quality assurance & audit -...
TRANSCRIPT
QUALITY ASSURANCE & AUDIT
Birinder KaurSenior Pharmacist
Pharmacy DeptNational University Of Malaysia Medical Centre
Kuala [email protected]
LEARNING OBJECTIVES
To define quality assurance and state the importance of implementation in cytotoxic preparation and handling the products.
List factors and procedures involved in cytotoxic preparation
To ensure that end-product results acceptable quality and the adequacy of staff safety when handling these cytotoxic products
To identify relevant references and tools that can be incorporated in your practice
Quality Assurance (QA)
Refers to a program for the systematic monitoring and evaluation of the various aspects of a service or facility to ensure that standards of quality are being met.
Gives CONFIDENCE in a product.
Quality Assurance (QA)
“Fit for Purpose”• The product should be suitable for
the intended purpose
“Right First Time”• Error-free
2 KEY PRINCIPLES
Why QA is needed ?Healthcare Personnel’s Perspective • Occupational exposure
- Dermal contamination- Airborne contamination- Oral contamination
Signs and symptoms- Skin rashes- Infertility, miscarriage, birth defects- Leukemia, other cancers
What can Affect Quality?
Audit
Drug
Personnel
Facilities & Equipment
Procedures/Work
Processes
Factors Involved
Policies & Procedures Facilities & Equipment Aseptic Technique& Product Preparation Personnel education, training & evaluation Storage & Handling within the pharmacy Process validation Expiration dating Labeling Documentation End-product evaluation
Personnel education & training requirements
Preparation technique Process validation Labeling Use & maintenance of
facilities & equipment Product acquisition Storage & handling of
products & supplies
Policies & Procedures
• Up to date• Available to all involved personnel• Should be updated when changes occurs• Specific to handling cytotoxic drugs
Master formula and worksheets
Personnel Garb Describe environmental
monitoring devices & techniques such as air velocity, temperature & pressure meters
Cleaning materials & disinfecting procedures
Policies & Procedures
Laminar Airflow/Biohazard Safety Cabinets
Laminar Flow Cabinets (LFC)s are notsuitable for the preparation ofhazardous drugs. Biohazard safetycabinets (BSCs) should be usedinstead,with a vertical downwardairflow exhausting vertically from thecabinet and not towards the operator
PIC/S Guide to good practice for preparation of medicinal products in healthcare establishments-April 2008http://www.picscheme.org/.
Facilities & Equipment
Biological Safety Cabinets (BSC) Re-circulation in BSC of air :0/30/70% Running 24h/day:7 day/week Alarm for insufficient exhaust Alarm for insufficient internal flow External exhaust….pressure BSC Validation 6-12 months
- DOP - Leak - Air velocity- Smoke -Temp -Microbiology- Noise - KI disk
DOP=dioctyl phtalate KI= potassium iodine
ISOPP Safe Handling Standards
Facilities & Equipment
Pharmaceutical Isolator A containment device which utilises
barrier technology to provide an enclosed controlled workspace
Positive or negative pressure Running 24h/day:7 day/week Alarm for insufficient exhaust Alarm for insufficient internal flow Double HEPA air filtration
(inlet/outlet) Preparation with attached rubber
gloves/half suit Validation 6-12 months - DOP -Leak - Air speed - Microbiology
PIC/S Guide to good practice for preparation of medicinal products in healthcare establishments-April 2008 http://www.picscheme.org/.ISOPP Safe Handling Standard
Facilities & Equipment
Surface Environmental Sampling Recommendation USP<797>2008 Frequency:
- Initially
- At least every 6 months
Sample localizations:- Working area of BSCs and CACIs
- Counter Tops (finished preparation)- Areas adjacent to BSCs/ CACIs (Floor)- Patient administration areasBSC: Biological Safety Cabinets
CACI: Compounding Aseptic Containment Isolator
• If measurable level of •Contamination:- Identify cause of contamination
- Document- Contain
- Retraining- Cleaning (high pH soap & water)- Improving engineering controls
Engineering controls improvements
• Venting BSCs/CACIs 100% to outside• Implement CTSD• Re-assessing type of BSCs /CACIsCTSD= Close System Transfer Device
USP United States Pharmacopeia. Pharmaceutical compounding sterile preparations (general chapter 797) in: second supplement to UPS 31-NF 26: 2008
Maintenance of Premise More GMP related but important for the patients safety!! Validation tests for cleanrooms should be performed once a year and
pass standards Some parameters:
- Grade of room (B or C) and workstation (A)- Air changes/hour: 20- Pressure difference: 10-15 Pa
GMP= Good Manufacturing PracticeSingapore Guidelines for Safe Handling of Cytotoxic DrugsISOPP Safe Handling Standards
Tests included:- Particle Count Test- HEPA Filter Patency Test- Temp Test- Humidity Gradient Test- Lighting Level Test- Sound Test- Bacteriological Test
Premises
environmental monitoring
cleaning and disinfection
People
operator broth transfer tests
hand cleaning and disinfection
Microbiological Monitoring
Environmental Control and Monitoring Evaluated by measuring the viable particles in the environment
Count reported as colony forming unit (cfu) per cubic metre is a measure of microbial contamination
Air sampling carried out at least once a month using an air sampler set for sampling 320 litres for 8 minutes
Each sampling exercise must be carried out using two types of agar strips/plates:- TSA for total count at 30 – 35C for 48 hours- Rose Bengal-Agar for yeast and mould 28 – 30C for 120hours
If counts >1cfu per cubic metre no preparations to be done in that cabinet
Remedial actions to be carried out and cause of contamination traced
Singapore Guidelines for Safe Handling of Cytotoxic Drugswww.asia4safehandling.org
Personnel Education, Training & Evaluation
Basic concepts of cytotoxic reconstitution
Written and practical training
Clinical, Pharmaceutical & Chemical drug properties
Facilities, Equipment & supplies
Cytotoxic Reconstitution Documentation
ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile ProductsASHP: American Society Of Health-System Pharmacists
Personnel Education, Training & Evaluation
Proper gowning & gloving technique
General conduct in the controlled area
Principles of “GMP” Cleanroom design Aware of safety measures
on handling CD
ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile ProductsASHP: American Society Of Health-System Pharmacists
GMP: Good Manufacturing Practice
Cytotoxic Drug Reconstitution
Drug Reconstitution With Needle and Syringe
Drug Transfer With Needle and Syringe
Chemospike Filter Needles Dispensing
Pin Closed System Drug-
Transfer Deviceeg:Phaseal, ICU Medical Choice Of Device Dependant on
Degree of Safety & Quality of DeviceISOPP Safe Handling Standards: Must Be Air Tight & LeakProof
Safety Devices/TerminologyClosed system drug transfer device (NIOSH) A device that mechanically prohibits the transfer of
environmental contaminants into the system and the escape of hazardous drugs or vapor concentrations outside the system
US ASHP Guideline QA sterile products Closed system = aseptic transfer of sterile
nonpyrogenic finished pharmaceuticals (e.g. from vials or ampoules) obtained from licensed manufacturer into sterile final containers
NIOSH= National Institute for Occupational Safety and Health, available at www.cdc.gov/niosh
Expiration Dating Should be done on a product by
product basis & be based on currently available drug stability information & sterility considerations
consider all aspects of sterile product, drug reservoir, drug concentration & storage conditions
methods should be documented Should be evidence based with
reference ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile ProductsASHP: American Society Of Health-System Pharmacists
Documentation
Training & competency evaluation of employees in sterile product procedures
Refrigerator temperatures Certification of cabinets Dispensing records for
cytotoxic products Documentation of dose
calculations & batch preparation record
Worksheet preparation
ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile ProductsASHP: American Society Of Health-System Pharmacists
Labeling Patient name and identification Batch no if batch prepared All solution & ingredient
names, amounts,strengths & concentrations
Expiration date ( and time when applicable)
Volume of regimen, flow rate and route Appropriate auxiliary labeling Storage requirements Identification of pharmacist/staff in
charge Contact numbersASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile ProductsASHP: American Society Of Health-System Pharmacists
CYTOTOXIC DRUGHANDLE WITH CARE
End Product Evaluation
container leaks container integrity solution cloudiness particulates in the solution appropriate solution colour solution volume when preparation is
completed verification that product was
reconstituted accurately
ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile ProductsASHP: American Society Of Health-System Pharmacists
Audit
Verify the effectiveness of a quality management system
Hands-on management tool for achieving continual improvement
