In this article we:
- Define Pharmacovigilance and look at the types of adverse events that can happen in the pharmaceutical industry.
- Discuss the need for adverse event reporting and its advantages.
- Share the steps to building comprehensive queries to capture all mentions.
The pharmaceutical industry is driven by a steadfast commitment to patient safety and the delivery of life-changing medicines. Yet, as science propels us forward into uncharted territories of medical advancement, the responsibilities of pharmaceutical companies extend beyond the confines of the laboratory.
Every medication that finds its way to the pharmacy shelves does so only after rigorous research, stringent testing, and exhaustive scrutiny by regulatory bodies. However, despite the meticulous processes and safeguards in place, unforeseen challenges can emerge post-approval. These challenges are known as adverse events, and one of the first things people do when there is an adverse event is tell the internet.
That is why one of the quickest ways to detect adverse events online is through media intelligence.
What is Pharmacovigilance and How is Social Media Monitoring Integrated Into It?
Pharmacovigilance is the science and practice of monitoring, detecting, assessing, understanding, and preventing adverse effects or any other medicine- or vaccine-related problems to ensure the safe and effective use of pharmaceutical products.
The growing number of social media users has spurred the growth of self-organised online health communities where patients and carers are more likely to share adverse event information in real time. Moreover, many people are more likely to share their symptoms with strangers on Twitter (or now X) before alerting HCPs. This is why pharmacovigilance teams within pharmaceutical companies are increasingly turning to media monitoring companies such as A Data Pro to enhance their adverse event surveillance efforts.
Media monitoring companies actively scour the internet to identify unreported adverse events. To ensure the effectiveness of this process, pharma personnel involved in media monitoring undergo pharmacovigilance training. This training equips them with the necessary skills to spot and report potential adverse events accurately.
What are Adverse Events in the Pharmaceutical Industry?
Adverse events, often referred to as adverse drug events or AEs, are unexpected and undesirable medical occurrences or side effects that can occur when a patient is using a pharmaceutical product. These events can encompass a wide range of issues, including:
Adverse Reactions
These are unintended and harmful responses to a medication that occur at normal doses used for treatment. Adverse reactions can manifest as side effects such as nausea, dizziness, or skin rashes.
Allergic Reactions
Some individuals may develop allergic reactions to a medication, which can range from mild skin irritation to severe anaphylactic reactions.
Drug Interactions
Adverse events can occur when a medication interacts with another medication, food, or substance in a way that affects its effectiveness or safety.
Overdose
Taking more than the prescribed dose of a medication can lead to adverse events, which can range from mild symptoms to life-threatening conditions.
Medication Errors
Errors in prescribing, dispensing, or administering medications can result in adverse events. These errors may involve the wrong medication, dose, or route of administration.
Delayed Effects
Some adverse events may not become apparent until a significant amount of time has passed after starting a medication. For example, certain long-term side effects or complications may only become evident after months or years of use.
Unintended Consequences
Adverse events can include unintended consequences of a medication’s actions, such as rebound effects or withdrawal symptoms when discontinuing a medication.
The Need For Adverse Event Reporting
Adverse events have the potential to:
- disrupt lives,
- erode trust, and
- tarnish the reputation of pharmaceutical companies.
Therefore, the ability to swiftly detect, assess, and respond to adverse events is fundamental to the industry’s commitment to patient safety. Adverse event surveillance helps identify potential risks associated with pharmaceutical products, leading to improved patient safety and regulatory decisions, including labelling changes and, in rare cases, product recalls.
Advantages of Real-Time Media Monitoring For Pharmaceutical Companies
We spend a big portion of our lives in digital spaces, so whether a person is a patient, a caregiver, or simply someone who knows someone who has experienced an adverse reaction to a medication, they are highly likely to turn to the internet for information, support, and insights into similar experiences.
More importantly, if they have negative experiences to share, they will run to social media to raise awareness and directly attack the pharma company that produced the medication or wearable medical device.
Here are 9 advantages of real-time media monitoring for pharma companies:
- Detect adverse events early
Real-time monitoring allows pharmaceutical companies to quickly identify and investigate adverse events associated with their products. This early detection can lead to timely interventions to mitigate risks and protect patient safety.
- Stay compliant with regulations
Regulatory agencies require pharmaceutical companies to report adverse events promptly. Real-time monitoring helps ensure compliance with these regulations by enabling companies to gather and report adverse event data in a timely manner, reducing the risk of regulatory penalties.
