Baxter International Inc'

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Purchasing for Safety
I M Beaumont Director, Quality Control North
West, Regional Quality Assurance Pharmacist June
2007
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OverviewPurchasing for Safety

• What is it?
• What it is not
• Why do it?
• How to do it
• Future action

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Purchasing for SafetyWhat is it?

• Safeguarding patients
• Reducing medication errors
• Systems to
• Select products with low potential to lead to a
  medication error
• Inform users when risks are unavoidable

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Purchasing for SafetyIt is not

• Restrictive practice
• Therapeutic substitution

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Purchasing for SafetyWhy do it?

• Improve patient safety
• Reduce incidence of medication errors by
  introducing an error trap
• Assessment of potential risks associated with
  the labelling and packaging of products should be
  a routine part of NHS procurement processes
  Building a Safer NHS For Patients Improving
  Medication Safety DoH Jan 2004
• Required by NPSA Safety Alert 20!
• The NPSA recommends that policies advocate the
  purchase of injectable medicines that
• Include technical information about how they
  should be prepared and administered
• Are designed in such a way as to promote safer
  practice

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Purchasing for SafetyHow to do it?

• Implement policies
• Include Medication Error Potential
• Assessment (MEPA) in all medicines
• procurement
• Assess the quality of all unlicensed
• medicines before purchase

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Medication Error Potential Assessment (MEPA)

• Risk assess products into high, medium, or low
  medication error potential.
• Not buy lowest price
• High or medium risk products not awarded
• contracts where possible
• Inform users via Medication Safety Bulletin
• Communicate to MHRA, NPSA, and
• manufacturer
• Coordinated nationally
• PharmaQC database

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• Aide Memoire
• Semi-quantitative
• Likelihood score
• Consequence weightings
• Review recorded medication errors
• Overall risk assessment score
• Low 0-99
• Medium 100-249
• High 250 and above

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• Assessment of technical information
• E.g. compatibility/stability data for aseptic
  products
• Use in children
• Unknowingly use outside licensed indications
• Poor/insufficient technical data
• Assessment of presentation
• Images requested from suppliers
• All products, but especially Potassiums,
  concentrates, intrathecals, Parallel imports,
  injections for critical care areas, products for
  aseptic units, those with history of medication
  errors (CIVAS database), products stored
  adjacent, similar sounding or similar looking
  names.

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• Incorrect dose due to manipulation
• Ready to administer/use
• Confusion with another product
• Poor labelling of critical information
• Poor label/pack design
• No substitute for carefully reading label
• Packaging design appearance
• Different strengths of same product
• Different products from same manufacturer
• Products adjacent on shelves
• Confusing drug names, labels and packaging
• Sound-alike names
• Look-alike names lead to selection of wrong
  product
• Small fonts/similarity of labels on ampoules
• Blister strips/vials removed from outers
• When removed from outer packaging

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• Product quality fitness for purpose
• Suitability of container, e.g. pvc/non-pvc
• Dissolution characteristics
• Displacement value for powders
• Formulation and stability data diluents,
  containers, other drugs, temperature
• Ease/method of opening
• Different vial sizes for different strengths
• Absence of visible particulate contamination
• Printing of batch no. stable if swabbed

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Unlicensed Medicines

• Trust Policy
• Product specifications
• Clinical assessment
• Procurement assessment

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Purchasing for SafetyFuture action

• Implement policies for medication error potential
  risk assessment of all licensed and unlicensed
  medicines procured outside NHS contracting
  systems.

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Some useful references/websites

• Building a Safer NHS for Patients. Improving
  Medication Safety. Dept. of Health 2004
• Information design for patient safety. Helen
  Hamlyn Research Centre (Royal College of Art)NPSA
  2006. http//www.hhrc.rca.ac.uk/resources/publica
  tions/IDPS.pdf
• Best practice guidance on labelling and packaging
  of medicines. MCA (now MHRA) December 2002
• Quality assurance and risk assessment of licensed
  medicines for the NHS. NHS Pharmaceutical QA
  Committee. 1st Edition June 2004
• Guidance for the purchasing and supply of
  unlicensed medicines. NHS Pharmaceutical QA
  Committee. 3rd Edition June 2004
• www.qcnw.nhs.uk
• www.nelm.nhs.uk/qa/default.aspx