HomeMy WebLinkAboutexelixisinc2015annualreport-archiveAlameda County Safe Drug Disposal Regulation Annual Report
Plan Owner:
Submitted By:
Original Plan Approval Date:
Annual Report Due Date:
Exelixis, lnc.
Donald Campodonico, Plan Liaison
25-February-2015
On or Before 25-February 2OL6
Part l: Report Narrative
l. Executive Summary
Exelixis, lnc., ("Exelixis"), a low volume Producer of our lone commercial product, Cometriq@,
within the county of Alameda, received approval of our Plan on February 25,2075 (see "Notice
of Determination After Public Hearing" attached as Appendix A). Exelixis' Plan within Alameda
County does not require formation of individual physical Collection Points, or other collection
requirements under the Ordinance, other than our developed mail-back program for the
arrangement and safe disposal of Unwanted Product. Additionally, Exelixis' Plan does not
require oversight or reporting on other metrics under the Ordinance, such as, goals, broader
outreach activities, and other stated take-back measures that do not apply to our mail-back Plan
under the Ordinance. Therefore, certain required Annual Report information or data will be
marked as "not applicable" in Exelixis' Annual Report.
As indicated in our Plan, Exelixis provides information on the safe disposal of Unwanted
Products sold into Alameda County on our website, and any patients within Alameda County
purchasing our Product receive a copy of our mail-back flyer that provides our patients with
instructions related to Exelixis' mail-back option, as well as free drop off locations available
within Alameda County.
To date, Exelixis' proposes no new collection efforts for our product sold into Alameda County
and Exelixis also notes that we have not encountered any challenges or difficulties related to our
mail-back program as of the submission date of our report.
Reporting on Goals
For the past year, the goals for Exelixis' Plan were to implement the mail-back instructions on
our product's website, implement the specific changes to our flyer requested by Alameda
County, include information on drop off locations within Alameda County on our website and on
the flyer that Exelixis' specialty pharmacy provides to its patients when Product is shipped to a
patient living within Alameda County. For the past year, since the Plan was implemented, the
stated goals were met and achieved.
ilt.Future Goals
Currently, Exelixis does not have any future goals for our Plan within Alameda County. Exelixis
will continue to operate our mail-back program with the same oversight and requirements as in
the past year. This aspect of the report is therefore deemed, not applicable.
Collection Practices
Due to the low volume of product distributed within Alameda County, Exelixis' Plan is strictly a
mail-back program operated in concert with our specialty pharmacy and third party logistic
company within our supply chain. Upon receipt of a prescription for a patient within Alameda
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County, the patient receives our product, and a copy of Exelixis' mail-back flyer that provides the
patient with an 800 phone number in the event the patient wishes to have any Unwanted
Product safely reclaimed and disposed.
After calling the 800 number, the patient informs the representative that he or she would like to
return the unused or expired product in his or her possession. The representative generates a
pre-paid, self-addressed package that is sent to the patient, and the patient may then place the
unused or expired product, inside the pre-paid self-addressed package, seal the package, and
drop it off at the near mail carrier's site.
Additionally, the flyer provided to the patient, as well as the mail-back information located on
our product's website, includes information instructing patients where they can obtain
additional information on the safe disposal of their medicines, as well as information for drop-
off locations operating in Alameda County.
Educational Efforts and Public Outreach Activities
Exelixis, by way of our website (and through our specialty pharmacy, as specifically instructed by
Exelixis, and on Exelixis' behalf) provides information (an example is attached to this report as
Appendix B) with every shipment of drug that is sent to any patient located within Alameda
County, and includes the following information:
. A reference to the Ordinance
o Notice of Exelixis' intent to comply with the Ordinance
. lnformation regarding the safe disposal of Cometriqo
. An overview of the return process of Cometriq@ and what to expect
. A toll free number for questions concerning Cometriq@ disposal
. Links to websites where patients can obtain additional information
. lnformation for drop-off locations operating in Alameda County
The educational materials will be in English, but Exelixis has consultants available to provide
translated versions of the educational materials to patients in their native language as needed,
including the toll free number provided.
Vl. Safety and Security Report
ln accordance with Section 15(C)(vi), please see Appendix C attached to this report.
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Part ll: Report Data
Producers Participating in the Plan
Exelixis, lnc.
