Hazardous and non sterile compounding.

Name three regulations dictated by the FDA modernization act of 1997 that apply to pharmacies

1. compounded drugs should be made in limited quantities 2. approved ingredients must be used to prepare compounded products and must adhere to safety and manufacturing standards 3. the drug product must not be considered by the US FDA as one which presents obvious difficulties for compounding, thereby affecting its safety or effectiveness.

Pharmacy and Therapeutics Committee (P&T)

A P&T Committee routinely reviews an organization's formulary (medications in stock). This is based on current medical practice and evidence to ensure the best patient care and cost management. (For example, if two medications provide the same effect and side effect profile but one is cheaper, the cheaper agents will be selected.) The members on the committee will vary but consist of various medical professionals (pharmacy included). The primary focus of the P&T Committee is divided into three parts: Maintain a medication list (medications in stock) Develop policies for adding and deleting medications to the list Maintaining medication information, such as dosing, effectiveness, and availability

Quality Assurance Practices

A QA program is a way to monitor, evaluate, correct, and improve all the aspects of compounding sterile preparations. The QA plan should include a formalized plan, which is provided to all personnel involved in compounding. The plan should include SOPs, which are detailed and include step-by-step instructions to guide a compounder through each procedure. Per USP guidelines, the program should address: Personnel qualifications and required trainingThis includes periodic review 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 environmentEnsure that environment and facilities are being assessed and maintained in accordance with the guidelines.Any records outside of 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 handlingEnsure quality of components from the US Food and Drug Administration (FDA) qualified vendors and proper inventory and disposal. Actual compounding processesReview and maintain SOPs and master formulas.There must be processes for investigations of any deviations or errors found. (example: root cause analysis). Final release of CSPs proceduresThis should include the types of inspections that are required before the release of each compounded CSP. DocumentationThis should include the SOP creation and review or change procedures.Evaluate the overall compliance regarding compounding sterile preparations.

HOT-CELL

A device made of lead that's used to shield or contain radioactive materials

CLOSED SYSTEM DRUG TRANSFER DEVICE CSTD

A device that allows for a closed filter capturing aerosols that can escape from the vial as well as a needle-less puncture system to avoid a stick from an HD-contaminated needle

RADIOPHARMACEUTICAL

A finished dosage form that contains a radioactive substance. This term is also interchangeable with "radioactive drug."

Veterinary Medications

A number of medication delivery systems have been developed to dose animals safely and provide specialized treatment. Examples include the following: Chewable treats such as Heartgard Plus real-beef chewable tablet for heartworm prevention in dogs Pet pillers and pill guns for dogs and cats Transdermal patches to deliver pain medication Liquid medication forms that can be added to pet food to avoid stressful dosing

QUALITY ASSURANCE QA

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

MEDIA FILL TEST

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

USP Guidelines

Patient safety, accuracy, and the prevention of errors should be priorities in every aspect of the aseptic preparation of CSPs. Each facility should have standard operating procedures (SOPs) in place. Each facility should have a quality assurance (QA) and quality control (QC) program to ensure that personnel involved in the preparation of CSPs are trained, the environment and processes meet and maintain established criteria, and corrective solutions are provided when necessary.

Patient Rights of Administration

Patients are guaranteed certain rights when it comes to receiving medications. Your textbook describes these rights in more detail in this chapter. These rights include the following: Right patient Right medication Right strength Right route Right time

SEGRATED RADIOPHARMACEUTICAL PROCESSING AREA SRPA

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

Stability of Stored Drugs

The expiration date changes once a drug is removed from its original packaging. The beyond-use dates are established according to USP 795 guidelines (US Pharmacopoeia "Pharmaceutical Compounding—Nonsterile Preparations.") US Pharmacopoeia (Pharmaceutical Compounding—Nonsterile Preparations.) http://www.usp.org/compounding/general-chapter-795

Examples of Sterile Radiopharmaceuticals

The following are examples of Sterile Radiopharmaceuticals. Sterile radiopharmaceuticals: injectables, including intravenous, subcutaneous, intraperitoneal, inhalations, ophthalmics, intradermal, and intrathecal dosage formsUsually packaged in vials using aseptic techniques Radioisotopes are often used for diagnostic procedures, such as imaging tests.Examples include:GalliumTechnetium Tc99m lidofeninTechnetium Tc99m mebrofenin Certain cancers of the bone, thyroid, or prostate use radioactive drugs. Examples include:Radioactive iodineStrontiumSamariumRadium

Compounded Drug Stability

The following factors can affect the stability of drugs, and thus, the BUD: Light and air exposure Temperature pH

Solubility and Dosage Forms

The technician must be aware of certain concepts of solubility: Small particles can dissolve more quickly than large particles. The dissolution rate can be increased with stirring and heating. Dissolution is the act of a solute dissolving in a solvent. The more soluble the drug, the faster it dissolves. Substances dissolve slower in viscous liquids. Viscosity refers to the thick and solid consistency of a liquid. The dissolution rate can be affected when mixing with other drugs or electrolytes. A technician must be aware of the compounding mixtures used for different types of medication. For example, syrups are prepared for soluble drugs; elixirs, suspensions, and emulsions are made up of insoluble drugs; and buffers are used to achieve the desired solubility. Buffers are solutions that can resist pH changes with acid or base additions.

HAZARDOUS DRUGS HD

antineoplastic and other drugs considered hazardous, as identified by the NIOSH organization

Radiopharmaceuticals

are finished dosage forms that contain radioactive substances. The techniques and required practices for handling radiopharmaceuticals are similar to USP, with some additional requirements.

American Society of Health-System Pharmacists (ASHP)

has two meetings each year with CE sessions. As a member, there are opportunities to attend webinars, lectures, and state-sponsored affiliate meetings.

Each encounter with an HD needs to be reviewed and evaluated. Some examples of exposure are:

inventory process dispensing compounding cleaning/deactivation administration spills transportation waste

The Society for the Education for Pharmacy Technicians (SEPhT)

offers ACPE skills-based one day and a half-certification training (boot camp) for sterile compounding.

