A Patient information leaflet (PIL) is a small folded document enclosed in the package of a medicinal product containing consumer medical information written in the national language of the country where it is available. Also referred to as ‘package inserts’, ‘instruction leaflets’ or ‘patient package inserts’, PILs are issued by pharmaceutical companies and are required to fulfil country-specific regulatory requirements prior to the marketing of any drug.
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Genre and LSP context
Text types belonging to the same genre share elements of content, structure, style and target readership. Accordingly, PILs may be defined not only as a medical genre since their content and structure are distinctively health-oriented, but also as a mandatory genre in that they are governed by legal and institutional aspects. Using genre theory (Swales, 1990, p. 58), PILs can be identified as a set of communicative events (instructions, warnings, recommendations) relating to medicinal products and their usage that share the same communicative purpose (the safe and effective use of medication). In her paper on genre and LSP translation Scarpa (1999, p. 315) maintains that
genre-theory – with its focus on the main
purpose of a text as the contextual variable
its rhetorical or generic shape – is particularly
the translation of languages for special
Accordingly, awareness of the correlation that exists between genre and LSP is required to identify the intrinsic conventions of PILs. Méndez-Cendón suggests that, “LSP phraseology is the study of specialised word combinations that occur frequently in technical and scientific language” (2009). LSP phraseological units (LSP PUs) characterising PILs may include routine formulae, collocations and combined interdisciplinary terms. Therefore in-depth knowledge of the specialised field is expected in order to achieve proficiency in LSP-based approaches.
In her contrastive analysis of British and Italian PILs, Cacchiani (2006, p. 28) suggests that “culture-specific genre conventions are of primary importance to the translation process”. These conventions refer to the macro-aims shared by PILs in both languages stemming from their common social function and legal connotations. In this sense, such texts are endowed with “mutually relevant intentions” (Hatim and Mason, 1990, p. 139), given that from a pragmatic viewpoint all PILs promote safe health practices while providing information which needs to meet legislative requirements. In particular, Hatim and Mason define text type as “a conceptual framework which enables us to classify texts in terms of communicative intentions serving an overall rhetorical purpose” (1990, p. 140). Genre, on the other hand is viewed as a set of features relevant to a given social occasion whose conventions, in turn, define genre itself (Hatim and Mason, 1990, p. 140-141). However, it may be observed that genre conventions also contribute to identifying salient information according to the structural expectations of such text types when considered individually in their respective language. At the macro-level Italian PILs present a conventional structure which is made up of at least 9 section headings written in bold type, as indicated on the online portal of the Italian Medicines Agency (AIFA, “Il foglio illustrativo”), appearing in a specific order and containing the following key information that introduces specific content:
• ‘ll nome commerciale del medicinale, la composizione, il dosaggio e la forma farmaceutica’ [drug brand name, composition, dosage and pharmaceutical form of the medication]
• ‘La categoria farmacoterapeutica e le indicazioni terapeutiche’ [pharmacotherapeutic drug classification and treatment instructions]
• ‘Le controindicazioni’ [adverse reactions]
• ‘Le precauzioni d’uso’ [precautions for use]
• ‘Le interazioni’ [potential interactions]
• ‘Le avvertenze speciali’ [special warnings]
• ‘La posologia’ [dosage indications]
• ‘Sovradosaggio’ [overdose guidelines]
• ‘Effetti indesiderati’ [side-effects]
Other heading formulations may include product expiry and storage indications, manufacturing details and PIL review date. Despite the enforcement of European genre schemata demanding the compulsory compliance of PIL content and structure with the template published by the Quality Review of Documents (QRD) group of the European Medicines Agency (EMEA), available in 25 languages and downloadable from the EMEA official website, only a small number of Italian PILs referring to centrally approved drugs endorses such tight regulatory requirements. Almost all printed patient information is currently authorised by AIFA and approved by the ‘Ministero della Salute’ [Ministry of Health] in accordance with the provisions set out in the ‘Decreto Legislativo 219/2006’ [Legislative Decree 2006/219] in compliance with the ‘Direttiva 2001/83/CE’ [Directive 2001/83/EEC] as amended, and with the ‘Direttiva 2003/94/CE’ [Directive 2003/94/EEC] relating to medicinal products for human use.
