Transcript 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
 Nuclear
 Community
 Mail order
 Institutional
 Sterile-compounding
 Hospital
 Long-term care
 Special or limited-use
pharmacies
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
2. Pharmacist must approve the sale
3. Purchaser is at least eighteen years of age
4. Pharmacy maintains record book including:
1.




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_0
81106.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