What if I don't want to take unlicensed medicines? It is important to talk over your concerns with your doctor, key worker or pharmacist and tell them what you are worried about. They can tell you more about the medicine from the information or advice that they have. They can also tell you about other treatments that are available and help you decide what the right choice is for you. They can also help put you in touch with a support group for your illness or condition.
What else do I need to know? Sometimes it will take longer for the pharmacist to obtain an unlicenced medicine especially if it is being ordered from overseas. You will need to give the pharmacist enough notice to obtain further supplies of your medicine on a repeat prescription.
If I'm confused what should I do? Please talk to your doctor, key worker or pharmacist if there is anything further that you would like to know.
Lancashire Care
Further advice and information is available from the Pharmacy Team
NHS Foundation Trust
Contact Details: Central Lancashire 017872 406640
Fylde Coast East Lancashire 01253 306883 01254 226077
Other sources of information: The Mental Health Helpline This provides an information and listening service for people in Lancashire. It is available between 7:00pm and 11:00pm Mondays to Fridays and from 12:00 noon until 12:00 midnight on Saturdays and Sundays. Freephone 0500 639000. Customer Care If you wish to pay a compliment about the Trust’s services, make a comment, raise a concern or complaint, please contact the Customer Care Department on 01772 695315, freephone 0808 144 1010 or email
[email protected]
Use of Unlicensed Medicines and Off-label Use of Licensed Medicines
If you have problems reading the print we can provide this leaflet in large print, audio book or Braille.
Copies of this leaflet are available from: Lancashire Care NHS Foundation Trust, Sceptre Point, Sceptre Way, Walton Summit, Preston PR5 6AW Tel: 01772 695300 Email:
[email protected] Website: www.lancashirecare.nhs.uk ©Lancashire Care NHS Foundation Trust. All Rights Reserved. Not to be reproduced in whole or in part without the permission of the copyright owner. Data Protection Lancashire Care NHS Foundation Trust adheres to The Data Protection Act 1998. The Trust will endeavour to ensure that your information remains secure and confidential at all times. For further information regarding data protection please visit the Trust’s website or ask a member of staff for a copy of our leaflet entitled “Sharing Information With Us”. Date Produced: September 2013
Review Date: September 2014
Leaflet Code:
Name of Leaflet: Use of Unlicensed Medicines
Pharmacy
What is this leaflet about? You have been given this leaflet because a medicine that you have been prescribed is not licensed (unlicensed use) or is being used in a way that is not covered by the license (off-label use). This leaflet is intended to explain why we sometimes prescribe unlicensed medicines and to help answer any questions that you may have.
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Why are medicines licensed?
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Pharmaceutical companies must hold a license for each medicine that they sell in the United Kingdom. The Medicines and Healthcare Products Regulatory Agency (MHRA) issue these licenses only after they have assessed information on the quality, safety and efficacy of the medicine. They have to be sure that the medicine is made to an acceptable standard of quality, that it works to treat the illness concerned and that the incidence of side effects is understood and any risks can be managed. Medicines are tested in clinical trials to generate the information that is necessary for licensing.
Why don't all medicines have licenses? Medicines are usually only licensed for conditions that have been investigated in clinical trials. However, many illnesses may not have been studied in this way, but still need to be treated. In these situations, doctors and pharmacists can use their medical experience and specialist knowledge to recommend the use of unlicensed medicines or off-label use of licensed medicines. They may choose to use: · ·
Off label use: - where a licensed medicine is used for a purpose that is not covered by the license Clinical trial: - medicines that are currently undergoing clinical trials, but do not yet have a full product license
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Withdrawn: - a medicine that used to be licensed in the UK, but is no longer available but can still be obtained from the manufacturer as a special drug Imported: - a medicine that is only available from abroad and needs to be imported. This can also apply to withdrawn as above where a medicine is still being used as a licensed product outside of the UK Specially made by either a manufacturer or Pharmacy: - a medicine that needs to be made specially, because it is not readily available from a manufacturer
Why have I been given an unlicensed medicine? The doctor who is treating you has prescribed an unlicensed medicine because no suitable licensed alternative is available to treat your condition. Examples of unlicensed use are: · You are allergic to the normal medicine · You may be experiencing unacceptable side effects with your current medication · Your current medication may not have worked and no suitable licensed drug is available as an alternative · The medicine has never been sold in the UK · The medicine has been withdrawn from the market Your doctor will have thought very carefully about prescribing the most appropriate medicine for you.
Common examples of off-label use of medicines Atypical antipsychotics to treat psychotic depression.
Benzodiazepines (e.g. Diazepam) and “Z” night sedations (e.g. Zopiclone) where they are prescribed for more than 28 days. Acetylcholinesterase inhibitors to treat non- Alzheimer's dementia. Sodium Valproate and Lamotrigine to treat bipolar affective disorder.
Information Leaflets It is a legal requirement that all medicines dispensed in the UK must have an information leaflet explaining about the medicine, its uses and side effects. Where a medicine is being used as an unlicensed medicine the leaflet may not mention the condition you are being treated for. The leaflet may also mention other conditions, which you do not have. If you are concerned about this ask your doctor, key worker or pharmacist to confirm that the medicine is the right one for you.
Should I be worried about taking an unlicensed medicine? Your doctor will have explained to you why this medicine has been prescribed. If you are worried about taking it, talk to your doctor, key worker or pharmacist about your concerns and they will be able to give you further information. If you experience any unpleasant or unexpected side effects whilst taking the medicine, you should report this to your doctor or pharmacist who will send a “Yellow Card” to the MHRA about your experiences. This will help provide a clearer picture of the adverse effects and side effects of the medicine. Alternatively you can send in a ‘Yellow Card’ to the MHRA yourself. These are available either on line at www.mhra.gov.uk or from the Community Mental Health Teams (CMHTs), Hospitals or from your local Pharmacist.
