Memorandum by IDIS (PS 59)
1. This submission addresses patient safety
specifically in relation to named-patient medicines, (also known
as unlicensed medicines) their source, supply and use in the NHS.
2. IDIS, founded in 1987, is a major supplier
to the National Health Service and the leading authority in the
sourcing and supply of named-patient medicines on a global basis.
Named-patient medicines are necessarily prescribed for a variety
of diseases and disorders including, cancers, rare genetic disorders,
serious infection and post operative pain relief, most of which
would otherwise go untreated as a result of the lack of availability
of a suitable, licensed alternative. The prescription of named-patient
medicines makes-up almost three quarters of medicines used in
neonatal intensive care units and around one quarter on children's
wards. In paediatric pain management, 33% of medicines are prescribed
off-label and in paediatric gastroenterology, the figure is 49%.
In general practice, at least one in ten medicines prescribed
for children are off-label or unlicensed.
3. From IDIS's perspective there are several
issues that need addressing in relation to named-patient medicines
and patient safety. There is a need to ensure that all named patient
medicines are ethically sourced and supplied and that a formal
risk assessment is carried out at local prescribing level. A recent
World Health Organisation report estimates that sales of counterfeit
drugs will reach $75 billion by 2010, and a recent Healthcare
Commission report, The Best Medicine, highlights
that only 36% of PCTs have a formal robust risk assessment in
place when prescribing medicines on a named-patient basis.
4. Furthermore the MHRA do not audit annually,
collect data or police sufficiently the use of named-patient medicines
in the UK. In recent communications with the MHRA, it has been
clear that importers need only notify the MHRA of their "intention
to import" in order to comply with current legislation. Furthermore,
current legislation excludes the supply of unlicensed medicines
which do not require importation into the UK. IDIS believes this
does not sufficiently protect prescribers and their patients from
5. In summary, named-patient medicines are
a necessary provision for some patients especially children and
patients with life threatening illnesses and as a result are expected
to play an increasingly important role within the NHS as medicines
become more specialist (targeted) and patient expectations and
choice rise. However, at present there exists no formal policy
on the use of named-patient medicines within the NHS and inadequate
regulations in place for their supply.
Response to the Inquiry's specific questions
What are the risks to patient safety and to what
extent are they avoidable?
6. Potential risks to patients through an
inadequately managed or unaudited supply chain include exposure
to counterfeit medicines, adverse events and possibly serious
side effects as a result of a compromise to product stability
or Good Distribution Practice (GDP) and inappropriate prescribing.
7. The MHRA, supported by the Department
of Health, should impose greater regulation on all suppliers of
unlicensed medicines (including those unlicensed medicines that
originate in the UK), expanding supplier obligations in order
to provide a more secure, and therefore, auditable, supply chain.
8. In addition to which, recent MHRA activity,
specifically publishing in the public domain the top 50 unlicensed
imported medicines presents even greater risks to patient safety.
IDIS believes that this practice by the MHRA allows access to
data that can be utilized for suppliers to gain competitive advantage,
potentially commoditizing these specialist medicines. Without
enhanced regulation, the availability of such data further increases
the risk to both patients and the NHS of unsafe medicines through
a weak and unmonitored supply system, open to wholesalers supplying
named-patient medicines without any policing or specialised knowledge.
9. IDIS have set clear industry standards
to minimise patient risk and these should be engrained within
a regulatory process, monitored and policed by the MHRA as our
medicines watchdog, to improve patient safety. We are confident
that IDIS are considered the gold standard in this respect.
10. As a member of the European Alliance
for Access to Safe Medicines, that actively campaigns for the
exclusion of counterfeit and substandard medicines from the supply
chain, we believe there are a number of mechanisms that can be
imposed on importers and suppliers in order to mitigate these
11. Greater awareness needs to be raised
with the public on the dangers and risks associated with the procurement
of unlicensed medicines via internet pharmacies. We are not aware
that this is currently monitored or policed efficiently by the
MHRA and IDIS believes that more should be done to achieve this.
What is the current effectiveness of local and
regional NHS bodies, systems for reporting risk management and
national policy in ensuring patient safety?
12. To inform IDIS's best practice in our
business operations and ensure pharmacists and patients receive
the best quality treatments and information, we undertake regular
focus groups with NHS Trusts, PCTs and Hospital pharmacists. These
focus groups reveal a concerning picture of risk management when
using named-patient medicines.
13. For example, few Trusts across the country
use the same polices for medicines management; there is a major
variation of risk assessment across hospitals including risks
assigned to different named-patient medicines.
14. The Healthcare Commission report Best
Medicines outlined the type of guidance required to improve
risk management when using named-patient medicines, such as maintaining
the level of risk to an acceptable level on both the supply and
patient side. For example the quality of medicine, information
provided with medicines, the security of supply, and the potential
risk to patients such as effectiveness of treatment is essential.
IDIS broadly supports these recommendations but would specifically
like to see our above recommended systems in place to ensure robustness
along with the requirement for reporting.
What should the NHS do next regarding patient
15. In light of the increase in counterfeit
drugs and the need for named-patient medicines, IDIS would like
to see the introduction of a robust regulatory system within the
UK for the sourcing, supply, use and monitoring of named-patient
medicines. IDIS believes that the NHS should be able to rely on
legislation to enable them to provide these important and often
life saving medicines in an environment that is as safe as it
16. IDIS are therefore seeking the following
a. Enhanced regulation to impose greater
obligations and improve standards on all suppliers of unlicensed
b. Increased frequency of audits by the MHRA,
demanding transparency throughout the supply chain from these
c. Ensuring that suppliers involved in the
sourcing and supply of NPMs have a thorough system in place to
provide all relevant documentation in support of full product
traceability and can demonstrate risk mitigation.
d. An approved list of screened, audited
and validated suppliers both importers and UK based.
e. The removal of the top 50 unlicensed imported
medicines from the MHRA website and prevention of the future publication
of any other such data.
17. IDIS therefore urges the committee to
establish an expert working group to take forward the development
of standards and regulation for the source, supply and use of
named-patient medicines in the NHS. We would welcome the opportunity
to come before the committee to answer your questions in relation
to named-patient medicines and to discuss this niche but important
issue in the context of patient safety.
360 NSF for Children, Young People and Maternity Services:
Medicines for children and young people: Standard 10, 4.1. Back