CriticalPoint

offers ACPE-accredited custom training and compliance tools in sterile compounding. The 28 lessons cover many topic areas relevant to sterile compounding.

The National Pharmacy Technician Association (NPTA)

offers an ACPE-accredited IV certification course.

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 the USP guidelines. Use of chemotherapy gloves (thicker and must meet the American Society for Testing and Materials (ASTM) requirements)Use two pairs.Change every 30 minutes or sooner if compromised. Gown must be resistant to the permeability of HDs.No seams or closures where HDs can penetrateChange 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 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.

ANTINEOPLASTIC AGENT

An agent that prevents the development or growth of malignant cells

Continuous Quality Improvement (CQI)

An organization needs to continuously review and improve services to deliver medications on time and safely to patients. Compounding technicians play a crucial role in the quality improvement process because they're frontline and can identify potential areas for errors and improvement. 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 Pharmacy technicians are involved in many of these categories and must always be aware and attentive while handling medications. The selection of medication is one crucial step that pharmacy technicians are heavily involved in. Selection errors can often occur due to various scenarios. ISMP has created lists and methods to decrease these errors, which include: Look-alike, sound-alike list. For example:Dopamine and dobutamineMorphine and hydromorphoneLantus or lente insulin High-alert list. For example:InsulinHeparinWarfarin Confused names list. For example:Acetaminophen and acetazolamideAdvair and Advicor Tall man lettering list. For example:diphenhydrAMINE and dimenhyDRINATEDOPamine and DOBUTamine Using a continuous evaluation and monitoring process (by all individuals) in inventory management is critical in the ability to provide cost-effective mediations safely.

Over 200 hazardous drives can be found

Any active pharmaceutical ingredient (api) that is considered hazardous. any antineoplastic (chemotherapy)

Hd environmental cleaning guidelines

Areas where the handling of HDs take place must be deactivated, decontaminated, disinfected, and cleaned. The materials used and surfaces need to be compatible with each chemical agent. Deactivation: Used to make a compound inert or inactiveExamples: Hypochlorite, hydrogen peroxide Decontamination: Removes HD residueExamples: Alcohol, water, hydrogen peroxide, sodium hypochlorite Cleaning: Removes inorganic or organic materialExample: Germicidal agent Disinfecting: Destroys microorganismsExamples: Sterile alcohol or other Environmental Protection Agency-approved disinfectant

Preparation of Chemotherapy Agents

Aseptic technique should be followed when preparing any IV admixture, but when handling HD or cytotoxic agents, there are additional precautions. There are many similarities in the compounding process, but be aware of any contamination or exposure with HD. Refer to Procedure 14.1 in your textbook for a review of the procedure for preparing a hazardous (chemotherapy) preparation. There are some differences in the supplies used for hazardous drugs compared to the sterile preparation of nonhazardous compounds. The following are some different supplies: Yellow disposal containers (versus 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 the regular trash bags.

Bulk Repackaging Equipment

Automated packaging machines can fill unit dose containers, generate bar-coded labels, and apply the labels to the containers. A technician doing this must use aseptic technique although this repackaging will still be considered nonsterile.

Mechanics of Inventory Control

Balancing a pharmacy's inventory can be difficult. There must be medications to prepare all IV compounds ordered, but not an excessive amount that will expire before the medication is used. If on average, 25 packages of furosemide (a common diuretic) are used per month and expire within one year of purchasing, it would make sense to purchase slightly more than the necessary amount each month to ensure the stock isn't building and going unused. This would also ensure that there are enough doses for all the patients who require the medication. Additionally, ordering the most cost-effective package size is crucial for cost 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 cost 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 determine the most cost-effective way to purchase this medication. Generally, facilities will have a purchasing team (often with pharmacy technicians) that evaluates and makes purchasing decisions.

Planning Requirements for Disasters

Before an event, there must be plans in place and coordination efforts with many organizations. The National Boards of Pharmacy (NABP) developed a guide known as "Recommendations for Preparing and Responding to an Emergency or Disaster," which includes responses and a planning template for events that affect drug distribution systems. Under this guide, state boards of pharmacy are encouraged to develop plans more specific to their community's needs. The federal government has set up the Natural Disaster Medical System (NDMS), which coordinates with US Departments of Homeland Security, Defense, and Veterans Affairs. They're responsible for sending: Medical teams Equipment Supplies Under NDMS, specialized teams are organized to assist with various tasks. These teams include: Disaster Medical Assistance Team (DMAT): Sets up temporary medical treatment sites for burns and mental health emergencies 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 the identification of victims and support family members in the grieving process in a disaster or emergency event National Veterinary Response Team (NVRT): Responsible for treatment and care of working and victim animals in the affected area International Medical Surgical Response Team (IMSRT): Performs as an operating room in the field and manages major traumas The following are disaster and emergency considerations: RecordsVictims can be confused or distraught and unable to communicate their medical history or medication histories. Maintaining these in a secured location and/or electronically can assist in helping these patients.Information, such as vendor contacts, 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 part of this process.

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. 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, ceilings, and surfaces follow the USP guidelines. A hot-cell may be used to provide a segregated ISO Class 5 processing area. This is a device that allows the operator to work remotely and outside of the PEC, limiting exposure distance.

Two common tasks performed by pharmacy technicians include

Bulk repackaging and nonsterile compounding. Bulk repackaging involves repackaging medications into a single dose. Nonsterile compounding is the preparation of patient-specific medication doses when no clean room is required. These activities take place in various pharmacy settings including retail, specialty, and compounding pharmacies.

Capsule Compounding

Capsules have the benefits of masking taste and are easier to swallow than tablets. The steps of capsule compounding include: Powder is blocked after the proper proportions have been prepared. Powder is compressed onto a flat surface with a steel spatula. Capsule is filled using the punch method (the longer, thinner part of the capsule is punched, then attached to the cap). The capsule is weighed to ensure consistency in the filling of the capsules. Each capsule's weight is recorded and the average weight is calculated. The capsules must not weigh less than 90% or more than 110% of the calculated weight for each unit (USP 795). The punch method is used when smaller quantities of capsules are prepared. Larger pharmacies use automated capsule-filling machines to fill various capsule sizes more rapidly and accurately.

