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Medicines Shortages
The Patient Safety View
Dr David Cousins
Associate Director
Safe Medication Practice and
Medical devices
1 NHS | Presentation to [XXXX Company] | [Type Date]
Domain 5 Patient Safety
The Top Down – Bottom Up Approach To
Patient Safety
NHS Commissioning Board
National Patient Safety Agency
NRLS Analysis
Identifying National Risks and Actions
Quality
improvement
methods
Quality
improvement
methods
Local
National
Local
National
Organisations – Identifying Local Risks and Actions Implementing and Evaluating National and Local Initiatives
Local
NRLS medication incidents 2005 - 2010
Cousins D, Gerrett D, Warner B. Br J Clin Pharmacol. 2012
22nd June 2012
Lives put at risk by shortage of drugs, NHS leaders
warn
Four in five NHS trusts in England and Wales say patients are suffering
“unacceptable” delays for drugs to treat life-threatening conditions
including cancer, Parkinson’s disease, schizophrenia and organ failure.
survey of 60 NHS authorities found that the shortage was doing
patients “serious harm”, with some having to be admitted to hospital
for emergency treatment after they were unable to get their medicines
Foreign anaesthetic alternatives
Water for humidifiers
• There was no stock of respiratory water to humidify
breathing systems. Pharmacy stores were contacted and
stated that there was a national shortage and that this
problem had been known about for the last two weeks.
There was an enquiry as to whether their were any
alternatives and the answer was no.
• This is a serious clinical risk as the water is needed to
humidify patients on ventilators and breathing systems to
prevent blockage of their airways.
• The problem should have been relayed sooner. Interim
measure of using bottled sterile water. Underlying causes:
Shortage of supplies, poor communication in alerting the
ward to the problem.
Thiopentone given instead of augmentin
• Due to the national shortage of thiopentone, our usual
protocol of drawing up and labelling thiopentone prior to a
shift was changed to not drawing up thiopentone.
• A category 1 section was called. After transferring the patient
onto the operating table the AAGBI monitoring was attached
and the level of block was confirmed as a T2 sensory block .
As required by the change in protocol of administrating IV
Augmentin , IV Augmentin was administered immediately
prior to knife to skin and shortly afterwards Dr R noticed the
patient was unresponsive.
Wrong dose of IV diazepam
• Child in status epilepticus - jerking and twitching movements
lasting longer than 10 minutes. Staff contacted the Neuro
SHO who came to review the patient .
• Originally prescribed dose of IV Lorazepam but there was no
Lorazepam in the hospital, due to a national shortage, so IV
Diazepam was prescribed
• The doctor prescribed 17mg of Diazepam. The dose given
should have been 5.3mg (300 micrograms / kg).
14
Shortage of IV esmolo
• A patient on the ward was prescribed esmolol IV to run at 50mcg / kg 2.5gm in 250 ml ( patient weight 86kg ). Due to underlying renal failure
and issues of fluid intake , the doctors did not wish to use the weaker
solution.
• Pharmacy supplied 2.5gm ampoules on 17th December , 2 of which
expired in November. Pharmacy were not able to supply any other
ampoules due to a national shortage of the drug.
• We were asked to return the expired ampoules to pharmacy, which were
in the possession of the Consultant. The Consultant on call for the
weekend wished to use the ampoules supplied by pharmacy if they were
the only ones in the Trust . The Assistant Chief Pharmacist said it would
be an SUI if those ampoules were used
Medicine not available
• Patient prescribed sinemet slow release, our pharmacy is
out of stock, they say due to a national shortage of the
medication. The patient has therefore missed out on 8 days
doses so far. Medical staff are aware.
• Patient admitted to ED Resus, ICU reg attended patient and
requested Sodium Bicarbornate 1.26% infusion . No soda
bic in department apart from 2x 500ml 1.4% which was out
of date. Patient treatment delayed as had to ring other wards
for soda bic . Also out of IV lorazepam, same patient fitting
unable to give prescribed drug.
Shortage of heavy marcain
• Informed by Directorate Pharmacist of national shortage of
Heavy Marcaine. No additional stock to be received by the
Trust until weeks in the future. Current stock level is
approximately 100 ampoules across all theatre sites.
• This drug is used for neuraxial anaesthesia predominantly
within the Obstetric operating theatre for caesarian sections ,
retained placenta and suturing procedures.
• Concerns pertain that if a shortfall of this drug is realised due
to the shortage that potential patient care can be affected as
general anaesthetic would have to become the primary
option for anaesthetic, this then presents a staffing issue due
to the need for recovery of patients and appropriately trained
personnel.
The Pharmaceutical Journal 11th September 2012; 289: 306
Failure Modes and Effects Analysis
Risks known via the NRLS
FMEA – criticality scores
Criticality score = severity x frequency x detectability
100
=
5
x
5
x
4
In total there were 61 failure modes identified and
scored for the fourteen process steps for
managing medicine shortages.
Risks with highest criticality scores
High criticality scores by process
Risk assessment of alternative products
Risk assessment checklist for alternative
Hospital procedures for managing
medicines shortages
• No national NHS procedure for managing medicine
shortages
• Relatively few hospitals have written procedures
• NHS South-West trialling a regional approach to managing
shortages
• An electronic tool to gather and disseminate information
on medicine shortages in the region
• A risk assessment tool provides a ‘traffic light’
classification for medicine shortages.
Internal communications
• Multidisciplinary hospital steering group to manage medicine
shortages (more involvement/oversight of senior staff)
• Regular medicines shortages briefing
• Use of verbal, written and electronic methods to advise
doctors, nurses and pharmacy staff of medicine shortages
issues
• Alternative products, prescribing, storage, storage,
preparation, administration and clinical monitoring issues
External communications - NHS
• Gaining information externally about the extent and length of
the medicine shortage is problematic and information is
often incorrect and even misleading.
• Occasional briefings from the DH Commercial Medicines
Unit
• www.uclhsolutions.com
• Regional NHS medicines procurement leads also provide
proactive and reactive information and advice on medicines
shortages
• These solutions are informal at best and rely on good quality
information from the manufacturers which is not always
available.
External Communications - Industry
• Pharmaceutical manufacturers and wholesalers also appear
to have ad hoc systems to communicate with hospitals
concerning medicine shortages.
• It is usually unclear to customers which department, or
individual they should contact to obtain accurate information
about medicine shortages.
• Pharmaceutical manufacturers and wholesalers need to do
more to clarify a single point of contact on medicine shortage
issues for their customers.
External Communications - USA
• ASHP – Medicines shortages site
www.ashp.org/DrugShortages/Current/
• FDA – Medicines shortages site
www.fda.gov/Drugs/DrugSafety/DrugShortages
• These sites including information on current shortages and
resolved shortages as well as other information for example
information for patients and consumers. Hospitals and others
can review and share information about medicines shortages
on these sites.
• Although it is often not possible to predict when
medicine shortages will occur;
• effective processes for dealing with them and
communicating internally and externally can be
defined beforehand;
• we can all improve our systems to better manage
medicine shortages.