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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

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briefing to pharmaceutical manufacturers and suppliers

Briefing to Pharmaceutical Manufacturers and Suppliers

Chief Pharmacist’s Office (CPO) &

Pharmaceutical Supplies Services Team (PSST)

Hospital Authority

slide3
Aim
  • Explains HA’s :
    • Objectives
    • Procedures
    • Plans

on managing pharmaceutical quality and procurement

  • Communicate to improve cooperation
topics
Topics
  • Introduction
  • Product selection
  • Product Procurement
  • Product Use
  • Product Supplies
  • Upcoming Plans
organization structure of ha s pharmaceutical service
Organization Structure of HA’s Pharmaceutical Service

Chief Executive

Director (Cluster Services)

7 Clusters

Pharmacy Service Coordinators

(Public Hospitals & Clinics)

Chief Pharmacist’s Office (Chief Pharmacist)

Senior Pharmacist

Senior Pharmacist

Senior Pharmacist

SeniorPharmacist

Corporate Pharmaceutical Management

Pharmacy Practice Management

Professional & Clinical Service Development

SpecialServices Development

roles of cpo
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
slide9

Corporate Pharmaceutical Management

  • Objectives
    • to ensure 5 Rights
      • right drug
      • right quality
      • right source
      • right purchasing channel
      • right price
organization structure of ha s business support services department
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

Procurement Team B

Procurement Team C

Procurement Team D

Procurement Team E (PSST)

IT products & Services

Medical Consumables

Services & Food

Medical Equipment

Pharmaceuticals

product registration
Product Registration
  • Safety
  • Efficacy
  • Quality
slide15
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
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
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
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
Manufacturer Information

*Separate GMP compliance documents may be required if status not manifested on submitted Manufacturer’s License

product information
Product Information

* Applicable for multi-source purchase

product sample
Product Sample
  • Actual sales pack must be provided
  • Essential for evaluation and logging of product details
change in product particulars
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
slide24
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
Product Patents
  • Respect Intellectual Properties
  • Request to provide product patent information as necessary
    • Ad-hoc enquiry
    • Tender / SQ requirements
slide27

Drug Procurement Channels

  • Bulk Supplies Contract through Tender
  • Standing Quotation
  • Direct Purchase
procurement channels analysis proportion by expenditure 07 08
Procurement Channels Analysis Proportion byExpenditure (07/08)

Note: Expenditures in Million HK$

slide30

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
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
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 pmmm1
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
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
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
Tendering Procedure

Hospital

CPO

PSST

TAP

MTB

Provide estimated quantity requirement

Provide specification and raise request for tender to PSST

Conduct tendering process

Evaluate and recommend tender offers for MTB approval

Approve tender recommenda-tions

Perform technical evaluation of tender offers (DSC where applicable)

standing quotation
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
Direct Purchase
  • Conducted at hospital level following the procurement procedures stipulated in the PMMM
laboratory testing
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 management1
Risk Management
  • Surveillance of overseas health authorities
  • Product quality incidents
  • Product presentation
overseas surveillance
Overseas Surveillance
  • Daily screening of :
    • US FDA
    • TGA
    • MHRA etc.

For product related clinical/quality information

overseas surveillance1
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
Product quality incidents
  • In-house quality surveillance
  • Manufacturer’s product alert
  • Manufacturer’s product recall
in house quality surveillance
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
product quality complaint procedure
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
Quality Complaint Classification - Action Index

Complaint that may cause harmful effect

Batch Suspension

II

Complaint that may diminish therapeutic effect but doesn’t cause harmful effect

I

General Alert

Complaint that doesn’t diminish therapeutic effect

Keep In View

0

product quality complaint procedure1
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
Manufacturer’s product alert
  • pharmaceutical-related safety alert (e.g. clinical updates, adverse reaction, labeling changes, etc.)
manufacturer s product alert1
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
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
slide56

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 recall1
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
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
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
continuity of 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
Commercial Risk Assessment
  • Financial vetting of potential contract suppliers
  • Assess company stability
upcoming plans
Upcoming Plans
  • Medication Safety
  • Public Private Partnership
  • Corporate ERP Implementation
product presentation
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
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
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
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
Summary
  • Understanding of :
    • Objectives, procedures, plans
  • Cooperation on :
    • Documentations
    • Supplies
    • Contingency support
  • Most importantly :
    • Enhance communication
how to find us cpo quality
How to find us (CPO) - Quality
  • Location
    • 7/F Multicentre Block A, PYNEH, Chai Wan
  • Telephone
    • Enquiry 2515 2455
  • E-mail
    • Enquiry cpo.cpm@ha.org.hk
how to find us psst procurement
How to find us (PSST) – Procurement
  • Location
    • 7/F Multicentre Block A, PYNEH, Chai Wan
  • Telephone
    • Enquiry 36925108
  • E-mail
    • Enquiry psst@ha.org.hk