1. Introduction to Pharmacy Practice
Chapter 2: Pharmacy Law

2. 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

3. 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

4. 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)

5. 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

6. 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)

7. 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

8. 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

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

10. 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

11. 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

12. 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

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

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

15. 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

16. 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

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

18. 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

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

20. 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

21. 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)

22. 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

23. 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

24. 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

25. 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”

26. 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

27. 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)

28. 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

29. 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

30. 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

31. 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

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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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)

43. 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

44. 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

45. 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

46. 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

47. 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)

48. 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

49. 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

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