Transcript Why do we set up a QCS?

Briefing to Pharmaceutical
Manufacturers and Suppliers
Chief Pharmacist’s Office (CPO) &
Pharmaceutical Supplies Services Team (PSST)
Hospital Authority
Welcome
Aim
 Explains HA’s :
 Objectives
 Procedures
 Plans
on managing pharmaceutical quality and
procurement
 Communicate to improve cooperation
Topics
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Introduction
Product selection
Product Procurement
Product Use
Product Supplies
Upcoming Plans
Introduction
Chief Pharmacist’s Office (CPO)
Organization Structure of HA’s
Pharmaceutical Service
Chief Executive
Director (Cluster Services)
Chief Pharmacist’s Office
(Chief Pharmacist)
Senior
Pharmacist
Senior
Pharmacist
Corporate
Pharmaceutical
Management
Pharmacy Practice
Management
Senior
Pharmacist
Professional &
Clinical Service
Development
7 Clusters
Pharmacy Service
Coordinators
(Public Hospitals &
Clinics)
Senior
Pharmacist
Special Services
Development
Roles of CPO
 Advise on pharmaceutical matters
 Steer the directions on pharmaceutical service
 Lead the development and monitor standards
and quality
 Support and develop IT systems and applications
 Establish and monitor drug quality, standards and
selection
 Promote and enhance efficacious, safe and costeffective use of drugs
Corporate Pharmaceutical
Management
 Objectives
 to ensure 5 Rights
 right drug
 right quality
 right source
 right purchasing channel
 right price
Cluster Services Division
Business Support Services (BSS)
Organization Structure of HA’s Business
Support Services department
Chief Executive
Director (Cluster Services)
Chief Manager (Business
Support Services)
Other BSS
functional Sections
Procurement and Materials Management Section
Procurement
Team A
IT products &
Services
Procurement
Team B
Medical
Consumables
Procurement
Team C
Services & Food
Procurement
Team D
Medical
Equipment
Procurement
Team E (PSST)
Pharmaceuticals
Pharmaceutical Supplies Services
Team
Chief Supplies Officer
Stephen LEE
Unit E1
Unit E2
Unit E3
Unit E4
Vivian LAW
LAU Chun Loy
Claudia NG
Natalie WU
Product Selection
Product Registration
 Safety
 Efficacy
 Quality
HA
 Safety and efficacy demonstrated by
proprietor through clinical trials at R&D,
evaluated by Drug Advisory Committee
(DAC), monitored by Drug Utilization
Committee (DURC), and managed by the
Drug Formulary (HADF)
 Quality evaluated by Drug Selection
Committee (DSC) and CPO
Patented Proprietary Products
 Single supplying source
 Use defined by clinical needs
 Product quality criteria :
 Manufacturing quality
 GMP
 Product Registration
evaluated by CPO
Multi-source Products
 Drug clinical use established
 Product quality criteria :
 Manufacturing quality
 GMP
 Product registration
 Clinical application
 Interchangeability
evaluated by Drug Selection Committee (DSC)
Product Quality Requirements
 Joint Procurement Policy with
Department of Health
 Applicable to all pharmaceutical
products used in HA
 Require documentary evidence on :
 Manufacturer
 Product
 Local Supplier
Manufacturer Information
Documentary Evidence
Certified true copy of
Pharmaceutical
Manufacturer’s License,
indicating compliance with
GMP*
*Separate GMP compliance documents may be
required if status not manifested on submitted
Manufacturer’s License
Use
Confirms valid
manufacturing
status of
manufacturer
Product Information
Documentary Evidence
Use
Certified true copy of Certificate Confirms valid local
of Drug/Product Registration
product registration
Master formula, method of
assay, finished product
specifications and stability data
Certificate of analysis
Confirms product
particulars, product
presentations, facilitate
laboratory testing
Certified true copy of marketing Confirms valid product
authorization issued by ICH
registration in
member countries, PRC,
recognized countries
Australia or Canada *
* Applicable for multi-source purchase
Supplier Information
Documentary Evidence
Use
Certified true copy of
Confirms valid
relevant licences (e.g.
