Hi Amy,

 

Hope all is OK on your end!

 

When do you think we can get the e-prescribing specifications? Sorry for pushing, but time is a serious constraint, as I’ve mentioned couple times. If we get a complete document sometime soon, then it would be better to wait, if no can you please whatever is available for the moment so that we start working and whatever is added we’ll incorporate later on. We are about to complete pre-work around drug database and are ready to move on e-prescribing. Again, understand that it takes time, but would be great if we have the final doc no later than the end of this week, if we get it earlier would be just terrific.

 

Many thanks in advance!

 

K

 

From: Amy Sletta [mailto:amy@mdinformatics.com]
Sent: Friday, April 13, 2012 7:07 PM
To: Ketevan Tatoshvili; Alexander Nodia; Aleko
Cc: Terry; Ahmad Hashem; Tamta Kobakhidze
Subject: RE: Drug Database fields

 

Keti and all,
Please use the attached Drug database document.  When I reviewed it this morning I realized that the product type codes in Appendix A included SPL processing codes that would not be relevant for Georgia so I have deleted them.  Have a good Easter holiday.

 

From: "Amy Sletta" <amy@mdinformatics.com>
Sent: Thursday, April 12, 2012 8:15 PM
To: "Ketevan Tatoshvili" <ktatoshvili@hssp.org.ge>, "Alexander Nodia" <anodia@hssp.org.ge>, "Aleko" <a.turdziladze@caucasus.net>
Subject: RE: Drug Database fields

Keti,
Attached is the updated Drug database field document.  I made changes to the two red highlighted fields:

1. Product Type

This field indicates the type of product, such as Human Prescription Drug or Human OTC Drug.   

The complete list of codes and translations is listed in Appendix A under Product Type.  These codes are a subset of Logical Observation Identifiers Names and Codes (LOINC) maintained by the Regenstrief Institute, Inc.

2.  UNII
UNII is the defined code FDA uses for ingredients/substances. FDA along with United States Pharmacopeia (USP) maintains the UNII using the FDA Substance Registration System. These names and identifiers are generated for substances in drugs, biologics, foods, and devices. The UNII is a non- proprietary, free, unique, unambiguous, non semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.  The list of UNII may be downloaded at http://fdasis.nlm.nih.gov/srs/jsp/srs/uniiListDownload.jsp.  The Georgian Drug Regulation Agency may create their own version of the UNII but could save tremendous time and effort by utilizing the existing United States UNII codes.

Please let me know if you would like any additional information or changes to this document.  It was hard for me to hear you the other day on the Skype call because the quality was poor so please let me know if you are expecting any other information on the drug database fields.

MDi is also working on the e-prescribing requirements and trying to obtain price information for the clinical and scientific databases (First Data Bank, Multum and Gold Standard).  Please let us know if you need any other information to move forward with the Pharmaceutical module.  Thank you

 

 

From: "Ketevan Tatoshvili" <ktatoshvili@hssp.org.ge>
Sent: Thursday, April 05, 2012 3:58 AM
To: "amy@mdinformatics.com" <amy@mdinformatics.com>, "Alexander Nodia" <anodia@hssp.org.ge>, "Aleko" <a.turdziladze@caucasus.net>
Subject: RE: Drug Database fields

Thanks Amy,

 

Yes “Yellow Fields” are provided by Tina. Today, I have whole day already booked, so will work on field definitions tomorrow and send it right away.

 

Agree with the DUN system. Let us discuss the rest and share our feedback during the Skype call. I think having a conf. call will be very useful, no matter how far we are advanced in our research. Please note, that Monday and Friday are public holidays (April 9 and 13), so maybe we do it on Thursday, April 12 @ 19:00 Georgian time.

 

Amy, local colleagues: can you please confirm if suggested time works for you or not?

 

Amy: do we know when to expect the specifications for E-prescribing part?

 

Thanks again and again for a very productive work!

 

Best,

 

Keti

 

From: Amy Sletta [mailto:amy@mdinformatics.com]
Sent: Thursday, April 05, 2012 8:15 AM
To: Ketevan Tatoshvili; Alexander Nodia; Aleko
Cc: Terry; Ahmad Hashem
Subject: RE: Drug Database fields

 

Keti,
I have incorporated your comments into the attached document and expanded the document to include the fields to capture the actual drug registration in Section II.   This is a very rough draft.  There are items highlighted in yellow and red.
Yellow fields are those proposed by the local Georgian expert (Is this Tina?) - if you can provide definitions for these fields, we can map them to the list of fields or add them if they are not already included.
Red fields are those that we (MDi) need to research more and/or to think about how this would best work in Georgia. 

