Quality, safety and sourcing in unlicensed medicines

The purpose of this guide is to provide Pharmacy Technicians, Pharmacists and the wider pharmacy team with information to assist with their practice and professional development in unlicensed medicines.

The guide covers steps the pharmacy team should undertake when procuring unlicensed medicines, including:

  • Risk Assessment – how to safeguard patients and protect your status as a trusted healthcare professional (HCP)
  • Sourcing – knowing what questions to ask to ensure suppliers are best placed to guarantee quality and patient safety
  • Documentation - ensuring your product has the correct paperwork

 

Disclaimer: This CPD module is supported and sponsored by the Association of Pharmacy Technicians UK (APTUK). APTUK is responsible for the contents in this module.

The information contained in this module is based on current UK and EU regulations and industry best practice expertise. Please ensure that you refer to your Trusts guidelines and stay up to date with regulation changes.


 

What this guide will cover:

  1. What is an unlicensed medicine? 
  2. When should you consider using an unlicensed medicine?
  3. Accountability
  4. Section 1: Risk Assessment 
  5. Section 2: Sourcing
  6. Section 3: Documentation
  7. Resources
  8. Glossary

 



  • When there is no equivalent licensed medicine available in the UK to meet the special need of the patient
  • If a licensed medicine is available but not in a suitable formulation / presentation (e.g. oral liquid form in paediatrics)
  • When the equivalent licensed medicine is likely to be unavailable for a significant period (e.g. manufacturing difficulties)
  • For commercial reasons - either the licence has been relinquished or is maintained without the product being marketed
  • Unlicensed medicines should not be supplied for reasons of cost, convenience or operational needs

WHEN SHOULD YOU CONSIDER USING AN UNLICENSED MEDICINE?



SECTION 1: RISK ASSESSMENT

Safeguarding pharmacist and patient

Where do unlicensed medicines fit in the MHRA hierarchy of risk?

 

Risk assessment

The pharmacy team has an important and responsible role in assessing the evidence.

No aspect of quality should be assumed and all reasonable steps should be taken to ensure the quality of the unlicensed medicine meets appropriate standards.

When an unlicensed medicine is being ordered, there needs to be a critical, evidence- based evaluation for its use:

Calculating overall risk

Risk is calculated as a combination of the clinical risk and those risks associated with a product’s preparation:

 

 

 

 

 

 

The pharmacy team should ask if the product is fit for purpose. A product should not be supplied if you are not totally satisfied.

Clinical risk assessment considerations:

  1. Is there a definite clinical need for this product?
  2. Is there an equivalent licensed product available?
  3. Is there any evidence to support its use for the proposed indication? If not, is there any evidence to support its use for other indications? Is there evidence to support its proposed administration schedule?
  4. Does the product have a product licence (PL) or EMEA MA?
  5. Is the product licensed for the specified indication in an EU or non-EU member state?
  6. Are other NHS Trusts using this medicine?
  7. What are the risks to the patient of not using this medicine?
  8. What could go wrong? What is the likelihood of something going wrong? What would the consequences be?

Your ongoing responsibility

Once the product has been obtained and supplied, the responsibility of the pharmacy team doesn’t end there. You must ensure:

The pharmacist should ensure that both the patient (and carer) and any other HCP involved understands the differences between an unlicensed medication (bespoke and batch) and the usual licensed pharmaceutical product.

Quality and safety assurances


SECTION 2: SOURCING

Maintaining quality and compliance

How to choose the right supplier?

Before ordering an unlicensed medicine make sure to check the credentials and licenses of your supplier:

Standards and checks

Factors to consider when selecting a supplier of unlicensed medicines include:

Compliance

  1. The supplier should be MHRA approved. This means they will undergo regular inspections, often at short notice. This provides reassurance products are safe and compliant
  2. They must comply with GMP / GDP. They should have a named production manager, quality controller and Qualified Person (QP). Check that these procedures are in place
  3. A wholesaler licence is required to import unlicensed medicines from the EU
  4. In addition to mandatory requirements, ask whether the supplier conducts their own quality checks and risk assessments prior to supplying a product

Where is the unlicensed medicine to be sourced from?

Who is the supplier?
Identify who is providing the unlicensed medicine. Is this an NHS specials unit? A commercial specials manufacturer? A licensed importer? A company which already has licensed products of the same active ingredient? A licensed pharmaceutical wholesaler?

Where is the supplier manufacturing?
In the UK? If not, which country? Is this country within the EU/EEA? If not, ensure this country has a mutual recognition agreement with the UK for the manufacture of medicinal products.

If the supplier is importing?
Does the importer have a Wholesaler and/or MS Licence?

Think about service - can they deliver?

  1. What is the quoted delivery time?
  2. What quantity is to be ordered?
  3. Are there any delivery charges?
  4. Are there any problems associated with continuity of supply?
  5. What are the costs involved in obtaining this medicine?
  6. Can they provide translated documentation?

SECTION 3: DOCUMENTATION

Quality in black and white

Know your documents

Once you have ordered your unlicensed medicine, it is the responsibility of the pharmacy team to check they have received all the supporting documentation that provides evidence of the purchasing specification i.e. the prescriber’s requirements, appropriate pharmaceutical quality, and suitability for the patient.

 

Imported products

  • The MA holder will supply the appropriate paperwork with the product, such as the PIL and SPC
  • The importing unlicensed medicine supplier should also provide the batch number and MHRA Import Licence number
  • Products with non-English packaging, may be over-labelled by the supplier. Translated labelling and PILs help ensure the medicine is taken correctly by the patient

Ressources


MHRA Guidance Note 14, The supply of unlicensed relevant medicinal products for individual patients. MHRA, London, 2014

Guidance for the Purchase and Supply of Unlicensed Medicinal Products - Notes for prescribers and pharmacists. NHS Pharmaceutical Quality Control Committee. 3rd edition. June 2004, (superseded by Good Practice in Prescribing Medicines (2013) GMC)

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide). MHRA, London. 2015

The Medicines (Standard Provisions For Licences And Certificates) Amendment Regulations 1999, Statutory Instrument SI 1999/4

Drug Safety Update April 2009 Vol 2 Issue 9. Off-label or unlicensed use of medicines: prescribers’ responsibilities

Handbook of Extemporaneous Preparation. A Guide to Pharmaceutical Compounding 1st Edition. Published 24th May 2010, updated 1st March 2016. NHS Pharmaceutical Quality Assurance Committee

APTUK - Association of Pharmacy Technicians UK 

CofA - Certificates of Analysis

CofC - Certificate of Conformity 

EEA - European Economic Area 

EU - European Union

GDP - Good Distribution Practice  

GMP - Good Manufacturing Practice

HCP - Healthcare Professional 

MA - Marketing Authorisation

MHRA - Medicines & Healthcare products Regulatory Agency 

MRA - Mutual Recognition Agreement

MS - Manufacturing Specials 

NHS - National Health Service 

PIL - Patient Information Leaflet 

PL - Product Licence

QA - Quality Assurance 

QP - Qualified Person

SPC - Summaries of Product Characteristics 

TSE - Transmissible Spongiform Encephalopathies