Pharmacovigilance System and Pharmacovigilance System Master File
Each MAH must have one or more pharmacovigilance systems – based on the drug category – aimed at monitoring the safety of authorized medicines and detecting any changes in their risk/benefit ratio.
The procedures are reported in the Pharmacovigilance System Master File (PSMF), a document drawn up for each pharmacovigilance system implemented by the company. It contains information relating to the QPPV, the sites where pharmacovigilance activities are carried out, the sources of safety data, computerized systems and databases, the processes and management of pharmacovigilance data, the Quality System and the performance of the pharmacovigilance system.
The importance of the safety database in the company pharmacovigilance system
For an efficient pharmacovigilance system, the pharmaceutical company should make use of a safety database, a specific software to collect, manage, analyze and submit the Individual Case Safety Reports (ICSR), as required by the regulations.
Among the safety databases there is SafetyDrugs, an Italian software developed by Max Application. It stands out for its advanced functions such as Selective Import, Work Planning and Business Intelligence.
SafetyDrugs, the safety database
How does the authority perform pharmacovigilance
Each country has its own competent authority, in Italy it is AIFA (Agenzia Italiana del Farmaco). Each authority collects the reports received and sends them to the EMA (European Medicines Agency).
AIFA uses a system based on the national pharmacovigilance network (RNF) in which reports of suspected adverse drug reactions (ADR) converge. Only authorized users registered on the AIFA Service Portal can access it.
Adverse reactions posted on the Network are electronically transmitted to EudraVigilance, EMA’s European pharmacovigilance database.
AIFA makes available the visualization of reports after 2002, divided by year and updated monthly, within the sistema Reazioni Avverse dei Medicinali (Adverse Drug Reactions system).
EMA, the European Medicines Agency is the European authority responsible for pharmacovigilance.
The main tasks are:
- Collect the reports received
- Enter the data in EudraVigilance
- Make data available to marketing authorization holders for analysis purposes
- Analyze the periodic reports of the companies
- Investigate any new signal
EMA uses EudraVigilance, the European database for the collection, management and analysis of reports of suspected adverse reactions. The database is divided into two modules:
- Eudravigilance Clinical Trial (EVCT), where reports of suspected serious and unexpected adverse reactions (SUSAR) reported by sponsors of clinical trials are collected;
- EudraVigilance Post Marketing (EVPM), which collects reports of suspected adverse drug reactions and post-marketing studies.
All ADRs received by EudraVigilance are then electronically transmitted to Vigibase, the world database of the World Health Organization (WHO).
Typologies of pharmacovigilance
Depending on the origin of the report, several types of pharmacovigilance are distinguished: active pharmacovigilance, passive pharmacovigilance, scientific literature and social networks.
Active pharmacovigilance. It concerns spontaneous reports from citizens, health professionals and pharmaceutical companies. In Italy, it is often promoted by AIFA through specific programs and studies.
Passive pharmacovigilance. It consists of looking for adverse reactions during, for example, clinical trials.
Pharmacovigilance from the scientific literature. Often cases of adverse reactions are reported in medical journals. Among the tasks of the pharmacovigilant is the periodic screening of items to be added to its database.
Pharmacovigilance in social media. The guidelines advise the pharmacovigilant to scan all digital places for information on adverse events. Social media, but also blogs or forums, are among them, as places of conversation where people discuss medical issues.
Particular cases of pharmacovigilance
Pharmacovigilance in special populations
This is how those population groups that can be distinguished by specific vulnerabilities are defined: children, elderly and pregnant women. They are commonly excluded from clinical studies and the clinical data available are few, consequently, the pharmacovigilance activity is difficult.
Pharmacovigilance in special populations: pregnancy and breastfeeding
Pharmacovigilance in special populations: pediatric patients
Pharmacovigilance in special populations: geriatric patients
Pharmacovigilance in medicinal products subject to additional monitoring
There are some medicines for which the European Union has established additional monitoring of the usual duration of five years.
In these cases, the following are included:
- Medicines based on active ingredients authorized in Europe after 1 January 2011
- Biological drugs, such as those derived from plasma or vaccines. For the latter, there is specific legislation called vaccinovigilance.
- Biosimilar drugs, for which there are few post-marketing data
- Medicines subjected to additional monitoring after placing on the market, in cases where long-term results are not known or rare adverse reactions have emerged during the phase of clinical trials
- Drugs that have been authorized in special cases, for which there may not have been enough data
Pharmacovigilance is a complex subject whose process management requires adequate expertise and technologies.
The responsible of pharmacovigilance in the company has a valid technological ally, the safety database. SafetyDrugs, the safety database developed by Max Application, helps each QPPV in the effective performance of their duties.
A well-managed pharmacovigilance system results not only in regulatory compliance but above all in essential personal protection.