Federal Laws

CHAPTER 3

DRUG REGULATION• Timeline highlights

– Food Drug & Cosmetic (FDC) Act– Durham Humphrey Amendment– Poison Prevention Packaging Act– Controlled Substances Act– Omnibus Budget Reconciliation Act

(OBRA)– Health Insurance Portability and

Accountability Act (HIPAA)– Medicare Modernization Act– Patient Protection and Affordable Care

Act

HIPAA Defines scope of patient information that may and may not be

shared among health care providers without patient consent

All “covered entities” are required to be compliant with HIPAA regulations

“Covered entity” means any provider using electronic communication methods but regulations also cover oral and paper communication

Health care providers must:– Provide for privacy and security of protected health

information (PHI)– Inform patients of their privacy policies and procedures– Allow patients to review and correct any records

New Drug Approval Process Laboratory tests Animal tests Clinical trials

– phase 1• 20-100 participants• months• tests safety

– phase 2• hundreds of participants• up to two years• tests safety and effectiveness

– phase 3• up to thousands of participants• one to four years• tests safety, dosage and effectiveness

Product Labeling• Patient Package Inserts (PPIs) – required by

FDA for some potentially dangerous drugs – info on how to sagellu use meds (i.e. oral contraceptives

• Medication Guides (MedGuides) – can be provided voluntarily by drug manufacturer

• OTC Labels – should contain product name, address of manufacturer, list of ingredients, amount of contents, adequate warnings, adequate directions for use

FDA LABEL FORMAT FOR OTC MEDICATIONS

Behind-the-Counter OTC Meds OTC Medications Containing Ephedrine and

Pseudoephedrine

Combat Methamphetamine Epidemic Act (CMEA) (3.6 gms per day)

Exempt Narcotics – meds that contain habit forming ingredients but can be sold without a Rx i.e. cough syrup with codeine

Emergency Contraceptives– Plan B®

– Dual-marketing status (like Plan B)

DAILY SALES LIMIT OF PSEUDOEPHEDRINE

Controlled Substances Schedule I

– high abuse potential, no accepted medical use

Schedule II– high abuse potential, accepted medical use

Schedule III– less abuse potential than above, accepted medical use

Schedule IV– less abuse potential than above, accepted medical use

Schedule V– less abuse potential than above, accepted medical use

Regulations for Controlled Substances

• Labels• Record keeping – schedule II records must

be kept for 7 years and all other records for 2 years unless state specifically changes requirement

• Security – stored in locked, tamper-proof cabinet

• Joint responsibility – prescriber and dispenser• DEA number - 2 letters followed by 7

numbers

DEA Forms

• DEA 222 order form

• Other DEA forms

To check a DEA number: Add the sum of the 1st, 3rd, and 5th

digits to twice the sum of the 2nd, 4th, and 6th digits; the total

should be a number whose last digit is the same at the last

digit of the DEA number on the prescription.

i.e. AB1234563

since (1+3+5 )+ 2 (2+4+6) =33 the DEA number is valid

Recall Classifications Class I

– strong likelihood product will cause serious adverse effects

Class II– chance the product may cause temporary but

reversible adverse effects or little likelihood of serious adverse effects

Class III– not likely to cause adverse effects

Laws and Standards

• Federal laws• State laws• Professional standards

– ASHP– USP – published guidelines that are considered

standards in pharmacy practice• Chapter <795> Compounding• Chapter <797> Sterile Compounding

– TJC – The Joint Commission– ASCP – American Society for Consultant Pharmacists

• Liability and negligence

Ethics• Basic values

– Autonomy – right to choose your own treatment

– Beneficence – actions should be in te best interest

of the patient

– Dignity – treat all patients with respect

– non-maleficence – do no harm

– Justice – fairness and equality

– truthfulness and honesty – truthful and honest with

all patients

Compliance

• Institutional review boards

• Federal guidelines for compliance