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STANDARD OPERATING PROCEDURE
SUPPLEMENTARY PROCEDURES
ADVICE TO PATIENTS REGARDING SAFETY OF HERBAL MEDICINES
DISPENSARY
PURPOSE:
SCOPE:
 To adopt a procedure advising  This
procedure
includes
known
patients regarding the safety of
interactions between licensed herbal
herbal medicines
medicines and conventional medicines.
 To advice patients of the potential of  This procedure does not cover advice to
interaction
between
herb
1. Pregnant women
preparations
and
conventional
2. Breast feeding mothers
medicines.
3. Children
4. Elderly
as safe use of herbal medicines has not
been established in these groups of patients.
General advice to Consumers
Appendix 1 includes an advice sheet for consumers from MHRA.
Useful Information for Dispensary team
 Herbal products for medicinal reasons include licensed medicines (products
assessed by the MCA for safety, quality and efficacy in accordance with UK & EU
regulations), herbal products exempt from licensing (products compounded and
supplied by herbalists on their own recommendations) and unlicensed products
(mainly sold as food supplements).
 Dispensers supplying herbal products have a professional responsibility not to
recommend any product where they have reason to doubt its safety or quality, and
only to offer advice on herbal products if they have appropriate knowledge.
 Wherever possible, licensed herbal medicines should be used in preference to
unlicensed herbal products.
 Herbal products can interact with conventional medicines.
 Suspected adverse reactions associated with herbal products should be reported.
The Committee on safety of medicines actively seeks Yellow card reports of herbal
products.
Herb-Drug Interactions
As with conventional drug interactions, herb-drug interactions may be
Pharmacodynamic or Pharmacokinetic.
 Pharmacodynamic interactions could result when a herbal drug and a conventional
drug have similar or antagonistic pharmacological effects or adverse effects. These
interactions are usually predictable from knowledge of the Pharmacology of the
interacting herb and drug.
 Pharmacokinetic interactions could occur when the herb alters the absorption,
distribution, metabolism or excretion of the drug. These are not easily predicted.
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Potential Herb-drug interactions of particular concern
When patients are stabilised on Drugs with a narrow therapeutic window- e.g. warfarin,
digoxin, anticonvulsants (e.g. Phenytoin) and Cyclosporin
Procedure to be adopted to advice on reported Herb-drug interactions
1. St. Johns wort (Hypericum perforatum)-Background
The information provided here identifies the principal interacting medicines. It may be
used with other information sources, as a basis to provide advice to patients.
Most products containing St. John’s wort for oral use do not have a marketing
authorization. They are supplied as herbal medicines exempt from licensing under the
Medicines Act, and no medical claims are permitted.
Evidence from controlled clinical trials suggests that St. John’s wort extracts are
effective in the treatment of mild to moderate depression
St. John’s wort is not considered appropriate for the treatment of major depression
PROCEDURE
RESPONSIBILTY
Patients considering taking St. Johns wort
1. Ask patient considering taking St. John’s wort about
their prescribed medicines.
2. If patient is taking any of medicines known to interact
with St. John’s wort (see list below), advise patients
not to take St. John’s wort, and explain the reasons
for this.

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







Anticonvulsants
(Carbamazepine, Phenobarbitone, Phenytoin)
Oral contraceptives
Digoxin
Warfarin
Selective serotonin reuptake inhibitors (SSRIs)
(Citalopram, Fluoxetine, Fluoxamine, Paroxetine,
Sertraline).
Theophyliine
Ciclosporin
HIV protease inhibitors
(Indinavir, Nelfinavir, Ritonavir, Saquinavir)
HIV
non-nucloeoside
reverse
transcriptase
inhibitors
(Efavirenz, Nevirapine)
Triptans
(Sumatriptan, Naratriptan, Rizatriptan, Zolmitriptan)
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For use within your practice only. You are not permitted to supply this to any other organisation.
Page 2 of 7
Patients already taking St. John’s wort
3. Patients already taking St. Johns wort and interacting
prescribed medicines (or OTC Triptans) (see list in 2.
above), advice to stop taking St. John’s wort, after
consulting their GP because dose adjustment of these
medicines may be necessary.
Patients taking St. John’s wort and Oral
contraceptives
4. Patients taking St. John’s wort and an oral
contraceptive , advice to stop taking St. John’s wort
and to use an additional contraceptive method for at
least 4 weeks.
PROCEDURE
RESPONSIBILTY
Medicines not likely to interact with St. Johns wort
5. Medicines (other than SSRIs and triptans) that are not
metabolized by the liver
6. Topical medicines
Other Herb-Drug interactions
Unlike St. Johns’ wort, the evidence and understanding of
most drug-herb interactions is limited.
Some examples of potential drug-herb interactions are
included in Table 3 of the attached document.
If an interaction is suspected, please advice patient to
stop taking the herbal medicine, and seek further advice
from GP.
REVIEW PROCEDURE:
KNOWN RISKS:
This procedure will be reviewed in the light 
of further knowledge of herb-drug 
interactions, regulatory changes, staff 
changes, and incidents/events.
New or untrained staff/locums
Unknown herbal products
Unknown herb-drug interactions.
In the absence of any events it will be
reviewed on or before the date shown
below.
PREPARED BY:
SIGNATURE:
DATE OF PREPARATION:
DATE EFFECTIVE FROM:
VERSION NUMBER:
DATE OF REVIEW:
© Practice Services UK Limited.
