Introduction to Pharmacy Practice

Introduction to Pharmacy Practice Chapter 2: Pharmacy Law

Learning Outcomes • Understand pharmacy federal & state laws, regulations & role of state boards of pharmacy • Discuss state pharmacy laws & regulations that govern pharmacy technicians • Discuss laws that regulate controlled substances • Describe restrictions on sales of products containing pseudoephedrine & ephedrine

Learning Outcomes • Describe FDA approval process for drugs • Discuss generic drug substitution • Discuss difference between prescription drug inserts for prescribers & for patients • Discuss patient privacy in the pharmacy & federal law that governs privacy of protected health information

Key Terms • Biennial inventory • Child-resistant packaging • Controlled substances • Drug Enforcement Administration (DEA) • Initial inventory • Legend drug • Practice of pharmacy • Prescription monitoring programs • Regulations (or rules)

Introduction • Pharmacy laws & regulations • states require pharmacies & pharmacists to be licensed • many states require pharmacy technicians to be licensed or registered • If state pharmacy law or federal law has stricter requirements, the more strict requirement must be followed

Ethical Principles • “Doing the right thing” • complying with laws & regulations • maintaining competency • respecting patient privacy & confidentiality • Code of Ethics for Pharmacy Technicians • American Association of Pharmacy Technicians (AAPT)

State Pharmacy Laws • Cover pharmacies, pharmacists, pharmacy technicians, and pharmacy practice • Laws • usually more general • enacted through state legislative process • Regulations or rules • provide the details to implement the law • issued & adopted by state regulatory agencies • usually adopted through state board of pharmacy

State Laws & Rules • Vary by state • Universal distinction for pharmacy technicians • work under the supervision/direction of pharmacists • may only perform the tasks permitted under state law • Pharmacy technicians may not perform tasks • that are limited to pharmacists • require the professional judgment, education, & training of pharmacist

State Boards of Pharmacy • Regulate the practice of pharmacy • Pharmacies • Pharmacists • Pharmacy interns • Pharmacy technicians

State Board’s Authority • Licensing pharmacies and pharmacists • Registering or licensing pharmacy technicians • Inspecting pharmacies • Issuing rules and regulations • Investigating complaints • Disciplinary actions • National Association of Boards of Pharmacy (NABP). Website www.nabp.net

Pharmacy Licensure • Requirements for pharmacy licensure • record keeping requirements • security • pharmacist-in-charge • licensed pharmacist on duty while pharmacy is open • Rules regarding pharmacist’s break period • Inspections to check on compliance

Categories of Pharmacy Licenses(In some states) • Retail • Community • Institutional • Hospital • Long-term care • Special or limited-use pharmacies • Nuclear • Mail order • Sterile-compounding pharmacies • Non-resident pharmacies must be licensed in state if they mail, ship, dispense, or deliver prescription drugs to state residents

Technician Requirements • Pharmacy technician registration or licensure • Accompanying qualifications • Permitted tasks • Prohibited conduct • Criminal background checks in some states

General Qualifications for Techs • Minimum age • High school graduation or the equivalent • Completion of training program • An examination (Pharmacy technician certification) • Technician: Pharmacist ratio

Patient Counseling • Pharmacy technicians are not authorized to counsel patients on their medications • Pharmacists provide patient with med information • Purpose of medication • when & how much to take • whether to take with food • how to store the medication • possible side effects

Patient Counseling • Important to ensure meds are safe & effective • Pharmacists required to offer to counsel patients on new prescriptions in most states • Offer to counsel differs from patient counseling • Pharmacy technicians may assist the pharmacist • language translation if they are fluent • services needed during patient counseling process

Controlled Substances Act • Federal law regulates all facets of controlled substances • Manufacturing • distribution • dispensing • storage & record keeping

DEA • Drug Enforcement Administration • Pharmacies, prescribers, wholesalers, drug manufacturers, & others must be registered with DEA • DEA numbers • physician: number starts with either letter A or B followed by first letter of physician’s last name • Process for verification of DEA number

