CIVAS IN SWITZERLAND 2002

CIVAS IN SWITZERLAND 2002 William Griffiths Pharmacy September 13th, 2002 Lugano, Switzerland. William Griffiths, Pharmacie des HUG, Lugano sept. 2002 1

INTRODUCTION HOSPITAL PHARMACY General orientation towards quality assurance of drug processes. Pharmaceutical Services and Clinical Pharmacy. Ready to use injectable drugs: Parenteral Nutrition Cytotoxics CIVAS (Centralized IntraVenous Additive Services) William Griffiths, Pharmacie des HUG, Lugano sept. 2002 2

INTRODUCTION CIVAS ARE A REPLY TO PROBLEMS OF: SECURITY for the patient: - Errors: wrong drug, wrong dose, wrong time - Risk of infection:multiple adjunctions:long administration - High risk administration route i.e. Intrathecal for the health care worker (HCW) : - Acute or chronic toxicity due to drugs! COST HCW S MISSION : TAKE CARE OF THE PATIENT William Griffiths, Pharmacie des HUG, Lugano sept. 2002 3

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 4 CIVAS IN SWITZERLAND 2002 CIVAS began in the UK in 1990. In Belgium in 2000. Switzerland in 2001 (first steps)

CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the needs. Determine the priorities (risk levels). Determine the feasibility (stability). Develop industrial partnerships whenever possible. Begin manufacture according to a staff capacity plan. Contact other Swiss hospitals William Griffiths, Pharmacie des HUG, Lugano sept. 2002 5

CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the needs. Determine the priorities (risk levels). Determine the feasibility (stability). Develop industrial partnerships whenever possible. Begin manufacture according to a staff capacity plan. Contact other Swiss hospitals William Griffiths, Pharmacie des HUG, Lugano sept. 2002 6

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 7 DETERMINING THE NEEDS A questionnaire was sent out to the senior nursing and medical staff.

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 8 DETERMINING THE NEEDS Would you be interested in a service of «ready to use»iv preparations supplied by the pharmacy? Yes: for what reasons? No: for what reasons? Would you like more information before deciding?

DETERMINING THE NEEDS 60% 50% REPLY LEVEL yes 40% 30% 20% 10% 0% no Info Yes/No No/info SENT OUT:190 RETURNED : 81 PERCENT: 43 William Griffiths, Pharmacie des HUG, Lugano sept. 2002 9

DETERMINING THE NEEDS TENDENCIES FOR THE ANSWER : NO ( 136 remarks taken from 47 replies) Competence and Responsibilities 48% Logistic 30% Manpower 7% Miscellaneous remarks 15% 100% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 10

DETERMINING THE NEEDS TENDANCIES FOR THE ANSWER : NO Competence and Responsibilities 48% Responsibilities (who controls who?) 19% Nurses competence 14% Loss of skills 13% Particularisation 2% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 11

DETERMINING THE NEEDS TENDANCIES FOR THE ANSWER : NO Logistic 30% Emergency supplies 24h/24h 19% Last minute prescription changes 7% Distance from the pharmacy 3% Time lag between order/delivery 2% Stability: Expiry date 2% Stock control (space) 2% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 12

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 13 DETERMINING THE NEEDS TENDANCIES FOR THE ANSWER : NO Manpower 7% Loss of nursing staff 4% Cost 3%

DETERMINING THE NEEDS TENDANCIES FOR THE ANSWER : NO Miscellaneous 15% See no reason for this service 5% Not adapted to a particular ward 3% Ask the pharmaceutical industry 3% Only for very difficult preparations 1% Great variety of paediatric dosages 1% What is the added value for the patient? 1% Quality of the pharmacy service? (mistakes) 1% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 14

DETERMINING THE NEEDS TENDANCIES FOR THE ANSWER : YES (10%) More reliable Less risk Reduction of preparation time Better hygiene More practical Reduces errors of dosage and calculation Aseptic ( less manipulation and stock on the wards) Security Products not available on the market William Griffiths, Pharmacie des HUG, Lugano sept. 2002 15

