Procedure (Non-Hazardous and Hazardous Drug Compounding) Flashcards
P3 - Procedure
All tasks once removed and in support of compounding.
Procedure Addresses
Management Monitoring Maintenance Operational Control Ongoing Certifications Inspections Verifications - Engineering Controls
Procedure Involves
> Safe Handling > Receipt > Quarantine > Inspection > Distribution > Storage > Chemical & Used > Disposable Supplies Disposal > Deactivation > Decontamination > Cleaning > Facility Disinfecting
Procedure Supports
> Emergency measures from incidents, accidents, injury, chemical spills, power outages
Purpose of Environmental Maintenance and Monitoring Program
1> Ensures and takes action to maintain proper function/ operation of the facility’s environment.
2> Ensures that all general maintenance items are recorded in a general maintenance log/ logs that are associated with specific policies and procedures
Policy & Procedure detail
Description of tasks
Associated Policy & Procedure logs include
Task Name, Date, Time, Name of Personnel, Associated numerical values of the task
Tasks to include in Policy & Procedures
> Indicators for Proper Operation > Cleaning > Calibration > Certification/ Maintenance > Surface Contamination Monitoring > Temperatures
Secondary Engineering Control
The controlled environment in which compounds are prepared and stored
Storage Area Monitoring
Temperature and humidity in the designated compounding and storage areas must be maintained, monitored daily and recorded in the associated log
Standard Temperature for Designated Compounding Area
Less than or equal to 20C
Standard Temperature for Storage Area
20C to 25C
Standard Temperature for Refrigerators
2C to 8C (not exceeding 8C)
Standard Temperature for Freezer
-25C to -10C
Relative Humidity inside designated compounding and storage areas
Not Greater that 60%
Environmental Control Measuring Devices
Each facility should have a thermostat and a hygrometer located in a neutral area away from direct sunlight and any vapor source.
Temperature Monitoring
> Information documented and retrievable at any time
Integrated recording device: Checked Daily
Thermometer: Manually checked and recorded twice daily
Air Quality
> Fresh Air supply; quality and quantity
Movement of Air between rooms of different air qualities and pressure differentials
Movement of air within the compounding environment
C-SEC
Containment Secondary Engineering Control.
-2.5 Pa
> 11 ACPH
>Pressure differential continuously monitored
>Alarm if negative pressure gradient is not maintained
> C-SEC externally vented through HEPA filters.
C-SEC & C-PEC Certification
> At the time of installation
At least every 6 months
Repair of equipment or room that may affect environmental or operational parameters
Investigation of a contamination problem/ non-compliance requires exclusion of malfunctioning facilities.
Requirements for Walls, Floors, and Ceilings of the controlled room
> Must withstand any cleaning, disinfecting and decontaminating agents used.
Recording Room Temperature and Equipment (C-PEC) Functionality checks.
Recorded in the maintenance log daily.
Storage Area
> All APIs and excipients must be stored according to manufacturers’ recommendations.
Environmental control is vital to API purity and quality
Temperature related abnormalities
Must be followed by a review to determine if the integrity of any materials was affected.
If the integrity of any materials is compromised by environmental abnormalities (eg Temperature excursions)
> Chemicals of concern need to be segregated and properly disposed of.
Shelve cleaning frequency
3 months
Floors
Must remain free of packages
Storage Area - Hazardous Drugs
> Physically separated from non-hazardous drug storage and preparation areas
Signs must clearly indicate hazardous storage areas
Antineoplastic and other hazardous drugs need to be stored in an externally ventilated negative pressure room (> 11 ACPH)
Refrigerated hazardous drugs must be stored in a dedicated refrigerator in the hazardous drug storage area
Dedicated Hazardous drug storage area
> Restricts access to properly trained personnel
Prevent drug errors & cross contamination of other drug inventory
Minimize exposure and adverse health risks to personnel and the environment
PEC
> A ventilated devise that will protect the worker and the environment from harmful particulates by using high velocity air and HEPA filters.
> Placed in the secondary engineering control (SEC) or designated compounding area.
> Verified annually to ensure that they protect the operator as intended
One of the Biggest Health Risks to Compounders
Aerosolized Powders
PEC Testing
> Assure that the device can maintain an adequate airflow across the intake area (face velocity)
HEPA filter and the enclosure do not leak
Performed by a qualified testing provider using specially designed equipment,
C-PEC
> e.g. Biological Safety Cabinet.
