Hazardous and Nonsterile Compounding and Pharmacy Management

Preparing a Hazardous (Chemotherapy) Preparation Continued

(10) Discard unneeded items except vial, mat, and prepared compound. Lay out both the syringe drawn back to the amount added and the drug inside the BSC and ask for a pharmacist check. (11) Once the bag is checked, it can be removed. While still sitting at the BSC, discard trash and medication in the appropriate containers (yellow sharps for the syringe, needle, medication) and yellow container for the mat, only the OUTER pair of gloves, supplies, and any other items left in BSC. (12) Remove PPE (HD) including the INNER (second) set of gloves outside the BSC and place in larger hazardous waste container in the ISO Class 7 area. (13) Wash hands again in the ante area before leaving the sterile compounding area.

Kit-splitting

(fractionation) dividing a kit's vial contents to transfer aliquots into other containers.

The ISO Class 5 PEC used for preparing HDs requires a controlled (C) PEC, such as:

- A Class I or II biologic safety cabinet (BSC) - A containment ventilated enclosure (CVE) - A compounding aseptic containment isolator (CACI) - C-PECs must be externally ventilated and move air downward through a high-efficiency particulate air (HEPA) filter (rather than toward the compounder). - Large hospitals will have a sperate department or area for chemotherapy infusion compounding.

Purchasing and Medication Shortage Management

- Sources for inventory will vary from one facility to another depending on their patient population, and medication can be purchased from a drug manufacturer or purchased through agreements with drug wholesalers (stock medications from multiple manufacturers). - Purchase orders (PO) are documents used to order and track ordered items. - Just-in-Time: allows for a minimum inventory amount to be kept. - Shortages can cost more money for the facility if the alternative medication costs more. - The best way to control inventory is visually. - Based on usage, create a periodic automatic replenishment (PAR) level of all medications (the minimum amount of a specific medication that's on hand). Ex. PAR level is 100 units, purchaser will reorder medication when it reaches 100 units. - Maximum levels should also be noted and maintained so no medication expires before it's used. - Max and min levels can fluctuate based on the season (ex. influenza vaccines). - Ordering is done by using a tracking system that involves the National Drug Code (NDC) numbers and bar codes.

Radiation Detection and Measuring Devices

- Personnel who are handling radiopharmaceuticals must wear extremity dosimeters. - Devices used to measure long-term radiation exposure and are usually worn on the ring finger and under the glove. - Body dosimeters can be used and worn under the gown. - Measuring devices may be placed inside the ISO Class 5 PEC.

Special Considerations, Techniques, Equipment and Precautions

- Placement of items in the C-PEC should allow for the air above each item to be unobstructed during manipulations. - As trash is accumulated, discard it to the side of the workspace in a puncture-proof container marked as hazardous. - Any open liquids should also be discarded in this container. - Other materials used (wrappers and alcohol swabs), which had minimal exposure, can be placed in a sealed plastic bag and transferred to a container outside the hood. - If possible, open packaging, such as syringes, tubing, and plastic bags, before opening the HD. (This trash may be thrown away in a regular bag.) - IV tubing should be primed (allowing fluid from the IV bag to run through the IV tubing; the administering personnel normally completes this directly before administration) before adding the cytotoxic agent to the IV bag. - Spray most often occurs with withdrawing the contents from a vial; therefore, a closed system vial transfer device (CSTD) must be used when the dosage form allows. - CSTD allow the air to escape through the closed system rather than in the air (decreasing chances of spray).

Regulatory Organizations

- Radiopharmaceuticals fall under the control of the US government's Nuclear Regulatory Commission (NRC) as well as the US Food and Drug Administration (FDA). - Federal and state organizations limit radiation exposure to all personnel who handle radiopharmaceuticals and require detection and measuring devises to be used. Time: - The time that aseptic preparation of radiopharmaceuticals is performed must be balanced with the exposure time to the medication. - The ALARA, or "as low as reasonably achievable," practice is used to ensure safety and the least exposure time to radiopharmaceuticals. - Measuring devices must be used to allow the compounder to know the exposure readings. - Limit the time and hand movements in and out of the ISO Class 5 environment. Distance: - The closer to the radioactive material the person is, the more exposure is received. - There are tools that can be used to allow more space between the compounder and radiopharmaceutical. Shielding: - Special equipment, such as shields made of lead or tungsten, are used to protect the compounder from exposure to radiopharmaceuticals. - Torso vests and L-blocks (mini walls) can be used.

