Management of medical inquiries, product complaints and adverse events due to the complaints is critical for any pharmaceutical company. In current era of pharmacovigilance, the newly updated regulations from regulators for reporting of adverse events, product inquiry, product quality complaint, and medical inquiry makes it difficult to automate these processes. It is necessary for the pharma companies to have the automated solutions at place to avoid use of their valuable resources on these cumbersome tasks. The companies want to track all the product relevant information, which we may term as Pro-pharmacovigilance (in support of pharmacovigilance). This includes, but is not limited to,
- Product Inquiry: such as inquiry on labeled information, general query from the consumer, Lack of efficacy information e.g.: Probable emergence of a resistant strain to anti-microbial, allergic reaction of any nature, Misuse/abuse of product.
- Medical information inquiry: Question of healthcare professionals on drug usage technique, query on drug package leaflet etc.
- Product complaints: Involves any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a medicinal product or device after it is released for distribution to market
- Adverse events after drug intake/administration including medication error, overdose, off label use or lack of efficacy
- Other inquiries: Any other general inquiry that does not fall in the above criteria
Compliance requirement:
As per GMP guidelines the pharmaceutical companies should develop and implement rigid, systematic procedures to document and investigate each complaint/inquiry thoroughly. SOPs must provide complete details for handling complaints.
Some other requirements include,
- The Sponsors/MAH should maintain a file for the product inquiries (PI), medical inquiries (MI), and product quality complaints (PQC)
- Record of closed complaints and inquiries should be maintained
- A separate designee should be appointed from PV-QA department for reviewing the complaints and inquiries
- If the complaint is confirmed after investigation, then affected product within a batch, or other batches of that product, must be investigated to determine if they are affected as well or not
- All written records involving drug product complaints must be maintained until at least one year after the expiration
Modes of receiving inquiries and complaints:
Different channels such as call centers (via phone on toll free numbers), chat rooms, e-mails, post boxes, faxes etc.
Investigation pattern for investigation of inquiries and complaints:
Upon receipt of complaint/inquiries the investigation form should be completed. The form must document basic information such as the customer’s name, address, phone number, and email address, as well as information about the problem, such as product name, lot number, and manufacturing and expiration dates. After further investigations, the QA person will publish the results and confirm the complaint as confirmed complaint.
Further the PV-QA or designated personnel (safety officer) will provide the response (for inquiry) or investigational results (for PQC) to the reporter and close the compliant.
Sarjen’s PrITR (Product Inquiry Trail and Response system) is an efficient solution to receive, paperless processing, evaluate, and record all the Product Inquiry, Medical information inquiries, and Product quality complaints (PQC) along with adverse events due to PQCs with regards to global compliance. This product inquiry module generally used to maintain the risk benefit profile of the product.
PrITR benefits
- Keeps a track of the inquiries/complaints that were generated
- Ensures that all the customer and HCP queries are dealt with and documented
- Tracks the issues faced for the marketed product
- Detects a potential adverse event or other drug use problems
- It analyzes trends generated of these inquiries for a product and hence, finding root-cause
- Tracks product history through recorded information
- Improves the quality of responses generated through quality assurance and training
- Prepare FAQs and material for common and frequent inquiries
PrITR major functionalities
- Client master, User scope master: For addition of clients & scope
- For MI/PQC/PI/MI + AE, a direct interface for case creation with safety database, Inquiry copy functionality, re-versioning for inquiry, routing back facility, file inbox module
- Listings: MI/PI/PQC/MI excel logs and case snapshots are some unique features available
- Dynamic dashboard inquiry management
- Workflow efficiency module: Tracking of productivity data
- Inquiry can be transferred in any safety database or locked/followed up in PrITR if any AE is present
- Follow up alert section for reporter follow ups
- Availability of Audit trail to track the changes
- Extraction of R2 XML file for processed MI/PI/PQC/MI + AEs
- Data privacy encryptions for reporter and patient details (GDPR compliance)
At the end, PrITR offers an 100% assurance to the client with regards to overall product quality enhancement and its universal acceptance throughout the global market.