Containment Primary Engineering Controls must be externally vented or internally vented through at least 2 HEPA filters in series.
C-SEC prevents
Hazardous contaminants from escaping the compounding room.
C-PEC
Protects personnel in the direct compounding area
C-PEC + C-SEC
Required to protect personnel who are actively compounding and personnel working in the surrounding environment.
Level of Protection needed depends
> More on the risk posed by the hazardous product than on the complexity of the preparation.
The quantity of a specific API is important in determining engineering requirements,
The cumulative impact of multiple combination of APIs each of which pose an individual risk must be taken into account.
Inclusion of the occasional compounding of a HD preparation influences risk levels
All these factors need to be collated into one definitive decision.
Risk Mitigation
Starts with listing circumstances under which risks may occur: > Receiving > Handling > Unpacking > Inspecting > Storing > Compounding > Dispensing > Shipping > Managing Waste > Spill Control
Determine needed safeguards based on: > Facility > Physical Layout > Day-to-day operations > Total Volume > Raw Ingredient Turnover > Finished preparations Turnover
Receiving Ingredients
in a Designated Area
Shipping Containers, Cardboard boxes and Packing Materials carry dust and dirt, and shed particles.
If a chemical is identified as damaged or compromised during receiving
> It should be immediately segregated so it will not be mixed up with other inventory.
> It should then be returned to the supplier or disposed of.
Damaged Containers
> Represent a significant exposure risk to the environment and to employees by having the potential to contaminate the air and surfaces as liquids, powders, aerosols and vapours.
Shall be considered contaminated and proper segregation techniques are to be employed.
Spill Kit
Must be available in the receiving/ storage area.
If a shipping container containing a hazardous drug is damaged
> Ship it back to the supplier
Package the damaged shipping tote in a second non-permeable container
label with a hazard label
contact the supplier to obtain further instruction
If a hazardous drug package container is identified as damaged after removing it from the shipping tote
> Treat it as a hazardous drug spill.
Don two pairs of chemotherapy gloves, a non-permeable disposable gown, eye protection and a chemical cartridge respirator
Unpack it in a Class 1 BSC
Follow the appropriate procedure to contain the spill and discard utilizing proper waste management for hazardous drugs.
Discard drug/ vial/ bottles and shipping container as hazardous waste.
Diminish/ Eliminate potential hazard to compounding personnel by
> First Aid supplies, safety and emergency equipment eg fire extinguisher and retardants accessible to everyone at all times
Emergency supplies and equipment located in well identified designated areas
Training regarding safety items provided on an ongoing basis
Following proper procedures and using safety equipment
Use of SECs and PECs + PPE
Personnel who know how to respond quickly and appropriately can reduce the degree of injury
Rules when working with chemicals
> Never taste or smell chemical agents
Read chemical container labels at least twice to confirm name, concentration, or strength
Be familiar with cautionary notations on chemical labels before they are used
Report and record discrepancies between labels and container content if they occur
Never return chemicals to their original storage container once they have been removed from their original container - This includes any overage during weighing
Dispose of chemical waste in an appropriate manner and by appropriate means
Globally Harmonised System of Classification and Labelling of Chemicals
is a single internationally agreed system of chemical classification and hazard communication through labelling and SDS.
> Classifies physical, health and environmental hazards
> Precautionary statements describe the recommended measures that should be taken to minimise or prevent ADE resulting fro exposure, improper storage or handling of hazardous chemicals.
> Categorises precautionary statements according to whether they relate to prevention, response, storage, and disposal.
GHS Chemical Symbols
There are eight hazard pictograms in the GHS that represent physical and health hazards
Acid & Base storage
> stored separately from each other, ideally in cabinets or containers that offer secondary containment.
small quantities - plastic bins ok.
larger quantities - dedicated corrosive product storage cabinets
transporting from storage, secondary containment such as polyethylene carriers should be used
stored near the floor to minimize the risk of splash if a glass container is dropped or falls from a shelf
pour acid in water not the reverse
add the acid slowly while stirring
Cleaning and Sanitizing
> All surfaces and equipment used in compounding need to withstand the cleaning and sanitizing agents.