Special Storage and Delivery Considerations

- Some events provide an opportunity for planning, such as the preparation of batches or extra medications in preparation for the loss of electricity or supplies. - Requires additional stocking and ordering ahead of medications and supplies. - Common items to consider purchasing an addition supply of include syringes, needles, coolers, ice packs, (PPE, alcohol-based hand sanitizer), and medications.

Examples of Sterile Radiopharmaceuticals

- Sterile radiopharmaceuticals: injectables, including intravenous, subcutaneous, intraperitoneal, inhalations, opthalmics, intradermal, and intrathecal dosage forms. - Usually packaged in vials using aseptic techniques. - Radioisotopes are often used for diagnostic procedures, such as imaging tests. - Examples include: Gallium, Technetium Tc99m lidofenin, Technetium Tc99m mebrofenin. - Certain cancers of the bone, thyroid, or prostate use radioactive drugs. - Examples include: Radioactive iodine, Strontium, Samarium, Radium.

Quality Controls and Testing

- Surface sampling, media fill testing of personnel, and daily monitoring of temperature and humidity are required. - Cleaning and disinfecting are performed daily for the PEC, torso shield, surfaces (such as sink, hot-cells interior), and equipment within the PEC. - Walls, ceiling, and storage shelving should be cleaned and disinfected monthly, and sporicidal should be used.

Supplies and equipment used for administering are also billed using the same coding system. Some examples are below:

- Syringes and needles for flushing peripherally inserted central catheter (infusion line) - IV pole (if stationary pump is used) - IV pump (if applicable) - Gloves - Alcohol swabs - Heparin and saline for flushing the IV line between administration - Sharps container - Batteries (back up for electrical outages)

If an ampule is used during compounding an HD:

- Tap down any drug from the top of the ampule and put gauze around the neck when you break it. - Change the standard needle to a filter needle/filter straw before withdrawing from the ampule. - Dispose of any remains of the ampule in the puncture-proof container.

Additional Considerations

- The BUD (beyond-use-date) is based on the time when the first puncture into the vial septum occurs. Considerations: - Radiochemical stability - Radionuclidic purity: radioactive materials decay over time (material breakdown and loses energy) - Age of generator: natural chemical changes to the atoms and nuclides of the material - Specific activity - Number of particles

Planning Requirements for Disasters

- The National Boards of Pharmacy (NABP) developed a guide known as "Recommendations for Preparing and Responding to an Emergency or Disaster." - Under this guide, state boards of pharmacy are encouraged to develop plans more specific to their community's needs.

Immediate Response

- The initial response is often coordinated by key agencies to provide food, water, and essentials to life first. - Staying current on tasks, drills, and education. Ex. staying current on immunizations, CPR certification, and additional training related to assisting victims. - Before medication can be distributed in situations such as hurricanes, floods, or tornadoes, the victim's safety and control over their medication come first. Determining the risks associated with a location must be determined with the following guidelines: - Hot zone: area where the event took place - Warm zone: are at least 300 feet from the event - Cold zone: area close to the warm area but away from the event

Medical Surveillance

- The new USP guidelines include a comprehensive exposure plan. - Plan reviews the protection provided by environmental controls, practices, and education. - Workers are monitored for health changes due to exposure to HDs.

Transporting Guidelines

- The ports or generator needle must be capped with sterile protectors within the ISO Class 8 environment or better. - Use special leaded containers to deliver doses. - Use USP for sterile and USP for nonsterile compounding for guidance.

Inventory Management Considerations

- There are specialized engineering controls for HDs and certain areas must have negative pressure. - HDs should not be stored on the floor or in areas that are at high risk for flooding or high traffic. - Inventory processes should occur in a neutral or negative pressure area. - There should be a dedicated refrigerator for the store of HDs that's separate from other stock. If shipment appears to be damaged, the following guidelines should be observed: - Container doesn't require opening: Label it as "hazardous" and return it to the wholesaler or manufacturer. - Container is broken or opened: Open it in the controlled primary engineering control on a plastic-baked mat, then wipe the outside and place it in a plastic bag. Then, either return the HD or dispose of it after.

Mechanics of Inventory Control

- There must be medications to prepare all IV compounds ordered, but not an excessive amount that will expire before the medication is used. - Ordering the most cost-effective package size is crucial for costs savings. - If a pre-mixed bag (IV bag that's ready to administer and doesn't require compounding) of 200mg of furosemide costs $10, but a vial of furosemide 200mg costs $5, you would then have to further evaluate the costs of time to prepare (this will vary based on the complexity of the compounding) and beyond use dating (IV room compounded medications have a short BUD date) to the determine the most cost-effective way to purchase this medication. - Facilities will have a purchasing team (often with pharmacy technicians) that evaluates and makes purchasing decisions.