HD Hazardous Drugs

Certain drugs pose a threat during compounding through skin contact of inhalation contact alone. These are called??

DEACTIVATION

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

What are the examples of compounding and medical delivery systems for animals?

Chewable heartworm preventative treats, pet pillers and pill guns for dogs and cats, and transdermal patches to deliver pain medication.

Compounding Areas and Equipment

Compounding Area USP 795 provides guidelines for setting up compounding areas. These specifications include the following: The compounding area should be located away from chemicals, open boxes, dust, and normal prescription processing areas. The compounding surface area should be smooth and nonporous. The compounding surface area should not be located under shelving or ledges. A sink should be nearby for handwashing. Cleaning of the area should take place at the beginning and end of the work day and between uses. Equipment Personal protective equipment. Pharmacy technicians are required to don personal protective equipment. This is done to protect the preparer and the product. This includes gloves, goggles, laboratory coat, mask, gown, hair cover, and shoe covers.Measuring devices. The equipment that technicians use to measure drug components can include pipettes for minute volumes, syringes, graduated cylinders (a glass container used to measure liquid volumes), and large automated measuring machines.Mixing equipment. The equipment that technicians use to mix drug components can include spatulas, and glass, porcelain, and automated mortars and pestles.Weighing equipment. Various classes of balances and scales are used to weigh product in pharmacies. Class III (Class A) balance is a torsion balance that uses a counterbalance with special weights to determine the weight of the substance measured. The minimum amount that can be weighed is 120 mg. Class II balance is an analytical electronic balance. All calibrations are electronic and no weights are used. These have weighing capacities up to 200 g. Refer to Figure 11.12 and 11.13 in the reference book Mosby's Pharmacy Technician: Principles and Practice. Mold forms. Pharmacy technicians use this equipment to mold medication into standard shapes and sizes. For example, suppository molds are used to prepare suppositories. The molds come in different sizes. Excipients. Excipients are inert ingredients, inactive drug components that are used with the drug to promote effectiveness, absorption, consistency, or other factors. Flavorings. Pharmacy technicians use flavorings to aid palatability. Learn about the various excipients used in tablets and capsules.

Nonsterile Compounding

Compounding allows the preparation of medication for a specific patient. This is beneficial for those with multiple conditions or with factors that require more personalized dosing. This also allows healthcare personnel to provide medications in different forms to those who can't easily take conventional drug forms such as capsules and tablets. For example, popsicle-style medications can be made for young children and hospitalized patients who can't swallow drugs supplied in tablet form. There are various reasons to compound drugs: The medication is no longer manufactured. A patient is allergic to a component in the conventional drug form. A special drug strength is needed for a patient with special needs. The normal drug form can't be taken by a given patient. To increase palatability To enhance patient compliance There are three parts to a nonsterile compound: Active ingredient Inactive ingredient(s) Vehicle, or diluent The type of formulation is considered when determining the BUD for nonsterile compounds. Nonaqueous formulations have BUDs of less than 6 months or the earliest of the ingredients' expiration dates. Formulations containing water have BUDs of no more than 14 days with refrigeration. All other formulations have BUDs that are the earlier of 30 days or until the end of therapy.

Complaint Handling and Reporting of Adverse Events

Compounding facilities must have a formal plan for receiving and reviewing complaints. If the complaint requires an assessment, there must be an investigation performed and corrective action applied as necessary. The complaint must be kept, and documentation must include: Name of complainant 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 The goal of this process is to prevent future occurrences, ensure patient safety, and provide solutions that will be customized based on the complaint; for example: compounding technique correction or compounding environment improvement. Successful QA programs and medication error prevention is a team effort. 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. The more knowledgeable the technician is, the better equipped he or she is at performing the correct practice and limiting medication errors. Continuing education (CE) for technicians is a good method to enhance your knowledge and is often free. 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)

Personnel Training and Qualifications

Compounding personnel must have additional training and knowledge of radiopharmaceutical exposure risks. Competencies that are necessary include aseptic technique, garbing, PEC cleaning, media fill testing, and gloved fingertip sampling and these 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.

C-PEC

Controlled primary engineering control, such as the Class II BSC (biologic safety cabinet)

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

DUEs and DURs are methods to evaluate medication usage and ensure that medications are being used appropriately. These are used to keep patient safety a priority in any setting. The Joint Commission has created nine steps for the DUE process: Assign responsibility and obtain administrative approval to conduct DU—performed by the P&T committee. Delineate scope of drug usage within the organization—review of drug literature and clinical practice guidelines. Identify specific drugs that should be monitored and evaluated—identify high-risk, high-usage, or high-cost drugs. Identify indicators—develop criteria for a drug to be used. Establish thresholds—establish the limits for optimal use of a drug. Collect and organize data. Evaluate drug use. Perform actions from information gathered to improve drug usage. Communicate the findings and improvements to the appropriate responsible parties

DOSIMETERS

Devices that are used to measure long-term radiation exposure

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 manipulations Incorrect procedures Critical areas compromised through touch or interruption of first air in the LAFW LAFW isn't cleaned properly or turned on for the required 30 minutes before manipulations Improper cleaning schedules or products Improper garbing Inaccurate automated compounding devices Incorrect storage environment Inaccurate BUD Incorrect dosages, strength, and quality of correct ingredients are also types of errors. Labels for CSPs should include accurate: Dosage Names of all ingredients Total volume Route of administration Storage conditions It's important that calculations, additives, and fluids used always be double-checked.

Labeling and transporting and disposal

Each facility must have SOPs for HDs that describe the designation of HD areas, training requirements for compounders, receipt and storage procedures, hand hygiene and garbing requirements, transport and administration, disposal, and environmental sampling and monitoring guidelines. Any persons transporting HDs must be trained in Occupational Safety and Health Administration (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 a leak or spill. Syringes that are prefilled should be capped and should not be delivered with a needle attached.

