Our client is one of the UK’s and America’s largest pharmaceutical organisations. They also have operations in Ireland. Our client prides themselves in their level of patient service and the professional and empathic manner in which their team operates. Their Customer service team deal with medical emergencies 24 by 7 hours a day.
Objective of the Pharmacovigilance Case Study
This case study will provide an insight into:
- Demonstrate our experience in the pharmaceutical sector
- Demonstrate our experience with pharmacovigilance
- Prove our ability to deal with medical emergencies
- Call Management as a reliable and trustworthy partner
- Experience in dealing with sensitive data from our clients
- Data Protection handling process requirements
- Flexible hours 24 by 7
- Capacity to fulfil expectations
- Experienced team in pharmacovigilance
Description of Project & Scope of Work
The main objective is to offer a 24 by 7 patient support service. This service needs to meet our client’s high standards in quality, confidentiality and reliability. Because of the critical nature of each call, various levels of escalation need to be adhered to.
The main challenges were:
- To deal with medical emergencies
- To provide accurate reports and analysis
- To provide recording of the calls (if required and following data protection policies)
- Familiarising the team with the drugs of the client
- 24 by 7 Support including weekend and evenings
- Data Protection and Security
- Reliable and Trustworthy outsourcing partner
- Getting to know the clients’ pharmacovigilance policies and procedures
Our client researched Call management and noted that we could meet their 24 by 7 pharmacovigilance support requirements. Our competitive price and excellent presentation were major factors in the acquisition of the contract.
A representative from our client’s team came to us to carry out a ‘Train the Trainer’ course with our front line team. They also wanted a list of all staff on the service (on-going) and every staff member that takes their calls must complete an exam after the pharmacovigilance training. If they fail this exam they cannot handle calls for the client.
A confidentiality agreement was signed which is a standard in the industry but it’s essential in the pharmaceutical sector.
Pharmacovigilance and Telephone Answering Service
We provide our client with 24 by 7 pharmacovigilance telephone answering service. Our team answer the call by introducing themselves and clarifying that they are through to the client in question. Then the caller’s details are logged. The calls we handle for this client tend to be emergencies so specific details are required from each patient. The information collected includes patient details, the nature of the adverse effect and which drugs were involved. It also needs to be determined if someone else is calling on behalf of the patient.
Data mining like this is the focal point of pharmacovigilance. We fill out an ‘Adverse Event Report’ for each emergency and calls are escalated to their on call team accordingly.
Pharmacovigilance and Data Recording
As it is determined who is calling and why, the details are logged and stored. Information such as the adverse effects suffered and their drug dosage are recorded. Adverse events are critical so regardless of how implausible the event it must be reported in case their drug is causing a reaction. If an adverse event is reported in Ireland it must be reported to every country in the world within 7 days, just in case it was a bad batch.
Our agents are provided with a full list of the drugs the patients take, which helps in the identification of said drug in question. In most cases a spontaneous report form is filled out. In compliance with the clients’ policies, this spontaneous report form is emailed to our point of contact in the clients’ organisation. If it is an urgent call this point of contact is phoned immediately.
This a heavily regulated industry with penalties in place if procedure not followed as set out by the FDA. Our client ‘Mystery Shop’ us twice a year to ensure we are compliant with their procedure. If we fail on either then re-training must be done and a report sent on why we failed.
The 24 by 7 pharmacovigilance service is delivered in on-going basis. Call Management have been providing pharmavovigilance service to this client for the last 5 years. We handle emergency calls concerning adverse drug reactions and comply with the relevant policies and procedures regarding data recording and call escalation. Our team deal with the fluctuating demand of calls and adheres to the high standards of the pharmaceutical sector.