Pharmacy Technician Principles and Practice: Chapter 2 & Chapter 8

Drug Addiction Treatment Act of 2000 (DATA 2000)

Premits physicians to prescribe controlled substances (preapproved by the DEA) in schedules C-III, C-IV, or C-V to individuals suffering from opiod addiction.

Harrison Narcotics Act 1914

- Controls the use of Opium; cannot obtain w/o prescription, records required, importation and distribution are restricted.

Handling and Disposing of Hazardous Waste: Assume everything is hazardous

- A hazardous drug is one that exhibits one or more of the following effects in humans or animals: > Carcinogenicity > Teratogenicity (fetal malformation) > Reproductive toxicity > Organ toxicity > Genotoxicity (damages genes causing cell mutations)

Combat Methamphetamine Epidemic Act of 2005 (CMEA)

- Addresses all areas of the manufacyure and sale of psuedoephedrine (ingredient used to make meth), as well as law enforcement -Only a licensed pharmacist or technician may dispense, sell, or distribute this drug.

Food and Drug Administration Safe Medical Devices Act of 1990

- All medical devices are to be tracked and records be maintained for durable medical equipment

Durham-Humphrey Act of 1951

- An amendment to FDCA 1938 requiring all products to have adequate directions for use unless they contain the federal legend "Caution: Federal law prohibits dispensing without a prescription" - Requires a doctor's order or supervision for certai n drugs - Separated drugs into two categories: legend and nonlegend (OTC)

Pharmacy Standards: United States Pharmacopeia <795> (Retail)

- Areas addressed include: > Ingredient selection > Compounding nondrug requirements > Criteria for compounding > Compounding process > Compounding records and documents > Quality control > Verification > Patient counseling

Storage and Handling Requirements for Hazardous Substances

- Chemotherapeutic agents and cytotoxic materials must be prepared in a biologic safety cabinet or vertical flow hood and placed in bags identifying them as such > The preparer should wear a gown, goggles, and two pairs of gloves to protect him or her from possible contamination - A preparer should know the location of the cleanup kit > Hazardous substances include syringes, needles, and toxic medications

Drug Recalls

- Class I recall: There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death - Class II recall: The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote - Class III recall: The use of or exposure to a violative product is not likely to cause adverse health consequences

Restricted Drug Programs: Clozaril

- Clozaril has potentially dangerous side effects - Clozaril National Registry (CNR) developed to ensure safety of patients > Dedicated 800 numbers for internal clients, consumers, and health care professionals to call for information, education, and patient enrollment - CARE (Clozaril Administration Registry Enrollment): > Secured Internet application for reporting white blood cell values and absolute neutrophil counts of patients taking Clozaril

Occupational Safety and Health Act of 1970 (OSHA)

- Created the Occupational Safety and Health Administration (OSHA) - Ensures a safe and healthful workplace for all employees - Requires a reporting system for job-related injuries and illness - Attempts to reduce hazards in the workplace - Requires use of Safety Data Sheets (SDSs) - Established universal precautions

Pharmacy Standards: United States Pharmacopeia <797> (Hospital)

- Designed to cut down on infections transmitted to patients through pharmaceutical products - Designed to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals - Contains many procedural training and quality assurance requirements for preparing sterile products - The following areas are addressed: - Microbial contamination risk levels - Personnel training and evaluation in aseptic manipulation skills - Clean rooms and gowning procedures - Barrier isolators - Formalized quality assurance program - Cleaning and sanitizing workspaces - Environmental monitoring

Patient Protection and Affordable Care Act of 2010 (ACA)

- Electronic health records (EHR) incentives and e-prescribing. - Medication therapy management (MTM) - Accountable care organization (ACOs) - The independence at Home Demonstration Project

Hatch-Waxman Act of 1984

- Encouraged the creation of both generic and new medications by streamlining the process for generic drug approval and by extending patent licenses

Expiration Dates of Prescriptions

- Expiration dates are assigned by the manufacturer's expiration means it is good by the last date of the month. ex: 9/15 - Beyond-use dates are calculated by the pharmacy when repackaging or compounding medications

Drug Quality and Security Act of 2013

- FDA tracking system for bulk compunding supplies

Food and Drug Administration (FDA)

- FDA's main function: enforce guidelines for manufacturers to ensure safety and effectiveness of medications. - FDA is under the direction of the Dept of Health and Human Services.