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 16 DETERMINING THE NEEDS A meeting was arranged with the senior nursing staff to allow the pharmacy to reply to the doubts raised by the negative results obtained from the questionnaire

DETERMINING THE NEEDS (REPLY) Competences and responsibilities Only high risk drugs and expensive products will be taken into account Protection of the healthcare workers Patient security (bacteriology and errors) Cost William Griffiths, Pharmacie des HUG, Lugano sept. 2002 17

DETERMINING THE NEEDS (REPLY) Competence and responsibility Content= label: Responsibility of the Pharmacy No difference from the pharmaceutical industry (in house manufacturing) Some legal questions to be resolved William Griffiths, Pharmacie des HUG, Lugano sept. 2002 18

DETERMINING THE NEEDS (REPLY) RESPONSIBILITY/PHARMACY Licensed clean rooms Trained staff Validated working methods Documentation (SOP s) Trace - back Quality control William Griffiths, Pharmacie des HUG, Lugano sept. 2002 19

DETERMINING THE NEEDS (REPLY) Logistic Choice of products sufficiently stable Place in the refrigerator? William Griffiths, Pharmacie des HUG, Lugano sept. 2002 20

DETERMINING THE NEEDS (REPLY) Logistic Individualised dosages. Whenever its necessary to adapt the dosage: eg cytotoxics, antivirals, paediatric dosages etc.. Will be avoided if possible William Griffiths, Pharmacie des HUG, Lugano sept. 2002 21

DETERMINING THE NEEDS (REPLY) Logistic Batch production. Manufacture and stocking of small batches Stability from one to several months Exactly like other drugs (orders and supply) William Griffiths, Pharmacie des HUG, Lugano sept. 2002 22

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 23 DETERMINING THE NEEDS Outcome The OK has been given to collect hospital needs

CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the needs. Determine the priorities (risk levels). Determine the feasibility (stability). Develop industrial partnerships whenever possible. Begin manufacture according to a staff capacity plan. Contact other Swiss hospitals William Griffiths, Pharmacie des HUG, Lugano sept. 2002 24

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 25 CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the priorities (risk levels).

DETERMINE THE PRIORITIES Work has begun in the following high risk services: Anaesthesiology Paediatrics Intensive care units Emergency room Transplant unit William Griffiths, Pharmacie des HUG, Lugano sept. 2002 26

DETERMINE THE PRIORITIES Examples of products already made: Isoprenalin 0.1mg/ml syringes 50ml Midazolam bags and syringes Apomorphine cassettes Gancylovir syringes from 6,5-400mg William Griffiths, Pharmacie des HUG, Lugano sept. 2002 27

CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the needs. Determine the priorities (risk levels). Determine the feasibility (stability). Develop industrial partnerships whenever possible. Begin manufacture according to a staff capacity plan. Contact other Swiss hospitals William Griffiths, Pharmacie des HUG, Lugano sept. 2002 28

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 29 CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the feasibility (stability).

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 30 DETERMINE THE FEASABILITY Several products on test: Vancomycine for neonatal use: syringes 50mg/10ml Midazolam syringes for ICU s

CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the needs. Determine the priorities (risk levels). Determine the feasibility (stability). Develop industrial partnerships whenever possible. Begin manufacture according to a staff capacity plan. Contact other Swiss hospitals William Griffiths, Pharmacie des HUG, Lugano sept. 2002 31

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 32 CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Develop industrial partnerships whenever possible.

INDUSTRIAL PARTNERSHIP Products already available : Bupivacain bags Bupivacain/Fentanyl bags Morphine 100mg bags In preparation: Heparin bags William Griffiths, Pharmacie des HUG, Lugano sept. 2002 33

CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the needs. Determine the priorities (risk levels). Determine the feasibility (stability). Develop industrial partnerships whenever possible. Begin manufacture according to a staff capacity plan. Contact other Swiss hospitals William Griffiths, Pharmacie des HUG, Lugano sept. 2002 34

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 35 CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Begin manufacture according to a staff capacity plan.