At the micro-level, it is possible to observe a plethora of multi-faceted lexical, grammatical and culture-specific features in Italian and English PILs which provide insight into the degree of dis/similarity between both genres from a linguistic perspective and pose a number of comprehensible problems in translation.
From a lexical angle, specific medical terminology is the factor that most affects the legibility and reception of package inserts. This may include named entities such as ‘Lasonil’, ‘CYP3A4’ and ‘MedDRA’ which cannot be replaced in translation and therefore remain unaltered. Scientific terms such as ‘cefalea’ may be converted to ‘cephalea’ or ‘headache’, depending on the expectations of the target audience (TA). Likewise, ‘ipersensibilità alle penicilline’ may retain the same register in translation, namely ‘patients with hypersensitivity to penicillin’ or transferred via a more popular alternative such as ‘patients who are allergic to penicillin’, which is a generally favoured option in the English PIL genre in order to conform to Community guidelines sanctioning the implementation of accessible syntax, as established by the European Commission (“Guideline on the readibility of the labelling and package leaflet of medicinal products for human use”, 2009) and by the Medicines and Healthcare products Regulatory Agency (MHRA) in its Report of the Committee on Safety of Medicines (“Always Read The Leaflet – Getting the best information with every medicine”, 2005).
Another lexis-related feature typical of PILs is the use of eponyms used to define medical devices, remedies or illnesses such as ‘morbo di Crohn’ (‘Crohn’s disease’, also known as ‘regional enteritis’), ‘edema di Quincke’ (‘Quincke’s oedema’, better known as ‘angiooedema’) and ‘sindrome di Lyell’ ‘(‘Lyell’s syndrome’ or ‘toxic epidermal necrolyses’). Moreover, eponyms may be noneponymic in the target language (TL), and often abbreviations may be more appropriate as in the case of ‘sindrome di Gilbert’ (‘Gilbert’s syndrome’) which is habitually shortened to GS in English.
Italian PILs also make abudant use of acronyms, which require a deep understanding of the subject-matter prior to being addressed in translation. For instance in this genre it is not uncommon to come across ‘SNC’ which is an acronym of ‘sistema nervoso centrale’ shortened to CNS in English and corresponding to ‘central nervous system’. However, sometimes Italian and English may also share the same acronyms which remain unvaried in translation, such as ‘INR’ (International Normalized Ratio) or ‘AIDS’ (Acquired Immune Deficiency Syndrome).
By and large, English terms such as ‘clearance’, ‘shock’, ‘anti-doping’ or ‘reuptake’ are often found in Italian PILs. Many scientific terms and expressions are frequently imported from the English language and used to define specific notions shared and widely understood by a community of medical experts. This convention may be problematic in translation, as the translator needs to negotiate whether the anglicisms actually require conversion in the TL, since the English genre tends to preserve a more informal approach due to the adduced legislative requirements.
Various Italian medical terms in PILs are in fact of Latin origin as ‘ictus’ and ‘lupus’ for instance. Clearly, whereas such terminology is marginally easier to grasp for an Italian TA due to the fact that Italian is deeply rooted in the Latin language, an English layman readership would struggle with terms of radically different etymological origin. Therefore the above Latinates would require a supplementary explanation between brackets in the English genre, in this case ‘stroke’ and ‘systemic autoimmune disease’ respectively. A variety of terms defining specific bacteria such as pseudomonas, enterobacter, proteus, are currently preserved in Latin in Italian PILs, whereas several medical terms originating from the Greek in Italian instruction leaflets such as oligo-idroamnios, stenosi, leucopenia were historically latinised and subsequently adapted so that nowadays only prefixes, confixes and suffixes are indicative of their Greek derivation. According to Vermeer (2000, in Venuti 2004, p. 228), it is essential for the translator to consider the purpose or skopos of the text, which in the case of PILs is to transmit precise medical knowledge in a recipient-specific way, also by debating whether the TL conventions embrace standard or learned equivalent terms. Only by bearing in mind the genre conventions of the TL and the translation brief is the translator able to discern how to transfer this terminology and its meaning in translation.