DEA Forms • DEA Form 222 • Used for ordering Schedule II controlled substances • Alternatively, pharmacies may use online CSOS (http://www.deaecom.gov/ ) • DEA Form 106 • Reporting of Drug Losses • CII records must be separate from CIII, CIV, & CV records

Controlled Substances • 5 schedules for controlled substances • (I, II, III, IV, and V) • Based on criteria • potential for abuse or addiction • medical use • Schedule of drug determines level of control

Schedules • Schedule I (CI) • most restrictive • high potential for abuse • not available in pharmacy • examples: heroin and marijuana • Schedule II (CII) • high potential for abuse or misuse • high risk of dependence • examples: Meperidine (Demerol), methadone, morphine, oxycodone (OxyIR, OxyContin), methylphenidate (Ritalin)

Schedules (Cont) • Schedule III (CIII) • moderate potential for abuse, misuse & dependence • includes combination drug products • acetaminophen and codeine (Tylenol #3) • acetaminophen with hydrocodone (Vicodin) • Schedule IV (CIV) • low potential for abuse & limited risk of dependence • examples: Diazepam (Valium), lorazepam (Ativan), phenobarbital, & other sedatives and hypnotics

Schedules (Cont) • Schedule V (CV) • lower potential for abuse, misuse, or dependence • examples: cough medications with limited amount of codeine, anti- diarrheal medications containing limited amount of opiate, such as diphenoxylate/atropine (Lomotil) • in some states, no prescription required • May be dispensed by a pharmacist without a prescription if specific requirements are met

CV Rules In Some States • Substance is not a prescription drug • Pharmacist must approve the sale • Purchaser is at least eighteen years of age • Pharmacy maintains record book including: • purchaser’s name & address • name & quantity of product • date of purchase • name or initials of dispensing pharmacist

Labeling of Controlled Meds • Federal law: • drug manufacturer’s packaging labeled with C & appropriate Roman numeral • CII, CIII, CIV and CV • pharmacies must place specific caution message on patient container • “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”

Dispensing Controlled Meds • For controlled substance prescription to be valid • must be prescribed by licensed prescriber • for legitimate medical purpose • normal course of prescriber’s professional practice • prescribing practitioner must be registered with DEA • licensed to prescribe controlled substances by the state • pharmacist responsible for validity of prescription

Dispensing Controlled Meds • Federal & state laws require specific information • date issued • patient’s full name and address • practitioner’s name, address & DEA registration number • drug name, strength, dosage form, & # prescribed • directions for use • number of authorized refills (if any) • signature of prescriber (unless a verbal prescription is permitted)

CII Requirements • Need written prescription signed by practitioner • Exceptions • Emergency • practitioner may telephone or fax prescription to pharmacist • prescriber must • provide original prescription to pharmacist within 7 days • indicate authorized for emergency dispensing • Schedule II prescriptions may be faxed for • patient residing in long-term care facility • hospice patient

Refills of Controlled Drugs • Schedule III & IV prescriptions • refilled up to 5 times within 6 months • Schedule V prescriptions • may be refilled more than 5 times • have 6 month time limit on refills • Schedule II prescriptions • may not be refilled

Transfer of Prescriptions • Schedule II -not transferable between pharmacies • Schedule III, IV, V –may transfer for 1 refill • if state law permits • Real-time online computer system for chains • may transfer Schedule III, IV, V prescriptions up to max number of authorized refills

Records for Controlled Meds • Must maintain complete & accurate records for controlled substances • purchased, received, distributed, or dispensed • initial & biennial inventories required • Federal law requires pharmacy to • keep controlled substance records for 2 years • have records readily available for DEA inspection

Monitoring Programs • Many states (>35) have programs in place • Pharmacies report controlled substance prescriptions to designated state authority electronically on periodic basis

Monitoring Programs • Information reported: • patient information • prescriber information • pharmacy identification • prescription information • Purposes: • identify potential diversion and abuse of prescription controlled substances by the patient, pharmacy, or prescriber • identify potential patients that would benefit from drug abuse treatment programs

Ephedrine & Pseudoephedrine • Restrictions on sales • precursor chemicals to methamphetamine • Combat Methamphetamine Epidemic Act of 2005 (CMEA) is federal law • Ephedrine & pseudoephedrine commonly found in cough, cold, allergy products

