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“What’s so special about Specials?”. A personal perspective. DDA Conference 2010 Windsor. Legislative Framework. The Derogation. Article 5.1 in Directive 2001/83/EC

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what s so special about specials

“What’s so special about Specials?”

A personal perspective

DDA Conference 2010


John Bardsley MRPharmS

the derogation
The Derogation

Article 5.1 in Directive 2001/83/EC

“A member state may, in accordance with legislation in force and to fulfil special needs, exclude from the provision of this directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised Healthcare Professional and for use by an individual patient under his direct personal responsibility”

sector product


Reformulations or manipulations of existing licensed products

Extemporaneous preparations

Novel uses for existing actives

Sector Product


GMC Guidance

You can prescribe unlicensed medicines but, if you decide to do so, you must:

Be satisfied that an alternative,

Licensed medicine would not meet the patient's needs.

Be satisfied that there is a

sufficient evidence base

and/or experience of using the

medicine to demonstrate its safety and efficacy.

Take responsibility

for prescribing the unlicensed medicine and for overseeing the

patient's care, including monitoring and any follow up treatment (see also paragraphs 25-27 on prescribing for hospital outpatients)

Record the medicine prescribed and

, where you are not following common practice,

the reasons

for choosing this medicine in the patient's notes.

John Bardsley MRPharmS


GMC Guidance (Cont)


Responsibility for prescribing medicines for hospital outpatients

Where a patient's care is shared between clinicians, the doctor with the


for the continuing management

of the patient must be fully competent to exercise

their share of clinical responsibility. They also have a duty to

keep themselves informed

about the medicines that are prescribed for their patient. They should take account of

appropriateness, effectiveness and cost when prescribing any medicine. They should


keep up to date

with any relevant guidance on the use of the medicine and on

the management of the patient's condition.

John Bardsley MRPharmS


GMC Guidance (Cont)


Responsibility for prescribing medicines for hospital outpatients

If you are the doctor signing and issuing the prescription

you bear responsibility for

that treatment

; it is therefore important that, as the prescriber, you understand the

patient's condition as well as the treatment prescribed and can recognise any

adverse side effects of the medicine should they occur.

There should be

full consultation and agreement

between general practitioners and

hospital doctors about the indications and need for particular therapies. The decision

about who should take responsibility for continuing care or treatment after initial

diagnosis or assessment should be based on the patient's best interests rather

than on the healthcare professional's convenience or the cost of the medicine.

John Bardsley MRPharmS

how do i know it is unlicensed
How do I know it is unlicensed?
  • Check BNF/ Paediatric BNF
  • Check MIMS
  • Check with Royal Pharmaceutical Society info team

(usually no need to be a pharmacist)

  • Check prescribing software
  • Non DT tariff items are usually unlicensed medicines
  • Check with a reputable specials provider

How do we know we are prescribing an unlicensed medicine?

  • Pharmacists have an obligation to ensure that a product with a valid MA is supplied where such a product exists in a suitable formulation and is available, in preference to an unlicensed product or food supplement
  • Pharmacists have a professional responsibility to ensure that the prescriber is aware of the unlicensed nature of any Special dispensed. This requirement is detailed in MHRA Guidance Note 14: The Supply of Unlicensed Relevant Medicinal Products for Individual Patients 2008. (http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con007547.pdf)

John Bardsley MRPharmS


RPSGB Guidance for pharmacists

The pharmacist should also inform the patient that a medicine is being supplied without a marketing authorisation or is being used outside of marketing authorisation. This should be done without undermining their confidence in the prescriber or the medicine, moreover to discuss the reasoning behind the prescribing decision and advise the patient to report any adverse effects to their prescriber.

hierarchy of risk on basis of product origin adapted from mhra guidance
Hierarchy of risk on basis of product origin(adapted from MHRA guidance)

Preferred Choice

Lowest Net Risk

UK-licensed medicine

Off label use of a UK-licensed medicine

An imported product licensed in the country of origin

A UK manufactured special made in MHRA licensed facilities

A Section 10 extemporaneously dispensed medicine

An imported product not licensed in the country of origin

A non-UK-made unlicensed medicine or food supplement

Last Choice

Highest Net Risk

Hierarchy may differ in particular patient groups such as neonates

how do we procure an unlicensed medicine
How do we procure an unlicensed medicine

An effective SOP is key

  • Demonstrates that the practice understands the need to define a process
  • Provides an aide memoire and steer within a defined decision tree

John Bardsley MRPharmS

specials providers
Specials Providers
  • Traditional Providers

John Bardsley MRPharmS

specials providers1
Specials Providers
  • Traditional Providers
  • MHRA licensed specials manufacturers

John Bardsley MRPharmS

choosing a suitable product
Choosing a suitable product

A certificate of conformity is a signed statement by the manufacturer that they believe the product complies with the purchaser’s specification and should be available for all specials produced by an MS holder.

A certificate of analysis should be available for any batch manufactured special manufactured under a MS and is evidence that critical parameters have been confirmed by retrospective physical, chemical or microbiological assay of a sample of the final product.

specials providers2
Specials Providers
  • Traditional Providers
  • MHRA licensed specials manufacturers
  • MHRA licensed importers

John Bardsley MRPharmS


Importing unlicensed medicines into the UK

Importers of unlicensed medicines into the UK are required to hold appropriate licences:

  • Wholesale dealer’s licence - if importing from EEA country (EU + Norway, Iceland, Liechtenstein); or
  • Manufacturer’s ‘Specials’ Licence – if importing from non-EEA country.

Importers must comply with obligations set out in The Medicines for Human Use (Manufacturing, Wholesale dealing and Miscellaneous amendments) Regulations 2005 (SI 2005/2789).


