In my first blog on Pharmacovigilance, I expounded upon the definition and timeline that led to the formal practice of Pharmacovigilance (PV), which is a focus on adverse drug reactions, or ADRs. This is a vital practice because it furthers the commitment of all medical practitioners to “do no harm.”
Now I would like to expound on how information is gathered and utilized in the practice of Pharmacovigilance.
Many Different Pharmacovigilance Reports
As it is defined, ADRs are any response to a drug which is noxious and unintended, including lack of efficacy. They can occur any time the drug is taken regardless of the intent (treatment or accidental), including pre-marketed Clinical Studies, normal patient treatment protocol, and post-market clinical studies. When a patient has an ADR, this information is reported in many ways with the primary distinction being one of the following:
- a “Solicited” Report
- an Unsolicited or “Spontaneous” Report.
Below I’ve outlined the differences between the two along with other elements of reporting.
Solicited Pharmacovigilance Reports
Solicited reports are derived from organized data collection systems which include clinical trials, registries, post-approval named patient-use programs, other patient support programs, and surveys of patients or healthcare providers of information gathered on efficacy and patient compliance. 
Reports are received at point-of-service or by registration entity and entered into a Safety Management System. They will contain patient and reaction information including whether or not this is a “Suspected Unexpected Serious Reaction (SUSAR). A SUSAR is used to identify reactions that are believed to be associated with the drug, but are unexpected or have not been previously seen in patients.
Drug providers often have “Safety Data Management Exchange” agreements in place with all known registered entities. These agreements identify the legal components (timing, availability, completeness etc.) for entities to exchange data with the Market Authorization Holder of the drug. The data is often exchanged through formal Electronic Data Exchange procedures.
Spontaneous Pharmacovigilance Reports
These “unsolicited” communications to a company, regulatory authority, or other organization describes an adverse drug reaction in a patient given one or more medicinal products and which does not derive from a study or any organized data collection process (Solicited Report). 
This system of reporting relies on the motivation of individuals to send information about something that happened with the individual when they took a prescribed medication.
Potential sources include:
- Individual Case Safety Report (ICSR)
- Case medical information inquiries
- Product complaints
- Reports from medical representatives
- Reports from competent authorities
- Contractual partners (co-marketed products, in-licensing, out-licensing, and distribution partners).
ICSR must have an identifiable patient, suspect drug, suspect reaction, and an identifiable HCP reporter. Cases are assessed for seriousness, expectedness, and causality.
Literature Search Pharmacovigilance Reports
Another form of case reporting is from literature searches. ADRs, which appear in published literature, are included in the requirements for reporting ICSRs. Market Authorized Holders, or MAH, are expected to maintain awareness of possible publications by assessing a widely used systematic literature review and reference database, including journals. MAH perform literature searches to assist with Signal Detection, which is information arising from one or more sources, which suggest a potentially causal relationship or a new aspect of a known, expected event.
All three of these reporting components fulfill regulatory requirements and support the Reporting of Safety information and subsequent Safety Maintenance reports.
Wrapping Up The Pharmacovigilance Series
In my final blog post of this series on Pharmacovigilance, I will review Development Safety Update reports, Periodic Safety Reports, and Periodic Benefit Risk Evaluation Reports which are all vitally important safety reports produced by MAH or during the new drug filing process.
If you missed our first post of this series, read it here now. We hope this series further showcases Hawkins Point’s goal to provide relevant and important information regarding the nature of the work of our clients in the Life Sciences industry. I hope you have found this blog to be informative and useful in your own understanding of Pharmacovigilance. For any further information on the topic, reach out to our team and we will be happy to answer your questions.
- Post-approval safety data management: definitions and standards for expedited reporting E2D. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2003.