Reporting

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Patient Focused Products
Reporting
David Cousins
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What Is Patient Safety?
Patient safety is the freedom from accidental
injury in health care.
A patient safety incident is any unintended or
unexpected incident which could have or did lead
to harm for one or more patients receiving NHS
funded healthcare. This is also referred to as
an adverse event/incident, mistake or clinical
error, and includes near misses.

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ERROR TYPES based on the work of James Reason
Unsafe acts
Skill based errors Memory failures
Skill based errors Attentional failures
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Learning from other safety critical industries

• To minimise patient safety incidents, the NHS
  should learn from other safety-critical
  industries and target the underlying systems
  failures.

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The Importance of Design for Patient Safety
2003 http//www-edc.eng.cam.ac.uk/medical/
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Human factors confront two myths

• The perfection myth.
• If people try hard enough they will not commit
  patient safety incidents.
• The punishment myth.
• If we punish people when they make patient safety
  incidents they will make fewer of them.
• The Seven Steps to Patient Safety.NPSA
• (2003).

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EU DIRECTIVES ON MEDICINE PRODUCTS

• Currently do not require design or user testing
  to
• Take into consideration human factor
  considerations
• Safety in use
• Or pharmacovigilence of these factors which are
  usually classified as user error

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European Initiatives for Improving Medication
Safety

• Committee of Experts
• On Safe Medication Practice
• Council of Europe
• Report 2006

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Forms of NPSA Advice

• A patient safety alert requires prompt action to
  address high risk safety problems
• A safer practice notice strongly advises
  implementing particular recommendations or
  solutions
• Patient safety information suggests issues or
  effective techniques that healthcare staff might
  consider to enhance safety

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NPSA Safe Medication Practice Activity

• Epidural infusions
• Wrong route errors
• Injectable Medicines
• Anticoagulants
• Paediatric Infusions
• Dispensed medicines
• Psychotropic medicines
• Insulin
• Lithium
• Medication histories on admission and discharge

• Potassium chloride
• Oral methotrexate
• Confusing labelling, packaging and presentations
• Vaccines
• Diamorphine and morphine

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Purchasing for Safety

• Risk assessment of products as part of healthcare
  contracting and purchasing.
• Safety before price purchase products with the
  following
• Clear labelling and packaging.
• Well differentiated from similar products to
  prevent misidentification.
• Appropriate secondary and warning labels.
• Bar codes.
• Ready to administer/use or simple preparation and
  administration.
• Adequate information for practitioners, patients
  and carers.

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Diamorphine and Morphine Injections

• Between 2000 and 2005 there have been seven
  published case reports of deaths due to the
  administration of high dose (30mg or greater)
  diamorphine or morphine to patients who had not
  previously received doses of opiates.
• Between January and October 2005, the NPSA
  received 16 reports of similar patient safety
  incidents of which two had resulted in the death
  of the patients.

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Diamorphine and Morphine Injections

• Many of these incidents involved diamorphine and
  morphine 30mg ampoules being selected in error
  for lower strength ampoules and overdoses were
  administered.
• In addition 30mg doses or higher were sometimes
  prescribed as first doses for patients who had
  not previously received doses of opiates and this
  can result in overdose, respiratory depression,
  loss of consciousness and death if support
  procedures are not implemented.

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Problems with labelling
Ampoule Labelling
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Ampoule Labelling
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Repevax and Revaxis Vaccine

• In January 2005 the NPSA received a report that
  93 teenage school children were vaccinated with
  Repevax instead of Revaxis.
• Repevax (diphtheria, tetanus, 5 component
  acellular pertussis, and inactivated polio
  vaccine dTaP/IPV)
• This vaccine is supplied as a pre-filled syringe
  and is administered by intramuscular injection as
  a pre-school booster following primary
  vaccination. The vaccine may be given from the
  age of three years onwards.
• Revaxis (tetanus, diphtheria and inactivated
  polio vaccine Td/IPV)
• This vaccine is supplied as a pre-filled
  syringe. The vaccine may be administered by
  intramuscular injection from the age of six
  years, and may be used for adolescents and adults
  as a booster following primary vaccinations.

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Royal College of Arts / NPSA January 2006
www.npsa.nhs.uk
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Critical Information In The Same Field of Vision
On At Least Three Non-Opposing Faces
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Orientate Text In The Same Direction
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Use Blank Space To Emphasise Critical Information
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Use Colours To Differentiation to Highlight
Information
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Optimum Font Size, Font, and Spacing
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Do Not Use Trailing Zeros
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Use of Tall Man Lettering to Differentiate Look
Alike and Sound Alike Names
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Allocate Space for a Dispensing Label
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Put Medicine Name and Strength Clearly on Each
BlisterUse Non-reflective Foil
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Match Styles of Primary and Secondary Packaging
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Machine Readable Codes On Medicines
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Poor Systems of Use
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Ready to Administer Products
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Conclusion

• It cannot be assumed that all medicine products
  are equally safe in use.
• Risk assessment and purchasing for safety
  initiatives are integral to the NHS Patient
  Safety Strategy
• The NHS should clearly specify to industry the
  patient safety requirements for medicine products
  ( these may exceed those required by the EU
  Medicines Directive)
• NPSA safer practice recommendations will
  increasingly include purchasing for safety and
  supply chain initiatives.