Академический Документы
Профессиональный Документы
Культура Документы
Category Frequency
Very common ≥ 1/10
Common ≥1/100 and <1/10
Uncommon ≥ 1/1,000 and <1/100
Rare ≥ 1/10,000 and <1/1,000
Very rare < 1/10,000
Did the adverse event appear after the suspect drug was administered? +2 -1 0
Are there alternate causes [other than the drug] that could solely have
-1 +2 0
caused the reaction?
Was the drug detected in the blood [or other fluids] in a concentration
+1 0 0
know n to be toxic?
Was the reaction more severe when the dose was increased, or less
+1 0 0
severe when the dose was decreased?
Did the patient have a similar reaction to the same or similar drugs in any
+1 0 0
previous exposure?
Environment dependent
Xenobiotics (pesticides, veterinary antibiotics) can
interact with drugs metabolism, most commonly on
CYP 450 level
Healthcare
Professionals
Pre-Approval
Post-Approval
National Regulatory
Patients
Authority
Pharmaceutical
Companies
International Safety
Databases
Pre-clinical studies
Clinical trials (pre- and post-marketing)
Spontaneous adverse reaction reporting
Epidemiological studies
Data collected for other purposes
Routine statistics
Databases of prescription and outcomes
Ostatné
lieky
obligated to report suspected 2
lower compared to other EU Používal pacient liek v minulosti? áno - nie - neviem
Safety warnings
Labeling change/changes in SPC
Withdrawal
Homeopathic preparations
Zycam Cold Remedy case – unusual dilution resulted in permanent loss of
smell in several subjects and 340 filed and settled lawsuits
Content of alcohol in some preparations for children is higher than allowed in
allopathic medicines
Anny Lumban Toruan 44
Special Cases for Pharmacovigilence
Trial with Zheng Xiaoyu, former director of State Food and Drug Administration
of China, Beijing Intermediate Court, May 29, 2007
Zheng Xiaoyu was convinced of taking bribes for enabling approval of unsafe
medicinal products. He was executed
Anny Lumbanon July 10, 2007
Toruan 50
Where to find information
Monographies/Compendia
Davies: Textbook of adverse effects
Dukes: Meyler`s side effects of drugs
Journals
Regulatory Toxicology and Pharmacology
Newsletters
Drug Safety Update – published by MHRA
Regulatory Agencies
FDA: http://www.fda.gov/
EMEA: http://www.emea.europa.eu/
SIDC: http://www.sukl.sk