Professional Documents
Culture Documents
Content
1. Pharamcovigilance Methods
6. CIOMS Forms
7. ADR Reporting
PHARMACOVIGILANCE METHODS
Spontaneous reports
1.Passive Surveillance
Spontaneous Reports
A spontaneous report is an unsolicited communication by healthcare professionals or consumers to a national pharmacovigilance centre, pharmaceutical company, regulatory authority or other organization. Describes one or more suspected adverse drug reactions in a patient who was given one or more medicinal products. Does not derive from a study or any organized data collection scheme. Play a major role in the identification of signals of drug related problems once a drug is marketed. Also provide important information on at-risk groups, risk factors, and clinical features of known serious adverse drug reactions.
2. Stimulated Reporting
Stimulated reporting are those that may have been motivated , prompted or induced and can occur in certain situations such as notifications by a Health Care Professional Communication (HCPC), public advisory, literature report or questioning of health care professionals. These are unsolicited in nature and a form of Spontaneous Reporting. It mainly includes on-line reporting of adverse events and systematic stimulation of reporting of adverse events based on a pre-designed case definition.
3. Active Surveillance
Active surveillance, seeks to ascertain completely the number of adverse events via a continuous pre-organized process. It includes : Sentinel sites Drug event monitoring Registries
Sentinel Sites
Active surveillance can also be achieved by reviewing medical records or interviewing patients and/or physicians in a sample of sentinel sites. To ensure complete and accurate data on reported adverse events from these sites. The selected sites can provide information, such as data from specific patient sub-groups. Further, information on the use of a drug, such as abuse, can be targeted at selected sentinel sites. Some of the major weaknesses of sentinel sites are problems with selection bias, small numbers of patients, and increased costs.
Registries
A patient registry is a list of patients presenting with the same characteristic(s). This characteristic can be pregnancy (pregnancy registry), a disease (disease registry) or a specific exposure (drug registry). In each type of registry, which only differs by the type of patient data of interest, can be collected by a battery of information using standardised questionnaires in a prospective fashion.
Descriptive study
Descriptive studies are observational studies which describe the patterns of disease occurrence in relation to variables such as person, place and time Uses 1. Health care planning Descriptive studies provide knowledge about which populations or subgroups are most or least affected by disease. This enables public health administrators to target particular segments of the population for education or prevention programmes and can help allocate resources more efficiently.
2. Hypothesis generation Descriptive studies identify descriptive characteristics which frequently constitutes an important first step in the search for determinants or risk factors that can be altered or eliminated to reduce or prevent disease.
The methodology is flexible and has been adapted to address specific safety issues, for example for the PEM studies of the COX-2 inhibitors, information was collected on patients past medical history, also their past and current use of particular medications.
The drug regulator, MHRA, may license a new medicine on condition that the manufacturer agrees to commission a safety study by the DSRU
Six or twelve months after the first prescription for an individual drug in an individual patient, the DSRU sends a green form questionnaire to the general practitioner who wrote the original prescription. Thus, the prescriptions provide the exposure data showing which patients have been exposed to the drug being monitored, and the green forms provide the outcome data showing any events noted during the period of monitoring. The great strengths of this method are that it provides a numerator (the number of reports) and a denominator (the number of patients exposed), both being collected over a precisely known period of observation. The main weakness of PEM is that only 50%70% of the green forms are returned. In addition, because PEM limits follow-up to 6 or 12 months, it cannot identify events of long latency.
Generates disease registries and health surveillance systems . Record Linkage helps in follow-up studies of cohorts or other groups to determine factors such as vital status, residential status, or health outcomes.
Record linkage is also used to create health indicators.
CIOMS
CIOMS is a body set up under WHO and UNESCO. It has developed a series of guidelines on pharmacovigilance, drawn up by a committee of volunteers from Industry, regulatory authorities, WHO and others.
The main guidelines concern the international reporting form (CIOMS I); periodic safety update reports (CIOMS II); core data sheets (CIOMS III); benefit-risk assessments (CIOMS IV); practical issues in pharmacovigilance (CIOMS V); clinical trial safety data (CIOMS VI); and development safety update reports (CIOMS VII)
ADR Reporting
Health professionals play an important role in monitoring the safety of medicines by reporting any suspected adverse drug reactions (ADRs)
As health professionals, you are likely to observe adverse reactions to medicines. When you submit a suspected ADR report, you contribute to the ongoing collection of information that occurs once health products are on the market.
THANK YOU