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Sustainability of Mobile Application for Reporting Adverse Drug Events (ADEs) in DOH Hospitals

Requested from DOH by Kimberly Faye Cuenco at 12:38 PM on Aug 09, 2020.
Purpose: Research and Development
Date of Coverage: 08/09/2020 - 08/09/2020
Tracking no: #DOH-295883105220

Kimberly Faye 12:38 PM, Aug 09, 2020

In line with the previous response, we would like to request for additional details to improve the mobile application:
1.Regarding the interoperability, may we kindly request the VigiFlow’s Integration Specifications and Interoperability Implementation Plan/Strategy, if available. 
2.Kindly explain further the anticipated problem on political will. Does this include fear of litigation or investigations against the person who reports and guilt at having administered treatment that may have harmed a patient or ability of the organization’s work processes in reporting ADRs, etc?

FOI 08:02 AM, Aug 10, 2020

August 10, 2020

Dear Kimberly Faye,

Thank you for your request dated Aug 09, 2020 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Sustainability of Mobile Application for Reporting Adverse Drug Events (ADEs) in DOH Hospitals.

We received your request on Aug 09, 2020 and will respond on or before Aug 28, 2020 12:38:00 PM, in accordance with the Executive Order's implementing rules and regulations.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://pcoomaster04022018130000-dot-efoi-ph.appspot.com/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0yOTU4ODMxMDUyMjAM, for request with ticket number #DOH-295883105220.

Thank you.

Respectfully,

FOI Receiving Officer

Dr. Kenneth 09:43 AM, Aug 10, 2020

Hi Kimberly Faye Cuenco

Please be informed that your request has been endorsed to the Food and Drug Administration for action. Kindly await for their response, thank you

Dr. Kenneth 01:51 PM, Sep 03, 2020

September 3, 2020

Dear Kimberly Faye Cuenco,

I refer to my letter of Aug 09, 2020 12:38:00 PM; about your request under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Sustainability of Mobile Application for Reporting Adverse Drug Events (ADEs) in DOH Hospitals.

Our response to your request is due on Aug 28, 2020 12:38:00 PM. Unfortunately, it is taking longer than expected to deal with your request because we awaited the response from FDA. 

I apologize for this delay but have applied for an extension so we could work further on your request. We hope to be able to send you a response on or before Sep 25, 2020 12:38:00 PM.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0yOTU4ODMxMDUyMjAM, for request with ticket number #DOH-295883105220.

Thank you.

Respectfully,
FOI Officer

Dr. Kenneth 01:53 PM, Sep 03, 2020

September 3, 2020

Dear Kimberly Faye Cuenco,

Greetings!

Thank you for your request dated Aug 09, 2020 12:38:00 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

Your Request

You asked for Sustainability of Mobile Application for Reporting Adverse Drug Events (ADEs) in DOH Hospitals.

Response to Request

Your FOI request is approved. 

1. Some reporters, especially the HCPs, do not report ADRs, including medication errors, because they are afraid of litigation. Here in Pharmacovigilance, we practice a blame-free environment. We are more focused on the benefit-risk balance of the drug product for public consumption rather than pin-pointing the person who had an error, it is beyond our duties. Therefore, we always emphasize these matters to the HCPs when reporting and during seminars.

2. Political will. It would really depend on the head of the agency if his/her priority is maintaining the system of reporting. As you know, our membership including the use of WHO-UMC database is quite pricey. So if you plan to create a mobile application for ADR reporting, we would advise you that it would be free and easily accessible for the public and HCPs. Because if the government would need to procure this mobile app, it would undergo different steps first and approval from the head of the agency (and depending on the allotted budget too).

This response was already sent to you via email last August 10, 2020

Your right to request a review

If you are unhappy with this response to your FOI request, you may ask us to carry out an internal review of the response by writing to Undersecretary Lilibeth C. David, Chair of Data Governance Oversight Committee/ DOH Central Appeals and Review Committee, at foi@doh.gov.ph. Your review request should explain why you are dissatisfied with this response, and should be made within 15 calendar days from the date when you received this letter. We will complete the review and tell you the result within 30 calendar days from the date when we receive your review request.

If you are not satisfied with the result of the review, you then have the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).

Thank you.

Respectfully,
FOI Receiving Officer

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