For use within your practice only. You are not permitted to supply this to any other organisation.
Page 3 of 7
STANDARD OPERATING PROCEDURE
SUPPLEMENTARY PROCEDURES
ADVICE TO PATIENTS REGARDING SAFETY OF HERBAL MEDICINES
I have signed to say that I have read the procedure and understand its implications.
NAME
SIGNATURE
DATE
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For use within your practice only. You are not permitted to supply this to any other organisation.
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Appendix 1
Using herbal medicines - (Ref MHRA web-site)
General advice to consumers
 Remember that herbal remedies are medicines. As with any other medicine they
should be used with care.
 Any medicine – herbal or otherwise – has the potential to have adverse effects.
 Before you take any herbal medicine you need to be sure it is the correct product
for you.
 Remember that natural does not mean safe. Many plants can be poisonous to
humans. Many pharmaceutical medicines have been developed from plants
because of the powerful compounds they contain.
 Herbal remedies can interact with other medicines. This could result in the other
medicines having reduced or enhanced effects, including side-effects. When
consulting your doctor or dispenser about your health always tell them about any
herbal medicines you are taking.
 As with all medicines, keep herbal medicines out of the sight and reach of
children.
Are any particular groups at risk?
 In many cases the safe use of herbal medicines has not been established in:
o pregnant women
o breastfeeding mothers
o children
o elderly
 Therefore caution should be taken about use of herbal medicine in pregnancy,
when breast feeding or in children/elderly.
 If you are due to have a surgical operation always remember to tell your doctor
about any herbal medicines you are taking. Some herbal medicines could alter
the effects of anesthetics or other medicines during surgery.
 Anyone with a history of liver complaints or any other serious health condition is
advised not to take any herbal medicine without speaking to their doctor first.
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Which herbal medicines have been assessed by the Regulator?
Look for PL or THR on the product labels. Herbal medicines licensed in the UK
have a PL (product licence) number on the label.
Traditional herbal medicines registered in the UK have a THR (traditional herbal
registration) number on the label. The first registered products under this new
scheme are expected to reach the UK market in the coming months.
Both these kinds of medicines are regulated by the MHRA and meet assured
standards.
Other herbal medicines on the UK market have not been assessed by the
MHRA.
How can I tell if an unlicensed medicine is made to acceptable standards?
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
Consumers should be aware that unlicensed herbal medicine on the UK market
have not been assessed by the MHRA as to their safety, quality or patient
information.
 There is evidence that standards vary considerably in the unlicensed sector. It is
likely that some companies manufacture products to good standards. However,
there is also evidence of poor or patchy standards in parts of the sector.
Information about this is regularly published on the MHRA’s website in 'Herbal
Safety News'.I
 It is not generally possible for consumers to identify which unlicensed medicines
are made to acceptable standards. However, there are a number of pointers, in
particular from the product information, which may be indicative of poor or
unreliable standards.
Advice for consumers when buying unlicensed herbal medicines
 Treat with caution claims about safety that are not backed by credible evidence.
Be wary of products making claims such as :
o The herbal remedy is “100% safe”
o Herbal remedies are “safe because they are natural”
o This herbal medicine “has no side effects”
o “Chinese medicines will not interfere with the effects of any western medicine”
o You can avoid Chinese medicines interfering with other medicines if you take
them an hour apart.
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Be wary of any unlicensed medicine suggesting the consumer should stop
taking, or change the dosage of, a prescribed medicine. The MHRA advise you
not to follow such advice - you should always consult your doctor about making
changes to your prescribed medication
Treat with caution any unlicensed herbal medicine that makes medicinal claims
for the product (that is claims to prevent, treat or cure illnesses). These claims
will not have been assessed by the MHRA and could be misleading
Be wary of any product if:
o It is not labelled in English
o It does not have information about safe usage
o The herbal practitioner cannot or will not give a list of ingredients.
Apparently similar unlicensed herbal medicines may be accompanied by
different patient information. Do not assume that the medicine with fewer
warnings
is
necessarily
safer
to
use.
Buying herbal medicines over the Internet
 There is an international trade in poor quality unregulated herbal products.
Unlicensed “herbal” products in the UK and elsewhere have been found
containing banned pharmaceutical ingredients, heavy metals. Products may
contain harmful herbs that are not permitted in the UK. Be aware that
unlicensed herbal medicines manufactured outside the UK may not be subject to
any form of effective regulation.
 If a product refers to licences granted in other countries there may be no
guarantees that the product actually complies with requirements or that
standards applied in other counties match those that a UK consumer would
expect from regulated products.
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What to do if you think you have had an adverse reaction to your herbal
medicine?
 All medicines, including herbal medicines, may cause side effects or unwanted
reactions.
 If you think you have had a reaction to your herbal medicine, you should
discontinue use and tell your doctor or dispenser.
 If you think you or someone else has had an unwanted or harmful reaction after
taking a herbal medicine (commonly referred to as a suspected adverse drug
reaction), we would like to know. This will help us give advice to other patients
and healthcare professionals - and will help us make sure herbal medicines in
the UK are safe.
 You can report a reaction yourself directly to us using a system called the Yellow
Card Scheme.
 This can be done online or by filling out a paper yellow form which is available
upon request by calling 020 7084 2000.
 Alternatively, you can ask your doctor or dispenser to report the reaction us on
your behalf.
 Any information received by us will be held in complete confidence and your
personal details will not be given to anyone else without your permission.
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