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Statutaire Dag VZA 19022000

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Statutaire Dag VZA 19022000 Powered By Docstoc
					Quality in pharmacy

apr. A. Heeremans University Hospital Gent
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Content
1. Organigram :who are we and what do we do? 2. General introduction of quality 3. Theoretical aspects 4. Structure of the quality management system 5. Practical implementation 6. Conclusion
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1.1.Organigram of the 1. Introduction department
DEPARTMENT PHARMACY AND LOGISTIC CARE Prof. apr. H. Robays 181 FTE LOGISTIC CARE Operation quarter Dhr. Ph. Hauspie 24 FTE CENTRAL PHARMACY Prof. apr. H. Robays 94 FTE + 48 FTE
BIOMEDICAL TECHNICAL SERVICE Ir. E. Billiet 15 FTE maintenance/validation/medical gases

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1.2. Organigram of the pharmacy
PHARMACY Prof. apr. H. Robays QUALITY Apr. A. Heeremans
Production Unit Apr. J. Vandenbroucke Distribution and clinical pharmacy Apr. M. Van Hooreweghe Medical devices Implants Apr. A.M. Moens Central sterilisation unit Apr. D. Janssens

Sterile preparations Apr. B. Pelfrene
QC laboratory Apr. A. Heeremans 7/09/06

Non sterile preparations Apr. M. Van Seymortier

Clinical trials Apr. E. Kestens Data management Apr. K. Kint
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Production unit
• Non sterile preparations : capsules, ointments, solutions (e.g. antiseptic solutions), … • Sterile preparations : total parenteral nutrition, eye drops, infusion solutions, cytotoxic drugs, … • Repackaging in unit doses of drugs • Staff :
– 6 pharmacists – 2 laboratory technicians – 16 pharmacy assistants
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Distribution and clinical pharmacy
• Purchase, storage and distribution of commercially available medicines • Information on dosage, stability and pharmacotherapy • Follow up of guidelines (e.g. for the use of antibiotics, antimycotics, …) • Clinical pharmacists on different wards : pediatrics, intensive care, geriatics • Projects : risk management, electronic presciption • Clinical trials • Staff:
– – – – – 9 pharmacists 20 assistants 4 secretaries 15 logistic co-operators 1 clinical trials administration

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Medical devices, implants
• Purchase, storage and delivery of medical devices and implants • Product information , tarification • Staff :
– 2 pharmacists – 9 administrative co-operators

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Central sterilisation unit
• Cleaning, desinfecting and sterilisation of surgical instrumentation • Packaging and sterilisation of dressings • 3 locations : steam, Etox and H2O2 sterilisation • Staff :
– 1 pharmacist – 4 nurses – 42 technicians

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2. Organigram of the quality 2. Introduction to pharmacy
• Definition of ‘quality’:
– to achieve certain requirements or specifications

• Key of a quality system:
– ‘say what you do’ in the standard operating procedures and prove that you’ do what you say’ by quality registrations

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How to achieve quality?
• • • • Adequate infrastructure and equipment Well trained staff Good policy Development of your own quality management system

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Why do we want quality?
• Organisation :
– long term positive cost/benifit ratio – Clinical trials

• Customer (nurses, physicians, patients,..) requirements
– = right drug for the right patient in the right dosage on the right time by the right route of administration – = correct assembled and labelled surgical instrumentation, sterilised by the right method (steam, EtOx, ..)
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Principles of a quality system
- Customer oriented organisation - Continuing improvement by - Verification and release (double check) - Internal audits - Reporting of non conformities and complaints - Plan-Do-Check-Act (PDCA or Deming Circle)

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Quality improvement: Deming-circle
PLAN DO

Satisfaction

ACT

CHECK

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Aim
– Consequently deliver products that fulfill the requirements of the customer and fulfill the local regulations – To have satisfied customers , this can be achieved by continuing improvement and prevention of non conformities

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Choice of the quality system
• ISO 9001:2000
– International Organisation for Standardisation – = network of national standardisation institutions with a central secretariat in Switserland (www.iso.org)

• ISO 9000 family :
– ISO 9000:2000 : Quality management systems – Basic principles ISO 9001:2000 : Quality management systems - Requirements – ISO 9004:2000 : Quality management systems – Quidelines for performance improvement – ISO 10011 : Quidelines for quality and environment audits

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Choice of the quality system
• ISO 9001:2000
– General, well known quality management system – Experience and know how in 7 other pharmacy hospitals

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Situation in University Hospital Gent (UZG)
• Pharmacy and central sterilisation unit are ISO 9001:2000 certified since July, 2002 • Scope :
– ordering, receiving, storage and distribution of drugs, medical devices and implants – preparation of cytotoxic drugs, TPN, non sterile and sterile preparations – washing, desinfecting, assembling and sterilisation with steam and EtOx of surgical instruments
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ISO 9001:2000 certificates in UZG
• Since february 2004 : purchase department of the hospital • Other departments :
– Drug Research Unit – May 2006 : Medical Oncology Day Hospital

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3. Theoretical aspects ISO 9001:2000 norm
• ISO 9001:2000 standard :
– divided into 8 chapters : – important chapters are :
• • • • 4. Quality management system 6. Management of means 7. Realisation of the product 8. Measurement, analysis and improvement