210 East Grand Avenue
South San Francisco, CA 94080
Collection Point I nformation
Under our approved Plan, Exelixis is not required, and does not operate any Collection Point
locations. The data requested under this section of the Annual Report is not applicable.
Mail-Back Program I nformation
ln the past year, under our Plan, Exelixis provided zero (0) mail-back containers to our patients
within Alameda County under our approved Plan. Since no patients within Alameda County
utilized the mail-back disposal option under our approved Plan, our third party logistics
company and the third party destruction facility our third party logistics company utilizes,
processed zero (0) mail-back containers for destruction. The Collected Unwanted Products by
weight for the past year totaled 0.0lbs or 0.0kgs.
Disposal Facility I nformation
Our third party logistics vendor utilizes the services of Stericycle for its destruction of materials.
Stericycle's destruction and certificate site is located at:
Stericycle Environme nta I So I utio ns - Destruction Ce rtificate Co ntact
2120 Southwest Blvd
Tulsa, OK 74LO7
Total weight of Collected Product disposed of at |CS/Stericycle under our Plan: 0.0lbs or 0.0kgs.
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Appendix A
Copy of Exelixis' Notice of Determ¡nation After Public Hearing
AlomcdoCounty
Environmcnlol
H¡ollh Deporlmcnl
nll rbtd srr Arh,lq. 4ú.&. C¡ ÍlSC lll¡l taf að0
Af iu Levl, D¡rtttor of Eívirwlmenhl l-leelth
Pfi onÊ: 510_5õ7.6177 Fz'; 510.33].9135
NOTICE OF DETERMINATION AFTER PUBTIC HEARING
Produc Steumrdshlp Rsn Revlew
Alameda County SafÊ Orug Dlsposal Ordlnanæ
PIAH Ol¡t/t{ER¡Exelixis, lnc.
ll0 Eðst Gr¿nd Avenue
South 5¿n Frenclsco, CA 94081)
PLA.N LIAISOH: Jeffrey Hêsreftiel & Donald Campodonico
Pl¡¡{ DESËRIPÏOi{: Â ProductStewardship Flan proposed and operated individually bT Exeh:rs for
the collecllan ¿fd dispo¡¿l of thelr ofle Coveæd Dru& CürÐetrlq,
HEAßING DATE: February ?3.2015
OETEÊltttltlAÎlOt{ r
The Exellxls, lnc, revired Stewardship Plan dated 1-3G2015, as updated 2-2-2A15, is approved.
ThÈ Plän a pprovel datp ls February ?S. 2015.
Thc first Ånnual Report Is due on or before: February 25r lO15
Slgrredr_.
Arlü D,lrÊctor
Alåmsdã Countv,
He¡lth Crrc ÁgÊncY
of I rwironmBntðl Hsalth
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Appendix B
Exelixis'Safe Drug Disposal Program Flyer
The Alameda County Board of Supervisors unanimously passed an ordinance in July 2OL2 requiring
pharmaceutical producers that sell, offer for sale, or distribute certain prescription drugs covered
by the ordinance to patients who reside in Alameda County to develop and implement a process
for the safe collection and disposal of any "Unwanted Products" from such residential prescription
drug patients within Alameda County.
As the producer of Cometriq@, if you are in possession of Cometriq@ that is either expired, or will
not be used, please follow the following steps:
L. Call our specialty pharmacy, Diplomat, at the following toll free number:
1-8ss-253-EASE ( 1-85 5-253-327 3l
lnform the representative that you would like to return your unused or expired
Cometriq@
The representative will send you a pre-paid self-addressed package
Simply place the unused or expired Cometriq@ in its original packaging inside the pre-
paid self-addressed package, sealthe package, and drop it off at the near mail carrier's
site
Call: 1-855-253-EASE (1-855-253-32731 for Safe Disposal
Additional information on safe disposal of Cometriq@ is also available at:
There are also fixed locations currently operating in Alameda County where residents can drop-off
their unwanted prescription drugs. You can find a local drop off location within Alameda County by
visiting the following websites:
At Exelixis, we recognize the importance of safe drug disposal, and our responsibility to do our part
in providing a way of disposing of unused or expired medications in an environmentally sound way.
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Appendix C
Safety and Security Report
Exelixis had no known security or safety incidents during the past year of the collection of our product and
no known legal proceedings arising from any such incident.
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