- Guarantee patient safety
Pharmaceutical companies can take proactive measures to enhance patient safety. This might include issuing warnings, updating product labelling, or even recalling products when necessary to prevent further harm.
- Manage your reputation
Swift and transparent responses to adverse events can help protect a company’s reputation. Real-time monitoring allows companies to address concerns, correct misinformation, and demonstrate a commitment to patient safety and ethical practices.
- Improve your products
Continuous monitoring of adverse events data can provide insights into potential product defects or areas for improvement. This information can inform product modifications, leading to safer and more effective medications.
- Gain competitive advantage
Being proactive in monitoring and addressing adverse events can give pharmaceutical companies a competitive advantage. It demonstrates a commitment to patient safety and regulatory compliance, which can enhance trust among healthcare providers, patients, and regulatory authorities.
- Assess risk and mitigate crises
Real-time monitoring allows for continuous risk assessment and mitigation. Companies can identify potential safety concerns and take immediate steps to reduce risks or discontinue products if necessary.
- Allocate resources
By monitoring adverse events in real time, pharmaceutical companies can allocate resources more efficiently. They can prioritise investigations and actions based on the severity and frequency of adverse events, ensuring that critical issues are addressed promptly.
- Make data-driven decisions
Real-time monitoring provides a wealth of data that can inform decision-making. Companies can use this data to assess the overall safety profile of their products, make informed decisions about ongoing clinical trials, and guide research and development efforts.
How Can You Monitor Adverse Events in Real Time?
The real-time adverse event monitoring process begins with the proper setting of monitoring platforms also known as social listening tools. To initiate this process, query building plays a pivotal role. What are queries?
Queries are predefined search parameters or search strings used to collect and retrieve specific information from various media sources, including news articles, social media platforms, blogs, and forums. These queries consist of keywords, phrases, Boolean operators, and other search criteria that are carefully crafted to target and filter content related to a particular topic, brand, event, or keyword of interest.
Adverse event queries have to be as comprehensive as possible. Brand or product names have to be combined with keywords and phrases related to different therapeutic areas and potential adverse events.
To build proper queries that will not miss important mentions of your product, there are two things you should do:
- Research all types of adverse events that can happen and include all keyword variations. For example, if you want to look out for allergic reactions to your medicine, you can combine your brand name with allergy-related vocabulary such as: allergy OR allergic OR allergen* OR “skin rash” OR (skin NEAR/3 (“breakout” OR “break out” OR rash* OR irritated OR itchy)) This is just a very simplified example of a Boolean query. The operators you will use to determine the relations and distance between the keywords and phrases you include will depend on the capabilities and rules of the social listening tool you are using.
- Design queries in multiple languages, particularly if your company distributes medications globally, so you can capture mentions across diverse regions and languages. Each language has its own unique nuances, idioms, and cultural references that affect the way people communicate. Simply translating a single query into multiple languages may not effectively capture all conversations, as it may miss context-specific keywords or sentiments that are relevant to each linguistic and cultural context.
What Happens After You Build Your Queries?
Once an adverse event is detected, automated reporting mechanisms can alert the relevant individuals or teams in charge of media monitoring. This timely reporting ensures that the right people are informed promptly, allowing for a swift response and appropriate actions to address the adverse event.
One important thing to note is that regardless of how well you design your query, there is always a chance that spam will make its way into your platform. More often than not, queries act like living organisms, constantly evolving and adapting to changes in online behaviour and spam tactics.
Maximise Your Adverse Event Monitoring Efforts
To truly safeguard patients and proactively manage risks, pharma companies must embrace the power of real-time media monitoring. Real-time monitoring not only identifies adverse events swiftly but also empowers companies to respond promptly, mitigating potential crises before they escalate. It is a shift from reactive to proactive, from passive to engaged.
To achieve this, pharmaceutical companies need a partner with the expertise and technology to navigate the vast sea of digital information effectively.
This is where A Data Pro’s media intelligence services come into play.
With a proven track record in the industry, our solutions are tailored to the unique needs of pharma companies, providing a comprehensive view of adverse events and sentiment analysis in real time. Our multilingual teams can make sure that no critical information is missed in any corner of the world, ensuring a global perspective on adverse event monitoring.
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