7 years of operational success in Belgium

The experience of a National Pharmacy Association with AEGATE

Jan Saevels, Scientific Director APBBelgian association of community pharmacists

Aegate Safe Medicine Eco-Partner Symposium

• APB = Association Pharmaceutique Belge = Algemene Pharmaceutische Bond• National federation of professional associations of independent community pharmacies• Representing >90% of independent pharmacies and >80% of all community pharmacies in Belgium• Role: support, develop and promote the community pharmacist ‘s added value to the benefit of the patient’s health• Staff : 120• Brussels

Table Of Content

• Introduction of medicines pack serialisation in Belgium, legislation and outcome• Why did APB enter into a collaboration with Aegate?• How do Aegate and APB work together?• The Aegate APB experience

Introduction of medicines pack serialisation in Belgium, legislation and outcome

2004: Introduction serialisation reimbursed products

• UBC “Unique Bar Codes”• Government measure against reimbursement fraud• Expected savings: 6 million Euro per year -> never proven• Manufacturers obliged to submit the released UBC’s to the reimbursement

authorities after their release to the market.• Reimbursement authorities admit the control system is ineffective

2004: Introduction serialisation reimbursed products

Why did APB enter into a collaboration with Aegate?

APB’s focus on quality and safety

• The Belgian Pharmaceutical Practice Law has granted the pharmacist with « NO FAULT responsibility »

• Medicines Control Laboratory: Independent quality control lab, operated by APB in conjunction with the National Drug Regulatory Agency

• Operates centralised recall procedure on behalf of MCL, DRA or the manufacturer• 2014: 134 batches (of 45 products) recalled

Extra layers of patient safetyat the point of dispensing

• Recall warnings• Expiration date warnings• Patient counselling messages• Medicines authentication• …

Recall warnings

• All product recalls are communicated to the Belgian pharmacists by APB• Classic communication channels do not prevent that recalled products still reach the

patient– Time lack between decision, communication, reaching the pharmacist– Pharmacist can still forget to take the product from the shelf

• Aegate offers the possibility to start the recall communication the moment the decision is made

• Pharmacist automatically alerted the moment he is at the point of dispensing a recalled product

Recall warnings

• All product recalls are communicated to the Belgian pharmacists by APB• Classic communication channels do not prevent that recalled products still reach the

patient– Time lack between decision, communication, reaching the pharmacist– Pharmacist can still forget to take the product from the shelf

• Aegate offers the possibility to start the recall communication the moment the decision is made

• Pharmacist automatically alerted the moment he is at the point of dispensing a recalled product

Expiration warnings

• Current packs: no machine readable expiration dates• All expiration dates need to be checked visually -> time consuming and error risks• When Aegate receives the tags from the manufacturer to download into the Aegate

database, UBC’s can be linked to expiration dates• Pharmacist automatically alerted the moment he is at the point of dispensing an

expired or almost expired product

Patient counselling messages

• APB: own product information system (DelphiCare®), integrated in all dispensing softwares in Belgium.

• DelphiCare®: scientific information on the products and clinical decision support (including contra indication, alerts, incompatibility alerts, etc…)

• APB finds the Aegate messaging capability complementary because of:– Real time communication (communication over short periods of time)– Communication is always done at time of dispense (until filtered)– Possibility of 2 way communication

Patient counselling messages

• APB: own product information system (DelphiCare®), integrated in all dispensing softwares in Belgium.

• DelphiCare®: scientific information on the products (including contra indication, alerts, incompatibility alerts, etc…)

• APB finds the Aegate messaging capability complementary because of:– Real time communication (communication over short periods of time)– Communication is always done at time of dispense (until filtered)– Possibility of 2 way communication (internet connection)

• APB wanted to avoid that the authentication requirement would increase the costs for the pharmacist and impact his workflow

• By choosing early on Aegate as an authentication partner APB believes it has created a strong position for the pharmacists in the negotiations between stakeholders for selecting an authentication service provider

Preparation for the authentication requirement

How do Aegate and APB work together?

Aegate Confidential18

APB has direct access to the Aegate system for Recall warnings and new product information

• All messages displayed in the Aegate system are first submitted to a panel of 20 pharmacists member of APB

• Panel is anonymous to Aegate and industry• Panel members change over time• Panel gives advice on content and format

Advisory panel for counselling messages created by the industry

Monthly reporting

Pharmacy Status:

Pharmacy Status Total to date Number Actively Scanning 2483

Monthly reporting

Product Status:

Product Status Cumulative total

to date

Companies who have joined 19

Number of recalled Product Notifications 777

Products that can be authenticated 1845

Recalled product notifications that are currently live 130

Special Messages added 1533

Total unique pack IDs in database (million) 125.28

Monthly reporting

Safety Notifications delivered to Pharmacies:

Safe. Notif. Deliv. Pharmacies Last 12 months

(to date) Already Dispensed Elsewhere (Distinct Packs) - Warnings* 276

Items Authenticated 630669

Notification that the item has been recalled (Distinct Packs) 815

Notifications that an Item has Expired (Distinct Packs) 723

Warning that packs are soon to Expire (Distinct Packs) 528

Monthly reportingSystem Performance:

System Performance Mean Response

Time, 12 Months

Pharmacy End to End response time (Average) 184 ms

2006 2007 2008 2009 2010 2011 2012 2013 2014 20150

100

200

300

400

500

600

700Average response time by year

Resp

onse

Tim

e (m

s)

Quarterly meetings

• Feedback from members• Future projects and services shaped together• Common communications• FMD status and Belgian stakeholder position

The Aegate APB experience

Multiple scan events

• Aegate notifies APB immediately when a suspicious multiple scan event occurs• Aegate conducts an investigation and informs APB and the manufacturer on the

outcome • Manufacturer decides on action steps in consultation with reimbursement

authorities and APB• All events are handled swiftly by Aegate• This results in:

– Savings for the pharmacist: who is otherwise at risk of not getting reimbursed– Savings for the industry: who is otherwise always obliged to do a full recall– Extra patient safety

• On 2nd of December 2014 Aegate received a multiple scan alert on their system. A unique barcode on an antibiotic from a top ten pharmaceutical company was being scanned in 5 different pharmacies.

• The Belgian Aegate team immediately started an investigation and discovered that an entire batch was labelled with the same barcode. They promptly informed the manufacturer and the Belgian pharmacy association (APB).

• Reimbursement authorities (RIZIV/INAMI) were contacted and measures were taken to re-label the remaining products of the concerned batch.

• It took less than 8 hours from the first multiple scan to the resolution of the issue.

Outcome of a recent multiple scan event

Recalls

• In 2014 the Aegate system prevented the dispensing of 815 recalled packs, possibly preventing serious harm to the patient.

• Without the Aegate system in place these packs could have reached the patient.

Aegate Confidential

Antibiotics awareness campaign

Conclusions

• APB supports the Aegate system because:– it doesn’t impact the workflow of the pharmacist– It comes free of charges for our members– It brings added value through recall warnings, expiration warnings and counselling messages– The system is simple, user-friendly and flexible, whilst effectively increasing the safety of our

patients

THANK YOU !jan.saevels@apb.be