Limitation of Sales • Products not available for public access • Purchaser must sign logbook • Federal law limits sales • 3.6 grams/day (~ 146 tablets of pseudoephedrine 30 mg) • 9 grams in 30-day period • Information is available at http://www.deadiversion.usdoj.gov/meth/trg_retail_081106.pdf

Brand & Generic Drugs • FDA approves all drugs as safe & effective • FDA requires new drug application (NDA) • NDA • information about drug • results from clinical trials in humans • results of animal studies • how drug acts in body • how drug manufactured, processed, & packaged

NDA • FDA reviews NDA to assess • Whether drug is safe & effective • if benefits of drug outweigh potential risks • if proposed labeling appropriate • whether methods used in manufacturing are adequate to ensure quality of drug • Companies market drugs with trade or brand name

Example of Brand/Generic • Lipitor -brand name • Generic-atorvastatin • Pfizer developed atorvastatin & submitted NDA to FDA • Granted patent-exclusive rights until patent expires • When patent expires-drug manufacturers may seek approval from FDA for generic equivalents

Generic Equivalents • Same as brand • active ingredients • dosage form • strength • formulation • Must submit abbreviated new drug application (ANDA) • do not need to repeat the original research • Generic drugs have different appearance • Drug is distributed under generic name- not brand name

Generic Drug Substitution • May substitute generic for brand • unless prescriber prohibits • Generic substitution regulated by state • State laws & regulations for generic substitution • determine how physicians indicate preference • Patients may request brand or generic drug • Pharmacists may be required to substitute generics for Medicaid patients

Orange Book • “Approved Drug Products with Therapeutic Equivalence Evaluations” • FDA list of therapeutic equivalents • Pharmacists use Orange Book to check generic equivalence • Not all drugs have generic equivalent

Manufacturer Label includes: • Name & address of drug manufacturer • Drug name • Strength • Dosage form • Manufacturer’s expiration date for drug • Lot number • Package size or quantity • DEA schedule (if appropriate)

Manufacturer Label includes: • “Rx Only” or “Legend drug” on prescription drugs • due to Durham-Humphrey Amendment-1951 • “Caution: Federal law prohibits dispensing without a prescription” • NDC (National Drug Code) must be on label • Package insert must be attached to container

Package Insert Includes • Indications for use • Dosage and administration • Adverse reactions, warnings, precautions • Contraindications for the drug • Preparation instructions • Proper storage • Available package sizes with NDC numbers • Prescription drug package insert is not intended for patients

Drug Information for Patients • Consumer medicine information (CMI) • Patient package insert (PPI) • Only for certain prescriptions • Example: estrogens and oral contraceptives • PPIs written specifically for patient • Medication Guide or Medguide • FDA-approved information • required by FDA for select medications & classes of medications • http://www.fda.gov/Drugs/DrugSafety/UCM085729

OTC Drug Labeling • Drug name • Total quantity • Uses for drug • Recommended dosage & frequency • Who should or should not take the medication • Side effects & precautions • Drug Facts section • active ingredients, uses, warnings, directions for use • Expiration date

Poison Prevention • Poison Prevention Packaging Act of 1970 • mandates child-resistant packaging • Prevent 80% of children from opening • Allow 90% of adults to open • Consumers may request nonchild-resistant packaging • Exemptions • sublingual nitroglycerin tablets • oral contraceptives (birth control pills)

Patient Privacy • Federal: • Health Insurance Portability & Accountability Act (HIPAA) • State • laws and rules vary from state to state • Applies to health care providers • includes discarding patient information in secure manner • precautions for privacy of pharmacy conversations with and about patients

PHI • Protected Health Information • Examples of pharmacy PHI • pharmacy prescription records • computer records • prescription container labels • other pharmacy records that identify the patient • oral communications about patients’ prescriptions & health care treatment

Allowable Disclosures • When necessary to provide patient health care services • Examples • dispensing prescriptions • patient treatment • billing for pharmacy services • managing patient

Introduction to Pharmacy Practice