Dietary Supplement Health and Education Act of 1994

- Herbal products are dietary supplements rather than drugs - The manufacturers of supplements are allowed to make claims with regard to general health promotion but not disease claims

Drug Listing Act of 1972: National Drug Code (NDC)

- Implemented under the authority of the FDA. - Every drug has a unique 10-digit number divided into three segments; labeler, product, and trade pkage size.

National Regulatory Commission Regulations and Standards

- Nuclear pharmacy: Specialized pharmaceutical service that prepares radioactive drugs > Has designated rooms and requires special equipment - Standards established for these areas: > Procurement > Compounding and quality assurance > Dispensing and distribution > Health and safety > Provision of information and consultation > Monitoring patient outcome > Research and development

Food, Drug, and Cosmetic Act of 1938 (established)

- Originated in 1906 but wasn't worded strictly enough & didn't include comestics. - Requires directions for use of a drug & package inserts. - All additive substances had to be labeled: "warning: may be habit forming" - FDA was created under this act - Requires all new drug applications be filed with the FDA - Clearly defined adulteration and misbranding (1938) - Requires mandatory food labeling, standards of identity, info on imitation foods, & nutritional info for special dietary foods.

Prescription Drug Marketing Act of 1987 (PDMA)

- Prescription Drug Marketing Act; helps prevent counterfeit drugs and ingredients from entering the supply chain & limits diversion ph pharmaceutical samples and prescription drugs.

Pure Food and Drug Act of 1906: prevented travel

- Prohibits the interstate transportation or sale of adulterated or misbranded food or drugs - Prove the drug's effectiveness

Medicare Modernization Act of 2003 (MMA)

- Provides a drug duscount card to those with low income who requires assistance from a pharmacy company to obtain medication. > Medicare is gov't insurance for those older then 65.

Pharmacy Standards: United States Pharmacopeia <795> (Retail)

- Provides guidance on applying good compounding practices in the preparation of nonsterile compounded formulations for dispensing to humans or animals - Areas addressed include: > The facility > Equipment > Stability of the compounded preparation > Primary packaging > Sterility > Stability criteria to include beyond-use dating > Beyond-use-labeling

Orphan Drug Act and 1983 (ODA)

- Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medications.

Kefauver-Harris Amendment of 1962

- Requires all medications in the United States to be pure, safe, and effective - Established procedures for both drug applications and investigational drugs - Drug manufacturers are required to be responsible for Good Manufacturing Process (GMP)

Poison Prevention and Control Act of 1970

- Requires all medications to be placed in containers with childproof caps or packaging (both OTC and legend drugs) * exceptions include: physician request for non-childproof cap, ceratin legend medications, & hospitalized patients or patient request

Restricted Drug Programs: Thalidomide

- Thalidomide is indicated for multiple myeloma but causes serious birth defects - Thalidomide must not be taken by women who are pregnant or who could become pregnant while taking this medication - System for Thalidomide Education and Prescribing Safety (STEPS) has been approved by the FDA to make sure that pregnant women do not take thalidomide - All people prescribed Thalidomide: > Must be registered with STEPS > Have a thalidomide prescription from a doctor who is registered with STEPS > Have the prescription filled at a pharmacy that is registered with STEPS in order to receive this medication

