2. What to Report ?

    • All suspected adverse reactions should be reported, especially those that are:
      • Unexpected, regardless of their severity
      • Serious, whether expected or not
      • Reactions to recently marketed health products (≤ 3 years on the market), regardless of their nature or severity.
    • A serious adverse reaction is one that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability, is life-threatening or results in death. Adverse reactions that require significant medical intervention to prevent one of these listed outcomes are also considered to be serious.
  3. Purpose and Scope

    In the perspective of medication safety, the Lebanese Order of Pharmacists (OPL) elaborated an "Adverse reaction (drug/product) reporting form" in order to report adverse reactions related to any drug or product administered to a patient in a community or hospital setting and has led to an adverse reaction. The aim is to create a standardized assessment system, reporting objectively any reaction based on a reliable and reproducible measurement of causality. The present form has been developed based on the causality assessment system proposed by the World Health Organization Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (WHO-UMC), and the Naranjo Probability Scale [1 2]. This tool will allow us to screen, detect, investigate, analyze and establish any causal relationship between the drug/product and the adverse event/reaction. Furthermore, evaluated data will enable us to classify the adverse event/reaction according to its severity, its probability, and the pharmaceutical category of drug/product behind its occurrence, creating a national adverse reaction database of health products, which will be forwarded, at a later stage, to the Global Pharmacovigilance Database managed by WHO-UMC. Our ultimate purpose is to support good decision-making regarding the benefits and risks of treatment options for patients taking medicines and thus enhancing the key role of the pharmacist in the practice of medication safety. We appreciate the time allocated to complete the form. If you have any questions or concerns, send them to the following email: medication.safety@opl.org.lb

  4. Confidentiality and Protection

    • Submission of a report does not imply that the reporter, the institution or the product caused or contributed to the adverse reaction. Adverse reaction reports are only suspected associations;[4] they do not imply a definitive causal link.
    • All obtained data will stay confidential and anonymous;they will be protected and handled in strict confidence, and will be used for medication safety reporting and follow up only.
  5. Instructions to complete the Adverse Reaction Reporting Form

    • Use the form to report adverse reactions to Lebanese marketed health products, including prescription and non-prescription medications, vitamins and herbal products, electrolytes and serums, biologically derived products such as vaccines and fractionated blood products, radiopharmaceuticals and diagnostics, and cosmetics.
    • All sections of the form should be filled in as completely as possible. Each reported adverse reaction requires a separate form for every patient.
    • Any follow-up information for an adverse reaction that has already been reported can be submitted by accessing "review previous submissions". Selecting the corresponding submission, and adding a note at the end of the page where indicated. Once done, press submit.
  6. References

    1. U.S. Food and Drug Administration, Medication Errors Related to Drugs [updated 07/08/2016]. Available from: http://www.fda.gov/drugs/drugsafety/medicationerrors/
    2. The use of the WHO-UMC system for standardised case causality assessment. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf
    3. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30(2):239-45.
    4. http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_indus_form-eng.php

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