No residue left on surfaces by cleaning and sanitizing agents after cleaning.
Personnel need to know all policies and procedures related to general and hazardous cleaning procedure.
Personnel must be trained and found to be competent to fulfill responsibilities - including donning appropriate PPE while engaged in cleaning
Cleaning supplies stored in a way that reduces cross-contamination/ disposable wherever possible
Reusable supplies need to be washed and disinfected between uses.
Cleaning schedule that reflects cleaning activities in the facility must be implemented
Spills and splashes must be cleaned immediately (eg powder residue on the balance pan/ drop of wetting agent on the counter)
Work surfaces cleaned regularly and free of non-viable particulate and visibly free of viable particulate
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Work Surfaces
- Beginning of each shift
- End of each shift
- After spills
- When surface contamination is known or suspected
- Between compounding preparations of different components
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Floors
- Daily for HD rooms ( also recommended for non-HD rooms)
- After spills
- When surface contamination is known of suspected
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Walls
- At least once a year and more frequently if necessary
- When surface contamination is known or suspected.
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Celings
- When visibly soiled
- When surface contamination (splashes) is known or suspected
- At least once a year
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Storage Shelving
- Every 3 months (recommended)
- When surface contamination is known or suspected
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Containment Ventilated Enclosure (PECs and C-PECs)
- At least daily when in use
- End of each shift
- Before and after certification
- Any time that voluntary interruption occurs
- If ventilation is moved
- After spills
- When surface contamination is known or suspected
- Between compounding preparations of different components
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Sink
- When visibly soiled
- At lease once a day (with detergent)
- Before and after compounding equipment are washed
Minimum Frequency for Cleaning and Sanitizing Surfaces and Equipment - Reusable devices and equipment
- Before first use and thereafter in accordance with the manufacturer’s recommendations
- After compounding preparations with different components
- Should be rinsed with purified water after cleaning; it is not sufficient to use only isopropyl 70% as the cleaning agent.
Deactivation, Decontamination, and Cleaning
- General rules for areas, equipment and surfaces prior to during and immediately following hazardous drugs manipulation:
> Hazardous drug containers (raw or finished) must be wiped down with a deactivation/ decontamination agent then isopropyl alcohol to remove possible contaminant.
> Floors, walls, ceiling, shelving, storage areas and work surfaces must be deactivate and decontaminated to remove hazardous drug residue. Residue from deactivation/ decontamination should also be removed using isopropyl alcohol
> C-PEC must be deactivated and decontaminated, and then cleaned immediately after use
> The area under the C-PEC work tray should be cleaned monthly
> Safety data sheets of all deactivating, decontaminating and cleaning agents must be easily accessible to personnel
Deactivation
Purpose: Render compound inert or inactive
eg: As listed in the HD labeling or agents incorporating EPA-registered oxidizers e.g. peroxide formulations, sodium hypochlorite
Decontamination
Purpose: Remove HD residue
eg: Materials that have been validated to be effective for HD decontamination or proven effective through testing eg alcohol, water, peroxide, sodium hypochlorite
Cleaning
Purpose: Remove organic and inorganic material
eg: Germicidal detergents, surfactants, water etc.
Waste Management
Includes Disposable items eg: weigh boats, syringes, PPE
Chemical Waste
> Must be disposed of separately
Drug waste disposed of according to guidelines published by the Canadian Environmental Protection Authority and applicable provincial/ territorial jurisdiction.
Designated Waste Management Area
Refuse generated during compounding and from general facility maintenance should be regularly removed from compounding area and placed in a designated waste management area.
Waste Management
> Prevent dispersal of particulates by removing bags from waste containers with little agitation at a time when active compounding is not in progress.
> Waste containers should be large enough to hold the amount of waste produced and the waste containers cleaned.
> Hazardous and chemotherapy waste must be handled separately from other waste
> Hazardous waste containers must be clearly marked and never filled more than three quarters.
> Any disposable items + PPE that have been in contact with hazardous materials are considered hazardous (e.g. outer gloves).
Accident
An action or situation in which the risk event occurs and has/ could have an impact on the health status or well being of the user (patient), personnel or a third party,
Incident
> An incident is an action or situation that has no impact on the health status or well-being of the user (patient), personnel or any third party, but that does have an unusual result that could, on other occasions, lead to adverse consequences.
