Pharmacovigilance Reporting in a Call Centre
The pharmaceutical sector is growing rapidly and the number of drugs being introduced to the market is increasing continuously. This, in turn, has increased the number of adverse drug events that need to be reported. The global pharmacovigilance market is estimated to reach a market value of $5,008.2 million in 2019 and the impact of this will be one of the themes discussed in the upcoming Europe Pharmacovigilance Conference 2016 in London (24th – 25th May 2016). Due to this massive growth, many pharmaceutical companies have chosen outsourcing to a third party as a viable ADR (adverse drug reaction) reporting option. Here are three steps call centres have taken to carry out this vitally important task:
Training and Compliance
From our experience in the sector, we can discuss the importance of training before taking on a Pharmacovigilance client. In-house training taken on by internally certified trainers must be carried out to explain the client’s policies and procedures as well as the identification of ADR’s, reporting (Spontaneous Report Forms) and the particular drugs that the client provides.
Annual ADR training is also completed as a refresher course and as a form of updating agents on new standards in the field. Training details such as the names of all partaking agents, the trainer name, training date, the location of training, duration of training are all noted and sent back to the client.
Clients can also ask a dedicated Pharmacovigilance team to take an AE (Adverse Event) assessment. This is for quality assurance, these questions aid in proving that the call centre team in question is reliable and knowledgeable.
Identification
The first step is to gather all the information. Who is calling: a pharmacist, GP, the patient themselves? Here are the types of information gathered:
– Gender
– Sex
– Adverse Event
– Date of the AE
– Drug Name
– Dose Regimen
All these questions can be formulated into a script that best suits the call centre and pharmaceutical client equally. For example, some clients require our team to determine the formulation of the drug (Liquid or Tablet) whilst other clients ask that we determine the strength of the product involved. It is totally up to the client’s preferences.
It goes without question that every bit of information no matter how small must be noted and in some cases, the call will not relate to an ADR at all. Sometimes it can be an order for a pharmacist who has run out of a particular drug or a GP looking for more information on dosage.
Reporting
The documentation of Adverse Drug Reactions is vital for the pharmaceutical sector. For example, if an adverse effect is reported in Ireland it must be reported to every country in the world within 7 days. When the details of the adverse effect are noted a Spontaneous Report Form is filled in. This form will include the dates, names, drugs etc relevant to the case. A detailed description of the ADR is also filled in. This report is then immediately sent via email to the point of contact within the pharmaceutical company that the call centre is working for. This point of contact is also contacted over the phone to confirm the details.
A call centre can also compile call volume reports and securely store call logs so a Pharmaceutical company can refer back to a case at any time.
A Dedicated Pharmacovigilance Call Centre Team
Pharmacovigilance companies are ethically and legally obliged to report all adverse drug reactions and by utilising a third party BPO such as a call centre the process can be streamlined. A call centre can set up a pharmacovigilance campaign effectively by using in-house training carried out by certified trainers, which minimises downtime. The identification and reporting of ADR’s are carried out 24 hours a day 7 days a week 365 days a year so that a pharmaceutical company can focus on analysing and communicating the data provided to ensure the well-being of the general public and patients alike. As for the future of Pharmacovigilance? Perhaps the May 2016 Conference in London will identify new trends in the sector.
