Federal Laws CHAPTER 3. DRUG REGULATION Timeline highlights –Food Drug & Cosmetic (FDC) Act...
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Transcript of Federal Laws CHAPTER 3. DRUG REGULATION Timeline highlights –Food Drug & Cosmetic (FDC) Act...
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