Study Set Content:
15 years
NDA
1-2 YEARS
ANDA
True or False Adverse reactions that occur in fewer than 1 in 3,000 – 5,000 patients are unlikely to be detected in Phase I – III investigational clinical trials, and may be unknown at the time a drug is approved.
TRUE
True or False Pre-marketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
FALSE
True or False Patients in clinical trials normally do NOT have other medical conditions which may exist in the general population.
TRUE
True or False If safety surveillance does indeed reveal concerns about the drug, it may be withdrawn from the market and no longer made available on prescription.
TRUE
The _______________ or ____________________ serves as the source of product information providing the list and information of adverse drug reactions that may be related to the use of a certain medicine.
PIL , package insert
Post-marketing surveillance • also known as _____________ or ______________ • involves ADR ____________ and __________
Phase 4, pharmacovigilance, reporting, monitoring
science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine related problem.
Pharmacovigilance
plays an important role in making sure that the medicines and vaccines we use are continuously providing benefits rather than the risk of having side effects.
Pharmacovigilance
The (), through its (), is the National Pharmacovigilance Center in the country who receives and processes reports of suspected adverse drug reactions from pharmaceutical industries, hospitals, healthcare professionals, patients/consumers, and public health programs
FDA, PV Section
The () works closely with the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM).
FDA
• Every time you report a side effect, you are contributing to improve the safety of medicines and vaccines used by Filipinos. • Medicines and vaccines are registered to and evaluated by the FDA considering the quality of the products and current evidence of its safety and efficacy. However, no medicines are guaranteed (). Although they are carefully tested and evaluated, some side effects or adverse reactions may become evident only after the product is used by the general population.
100% safe
Your report may contribute to: • The () of previously unrecorded or unrecognized rare or serious side effect; • Changes in()information or labelling, or other regulatory actions such as product recall or removal from the market;
identification, product safety
() data regarding benefit, risk or effectiveness assessment of medicines and vaccines.
International
are imposed by the FDA to secure the safety of the public. It also provides consumers and healthcare professionals guidance on the rational use of medicines and vaccines.
Regulatory actions
Any of the following should be reported: • all () adverse reactions • all () related to newly introduced medicines and vaccines • (), lack of efficacy, overdose, and off-label use that resulted to serious adverse reactions • adverse reactions suspected to be related to a ()
serious , adverse reactions, medication errors, product defect
Even if you are () if the medicine or vaccine caused the reaction, you may still report the suspected adverse reaction.
not sure
Source of safety reports
Patients
Healthcare professionals:
Pharmaceutical industry
are encouraged to report suspected side effects to medicines or vaccines.
: Patients or their caregiver/relatives