Cleaning

- Trained personnel must clean up spills immediately. Garb should include: - Outer pair of utility gloves - Inner pair of chemo gloves - Gown - Eye protection - Respirator (if aerosol droplets or powders are present) - If a large spill occurs, restrict the area and use an absorbent pad. - Use standard chemotherapy spill kits if available. - Spills on the skin need to be washed with soap and water immediately. - Contact with the eyes should be followed by a three-to-five-minute eye rinse.

When CSTD aren't available:

- Use caution to avoid pressure build-up inside the vial. - When adding diluent to a vial, inject slightly less air into the vial than required to maintain "negative" pressure. - Keep the access pin or needle in the vial when measuring the dose. - When removing the syringe from the vial, use a steady, slow motion. - When removing air bubbles from a syringe, clear any solution from the hub of the needle by drawing additional air into the syringe (ensuring no medication leaves the closed system). - Any excess drug that needs to be removed from the closed system should be expelled into a closed container, known as an empty evacuated container.

Every compounder must undertake annual refresher training. Core competencies include the following:

- Visual observations - Sampling - Media fill - Cleaning - Disinfecting

Supplies used for hazardous drug preparation:

- Yellow disposal containers (verses red): Marked with "Caution: Biohazardous Waste" or "Chemotherapy Waste" - Special spill kits - Chemo gloves (thicker form of gloves): For hazardous drugs, double gloving is required. - Use of a preparation mat (in case of spillage) - Gowns that close in the back with closed cuffs of elastic or knit - Yellow (marked chemo or HD) bags and red disposal bags or biohazard bags for trash should be used instead of regular trash bags

Patient Rights of Administration

Patients are guaranteed certain rights when it comes to receiving medications. These rights include the following: - Right patient: Be certain that names, birth dates, and any other identifying information specific to the patient is checked, when interpreting the order and preparing the IV therapy. - Right medication: Check the order for accuracy and completeness. - Right strength: Check the order for the correct dosage or strength and label it accurately. - Right route: Check references for the appropriate route, such as IV push, piggyback, or intramuscular (IM) injection. - Right time: Verify the directions for the proper intervals for infusion, for labeling, and for the storage requirements.

Complaint Handling and Reporting of Adverse Events

The complaint must be kept, and documentation must include: - Name of complaint - Date received - Nature of complaint - Any identifying information, such as name and strength of CSP, lot number, or prescription number - Any findings and follow-up - Goal of this process is to prevent future occurrences, ensure patient safety, and provide solutions that will be customized based on the complaint. - Reporting of adverse events is part of the QA process and must be reviewed promptly and assessed for further action or reporting to the FDA through MedWatch.

Disaster Medical Assistance Team (DMAT)

a team that sets up temporary treatment medical sites to treat burns and mental health emergencies.

Media fill test

a test designed to access the quality of compounding processes or aseptic technique of personnel by using a microbiologic growth medium.

Supplemental engineering control

an additional control used along with a primary or secondary engineering control, such as a BSC (biological safety cabinet), which is used to enhance protection from an HD.

CSPT (Certified Sterile Processing Technician)

an advanced certification in sterile compounding offered by the Pharmacy Technician Certification Board (PTCB).

Antineoplastic agent

an agent that prevents the development or growth of malignant cells.

Disaster

an emergency that requires outside assistance.

Emergency

an event which affects public safety, health, or welfare.

Responsible person

an individual who is held accountable for an activity.

The National Pharmacy Response Team (NPRT)

an organization which proves mass immunizations and is made up of pharmacy technicians and pharmacists.

Cytotoxic agents

antineoplastic agents that kill dividing cells.

Hazardous Drugs (HD)

antineoplastic and other drugs considered hazardous, as identified in the National Institute for Occupational Safety (NIOSH). Hazardous drugs are categorized in the following order: - Any active pharmaceutical ingredient (API) that's considered hazardous. - Any antineoplastic (chemotherapy agent).

Active Pharmaceutical ingredient (API)

any substance or mixture of substances used in the compounding process.

Deactivation

changing an HD to a less hazardous substance on surfaces by use of heat, sterilization, light.

Electronic health record (EHR)

computer-based record that records patients information to include demographic information and overall medication and medication information.

Chronic anemia

condition where there is a prolonged loss of red blood cells.

C-PEC

controlled primary engineering control, such as the class II BSC (biological safety cabinet).

