When you buy a veterinary medicinal product used to treat or prevent a disease in animals, there is a likelihood that the drug could bring undesirable effects either in the label or off label. So, what is your responsibility when the product brings out unfavourable or unintended results? The act of continuous monitoring to determine the safety and efficacy of a product is known as Pharmacovigilance.
Pharmacovigilance involves activities such as detecting, assessing, understanding and preventing adverse effects of any drug related problem. Adverse effects could be an example of reaction in humans after interacting with a veterinary product, potential environmental problems arising from the use of a product, a violation of approved residue limits or even transmission of infectious agents. Adverse effects could either be a Suspected Adverse Reaction (SAR) or a Suspected Lack of Expected Efficacy (SLEE) of the product. As a buyer, you could also express what is known as Product Quality Complaint (PQC). Examples of product quality related complaints could be for example, product counterfeit, damages or missing components of the product.
When you come across adverse effects and product quality complaints, it is important that you inform Cooper K-Brands Limited (CKL) within one business day (24 Hours) not exceeding three calendar days from receipt of the report. Ensure at all times, that you report every information you may have about the complaint whether this information is received outside working hours or not. Usually, timelines to report the cases are compromised when one starts to ‘handle’ the case without first reporting about it! Always, report about the case first! While reporting the case, always observe confidentiality either in written or verbal correspondence.
So, what makes a case one may wonder? For a product quality complaint, there is need to have information about the name of the product, the complaint and the reporter who is filing the complaint. For an adverse event, there is need to have information on the product, complaint, reporter and event (of what happened) of the patient.
There are other things to report as well. For instance, as long as you receive any adverse effect report, whether any product other than your company product caused an adverse effect, no matter what caused the adverse effect, one has to file such a report. One also has to report for any known or expected reaction or side effect. Often cases, expected side effects may be indicated on product leaflet or package. One is required to report such expected reactions or side effects. Usually, a buyer may use the product incorrectly or may have wrong expectations of the product, one is encouraged to report this as well.
Sometimes, a reporter of the complaint may inform you about an incident with the product but are unwilling to file a report, should such an occasion occur, one is also required to report about it and also indicate the state of the reporter as uncooperative. Further, one is encouraged to report every human exposure incident while handling the product both asymptomatic (nothing happened) and symptomatic (a reaction occurred).
Insufficient information collection, delays in reporting and investigation, uncooperative customers who wish not to file complaint or offer feedback on product safety and efficacy are some challenges experienced while actively engaging in Pharmacovigilance. To serve you better, we encourage our product consumers to take time an observe and feel free to send us feedback about our products especially where there could be adverse effects in less than 24 Hours. Help us serve you better by reaching us via Email: email@example.com