Packaging of Compounded Medications

Packaging for compounded medications is designed to protect the medication. As with other medications, the containers must be secured with child-resistant caps where applicable. They must have proper labeling and should include auxiliary labeling when required. Containers may be made of glass or plastic and can include bottles, syringes, dropper bottles, and jars.

Types of Emergencies or Disasters

Emergency responses must be preplanned and include an approach for medication delivery. Each disaster or emergency brings its own set of challenges and obstacles that will require prior education and training. Common disasters/emergencies: Wildfires:Can cause significant respiratory distress because of smoke inhalationCan cause mild to severe burnsMedications associated could include breathing treatments, wound care, IV antibiotics, large volume bags for hydration, immunizations, and pain medications. Tornados, hurricanes, floods (wind- or water-related) eventsCan render a community isolated from others because of road closures, debris, or floodingCan cause mild to severe traumaMedications associated could include IV pain management, antibiotic therapy, immunizations, and chronically ill patients' medications that must be uninterrupted. Radiologic or chemical exposureCan cause radiation exposureChemical exposure can produce a variety of effects depending on the substanceMedications associated could include antibiotics, antidotes, burn-related therapy, hydration, and sterile preparations for the eyes.

Reevaluation and Retraining Scheduling

Every compounder must undertake annual refresher training. Core competencies include the following: Visual observations Sampling Media fill Cleaning Disinfecting A person who fails any written tests, observations, or sampling and media fill must undergo repeat training before compounding again.

Internet-based CE courses

Example sites/organizations: Power-Pak CE, PharmacyTech CE, and Pharmacy Tech Topics

Semisolid Dose Preparations

Examples of semisolid dose forms are medication sticks, hard sticks, soft sticks, creams, ointments, and pastes. Suppositories are also considered semisolid forms and can be used for administration to the vaginal, rectal, or urethral area. Various bases are used to prepare suppositories including oleaginous, triglyceride bases, water-soluble bases, and glycerinated gelatins. These are used to provide a medium to carry the medication to the absorption site and to provide a time-release effect.

Hard Lozenges

For the preparation of hard lozenges, combinations of sugars are mixed with the medication and other ingredients. The mixture is then poured into a mold and allowed to cool before removal. Considerations for the preparation of hard lozenges include the following: Drugs that may degrade in high heat can't be made into hard lozenges. The drug form must have a low moisture content that ranges between 0.5 and 1.5 percent. Some types of syrups can't be stirred until a specific temperature is reached. To avoid a grainy consistency, use 55-65 percent sucrose or 35-45 percent corn syrup for lozenge preparation. Since acidic flavorings lower the pH, the pH can be raised to 5 or 6 with calcium carbonate, sodium bicarbonate, or magnesium hydroxide.

Environment for HD compounding.

HD sterile compounding must take place in an 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 placed at least one meter from the entrance to the negative pressure buffer room Closed-system drug transfer device (CSTD) protects the compounder from exposure to aerosols when the medication is withdrawn from a vial.

Soft Lozenges

Ingredients for soft lozenges include various bases such as PEG 1000 or 1450, chocolate, sugar, or acacia. Lozenges can be poured while warm into a plastic troche mold. Soft lozenge ingredients may include: Acacia gel, which adds texture and smoothness Silica gel, which helps keep materials from settling to the bottom of the mold Flavoring, which increases palatability Food extracts Syrup flavor concentrates Volatile oils Sweeteners Nine parts NutraSweet and one part saccharin

Medication Error Prevention

Medication errors can occur through many mechanisms. Some examples include poor handwriting, confusion about drugs with similar names, or lack of knowledge of sterile technique and best practices. 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 for unusual or unrecognized medication doses Checking for drug compatibilities/incompatibilitiesUse reference sources, such as the Handbook on Injectable Drugs by Trissel. Not storing sound-alike drugs or look-alike drugs on the same shelf (example: trazodone and tramadol or risperidone and ropinirole) Working as a team; prioritizing communication Continuing to learn (read, ask questions)

Nasal Preparations

Nasal preparations are compounded as solutions, jellies, gels, ointments, or suspensions. They're intended for topical application, sprays, inhalation, or as drops. Nonirritating excipients must be used for nasal preparations. A feature of these preparations is the rapid absorption and onset of action.

NIOSH

National Institute for Occupational Safety and Health; created list of HD

Radiation Detection and Measuring Devices

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

Bulk Repackaging

Pharmacies often purchase bulk drugs to save on costs. Technicians are required to repackage these bulk drugs into single doses, also called unit dose medications. Technicians may repackage the drugs manually or use an automated system. The single doses are placed in unit dose containers such as blister cards or bubble packs. Blister and bubble packaging help patients that need 28- to 31-day supplies of medication to maintain dosing compliance. The following are examples of the reasons why pharmacies repackage from bulk medications: Many medications aren't available for purchase as single doses. To save on costs, since bulk medications cost less per unit than single dose medications To facilitate dispensing medications to patients more quickly To reduce error by labeling individual doses To facilitate stocking of medication for later use, by returning a repackaged dose that isn't picked up or used Good manufacturing practices (GMP) are US FDA guidelines that guarantee safe and effective products for consumers. Good manufacturing practices must be used when repackaging bulk medications. The GMP guidelines include various concepts such as the proper type of packaging to use. For example, some drugs degrade when exposed to sunlight. Therefore, these are stored in amber-colored bottles. Some example GMP guidelines are as follows: All drugs must be checked by a registered pharmacist. All equipment must be in good and clean condition. The beyond-use date must be one year from the repackaged date or the manufacturer's expiration date, whichever is earlier. The packaging must be appropriate for the drug in question. Only one medication may be prepared at a time. All repackaged items must be logged.

