Brackets and other flaws of EMAs
Thread poster: Claudio Porcellana

Claudio Porcellana  Identity Verified
Italy
Local time: 00:33
Member (2004)
English to Italian
Jul 13

as you all certainly know, EMA QRD templates contain brackets whose removal generates bad wordings, and other issues

some time ago I sent a query to EMA that replied
I post the answer here hoping it can be useful for others

Oooops!
I see that brackets symbol disappeared so consider that for now
(if I'll find a better way to show symbols I'll change that)
triangular bracket = *tri*
brace bracket = *bra*
square bracket = *squ*
triangular bracket followed by a brace bracket = *tri bra*
brace bracket followed by a triangular bracket = *bra tri*

MY FIRST QUERY

in this case:
*tri bra*Name of the Member State*bra tri* *tri bra*Name of the medicinal product*bra tri*

if I remove all brackets, the result is:
Name of the Member State Name of the medicinal product
that is clearly a mess: hard to understand if it's one and only sentence, if there are 2 sentence, what is the adjective for what subject ...
a bad wording anyway

in this case:
Healthcare professionals are asked to report any suspected adverse reactions via *tri*the national*tri* reporting system*tri* *tri**squ*to be completed nationally*squ**tri*.

if I remove all brackets, the result is:
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system to be completed nationally.

now, the piece between triangular brackets can be fine without them, but the last part would need some separation, e.g. a comma or again round brackets, so:
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system, to be completed nationally
OR
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system (to be completed nationally)

EMA ANSWER
regarding the last paragraph you have mentioned in your email concerning the reporting of adverse reactions I agree with you that the wording given in the QRD templates are sometimes difficult to implement in a grammatically correct way.
This is the reason why some Member states (Austria, too) have published a wording on their websites to ensure that the mandatory statement regarding the reporting of adverse reactions is implemented correctly in their national translations.

For Austria you can find it on our BASG-Website in the FAQs regarding SmPC/PIL:
http://www.basg.gv.at/en/medicines/faq/smpcpil/#c9814

FAQ Number 11.1 has attached the document Guidance_on_the_implementation_of_reporting_ADRs.pdfwhich also includes the proposed wordings (in German and translated in english for a better understanding of small linguistic differences between the proposals).

So, if you have troubles with translations of the statement regarding ADRs try to find out if the national competent authorities of the relevant countries have some information published on their websites....

.... clearly, tried to find it in my country without avail
-------------------------------------------------
MY SECOND QUERY

"Take your example with the reporting of adverse reactions, let's imagine this should be done for Austria, the finished sentence should read:
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Österreich
Bundesamt für Sicherheit im Gesundheitswesen
Inst. Pharmakovigilanz
Traisengasse 5
AT-1200 WIEN
Fax: + 43 (0) 50 555 36207
Website: http://www.basg.gv.at/"

now, I still have the doubt that this "internationalized text" is not to be put during (my) translation, but later in a next step of EMA procedure, may be by the drug company that managed to have the translation in all languages

can you still confirm that is a duty of the first translator/reviser place the localized information?
-----------------------------
EMA ANSWER

this is in fact a good question.

As the actual details (complete contact data and addresses from Appendix V, the file I think you have seen) of the national reporting system(s) will only have to be included for the printed materials, I don't think that this is a duty of the first translator/reviser.

The QRD templates (also the ones translated in the different languages) contain only the wording for the electronic version of SmPC, PL and LAB with a hyperlink to Appendix V. And I think this is the version a translator/reviser is working with.
But filling in the actual details of the national reporting system is in fact not a work of "translation". At least in my opinion. This is more regulatory work I would say - finding out, which member state needs what version and when...

But I admit it could be possible that some companies think different about it.

As you mentioned referral texts, too, here is one more link that could be useful for you:
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/QRD/CMDh_201_2005_Rev7_2013_04-Clean.pdf

This is again an annotated template but this time not from EMA but from CMD(h) and adapted/commented with regard to referrals, too.
---------------------------------------------------------
MY LAST QUERY
there are differences between "adverse effects", "adverse events", "adverse reactions", and "side effects" that seems sometime used in an random/interchangeable way?

"adverse effects"
Note that according to EMA's Compilation of QRD decisions on use of terms Term, this term is not be used; the right terms are "adverse events" or "adverse reactions"

"adverse reactions" "To be used when there is a causal relationship with the use of the medicinal product"

"adverse events" "To be used when it occurs during the use of the medicinal product but its causal relationship is not yet established. Note that "adverse events" without at least a suspected causal relationship should not be listed in the SmPC and the PIL"

"side effects" can be used only in PIL, and other mixed-up terms (e.g undesirable effects) are to be avoided as well
----------------------------------------------
P.S.

the last time I asked why "should" is so often used wrongly, for example "they should have a life-saving therapy" instead of " they must have a life-saving therapy"

the verbatim answer was quite funny: they should use "must" ...

[Edited at 2017-07-13 17:11 GMT]

[Edited at 2017-07-13 17:11 GMT]


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Kaspars Melkis  Identity Verified
United Kingdom
Local time: 23:33
Member (2005)
English to Latvian
+ ...
Thank you for sharing these queries Jul 14

I really appreciate that you posted these answers, Claudio.

EMA QRD templates are not perfect and sometimes it is really hard to balance between readability and requirements to follow them in every word and even replicate every mistake contained in them.

As for should vs. must, is it really a requirement? My understanding is that should is often used as a polite form of must. SmPCs are used by doctors and pharmacists and overuse of must would make the text too “abrasive”. The context usually makes it clear when should is a recommendation and when it is an indication.

Apart from that, it irks me when I see translations where should is translated as “vajadzētu” in Latvian without any attention to context. It is not ok if it sounds as a suggestion when the text is about clear contraindication as in not giving a pregnant woman the drug that is proven to cause birth defects.

[Edited at 2017-07-14 10:16 GMT]


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Claudio Porcellana  Identity Verified
Italy
Local time: 00:33
Member (2004)
English to Italian
TOPIC STARTER
should vs. must Jul 14

My understanding is that should is often used as a polite form of must. SmPCs are used by doctors and pharmacists and overuse of must would make the text too “abrasive”

sure, but the reason why I issued this query, is that EMA guidelines says to use "must" when speaking about a mandatory action/step, leaving "should" to the realm of chances, but most authors simply ignore the recommendation and immortalize tons of ambiguities

clearly, a really skilled medical translator is able to decipher the right meaning and translate it accordingly, but the risk to write down a dangerous information is always behind the corner

for example, the translation of "you should avoid ingesting hemlock" is easy to decipher even for a beginner, but other situations aren't, and there are situations that are hard to understand even for a senior specialized translator at the point one must ask to the author directly


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