Amazon’s about-face just highlights the overall complexity of this industry. Experts who truly understand all the sides of this business are few and far between. The pharmaceutical sales business is clouded with complex revenue streams, clawbacks, DSCSA, cold chain supply issues, limited distribution, rebates, buying groups, contracting, REMS programs, and too many more challenges to name.
clawbacks
For a medication used to treat severe vitamin deficiency, the pharmacy’s cash price was $92. The pharmacy processed the claim and was told to charge the patient $115.19. The PBM later performed a $55.47 clawback. So in the end, the patient was overcharged $23.19, the pharmacy lost $32.28, and the PBM pocketed it all. And again, while this was occurring, the pharmacist was prohibited in their contract from blowing the whistle on the charade, and helping the patient find a cheaper alternative method of payment.”
clawbacks
For a medication used to treat severe vitamin deficiency, the pharmacy’s cash price was $92. The pharmacy processed the claim and was told to charge the patient $115.19. The PBM later performed a $55.47 clawback. So in the end, the patient was overcharged $23.19, the pharmacy lost $32.28, and the PBM pocketed it all. And again, while this was occurring, the pharmacist was prohibited in their contract from blowing the whistle on the charade, and helping the patient find a cheaper alternative method of payment.”
Ohio Cracks Down on PBMs Valerie DeBenedette Apr 12, 2018
Challenges in Cold Chain
US FDA: Adulterated Drug Products, FD & C Act Chapter V, sec.501.
• Sub-chapter A, (2)(B) states:
"A drug or device shall be deemed adulterated - if the methods used in, or the facilities or
controls used for, its manufacture, processing, packing, or holding do not conform to or
are not operated or administered in conformity with current good manufacturing practice to
assure that such drug meets the requirements of this Act as to safety and has the identity
and strength, and meets the quality and purity characteristics, which it purports or is
represented to possess.«
• The use of the term holding is an interesting one. "Holding" of a drug occurs when the
drug is being distributed, transported, warehoused or stored.
• "Storage (holding) of a drug at appropriate temperatures and under appropriate conditions
is a requirement" within current Good Manufacturing Practices (cGMP). Code of Federal
Regulations Title 21, Sub-chapter C, Part 205 Sec. 205.50(c)
Drug Supply Chain Security Act (DSCSA) - FDA
https://www.fda.gov/Drugs/DrugSafety/.../DrugSupplyChainSecurityAct/
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (
No comments:
Post a Comment