PTCB: Patient Care & Laws

Compounding

The process of mixing ingredients to prepare a special medication for a patient

What are the types of compounding pharmacies

Communtity (nonsteril), Hospital, Home Care, Long-term care

What are the two types of non-sterile compounding formulas

Oral & Topical Use

Simple Compounding

Reconstitution or manipulation of a commercial product

Moderate Compounding

Making a preparation that requires special care or procedures

Complex Compounding

Making a preparation that requires special training, facilities, equipment or procedures to ensure appropriate therapeutic outcomes

Calibration

a comparison between a known measurement and the measurement using your instrument

Geometric Dilution

a technique to ensure even mixing of a small amount of a potent drug with a large amount of a non-potent or inactive compound

Levigation

dispersing a drug solid into a small amount of mineral oil, glycerin, or there liquid before incorporating the paste into an ointment

Tituration

The process of rubbing, grinding or pulverizing a powder to create fine particles

Increasing Dissolution

increasing the rate of dissolution using heat, reducing the size of the particle, using a solubilizing agent, or agitating the mixture

What factors should you consider when assigning a BUD?

Chemical Stability, Physical Stability and Microbial Contamination

Nonaqueous Formualtions

BUD is not later than the amount of time left until the earliest expiration date of any active ingredient, or 6 months, whichever is shorter

water-containing Oral formulations

BUD is not later than 14 days when store at controlled cold temperatures

Water-containing topical, dermal, mucosal liquid, or semisolid preparations

BUD is not later then 30 days

Master formulation record

the recipe file used for each compound and must be on record for every nonsterile compound in the pharmacy

Compounding Record

the documentation for each individual product that is compounded in the pharmacy and must be completed each time a compound is made

Aseptic technique is a special effort to keep the preparation free of what microbial growths

fungi, bacteria, viruses

Laminar flow hood

blows air across the work surface from back to front to create a sterile environment

Clean Room

an entire room that meets certain requirements and generally has a high efficiency particulate air filter that prevents microorganisms from entering *often times laminar flow hoods are kept in clean rooms to maintain a controlled environment

Garbing products

gowns, masks, shoe and hair covers, gloves, goggles

Laminar airflow hood should be cleaned with

70% alcohol

Food and Drug Administration (FDA)

• evaluates the safety of drug products

• ensures the safety, efficiency & security of human and vet products

• reviews info supplies on MedWatch forms

• reviews new drug & investigational drug applications

• Maintains REMs list

• approves & clears all medical devices, surgical implants, prosthetics & in vitro diagnostics; issues alerts, notices & medical device recalls; provides post market surveillance on med devices

• responsible for approval process of vet meds

• responsible regulating the manufacturing & distribution tobacco

• regulates radiation-emitting products

• Makes the laws

Drug Enforcement Agency (DEA)

• enforces the provisions of the controlled substances act as they pertain to the manufacturing, distributing & dispensing of legally produced controlled substances

• investigates & prepares for the prosecution of major violators of controlled substance laws

• manages a national drug intelligence program in cooperation with federal, state, local & foreign officials

• seizes and forfeits assets derived from traceable to, or intended to be used for illicit drug trafficking

• coordinates & corporates with federal, state, local agencies and with foreign gov. programs designed to reduce the availability of illicit abuse-type drug on the US market

• enforce the laws

Unites States Pharmacopeia (USP)

• an official public standards-setting authority for all prescription & OTC meds manufactured in the US

• establishes standards for for food ingredients & dietary supplements

• creates standards for the quality, purity, strength, & consistency of these products; critical to public health

• sets standards for the identity, strength, quality, and purity of meds, food ingredients & dietary ingredients

• publishes United States Pharmacopeia & national formulary which contains for standards for chemical & biological drug substances, dosage forms, compounded prep, excipient, medical devices & dietary supplements

• drugs marked in the the US must confirm to USP-NF standards

• establishes non-sterile compounding requirements USP <795> & USP <797>

• establishes requirements for labeling of meds whether they are in a multi-dose vial, unit-dose, & an intravenous admixture

The Joint Commission (TJC)

• addresses quality of patient care & safety

• establishes standards & accredits healthcare providers

• TJC has been granted & “deemed Status” for participation in Medicare

• addresses health-care associated infections, infection control & patient safety concerns to include med errors

Occupational Safety & Health Administration (OSHA)

• ensures healthy & safe working conditions by establishing & enforcing standards & providing training, outreach, education & assistance

• responsible for requiring Safety Data sheets to be maintained in pharmacy for meds & hazardous compounds

National Institute for Occupational Safety & Health (NIOSH)

establishes a list of drugs that are deemed hazardous & require special handling

State Boards of Pharmacy (BOP)

• regulatory state agency that oversees the practice of pharmacy in a given state

• define regulations affecting pharmacy & the roles, duties, expectations of pharmacists & pharmacy techs in the state

• establishes criteria for CE for pharmacists & techs to remain credentialed for their profession

• has auth to discipline pharmacies, pharmacists & techs

National Association of Boards of Pharmacy (NABP)