National Incident Management System (NIMS)

established by the Department of Homeland Society to manage the coordination and support of needed facilities and establish guidelines for responders to understand ways to assist before, during, and after an emergency.

Dynamic operation condition

existing conditions in the segregated radiopharmaceuticals compounding processing area (SRPA) or classified area, where compounding activity is taking place.

Point of Care (POC) testing

immediate tests performed in pharmacies.

Disaster Mortuary Operations Response Teams (DMORT)

made up of mortuary directors, pathologists, dental assistants, medical examiners, medical record technicians, and mental health staff, which are responsible for identification of victims and support family members in the grieving process in a disaster or emergency event.

Radio assay

measurement with a special device for amount of radioactivity present in a container.

Drug Use Evaluation (DUE) or Drug Use Review (DUR)

methods to evaluated medication usage to ensure that medications are being used appropriately. The Joint Commission has created nine steps for the DUE process: (1) Assign responsibility and obtain administrative approval to conduct DU, performed by the P&T committee. (2) Delineate scope of drug usage within the organization: Review of drug literature and clinic practice guidelines. (3) Identify specific drugs that should be monitored and evaluated: High-risk high-usage, or high-cost drugs. (4) Identify indicators: Develop criteria for a drug to be used. (5) Establish thresholds: Establish the limits for optimal use of a drug. (6) Collect and organize data. (7) Evaluate drug use. (8) Perform actions from information gathered to improve drug usage. (9) Communicate the findings and improvements to the appropriate responsible parties.

Pharmacy Patient Care Process (PPCP)

plan designed to assist patients in their overall wellness and disease management.

Release testing

process to ensure that a compounded sterile preparation (CSP) meets a predetermined set of requirements or characteristics.

ALARA

represents "as low as (is) reasonably achievable." The effort of maintaining exposures to ionizing radiation as low as possible.

C-SEC containment secondary engineering control

room with fixed walls with airflow and pressure requirements where the C-PEC is placed.

Standard operating procedures (SOPs)

set of procedures, including environmental controls, personnel training, and validation of technique, to ensure the sterility of all CSPs.

Metastasize

spreading of cancer cells to other organs or tissues.

Malignant

tending to or threatening to produce death; a neoplasm that is cancerous and opposed to benign.

Quality control (QC)

the actual sampling, testing, and documentation of quality assurance results or evidence to ensure a quality protect.

Segregated radiopharmaceutical processing area (SRPA)

the designated area that contains the PEC, where the radiopharmaceutical compounding takes place.

International Medical Surgical Response Team (IMSRT)

this team performs as an operating room in the field and manages major traumas.

Chemotherapy

treatment of disease with chemicals that destroy disease-causing cells. - Cells of the oral mucosa, gastrointestinal tract, bone marrow, and lymph tissues grow rapidly; therefore agents have high side effect rates. - Can be administered in an inpatient setting or an outpatient setting. - Medications will be given as outpatient infusions since these patients are often immunosuppressed.

Decontamination

using chemicals to remove, deactivate or neutralize an HD substance.

Quality Assurance Practices

- A QA program is a way to monitor, evaluate, correct, and improve all aspects of compounding sterile preparations. Per USP guidelines, the program should address: - Personnel qualifications and required training - This includes periodic reviews of files for qualifications (performance competencies including handwashing, proper garbing techniques, cleaning and disinfecting procedures, and aseptic manipulation skills) and completion dates for training (glove fingertip/thumb and media-fill testing). - Design and maintenance of the environment - Ensure that environment and facilities are being assed and maintained per the guidelines - Any records outside the defined limits for air or humidity, storage temperatures, and results from outside certifications or testing of equipment must be retained and reviewed. - Component selection and handling - Ensure quality of components from the US Food and Drug Administration (FDA) qualified vendors and proper inventory and disposal. - Actual compounded processes - Review and maintain SOPs and master formulas. - There must be processes for investigations of any deviations or errors found (ex. route cause analysis). - Final release of CSPs procedures - This should include the types of inspections that are required before the release of each compounded CSP. Documentation - This should include the SOP creation and review or change procedures. - Evaluate the overall compliance regarding compounding sterile preparations.