Conventional grammatical features typical of Italian PILs including passivisation, nominalisation, collocation and verb forms may become translatorial issues, in that it may be difficult to retain the thematic patterning of the source text (ST) in the target text (TT).
Generally speaking, Italian PILs resort to passivisation not only in their instructing function, but also when signalling, advising and illustrating. For instance ‘XXX è controindicato nei seguenti casi’ is a standard warning which may be translated in English by adopting an active urging speech act such as ‘please do not use XXX if (...)’. This solution is selected since it conforms to the PIL standardising procedures established by the “Directive on the labelling of medicinal products for human use and on package leaflets” issued by the European Commission (Directive 92/27/EEC, as amended in Directive 2001/83/EEC and Directive 2004/27/EEC) drawn up in order to ensure the utmost clarity of user information.
Another tangible divergence between the two genres lies in the tendency of Italian PILs to favour nominalisation via ellipsis. For example, the sequence ‘se si ingerisce accidentalmente una dose eccessiva’ is nominalised by ellipting the verb and rendered as ‘in caso di ingestione accidentale di una dose eccessiva’ to indicate what steps to follow in the event of accidental ingestion. The English genre tends to require descripitive speech acts such as ‘(what happens) if you take too much’, which results in a less terse rendition.
Word combinations or sequences are also an archetypal factor in medical writing based on the association of co-occurring scientific and common terminology. Baker suggests that “collocational patterns carry meaning and can be culture-specific”(2011, p. 67). This is true of collocations detected in Italian PILs ranging from the more technical such as ‘emorragia gastrointestinale’ [gastrointestinal hemorrhage] translated via the more familiar collocation ‘gastrointestinal bleeding’, to the semi-technical collocation such as ‘soluzione iniettabile’ [injectable solution], resulting from the merging of a technical and a general term. A blend of general language words may also be found in this genre on a regular basis such as ‘pazienti a letto’ [bedridden patients]. It is crucial to determine if the mapping of collocational patterns is possible in translation, or whether the source language (SL) collocation content should be carried across to the TL by using different phraseology in order to preserve the scientific credibility of the information provided.
Italian PILs combine procedural and declarative functions relayed via a number of recurring verbs. The procedural function relates to instructions, advice and warnings such as ‘il trattamento deve essere continuato’ [patients should continue treatment] and ‘è necessaria stretta sorveglianza medica’ [patients should be carefully monitored], whereby the imperatives used in Italian are translated via less peremptory modal verbs in the TL. The declarative function relates to descriptions and definitions such as ‘questi effetti indesiderati sono generalmente transitori’ [the following side effects usually disapper after a few days’ treatment] and ‘la dose totale giornaliera dipende dal peso del bambino’ [daily dosage depends on your child’s weight], with the present tense prevailing in both languages. Reflexive passives also abound in Italian PILs: ‘si consiglia di’ [patients are advised to], ‘si raccomanda’ [patients are recommended to], ‘si deve evitare la somministrazione’ [patients should not take the medication]. These are transmitted by referring to a specified subject in the TL.
Stylistic and cross-cultural features
As regards stylistic features, it may be observed that Italian PILs are more rigid and detached than their more user-friendly English counterpart. This is apparent in the use of impersonal verb forms such as ‘è importante comunicare al medico’ [please talk to/tell your doctor], and in the use of polite pronoun forms as in: ‘deve discutere la sua terapia con il suo dottore’ [please ask your doctor for advice on your medication] or ‘consultate il medico’ [please consult your doctor] instead of the familiar ‘you/your’ pronoun forms characterising English PILs. These country-specific linguistic conventions reflect the existing cultural gap between both genres. Furthermore, Italian PILs present longer and more complex clauses interspersed by lesser punctuation than their English counterpart, favouring small font size and lacking any colour or pictograms, unlike English PILs which mostly adhere to such stylistic requirements.
