Select Committee on Health Written Evidence

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[360].

  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 potential risks.

  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 potential risks.

  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 safety?

  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 can be.

  16.  IDIS are therefore seeking the following

    a.  Enhanced regulation to impose greater obligations and improve standards on all suppliers of unlicensed medicines.

    b.  Increased frequency of audits by the MHRA, demanding transparency throughout the supply chain from these suppliers.

    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.

September 2008

360   NSF for Children, Young People and Maternity Services: Medicines for children and young people: Standard 10, 4.1. Back

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