Transmissible Spongiform Encephalitis (TSE) regulations

All manufacturers, importers and exporters of unlicensed medicines must comply with the TSE regulations to minimise the risk of transmitting animal spongiform encephalopathy from use of unlicensed medicines administered to humans. The guidance is defined in The Medicines (Standard Provisions for Licenses and Certificates) Amendment Regulations 1999 (SI 1999/4).

Counterfeit Medicines!

specials providers3
Specials Providers
  • Traditional Providers
  • MHRA licensed specials manufacturers
  • MHRA licensed importers
  • Wholesale dealers specialising in unlicensed medicines

John Bardsley MRPharmS


Be complete (e.g. postcode)

  • Reference the Rx (Patient confidentiality/consent)
  • Be specific
  • Active, strength, form.
  • Manufacturer?
  • Formulation? (e.g. St. Johns)
  • GMP/GDP compliant?
  • Will the product be accompanied by the relevant quality documentation?
  • Shelf life required?
  • Is a PIL available/required? (counselling resource?)
  • Is the order legislatively compliant?


The following records MUST be kept for FIVE years:

· Source of product

· Person to whom it was supplied

· Date of sale or supply

· Quantity of each sale or supply

· Batch number of the product

· Details of any adverse drug reactions to the product sold or supplied

of which he/she is aware


Reporting adverse drug reactions (ADRs)

All healthcare professionals have a professional obligation and the responsibility to help monitor the safety of medicines in clinical use. Any suspected adverse reactions must be reported to the MHRA through the Yellow Card Scheme, stating the manufacturer and an indication that the product is unlicensed (http://yellowcard.mhra.gov.uk/ ).

Manufacturers of unlicensed medicines have a mandatory requirement to report suspected ADRs electronically. Where this is not possible, a paper report form must be sent to the MHRA. (Please visit the MHRA website for further details.)


Reimbursement of dispensed unlicensed medicines

(excludes category E items)

Dispensers are advised to endorse prescriptions for unlicensed medicines fully with the following information:

  • Name of product
  • Trade price (before discount and excluding VAT)
  • Pack size
  • Manufacturer’s name / supplier’s details.
  • Out-of-pocket expenses
  • DNG?

Out of pocket expenses

(FP34D and FP34PD)

This area is for you to tell the PPA the total amount you’re claiming for ‘out of pocket expenses’ so that we can capture the information more accurately and efficiently. For auditing purposes, you will still need to endorse your prescription forms. You can claim ‘out of pocket expenses’ for any exceptional costs you have been charged when ordering a drug or appliance. But the cost of the product supplied must not be included in the claim. The Drug Tariff Part II, Clause 12, provides the detail on which products are eligible for claims for out of pocket expenses.





Incumbent Specials Supplier

specials providers4
Specials Providers
  • Traditional Providers
  • MHRA licensed specials manufacturers
  • MHRA licensed importers
  • Specialist wholesale dealers
  • “RPP-only” Wholesalers!

John Bardsley MRPharmS

sector interventions
Sector interventions
  • DoH Margin analysis
  • BSA - Fraud
    • Endorsements
    • Collusion
    • Variable pricing
  • Drug tariff proposals
  • Local interventions

John Bardsley MRPharmS



  • Be confident that an unlicensed medicine is essential for your patient, both when prescribing and dispensing
  • Scrutinise your suppliers licenses and received product quality
  • Ensure your dispensing practice is fully compliant from a regulatory perspective and you have all the documentation you need
  • Familiarise yourselves with the supportive resources and organisations available to you
  • Be conscious of the relationship between elevated discount offerings and consequent invoice values
  • Be sure you can robustly justify your specials purchasing in terms of your patients outcomes

John Bardsley MRPharmS


My thanks to you all


John Bardsley MRPharmS


Spare/Reserve Slides

John Bardsley MRPharmS

mhra review of unlicensed medicines
MHRA review of unlicensed medicines
  • MHRA ambition is almost entirely product quality and patient safety
  • In addition to any wider associated legislation, the MHRA currently directly exercise the following controls over the prescribed “unlicensed” sector product operators
    • Licensing and inspection of Wholesalers
    • Licensing and inspection of Manufacturers
    • Approval of Import notifications
  • The purpose of the review is to seek stakeholder views on possible reform
  • The regulator is exposed in the following key respects
    • There is no assurance that UK prescribing of unlicensed medicines is entirely within the constraints of the derogation
    • Full visibility of imported medicines only
    • MS holders licensed as quality organisations but no active control over what is being manufactured
    • No consistency of patient and prescriber information or education around products used within the UK
mhra review of unlicensed medicines1
MHRA Review of unlicensed medicines
  • Objectives include;
    • Update and strengthen professional guidance and accountability
    • Revamp archaic import notification process
    • Harmonise import notification with UK specials
    • Improve MHRA visibility and control around UK GMP “specials”
review of unlicensed medicines
Review of Unlicensed Medicines

Various proposals put forward

  • Notify MHRA for each product made
  • Have a “positive” list for free manufacture
  • Include patient leaflets and standard pack label design information
  • Regulatory compliant provision of translations for imported medicines
  • Defined specific pharmacovigilance requirements
review of unlicensed medicines1
Review of Unlicensed Medicines
  • Currently under assessment
  • Next round of public consultations due early 2011
    • Seek comments from all stakeholders including prescribers
  • Unsure of what final proposal looks like
  • Maybe introduced 2012
  • http://www.mhra.gov.uk/Howweregulate/Medicines/Reviewofunlicensedmedicines/CON018138



Specials Direct

(Dispensing solution)