What are the best ways to document and report adverse events for your medical sales products?

1 Know the definitions

Before you document and report adverse events, you need to understand the definitions and classifications of different types of events. According to the World Health Organization (WHO), an adverse event is any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. An adverse reaction, on the other hand, is a response to a pharmaceutical product which is noxious and unintended and which occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease, or for modification of physiological function. A serious adverse event or reaction is one that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer. These definitions are important because they determine how you should document and report the events, as well as the timelines and responsibilities involved.

2 Follow the guidelines

Depending on the type and severity of the adverse event, you may need to follow different guidelines and procedures for reporting it. The main sources of guidance are the regulatory authorities, such as the Food and Drug Administration (FDA) in the US, the European Medicines Agency (EMA) in the EU, or the Therapeutic Goods Administration (TGA) in Australia. These authorities have specific requirements for reporting adverse events, such as the forms, formats, data elements, and timelines that you need to comply with. For example, the FDA requires that you report serious and unexpected adverse events within 15 days of becoming aware of them, and that you submit periodic safety reports every six months for the first two years after approval of a new product, and annually thereafter. You should also consult the guidelines and policies of your company, as well as the contractual agreements with your customers, to ensure that you follow the internal and external reporting obligations and expectations.

4 Communicate clearly

When documenting and reporting adverse events, it's essential to communicate clearly and accurately with the relevant parties, such as your company, customers, patients, regulators, and manufacturers. To do this, you should provide complete and accurate information about the event, such as the product name, batch number, dosage, route of administration, indication, onset, duration, severity, outcome, and concomitant medications or medical conditions. Additionally, you should describe the causal relationship between the product and the adverse event based on available evidence and criteria. Furthermore, you should explain the actions taken or planned to address the event. When writing your report or documentation, be sure to use clear and concise language and follow standard terminology and coding systems.

5 Learn from the experience

Finally, documenting and reporting adverse events is not only a regulatory obligation, but also a learning opportunity. You should use the information and feedback that you receive from the adverse event reports to improve your knowledge and skills, as well as your products and services. To do this, you should review and evaluate the adverse event data and reports regularly to identify patterns or trends that may indicate a safety or quality issue with your products or processes. Additionally, you should update product information based on new evidence or recommendations from the authorities or manufacturers. Furthermore, it is important to educate customers, patients, and colleagues about the adverse events, their causes, prevention, and management. Lastly, you should seek feedback and suggestions from your stakeholders on how to improve your adverse event documentation and reporting practices.