‘Best practices’ guidelines on the use of MedDRA for labelling have been published by the MSSO (MedDRA Maintenance and Support Services Orga-nization, 2005).
MedDRA AND LABELLING
‘Best
practices’ guidelines on the use of MedDRA for labelling have been published by
the MSSO (MedDRA Maintenance and Support Services Orga-nization, 2005). They
propose three tiers of product labelling: the Company Core Data Sheet (CCDS)
for use by the manufacturer and for interacting with regu-latory agencies;
information for the prescriber; and information for the patient. The MSSO
states that it does not foresee a role for MedDRA in any form of
patient-oriented product information.
For
the CCDS, it is proposed in the MSSO docu-ment that MedDRA should be used in
narrative and tabular presentations of information, but that flexibil-ity is
required, as MedDRA may not be applicable in some sections, such as for
indications or dosage. In the adverse reaction section of the CCDS, the MSSO
proposes the use of MedDRA, generally at the PT level, but with HLTs, HLGTs
and/or SMQs or similar groupings to represent particular conditions, if needed.
The
guidelines suggest that, in the CCDS, it might be possible to supplement PTs
with lists of corre-sponding LLTs, to assist in judging listedness and to
facilitate automated expectedness determination. However, it is made clear that
such lists are no substi-tute for medical judgement, and that it may be
neces-sary to review additional case-level information in order to provide
context in deciding upon listedness or expectedness.
For
product information directed at the health professional, the MSSO recommends
the use of famil-iar medical words and logical groupings, supple-mented by
specific MedDRA terms or groupings. They point out that the specificity of
MedDRA may be problematic when summarising data in a clini-cally meaningful way
and that prescribers may not be familiar with MedDRA conventions. Hence, it may
be necessary to translate MedDRA terms into more familiar and understandable
medical terms. Again, it may be appropriate to use MedDRA group terms, or SMQs,
or ad hoc groupings may be needed.
One example of such a grouping would be the use of a single term for
thrombocytopenia to include PTs for the medical condition (e.g., PT Thrombocytopenia) with those for the
corresponding laboratory findings (e.g., Platelet
count decreased).
Existing
regulatory guidance on the use of MedDRA in the Summary of Product
Characteristics in the EU can be found in Volume 2 of the Notice to Applicants,
published by the European Commis-sion (European Commission Enterprise
Directorate General, 1999). Draft amendments to these guidelines have been
issued and are awaiting the outcomes of consultation at the time of writing
(Proposal for Revi-sion of a Guideline on Summary of Product Character-istics
Committee for Medicinal Products for Human Use, 2005). Despite the possibility
that these may change in due course, it is worth summarising the proposed SPC
guidelines as an indication of current EU regulatory thought on the use of
MedDRA.
The
present and proposed SPC Guidelines propose the use of MedDRA in Section 4.8,
Undesirable effects, with a table of ADRs according to MedDRA SOC, listed in
accordance with the International SOC Order. ADR descriptions should be based
on the most suitable representation within MedDRA, usually PTs, but sometimes
the use of LLTs or exceptionally group terms may be appropriate. Within each SOC,
ADRs should be ranked under headings of frequency. In addition, the proposed
guidance states that, as a general rule, any ADR in the SPC should be assigned
to the most relevant SOC related to the target organ. For example, the PT Liver function test abnormal should be
assigned to the SOC Hepatobiliary
disorder rather than to the SOC Investigations.
The
proposed SPC Guidelines include an Annex devoted to the use of MedDRA. This
states that a pragmatic approach to the location of terms should be taken in order
to make the identification of ADRs simpler and clinically appropriate for the
reader. Thus, it may be helpful on some occasions to use secondary SOC
locations of some MedDRA PTs, or to use loca-tions that do not accord with
MedDRA architecture. The example is given for the terms Liver function test abnormal,
Hepatitis and Hepatic encephalopathy –
it would be acceptable to include
them all under the ‘Hepato-biliary disorders’ SOC, instead of distribut-ing the
reactions among ‘Hepato-biliary disorders’, ‘Nervous system disorders’ and
‘Investigations’ SOCs as dictated by their primary location in MedDRA.
The
Annex then suggests that it is acceptable to adapt names of group terms if this
makes their mean-ing more transparent, for example HLT Genitouri-nary tract disorders NEC could be presented without ‘NEC’ (not elsewhere classified). ADR
terms should be expressed in natural word order, such as ‘Intersti-tial
pneumonia’ not ‘Pneumonia interstitial’. Also, the most widely recognised term
for a particular condition should be used, for example the LLT ‘Churg Strauss
syndrome’ might be more appropriate than the PT ‘Allergic granulomatous
angiitis’.
With
regard to estimating frequency of occur-rence of adverse events from studies,
the proposed guidelines state that appropriate levels of MedDRA should be used
in order to group together clinically related conditions in a meaningful way.
For exam-ple if ‘postural dizziness’, ‘exertional dizziness’ and ‘unspecified
dizziness’ were each reported by 2% of patients, this might be represented in
the SPC as ‘Dizziness’ occurring in 6% of patients (assuming that only one
report of dizziness applied to each patient). It may also be appropriate to use
ad hoc groupings, or to adapt MedDRA
group terms, for example reports of ADRs represented as PTs ‘Diarrhoea’,
‘Diarrhoea aggravated’, ‘Loose stools’, ‘Stools watery’, ‘Intesti-nal
hypermotility’ could not really be represented as standard MedDRA groupings,
which comprise three separate HLTs – ‘Diarrhoea (excl infective)’, ‘Gastrointestinal
spastic and hypermotility disorders’ and ‘Faeces abnormal’. To make the SPC
relevant and comprehensible to clinicians, the condition might simply be
represented as ‘Diarrhoea’.
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