briefing to pharmaceutical manufacturers and suppliers
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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 Planson managing pharmaceutical quality and
procurement
Communicate to improve cooperation
Topics
Introduction Product selection Product Procurement Product Use Product Supplies Upcoming Plans
Introduction
Chief Pharmacist’s Office (CPO)
Organization Structure of HA’s Pharmaceutical Service
Director (Cluster Services)
Chief Pharmacist’s Office (Chief Pharmacist)
Corporate Pharmaceutical Management
Professional & Clinical Service Development
Pharmacy Practice
Management
Chief Executive
Senior Pharmacist
Senior Pharmacis
t
Senior Pharmacist
Senior Pharmacist
Special Services Development
7 ClustersPharmacy Service Coordinators(Public Hospitals & Clinics)
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 cost-
effective 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
Director (Cluster Services)
Chief Manager (Business Support Services)
IT products & Services
Services & Food
Medical Consumable
s
Chief Executive
Procurement Team A
Procurement Team B
Procurement Team C
Procurement Team E (PSST)
Medical Equipment
Other BSS functional Sections
Procurement Team D
Pharmaceuticals
Procurement and Materials Management Section
Pharmaceutical Supplies Services Team
Chief Supplies Officer
Stephen LEE
Unit E1
Vivian LAW
Unit E2
LAU Chun Loy
Unit E3
Claudia NG
Unit E4
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 Use
Certified true copy of Pharmaceutical Manufacturer’s License, indicating compliance with GMP*
Confirms valid manufacturing status of manufacturer
*Separate GMP compliance documents may be required if status not manifested on submitted Manufacturer’s License
Product InformationDocumentary Evidence Use
Certified true copy of Certificate of Drug/Product Registration
Confirms valid local product registration
Master formula, method of assay, finished product specifications and stability data
Confirms product particulars, product presentations, facilitate laboratory testing
Certificate of analysis
Certified true copy of marketing authorization issued by ICH member countries, PRC, Australia or Canada *
Confirms valid product registration in recognized countries
* Applicable for multi-source purchase
Supplier Information
Documentary Evidence Use
Certified true copy of relevant licences (e.g. Wholesale Poisons Licence)
Confirms valid status as 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 : 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
Bulk Supplies Contract through Tender
Standing Quotation Direct Purchase
Procurement Channels Analysis Proportion by No. of Items (07/08)
Other185 (5.9%)
Standing Quotation
603 (19.3%)
Bulk Supplies Contract
634 (20.3%)
Direct Purchase
1,702 (54.5%)
Procurement Channels Analysis Proportion by Expenditure (07/08)
Bulk Supplies Contract1979.47 (71.6%)
Other5.99 (0.2%)
Direct Purchase203.49 (7.4%)
Standing Quotation
575.30 (20.8%)
Note: Expenditures in Million HK$
Bulk Supplies Contract
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:
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 PSST TAP MTB
Provide specification and raise request for tender to PSST
Conduct tendering process
Perform technical evaluation of tender offers (DSC where applicable)
Evaluate and recommend tender offers for MTB approval
Approve tender recommenda-tions
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 : 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 doesn’t diminish therapeutic effect
Complaint that may diminish therapeutic effect but doesn’t cause harmful effect
Complaint that may cause harmful effect
Batch Suspension
General Alert
Keep In View
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 un-
disturbed 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/pdfs/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 2515 2455
E-mail Enquiry [email protected]
How to find us (PSST) – Procurement
Location 7/F Multicentre Block A, PYNEH, Chai Wan
Telephone Enquiry 36925108
E-mail Enquiry [email protected]
Thank you
Q&A