Wednesday, June 04, 2008

CA E-Pedigree Timeline in Flux

I hope you are still paying attention to the California pedigree situation.

Yes, we all know that the CA Board of Pharmacy extended the e-pedigree implementation deadline to January 1, 2011. But SB1307, which was introduced by CA State Senator Ridley-Thomas in February, proposes the following new e-pedigree implementation timelines:

  • Wholesalers: January 1, 2011
  • Pharmacies: January 1, 2012
  • Manufacturers: January 1, 2011 to January 1, 2013

The manufacturers have a phased in serialization schedule under SB1307 because “the process of implementing serialized electronic pedigree for all prescription drugs in the entire chain of distribution is a complicated technological and logistical undertaking for manufacturers, wholesalers, pharmacies, and other supply chain participants. The Legislature seeks to ensure continued availability of prescription drugs in California while drug manufacturers implement these requirements.” (according to page 10 of the bill’s text.)

Here is the proposed schedule by which a manufacturer must (1) designate the particular drugs that will be serialized, and (2) actually comply with the serialized electronic pedigree requirements:

  • Designated by January 1, 2010; Compliance by January 1, 2011: 20 percent of drugs
  • Designated by January 1, 2011; Compliance by January 1, 2012: 30 percent of drugs (Total = 50 percent)
  • Designated by January 1, 2012; Compliance by January 1, 2013: 50 percent of drugs (Total = 100 percent)

I’m encouraged that California will be incorporating more realistic timelines for serialization, especially given the unknown prospects for national standards. However, it's harder than ever to predict the precise future deadlines.

Where's Doc Brown when you need him?

READER OF THE WEEK

The Texas Startup Blog recently interviewed Jon Cameron, founder and President of Pop Technology. According to the article: “When Jon isn’t inventing cool gadgets for the retail industry he can be found reading Drug Channels…”

Gosh, your friendly neighborhood blogger is now someone’s hobby!

Thanks for the shout-out, Jon.

COMMENTS, WE GOT COMMENTS

There are many interesting comments on yesterday's analysis of the latest AMP study. Read them below the original post. Perhaps you'll even add you own $0.02?

2 comments:

  1. Jon CameronJune 04, 2008

    After reading your article, I was incredulous. How could a pharmacist use pedigree before a manufacturer serializes the product? However, after a quick read of the bill, I think their dates are in order. Here are the significant dates from what we read:

    January 1, 2010 – Manufacturer must designate 20% of their drugs to be subject to the initial phase.

    January 1, 2011 – Manufacturers must increase designated drugs to 30% of their drugs.

    January 1, 2012 – Wholesalers and manufacturers must begin compliance. Manufacturers must increase compliance to 50%.

    July 1, 2012 – Pharmacist must comply

    However, this new language actually accelerates the deadline for establishing epedigree standards and technology. On the January 2010 deadline, manufacturers “shall include in the notification, the technology to be used to meet the serialized electronic pedigree.” This gives manufacturers precious little time to research requirements, review technologies, select vendors, reconfigure operations and commence. So much for 2011. The date is now January 1, 2010.

    The last three words of the requirement, “serialized electronic pedigree” are also of particular note about the new language. This is the first time “serialized” has been specified. 4163.5. (a) (2) (b) also says, “shall be the subject of its initial phase of compliance with the state’s serialized pedigree requirement…” Previously, this identifier was only referred to as “unique identification number” which could have been a single code for each drug/dosage/strength. There is also the suggestion the serialization would be assigned by the manufacturer and that now both terms are now synonymous.

    There is some other significant language:.

    One, the bill deletes the board’s authority to “extend these compliance dates.” Later, some exceptions are specified.

    Two, the bill removes the case for the use of RFID. RFID proponents have saddled their case to the ability of RFID to passively scan a case or pallet, and thereby preventing the need to open cases and scan each item. Under Section 5, the board is mandated to establish rules that allow supply participants to infer the contents of the case or pallet. This is a nod to current practices and should significantly ease the concern of slowing the channel or increasing labor costs for shipping and receiving.

    Three, if federal standards are developed for data elements or standards, the federal requirements would trump. This is the real issue that places the timeline in flux. This language, and H.R. 5839, make it impossible to set a reliable business course without significant legislative risk.

    ReplyDelete
  2. Good points, Jon. Funny that the CA Board of Pharmacy pushes RFID hard in its response to the FDA. (See Board Comments to the FDA on Docket No. 0121).

    Jon, your designation as "Reader of the Week" is well earned!

    Adam

    ReplyDelete

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