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Briefing to Pharmaceutical Manufacturers and Suppliers

Briefing to Pharmaceutical Manufacturers and Suppliers

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Briefing to Pharmaceutical Manufacturers and Suppliers

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  1. Briefing to Pharmaceutical Manufacturers and Suppliers Chief Pharmacist’s Office (CPO) & Pharmaceutical Supplies Services Team (PSST) Hospital Authority

  2. Welcome

  3. Aim • Explains HA’s : • Objectives • Procedures • Plans on managing pharmaceutical quality and procurement • Communicate to improve cooperation

  4. Topics • Introduction • Product selection • Product Procurement • Product Use • Product Supplies • Upcoming Plans

  5. Introduction

  6. Chief Pharmacist’s Office (CPO)

  7. 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

  8. 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

  9. Corporate Pharmaceutical Management • Objectives • to ensure 5 Rights • right drug • right quality • right source • right purchasing channel • right price

  10. Cluster Services Division Business Support Services (BSS)

  11. 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

  12. Pharmaceutical Supplies Services Team

  13. Product Selection

  14. Product Registration • Safety • Efficacy • Quality

  15. 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

  16. Patented Proprietary Products • Single supplying source • Use defined by clinical needs • Product quality criteria : • Manufacturing quality • GMP • Product Registration evaluated by CPO

  17. Multi-source Products • Drug clinical use established • Product quality criteria : • Manufacturing quality • GMP • Product registration • Clinical application • Interchangeability evaluated by Drug Selection Committee (DSC)

  18. 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

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

  20. Product Information * Applicable for multi-source purchase

  21. Supplier Information

  22. Product Sample • Actual sales pack must be provided • Essential for evaluation and logging of product details

  23. 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

  24. 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

  25. Product Patents • Respect Intellectual Properties • Request to provide product patent information as necessary • Ad-hoc enquiry • Tender / SQ requirements

  26. Product Procurement

  27. Drug Procurement Channels • Bulk Supplies Contract through Tender • Standing Quotation • Direct Purchase

  28. Procurement Channels AnalysisProportion byNo. of Items (07/08)

  29. Procurement Channels Analysis Proportion byExpenditure (07/08) Note: Expenditures in Million HK$

  30. 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)

  31. Governance • Guidelines • Worldwide: • World Trade Organization (WTO) • In-house: • Procurement & Materials Management Manual (PMMM) • Board & Committee • Tender Assessment Panel (TAP) • Main Tender Board (MTB)

  32. 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)

  33. Procurement & Materials Management Manual (PMMM)

  34. 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

  35. 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

  36. 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

  37. 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)

  38. 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

  39. Direct Purchase • Conducted at hospital level following the procurement procedures stipulated in the PMMM

  40. Product Use

  41. Quality Assurance

  42. 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

  43. Risk Management

  44. Risk Management • Surveillance of overseas health authorities • Product quality incidents • Product presentation

  45. Overseas Surveillance • Daily screening of : • US FDA • TGA • MHRA etc. For product related clinical/quality information

  46. 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

  47. Product quality incidents • In-house quality surveillance • Manufacturer’s product alert • Manufacturer’s product recall

  48. 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

  49. Examples of Complaint Samples

  50. 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