Transferring of Prescriptions and Types of Fraudulent Prescriptions

- The DEA allows transfer of the original prescription information for Schedule III, IV, and V controlled substances for the purpose of refill dispensing between pharmacies on a one-time basis - Types of fraudulent prescriptions: > Legitimate prescription pads are stolen from physicians' offices, and prescriptions are written for fictitious patients > Drug abusers alter the physician's prescription to obtain larger quantities of medications > Drug abusers may have prescription pads from legitimate physicians printed with a different callback number

Verifying DEA Number is Valid

- The first letter is an A, B, F, or M - Second later is first letter of the physician's last name. - Add the first, third, and fith numbers together - Add the second, fourth, and sixth number together and then multiply by 2 - Then add both sums together.

Infection Control Standards

- Universal precautions implemented in pharmacy to reduce transmission of pathogens: > Wash hands > Wear gloves if possibility of contacting blood or other body fluids

Regulatory Agencies

1. Centers for Medicare and Medicaid Services - Oversees Medicare and Medicaid - Establishes conditions for a facility to be reimbursed for services rendered 2. Department of Transportation - Regulates the shipment of hazardous materials that includes radioactive materials - Controls the packaging, labeling, and transportation of radioactive materials 3. Drug Enforcement Agency (DEA) - Enforces compliance with the Controlled Substances Act - Places medications into the appropriate schedule - Monitors records and reports of controlled substances

Prescription Transfer Process

1. Date of transfer 2. Name, address and tellphone # of receiving pharmacy 3. Nmae of the pharmacist at the receiving pharmacy 4. Number of refills transferred 5. National Association of Boards of Pharmacy (NABP) number for the receiving pharmacy 6. DEA number of the receiving pharmacy *sender must have all the above + original date of written prescription

Electronic Pharmacy References: Report errors to

1. EA.gov 2. FDA.gov - Drug Recalls - Orange Book-Approved Drug Products with Therapeutic Equivalence 3. MEDWATCH 4. OSHA.gov 5. USP.org 6. ISMP.org

Roles and Responsibilities of Pharmacists

1. Fill prescriptions, verifying instructions from physicians on the proper amounts of medication to give to patients 2. Check whether the prescription will interact negatively with other drugs that a patient is taking or conditions the patient has 3. Instruct patients on how and when to take a prescribed medicine 4. Advise patients on potential side effects they may experience from taking medicines

Responsibilities of Community Pharmacy Technicians

1. Help patients who are dropping off or picking up prescription orders 2. Enter prescription orders into the computer 3. Create a profile of the patient's health and insurance information in the computer or update the patient's profile 4. Screen telephone calls for the pharmacist

Pharmacy Law: Prescribing Authority

1. Medical doctors (MDs) 2. Physician assistants (PAs) 3. Nurse practitioners (NPs) 4. Dentists (DDSs and DMDs; limited to prescribing dental medications) 5. Optometrists (ODs) 6. Osteopaths (DOs) 7. Podiatrists (DPMs) 8. Veterinarians (animals only)

Regulatory Agencies

1. National Association of the Boards of Pharmacy (NABP) - Composed of all state BOPs - No regulatory authority but meets to discuss current trends and issues in pharmacy 2. State Boards of Pharmacy (BOP) - Regulatory state agency that oversees the practice of pharmacy in a given state - Defines regulations affecting pharmacy and the roles, duties, and expectations of pharmacists and pharmacy technicians in that state - Establishes criteria for continuing education for pharmacists and pharmacy techs 3. United States Pharmacopeia (USP) - Standards-setting authority for all prescription and OTC medicines in U.S. - Establishes standards for food ingredients and dietary supplements

Drug Enforcement Agency:

1. Registration: - Every facility that dispenses controlled substances must be registered with the DEA >The pharmacy registers with the DEA by submitting a DEA Form 224 - The pharmacy must renew this registration every 3 years 2. Ordering and receipt: - Schedule II medications are ordered by properly completing a DEA Form 222 - A DEA Form 222 is valid for only 60 days - Unused forms must be kept in a secure location in the pharmacy 3. Retention of Drug Enforcement Agency records: - Maintained for a minimum of 2 years, kept separately from other invoices, and kept readily retrievable - A red "C" must be stamped on Schedule III to V records and provided within 72 hours 4. Defective DEA Form 222: - A form is considered defective if it is incomplete or illegible or shows signs of alteration, erasure, or change

Responsibilities of Institutional Pharmacy Technicians

1. Rotate through all work areas of the pharmacy 2. Transport medications, drug-delivery devices, and other pharmacy equipment from the pharmacy to nursing units and clinics 3. Assist pharmacists with entering medication orders into the computer system 4. Pick up copies of physician orders, automated medication administration records, and unused medications from the nursing units and return them to the pharmacy

Board of Pharmacy (BOP): Facilities

1. State board that regulates the practice of pharmacy within the state. 2. A minimum amount of counter space in a pharmacy 3. An alarm system to be activated when the pharmacy is not open 4. Separate refrigerators for refrigerated medications and controlled substances 5. Must be lockable 6. A safe for Schedule II medications 7. A sink with hot and cold water 8. Heating, ventilation, and air conditioning systems must be controlled to avoid decomposition 9. The area to be well lighted

Additional Reference Books (Pharmacy Resources): must be updated yearly

1. Training Manual for Intravenous Admixture Personnel 2. The King Guide to Parenteral Admixtures 3. Pediatric Drug Formulations 3. Poisindex System 4. The Science and Practice of Pharmacology 5. Handbook on Injectable Drugs, with Supplement 6. Understanding and Preventing Errors in Medication Orders and Prescription Writing

Drug Enforcement Agency:

5. Destruction of outdated or damaged controlled substances: - A DEA Form 41 must be submitted to the DEA, indicating the name, strength, and quantities of controlled substances; the date of destruction; the method of destruction; and witnesses present for the destruction - A retail pharmacy may submit one DEA Form 41 each year 6. Theft of controlled substances: - Complete DEA Form 106 - The pharmacy must also notify the nearest DEA diversion office and local police

Safety Data Sheet (SDS) (formly known as MSDS sheets)

A document providing chemical product information. An SDS includes the product name, composition (chemicals in the product), hazards, toxicology, and other info anout the proper steps to take with spills, accidentsal exposure, handling, and storage of the product.

Auxiliary Label

A label that provides supplementary info about proper and safe administration, use, or storage of a medication

Dispense as Written (DAW)

A numeric set of codes, created by the National Council for Prescription Drug Programs (NCPDP), that is used when filling prescriptions; they can affect reimbursement amounts from insurance companies.

Protected Health Information (PHI)

A term used to describe a patient's personal health data. Under HIPPA, this info is protected from being shared or distributed w/o permission.

The Joint Commission (TJC)

An independent, nonprofit organization that accredits hospitals and other health care organizationin the U.S.

Drug Utilization Evaluation (DUE)

An authorized, structured, omgoing review of healthcare provider prescribing, pharamacist dispensing, and patient use of medication.

Refills for Controlled Drugs

C-II: No refills C-III & C-IV: 5 times within 6 months C-V: No restrictions

DAW Codes

DAW 0: Physician signed substitution allowed DAW 1: Prescriber said only drug on script; no substitute allowed DAW 2: Patient requested brand name drug DAW 3: Pharmacist can substitute if not in stock.

