Corso di Laurea Magistrale in Chimica e Tecnologia Farmaceutiche E25

Transcription

1 Sezione di Tecnologia e Legislazione Farmaceutiche Maria Edvige Sangalli Corso di Laurea Magistrale in Chimica e Tecnologia Farmaceutiche E25 Fabbricazione Industriale dei Medicinali 4 CFU Supply Chain Management In The Healthcare Sector Angelo Vedovi Prof. Andrea Gazzaniga

2 w o r k i n g a s o n e Supply Chain Management In The Healthcare Sector Challenges, Risks & (R)Evolutions (Extract) Angelo Vedovi Università degli Studi di Milano, 20 th December 2017

3 AmerisourceBergen - Solutions that Span the Industry s Needs Global Clinical Trial Logistics Global Market Access Strategy Health Economics and Outcomes Research Payer Messaging and Marketing Strategy Data Analytics, Market Research, and Market Intelligence Reimbursement Strategy and Patient Support Services Physician GPO Contracting Specialty Pharmacy Services Patient Adherence and Compliance Services Product Awareness Services for Physicians, Pharmacies, and Health Systems Field Reimbursement Programs Third Party Logistics Wholesale and Specialty Distribution Generics and Biosimilars Strategy

4 Agenda w o r k i n g a s o n e Introduction Healthcare Challenges Healthcare Supply Chains Global Clinical Trial Supply Chain Global Commercial Supply Chain Supply Chain Management Healthcare Quality Assurance Temperature-Controlled Management Patient-Centric Supply Chain Community Management Roadmap for Future Health The Supply Chain Manager s Challenge

5 w o r k i n g a s o n e Supply Chain Management

6 Supply Chain Management w o r k i n g a s o n e Objective: Ensure the availability of the right healthcare product (and/or service) in the right conditions, at the right time, in the right place, to the right customer or patient, with the right cost Scope: Research & Development Phases Launch & Commercialization Phases Definition: Supply Chain Management is the process of planning, implementing, and controlling the efficient, cost-effective flow and storage of raw materials, in-process inventory, finished goods, and related information flow, from point-of-origin to point-of-consumption, for the purpose of conforming to customer/patient requirements Supply Chain Management optimizes planning and decision making across key business processes over time

7 w o r k i n g a s o n e Supply Chain Management Infrastructure Carriers CUSTOMER SUPPLIER DISTRIBUTION CENTER CUSTOMER Carriers Carriers CUSTOMER SUPPLIER MANUFACTURER CUSTOMER Carriers SUPPLIER DISTRIBUTION CENTER CUSTOMER Material Flow Information Flow CUSTOMER

8 Supply Chain Management w o r k i n g a s o n e Integrated Levels Decisions Strategic Planning (1-3 Years) Depth Tactical Planning (3-12 Months) Feedback Operational Planning (1 Day - 3 Months) Suppliers Manufacturers Distribution Channels End Customers Breadth

9 Know the Service Level Requirements of w o r k i n g a s o n e the Healthcare Players involved Various Products Different Players Biotech Generics OTC Pharmaceuticals, Biosimilars Cell & Gene Therapies Medical Devices, incl. Diagnostics, Kits Medical Equipment Disposables, Supplies Blood, Tissue Banks Investigational Drugs, Ancillaries Comparator Drugs Etc. Patients Healthcare Manufacturers R&D CRO s Labs Universities Hospitals Government Live Animals Animal Health Food/Nutrition Cosmetics Manufacturers Anti-doping Scientific Research Environmental Sciences Space Exploration United Nations Organizations Logistics, Transportation Companies Customs Veterinary Wholesalers Pharmacies Doctors Healthcare Providers Etc.