Personnel Training

Pharmacies should provide periodic training to ensure that pharmacy technicians maintain proper technique and up-to-date knowledge in their areas of responsibility. The pharmacy technician should also maintain continuing education efforts with the same objective. In the case of compounding instruction and training, the following areas should be addressed: Performing calculations Use and maintenance of compounding equipment Dosage forms Symbol interpretation Reference sources Safety Compounding sterile preparations and other techniques

Solid Dose Preparations

Pharmacy technicians can compound solid preparations such as lozenges and capsules customized to a patient's particular needs. Molds are used to make these solid preparations. For example, triturate molds are used to prepare molded tablets. Molded tablets disintegrate easily upon exposure to moisture. These are used for substances requiring smaller doses. The steps to compound molded tablets are as follows: Prepare powder mixture and sift it through a sieve. Moisten mix until it sticks to the pestle. Place a cavity plate on a glass plate. Press mixture into the cavity plate using a spatula. Make sure that all cavities are filled to capacity. Align the cavity plate onto the peg plate and slowly press down evenly on the peg plate. The tablets will be pushed out onto the pegs. Leave tablets on the pegs until they dry (1 to 2 hours). Invert the plate and press the tablets off.

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 opened liquids should also be discarded in this container.Other materials used (wrappers and alcohol swabs), which have 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.CSTDs allow the air to escape through the closed system rather than in the air (decreasing chances of spray). Refer to Figure 14.5 in your textbook for more detail on CSTD. When CSTDs 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. 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. 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." 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 the 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:Remove the outer pair of gloves in the BSC and place them in a sealed bag.Remove the gown.Remove the inner pair of gloves, and discard all the items in the hazardous waste container

Documentation

Product integrity and demonstration of the adherence to US FDA guidelines is achieved through thorough and accurate recordkeeping. Formulation records include an ingredients list, preparation methods, safety requirements, BUD information, and references for the preparer. Formulation records help maintain consistency in procedures and product quality. Pharmacies must maintain compounding records, or a log sheet that contains data on the compounds prepared. The information includes ingredients in the mix, the BUD assigned, the preparer's name, and assigned lot numbers. Safety data sheets (SDS) are also required for all chemicals and drug substances. Package inserts are used as documentation for commercial products.

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.

MALIGNANT

Tending to or threatening to produce death; a neoplasm that's cancerous as opposed to benign

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 devices to be used. Time, distance, and shielding are key concepts in the efforts to protect individuals from radioactive medications. 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.

SHIELDING

Refers to special equipment, such as vial and syringe shields made of lead or tungsten, that are used to protect the radiopharmaceutical exposure to the compounder

ALARA

Represents "as low as (is) reasonably achievable;" the effort of maintaining exposures to ionizing radiation as low as possible

Safety

Safety measures include providing storage that prevents spillage in cabinets or behind shelf brackets. Every pharmacy needs an SDS book containing information concerning the handling of spillages or bodily contact.

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. Medication shortages can disrupt normal ordering procedures and patient care. It can also affect the patient's treatment and cost additional money. An action plan needs to be in place and communicated to the medical team when medications go on shortage. This should notify the medical team on the status and severity of the shortage as well as alternative medication to use if necessary. (This can cost more money for the facility if the alternative medication costs more.) A shortage can last days or months depending on the product and reason for the shortage. Working proactively provides an approach to ensure medications are available when they're needed to prepare a compound. Knowing the contracts and relationships for your organizations creates an efficient process for ordering and maintaining a proper stock level of medications. 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). For example, if a PAR level of a medication is 100 units, the purchaser will visually or manually confirm this level when it reaches 100 units and reorder the medication to ensure that more is stocked before the number on hand is 0. Maximum levels should also be noted and maintained so no medication expires before it's used. Maximum and minimum levels can fluctuate based on the season (for example, influenza vaccines), but most medications will be frequently analyzed on their usage to estimate these levels. Ordering is done by using a tracking system that involves the national drug code (NDC) numbers and bar codes.

HD medication preparation USP and guidelines:

Specialized engineering controls for HD Certain areas must have negative pressure. HD should not be stored on the floor or in areas with high risk for flooding or high traffic. Inventory processes should occur in neutral or negative pressure area There should be a dedicated refrigerator for the storage of HD thats separate from other stock. HD shipment must appear to not be damaged and following guideless 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-backed mat, then wipe the outside and place it in a plastic bag. Then, either return the HD or dispose of it after deactivating/decontaminating.

METASTASIZE

Spreading of cancer cells to other organs or tissues

Techniques in Bulk Repackaging

Sterile technique isn't officially required, but the following are still recommended: Wear a laboratory coat. Keep hair pulled back. Perform proper handwashing technique. Wear face mask and gloves. Use a pill-counting tray and spatula when dispensing tablets and capsules from a tray. Repackage drugs away from high-traffic areas to reduce contamination. Clean pill-counting trays with alcohol after each use to prevent cross-contamination. Maintain logbook documentation for repackaged drugs with pertinent information such as Date Generic and brand name of drug Dosage form Manufacturer name Manufacturer lot number Manufacturer's expiration date Pharmacy lot number Pharmacy beyond-use date Technician initial Pharmacist check-off

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

The "Model Emergency Disaster Preparedness and Response Plan" is provided to state boards of pharmacy to assist in planning for disasters. The plan consists of six sections: Section 1: Emergency planningContact listing for all personnel with address, phone numbers, and emergency contact informationA 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 containersImmunization records of staff and board membersTraining records and participation in drills Section 2: Maintaining board of pharmacy operationsListing that defines the leadership and individual roles of members and staffRemote record access in case of damaged facilitiesAn alternate site location for operationsA critical function listing for each member is identifiedA listing of suppliers and wholesalers for medications and suppliesRecord preservation methods for prescription and medical histories—both electronic and hard copy Section 3: CommunicationMethods to communicate before, during, and after the eventExamples: websites, local news stations, telephone call tree, or special passwords for entry into records Section 4: Evacuation planningProcedures to evacuate if needed. It includes communication methods, primary and secondary locations, reporting managers, and "all clear" methods Section 5: Shelter-in-place planningProvides instructions for staying in the event of a disaster, methods to identify those entering and leaving, and any special training for warnings Section 6: Protecting resourcesExplains 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 ways to support staff as a valuable resource. The wellbeing of personnel is critical for proper functioning during the event, and the plan should include providing counselors for stress or burnout.

