“Primum Non Nocere” - A Latin phrase which means "First, Do No Harm" is one of the principal precepts of medical ethics and is a fundamental principle for emergency medical services around the world.
- 400 B.C. Hippocrates
Hope, intention, humility, and recognition that a human acts with good intentions may have unwanted consequences.
November 1999 :The U.S. Institute of Medicine issued a report (To Err is Human: Building a Safer Health System) this report has resulted in increased awareness of the medical errors. The push for patient safety that followed its release, continues.
Pharmacovigilance is “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug relating problems”.
• Proactive monitoring and reporting on the quality, safety and efficacy of drugs
• Assessment of the risks and benefits of marketed medicines
• Monitoring the impact of any corrective actions taken
• Providing information to consumers, practitioners and regulators on the effective use of drugs
• Designing programs and procedures for collecting and analyzing reports from patients and clinicians
• At the time of approval, clinical trial data are available on limited numbers of patients treated for relatively short periods
• After marketing, new safety information may become available:
• Through use of the product domestically or in other countries
• Through use of other drugs in the same class
• From preclinical studies
• From pharmacologic studies
• From controlled clinical trials
• To create an awareness of safety issues and drugs
• To encourage health professionals to share concerns about drugs
• To determine the concerns health professionals have over drugs and their best use, including interactions.
• To react with helpful information to improve therapy
• To minimize undue concern about safety of therapies known to cause ADRs
• To allow for comparison of reporting rates among different therapeutic classes of medicines
• Improve patient care and safety
• Improve public health and safety in relation to the use of medicines
• Contribute to the assessment of benefit, harm effectiveness and risk of medicines.
All non-study / spontaneous AEs, and incidents including :
• Reports of lack of efficacy
• Reports of product complaints involving an AE / incident including the batch number
• Reports of medication errors (including maladministration)
• Reports of misuse abuse and overdose.
• Reports of suspected transmission of an infectious agent via a medicinal product.
• Reports of pregnancies
• Reports of exposure via breast milk.
