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 DEA Form 106 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) Schedule II (CII) 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) Schedule IV (CIV) 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: Purposes: 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 FDA list of therapeutic equivalents “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: State Applies to health care providers 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