• composed of all state BOPs

• no regulatory auth but meets to discuss current issues & trends in the pharmacy that affect the practice of pharmacy

• responsible for monitoring the reciprocation of pharmacists; administers both the NAPLEX & MPJE exam for pharmacists; accredits online pharmacies; maintains the CPE monitor system for completed CEs for Pharmacists & techs

Health Insurance Portability and Accountability Act (HIPAA)- 1966

• protects patients’ private health information (PHI)

• limits who can access or share patient info

• Pharmacy staff must keep patient records confidential

• HIPAA = privacy

Combat Methamphetamine Epidemic Act (CMEA) - 2005

• restricts the sale of products containing pseudoephedrine, ephedrine, and phenylpropanolamine because they can be used to make methamphetamine

• Meth law = pseudoephedrine

Americans with Disabilities Act (ADA)

• prohibits discrimination against people with disabilities

• requires pharmacies and other businesses to provide reasonable accommodations

• ADA=equal access for people with disabilities

Omnibus Budget reconciliation Act (OBRA ‘90)

• requires pharmacists to review patients’ med profiles; offer counseling for new prescriptions; screen for drug interactions, allergies and duplicate therapy

• OBRA ‘90 = patient counseling + Drug Utilization Review (DUR)

Drug Quality and Security Act (DQSA) - 2013

• improves the safety of the drug supply chain

• allows meds to be tracked from manufactured to pharmacy to help prevent counterfeit or stolen drugs

• establishes standards for compounding pharmacies

• barcode tech

• DQSA = drug tracking and supply chain security

Durham-Humphrey Amendment - 1951

• created two categories: RX only & OTC

• authorized verbal prescriptions from prescribers

• allowed prescription refills if authorized

Food, Drug and Cosmetic Act (FD&C Act) -1938

• gave the FDA authority to regulate drugs and cosmetics

• required manufacturers to prove drugs are safe before marketing

• required adequate labeling and directions for use

• FD&C Act = Drug Safety before sale

Medicare Moderinzation act (MMA) - 2003

• created medicare part D which provides prescription drug coverage for medicare beneficiaries

• expanded access to prescription medications for seniors and eligible individuals

Hazardous material

Substance capable of producing adverse affects on the health and safety of humans

Infectious waste

includes blood, blood products, bodily fluids, infectious sharps waste, and laboratory waste

P- List

list of hazardous waste that are considered acutely hazardous by the EPA, including certain drugs than can pose significant risks to human health and the environment

• picrotoxin

• warfarin

• phenol

• nicotine

• ephedrine

• strychnine

• physostigmine

• colchicine

C1

No accepted medical use in the US. Extremely high potential for abuse

• heroin

• lysergic acid diethylamide

• 3,4- methylenedioxymethamphetamine (MDMA)

• Methaqualone

• Cannabis

C2

have accepted medical use but have a high potential for abuse with severe psychological or physical dependency

• morphine

• oxycodone

• hydrocodone

• fentanyl

• methadone

• amphetamines

C3

have accepted medical use with moderate to low potential of dependency. the abuse potential is less that with C1 and C2

• testosterone

• acetaminophen/codeine

• buprenorphine

• ketamine

• benzphetamine

C4

have accepted medical use with low potential for abuse or dependency

• zolpidem

• lorazepam

• clonazepam

• tramdol

• Alprazolam

• phentermine

C5

lower potential for abuse and dependency

• gabapentin

• pregabalin

• cough syrups with small amounts of codeine

requirements for new controlled substances prescriptions

date of issue; patient’s name & address; practitioner’s name, address, DEA #; drug name, strength, dosage form & quantity spelled out or written; directions for use; # of refills if any

Schedule 2

refill no permitted

schedule 3-4

refills allowed up to five times within 6 months of the date of issue

What should be included on prescription labeling for schedule C-II through C-V prescriptions?

• pharmacy name & address

• the serial (rx) & date of filling

• name of the patient

• name of issuing practitioner

• directions for use

• caution

Reverse Distribution

process of returning expired, recalled, damaged or unwanted medications from a pharmacy to a reverse distributor for proper disposal, credit or destruction

DEA Form 224

Facility registration form: application used to apply for a DEA registration to prescribe, dispense, administer or handle controlled substances

DEA Form 222

Used to order or transfer schedule I and II controlled substances

DEA Form 106

Used to report the theft or significant loss of controlled substances

DEA form 41

Document the destruction of controlled substances

Characteristics of forged prescriptions

• prescriber’s handwriting look “too good”

• quantities directions or dosage differ from usual medical usage

• rx doesn’t comply with the acceptable standard abbreviations

• rx appears to be photocopied (void in the back)

• directions are written in full with out abbreviations

• different colored inks, pens used or different handwriting

PDMP

• statewide electronic database that collects designated data within the state on substances dispensed

• housed by a specific regulatory, administrative or law enforcement agency

• support access to legitimate medical use of controlled substances

• identify, deter or prevent drug abuse & diversion

• facilitate & encourage the identification, intervention with treatment of persons addicted to rx drugs