Audit Tools Can be developed and tested in cancer centres
(with cytotoxic drug preparation service) Can be used to assess current procedures
complies to established standards Areas to look into:
- microbiological testing of facility (air sampling every month)- checking procedures ( drug and dosage errors)- facility maintenance ( cabinets and cleanrooms every 6
months)- staff validation- safety measures among staff ( nurses, pharmacists)
ISOPP Audit Tool
Audit
Report
NegativeImprove
Corrective Actions
Positive Highlight & Share
Audit on Work Process to Complete Prescription Orders In CDR Unit
1. Chemotherapy prescriptions from Daycare Oncology ward from Sept 2011 to Nov 2011
2. Parenteral chemotherapy prescriptions which require preparation in clean room
3. Prescriptions received during office hours on weekdays (Mon-Fri)
Fig1: Summary of the processes involved from prescription indenting in the Pharmacy
system to completion of chemotherapy prescription order
Receive indent from doctors in ward
Printing of cytotoxic drug prescription
Preparation of worksheet and labelling of cytotoxic drugs
Verification & confirmation by pharmacist if the dose or regimen in prescription is ambiguous
Filling of cytotoxic drugs into cytotoxic drug bags
Preparation of cytotoxic drugs in clean room
Dispensing of cytotoxic products on trolley
Collection by staff nurse from wards
32
September– November 2011All Daycare Oncology cases were evaluated
(N=218)
9 cases excluded
3 cases excluded
Receive indent from doctors in ward
Printing of cytotoxic drug prescriptions
Preparation of worksheet and labeling of cytotoxicdrugs
Verification & confirmation by pharmacists if the dose or regimen in prescription is ambiguous
Filling of cytotoxic drugs into cytotoxic drug bags
Preparation of cytotoxic drugs in clean room
Dispensing of cytotoxic products on trolley
Collection by staff nurse from wards Only 206 cases were analyzed in the study
Figure 4: Flow chart on therecruitment and exclusion
of DayCare Oncology Cases
Figure 3: Comparison of mean of time taken for each process
0.09 1.27
6.28
1.97
7.63
44.64
2.69
0
5
10
15
20
25
30
35
40
45
50
Tindent Tprint Twsheet Tverify Tfilling Tprepare Tdispense
Dura
tion
(min
)
Table 2: Time taken from one process to another process
1to 2 2to3 3to4 4to5 5to6 6to7 7to8
n 206 206 206 206 206 206 206
Mean (min) 2.97 ± 1.00 6.30 ±10.732
14.71 ±15.617
7.28 ±10.019
5.15 ±6.515
3.17 ±4.691
48.02±22.510
Median (min) 1.00 2.00 10.00 3.00 3.00 1.00 45.00Minimum (min)
0 0 0 0 0 0 0
Maximum (min)
101 78 103 55 40 30 145
Worksheet
Verify
FillingIndent
Prep
Dispense
1 2 3 4 5 6 7 8
Collect
1.02.0
10.0
3.0 3.01.0
45.0
0
5
10
15
20
25
30
35
40
45
50
1-->2 2-->3 3-->4 4-->5 5-->6 6-->7 7-->8
Dura
tion
(min
)
TrolleyCollection
Figure 4: Comparison of median of time taken from one process to another process
Findings of the Audit:1. Time of preparation
Only one technician reconstituting drugs.
Drug reconstitution is a highly skilled procedure.
Requires full concentration to prevent errors.
2. Time of filling
NF drugs (purchase from kedai farmasi)
3. Time of worksheet
>1 cytotoxic drugs per patient
Change of dose by prescriber, time taken to redo worksheet
4. Trolley to Collection
Delay of collection from ward staff
Only one PK involved in collection
5. Worksheet to Verify
Only one CDR pharmacist to verify all worksheets
Error in labeling done by inexperienced personnel (student & PRP)
Conclusion- The pharmacy should have written policies and
procedures which is- available to all personnel involved in cytotoxic drug preparation
- important for personnel to understand before being allowed to prepare cytotoxic preparations
- allows personnel competency to be assessed periodically
- ISOPP Standard of Practice for Safe Handling of Cytotoxic Agents is a powerful instrument because of its global acceptance and distribution.
- The audit tool completes the standards and helps the hospital to evaluate and progress.
References: ASHP: ASHP technical assistance bulletin on quality assurance for
pharmacy - prepared sterile products:Am J Hosp Pharm. 1993; 50:2386-98
Brier K Leo. Evaluating aseptic technique of pharmacy personnel. Am J Hosp Pharm. 1983;40:400-3
Buchanan E. Clyde, et al. Principles of sterile product preparation. Bethesda, MD: American Society of Health-System Pharmacists, 1995
National Institute for Occupational Safety and Health, available at www.cdc.gov/niosh
USP United States Pharmacopeia. Pharmaceutical compounding sterile preparations (general chapter 797) in: second supplement to UPS 31-NF 26: 2008