Reading 6 Flashcards
What is the PDMA?
- Helped divert Rx drugs/samples from normal distribution
What are the different area of the PDMA?
- Reimportation
- Preferentail Pricing
- Samples and Coupons
What is Reimportation within pharmacy law?
- Prohibits it 8 UNLESS by FDA
- Bans importation of american made drugs from other countries
What made Reimportation illegal?
- American drugs from other countries cost less; so people would buy from them, bring it to the US, then sell for more
What are the two situation where Reimportation is LEGAL
- Manufacturer move supply to sell in US
- Drug needed for emergency use
What is Perferential Pricing?
- Bans the sale, purchase or trade of Rx drugs purchased at lower prices [by hopsital…]
What is important to know about Samples and Coupons in the PDMA?
- Prohibits the sale, purchase or trade of Samples or Coupons
- Practitioners need to ask in writing
- Since free CANNOT make money off them
Samples: promote the sale of a drug
Who is able to have Samples or Coupons?
- RETAIL cant have them
- HOSPITAL can
What is the final part of the PDMA?
- Whistleblower: basically awarding people for turning others in
- Snitch
What is the Federal Anti-Tamper Act?
- ## Act helps to prevent tampering
What are the FIVE crimes that the Federal Anti-Tampering Act created?
- Tampering with LABEL
- TAINTING Product
- FALSE INFO that prodcut is tainted
- THREATENING to tamper
- CONSPIRING to tamper
What is a Tamper-Evident Packaging?
- Packaging that doesnt stop someone from Tampering, just shows that it has been tampered
What are some of the requirements that shows that it is a Tamper-Evident Package?
- Must have barriers that show if its been tampered
- Must have a unreplicatable design
- Possilbly a picture on the barrier
NOT MET = Adulteration or Misbranding or Both
What are some of the design features assoicated with Tamper-Evident Packaging?
- Wrappers, Cartons, Breakable Caps, Mouth Seals, Blister Pack…
- SEAL CAPSULES if used capsules
What is the DSHEA?
- Dietary Supplement Health and Education Act
- Alterd FDA authority over dietary supplements
DIET SUPPLEMENTS = FOOD not drugs
What are some of the differences between a dietary supplement and a drug?
- Dietary Supplements cannot claim too cure
- Baically “Food” the FDA cannot require premarker approval; doesnt show how safe or effective it is
**FDA has too prove; safety, effectiveness or adulteration before remova
What is the evidence that a manufacturer or the FDA must show for a dietary supplement to be added to or removed from the market?
- ADD: not really anything since its “food”
- REMOVE: FDA must show that is unsafe or uneffective or adultered
What are the claims that Manufacturers can make about Dietary Supplements?
- Claims benefit to classical deficienies
- Describes a role of an ingredent that affects humans
- How the supplement acts
- What happens when taken
What type of labeling is require for a dietary supplement to have?
- ALL MUST SAY: not been evaluated by the FDA. This product is not for cure, treat, prevention
- IN BOLD
What information does HIPAA protect, and who is it that its protecting?
- Transaction and Code sets, National Providers Indentites, Security, Privacy
- Protecting really anyone; mainly patients
What is the main aspects of HIPAA that are most considered?
- Security: preventing breaches
- Privacy: Patient right and when to use it
What and who are Entities within HIPAA?
- Groups that use HIPAA
- Health Plans, Insurance, Providers, Pharmacy…
What is PHI?
- Protected Health Information
- Health and payments that can identify a patient
Name, Address, Health Plan ID, Medical Record Number
What is the PDMA?
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