1. Federal Laws CHAPTER 3

2. 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

3. 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

4. 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

5. 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

6. FDA LABEL FORMAT FOR OTC MEDICATIONS

7. 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)

8. DAILY SALES LIMIT OF PSEUDOEPHEDRINE

9. 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

10. 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

11. DEA Forms DEA 222 order form Other DEA forms To check a DEA number: Add the sum of the 1 st, 3 rd, and 5 th digits to twice the sum of the 2 nd, 4 th, and 6 th 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

12. 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

13. Laws and Standards Federal laws State laws Professional standards –ASHP –USP – published guidelines that are considered standards in pharmacy practice Chapter Compounding Chapter Sterile Compounding –TJC – The Joint Commission –ASCP – American Society for Consultant Pharmacists Liability and negligence

14. 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

15. Compliance Institutional review boards Federal guidelines for compliance