Class of chemotherapeutic agents used in intravenous therapy:

- Alkylating agents: These attach "alkyl groups," or side chains (chemical structures), to the proteins within the cancer cell and interfere with their function. Ex. Carboplatin, cisplatin, cyclophosphamide, and mechlorethamine oxide Mustargen. - Antitumor antibiotics: These antibiotics interfere with the DNA or RNA synthesis. Ex. Bleomycin, doxorubicin (Adriamycin), mitomycin, and dactinomycin (Cosmegen). - Antimetabolites: These substances replace, compete with, or antagonize a metabolic or body function by interfering with cell metabolism. Ex. Methotrexate (Rheumatrex Dose Pack, Trexall), fluorouacil (Adrucil), cytarabine, and gemcitabine (Gemzar). - Hormones: Antagonize certain reproductive tumors and accessory tract organs by altering hormonal balance. Ex. Fulvestrant (Faslodex), leuprolide (Eligard, Lupon), and triptorelin pamoate (Trelstar). - Enzyme inhibitors: Interfere with tumor enzymes. Ex. Asparaginase (Elspar), irinotecan (Camptosar), and pegaspargase (Oncaspar). - Immunomodulating agents: Inhibit growth of the cells. Ex. Aldesleukin (Proleukin). - Miscellaneous agents: Interfere with cellular division. Ex. Vincristine (Vincasar) and vinblastine (Toposar).

Environmental Cleaning Guidelines

- Areas where HDs are handled must be deactivated, decontaminated, disinfected, and cleaned. - Deactivation: Used to make a compound inert or inactive. Ex. Hypochlorite, hydrogen peroxide - Decontamination: Removes HD residue. Ex. Alcohol, water, hydrogen peroxide, sodium hypochlorite. - Cleaning: Removes inorganic or organic material. Ex. Germicidal agent - Disinfecting: Destroys microorganisms. Ex. Sterile alcohol or other EPA-approved disinfectant.

When the admixture is complete:

- Check the IV bag for leakage. - Wipe the entry port and place it in a sealed bag. - Label (drug container and the sealed bag) with: "Caution: Hazardous Drug. Handle with Gloves. Dispose of Properly."

Personnel Training and Qualifications

- Compounding personnel must have additional training and knowledge of radiopharmaceutical exposure risks. - Necessary competencies include aseptic technique, garbing, PEC cleaning, media fill testing, and gloved fingertip sampling. - Must be completed/reviewed every 12 months. - Anyone who has rashes, sunburn, recent tattoos, or respiratory infections should be assessed because these conditions could increase the risk of exposure.

Documentation and Labeling

- Documentation should include maintaining a Master Formula Records (MFR) if compounding a radioactive preparation with minor deviations. - Labeling requirements are governed by several agencies, including State Boards of Pharmacy and federal agencies. Some requirements of the INNER label include: - Standard radiation symbol - The words "Caution-Radioactive Material" - Radionuclide and chemical name - Radioactivity (units at the time of calibration) The OUTER label includes: - Standard radioactive symbol - The words "Caution-Radioactive Material" - Radionuclide and chemical name - Radioactivity (units at the time of calibration) - Volume dispensed - Number of dosages - BUD

Labels for CSPs should include accurate:

- Dosage - Names of all ingredients - Total volume - Route of administration - Storage conditions

Environment

- HD sterile compounding must take place an in ISO class 5 or better environment. Acceptable C-PECs for compounding of HDs are: - Class II biologic safety cabinet (BSC) - Compounding aseptic containment isolator (CACI) The C-PECs must be placed in a containment secondary engineering control room (C-SEC): - C-SEC air exchanges: At least 12 air changes per hour and externally vented. - C-SEC must have fixed walls in the ISO Class 7 room. - Must monitor air exchanges, temperature, and humidity. - A sink must be places at least one meter from the entrance to the negative pressure buffer room. - A closed-system drug transfer device (CSTD) protects the compounder from exposure to aerosols when the medication is withdrawn from a vial.

Other compounding notes:

- HDs must be stored separately from other inventory. - Wearing appropriate chemotherapy gloves and other required personal protective equipment is required with all handling of HDs. - Limit access to HDs. - When wearing double gloves, tuck the cuff of inner glove under the gown sleeve, and tuck the cuff of the outer glove over the gown sleeve. Follow these steps for removal of gloves and gown once compounding is complete: (1) Remove the outer pair of gloves in the BSC and place them in a sealed bag. (2) Remove the gown. (3) Remove the inner pair of gloves and discard all the items in the hazardous waste container.

