Unit 4.3 Pharmacovigilance Flashcards
What is defined as by WHO ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem’?
Pharmacovigilance (PV)
What has the aim of enhancing patient care and patient safety in relation to the use of medicines and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines?
Pharmacovigilance (PV)
What is neccessary for the protection of public health, as the full safety profile of medicinal products can only be known after they have been placed on the market?
Drug safety or PV rules.
What is it both a legal and ethical requirement for companies to do regarding the safety of their medicinal products?
For them to document, analyse and report information about the safety of their medicinal products.
Who has the responsibility to report information about the safety of the company’s medicinal products to the company’s PV department?
Any person employed directly by a pharmaceutical company or contracted to work for the company.
What must all companies provide to all employees and agents on their processes for reporting safety information, so they know what to do if they become aware of a safety concern?
Must provide training.
When should safety information be reported by the employee or agent of the company?
“should normally be reported immediately or at least within one business day”
What term is used to describe the continuous drug safety monitoring of medicinal drugs manufactured by pharmaceutical companies?
PV.
What are the underlying objectives of PV?
- Prevent harm from adverse drug reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure.
- Promote the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, HCPs and the public.
What issues is PV neccessary for the protection of patient and public health?
The information from PV is used to identify safety issues that might not have been previously known about before a drug was place on the market.
Where were international effort to address drug safety issues through the practice of PV first initiated and in response to what?
In 1968 in response to the thalidomide tragedy in which thousands of infants were born with congenital deformations following foetal exposure to thalidomide, a medicine that had been used to treat morning sickness in pregnancy.
All pharmaceutical companies have a legal and ethical obligation to document and report information about the safety of their products. What two key reasons do pharma companies collect safety information on their drugs?
- To safeguard patients’ and public health and prevent such tragedies as the thalidomide disaster.
- It is a legal requirement - national and international regulatory authorities require pharmaceutical companies to track and report safety information to help protect the public and patients who are taking medicinal products.
Why is it more likely that only more common AE/ ADR will have been identified when a new product is first marketed?
A relatively small number of patients who fit particular inclusion and exclusion criteria will have taken part in clinical trials during development of a new medicine.
When do less common ADRs become detected and an indication of the frequency of the more common ADRs determined?
Only after larger scale post marketing use of the product in normal clinical practice.
Monitoring and safety of a medicinal product is therefore a continuous process, which applies to which stages of the products life?
All stages:
- during clinical trials when a medicine is developed
- once a medicine is launched
- throughout the entire period when a medicine is available for patient use.
What does continuous monitoring of the safety of a medicinal product enable?
The company and regulatory authorities to continuously monitor the benefit-risk profile of a product and identify potential new safety issues at an early stage.
What are limitations associated with safety data collected during clinical trials?
- Small number of patients.
- Short duration of exposure to developmental drug
- Selected population
- Participants with fewer complication factors e.g. concurrent illnesses/medicines.
- No access to special populations (elderly, children, pregnant women)
What are the advantages with collecting safety data after post marketing?
- Drug exposure to wider patient population
- Longer duration of exposure to approved drug
- Builds on the safety profile defined during clinical trials
- Picks up signals of potential problems or at risk populations
- Helps Marketing Authorisation Holder to pit in place additional risk minimisation activities for newly identified risks.
Full established safety profile of a medicinal product allows physicians to assess benefit/risk for wider patient population and improve in general patients care and overall public health.
What is an untoward medical occurrence in a patient administered a pharmaceutical product, whether or not the occurrence is related to or considered to have a casual relationship with the treatment.
An Adverse Event (AE).
What can an AE be?
Any unfavourable and unintended sign ( abnormal lab finding, abnormal ECG, X-ray/CT scan), symptom (nausea, headache, vomiting, rash), or disease (pneumonia) temporally associated with the use of a medicinal product.
What is defined as a response to a drug 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 modifications of physiological function?
An Adverse Drug Reaction (ADR)
What definition implies that a casual relationship between a medicinal product and an AE is at least a reasonable possibility?
The ADR definition.
ADRs may arise form use of the products within or outside the terms of the marketing authorisation of from occupational exposure. What are examples conditions of use outside the marketing authorisation?
Off-label use, overdose, misuse, abuse and medication errors. - ADRs can vary from life-threatening to minor common side-effects.
What are the following classes as if associated with the use of a medicinal product and should be reported, whether or not there is an associated AE:
- Inappropriate exposure during pregnancy (whether the foetus expose via mother taking product or transmission via semen following paternal exposure)
- Inappropriate exposure during breast feeding/lactation.
- Overdose (whether intentional, accidental or prescribed)
- Drug abuse or misuse.
- Medication errors or near misses (inc. dispensing errors, accidental exposure, maladministration etc)
- Unapproved or off-label use, inc off-label use in children or elderly.
- Reports of lack of therapeutic effect or other product complaints associated with an AE, inc suspected use of counterfeit medicines.
Events of Special Interest.
If pregnancy is associated with an event (e.g. miscarriage, induced abortion, congenital defect) what is is known as and when should it be reported?
It is known as a serious AE (SAE) and must be reported in the same time frame as all other SAEs: notification of pregnancy outcome should be within one business day of awareness.
Should the following other safety situations also be reported?
- Drug-drug or drug-food interactions.
- Suspected transmission of an infectious agent
- Occupational exposure (as a result of one’s professional or non-professional occupation)
ADRs that are known about and documented within the labelling i.e. Summary of Product Characteristics for the medicinal product are considered as what?
Expected or listed.
What are events that are not consistent with the nature, severity or outcome of the events documented within the products labelling considered as?
Unexpected or unlisted.
What criteria does an AE have to meet for it to be considered as serious?
It has to meet one of these well-established international criteria:
- Results in death, or is life-threatening
- Required hospitalisation or prolongs and existing hospitalisation.
- Results in persistent or significant disability or incapacity.
- Results in congenital anomaly
- Is otherwise medically significant i.e. the event would not meet the preceding criteria but is considered serious because treatment or intervention would be required to prevent one of the preceding criteria.
What are all companies holding innovative or generic marketing authorisation for medicinal products in the EU legally obliged to have?
An appropriate system of PV in place to ensure the appropriate use of their medicines and to take appropriate action when necessary.
Part of this system is to promptly report relevant safety information to the worldwide regulatory authorities, for example?
European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)
In order to ensure compliance with this legislation ‘to promptly report relevant safety information to the worldwide regulatory authorities’ What must all companies undergo?
Regular PV inspections by the regulatory authorities, inc. the Medicines and Healthcare products regulatory Agency (MHRA), the UKs regulatory authority.
