TRAMO DEL CORREDOR VIAL INTEROCEÁNICO SUR, PERÚ – BRASIL

An unlicensed medicine is the term used to refer to a medicine that does not have a Valid Marketing Authorisation for use in the UK.

If an unlicensed medicine is administered to a patient, the liability rests with the prescriber rather than the manufacturer.

Unlicensed medicinal products are only to be used when no pharmaceutically equivalent licensed product or suitable alternative licensed product is available for use at the time the patient requires it.

Refer to the NHS Wirral document, “Guidance on the Prescribing and Use of Unlicensed and “Off-label” medicines” available on the NHS Wirral website for full details.

Complementary and alternative medicines, such as homeopathy and herbal medicines without a valid Marketing Authority for use in the UK are also classified as unlicensed medicines.

12.1 Responsibilities of Prescribers

Prescribers of unlicensed products carry their own responsibility and are professionally accountable for their judgement in so doing. Prescribers are responsible for the patient‟s welfare and in the case of adverse events they maybe called upon to justify their actions. Following amendments to the Medicines for Human Use Regulations 2009, independent nurse or pharmacist non-medical prescribers are now permitted to prescribe unlicensed medicines. However, non-medical prescribers should only prescribe unlicensed medicines in justifiable exceptional and approved circumstances for example, justified by current best practice (e.g. national NHS guidance)

12.2 Responsibility of Supplying Pharmacist (Community or Hospital)

Supplying pharmacists are responsible for ensuring that prescribers are always aware that a medicine they have requested is only available as an unlicensed product.

Safe Handling and Administration of Medicines Policy

Pharmacists will share the responsibility as the purchaser of the product, particularly when this involves specifying the product to be purchased. Pharmacists are responsible for ensuring that the manufacturer holds the appropriate licence to manufacture and that the product complies with the product specification.

12.3 Responsibilities of NHS Wirral Medicines Management Team

When an unlicensed medicine is to be prescribed or administered for the first time, there needs to be critical, evidence based evaluation for its use. The Locality Prescribing Adviser is responsible for assessing the evidence and challenging its use.

12.4 NHS Wirral Staff Involved in Administering Unlicensed Medicines

In exceptional circumstances NHS Wirral staff may be requested to administer unlicensed medicines. Staff must contact their senior manager (or on call manager) who must establish the medicine is clinically appropriate by contacting the Medicines Management Information Service on 0151 643 5338 or internal extension 1026 who will direct the inquiry to the most appropriate specialist pharmacist. All evaluation, advice and risk assessments must be appropriately documented. Out of hours medicines advice can be obtained from the referring prescriber or the General Practitioner „Out of Hours‟ Service.

In addition it is also the responsibility of each individual registered nurse to satisfy themselves that the medicine may be administered safely and wherever possible, that there is acceptable evidence for the intended use of the unlicensed medicine.

If a medicine is unlicensed, it should only be administered to a patient against a patient- specific prescription and not against a patient group direction.

However, medication which is licensed but outside its licensed indications may be in exceptional circumstances administered under a patient group direction, if such use is clearly described and justified by current best practice (e.g. national NHS guidance).

Prior to administration of unlicensed medicines staff involved in administration should ensure they have appropriate informed consent.

12.4.1 Complimentary and Alternative Medicines

In the case of complementary and alternative medicines, such as homeopathy and herbal remedies, practitioners who administer such medicines to patients must have successfully undertaken training and have the role of administrating these medicines outlined in their job description and be competent to practice the administration of the particular medicine. Practitioners must also ensure that they have sufficient indemnity insurance and they must check with their line manager that the administration of these medicines will be covered by NHS Wirral‟s vicarious liability.

Safe Handling and Administration of Medicines Policy

The Wirral Drug and Therapeutics Committee is responsible for the approval for use of all medicines prescribed in primary care and WUTH. However in the case of an urgent clinical need, the Locality Prescribing Adviser may authorise use of a new unlicensed medicine, subject to formal ratification at the next Wirral Drug and Therapeutics Committee.

12.6 Definition of “Off -Label Medicines”

The Summary of Product Characteristics (SPC) lists:

Indications, dose ranges, methods of administration and age restrictions as granted by the Marketing Authorisation for each medicine licensed for use within the UK.

Any use not in accordance with the SPC is considered “off-label”, or an unlicensed use. This policy also applies to products used outside their Marketing Authorisation “off label use”.

13. Training and Medicines Information

The British National Formulary is the main source of reference for medicines. It describes the preparations likely to be prescribed and summarises the relevant legislation regarding prescriptions and controlled drugs. All health professionals involved in the administration of medications are responsible for familiarising themselves with the formulary. The Nurse Prescribers Formulary (incorporated in the British National Formulary) provides information of special relevance to Nurse Prescribers.

A copy of the British National Formulary (BNF), within 12 months of date of issue will be available in each department. The most current version of the BNF is available on the internet. www.bnf.org

The expert on all aspects of medicines and medicines related legislation is the pharmacist who should be consulted whenever necessary.

NHS Wirral Medicines Information Service is staffed by pharmacists during normal office hours and can be contacted on 0151 643 5338 or alternatively on internal extension 1026. All staff are encouraged to identify their Continuing Professional Development (CPD) needs regarding their own competency level in the safe use of medicines according to the needs of their role.

Staff and managers have joint responsibility to highlight training needs in regard to the safe storage and administration of medicines and highlight these needs in annual appraisals and management supervision as required.

All staff must adhere to NHS Wirral policy. Health Care Professionals are also accountable to their own Professional Bodies to promote safe practice for patients and for their own Continuing Professional Development.

Safe Handling and Administration of Medicines Policy

Staff are responsible for reading and acting within the Safe Handling and Administration of Medicines Policy and for any departmental SOPs regarding medicines.

A feedback form is available in the front of the Policy File for all staff to comment or make suggestions for changes when the policy is due to be reviewed. This will be a valuable feedback loop to promote best practice within NHS Wirral.

In addition NHS Wirral will provide training on medicines management specific to the requirements of individual departments, for example community nurses are required to attend, medicines management training every two years.