The PEC (laminar airflow workbench (LAFW) or biologic safety cabinet (BSC)) must be placed in a classified area:

- ISO Class 7 or better buffer room - ISO Class 8 or better ante room with fixed doors and walls - When using a LAFW, the airflow must be vertical and high-efficiency HEPA air. - BSCs must have an open front and inward and downward airflow that's HEPA-filtered. - Temperature, humidity control, and cleaning of surfaces to include walls, floors, and ceilings, and surfaces follow the USP guidelines. - A hot cell may be used to provide a segregated ISO Class 5 processing area. - Hot cell: a device that allows the operator to work remotely and outside of the PEC, limiting exposure distance.

Each encounter with HD needs to be reviewed and evaluated to ensure all personnel are properly protected. Some examples of exposure are:

- Inventory process - Dispensing - Compounding - Cleaning/deactivation - Administration - Spills - Transportation - Waste

Compounding Personnel Requirements

All personnel who handle HDs must be annually trained on the following: - Overview of HDs and their risks - Proper use of personal protective equipment (PPE) and performance of handwashing - Proper use of equipment to include cleaning (deactivation, decontamination) - Spill management - Review of the facility's standard operating procedures (SOPs) - Proper disposal requirements HD compounding requirements include the following: - Proper PPE must always be worn when handling HDs. - Handwashing must take place following USP guidelines. Use of chemotherapy gloves (thicker and must meet the American Society for Testing Materials (ASTM) requirements): - Use two pairs - Change every 30 minutes or sooner if compromised Gowns must be resistant to the permeability of HDs: - No seams or closures where HDs can penetrate - Change gown every two to three hours - Head, hair, shoe, and sleeve covers are required. - Face shields and goggles are required. - N-95 fitted mask is required (to decrease the risk of inhalation). Dispose of worn PPE before leaving the C-SEC: - Dispose of it into an approved hazardous containment device or sealable bag. - Gloves and sleeves should be discarded in a sealed bag inside the C-PEC.

Handwashing and Garbing Order

Before entering the segregated radiopharmaceuticals compounding processing area (SRPA): - Perform handwashing (hands and arms up to elbows). - Remove all outer clothing and jewelry. In SRPA: - Don shoe covers - Don head/hair covers - Don face mask - Use an alcohol-based hand sanitizer - Don a low-lint disposable gown with cuffs - Don sterile, powder-free gloves that cover the gown cuffs - Remember when leaving the SRPA to discard garb.

Labeling, Transporting, and Disposal

Each facility must have SOPs for HDs that describe: - Designation of HD areas - Training requirements for compounders - Receipt and storage procedures - Hand hygiene - Garbing requirements - Transport and administration - Disposal - Environmental sampling and monitoring guidelines - Any persons transporting HDs must be trained in OSHA standards for hazardous waste operations. - When transporting HD, there must be a clear label to identify them as hazardous. - The final product should be labeled and then placed in a hazardous labeled sealed bag in case of leak or spill. - Syringes that are prefilled should be capped and should not be delivered with a needle attached.

Adverse Events

During the preparation of CSPs, several types of errors can occur, the most common one being contamination. This can occur through many mechanisms such as the following: - Improper handwashing - Improper compounding environment - Incorrect medications - Incorrect procedures - Critical areas compromised through touch or interruption of first air in the LAFW - LAFW isn't cleaned properly or turned on the for the required 30 minutes before manipulations - Improper cleaning schedules or products - Improper garbing - Inaccurate automated compounding deceives - Incorrect storage environment - Inaccurate BUD - Incorrect dosages, strength, and quality of correct ingredient

Medication Error Prevention

Every facility will review and provide strategies to limit medication errors. Some of these strategies include: - Rechecking calculations and interpretations of all medication orders - Reconfirming confusing, rare, or specialty orders - Always checking reference materials and/or consulting the pharmacist unusual or unrecognized medication doses - Checking for drug compatibilities/incompatibilities - Use reference sources, such as the Handbook on Injectable Drugs by Trissel - Not storing sound-alike drugs or look-alike drugs on the same shelf (ex. Trazodone and Tramadol) - Working as a team; prioritizing communication - Continuing to learn (read, ask questions)

HCPCS

Health Care Financing Administration (HCDA) Common Procedures Coding System Uniform; language using codes to describe procedures, services, and diagnosis for billing purposes for Medicare and third-party providers. Infusions are based on three categories: (1) IV: injections into the vein over time (2) Intravenous push (IVP): or bolus; is medication injected quickly into a vein (3) SC (injection into the subcutaneous tissue) or IM (injection into the muscle) There are also medication levels or certain types of services which include: - Chemotherapy/biologic Ex. Doxorubicin and bleomycin - Therapeutic or diagnostic medication Ex. Diphenhydramine and ketorolac - Hydration Ex. 0.9% sodium chloride and dextrose 5% in water - The time of service that can be billed (regarding IV medications) is the time the medication is being infused. - Infusion time < 15min = Considered an IVP for billing - Infusion time > 15min = Billed for an hour of infusion