10 w o r k i n g a s o n e Healthcare Quality Assurance

11 What is Quality Assurance? System designed to prevent mistakes and avoid mistakes when delivering solutions or services to customers and patients It is not a system designed to find faults or pin the blame of mistakes on others

12 What is GxP? w o r k i n g a s o n e GxP is a collective term for the Good Practice quality guidelines and regulations used in many fields including the pharmaceutical industry It is designed to ensure product safety and integrity during the manufacturing, control, storage and distribution phases Responsibility for compliance lies with Pharmaceutical Companies/Manufacturers However, outsourced vendors also have the responsibility to comply with the GDP standards Compliance is required to ensure that the quality of the products - is not compromised and - does not affect the health and safety of patients

13 GDP - Topics Covered w o r k i n g a s o n e

14 Risks Overview w o r k i n g a s o n e Force Majeure Risks External risks cannot be influenced E.g. Natural disasters, strikes, terrorism, wars Climatic Impacts Environment related E.g. Weather, climate, season Demand Risks Market / Customer related Supply Process Risks, for example related to : Transportation mode (aircraft, ship, Train, truck) Transit time Human skills Counterfeit, thefts

15 Risks in the Logistics Chain? Risk Identification and Evaluation is required during the planning of each shipment step w o r k i n g a s o n e Shipment Management involves a lot of handovers, from pick-up of the product to its delivery to the point of use It is very important that all possible risks are evaluated before each shipment is sent The entire route must be planned for all temperature-controlled shipments, for example pending on the expected weather on route. All involved players as well as capabilities must be checked in advance. Prior to Pick up Prior to Export At Port of Entry & During Clearance Prior to Delivery Note: Initial Temperature-Controlled Management (TCM) plans may have to be adapted during transit, due to unforeseen incidents.

16 w o r k i n g a s o n e What Risks do shipments face? Examples? Delays in transit Humidity damage Radiation exposure Site delivery issues Loss Temperature excursions Consequences? Lack of efficacy of the product or potential harm to patients Delays and shortages in supply Lack of replacement product Missing start of disease season Removal of patient from trial Loss of data or product Disruptions, sanctions or delays for licence applications Financial & reputation impacts How to mitigate the identified risks? For example: How to ensure the right temperature and avoid temperature excursions? Select suitable logistics providers Choose adequate solutions for temperature-controlled management

17 w o r k i n g a s o n e Temperature-Controlled Management

18 w o r k i n g a s o n e Temperature Control of Healthcare Shipments Examples of Challenges Changing product profile Examples of products at risk: vaccines, biotech, blood products, etc. Globalization and variable ambient temperatures Variation in external temperature, e.g. at the same time in January: Cape Town (South Africa) : Summer 27.1ºC Ottawa (Canada) : Winter 9.3ºC Handover points and location of a shipment within a distribution chain Shippers environment Forwarders environment (pick-up / on hand / delivery) Airlines environment Customs environment (government run) Effective versus ineffective temperature-controlled packaging solutions Changing regulatory environment Storage and distribution guidelines from should be to must be Service provider capabilities Temperature control is vital to ensure GxP compliance with current regulations and most importantly to ensure the safety of the patients

19 w o r k i n g a s o n e Temperature-Controlled Management Technology Definition: Temperature-Controlled Management (TCM) is an uninterrupted series of storage and distribution activities which maintain a given temperature range 180 C 80 C 70 C 18 C 0 C +2 C +8 C +15 C +25 C Cryogenics Deep Freezing Freezing Refrigerated Controlled Ambient Each temperature range requires specific packaging technology solutions to maintain the integrity of pharmaceuticals: PCMs Phase Change Materials

20 w o r k i n g a s o n e Temperature-Controlled Management Technology Examples of Packaging Systems Active Systems Envirotainers C-Safe Semi-Active Systems Laminar Medica Softbox Passive Systems Polystyrene boxes Polyurethane foam boxes NanoCool boxes Thermal Blankets Note: Use only Qualified packaging, i.e. packaging which: has documented testing demonstrates to a high degree of assurance that a specific process will meet its pre-determined acceptance criteria

21 Temperature Monitors Examples of Electronic Data Loggers Used to track and record data about temperature sensitive shipments during transit Vital for the pharmaceutical industry but may also be required for food or chemical shipments Note: It is a regulatory requirement of GMP and GDP to record temperature

22 The Supply Chain Manager s Challenge w o r k i n g a s o n e Orchestrate a Dynamic System with Three Macro-Components Process People Technology