Additional Considerations

The BUD (beyond-use date) is based on the time when the first puncture into the vial septum occurs. Considerations:Radiochemical stabilityRadionuclidic purity: radioactive materials decay over time (material breakdown and loses energy)Age of generator: natural chemical changes to the atoms and nuclides of the materialSpecific activityNumber of particles Documentation should include maintaining 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 (These will vary state to state.) Some requirements for the INNER label include: Standard radiation symbol The words "Caution-Radioactive Material" Radionuclide and chemical name Radioactivity (units at time of calibration) The OUTER label includes: Standard radioactive symbol The words "Caution-Radioactive Material" Radionuclide and chemical name Radioactivity (units at time of calibration) Volume dispensed Number of dosages BUD

Primary Engineering Controls for HD Preparation

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) These C-PECs must be externally ventilated and move air downward through a high-efficiency particulate air (HEPA) filter (rather than toward the compounder). Often, large hospitals will have a separate department or area for chemotherapy infusion compounding where this may be accomplished.

CSPT

The PTCB provides national certification through testing known as CPhT. They also offer a specialty certification for a Certified Sterile Processing technician, or CSPT. Examination requirements include: CPhT in good standing Completed a PTCB-recognized sterile compounding education course (an ASHP-accredited program) AND have one year of work experience in sterile compounding OR have completed three years of work experience in sterile compounding The test consists of questions broken into different sections known as domains. The following information provides a breakdown. Medications and components content (17%)Covers the drugs, (brand and generic), dosages, characteristics, stability, storage, and safety information Facilities and equipment (22%)Covers equipment such as primary engineering controls, environmental monitoring, and operational standards per USP guidelines Sterile compounding procedures (53%)Relates to aseptic technique procedures, calculations, procedures for cleaning and decontamination, handwashing, and garbing and gowning Handling, packaging, storage, and disposal (8%)Relates to supplies used, disposal of sharps and other supplies, and handling completed compounded sterile preparations

Strategic National Stockpile

The US government maintains certain medications that are required in a disaster event. 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. These are delivered within 12 hours of a federal decision and can treat thousands of patients. Local pharmacies and hospitals often house a stockpile of similar items for first response scenarios. Stockpile should include at least 72-96 hours of medications and supplies. The stockpile will vary based on the input of local pharmacies, community organizations, and regional needs. Stock is maintained separately from the facility's normal stock. Inventories and expiration inspections are conducted regularly. Commonly stored items include the following: Antibiotics Vaccines Antidotes Contraception Insulin Medications for pain control Life support Surgical medications IV pumps IV fluids Respiratory products and supplies Diabetic supplies Batteries Alcohol Waste containers Personal protective equipment Updating or increasing the PAR levels of medications in stock may be necessary to ensure medications are in stock when needed. Ordering and delivery of items may be challenging depending on the disaster or emergency. Refer to Table 18.1 in your textbook for examples of common medications used during disasters.

Lozenges

The benefit of lozenges is the ability to use flavorings to increase palatability. These are often more appealing to children. The following ingredients are commonly used to make lozenges: Phenol Sodium phenolate Benzocaine Cetylpyridinium chloride Active ingredients may include anesthetics, antimicrobials, antitussives, antiemetics, or decongestants. Different mixtures are used to make different types of lozenges: Sugars are used to make hard lozenges. Polyethylene glycol (PEG) is used to prepare soft lozenges. Gelatin is used to prepare chewable lozenges.

Expiration and Beyond-Use Dates

The beyond-use date (BUD) of a repackaged drug is one year from the repackaging date or the manufacturer's expiration date, whichever is earlier. What's the BUD for amoxicillin that was repackaged on October 9, 2016? The manufacturer's expiration date is June 1, 2017. Answer: Because of the manufacturer's expiration date, the BUD for the amoxicillin would be June 1, 2017.

What is the correct meaning of meniscus?

The bottom line of a liquid line in a container, which is the point that should be used to take a measurement.

Immediate Response

The initial response is often coordinated by key agencies to provide food, water, and essentials to life first; this phase is "all hands on deck." Once this immediate need phase is completed, there may be a need for sterile medications ahead. Tasks and activities will vary, and participating in drills and education will ensure all tasks are well understood so they can be executed smoothly. For example, staying current with immunizations, cardiopulmonary resuscitation (CPR), and additional training related to assisting victims. It's the pharmacy technician's responsibility to know all these procedures. If isolated patients require medications, you must be aware of the protocols associated with those treatments. Before medication can be distributed in situations, such as hurricanes, floods, or tornados, the victim's personal safety and control over their medication comes first. Determining the risks associated with a location must be determined with the following guidelines: Hot zone—the area where the event took place Warm zone—area at least 300 feet from the event Cold zone—area close to the warm area but away from the event Communication is essential when working with other facilities or agencies. As a compounding technician you have the education and expertise to greatly assist during many disasters, emergencies, and/or public health crises.

Medical surveillance

The new USP guidelines include a comprehensive exposure plan. This plan reviews the protection provided by environmental controls, practices, and education. Workers are monitored for health changes due to exposure to HDs to ensure the safety and health of all workers involved with handling HDs.

