11th Pharmacovigilance 2016
ADE: Adverse Drug Event
ADR: Adverse Drug Reaction
AEFI: Adverse Events Following Immunizations
DTC: Drug and Therapeutic Committee
DIS: Drug Information Service
FMHACA: Food, Medicine and Healthcare Administration and Control Authority
IVD: In vitro Diagnostic Device
MAH: Market Authorization Holders
PHP: Public Health Programme
PSUR: Periodic Safety Update Report
PVDMS: Pharmacovigilance Data Management System
UMC: Uppsala Monitoring Centre
WHO: World Health Organization
Adverse drug event: “Any untoward medical occurrence that may be present during treatment with a medicine but does not necessarily have a causal relationship with this treatment, that is, an adverse outcome that occurs while the patient is taking the medicine but is not, or not necessarily, attributable to it.”
Adverse drug reaction: "A response to a medicine 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."
Consumer: A consumer in a healthcare is anyone who uses, has used, or may use any health or health related service. It is not limited to those currently using a service. The terms "patients" and "users" generally apply only to those currently undergoing some form of treatment.
Drug interaction: A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect not produced on its own. Typically, interaction between drugs comes to mind (drug-drug interaction). However, interactions may also exist between drugs&foods (drug-food interactions), as well as drugs&herbs (drug-herb interactions.
Health institution: A health institution is any governmental, non-governmental or private institution that carry out promotive, preventive, curative and rehabilitative activities or medicine trade or services.
Healthcare professional: Health professional means a person who is registered by the relevant body as a professional to protect human health or provide service.
Medication errors: “A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature;compounding; dispensing; distribution; administration; education; monitoring; and use."(National Coordinating Council for Medication Error Reporting and Prevention)
Overdose: This refers to the administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information. Clinical judgement should always be applied
Off-label use :This relates to situations where the medicinal product is intentionally used for a medical purpose not in accordance with the authorised product information
Misuse: This refers to situations where the medicinal product is intentionally and inappropriately used not in accordance with the authorised product information
Medicine: “Medicine means any substance or mixture of substances used in the diagnosis, treatment, mitigation or prevention of a disease in human and includes narcotic drugs, psychotropic substances and precursor chemicals, traditional medicines, complementary or alternative medicine; poisons, blood and blood products, vaccine, radioactive pharmaceuticals, cosmetics and sanitary items and medical instruments”.
Pharmacovigilance: "The science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.”
Product quality defect: Quality problems of products i.e; suspected contamination, questionable stability, defective components, poor packaging or labeling, or unexpected therapeutic ineffectiveness.
Serious adverse event/reaction: “A serious adverse event or reaction is any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically might have caused death if it were more severe),
- requires inpatient hospitalisation or results in prolongation of existing hospitalisation,
- results in persistent or significant disability/incapacity, * is a congenital anomaly/birth defect,
- is a medically important event or reaction. Medical and scientific judgment should be exercised in deciding whether other situations should be considered serious such as important medical events that might not be immediately life-threatening or result in death or hospitalisation but might jeopardize the patient or might require intervention to prevent one of the other outcomes listed in the definition above. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, or development of drug dependency or drug abuse.”
Signal “is a Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.” An additional note says: “Usually more than one report is required to generate a signal, depending on the seriousness of the event and the quality of the information.”
Medical instrument: Means any instrument or supply that may be used on the inner or outer part of the body for diagnosis or treatment of a disease in human, and includes various diagnostic, laboratory, surgery, dental medical instruments and suturing materials, syringes and needles.
KEY THEMES DISCUSSED AT THIS CONFERENCE:- Updates - legislation, policies, systems, technology, communication strategies and best practice in PV
Lessons to learn - Pharmacovigilance Programme of India (PvPI)
Clinical Trial Safety: Shift from Explanatory to Pragmatic Trials
Developing pharmacovigilance into high quality management system and its components
Integrate digital health initiative to minimize risks and enhance patient safety
Indigenous medicines for sex selection during pregnancy: How safe is it?
Negotiating Country-Specific annexes and adapting Risk Management Plans (RMPs) to Asia
Developing a refinement of quality in people, process and technology within your PV system
Changing landscape of PV technologies
Assuring certain submission in Patient Support Programs (PSP): Leveraging organizational collaboration to enhance data capture
Understanding the Indian Medical Association (IMA) good practice guide on risk minimization and prevention of medication errors
Mobile Apps to enforce pharmacovigilance and risk minimisation interventions
Using big data to advance drug safety
Negotiating the regulatory environment
Accelerating new medicine introduction in developing world & overcoming challenges
Be part of a major networking opportunity
WHO ATTENDED:- Vice Presidents, Directors, CRO’s, Heads and Managers of: •Pharmacovigilance Strategy •Drug Safety/Risk Management •Information and Clinical Data Management •Clinical Research •Research & Development •Product Safety/Assurance Assessment •Patient Safety & Outcomes Research & Data Analysis •Epidemiology project management •Regulatory Affairs and Compliance •Sales & Marketing •Biotech manufacturers From the following: •Pharmaceutical organizations •Generic pharmaceutical companies •Contract research organizations •Patient recruitment companies •Government- Department of health •Non-profit organizations/ Association •Consultants