This blog covers:
- Understanding Off-Label Use
- Defining Scenarios: What Constitutes Off-Label Use and What Doesn’t
- Elevating Off-Label Use in Pharmacovigilance: Recognizing Its Significance
Table of Contents:
- Introduction
- Definitions
- Intended use of drugs
- Unintended use of drugs
- Why might an approved drug be used for an unapproved use?
- Reports Indicating Off-Label Use
- Coding Off-Label Use
- Importance of Addressing Off-Label Use in Pharmacovigilance
- Key takeaways
- Conclusions
Introduction
The term “off-label use” is often misunderstood by many coders. Assessing off-label use can be little complex than usual. As many professionals overlook the need to thoroughly examine it unless it’s directly reported as a case.
Decoding:
- Off-label
- Off: Indicates deviation from a standard or usual path.
- Label: Refers to the official guided information provided with a product, such as a medication.
Together, “off-label” means using something in a manner that is not specified or approved by its official label or guidelines.
- Use
- Use: Refers to the act of employing or utilizing something.
Thus, “off-label use” means employing a use of product, in a way that is not approved or guidance or labeling for that product.
So here you look in to those scenarios with detailed overview:
Definitions
Off-label use:
Must be intentional usage of drug where for the unapproved labels. To explore potential benefits beyond its approved labels.
This practice must involves mutual awareness between physician and patient. That should be clearly explained the purpose to the patient of taking this action(s). It reflects with deliberate decision to pursue alternative treatment paths.
Definition from EMA: Off-label use:
This pertains to instances where a medicinal product is deliberately employed for a medical purpose that deviates from the approved product information.
FDA definition of Off-label use:
In essence: Utilizing Approved Drugs for Unapproved Purposes “off-label”
According to the FDA, it’s crucial to understand that prior to approval, a company must provide clinical data and other relevant information to the FDA for evaluation. This data demonstrates the drug’s safety and efficacy for its intended uses.
Note: The situations where the medicinal product is intentionally used for medical purpose not in accordance with marketing purpose.
Two Categories of Off-label Use Could Be:
- Intentional Off-label Use
- Unintentional Off-label Use
✍️ Note: The situations where the medicinal product is intentionally used for medical purpose not in accordance with marketing purpose.
As off-label medication usage cases continue to accumulate, there’s a growing concern about inadequate monitoring and underreporting to pharmacovigilance databases. It’s essential to remain vigilant and thoroughly assess these cases to ensure comprehensive safety oversight.
Ensure you never overlook a report with DrugVigil.
What is intended use?
- Using the drug for its recommended purpose.
- Administering the drug as intended by its design.
- Ensuring the drug’s safe usage as instructed; however, “safe” doesn’t mean it’s free of side effects.
- Employing the drug according to its labeled instructions.
- Following the provided information about the drug’s risks.
- The term “intentional” specifies, should not be a medication error.
- Prescribed by HCP that are not include in the approved label.
- Healthcare Providers Might Intentionally Believe in the Therapeutic Benefits of a Drug for the Patient’s Condition.
✍️ Note: Although being a condition of use is outside the marketing authorisation, off-label considered as an ADR.
What is unintended use of a drug?
- Using the drug for purposes that not approved.
- Prescribing a different drug than the one intended.
- Using the drug for conditions it’s not recommended for.
- Administering the drug in doses other than those recommended.
- Giving doses of the drug that are not advisable; for instance, using adult dosages for children.
- Unintentionally and not realized or by mistakenly prescribed.
Why might an approved drug be used for an unapproved use?
You might think it’s dangerous to use approved drugs for things they’re not officially approved.
Yes, it can be risky, but based on documentation it is applicable:
- When there isn’t any approved drug available for a specific disease or condition.
- After a doctor has tried all the approved medications, but none of them seem to be working well enough.
✍️ Note: In these situations, the FDA advises that doctors and patients have a thorough discussion about using certain drugs when others haven’t been effective, and we’ve decided together that trying this new approach might lead to improvement.
