WELCOME

Sunday 9 June 2013

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

Yellow Card Reporting and what it means for Pharmacy Technicians

Dr Anthony R CoxYellow Card CentreWest Midlands

Benefits

Regulation (EU) N

o 1235/2010

and Directive 2010/84/EU

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.

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.”

£637 million

Admissions In-patients

1955 neurological reports passed to company, 1960 Company stated “non toxic”

1961 withdrawn, 90,000 miscarriages, thousands deformed

LessonsNeed for adequate testingNeed for regulationNeed for pharmacovigilance

systems (spontaneous reporting)

Avoidance of unnecessary use of drugs in pregnancy

Some risks cannot be minimised

12

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

Tim

e

Patient Reporting

• Different types of reports

• New signals

Technicians?

“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

FRANCIS

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

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

WELCOMEBACK

Please switch off your mobile

phones

My role as a Pharmacy Technician Specialist in

HomecareDiane Meech, Pharmacy Technician

Specialist- Homecare & High Cost Drugs, Ealing Hospital NHS Trust

Integrated Care OrganisationIncorporating the Community Services of Brent, Ealing and Harrow

My Role in Homecare

Diane MeechPharmacy Technician SpecialistHomecare and High Cost Drugs

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.

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

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

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

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.

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

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

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!

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

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

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

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

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

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

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

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

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

Closing remarks

Steve Acres, President, APTUK

Thank you

See you in 2014!