Pharmacovigillance Flashcards
What does the world health organisation defined? Pharmacovigilance as?
The science and activities relating to the detection assessment understanding and prevention of adverse effects or any drug related problem
It aims to enhance patient care and patient safety in the use of medicines and support public health programs by providing reliable balanced information effective assessment and risk benefit profile for medicines
When should a safety event be reported and what should be included?
An event should be reported immediately or within one day of awareness by the employee agent company the date of the information should always be provided
Why is Pharma vigilance important and what started it?
Pharma vigilance started in 1968 response to the thalidomide tragedy and aims to protect patient and public health once a drug is already in the market
All pharmaceutical companies have a legal and ethical obligation to document and report information about safety
To safeguard patients and prevent such tragedies
As a legal requirement, national and international regulatory authorities require companies to track report safety information
When is safety monitored of a new product?
During pinnacle trials, once medicine is launched, throughout the entire period when a medicine is available for patient use
What are the limitations associated with safety data collected during clinical trials and what are the advantages of collecting safety data post marketing? I have?
Limitations
Small number of patients
Short duration of exposure
Selected population
Participants have fewer complications
No access to special populations, elderly children and pregnant women
Advantages to post marketing research
Drug exposed to wider patient population
Long duration of exposure to approved drug
Safety profile becomes more well defined
Pics of signals of potential problems
Helps marketing authorisation holder to put additional risk Mini Asian activities for newly identified risks
Fully established safety profile to allow better benefit to risk management
What is an adverse event?
An untoward medical occurrence in a patient administered a pharmaceutical product whether the occurrence is related to or considered to have a casual relationship with the treatment
This can include abnormal x-ray CT symptoms of nausea, vomiting, abnormal laboratory findings
What is the difference between an adverse event and an adverse drug reaction?
Adverse Event vs. Adverse Drug Reaction (ADR)
- Adverse Event (AE)
• Definition: Any undesirable medical occurrence that happens during treatment but is not necessarily caused by the drug.
• Examples: Headache after taking medication (may be unrelated), a patient falling and breaking a bone while on treatment.
• Key Point: May be due to underlying conditions, other medications, or external factors. - Adverse Drug Reaction (ADR)
• Definition: A harmful and unintended response that is directly caused by the drug at normal doses.
• Examples: Severe allergic reaction to penicillin, liver damage from paracetamol overdose.
• Key Point: Confirmed link to the drug (not just coincidence).
Main Difference:
• AE: Happens during treatment but may not be caused by the drug.
• ADR: Directly caused by the drug and occurs even at normal doses.
What are events of special interest in regards to Pharma vigilance?
Inappropriate exposure during pregnancy and if this is associated with any adverse affects to pregnancy, including inappropriate exposure during breastfeeding
Overdose/drug abuse or misuse
Medication errors on Mrs. Such as dispensing errors, accidental exposure or administration.
Unapproved or off label use
Lack of therapeutic effect
Drug drug or drug food interactions suspected transmission of infectious agent occupational exposure
What types of adverse drug reaction are there?
Expected which are detailed within the labelling i.e. summary of product characteristics SMP C are considered expected or listed however ones at four outside of this in terms of super Verity or nature are unexpected and unlisted
Serious and non-serious or defined according to well established international criteria serious is considered under the following
Results in death or life-threatening or requires hospitalisation/prolong existing hospitalisation
Persistent or significant disability or incapacity or congenital anomaly
What are the legal aspects of Pharma vigilance?
