Unlicensed Medicines

Why are medicines usually “officially approved”?

Most Medicines that are prescribed or sold in this country are approved for use by the government.

This helps ensure that medicines are:

• Effective

• Do not cause too many side-effects

• Manufactured under good conditions.

In order to give patients the best or most suitable treatment, it is sometimes necessary for Doctors and Pharmacists to supply medicines that have not gone through this approval process.

They will not do this unless they believe the medicine to be safe and effective.

Why do Doctors prescribe/use unlicensed medicines?

Research may have shown that the treatment is better than one that has been officially approved, but the manufacturer may not have asked for the treatment to be approved, or may be waiting for official approval.

It may be that no other effective treatment is available. This is often the case with some rarer diseases.

A medicine may only be approved for use in one group of patients, for example, in adults, but Doctors may have found that it also works for others, for example in children.

They may wish to use it for these other patients, if it is the most effective treatment available.

The medicine may not have gone through the approval process because it is one that needs to be made up specially, for example, a liquid that has to be made so a child can swallow easily.

What differences might I notice if I am prescribed or supplied an unlicensed medicine?

Your Doctor or Pharmacists may tell you the treatment has not been licensed but will normally explain that it is safe and effective, and why it is the preferred treatment.

In some cases, your Doctor or Pharmacist may give you some separate information about the medicine. If this is written please read it carefully and follow any instructions, you are given.

You may notice that a manufacturer’s information leaflet supplied with the medicine:

• Does not include information about the condition for which you are being treated.

• Does not include information about the use of medicine in children or older people.

• May state a different dose from that which your Doctor has prescribed.

Many of these medicines have to be made up specially or may take longer to obtain than other medicines. Your Pharmacist may need to make special arrangements for the supply of the medicine.

You may also be told that it will be necessary for you to ask the Doctor for another prescription up to 2 weeks before the next supply of medicine is needed.

What should I do if I want more information?

If you:

• Have worries about the medicine or information you have been given.

• Are confused and not sure about any information you have been given.

• Just want more information.

Please talk to your Doctor or Pharmacist.

They have lots of knowledge and experience with medicines and will be pleased to answer your queries.

What if I am unhappy about taking or using an unlicensed medicine?

If you have any concerns at all talk it over with your Doctor or Pharmacist. Tell them what you are worried about and why.

They can:

• Give you more information about the treatment.

• Explain why it is believed to be the most suitable for you.

• Discuss other treatments that may be available.

Contact Details

If you need further advice, or have any problems, please contact:

North Tees and Hartlepool NHS Foundation Trust

Medicines Advice

Email: [email protected]

Comments, concerns, compliments or complaints

Patient Experience Team (PET)

We are continually trying to improve the services we provide. We want to know what we’re doing well or if there’s anything which we can improve, that’s why the Patient Experience Team (PET) is here to help. Our Patient Experience Team is here to try to resolve your concerns as quickly as possible. The office is based on the ground floor at the University Hospital of North Tees if you wish to discuss concerns in person. If you would like to contact or request a copy of our PET leaflet, please contact:

Telephone: 01642 624719

Freephone: 0800 092 0084

Opening hours: Monday to Friday, 9:30am to 4:00pm

Email: [email protected]

Out of hours

Out of hours if you wish to speak to a senior member of Trust staff, please contact the hospital switchboard who will bleep the appropriate person.

Telephone: 01642 617617

Data protection and use of patient information

The Trust has developed Data Protection policies in accordance with Data Protection Legislation (UK General Data Protection Regulations and Data Protection Act 2018) and the Freedom of Information Act 2000. All of our staff respect these policies and confidentiality is adhered to at all times. If you require further information on how we process your information please see our Privacy Notices.

Telephone: 01642 383551

Email: [email protected]

Leaflet feedback

This leaflet has been produced in partnership with patients and carers. All patient leaflets are regularly reviewed, and any suggestions you have as to how it may be improved are extremely valuable. Please write to the Clinical Governance team, North Tees and Hartlepool NHS Foundation Trust, University Hospital of North Tees, TS19 8PE or:

Email: [email protected]