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ISO 9001:2000 standard
• 4. Quality management system :
– General requirements (4.1):
– Process description – Control, measure and analyse of the process – Continuing improvement of the process

– Documentation requirements (4.2):
• Quality manual • Stabdard operating procedures (SOP) • Quality registrations
• Documentation control (who authorises the procedure, actualisation of the procedure, management of changes to a procedure, announcement of changes, control of copies and expired documents)
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ISO 9001:2000 standard
• 6. Management of means – Availability of financial means (6.1) – Staff (6.2) :
• Capacities • Training and evaluation • Registration of qualification and training

– Infrastructure (6.3) (building, working area,
equipment, transport, …)

– Work environment (6.4)
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ISO 9001:2000 standard
• 7. Realisation of the product
– Determine product requirements (7.2.1) – Review product requirements (7.2.2) – Purchase (7.4) :
• Determine acceptation criteria for delivered goods (equipment, packaging materials, raw materials, …) • Requirements for qualification of personnel • Check if the deliverd goods are conform the acceptation criteria

– Identification and tracebility (7.5.3)(implants, preparations)
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– Maintenance of the product (7.5.5) (e.g. packaging, storage of sterile products) Quality in pharmacy

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ISO 9001:2000 standard
• 7. Realisation of the product
• Control of monitoring and measuring instruments (7.6)
– Calibration

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ISO 9001:2000 standard
• 8. Measurement, analysis and improvement
– – – – – Follow up of customer satisfaction (8.2.1) Internal audits (8.2.2) Follow up of products and processes (8.2.3 and 8.2.4) Control of non conformities (8.3) Continuing improvement by (8.5):
• Corrective actions (8.5.2) e.g. after non conformity, complaint, or internal audit • Preventive actions (8.5.3) e.g. purchase policy, education of staff
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3. Structure of the quality system Basisstructuur : piramide
Level 1 Level 2 Level 3 Policy SOP Work instructions Documents

Level 4
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3. Structure of the quality system Basisstructuur
• Level 1 : quality manual
– Mission and policy of the pharmacy – Covers all the chapters of the ISO standard

• Level 2 : SOP
– General procedures applicable for the whole department, e.g. staff, internal audits, purchase

• Level 3 : Work instructions
– Short procedures, typical for one unit e.g. how to work with a steam sterilisator

• Level 4 : Documentation – forms, manuals of equipment, books, …
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SOP
= standard operating procedure
– Describes the process (scope, method, responsibilities) – Signed for agreement by the responsible

– Validation of the procedure by the quality manager

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ISO 9001:2000 standard
– Written general SOPS necessary for:
• • • • • • • • • • Management of documents Management of quality registrations Internal audits Control of non conformities Corrective actions Preventive actions Calibration Purchase Preparations (sterile and non sterile preparations) Cytotoxic drugs (preparation, safety measures, waste control, stability, light protection…)
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4. Practical implementation Implementatie
• • • • • Lay-out for SOP Quality manual Write necessary SOP (say what you do) Qualification registration for staff Calibration and maintenance of equipment

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‘Preparations’
• SOP describes the proces from the ordering of the raw materials until the quality control of the finished product and delivery of the product to the customer
– Quality requirements for raw materials – Quality requirements for release of the finished product – Responsibilities

• Software Proaz II : on line registration of weight, in proces controls, release of raw 7/09/06 materials and finished product Quality in pharmacy

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Preparations : good practice
• Standard preparations in large quantities :
- uniformity of content (QC laboratory)

• • • • •

Capsules : uniformity of mass on 15 capsules Ointments : homegeneity Sterile preparations : incubation for sterility testing Every preparation is double checked by a pharmacist Written protocols for most of our preparations (method description, raw materials, packaging material, storage condition, shelf life, …)

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‘Treatment of non conformities’
• SOP :
– What should be done ? – Who should do what (responsibilities)

• Quarantine : marked space for non conform products • Registration of product, batch number, number of vials, date and signature, reason for quarantine • Follow-up if products are collected or destroyed and register
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Internal audits
• = internal investigation to see if the quality systems works well • Yearly for every proces
– – – – Auditplan Trained, independent auditors Written report with findings and recommandations List with standard questions for each proces

• Registration of follow up of actions
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Staff
• SOP
– – – – Job description Training and education Evaluation Resposibilities

• Qualification registration

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Qualification registration
• In QMS : tasks can only be performed by a well trained person • For each person : qualification registration, for each task the level of competence is mentioned (beginner, trained,expert)

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Calibration
– SOP :
• Equipment : balance, sterilisator, HPLC, thermometer, LAF,… • Frequency of calibration • Registration of calibration and status • Date of calibration, name, signature

– Specifications – Report of calibration

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Maintenance of equipment
• Should be done regularly and should be traceble:
– Logbook for each equipment – Written report necessary – E.g. refrigirators, sterilisators, sealing equipment

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6. Conclusion
• Added value :
– Try to avoid mistakes (right first time), mistakes that are expensive and dangereous in a medical setting – Written SOP : faster and uniform training of new personnel – Long term : cost effective by fault reduction – Cave :
• Each SOP means a lot ofadministration so only write SOP if it gives an added value

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Thank you for your attention

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