WELCOME
Sunday 9 June 2013
Yellow Card Reporting & What it
means for Pharmacy
Technicians
Anthony R Cox, Lecturer in Clinical Pharmacy,
University of Birmingham and
Pharmacovigilance Pharmacist, Yellow Card
Centre, West Midlands
Yellow Card Reporting
and what it means for
Pharmacy Technicians
Dr Anthony R Cox
Yellow Card Centre
West Midlands
Benefits
ADR Definition
Directive 2010/84/EU
A response to a medicinal product which
is noxious and unintended and which
occurs at doses normally used in man
for the prophylaxis, diagnosis, or
therapy of disease or for the restoration,
correction, or modification of
physiological function.
Directive 2010/84/EU
New to ADR definition:
“not only from the authorised use of a medicinal
product at normal doses, but also from medication
errors and uses outside of the marketing
authorisation, including misuse and abuse of the
medicinal product.”
Admissions
In-patients
 1955
neurological reports passed to
company, 1960 Company stated “non
toxic”
 1961 withdrawn, 90,000 miscarriages,
thousands deformed
Lessons
 Need
for adequate testing
 Need for regulation
 Need for pharmacovigilance
systems (spontaneous
reporting)
 Avoidance of unnecessary use of
drugs in pregnancy
 Some risks cannot be minimised
1
The Black Symbol – article 23
 list of medicinal products that are subject
to additional monitoring
– All medicines with a new active
substance and all biologicals
– Medicines which require further
information after authorisation
– Medicines subject to conditions or
restrictions on safe and effective use
Black Symbol (Triangle)
“This medicinal
product is
subject to
additional
monitoring"
The mean number of people
in phase three trials for an
NSAID in Europe, in 1994,
was
2128 patients
Homma. Drug Inj J 1994
.
Time
Patient
Reporting
• Different types
of reports
• New signals
“Pharmacists lack the knowledge of
clinical medicine necessary to
recognise adverse drug reactions.
However, their knowledge of
pharmacology and toxicology
should ensure a role for them in the
prediction and prevention of
adverse drug reactions”
1986
Some ADRs are easy to spot…
Where do reports come from
F
R
A
N
C
I
S
100
90
ADR reports per 100,000
admissions
80
70
60
50
40
30
20
10
0
A
B
C
D
E
F
G
H
I
J
K
L
M
NHS Acute Trust
N
O
Pharmacy should be the main
source of Yellow Card Reports.
What is stopping us?
Email: a.r.cox@bham.ac.uk
Poster prize awards
Supported by
Parallel Workshops
Session E
Please go to the designated rooms
WELCOME
BACK
Please switch off
your mobile
phones
My role as a Pharmacy
Technician Specialist in
Homecare
Diane Meech, Pharmacy Technician
Specialist- Homecare & High Cost Drugs,
Ealing Hospital NHS Trust
My Role in Homecare
Diane Meech
Pharmacy Technician Specialist
Homecare and High Cost Drugs
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Homecare
Aim
to support patients with chronic and acute illness
in the community
Definition
A homecare medicine service delivers ongoing
medicine supplies, and where necessary,
associated care initiated by hospital prescriber
direct to the patients home with the patients
consent.
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Background
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Market: £1.5 billion +
Growth: 23% per annum
Number of homecare providers: 15+
Often high cost meds / excluded from PbR
 Low tech: tablets and capsules via post or courier
 Medium tech: injections self administered or with
nursing training, cold chain delivery
 High tech: aseptic preparation, nurse
administration and monitoring
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
PAST (2004 to 2011)
 <10 patients increasing to >500 patients,
 1 drug increasing to 5 drugs/specialities:
rheumatology, dermatology, gastroenterology, growth,
oncology, HIV
 Prescription management by band 7/8 pharmacist
 Prescriptions on standard outpatient scripts
 Some service level agreements place
 Service levels not monitored
 By 2010, purchase orders sent with scripts and use of
spreadsheets to track approvals, orders & deliveries
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
PRESENT (2012 to 2013)
 Fulltime Pharmacy Technician Specialist post
 Homecare company prescription templates in use
 All repeat scripts reviewed for compliance with
NICE where applicable
 Liaison with clinical nurse specialists
 Service level agreements reviewed
 Development of IG data security agreement
template
 Standard operating procedures in place
 Medication incidents reported via Datix
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
MARK HACKETT REPORT
A review of the homecare medicines
supply and associated services in
England to establish what are the
current challenges and issues and
what should occur in the future.