Corrective Action &/or Preventative Action
All incidents and accidents need to be identified, reported, documented and evaluated.
Policies and procedures should be in place in the event of accidental exposure of personnel to any of the items listed
- Deactivation, decontamination, and cleaning agents
- Non-hazardous drug products
- Hazardous drug products
- Excipients
Information and products should be readily available and accessible at all times
- Safety data sheets, for products that have one
- Eyewash station and sink with hot and cold running water
- Deluge shower
- Emergency contact information;
- Spill kits
- Emergency spill-related PPE; includes chemical cartridge respirator equipped with a pre-filter for organic vapours
Spill Control
Negative consequences of inappropriately managed spills:
- Immediate injury, damage or irritation of skin, eyes and other tissue, for example, from strong acids or bases and other irritating substances.
- Respiratory damage from inhalation of toxic fumes.
- Systemic effects or chromosome damage from transdermal, respiratory or other absorption of chemicals, such as hormones and chemotherapeutic agents.
- Long-term effects from chronic exposure to chemicals that may have been left in the environment from spills which are not cleaned up or improperly cleaned up.
Spill Kit Location
A spill kit must be available in the compounding area in case of accidents.
Spill kits should be strategically located based on facility size, design, and workflow.
Location(s) are determined on the basis of where HD’s are handled (e.g., receiving, quarantine area, storage units, compounding rooms, waste disposal areas).
Types of spill kits
- Universal Spill Kits (oil, water-based liquids or chemical spills)
- Chemotherapy spill kits
- Acid spill kits
- Base spill kits
Spill - Priorities
> The first priority is to address any injuries or personal contamination as a result of the spill.
> An incident/accident report must be completed after the event.
> Other personnel can manage the spill while any affected personnel seek first aid and medical treatment. PRN
Spill Risk
> Based not only on the quantity, but on the potency and the particular hazard posed by the spilled substance.
> Even a small chemical spill can pose a significant hazard.
Track and Traceability
1. Vendor Qualification
Verified that the suppliers are in good standing with regulatory agencies and have appropriate quality control measures.
Track and Traceability
2. Chemical Selection
I have selected the required grade and pack sizes of required chemicals I have ordered.
Track and Traceability
3. Order Placed
Purchase order is placed. I am awaiting the receipt of the chemicals.
Track and Traceability
4. Shipment Tracking
Package is being tracked. I will be alerted with the status of my shipment.
Track and Traceability
5. Order Received
I have entered into my inventory management system the receipt of my shipment. I have advised the inventory manager that the chemicals received are in quarantine. I cannot utilize the chemical until it has been examined.
Track and Traceability
6. Order Quarantined; Inspection/ Return of Damaged Goods
An item received is out of specification or has arrived damaged, at the wrong temperature, or did not meet any other
number of conditions.
I will notify the customer service department of the distributor and obtain a return authorization form to send it back.
I will order its replacement.
Track and Traceability
7. Chemicals Labeled
The chemical has been examined successfully and is now assigned an internal label.
This label may include:
> items from the safety data sheet that will describe how to handle and store it.
> purity information that
could serve to aid in calculating a compounding worksheet.
> an internal bar code and pricing
information.
Track and Traceability
8. SDS & CoA
> SDS and CoA may be obtained from the distributor automatically with the order, faxed upon request, or downloaded directly from the distributor from a secure server.
Track and Traceability
9. Chemicals in Storage
Chemicals will be stored according to P&Ps for handling non-HD and HD active pharmaceutical ingredients and excipients.
Track and Traceability
10. Bottle Almost Empty
> A set point/threshold and re-order amount will determine when to re-order this ingredient.
> Once crossing this threshold,
a certain number and size of packages will be re-ordered.
> If a chemical is expired, the item may be re-ordered.
> Where
applicable, verify the utilization report to determine whether there is sufficient use of this product to require it to be re-
ordered.
> Expired items need to be quarantined and discarded appropriately.
Track and Traceability
11. Chemical Expired/ Residual to Waste Management
> Dispose of residual chemicals as per waste management P&P.
