Download - WELCOME
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WELCOME
Sunday 9 June 2013
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Yellow Card Reporting & What it means for Pharmacy
TechniciansAnthony R Cox, Lecturer in Clinical Pharmacy,
University of Birmingham and Pharmacovigilance Pharmacist, Yellow Card
Centre, West Midlands
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Yellow Card Reporting and what it means for Pharmacy Technicians
Dr Anthony R CoxYellow Card CentreWest Midlands
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Benefits
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Regulation (EU) N
o 1235/2010
and Directive 2010/84/EU
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ADR DefinitionDirective 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.
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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.”
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£637 million
Admissions In-patients
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1955 neurological reports passed to company, 1960 Company stated “non toxic”
1961 withdrawn, 90,000 miscarriages, thousands deformed
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LessonsNeed for adequate testingNeed for regulationNeed for pharmacovigilance
systems (spontaneous reporting)
Avoidance of unnecessary use of drugs in pregnancy
Some risks cannot be minimised
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12
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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
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Black Symbol (Triangle)
“This medicinal product is subject to additional monitoring"
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The mean number of people in phase three trials for an NSAID in Europe, in 1994,
was 2128 patients.
Homma. Drug Inj J 1994
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Tim
e
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Patient Reporting
• Different types of reports
• New signals
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Technicians?
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“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
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Some ADRs are easy to spot…
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Where do reports come from
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FRANCIS
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A B C D E F G H I J K L M N O0
10
20
30
40
50
60
70
80
90
100
NHS Acute Trust
ADR
repo
rts
per
100,
000
adm
issi
ons
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Pharmacy should be the main source of Yellow Card Reports.
What is stopping us?
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Email: [email protected]
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Poster prize awards
Supported by
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Parallel Workshops Session E
Please go to the designated rooms
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WELCOMEBACK
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Please switch off your mobile
phones
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My role as a Pharmacy Technician Specialist in
HomecareDiane Meech, Pharmacy Technician
Specialist- Homecare & High Cost Drugs, Ealing Hospital NHS Trust
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
My Role in Homecare
Diane MeechPharmacy Technician SpecialistHomecare and High Cost Drugs
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
Homecare
Aim to support patients with chronic and acute illness in the community
DefinitionA 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.
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
Background 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
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Integrated Care OrganisationIncorporating 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
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Integrated Care OrganisationIncorporating 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
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
MARK HACKETT REPORTA 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.
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
Recommendations forChief 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
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Integrated Care OrganisationIncorporating 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 OrganisationIncorporating 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!
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Integrated Care OrganisationIncorporating 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
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Integrated Care OrganisationIncorporating 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
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
Service level agreements 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
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Integrated Care OrganisationIncorporating 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
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
IT system to manage homecare
Funding request
Approval
Script Registration/
consent
Monitoring of deliveries
Review patientRepeat scripts
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
Patient audits
Communication Delivery times –
choice Delivery on time Customers services
support & compliance Driver attitude Shortfalls & incidents Clinical waste
collection
KPIs
Patients registered Patients on hold Number of invoices Total spend Performance -
deliveries Medicine errors Service failure Invoice errors
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
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/home-healthcare/
home-healthcare-market-reports/guide-to-moving-care-out-of-hospital
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Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow
My CPD to support my role
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
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Integrated Care OrganisationIncorporating 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
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Closing remarks
Steve Acres, President, APTUK
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Thank you
See you in 2014!