Mixing Products of Different Strengths

The next example explains how products of different strengths are mixed to prepare a medication of a desired strength. 120 grams of a 0.1% of hydrocortisone ointment is needed The following ingredients are available: 1 oz of 0.1% ointment base, 0.5 oz of 0.15% ointment base, 2.5 oz of 0.005% ointment base. Dimensional analysis is appropriate here to convert ounces into milligrams. Dimensional analysis is appropriate here to convert ounces into milligrams. Solving for the first ingredient, 1 ounce of 0.1% ointment base: Begin the dimensional analysis equation so that the units you want in the final answer are in the numerator of the first fraction of the equation; do not cancel this unit. Continue with the next fraction in the equation, placed so that the units of its numerator are the same as the units of the denominator of the first fraction, so they will cancel. Continue until all necessary information has been placed in the problem. Cancel your units and multiply the numbers, to get 30 milligrams. Using the dimensional analysis approach, the second ingredient, 0.5 ounces of 0.15% ointment base equals 22.5 milligrams. Using the dimensional analysis approach, the third ingredient, 2.5 oz of 0.005% ointment base equals 3.75 milligrams. Dimensional analysis helped you convert ounces into milligrams. Now, add the total amount. The total amount is 56.25 mg. 120 mg is needed for 120 g of a 0.1% hydrocortisone ointment. Therefore, 120 mg minus 56.25 mg equals 63.75 mg of additional hydrocortisone is needed. The next examples explains how to prepare the desired strength of a drug using solubility expressions. For example, if 130 mL of a 1 to 20 strength solution of a drug is needed, how much of the drug is needed to fill the order? Solve for x using the ratio and proportion approach. So, 1 g over 20 mL equals x over 130 mL. 20 mL multiplied by x equals 1 g multiplied by 130 mL. Divide each side by 20 mL to get x equals 1 g times 130 over 20. Solve to get 6.5 g. 6.5 g of the drug is needed for a 130 mL of a 1:20 strength solution. This last example uses dimensional analysis for unit conversion. There are 100,000 units of penicillin per gram of a special skin ointment. How much of the drug is needed to dispense 50 g? There are 4,400 (USP) units per mg. Using the dimensional analysis approach, starting with grams, place all of the information into the equation. Cancel your units and multiply the numbers. You'll need 1.36 gram of the drug to dispense 50 grams

COMPOUNDING CALCULATIONS

The pharmacy technician must be proficient in performing calculations needed to prepare compounded and other medications to be dispensed. The following example explains the calculation used to increase a formula's quantity. How much diphenhydramine powder is needed to prepare 275 mL of a 2.5% diphenhydramine gel? 2.5% is 2.5 g per 100 mL. Therefore, use "ratio and proportion" to complete the calculation. 2.5 grams over 100 milliliters equals x over 275 milliliters. Cross multiply to get 100 milliliters x equals 2.5 grams multiplied by 275 milliliters. Divide both sides by 100 milliliters to get x equals 2.5 grams multiplied by 275 milliliters. Solve the problem to get 6.9 grams of diphenhydramine powder. The following example explains the calculation used to reduce a formulas quantity. How much diphenhydramine powder is needed to prepare 30 mL of a 2.5% diphenhydramine gel? This calculation also uses "ratio and proportion." 2.5 grams over 100 milliliters equals x over 30 milliliters. Cross multiply to get 100x equals 2.5 grams times 30 milliliters. 100 milliliters x equals 2.5 grams times 30 milliliters. Divide both sides by 100 milliliters to get x equals 2.5 milligrams times 30 milliliters over 100 milliliters. Solve the problem to get 0.75 grams of diphenhydramine powder. The following example explains how to calculate partial dosage units. The pharmacy's amoxicillin tablets are available as 50 mg capsules. Three capsules are used to provide 150 mg of this active ingredient. How many capsules are needed to supply only 125 mg of this active ingredient? 50 milligrams over 1 capsule equals 125 milligrams over x. Cross multiply to get 50 milligrams x equals 125 grams times 1 capsule. Divide each side by 50 milligrams. X equals 125 milligrams times 1 capsule over 50 milligrams Solve to see that two and a half capsules are needed. Three capsules of amoxicillin plus filler weighs 1,000 mg. Therefore, the amount of a medication to be removed is calculated as follows: 1,000 milligrams over 3 capsules equals x over 2.5 capsules. Cross multiply to get 3 x equals 1,000 milligrams times 2.5 capsules. Divide each side by 3 to get x equals 1,000 milligrams times 2.5 capsules over 3. Solve to see 833.3 milligrams total medications are needed. 1,000 minus 833.3 mg equals 166.7 mg, which can be removed from the balance so that the needed 833.3 mg remain. These example deals with the change in the stock solution for preparing a medication of the desired strength. How will you prepare 22 mL of a 0.45% solution of drug A using a stock with a concentration of 15%? 0.45 grams over 100 milliliters equals x over 22 milliliters. Cross multiply to get 100 milliliters x equals 0.45 grams multiplied by 22 milliliters. Divide both sides by 100 milliliters to get 0.099 or 0.10 grams. 0.10 grams equals 100 milligrams. 15 grams over 100 milliliters equals 0.10 grams over x. Cross multiply to get 15 grams times x equals 100 milliliters times 0.10 grams. x equals 100 milliliters multiplied by 0.1 gram divided by 15 grams. 0.67 mL of the 15% solution is needed. Add 0.67 mL of the 15% solution to prepare 22 mL of a 0.45% solution of drug A.

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

CHEMOTHERAPY

Treatment of disease with chemicals that destroy disease-causing cells

USP CHATER 800

USP Chapter that discusses hazardous drugs (HD)

USP CHAPTER 825

USP chapter that discusses radiopharmaceuticals

Patient-Centered Care Future

The term patient-centered care refers to an approach of treating the patient as a whole entity, focusing all treatments and care with the specific patient that you're interacting with. As the pharmacist's role expands, so does the role of the pharmacy technician. Additional training is available to allow pharmacy technicians to participate in some of the following: Anticoagulation or blood draws Immunizations Compliance and patient safety Medication reconciliation Preadmission histories Education regarding smoking, alcohol, diet, and exercise Immunizations, point-of-care (POC) tests (tests done at the time and place of patient care with quick results), and blood pressure readings are being done in the pharmacy. Pharmacies are becoming a hub for routine care because it provides easy access to many types of care. POC tests (POCTs) are always expanding and provide an opportunity for pharmacies to increase involvement. Many diseases may be diagnosed earlier this way. Combining diagnosis and treatment in a single patient encounter can result in better patient compliance. Common examples of POCTs include: Influenza Group A Streptococcus POCTs can also include chronic disease screening and testing. Some examples include: Chronic disease screeningHIVCholesterol (lipid)Hepatitis CFecal occult blood Chronic disease testingA1C for diabetesInternational normalized ratio (INR)/prothrombin time (PT) for patients on anticoagulants Other POCTs include pregnancy, ovulation, drugs of abuse, and food pathogens. Some larger pharmacy chains are offering clinics with a variety of specialties. Expanding the roles of trained pharmacy technicians is a key part of a successful interdisciplinary healthcare team, according to ASHP. The pharmacy technician role will continue to evolve, as will the pharmacist's role.