Some additional comments: 

The DUNS number could be an optional number that is only captured if the business has registered with Dun and Bradstreet.  If available it could aid in further identification especially of non-Georgian businesses.  

We would envision that both manufacturers and importers would be stored in the same database but with different values for the field type of operation(s) performed at each entity.  There may need to be a way to link the Entity or overall Business Organization with their associated importers or suborganizations - we should probably discuss this situation further and then modify the Drug Database fields document as needed. 

The pdf files containing indication, contraindication, drug interaction and so on will be useful but are probably not in the format required to perform drug/drug, drug/allergy etc... checking in e-Prescribing.  One of our next tasks may be to price out the Drug Information databases like First Data Bank, Multum and Gold Standard that are embedded into e-Prescribing systems to perform these clinical checks.   

Please let us know if you have any questions or would like additional information or clarification in any area.  It may be useful to schedule a Skype call for next week (when Ahmad is back from Albania) to review this document and any areas requiring more discussion.  Thank you

 

From: "Ketevan Tatoshvili" <ktatoshvili@hssp.org.ge>
Sent: Sunday, April 01, 2012 3:31 AM
To: "amy@mdinformatics.com" <amy@mdinformatics.com>, "Alexander Nodia" <anodia@hssp.org.ge>, "Aleko" <a.turdziladze@caucasus.net>
Subject: RE: Drug Database fields

Hi all,

 

Thank you for yet another comprehensive review of the issue. The document includes lots of details that we’ll discuss in coming week, but before here’s my feedback, some comments and news from the drug regulation dep.

 

Answer to your comments (in the doc): 1. The decision re GeNDC had not been made yet. Will keep you posted on any progress. 2. That’s absolutely correct and it is the ultimate goal. Currently there is a negotiation going around with the Public Registry. Ako and team studied all the potential information/data what we need and what is available in Public registry database. So, the conclusion is that all this information is retrievable/available and we just need to be granted a permission. 3. Ako will probably answer the 3^rd comment

 

Other comments: Agree that Data Universal Numbering System could be of a lot of help here. We have also looked at this system, but originally we were searching for the ways of including this into the GeNDC. Shortly, establishing connection with DUN system is important, especially helpful for imported products. Probably, we need to check the possibility and ways of getting this information.

 

Company specific information re local manufactures will be derived from the database we are creating now. Let’s us see how we can make it more comprehensive. Ideally the information re importers should be derived from similar database and I’ll check in with the drug regulator where they stand in this regard and try to get importers’ registry, if available.

 

 

Meeting with the drug regulation dep.: There are no specific requirements on their end regarding the drug database. The only requirement is to include packaging and labeling information (images) and a possibility to automatically update the public site of registered drugs from this drug database. In fact both requirements are already included in our agenda.

 

Moreover, I’ve learned that they started uploading  drug related clinical/scientific information (PDF files)into the public site, such as: indication, contraindication, drug interaction and so on. However, this valid only for drugs registered in the frame of National (complete) registration procedure. Having this type of resource will help us a lot with e-prescribing.

 

That’s all for now. Looking forward to further information from you, Thanks again!!

 

K

 

 

                                                                                                                                                                                                                                                        

From: Amy Sletta [mailto:amy@mdinformatics.com]
Sent: Saturday, March 31, 2012 9:15 PM
To: Ketevan Tatoshvili; Alexander Nodia; Aleko
Cc: Terry; Ahmad Hashem
Subject: Drug Database fields

 

All,
Please find the first section of recommended fields for the Drug database.  This section contains fields used for the Registration of the Entity/Organization that will be manufactoring, importing etc... the drugs.  We are continuing to work on the fields for the registration of the actual drug and will send you those fields no later than Wednesday of the coming week.

Please let us know if you have any questions or would like additional information.  Thank you

 

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This message may contain privileged and confidential information intended solely for the addressee. Please do not read, disseminate or copy it unless you are the intended recipient. If this message has been received in error, we kindly ask that you notify the sender immediately by return email and delete all copies of the message from your system. Thank you.