Dear Maria

I am writing to follow up on our earlier communication regarding disposal instructions for unused drugs. I am resending the information e-mailed on August 18. I would appreciate receiving your guidance on disposal of listed drugs.

With kind regards

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

Dear Maria

Many thanks for your e-mail and follow up on this issue. I apologize for delayed replay. In summary, as we already mentioned. the drugs that expired or were returned (due to terminated treatment from 2015-2019) as part of   National hepatitis C treatment program are kept at “center of mental health and addiction prevention” and ltd “medpharma plus” in Tbilisi, Georgia. As of 28 of July 2020 there are 560 645 083,40 georgian laris worth of expired medical products under 5 different names.

Interferon - (Veil) - 1222 units

Ribavirin  (Pills) - 5547 units ;

Zepatier (Pills)- 2268 units

Sovaldi  (pills) - 16 834 units;

Harvoni (pills) - 205003 units

As for returned products due to termination of treatment, data is presented in two time periods and is listed as outside of  agencies balance.  The program continues accepting the returned products in 2020 as well.

2015-2018

Interferon  - (Veil) – 300  units

Ribavirin  (Pills) - 43 528units ;

Sovaldi  (pills) - 3 384units;

Harvoni (pills) - 6 925 units

Total price 11 574 129,80 Georgian Lari

01.01.2019-12.31.219

Epclusa 848 pills

Rabivirin2503 pills

Harvoni 1675  pills

Estimated total price 286 204,29 GEL

In appendix 1 “donated medical products”  you can see medical products that were returned due to termination of treatment or expired unused and are stockpiled in storage facilities. (Sovaldi, Harvoni, Epclusa)

In Appendix 2 you can see medical products that were purchased by the state program and expired or got returned to program (interferon, Ribavirin zepatier) 

Based on continuous monitoring of medical product usage we can say that stockpiled Harvoni (1 package) will be fully utilized. 

Should you have additional questions or require clarification please let us know.

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

Hi All,

Could you please provide us the below information as soon as possible.

Thanks

Maria

Hi All,

Could you please provide us the following information.

• The quantity, lot and product name
• When will product be ready for collection

Thank you.

Regards,

Maria Nolasco

Supply Chain Specialist III

Gilead Sciences Ireland UC

Eagle House, Elm Road

Dublin Airport Logistics Park

St. Margaret’s

Co. Dublin

K67 W240

Ireland

Direct phone: +353 1 2913507

Fax number:  +353 21 4825385

e-mail: maria.nolasco@gilead.com

Hi Sinead,

This is a donation program with the MoH so I don’t believe there is a D.A. I believe there is an MoU with the Minister of Health. Would that help?

Best,

Aida

Hi Aida,

Please confirm what the DA stipulates and we can review and provide feedback.

Thanks,

Sinead

Yep, Sinead and team can advise on the process.



Thanks Sean.

 

Lori,

Hope all is well. I can ask them to send it back. Do we have a current process for how this should be handled normally? I wasn’t sure what the process is since I’m new to this role for GPS.

 

Best,

Aida

 

From: Lori Mayall <Lori.Mayall@gilead.com>
Sent: Monday, July 06, 2020 12:32 PM
To: Sean Barr <Sean.Barr@gilead.com>; Aida Meskel <aida.meskel@gilead.com>; Brendan Power <Brendan.Power@gilead.com>
Subject: RE: Disposal instructions for unused drugs

 

Hi All – Thank you for the inclusion. We have several active counterfeit cases where expired HARVONI and expired SOVALDI tablets are relabeled with counterfeit HARVONI labels and sold. If feasible, we should have this product returned.

 

Kind regards, Lori

 

Lori (she/her/hers)

650-378-2184 (x802184)

 

From: Sean Barr
Sent: Monday, July 06, 2020 9:24 AM
To: Aida Meskel <aida.meskel@gilead.com>; Lori Mayall <Lori.Mayall@gilead.com>; Brendan Power <Brendan.Power@gilead.com>
Subject: Re: Disposal instructions for unused drugs

 

+ Brendan and Lori

 

Might be best to do returns to play it safe and avoid any chance of diversion/counterfeiting.  It looks to be about 7,300 bottles of harvoni and 700 sovaldi.  With that said, we’ve had a good relationship with with the Georgian MOH so perhaps we can trust them to destroy locally as long as they provide proof of destruction?

Sent from my iPhone

 

On Jul 6, 2020, at 6:07 AM, Aida Meskel <aida.meskel@gilead.com> wrote:



Hi Sean,

 

Hope all is well. Quick question, if a country needed help with properly discarding expired product in country, like below with Georgia, is this something you helped facilitate? If so, what was the process to do this? Is there someone I should reach out to in Gilead to help with this?

 

Thanks in advance for your help.

 

Best,

Aida

 

From: Aysan Murtezaoglu <Aysan.Murtezaoglu@gilead.com>
Sent: Tuesday, June 30, 2020 10:51 AM
To: Tamar Gabunia <tgabunia@moh.gov.ge>; Graeme Robertson <Graeme.Robertson@gilead.com>
Cc: Ron Somers <rsomers@indiafirstgroup.com>; Ekaterine Adamia <eadamia@moh.gov.ge>; Aida Meskel <aida.meskel@gilead.com>
Subject: RE: Disposal instructions for unused drugs

 

Dear Tamar

We are all good and trying to adapt to our new normal working environment.

Graeme is on leave since last week so I have forwarded your email to Aida – our colleague in operations department (supply chain etc). She will provide some info to you hopefully next week as this week our US colleagues are on holiday.

Best regards

Aysan

 

From: Tamar Gabunia <tgabunia@moh.gov.ge>
Sent: 23 Haziran 2020 Salı 20:25
To: Graeme Robertson <Graeme.Robertson@gilead.com>
Cc: Ron Somers <rsomers@indiafirstgroup.com>; Ekaterine Adamia <eadamia@moh.gov.ge>; Aysan Murtezaoglu <Aysan.Murtezaoglu@gilead.com>
Subject: [EXTERNAL] Disposal instructions for unused drugs

 

Dear Graeme and Aysan,

 

I hope all is well with you. I am writing to ask for your advice on the following:  As you are aware, under the National Hepatitis C Elimination program, due to treatment cancelations, patient deaths and other reasons, there are two different drugs (Sovaldi-16834 tablets and Harvoni-205003 tablets) on balance of LEPL Social Service Agency, which were not utilized. The drugs belong to a category of “expired/unusable” and are subject of disposal in accordance with the laws of Georgia. 

We would be grateful if you could provide any recommendations or additional instructions on the above mentioned subject.

 

Thank you in advance.

 

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

 

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

 

 

 

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