Pharmacovigilance Flashcards
what is the sceince and activities relating to the detection, assessment, understanding, and preventio of adverse effects or any other drug-related problems?
pharmacovigilance
what are the 4 aspects that differ from PH & other countries?
drug production
distribution & use
genetics, diet, traditions
pharmaceutical quality & composition
pharmacovigilance is needed for?
- humanitarian concern
- meds must save lives
- ADRs are expensive
- Promotion of rational use of drugs & adherence
- ensuring public confidence
- ethics
what are the limitations of clinical trials?
- small sample size
- restricted populations
- narrow indications for the drugs
- short duratio of drug exposure
What are the reasons why ADRs are expensive?
- INC hospitalizations/ER consult
- Prolngation of hospital stay
- Addtl clinical investigations in more serious cases (labs & clin tests)
What are the reasons why ADRs are expensive?
- INC hospitalizations/ER consult
- Prolngation of hospital stay
- Addtl clinical investigations in more serious cases (labs & clin tests)
what are the most common types of irrational medicine use?
- polypharmacy
- over-use of parenterals
- failure to prescribe in accordance w clinical practice guidelines
- Inappropriate self-medication
- Inappropriate use of antimicrobials
what are the goals of pharmacovigilance?
- early detection of unknown safety problems
- detection of increases in frequency
- Identification of risk factors
- Quantifying risks
- Preventing px from being affected nessarily
what are sapects of pre-marketing safety concerns?
animal experiments
clinical trials
limitations of pre-marketing trials
what are the diff phases of clinical trial and its purpose?
phase 1 = safety
phase 2 = efficacy
phase 3 = confirm results
phase 4 = post marketing surveillance
what are the limitations of pre-marketing trials?
- narrow population
- narrow indication
- short duration
should we monitor the increase in frequency of drug-related reports?
yes
what are the diff px risk factors?
- mechanisms of idiosyncratic ADRs
- risk factors in the vulnerable groups
- genetic factors
- systems failure
what are the diff mechanisms of idiosyncratic ADRs?
- pharmaceutical variation
- abnormalities in drug metabolism
- Immunological
- Drug-drug itneractions
- Multifactorial
What are the diff risk factors in the vulnerable grps?
- pediatric = spuitting of oral drugs
- geriatric = forgetfulness of drug intake
- Pregnancy & lactating = warned to consult their physician on whateer drug to take
what are the diff hospital monitoring committees & its use?
- pharmacy & therapeutics committee = drug safety
- ADR monitoring committee = concerns related to ADRs
- Antimicrobial surveillance committee = guidelines for rational antimicrobial use
what is indicated in the pharmacovigialnce drug safety management wheel?
- strategy = pharmacovigilance & risk management
- Network & communication = for compliance
- operations = for pharmacovigilance quality system
- governance = risk mitigation and communication
what are the diff strategies for phamacovigilance & risk management?
- safety reports and product labeling
- safety monitoring and pharmacoepidemiology
- px and disease characterization
what is the primary agency that deals with drug issues?
FDA
includes ADR monitoring
what are other drug-related problems?
- availability & rational distribution of drugs
- loss of confidence in physicians
what are the principles of achieving goals?
- human well-being
- equal respect
- global equity
- national equity
- reciprocity
*legitimacy
what are the specific aims of pharmacovigilance?
safety
patient care & safety
public healthy safety
assessment of benefit, harm, effectiveness, and risks
Safe, rational, and more effective use
what are selected areas of pharmacovigilance?
product quality
ADRs
Medication errors
what are the diff suggestions to prevent medication errors?
- correct faulty systems, proecsses, and conditions
- clarification of poorly handwritten prescriuptions
- create systems to overlook drug interactions
- double checking for sound-alike and look-alike products
what are the diff types of medication errors?
- patient-related error
- prescriber-related and general errors
- drug-related errors
- dosage form-related errors
- therapeutics-related errors
what are the 3 probles to watch out for when accepting drug donations during calamities?
- poorly labeled packaging
- expired/expiring mediactions
- drugs sent had nothing to do with the medical probelms ont he ground
what are the possible misinterpretation for “IU”?
IV or 10
what are the responsibilities of pharmacovigilance?
- timely collection of data
- appropriate assessments
- expedited and perioding reporting
what is the signal management lifecycle?
signal detection -> signal prioritization –> signal evaluation –> signal detection
what are the principles of causality assessment?
consistency - similar rxns
specifictiy = specific rxns to specific agents
biological plausibility = possible mechanism
what are the criteria of causality?
- time to onset
- time independent rxns
- time-dependent rxns
- comedication
- past medical hx
- pharmacology
what are the diff factors that strengthen a causal relationship?
- dechallenge & rechallenge
- positive dechallenge
- positive rechallenge
what are postiive dechallenge and rechallenge?
(+) dechallenge = ADR resolves completely ff the drug’s discontinuation
(+) rechallenge = adverse event re-occurs after the drug is restarted
what are the 5 factors necessary in causal assessment?
- consistency
- specificity
- biological plausability
- temporal relation
- strength & association
what should be done once safety signal has become a true concern?
- label changes/boxed warnings by coimpany have to be mandated by FDA
- targeted outreach & education
- product withdrawals
what should be done in risk management plan?
detect
assess
intervene
what is an important part of a report?
identifiable reporter
name, contact details of the reporter
what are diff strategies to improve drug safety?
- avoid chemical functional groups
- develop pharmaceutically & metabolically inert drugs
- development of stuiable in vitro & in vivo systems
- INC use of in vitro systems
- development of suitable in vitro & in vivo systems
- computer-based schemes
- encourage ADR reporting
- idetnify risk factors
- identify mult-genetic predisposing factors
what is the ave am tof time for experiemntal drugs to travel from lab to medicine chest?
12 yrs
what are the phases of product development?
drug discovery (3-5 yrs)
pre-clinical (1-2 yrs)
clinical trials (6-7yrs)
regulatory approval (1-2 yrs)
Post-marketing surveillance
what is the main goal?
further improvement of drug use for px care and safety
what is the field name for WHO collaborating center for international drug monitoring?
Uppsala monitoring center (UMC)
what are works of UMC?
- collect, assess, and communicate info from member countries
- collab with member countries
- coordination, collection, and collaboration in relation to international drug activities
- coordinate the WHO program
whata re indicators for quality of pharmacovigilance landscape?
- good manufacturing practices
- bioequivalence
- safewty issues that arise
- need for pharmacovigilance
what are the cGMP guidelines?
- choice of raw materials
- manufacturing process
- validation
- packaging
What is Bioequivalence test?
check to see if serum therapeutic level (80-90%) has been reaches