Preparing a Hazardous (Chemotherapy) Preparation

Perform outside of ISO Class 7 or 8 environment: (1) Complete any calculations needed and prepare label before entering the ISOC Class 8 ante area. Perform in ante area (ISO Class 8): (1) Perform handwashing and garbing. (2) Ensure the biologic safety cabinet (BSC) has been cleaned and is on. Perform in the following in buffer area (ISO Class 7): (1) Stage the medication, bag, label, and supplies needed on a (work surface) stainless-steel cart beside the BSC). (2) Lay out the mat in the BSC and items needed for priming the bag. (3) Prime the IV bag with clean fluid by attaching the spoke end of the tubing to the bag. Allow fluid to reach the end of the tubing and then clamp the line off. (4) Place primed bag with its tubing to the side and add other items in the BSC, one at a time, maintaining correct spacing of at least 6 inches, spraying each item with IPA, and removing outer packaging at the edge of the hood. (5) Before spiking the vial of HD medication, discard all trash possible (before exposure to the chemo drug) in regular trash or sharps if needed. (6) Attach the CTSD to the medication vial without touching the critical site areas (spike end). (7) Withdraw the contents using just a syringe attached via luer lock to the CSTD. There will be no need for using the seesaw method or removing air bubbles, since the CSTD is a vented, close transfer system. (8) Add a needle to the filled syringe and inject the medication into the IV bag and affix a seal on the port of the bag. (9) Inspect the bag for leaks, cloudiness, or particulate matter. Place the labeled bag in a labeled or marked as HAZARDOUS/CHEMO delivery bag. Wipe the bag with an alcohol wipe.

PCCA

Professional Compounding Centers of America

The following are disaster and emergency considerations:

Records: - Victims can be confused or distraught and unable to communicate their medication history or medication histories. Maintaining these in a secured location and/or electronically can assist in helping these patients. - Information, such as vendor contracts, employee contact information, and master formula records, needs to be obtainable. A duplicate source or electronic source may assist in the case of destruction of a facility or inability to reach it. Temporary sites must be preplanned: - Sites will vary in function, but if needed, a sterile compounding/pharmacy site might be necessary. Understanding sterile compounding procedures and practices are essential when coordinating and creating these sites. - Planning ahead is key. Reviewing potential challenges and creating solutions is a part of this process.

NABP's "Model Emergency Disaster Preparedness and Response Plan'" Continued

Section 5: Shelter-In-Place Planning: Provides instructions for staying in the event of a disaster, methods to identify those entering and leaving, any special training for warnings. Section 6: Protecting Resources - Explains cybersecurity measures, such as technology used to maintain patient histories and records, which must be protected even in a disaster. In the event computer hardware is damaged, there should be a backup to replace or recoup that information. - Also discusses support staff as valuable resource. The well-being of personnel is critical for proper functioning during the event, and the plan should include proving counselors for stress or burnout.

Continuing Education (CE)

Some organizations to review for possible CEs or other educational opportunities include: - American Society of Health-System Pharmacists (ASHP) - The Society for the Education of Pharmacy Technicians (SEPhT) - American Association of Pharmacy Technicians (AAPT) - National Pharmacy Technician Association (NPTA) - POWER-PAK C.E. - RxSchool - Pharmacy Technician Certification Board (PTCB)

FEMA

The Federal Emergency Management System

Education and Training Requirements

Training should include: - Didactic overview of drugs and ongoing training for new drugs - Safe manipulation practices - Negative pressure techniques - CSTD devices - Containment and clean-up of spills - Exposure treatment

Continuous Quality Improvement (CQI)

The medication use system is the most common method to organize errors such as those involved in the following: - Selecting medications - Ordering medications - Dispensing medications - Administering medications - Monitoring medications ISMP has created lists and methods to decrease these errors which include: - Look-alike, sound-alike list. Ex. Dopamine and dobutamine, Lantus or lente insulin - High-alert list. Ex. Insulin, Heparin, Warfarin - Confused names list. Ex. Acetaminophen and acetazolamide - Tall man lettering list. Ex. DiphenhydrAMINE and dimenhyDRINATE

NABP's "Model Emergency Disaster Preparedness and Response Plan'"