Reports Indicating Off-Label Use
When doctors knowingly use a drug in a way that’s not officially approved, it’s called off-label use.
However, if the drug used without the doctor’s knowledge or mistakenly prescribed, it’s considered a medication error.
For a better clarity, below are few scenarios where off-label use applicable.
Usually, off-label use involves three main scenarios in reports:
- Indications
- Dosage
- Frequency
- Patient population
- Age group
Off-label use of medicines consequently implies that the above elements are defied.
Making Off-Label Use Case Assessment Easier
Example:
“Lisa is experiencing stress at work and suffers from insomnia, but she finds that sleeping pills make her feel drowsy. To address this, her doctor prescribed an off-label analgesic medication.”
What did you extract from the above example?
The conditions are as follows:
| Intentional use | Seeking Therapeutic Advantages | Applied by/By Whom |
|---|---|---|
| Yes | Yes | HCP |
Differences in Indication:
These reports occur when a physician prescribes a drug for an unapproved purpose. When analyzing these reports, it’s important to distinguish between intentional and unintentional usage.
off-label use in unapproved indication
Differences in Dosage:
These reports involve instances where the prescribed medication dosage is either higher or lower than the recommended range for a specific population.
For instance, sometimes adolescents prescribed doses meant for adults, which isn’t the recommended amount for their age group.
off-label dosing
Differences in Dosage Frequency
These reports involve instances where physicians prescribe medications with frequencies that deviate from the standard.
One commonality among all three reports is that these prescriptions are intentionally made by the physician, often for various reasons we’ve discussed earlier.
Off-label prescriptions are particularly common in pediatrics and cancer treatments. They may involve well-known medications typically used to treat conditions such as pain, seizures, diabetes, and depression.
off-label dosing frequency
Coding Off-Label Use
Each scenario mentioned above corresponds to specific LLTs (Low-Level Terms), while they all typically fall under a common PT (Preferred Term) for off-label use.
Many companies adhere to conventions where reports containing only off-label use without accompanying associated events deemed invalid.
This determination can also be based on product-specific conventions. It’s advisable to always refer to your company’s conventions and product-specific guidelines before processing such reports.
| Various scenarios | LLT | PT |
|---|---|---|
| Drug used for unapproved indication | Off-label use in unapproved indication | Off-label use |
| Drug used in unapproved dose | off-label dosing | Off-label use |
| Drug used in unapproved frequency | off-label dosing frequency | Off-label use |
Importance of Addressing Off-Label Use in Pharmacovigilance
In terms of patient safety, off-label use has gained increasing attention in recent years due to its clinical benefits and liability considerations. A pivotal moment in medical and pharmaceutical regulation emerged from the thalidomide tragedy in the 1960s.
📢 Check out our existing blog, where we discusses in brief about the impact of thalidomide tragedy into pharmaceutical industry.
Off-label use cases regarded as special scenarios because, apart from standard practices, they aim to:
- Enhance patient safety.
- Explore and uncover new indications.
- Evaluate therapeutic effectiveness.
- Introduce novel therapeutic benefits.
Key takeaways
Interchanged drug reports don’t exclusively involve off-label use.
Reports must clearly indicate intentional actions.
Off-label use isn’t limited to changing the drug; it also encompasses alterations in frequency and dosage beyond recommendations.
As per FDA guidelines, off-label use can be legally permissible.
Patients should be adequately informed and provide consent before use.
The safety and efficacy of a drug for off-label uses may not be as well-established as for on-label uses
Off-label use of medicines is not illegal ; however, it can be risky and harmful, or beneficial and innovative.
Off-label use has both advantages and disadvantages.
However, healthcare professionals must carefully consider the available evidence, potential risks, and benefits when deciding to use a drug off-label.
Conclusion
Through the discussion above, you’ve likely gathered valuable insights into coding practices. There are plenty of associated things yet to discover. This is the one “off-label use” within pharmacovigilance data coding.
If there are any crucial details I’ve missed, feel free to mention them. Don’t hesitate to share this information with your network.
Thank you for taking the time to read through.
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