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Medical Coding and New FDA Guidelines for WHODrug B3/C3

Posted by Kim Rejndrup on Jun 26, 2018 9:00:00 AM

(This is the first of a three-part series on medical coding during clinical trials.)

The new U.S.  Food and Drug Administration (FDA) mandate for WHODrug B3/C3 is right around the corner.  The new standard will be required for all submissions by 15-Mar-2019.

If you have ever performed medical coding with WHODrug, you are familiar with the terms Drug name and Preferred name. However, if you are using the new WHODrug Insight browser, you realize that there are several new concepts. In both the B3 and C3 dictionaries, to which many companies are in the process of upgrading, there are new definitions surrounding Preferred name and Preferred base.  What’s more, a Generic Y/N flag has also been included.

What can be confusing is that the new term Preferred base is what used to be called the Preferred name, and the newer definition of Preferred name was often referred to as the Preferred salt name. So, please keep those changes in mind if you are reading older articles aboutBest Internet Concept of global business from concepts series WHODrug terms.

Derivations for Submissions

The OmniComm AutoEncoder provides a modern and sophisticated tool for performing coding activities. Out of the box, it is fully integrated with OmniComm’s TrialMaster® product for Electronic Data Capture.  After you have completed your coding in AutoEncoder, what information should you derive back to your TrialMaster trials?

If you follow the guideline* outlined by WHODrug for SDTM population, the CDISC SDTM CMDECOD variable should contain the generic name of the drug. However, also according to the guidance, your company’s conventions can determine which value you use as the generic name. OmniComm’s AutoEncoder, therefore, provides you with the flexibility of deriving back the Preferred base, Preferred name or the Generic name to the integrated EDC system. These values are populated as follows**:

Column

Algorithm

Preferred base

Look up via Drug Record Number and sequence1=01 and sequence2=001

Preferred name

Look up via Drug Record Number and sequence1 and sequence2=001

If the preferred name cannot be found use the Preferred base

Generic name

If the generic flag = Y use the drug name

Else use the preferred name per rules specified above

 To illustrate the population of these columns, please see the below examples**:

Column

Algorithm

Preferred base

PALONOSETRON

Preferred name

PALONOSETRON HYDROCHLORIDE

Generic name

PALONOSETRON HYDROCHLORIDE

Drug name

ALOXI

 

Column

Algorithm

Preferred base

ISONIAZID

Preferred name

ISONIAZID

Generic name

INH

Drug name

INH

 

Column

Algorithm

Preferred base

FYTIC ACID

Preferred name

FYTATE CALCIUM MAGNESIUM

Generic name

INOSITOCALCIUM

Drug name

INOSITOCALCIUM

 

Column

Algorithm

Preferred base

ANTACIDS

Preferred name

ANTACIDS

Generic name

ANTACIDS

Drug name

ANTACIDS

 

The 1,500-Character Name

Finally, you have to consider if your EDC is ready to receive drug names of up to 1,500 characters as the B3/C3 formats support. For example, can your EDC system handle the “term” below?

 ALGAE NOS;ALPHA-D-GALACTOSIDASE;AMYLASE;ASCORBIC ACID;BETACAROTENE;BETAINE HYDROCHLORIDE;BIOFLAVONOIDS;BIOTIN;BORON AMINO ACID CHELATE;BROMELAINS;CALCIUM CARBONATE;CALCIUM CITRATE;CALCIUM PANTOTHENATE;CELLULASE;CENTAUREA BENEDICTA;CHLORELLA SPP.;CHOLINE BITARTRATE;CHROMIUM PICOLINATE;COPPER AMINO ACID CHELATE;CORIANDRUM SATIVUM;CYANOCOBALAMIN;CYMBOPOGON CITRATUS;ELEUTHEROCOCCUS SENTICOSUS;ERGOCALCIFEROL;EUTERPE OLERACEA;FALLOPIA JAPONICA;FOLIC ACID;GANODERMA LUCIDUM;GRIFOLA FRONDOSA;HELIANTHUS ANNUUS OIL;HERBAL NOS;HERICIUM ERINACEUS;HORDEUM VULGARE;INOSITOL;INVERTASE;LENTINUS EDODES;LINUM USITATISSIMUM SEED OIL;LIPASE;MAGNESIUM CITRATE;MAGNESIUM OXIDE;MANGANESE AMINO ACID CHELATE;MEDICAGO SATIVA;MELISSA OFFICINALIS LEAF;MOLYBDENUM;NICOTINAMIDE;PAPAIN;PHELLINUS LINTEUS;PHYTOMENADIONE;PLEUROTUS OSTREATUS;POTASSIUM AMINO ACID CHELATE;POTASSIUM IODIDE;PROTEASE;PUNICA GRANATUM;PYRIDOXAL PHOSPHATE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;RUTOSIDE;SELENOMETHIONINE;SERRAPEPTASE;SODIUM;SPIRULINA SPP.;TARAXACUM SPP.;THIAMINE MONONITRATE;TILACTASE;TOCOPHERYL ACID SUCCINATE;TRAMETES VERSICOLOR;UBIDECARENONE;URTICA DIOICA;XANTOFYL;ZINC GLUCONATE

Approaching Deadline: March 2019

The FDA mandate for WHODrug B3/C3 is less than a year away. It is supported now, and it will be required for submission by 15-Mar-2019. Given that deadline, you have to consider if your coding solution and data capture system(s) are up to the task. It is also very important that your software provider continues to develop its software solution and to enhance the integration between the individual components. It can be difficult to change your coding solution, so with terminologies becoming more complex and updates becoming more frequent, it is crucial that you pick the right vendor and software.

If you are not ready or your current software solution is not ready for WHODrug B3/C3 format, maybe it is time for a change!

* https://www.who-umc.org/media/2940/how-to-use-whodrug-for-compliance-with-cm-domain-in-the-cdisc-sdtm-standard-march-2017.pdf

**Source: OmniComm AutoEncoder Screenshots

About the Author

kim headshotKim Rejndrup recently joined OmniComm as senior vice president-Product Development. Mr. Rejndrup spent nearly 20 years at Oracle Corporation, where he was a vice president of development for many clinical research applications, including systems for electronic data capture (EDC), clinical trials management, data management, medical coding and data warehousing. His experience is driving OmniComm’s products to new levels of innovation.  

Join Kim Rejndrup for a Free Webinar About Coding

Want to learn more about coding and the upcoming FDA mandate?  Kim Rejndrup  will take your questions during a live webinar:  11-July at 10 a.m. New York / 3 p.m. London Register today for this free webinar:  http://bit.ly/2rM1Wjw

 

 

Tags: Coding