The plan consists of six sections: Section 1: Emergency Planning - Contact listening for all personnel with addresses, phone numbers, and emergency contact information. - A risk assessment that determines what impacts different disasters may cause. This is used to determine a warning time and what efforts should be made ahead of time, such as evacuation or sheltering in place. - Emergency supply list of items and essential records that should be stored in fire and water-proof containers. - Immunization records of staff and board members. - Training records and participation in drills. Section 2: Maintaining Board of Pharmacy Operations - Listening that defines the leadership and individual roles of members and staff. - Remote record access in case of damaged facilities. - An alternate site location for operations. - A critical function listing for each member is identified. - A listing of supplies and wholesalers for medications and supplies. - Record preservation methods for prescription and medical histories, both electronic and hard copy. Section 3: Communication - Methods to communicate before, during, and after the event. Ex. websites, local news stations, telephone call trees, or special passwords for entry into records. Section 4: Evacuation Planning - Procedures to evacuate if needed. It includes communication methods, primary and secondary locations, reporting managers, and "all clear methods."

National Veterinary Response Team (NVRT)

a team responsible for treatment and care of working and victim animals in affected area.

Strategic National Stockpile (SNS)

United States national repository for medications and supplies needed for disasters or emergencies. The Strategic National Stockpile (SNS) includes: - Chemical antidotes - Immunizations - Antitoxins - Antiviral drugs - PPE - Medical/surgical items - Ventilators - The CDC keeps large quantities of these medical supplies and medications, known as Push Packs. - Delivered within 12 hours of a federal decision. - A stockpile should include at least 72-96 hours of medication and supplies. - Stock is maintained separately from the facility's normal stock. Commonly stored items include the following: - Antibiotics - Vaccines - Antidoes - Contraception - Insulin - Medications for pain control - Life support - Surgical medications - IV pumps - IV fluids - Respiratory products and supplies - Diabetic supplies - Batteries - Alcohol - Waste Containers - PPE

Types of Emergencies or Disasters

Wildfires: - Can cause significant respiratory distress because of smoke inhalation - Can cause mild to severe burns - Medications associated include breathing treatments, wound care, IV antibiotics, large volume bags for hydration, immunizations, and pain medications Tornadoes, hurricanes, floods (wind or water related) events: - Can render a community isolated from others because of road closures, debris, or flooding - Can cause mild to severe trauma - Medications associated include IV pain management, antibiotic therapy, immunizations, and chronically ill patients' medications that must be uninterrupted Radiologic or chemical exposure: - Can cause radiation exposure - Chemical exposure can produce a variety of effects depending on the substance - Medications associated include antibiotics, antidotes, burn-related therapy, hydration, and sterile preparation for the eyes

U.S. Public Health Service (USPHS)

a bank of trained healthcare professionals ready to act once needed in a disaster or emergency.

Kit

a commercially available kit that contains everything to compounding a radiopharmaceutical EXCEPT the radionuclide.

Pharmacy and Therapeutics Committee (P&T)

a committee that routinely reviews organization's formulary (medications in stock). The primary focus of the P&T Committee is divided into three parts: (1) Maintain a medication list (medications in stock) (2) Develop policies for adding and deleting medications to the list (3) Maintaining medication information, such as dosing, effectiveness, and availability

Natural Disaster Medical System (NDMS)

a department of the Federal Government, which is responsible for sending out medical teams, equipment, and supplies to the disaster areas affected. They're responsible for sending: - Medical teams - Equipment - Supplies Under the NDMS, specialized teams are organized to assist with various tasks. These teams include: - Disaster Medical Assistance Team (DMAT) - Disaster Mortuary Operations Response Team (DMORT) - National Veterinary Response Team (NVRT) - International Medical Surgical Response Team (IMSRT)

Hot-cell

a device made of lead that is used to shield or contain radioactive materials.

Radioactive materials (RAM) license

a document that is issues by the United States or an agreement state that allows for various activities involving radioactive materials, such as compounding, distribution, medical use, and possession.

Radiopharmaceutical

a finished dosage form that contains a radioactive substance. Term is interchangeable with "radioactive drug."

Hot lab

a nonclassified radiopharmaceutical processing area without a primary engineering control (PEC).

DUR/DUE (Drug use review, drug use evaluation)

a review of the drugs within an organization to determine where improvements in the process can occur.

Current Procedural Technology (CPT) codes

a set of codes used to identify surgical, diagnostic, and medical procedures, used for billing services. - Provided by the American Medical Association (AMA).

Spill kit

a special kit used to clean a spill for HDs.

Quality assurance (QA)

a system of procedures, activities, and management to ensure a set of predetermined standards are met.