status as
Wholesale Poisons Licence) supplier
Product recall system
Ensures proper
recall system
in place
Product Sample
 Actual sales pack must be provided
 Essential for evaluation and logging of
product details
Change in Product Particulars
 Relevant documentary evidence(s)
corresponding to the concerned
change(s) are required
 Statutory approval essential
 Advance notice to CPO on change
details and timeframe
IT
 Logging of essential manufacturing
and product information to facilitate :
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Ordering and receipt
Prescribing
Dispensing
Use
 Discrepancies in delivered product
versus logged details would result in
refusal of acceptance
Product Patents
 Respect Intellectual Properties
 Request to provide product patent
information as necessary
 Ad-hoc enquiry
 Tender / SQ requirements
Product Procurement
Drug Procurement Channels
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Bulk Supplies Contract through
Tender
Standing Quotation
Direct Purchase
Procurement Channels Analysis
Proportion by No. of Items (07/08)
Standing
Quotation
603 (19.3%)
Bulk Supplies
Contract
634 (20.3%)
Direct
Purchase
1,702 (54.5%)
Other
185 (5.9%)
Procurement Channels Analysis
Proportion by Expenditure (07/08)
Standing
Quotation
575.30 (20.8%)
Note: Expenditures in Million HK$
Direct Purchase
203.49 (7.4%)
Other
5.99 (0.2%)
Bulk Supplies
Contract
1979.47
(71.6%)
Bulk Supplies Contract
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For items with large consumption or
common use
Through tendering:
–Single tender: Patented proprietary
products
–Open tender: Off-patent products
(tender notice posted in www.ha.org.hk)
Governance
 Guidelines
 Worldwide:
 World Trade Organization (WTO)
 In-house:
 Procurement & Materials Management
Manual (PMMM)
 Board & Committee
 Tender Assessment Panel (TAP)
 Main Tender Board (MTB)
World Trade Organization (WTO)
 Agreement on Government
Procurement
 Prescribes a set of requirements
regarding non-discriminatory
treatment of goods, tender
procedures, tender specifications and
challenge procedures in order to
provide for open and fair competition
 HA as a non-government public entity
requires compliance for tender value
> 400,000 SDR (approx HK$4.6M)
Procurement & Materials
Management Manual (PMMM)
Procurement & Materials
Management Manual (PMMM)
 Tender for purchase value >HK$1M
 Tender notice placed on HA website
 Tender evaluated and endorsed by
the Tender Assessment Panel (TAP)
 Tender recommendation be approved
by Main Tender Board (MTB) for
award of contract
Tender Assessment Panel (TAP) for
Drugs
 Composition
 Chairman:
 Chief Pharmacist
 Members:
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Senior Pharmacist (CPM) + Pharmacists (CPM)
Chief Supplies Officer (PSST)
Department Manager (Pharm) – on rotation
Representative from Finance Department
Pharmacists and Supplies Officers
 Observer:
 Group Internal Audit
 Monthly meeting
 To make tender recommendation to tender
board for approval
HA Main Tender Board (MTB)
 Composition:
 Chairman:
 Chairman of HA Finance Committee
 Members:
 3 HA board members
 Chief Executive or his representative
 Director (Finance) or her representative
 Monthly meeting
 To approve tenders recommended by
TAP
Tendering Procedure
Hospital
Provide
estimated
quantity
requirement
CPO
Provide
specification
and raise
request for
tender to
PSST
Perform
technical
evaluation of
tender offers
(DSC where
applicable)
PSST
Conduct
tendering
process
TAP
MTB
Evaluate
and
recommend
tender
offers for
MTB
approval
Approve
tender
recommendations
Standing Quotation
 Procurement procedure similar to tender
 Normally for a 12-month period
 Provide estimated required quantity on a
no commitment basis
 Evaluation by the Quotation Assessment
Panel
 Recommended offers endorsed by
CM(BSS) for award of SQ
Direct Purchase
 Conducted at hospital level following
the procurement procedures
stipulated in the PMMM
Product Use
Quality Assurance
Laboratory Testing
 Discretionary at introduction of
particular product
 Random sampling of delivered stock
on contract items for once per
contract-cycle testing
 Ad hoc testing of complaint samples
where deemed appropriate
Risk Management
Risk Management
 Surveillance of overseas health
authorities
 Product quality incidents
 Product presentation
Overseas Surveillance
 Daily screening of :
 US FDA
 TGA
 MHRA etc.
