NEWS: The PrimeVigilance experience with MedDRA Change Requests

News brief: 02-Jun-2017
Prepared by:
Jennifer Parish, MD MPH, Certified MedDRA Coder
Cvijeta Bielen, MD, Medical Director
Medical Dictionary for Regulatory Activities (MedDRA) is maintained by the MedDRA Maintenance and Support Service Organisation (MSSO), and all MedDRA users are welcomed to submit Change Requests (CRs) with the goal of improving this dictionary to better meet user requirements. The MSSO utilises user-submitted CRs along with its internal review processes to update and maintain MedDRA with bi-annual versioning. All CRs receive a written response indicating the MSSO decision, many of which also include the rationale for rejecting or changing the original CR. WebCR is the online tool created for the management of CRs. This portal allows users to manage their own CRs as well as search the archive of CR submissions to view their corresponding responses from the MSSO.
In November 2016, PrimeVigilance initiated its program of Change Request (CR) submissions to the MSSO to highlight the need for new terms or Standardised MedDRA Queries (SMQs) that we noted would be useful. The 56 requests submitted by PrimeVigilance during the first six months of its program have thus far led to 53 changes to MedDRA. This includes terms that were accepted as-requested, those that were accepted after being slightly modified by the MSSO, and those terms that were added by the MSSO as ‘related-changes.’ PrimeVigilance has submitted CRs for 33 new LLTs, 19 new PTs, two PT moves to another place in MedDRA hierarchy, one new HLT and one new SMQ. Some of the approved CRs have included the addition of LLT Accidental occupational exposure, LLT Full-thickness chemical burn, PT Malignant glaucoma, and PT Tissue discolouration. The assessment of the proposed SMQ Acquired Fanconi Syndrome CR remains pending.
PrimeVigilance strives to provide the highest quality and accuracy in all aspects of pharmacovigilance, including MedDRA coding. The company has found that the data available on the MedDRA WebCR portal, as well as replies it has received to its CR submissions, are already providing PrimeVigilance valuable insight into further enhancing its use of MedDRA for data coding and retrieval.
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