> If the chemical is in its original container and expired, the use of a specialized waste management company may be required.
> Perform vendor qualification to ensure that the waste
management company is appropriately qualified.
> For controlled substances, ensure that they are also registered with
appropriate government agencies. The company should be compliant with any province/territory-specific requirements.
Track and Traceability
12. Chemical Required in CR
Track chain of custody and ensure traceability for chemicals used in formulas.
Track and Traceability
13. Chemical Accountability in Formulation
> It is important to keep vigilant control of the quantity of each chemical in perpetual inventory to enable the pharmacist
and pharmacy technician to verify their work, ensure the quality of the preparation, and for the accountability/integrity
of the inventory.
Ways to achieve this could include:
> bar code scanning,
> balances tethered to a computer software
program, or
> printouts from the balance attached to the compounding record.
Track and Traceability
14. Chemical Spill - Partial Loss/ Chemical Loss Accountability
Chemical loss from a spill must be recorded and handled according to the designation/class of drug.
Proper training and disposal should take place as part of routine and ongoing pharmacy training.
Take the time to analyze procedures to
mitigate this loss in future.
Parameters could include safe handling and storage, spill drills, package size selections,
weighing and measuring techniques, and other unidentified causalities.
Track and Traceability
15. Finished Prep in Quarantine
Once I have compounded my preparation from the CR, the finished preparation needs to be inspected and the compounding record reviewed.
Track and Traceability
16. Finished Prep Inspection
An inspection area with good lighting is set up for preparation inspection.
The preparations within the inspection area
are still within the pharmacy’s chain of custody and must be accounted for.
Track and Traceability
17. Labeling Packaging
The finished preparation can now be labeled and moved to the shipping area, or the holding area awaiting customer
pickup at the store.
These items remain in the custody of the pharmacy until such time as the delivery service or customer has signed for them.
HD medications can be stored in the C-SEC. or other controlled environment, until time to pick-up.
Track and Traceability
18. Sample Prep Sent to Lab
As part of the quality control program, samples are routinely sent to an external testing laboratory to examine the
potency of compounded preparation; sterility and endotoxin testing would be reserved for sterile compounded preparations.
Track and Traceability
19. Packaged Medication Awaiting Pick-Up
The compound may remain in the waiting bins if billed to a third party for only a short period of time. If the patient does
not pick up the preparation, then the claim must be reversed. Some HD compounded preparations would be held in HD storage in a controlled environment.
Track and Traceability
20. Package Dispensed
The point of sale (POS) system reports to the dispensing software that the prescription has been picked up and is now in the custody of the patient.
Track and Traceability
21. Packaged Medication Enroute to Patient
The pharmacy needs to take extra precautions to package the preparation in a manner that maintains the preparation within controlled environment specifications during its transport.
Track and Traceability
22. Shipment Tracking
Package is being tracked. The status of the shipment is being verified.
Track and Traceability
23. Packaged Medication Received by Patient
Track the prescription and obtain proof of delivery, which is different from a tracking number. This task must be done promptly as tracking and proof of delivery are not stored on servers indefinitely.
Track and Traceability
24. Controlled Substance Stolen
Stolen controlled substances need to be reported to the appropriate agency. Chemical inventory needs to be completed. Reports can be attained from security cameras and alarm sensor intrusions.
Track and Traceability
25. Report Submitted to Authorities
A report, would need to be filed as it pertains to lost or stolen controlled substances. The stolen inventory must be
removed from the database to restore an accurate record of what remains in the pharmacy’s chain of custody.
Track and Traceability
26. Report Submitted to Provincial/ Territorial Authority
Depending on the province/territory, it may be necessary to report chemical loss to the appropriate provincial/territorial authority. This discrepancy report should be accompanied by the inventory report.
Stolen chemicals, depending on the province/territory, may need to be reported to the police and the provincial college.
Track and Traceability
27. Chemical Stolen
Chemical inventory needs to be completed. Regardless of the cause of the theft, the amount of chemical missing must be determined. Once the amount and scope of chemical missing has been determined, reports can be attained from
security cameras and alarm sensor intrusions.
Track and Traceability
28. Insurance Claim Submission
If the loss is substantial, a claim could be initiated to the insurance company. Money from the settled claim may be utilized to recover stolen inventory.
