Thursday, September 16 2021

Advice to healthcare professionals:

  • be alert to any suspected adverse reactions associated with the use of herbal and homeopathic medicines and interactions with other medicines and report suspicions to the MHRA yellow card system (see section below for this that must be included in the reports)
  • if a side effect is suspected, ask patients if they are taking any herbal or homeopathic medicines and include a full list of medicines in the yellow card report
  • ask if patients are taking any herbal or homeopathic medicines during routine drug reviews and remind them to check that they are using licensed products (see advice for patients below)
  • remind patients to read the safety information provided in the patient information for herbal and homeopathic medicines, including when to see a doctor

Advice to healthcare professionals for patients:

  • to ensure that a product has been authorized by the MHRA and meets the required standards of quality, safety and patient information:
    • Look for the Traditional Medicinal Plant Registration Certification Mark (THR) and THR number on the traditional herbal medicine label (some herbal medicines have a product license, indicated by a product license number ( PL))
    • check the Homeopathic Simplified Registration (HR) or National Rules Authorization (NR) number on the homeopathic medicine label
  • always read the patient information that comes with any herbal or homeopathic medicine to make sure it is right for you and that you know how to use it safely
  • if you think you have had an adverse reaction to a herbal or homeopathic medicine, you can report it to your doctor or pharmacist, or directly to the MHRA Yellow Card program

Yellow card declaration for herbal and homeopathic medicines

The yellow card system is essential in helping the MHRA monitor the safety of all medicines in the UK, including herbal and homeopathic medicines.

Herbal and homeopathic medicines are available in outlets such as pharmacies, retail stores, online stores or provided by herbal or homeopathic practitioners and only some of them are authorized by the MHRA. Here we provide several examples of why it is important to monitor authorized and unauthorized herbal and homeopathic medicines in order to protect patient safety.

The yellow card reporting identified many important safety concerns for herbal medicines, for example the interactions between St. John’s Wort and hormonal contraceptives and anti-epileptic drugs, which were unknown before they were reported.

In addition, our vigilance with regard to herbal products has led to warnings regarding the use of butterbur (Petasites hybridus) products. Butterbur contains pyrrolizidine alkaloids, which can cause serious side effects such as liver damage and organ failure. The MHRA has previously issued a safety alert advising consumers not to take unauthorized Butterbur herbal remedies. This advice remains unchanged.

Although homeopathic medicines are sometimes diluted to contain only a few molecules of the active ingredient, a recent study revealed a manufacturing error of a homeopathic medicine which led to an accidental overdose of atropine and the hospitalization of a patient. patient in Germany. Although this has happened outside of the UK, this is an example of the need to consider these drugs in patients who experience an adverse reaction.

Who advises the MHRA on herbal and homeopathic medicines?

The Independent Herbal Medicines Advisory Board (HMAC) and Homeopathic Product Registration Advisory Board (ABRHP) advise MHRA and ministers on safety, quality and patient information for traditional medicines herbal and homeopathic.

HMAC and ABRHP review identified safety issues for traditional herbal and homeopathic products via reporting yellow card reactions and advise on changes to safety information for UK licensed products, if any .

Find out if a herbal or homeopathic medicine is authorized in the UK

For herbal medicines, patients should check:

For homeopathic medicines, patients should check:

  • A simplified homeopathic registration number (HR)
  • Or a national rules authorization number (NR)

Choosing a licensed product means that it meets the required standards of quality, safety and patient information.

Report suspected side effects of herbal or homeopathic medicines

A recent study of a cohort of people in Wales showed that less than one in three participants knew they could report an adverse reaction to a herbal or homeopathic medicine to the yellow card program .

Healthcare professionals and patients are encouraged to report any suspected side effects or adverse reactions to any herbal or homeopathic medicine using the yellow card system.

When reporting a yellow card, it is recommended that patients routinely ask what other medicines, including herbal medicines, supplements, and homeopathic medicines they are taking, in addition to those they have themselves. purchased, and list them in the report. You can also let patients know that they can report any side effects themselves directly using the Yellow Card app or website.

What to include when submitting a yellow card for herbal and homeopathic medicines

Use the Yellow Card website or the Yellow Card app (download from the Apple App Store or Google Play Store) to report suspected reactions to herbal and homeopathic medicines.

When submitting a yellow card for herbal and homeopathic medicines, it is important to provide additional details to aid us in our assessment and to identify the exact herbal or homeopathic product, such as:

  • the brand name (if it has one)
  • the list of ingredients
  • the contact details of the manufacturer or supplier and the THR / PL / HR / NR number (if there is one)
  • the state for which it was used
  • any other medication taken in the past 3 months
  • if the product was supplied by an herbalist or a homeopath, its name and address
  • a photograph of the packaging labeling (emailed to [email protected])

If you do not have all of the above information, please fill out a yellow card anyway.

If the reaction is severe, you can also keep a sample of the product, in case further investigation is needed. Please note that you may also report suspected reactions resulting from error, misuse, abuse, or improper use. If in doubt about whether to report a suspected reaction, please complete a yellow card.

Article citation: Drug Safety Update volume 14, number 12: July 2021: 2.


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