BEGIN CIVAS MANUFACTURE A capacity plan* is being developed in order to begin high risk projects. Actual CIVAS production: Individualised 1500/year Batch 2800/year Total 4300/year *Determine volume and type of workload/ /ressources necessary/strategy when inadequate William Griffiths, Pharmacie des HUG, Lugano sept. 2002 36

CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Determine the needs. Determine the priorities (risk levels). Determine the feasibility (stability). Develop industrial partnerships whenever possible. Begin manufacture according to a staff capacity plan. Contact other Swiss hospitals William Griffiths, Pharmacie des HUG, Lugano sept. 2002 37

William Griffiths, Pharmacie des HUG, Lugano sept. 2002 38 CIVAS IN SWITZERLAND 2002 THE GENEVA APPROACH Contact other Swiss hospitals

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists (30 replies = 60%) Are you considering going over to CIVA services? YES : 21 70% NO : 9 30% In the near future 5 23.8% Middle term < 4 years 10 47.6% Long term > 4 years 6 28.6% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 39

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists (30 replies = 60%) Do you actually prepare some aseptic preparations? YES : 21 70% NO : 9 30% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 40

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists(30 replies = 60%) Have you recieved requests for preparations from the nursing and medical staff? YES : 18 60% NO : 12 40% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 41

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists (30 replies = 60%) DO YOU ALSO PREPARE CYTOXICS and/or EPIDURALS? CYTOS EPIDURAL YES: 18 60.0% 10 33.3% NO: 10 33.3% 17 56.7% NO REPLY: 2 6.7% 3 10.0% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 42

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists (30 replies = 60%) DO YOU THINK THAT A CIVAS GROUP SHOULD BE FORMED IN SWITZERLAND AS IN THE UK? YES: 28 93.3% NO : 1 3.3% NO REPLY : 1 3.3 % William Griffiths, Pharmacie des HUG, Lugano sept. 2002 43

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists (30 replies = 60%) WOULD YOU BE INTERESTED IN ASEPTIC PREPARATION TRAINING MODULES IN SWITZERLAND? YES: 28 93.3% NO : 2 6.7% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 44

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists (30 replies = 60%) WOULD YOU BE INTERESTED IN «READY-TO-USE» SOLUTIONS SUPPLIED BY INDUSTRY? YES: 23 76.7% NO : 4 13.3% NO REPLY: 3 10.0% William Griffiths, Pharmacie des HUG, Lugano sept. 2002 45

OTHER SWISS HOSPITALS Questionnaire sent to 50 Chief Pharmacists (30 replies = 60%) WHAT PRODUCTS DO YOU PREPARE OR HAVE BEEN ASKED FOR? LOCAL ANAESTHETICS 19 ( ex: Bupivacain/fentanyl) 10 PCA: 18 (ex: Morphine bags) 10 ANTIBIOTICS 7 ANTIVIRALS 4 William Griffiths, Pharmacie des HUG, Lugano sept. 2002 46

CIVAS IN SWITZERLAND 2002 CONCLUSIONS A turning point for hospital pharmacy. High added value production for the hospital. Contributes to the security of drug processes. Be aware of doubts shown by the nursing profession. Work together : (Clinical Services and Production). William Griffiths, Pharmacie des HUG, Lugano sept. 2002 47

CIVAS IN SWITZERLAND 2002 Acknowlegements: PD. Dr P Bonnabry, Mrs B Matthey Pharmacy, University Hospitals of Geneva Download at www.hcuge.ch/pharmacie/ens/conferences.htm and for more CIVAS details www.hcuge.ch/pharmacie/rd/civas.htm William Griffiths, Pharmacie des HUG, Lugano sept. 2002 48