Techniques for Weighing and Measuring Substances

The use of Class A balances involves a number of steps to achieve accurate weighing of substances: Turn the arrest knob to arrest the balance, which means to lock the pans in place to prevent damage by jarring. Level the balance using the adjustable legs. Add weighing papers or boats to the balance and zero out the balance, so the weighing paper and boats aren't included in the substance weight. Place weights on the right side of the balance then set the balance to reflect the correct weight. Place the substance to be weighed on the left side of the balance, view pointer, and add or remove material until the pointer is in the center. When measuring using a Class A balance, tweezers should be used to adjust the weights. Never adjust with your hands. When measuring a liquid in a container such as a graduated cylinder, the liquid must be at eye level. The level is read at the meniscus, the bottom of the liquid line in the container. The 20 percent rule is used when choosing the proper measuring container for liquids. This means that no less than 20 mL should be measured in a 100 mL container. Syringes or micropipettes are used to measure minute liquid volumes.

Hazardous drug preparation= Cancer and cytotoxic agents

There are several classes of chemotherapeutic agents used in intravenous (IV) therapy, such as the following: Alkylating agents: These attach "alkyl groups," or side chains (chemical structures), to the proteins within the cancer cell and interfere with their function.Examples: carboplatin, cisplatin, cyclophosphamide, and mechlorethamine oxide Mustargen Antitumor antibiotics: These antibiotics interfere with the deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) synthesisExamples: 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.Examples: methotrexate (Rheumatrex Dose Pack, Trexall), fluorouracil (Adrucil), cytarabine, and gemcitabine (Gemzar) Hormones: Antagonize certain reproductive tumors and accessory tract organs by altering hormonal balance.Examples: fulvestrant (Faslodex), leuprolide (Eligard, Lupron), and triptorelin pamoate (Trelstar) Enzyme inhibitors: Interfere with tumor enzymesExamples: asparaginase (Elspar), irinotecan (Camptosar), and pegaspargase (Oncaspar) Immunomodulating agents: Inhibit growth of the cellsExample: aldesleukin (Proleukin) Miscellaneous agents: Interfere with cellular divisionExamples: vincristine (Vincasar) and vinblastine (Toposar).

Common Aspects of Billing

There are specific codes set by the Health Care Financing Administration known as Health Care Financing Administration Common Procedures Coding System (HCPCS) codes and Current Procedural Technology (CPT) codes provided by the American Medical Association (AMA). HCPCS codes are used when billing Medicare. The coding systems allow for a universal system to be used for billing. Infusions are based on three categories: IV intravenous push (IVP) or injections: subcutaneous (SC) or intramuscular (IM) As you may recall, IV infusions are injections into the vein over time, IVP (or bolus) is medication injected quickly into a vein, and injections are SC (injection into the subcutaneous tissue) or IM (injection into the muscle). There are also medication levels or types of services which include: Chemotherapy/biologicExamples: doxorubicin and bleomycin Therapeutic or diagnostic medicationExamples: diphenhydramine and ketorolac HydrationExamples: 0.9% sodium chloride and dextrose 5% in water The time of service that can be billed (in regard to 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 Supplies and equipment used for administering are also billed using the same coding system. Some examples are below: Syringes and needles for flushing the peripherally inserted central catheter (infusion line) IV pole (if stationary pump is used) IV pump (if applicable) Gloves Alcohol swabs Heparin and saline vials for flushing the IV line between administration Sharps container Batteries (back up for electrical outages)

Chewable Lozenges

These gummy-type lozenges are made mainly for children. Fruit flavoring is used to sweeten the ingredients. Ingredients are combined and heated at a low heat until fluid. This fluid is poured into preshaped gummy molds and cooled.

Cleaning

Trained personnel must clean up spills immediately. Garb should include:Outer pair of utility glovesInner pair of chemo glovesGownEye protectionRespirator (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. Education and Training Requirements Personnel who compound hazardous drugs need to be fully trained and educated in the storage, handling, and disposal of HD. Training should occur before handling HD and at least annually thereafter. 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 Disinfecting and deactivating the environment adhere to the same scheduling as USP guidelines.

Special Storage and Delivery Considerations

USP has created guidelines with specifics for assigning beyond-use dates (BUDs) and storage conditions for sterile compounds. These are especially useful during a disaster/emergency situation as they assist in setting the standards and expectations to keep patients safe. Consideration and planning for the storage of medications in the event of loss of electricity. Many compounded products will require refrigeration; this will also require planning (with scenarios for sites with and without electricity). Some events provide an opportunity for preplanning, such as preparation of batches or extra medications in preparation for the loss of electricity or supplies. This requires additional stocking and ordering ahead of medications and supplies. Common items to consider purchasing an additional supply of include syringes, needles, coolers, ice packs, personal protective equipment (PPE, alcohol-based hand sanitizer), and medications.

Regulatory and Quality Control

Using appropriate containers prevents degradation of the compounded and repackaged medication. Labeling requirements must be followed to avoid medication misbranding. Regulations dictated by the FDA Modernization Act of 1997 that apply to pharmacies include the following: Compounded drugs should be made in limited quantities. Approved ingredients must be used to prepare compounded products. Safety and manufacturing standards must be adhered to. The drug product must not be considered by the US FDA as one that presents obvious difficulties for compounding, thereby affecting its safety or effectiveness.

What is the guideline for assigning a beyond-use date to a bulk repackaged solid or liquid?

When assigning a beyond-use date to a bulk repackaged solid or liquid, the date will be one year from the date the drug is repackaged or the expiration date on the manufacturer's container, whichever is earlier.

Reflect and Respond

You need to measure a liquid in a graduated cylinder. What basic steps should you use to ensure an accurate measurement of 10 mL of liquid? You have 50, 100, and 200 mL graduated cylinders. Sample Answer: When measuring a liquid in a container such as a graduated cylinder, the liquid must be at eye level. The level is read at the meniscus, the bottom of the liquid line. The 20 percent rule is used when choosing the proper measuring container for liquids. For example, no less than 10 mL should be measured in a 50 mL graduated cylinder.