Isotretinoin Medication

• used to treat acne

• cause severe birth defects, spontaneous abortions

• produce adverse psychiatric affects (depression, psychosis, suicide)

Components of iPledge legislation

• mandatory registry of all patients, practitioners & wholesalers-education & training of all practitioners & pharmacists regarding risks associated with drug

• patients must be registered by prescriber and the patient must answer specific questions about iPledge REMS and pregnancy prevention - only 30 day supple - patients than can become pregnant must have a negative, monthly pregnancy test prior to the prescription being renewed

• the pharmacy must obtain the do not dispense to patient after (DNDA) date for each isotretinoin prescription. Annotate the risk management authorization (RMA) & DNDA on the image of the prescription, document the DNDA date on the leaflet of each iPledge rx, & add the RMA to the WAG override field before dispensing to the patient

what does thalomid/thalidomide treat

• multiple myeloma

• patient who are pregnant or who could become pregnant should avoid taking thalomid/thalidomide

What conditions apple to a 28-day supply with no refills? (thalomid/thalidomide)

• rx must be filled within 7 days of issuance for a female with reproductive potential

• rx must be filled within 30 days of issuance for a female with out reproductive potential or male patient

• patient should never donate blood while taking thalidomide

What are the elements of the assure safe use (ETASU) program?

• healthcare providers that dispense the drug must be certified

• the drug must be dispensed only in limited healthcare settings

• the patient using the drug must be subject to monitoring

• the patient using the drug must be enrolled in a registry

Class 1 recall

a dangerous or defective product that could cause serious adverse health consequences or death

Class 2 recall

a product that may cause temporary adverse health consequences or pose a slight risk of serious adverse consequences

Class 3 recall

a product that is not likely to cause adverse health consequences

Market withdrawl

a minor violation that would not be subject to FDA legal action. The manufacturer removes the product from the market or corrects the violation

medical device safety alert

a medical device that may pose an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.

Quality Assurance

all factors that influence the quality of med & related products, pharmacy services & patient care in the med use process

Quality Improvement

achieved by defining specific outcomes that are measured & monitored for improvement over time as changes are made in the system

Continuous Quality Improvement

the philosophy of continually improving the processes associated with providing any good or service

Quality Indicator

the measure of a particular process or outcome, such as the # of med errors that occur after implementation of new patient safety process

VAERS

vaccine adverse event reporting system: any vaccine specific adverse events must be reported through this specific system

FDA MedWatch

used to report side effects for general, non-vaccine medications and medical devices

NPLEx

tracks behind the counter pseudoephedrine sales

A technician is restocking an automated dispensing cabinet on a hospital floor and must scan the barcode of both the machine compartment and the medication vial. This process is a safety workflow known as what?

Barcode Medication Administration: uses scanning technology to confirm that the correct drug, the correct dose, and the correct storage location match up

All sterile compounding work must be performed at least ____ inches inside the front edge of a laminar airflow hood

6 inches

Before drawing up medication from a glass ampule for an intravenous injection, which specialized tool must the technician use to ensure glass fragments do not enter the final product?

Ampules are completely sealed glass containers that have to be snapped open manually by the tech. To keep microscopic glass shards from being drawn up into the syringe, you must use a 5-micron filter needle or filter straw to pull the fluid out. *you have to swap that filter needle out for a regular needle before you inject the medication into the final I-V bag

Fentanyl patches are subject to

Risk Evaluation and Mitigation Strategy or REMS program

To maintain a completely sterile environment, laminar airflow hoods should

remain running continuously 24 hours a day. If a hood is turned off, it must be left on to run for at least 30 minutes and then be meticulously sanitized before any compounding can take place

A syringe tip specifically designed to securely lock a needle into place via a twist-on mechanism for sterile perparations

Luer-lock tip

Vertical hoods

traditionally reserved for hazardous compounding

In what direction should the side panels and work surface of the hood be manually wiped?

cleaned from back to front—meaning you start at the cleanest air source near the HEPA filter and move out toward the open room air. Wiping must be done in a side-to-side sweeping motion to push any potential particles out of the hood safety

Which provides the standards for the compounding of sterile preparations

USP 797

Nearly all claim are processed in real time by direct internet communication according to electronic data interchange set by the

National Council For Prescription Drug Programs (NCPDP)

Four parts of Medicare

• part A: Hospital (hospice)

• part B: DME, Doctor visits, Preventative, Physical Therapy

• part C: Comprehensive (medicare advantage)

• part D: prescription drugs

Daw Codes

• Daw 0: no product selection indicated

• Daw 1: Sub not allowed by prescriber

• Daw 2: Sub allowed, Patient requested product dispensed

• Daw 3: Sub allowed, pharmacy requested product dispensed

• Daw 4: Sub allowed, generic drug not in stock

• Daw 5: Sub allowed, brand drug dispensed as generic

• Daw 6: Override

• Daw 7: Sub not allowed, brand drug mandated by law/regulation

• Daw 8: Sub not allowed, generic not available in the marketplace

• Daw 9: Other