Inscription

Name, dosage form, strength, and qty

3 Classifications of drugs

Over-the-counter (OTC), Legend drugs, & Behind-the-Counter (BTC)

Health Insurance Portability and Accountability Act of 1996

Purpose: To improve portability and continuity of health coverage in the group and individual markets Combat waste, fraud, and abuse in health insurance and health care delivery Promote the use of medical savings accounts Improve access to long-term care services and coverage Simplify the administration of health insurance Requires that health care providers ensure that patient confidentiality be maintained Establishes conditions on the use and the disclosure of protected health information (PHI) and requires patient notification on how their PHI will be used * Patients are entitled to a complete discussion of health care options from the health care provider Patients may request that confidential communication is made in a manner that they think is appropriate Every organization must have a written privacy procedure Training must be provided for all employees

Federal Privacy Act of 1974:

Regulates what personal information the federal government can collect about private individuals and how that information can be used

Omnibus Budget Reconciliation Act (OBRA) of 1990

Required states to establish drug use review programs consisting of three essential components: 1. Prospective drug use review - Pharmacist must review for contraindications, drug interactions, incorrect drug dosage, clinical abuse - Pharmacist must offer patient counseling - Also requires the pharmacist to make a reasonable effort to obtain, record, and maintain patient information 2. Retrospective drug use review 3. Educational programs 4. Requires Drug Utilization Evaluation (DUE); ensuring that all medications being prescribed to patients would be reviewed for appropriateness.

3 Dosage Form Categories

Solids, Liquids, & Semisolids

Comprehensive Drug Abuse Prevention and Control Act of 1970

The Drug Enforcement Agency (DEA) created and placed under the supervision of the Department of Justice - Controlled substances placed in one of five schedules (classifications or categories) based on a potential for abuse and accepted medical use a. Schedule I: no acceptable use in U.S. and extremely high potential for abuse b. Schedule II: have medical use but high abuse potential c. Schedule III: have medical use; abuse potential less than Schedule I and II drugs d. Schedule IV: less abuse potential than Schedule III; limited physical/psychological dependence f. Schedule V: less abuse potential than Schedule IV; includes exempt narcotics

Over-the-Counter Package Labeling

The FDA requires the following on all OTC packages: 1. "Use" or "Uses", followed by the indication(s) 2. "Warning" or "Warnings" and "Do not use" followed by all contraindications for use with the product 3. "Directions" followed by the directions for use 4. "Inactive ingredients" followed by a listing of the established name of each inactive ingredient 5. "Questions?" or "Questions or comments?" followed by the telephone number of the manufacturer to answer questions about the product

Over-the-Counter Package Labeling

The FDA requires the following on all OTC packages: 1. Drug's name and place of business of manufacturer, packer, or distributor of drugs and devices 2. National Drug Code number 3. Active ingredient 4. Established name of a drug 5. Inactive ingredient 6. Content requirements 7. "Purpose" or "Purposes" followed by the general pharmacologic category(ies) or the principal intended action(s) of the drug 8. "Use" or "Uses", followed by the indication(s)

Signa

The directions on a prescription that explains how the patient is to take the prescribed medication; write on label

Manufacturer Drug Labeling

The following information is required on all manufacturers' drug labels: 1. Manufacturer lot or control numbers 2. Declaration of presence of FD&C Yellow No. 5 or FD&C Yellow No. 6 in certain drugs for human use 3. Declaration of presence of phenylalanine as a component of aspartame in OTC and prescription drugs for human use 4. Prescription drugs containing sulfites; required warning statements 5. Labeling for systemic antibacterial drug products 6. Bar code label requirements 7. Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile

Manufacturer Drug Labeling

The following information is required on all manufacturers' drug labels: 1. Name and place of business of manufacturer, packer, or distributor 2. National Drug Code number 3. Adequate directions for use (must put caution; if adequate directions is missing) 4. No misleading statements 5. Statement of ingredients 6. Prominence of required label statements 7. Spanish-language version of certain required statements 8. Expiration date

Superscription

The heading of a prescription "Rx"

Subscription

The part of the prescription that provides specific instructions to the pharmacist on how to compound the prescription

National Provider Identifier (NPI)

Unique ten-digit identification number for covered health care providers that is issued by the Centers for Medicaid Services.

National Drug Code (NDC)

unique 10-digit, 3 segment number identifies the labeler, the product, and the trade package size