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 cpo.cpm@ha.org.hk

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

Thank you

Q&A