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Recommendations for
Chief pharmacists
 Set a strategy for homecare medicines
 Work with clinical directors to agree patient
cohorts and set realistic demand projections
 Ensure development of shared governance
 Ensure effective operational control of
procurement, ordering and invoicing
 Implement changes to enable direct inter-change
with trusts finance system for ordering, invoicing
and patient tracking
 Review services with Medicine & Nurse providers
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
2013 and the future
Develop 3 year strategy
Set up Trust wide homecare group
Agree strategy
Homecare policy and framework
Develop robust governance framework
All service level agreements reviewed and updated
Implementation of new therapies onto homecare,
Hep B, new biologics
 Development of IT system & upgrade of Ascribe
 Complete patient audits & develop patient charter
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Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
3 year strategy
 Where are we now?
 Form trust homecare group
 Priority – implement Hackett report
recommendations
 Identify strengths, weaknesses,
opportunities and threats!
 Our vision for homecare and
implementation of new services - the next
3 years!
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Homecare policy and framework
 Responsibilities of prescribers, nurses,
chief pharmacist, pharmacy support team
 Homecare governance – clinical /information
 Monitoring of arrangements & annual report
 Patient involvement and charter
 Implementation template for new services
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Develop robust governance framework
 Compliance with all relevant regulatory conditions
as would be required by Care Quality Commission
for an Acute Trust
 Set service standards – monitor by KPIs
 Training & development of staff to secure
standards
 Reporting of complaints, incidents, service
failures, medicine compliance
 Effectiveness of the service to the patient
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Service level agreements
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Patient access scheme/Pharma agreement
Delivery and Service
Product Prescribing and Dispensing
Equipment , refrigeration, ancillaries
Training and Education of staff/ patients
Nursing Services
Key performance indicators
Complaints and adverse incidents
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Implementation of new services
 Identify drugs & patient no.s (current /future)
 Risk assessment – financial /health & safety
 Obtain agreement from consultants, CCG, trust
drugs and therapeutics group
 Check if regional contract in place if not
negotiate trust tender (complex)
 Patient access schemes & Pharma agreements
 Agree service level agreement
 Develop inclusion criteria to recruit suitable
patients
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
IT system to manage homecare
Funding
request
Review patient
Repeat scripts
Monitoring of
deliveries
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Approval
Script
Registration/
consent
Patient audits
KPIs
Communication
Delivery times – choice
Delivery on time
Customers services
support & compliance
 Driver attitude
 Shortfalls & incidents
 Clinical waste collection
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Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Patients registered
Patients on hold
Number of invoices
Total spend
Performance - deliveries
Medicine errors
Service failure
Invoice errors
Homecare – more to come
 Overcoming the potential challenges in
relation to implementing out of hospital
care
 Outpatient and home parenteral antibiotic
therapy (OHPAT)
 Virtual ward schemes

http://www.bupa.co.uk/healthcare-providers/homehealthcare/home-healthcare-market-reports/guide-to-movingcare-out-of-hospital
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
My CPD to support my role
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Meetings with chief and principal pharmacists
Hackett report - especially recommendations
NHS toolkit for homecare medicine services
Visit to other trusts
National Medicines Homecare Committee (NMHC)
www.clinicalhomecare.co.uk
Experience as a high school governor - strategies
UCL hospital – draft policy
Commercial Medicines Unit (CMU) guidance
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
My CPD continued
 RPSGB – draft standards for homecare
 AAH award winner 2009 - Patient audit template
 Team building & inspirational leadership – 2013
CPP conference, building teams Mark Kettering
Future ??
 Charted Institute of Procurement level 3 or 4
 Accredited Checking Pharmacy Technician
 Medicines Management Pharmacy Technician
 Certificate in management
Integrated Care Organisation
Incorporating the Community Services of Brent, Ealing and Harrow
Closing remarks
Steve Acres,
President, APTUK
Thank you
See you in 2014!