For product related clinical/quality
information
Overseas Surveillance
 If issue concerns HA in-use products,
CPO would :
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Confirm relevance to delivered products
Request local stand
Confirm regulatory picture
Follow-up as necessary
Product quality incidents
 In-house quality surveillance
 Manufacturer’s product alert
 Manufacturer’s product recall
In-house quality surveillance
 Product quality complaint procedure
 Report on in use products :
 Concerns on safety, efficacy, appearance
and packaging, suspected contamination,
or any other circumstances observed
that may jeopardize patient safety or
cause reasonable doubt on the routine
and intended utilization of a
pharmaceutical item
Examples of
Complaint
Samples
Product quality complaint
procedure
 Centrally managed and follow-up by
CPO
 Reporting through frontline
pharmacies
 Assessment of severity and
prevalence for immediate precautions
and necessary follow-up
Quality Complaint
Classification - Action Index
II
I
0
Complaint that may cause
harmful effect
Complaint that may diminish
therapeutic effect but doesn’t
cause harmful effect
Complaint that doesn’t
diminish therapeutic effect
Product quality complaint
procedure
 Manufacturer’s follow-up :
 Examination of complaint sample
 Investigation report
 Corrective actions with timeframe
 Major concerns:
 Patient safety
 Isolated incident vs. system error
Manufacturer’s product alert
 pharmaceutical-related safety alert
(e.g. clinical updates, adverse
reaction, labeling changes, etc.)
Manufacturer’s product alert
 Manufacturer should :
 Advice relevance to delivered products
 Advice local stand
 Advice regulatory picture
 CPO would follow-up as necessary
Manufacturer’s product recall
 Action initiated by the manufacturer of the
product, for reasons relating to its quality,
safety or efficacy, to withdraw the product
or a certain quantity of the product, from
supply or use
 Depending on seriousness of underlying
problem, may involve intervention from
international/local health authorities
Product Recall - Extent
Consumer / User Level
(defects that may jeopardize
public health)
Retail Level
(more serious defects)
Wholesale Level
(not hazardous defects)
Manufacturer’s product recall
 Recall notice to confirm :
 regulatory awareness
 Product and manufacturer involved
 Batch involved (if applicable) with distribution
list of delivered stock to HA institutions
 Reason of recall
 Extent of recall
 Timeframe on completion of recall
 Clinical recommendations for affected patients
 Availability of alternative supplies
 Communication channel
Manufacturer action
 Inform CPO asap upon confirmation of
recall
 Ensure recall notice contains all required
information
 Facilitate as necessary during recall
 Provide recall summary to CPO upon
completion
 Provide investigation and corrective action
report, where applicable, in due course
CPO action
 Central dissemination and coordination
 Immediate cessation of use of concerned
product
 Monitor compliance to recall details
 Recall summary
 Clinical recommendations
 Coordinate with other departments on :
 Medical-legal implications
 Media interest
 Maintain continuity of supplies as necessary
Product Supplies
Continuity of Supplies
 Inform CPO/PSST asap on anticipated supplies
disruption
 Minimum 4 weeks stock to maintain undisturbed frontline operations
 Considerable turn-around time for securing and
procuring alternative stock
 Purchase alternative stock if disruption is
imminent
 Compensation on extra costs incurred
stipulated under contract/SQ penalty clauses
Commercial Risk Assessment
 Financial vetting of potential contract
suppliers
 Assess company stability
Upcoming Plans
 Medication Safety
 Public Private Partnership
 Corporate ERP Implementation
Product Presentation
 Look-Alike, Sound-Alike (LASA)
Medications - a WHO Patient Safety
Solution
http://www.ccforpatientsafety.org/common/pdf
s/fpdf/Presskit/PS-Solution1.pdf
 Potential for error due to :
 Confusion brand or generic drug names
 Similar packaging and labelling
Product Presentations
 Labelling and markings
 Recently implemented product
presentation requirements in tenders
 Will extend to standing quotations
 Strip-packaging
 Currently applicable to oral dangerous
drugs and cytotoxics
 Will extend to oral-hypoglycaemics
 Closed-system for infused products
Public Private Partnership Projects
 Pilot project at Tin Shui Wai North for
GOPC patients attending private GPs
 Direct deliveries of HA procured drug
supplies to GPs
 Planning on extension to other districts
Corporate ERP Implementation
 Currently no definite timeframe for
pharmacy implementation
 Finance implementation led to revised
payment practice
 Date of invoice that precede date of
delivery by >2 days would not be
accepted
Summary
 Understanding of :
 Objectives, procedures, plans
 Cooperation on :
 Documentations
 Supplies
 Contingency support
 Most importantly :
 Enhance communication
How to find us (CPO) - Quality
 Location
 7/F Multicentre Block A, PYNEH, Chai Wan
 Telephone
 Enquiry
 E-mail
 Enquiry
2515 2455
[email protected]
How to find us (PSST) – Procurement
 Location
 7/F Multicentre Block A, PYNEH, Chai Wan
 Telephone
 Enquiry
 E-mail
 Enquiry
36925108
[email protected]
Thank you
Q&A