| Q: |
Why has Abbott initiated this amendment? |
| A: |
The DEA has stated that "rogue" Internet websites are
the number one source of abused combination hydrocodone products. According to
the DEA, such sites commonly offer drugs for sale outside the context of a
legitimate doctor-patient relationship and without the benefit of a valid
prescription for a scheduled product. The safety and integrity of Abbott
products are of the highest priority and Abbott takes the threat posed to
public health and safety by illicit Internet purchases very seriously.
Accordingly, we are undertaking this initiative to prevent the sale of our
Vicodin-class products (e.g. Vicodin IR, Vicoprofen and any future hydrocodone
bitartrate/acetaminophen products) through such rogue Internet sites, while
preserving the ability to fill and re-fill legitimate prescriptions, issued
within the context of bona fide physician-patient relationships, using on-line
technology.
|
| Q: |
Can the 30-day deadline be extended? |
| A: |
: The threat of illicit Internet purchases to public health
and safety is serious and therefore dictates that we maintain the amendment's
effective date of 30 days beyond the date the ESA amendment letter was issued.
A wholesaler / distributor's agreement to comply with the ESA amendment letter
is required no later than 30 days after the ESA amendment letter is issued,
which is the deadline for signature and return of the original notification via
certified mail to Abbott Laboratories. Please refer to the
www.abbott.com/GlobalProductProtection website for more information. Only
those wholesalers/distributors in compliance with this ESA amendment will be
approved to purchase Vicodin-class products from Abbott Pharmaceutical Products
Division (Abbott).
|
| Q: |
What happens if a wholesaler/distributor does not meet
the 30-day deadline? |
| A: |
Unless Abbott receives the signed ESA amendment for
Vicodin-class products by the 30-day deadline, a wholesaler/distributor will
lose its status as a wholesaler/distributor for Abbott's Vicodin-class
products, and shipments of such products by Abbott to the
wholesaler/distributor will cease effective as of that date.
|
| Q: |
What products of Abbott are included in this ESA
amendment? |
| A: |
Vicodin-class products are addressed in this ESA amendment.
"Vicodin-class" is defined to include Vicodin IR, Vicoprofen, and any
future hydrocodone bitartrate/acetaminophen products.
|
| Q: |
What happens if a wholesaler or distributor elects not
to sign the ESA amendment for Vicodin-class products? |
| A: |
Any wholesaler or distributor who elects not to sign the ESA
amendment for Vicodin-class products will not be eligible to purchase
Vicodin-class products.
|
| Q: |
How does Abbott communicate the status of
wholesalers/distributors vis-à-vis this amendment? |
| A: |
Abbott provides a listing of wholesalers/distributors approved
to purchase Vicodin-class products at: www.abbott.com/ESAlist.
Regular updates are made to this listing.
|
| Q: |
Does the ESA amendment replace the terms of the
original ESA? |
| A: |
No. The terms regarding Vicodin-class products are in addition
to, and do not replace, the current terms of the ESA. The ESA is amended only
to the extent set forth in the amendment, and all the current terms of the ESA
remain the same and are not affected by this amendment.
|
| Q: |
How do the terms of the ESA amendment for
Vicodin-class product differ from Abbott's ESA for Abbott Diabetes Care (ADC)
product and other Pharmaceutical Products Division (PPD)
products? |
| A: |
The terms of the ESA amendment for Vicodin-class products
differs from the original ESA for ADC and other PPD products in 2 ways. The ESA
amendment for Vicodin-class products states that: 1) when selling to customers
in the United States who are predominantly Internet pharmacies, these
pharmacies must be VIPPS accredited. A predominant Internet pharmacy is defined
as generating greater than 50 percent of their
sales dollars via Internet transactions and 2) wholesalers and distributors who
sign the ESA amendment for Vicodin-class product are certifying that they have
designed and implemented prospective suspicious order monitoring or similar
programs to identify and report to the DEA suspicious orders of controlled
substances..
|
| Q: |
What does VIPPS stand for? |
| A: |
VIPPS stands for Verified Internet Pharmacy Practice Sites,
and is an accreditation awarded by the National Association of Boards of
Pharmacy ("NABP") to US-based online pharmacy web sites based in the
United States that are appropriately licensed, are legitimately operating via
the Internet, and that have successfully completed a rigorous criteria review
and inspection. A link to the website is attached below: http://www.nabp.net/index.html?target=/vipps/consumer/listall.asp.
|
| Q: |
What do prospective suspicious ordering programs need
to include? |
| A: |
Such programs shall comply with DEA regulations requiring
identification and reporting of suspicious orders including orders of unusual
size, orders deviating substantially from a normal pattern, and orders of
unusual frequency. Programs shall include controls reasonably sufficient to
prevent resale of Vicodin-class products to entities that dispense product via
illegitimate Internet websites.
|
| Q: |
Where should potential violations to the ESA be
reported? |
| A: |
Abbott Global Product Protection
D-GS27, Building J48
200 Abbott Park Road
Abbott Park, IL 60064
(847) 936-5959
|
| Q: |
Where should suspicion or leads on counterfeit,
diverted or stolen Abbott product be reported? |
| A: |
Abbott Global Product Protection
D-GS27, Building J48
200 Abbott Park Road
Abbott Park, IL 60064
(847) 936-8352
|