Legally pharmaceutical companies need to report relevant information to the authorities medicines and healthcare products regularity agency (MHRA), European medicine agency (EMA), and the US food and drug administration (FDA)
Describe the safety reporting workflow
Collect data
Capture the case in company PV database
Medical review case reviewed by medical expert and information captured
Report to regulatory agency
Explain the 2010 Pharma vigilance legislation and enhanced postmarketing surveillance
Updated European Pharma vigilance legislation sound 2010 and implemented in 2012 to reduce ADR in the EU by streamlining and then improve the process of post market monitoring
This is achieved through collection of better data on medicines and their safety
Rapid and robust assessment of issues related to medicines
Effective regulatory action to deliver safe effective use of medicine
Empowering patients through reporting and participation
Increase level of transparency and better communication
Although the UK left the EU the legislation for Pharma vigilance practice (GVP) is still continuing within the UK although changes to it have been made to fit the UK market
Explain the role of a qualified person responsible for Pharma vigilant and the UK Pharma vigilant system master file
This is a person who resides in the UK or the EU and is responsible for the establishment and maintenance of the Pharma vigilance system and must be accessible at 24 hours a day by the MHRA
They should be experienced in all aspects of PV and product safety and they are responsible for establishing and maintaining the system preparing reports defined by regulations having an overview of safety profiles and emergent concerns answering request of regulatory authorities and providing regulatory authorities with any other information relevant product safety
Explain importance of risk management plans in Pharma vigilance
Medicinal product which is authorise needs to contain a risk management plan which details the plan of PV activities and how the company plans to minimise and monitor identified potential risks
This needs to be handed to the MHRA upon request and at the time of application as well as altered and changed throughout PV as new information is collected
What is the importance of a periodic safety update report?
Companies are required to submit a periodic safety update report at defined time point following the medicines authorisations
It’s summarise and evaluate benefit risk profile based on all safety and efficacy information collected on the product up to that point in time and using this information regular agencies can’t decide if further investigation needs to be carried out or action taken for public health risk evaluating the year pro con
Explain the presence of an inverted black triangle
UKEU legislation recently introduced medicines under the criteria additional safety monitoring. These products are identified using inverted black triangle on the SMP COPIL.
The phrase this medicine product is subject to additional monitoring also followed as well as an explanation on what this monitoring is and this will remain in place for a mandatory of five years which can be extended
Explain the eudra vigilance
This is a database designed to be a single point of receipt for all PV information in the EU
It’s an electronic exchange for suspected ADR reports known as individual case reports both pre-and post authorisation
Early detection evaluation of possible safety signals for human medicine
Continuous monitoring
Decision making based on board and knowledge and adverse reaction profile to drugs
Post Brexit provisions mean the MHRA is no longer accessible to the system and does have our own version for UK and GB products respectively
What are the consequences for not following Pharma vigilance and reporting safety information?
Potential revoke of marketing authorisations as well as education fines based on company profits and potentially imprisonment
What are post authorisation safety and efficacy study?
These are studies done post authorisation with the aim of identifying characterising or quantifying safety profile effectiveness or risk management measures These can be imposed by regulators or carried out voluntarily by companies
At the time of marketing authorisation recommendation if they are questions of efficacy of the medicine that can only be answered when marketed
aftermarket authorisation has been granted if new data indicate benefits of medicine should be further study
Who is responsible for reporting adverse events, when and what information?
All pharmaceutical company employees regardless of station
Adverse event should be reported on the same day
Safety information must be sent to the companies PV department and all staff must receive training regularly on this. The PV department may then pass on this information and the HCP may be contacted again. Any further information should be directed to the company’s medical information department.
All information regarding the adverse event should be collected, regardless of if it expected or not and how serious the event is
The minimum information required for the companies PV department is the company product an AE or event of special interest an identifiable patient and identify a reporter
Which four elements are needed in a adverse drug or event report for it to qualifier as a complete report?
Identifiable patient
identify reporter
adverse event
specific product
No additional data on symptoms verity duration treatment medical attention should also be included. If so I’ve been complete reports should still be added to the data of us.
what is yellow card reports?
Reports can be made to the pharmaceutical company or directly to the MHRA using the yellow card reporting scheme which uses prepaid letters online at yellow card.hra.gov.uk and this data is deported directly to the MAH marketing authorisation holder
The final stage of the report is the world health organisation which uses VIGI base a global database for potential side effects
