Patient Information Leaflet: Use of Unlicensed Medicines and Off-Label Use of Medications in the UK
Introduction
This leaflet explains what "unlicensed medicines" and "off-label use", particularly focusing on their use in Hormone Replacement Therapy (HRT). We also include some examples relevant to HRT to help you understand how these practices may apply to your treatment.
What are Unlicensed Medicines?
Unlicensed medicines are drugs that have not received official approval from the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), for a specific condition or patient group. However, these medicines may still be prescribed by a healthcare professional when they believe it is in the best interest of the patient, especially if licensed alternatives are not suitable or available.
This does not mean the medicine is unsafe. It simply means that the manufacturer has not applied for a license for the medicine to be used for that particular condition, patient group, or formulation in the UK.
What is Off-Label Use of Medication?
"Off-label" use refers to the use of a medicine that has a license for specific conditions or patient groups, but is prescribed in a way that differs from the licensed instructions. This may involve using the medicine:
For a different condition or disease than it was licensed for.
In a different dose or method of administration than specified by the license.
In a different patient group, such as children or older adults.
Prescribing medications off-label is common practice, particularly in specialised areas such as hormone therapy, where healthcare professionals use their expertise to tailor treatments for individual needs.
Examples of Off-Label Use in HRT:
Testosterone for Women: Testosterone is commonly licensed for use in men, but in the UK, it is prescribed off-label to women experiencing menopausal symptoms such as low libido. Testosterone gel, such as Testim or Tostran, is often used off-label for women, as there is currently no testosterone preparation licensed specifically for women in the UK.
Higher than standard doses of oestradiol when there is poor transdermal absorption of oestradiol. we will always try to use alternative options before considering higher than licensed dose of medication.
Why Are Unlicensed Medicines and Off-Label Prescriptions Used?
Unlicensed and off-label uses are sometimes necessary because:
Patient needs vary: Everyone is different, and some patients may not respond well to standard licensed treatments.
Limited options: For some conditions, there may be few or no licensed treatments available. This is often the case in areas like HRT where specific patient needs or hormone preparations might not have a licensed option.
Emerging evidence: Sometimes, new evidence supports the use of a medication in a way that hasn’t yet been included in its license.
Off-Label Use of Hormone Replacement Therapy (HRT) in PMDD:
While hormone replacement therapy (HRT) is commonly used for managing menopausal symptoms, it can also be prescribed off-label to women with PMDD. In this context, oestrogen therapy can be used to suppress ovulation and stabilize hormone fluctuations, which are believed to trigger PMDD symptoms.
Oestradiol patches : These transdermal forms of oestrogen are commonly licensed for managing menopausal symptoms but can be prescribed off-label to women with PMDD. The goal is to provide a stable level of oestrogen throughout the menstrual cycle to alleviate the hormonal fluctuations that exacerbate PMDD symptoms.
Is It Safe to Use Unlicensed or Off-Label Medicines?
Yes, in the hands of experienced healthcare professionals, using unlicensed or off-label medicines is safe. Prescribing these medicines is always done after careful consideration of the risks and benefits. Your healthcare provider will discuss these factors with you to ensure you make an informed decision.
What You Should Know
If a medicine you are prescribed is unlicensed or being used off-label, your healthcare provider will explain why this is the best option for you.
You have the right to ask questions about why the medicine is being prescribed and to understand the possible risks and benefits.
Your treatment will be carefully monitored, and any side effects or concerns should be reported to your healthcare provider.
Conclusion
Unlicensed and off-label use of medicines is a common practice, particularly in areas like hormone replacement therapy, where treatments need to be tailored to individual patient needs. Your healthcare provider will always consider your personal circumstances and ensure you receive the best possible care.
If you have any further questions, please speak to your healthcare provider.
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