Description
c) Adverse drug reaction
Classifications – Excessive pharmacological effects, secondary pharmacological effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and pharmacokinetic drug interactions,
Methods for detecting drug interactions, spontaneous case reports and record
linkage studies, and Adverse drug reaction reporting and management
Adverse drug reaction
The World Health Organization(WHO) defines an adverse drug reaction (ADR) as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”(WHO)
Types of Adverse drug reactions:
• TYPE-A (augmented)
• TYPE-B (Bizarre)
• TYPE-C (continuous)
• TYPE-D (delayed)
• TYPE-E (End of Dose)
• TYPE-F (Failure of therapy)
Introduction:
What is Pharmacovigilance?
Pharmacovigilance is defined as the science and activities concerned with the detection, reporting,assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The ultimate goal of this activity is to improve the safe and rational use
of medicines, thereby improving patient care and public health. Why is Pharmacovigilance important?
When a medicine is released onto the market there is still a great deal that is unknown about the safety of the product. Once marketed the medicines are used by patients who have many different diseases, who are using several other drugs and who have different traditions and diets which may
affect the way in which they react to a medicine. Different brands of medicines may differ in the manner in which they are produced and the ingredients that are used. The adverse drug reactions
and poisonings associated with traditional and herbal remedies also need to be monitored in each country. The information we receive on the adverse effects of drugs in other countries may not be relevant or applicable to {Country}’s citizens. In some cases, adverse effects to certain drugs may only occur in {Country}’s citizens.
In order to prevent unnecessary suffering by patients and to decrease the financial loss sustained by the patient due to the inappropriate or unsafe use of medicines, it is essential that a monitoring system for the safety of medicines in {Country} is supported by doctors, pharmacists, nurses and
other health professionals in the country.
The {Drug Regulatory Authority} and the Department of Health’s Essential Drug Program are committed to improving drug safety through adverse drug reaction monitoring in {Country}.
Through the {Drug Regulatory Authority}’s national pharmacovigilance program, adverse reactions should be reported on a daily basis.
General information on adverse drug reactions reporting:
• WHAT TO REPORT?
• WHO SHOULD REPORT
• WHEN TO REPORT
• HOW TO REPORT
• WHERE TO REPORT
WHAT TO REPORT?
• Any undesirable adverse event suspected to be associated with use of drug.
• Include – All ADRs as a result of prescription and non-prescription
• All ADRs – irrespective of the used (acc with PI provided by company)
• Unexpected reactions – regardless of their nature or severity
• ADRs-in special field – drug abuse, drug use – pregnancy / lactation
• ADRs occurring from overdose or medication error. Information required for adverse reactions reporting:
• Patient information (name, age, sex etc.)
• Adverse events and problems
• Suspected medication
• Reporter Who should report the adverse drug reactions?
Doctors, dentists, pharmacists, nurses, assistant medical officers, clinical officers, pharmaceutical technicians, pharmaceutical assistants, traditional medicine practitioners and others health care providers.
When to report the adverse drug reactions?
• Any suspected ADR should be reported as soon as possible.
• Delay in reporting will make reporting inaccurate and unreliable.
• If possible, report while the patient is still in the health facility this gives a chance to reporter to clear any ambiguity by re-questioning or examining the patient.
How to report the adverse drug reactions? By adverse drug reactions reporting forms.
Adverse drug reactions reporting according to official guidelines
There are many guideline for detecting, reporting, assessments, preventions and
management of adverse drug reactions. And some of them are as follows:
WHO GUIDELINES ON ADVERSE DRUG REACTIONS:
Introduction:
Reducing medical errors has become an international concern. Population-based studies from a number of nations around the world have consistently demonstrated unacceptably high rates of medical injury and preventable deaths. In response, a global effort, the World Alliance for Patient Safety, has been launched by WHO to galvanize and facilitate efforts by all Member States to make health care safer. These draft guidelines are a contribution to the Forward Program 2005 of the World Alliance for Patient Safety (1). The guidelines introduce adverse event reporting and focus on reporting and learning to improve the safety of patient care.
Purpose: In seeking to improve safety, one of the most frustrating aspects for patients and professionals alike is the apparent failure of health-care systems to learn from their mistakes. Too often neither health-care providers nor health-care organizations advise others when a mishap occurs, nor do they share what they have learned when an investigation has been carried out. As a consequence, the same mistakes occur repeatedly in many settings and patients continue to be harmed by preventable errors. One solution to this problem is reporting: by the doctor, nurse, or other provider within the hospital or health-care organization, and by the organization to a broader audience through a system-wide, regional, or national reporting system. Some believe that an effective reporting system is the cornerstone of safe practice and, within a hospital or other health-care organization, a measure of progress towards achieving a safety culture. At a minimum, reporting can help identify hazards and risks, and provide information as to where the system is breaking down. This can help target improvement efforts and systems changes to reduce the likelihood of injury to future patients.
Objectives:
The objective of these draft guidelines is to facilitate the improvement or development of reporting systems that receive information that can be used to improve patient safety. The target audience is countries, which may select, adapt or otherwise modify the recommendations to enhance reporting in their specific environments and for their specific purposes. The guidelines are not meant to be an international regulation and will undergo modification over time as experience accumulates. ADR Reporting Internationally
Type of reporting system:
ISMP is a national, confidential medication error reporting system. That distributes hazard alerts and other medication safety information to 600,000 providers every other week.