Lastly, in her paper Cacchiani (2006, p. 28-29) argues that:
it is important that more research is carried
out in order to establish
the basic requirements for functionally
adequate translations of PILs
between English and Italian.
In order to attain such functional adequacy PILs require an equifunctional translation, since they accomplish the same function across both genres in their respective languages, as well as an instrumental translation in the sense of Nord (1997, p. 41), viewed as a process resulting in an independent end-product fulfilling a target-culture situation endowed with a new communicative action, regardless of the original ST communicative purpose. Since PILs contain considerable information referring to specific medication, side-effects, dosage administration and risk communication, all information condensed in this genre should be easy to read and retain user attention. With this in mind, PIL translators should focus on the goals of the TT and reflect the cultural awareness and the level of domain knowledge of the receiving audience. This is the only feasible translational outlook enabling the patient/reader to access all the information available in package inserts advancing the safe and appropriate use of medication.
Agenzia Italiana del Farmaco. (n.d.). Il foglio illustrativo [The patient information leaflet]. Retrieved from the AIFA website http://www.agenziafarmaco.gov.it/it/content/il-foglio-illustrativo
Always Read the Leaflet – getting the best information with every medicine. (2005, July). Retrieved from http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2018041.pdf
Baker, M. (2011). In Other Words; a course book on translation (2nd ed.). London: Routledge.
Cacchiani, S. (2006). Dis/Similarities between patient information leaflets in Britain and Italy:Implications for the translator. New Voices in Translation Studies 2. Retrieved from http://www.iatis.org/images/stories/publications/new-voices/Issue2-2006/cacchiani-paper-2006.pdf
Citalopram EG. (September 2008). Retrieved from http://www.eglab.it/pdf/FI/036503023_FI.pdf
Citalopram 10/20/40 mg Tablets. (May 2011). Retrieved from http://www.medicines.org.uk/EMC/medicine/25839/PIL/Citalopram+10+20+40+mg+Tablets/
Directive 92/27/EEC. Council directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. (1992). Official Journal L - 113 , 30/04/1992, 0008 – 0012. Retrieved from http://www.ikev.org/docs/eu/392L0027.pdf
Directive 2001/83/EC of the European Parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. (2004). Official Journal L – 311, 28/11/2004, 67 – 128. Retrieved from http://www.edctp.org/fileadmin/documents/ethics/DIRECTIVE_200183EC_OF_THE_EUROPEAN_PARLIAMENT.pdf
Directive 2004/27/EC of the European Parliament and the council of 31 March 2004
amending directive 2001/83/EC on the community code relating to medicinal products for
human use. (2004). Official Journal L – 136, 30/04/2004, 34 – 57. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0034:0057:EN:PDF
Guideline on the readibility of the labelling and package leaflet of medicinal products for human use, revision 1, 12 January 2009. (2009). Retrieved from http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf
Hatim, B. & Mason, I. (1990). Discourse and the translator. Edinburgh: Longman.
Méndez-Cendón, B. (2009, January). Combinatorial patterns in medical case reports: an English-Spanish contrastive analysis. The Journal of Specialized Translation, 11. Retrieved from http://www.jostrans.org/issue11/art_mendez.php#note_1
Ministero della Salute. (nd.). Decreto Legislativo 24 aprile 2006, n. 219 [Legislative Decree of April 24, 2006, n. 219]. Retrieved from http://www.normativasanitaria.it/jsp/dettaglio.jsp?id=23926
Ministero della Salute. (n.d.). Direzione generale dei farmaci e dei dispositivi medici [Directorate general for drugs and medical devices]. Retrieved from http://www.salute.gov.it/ministero/sezMinistero.jsp?label=dipq&id=314
Nord, C. (1997). Defining translation functions. The translation brief as a guideline for the trainee translator. Revista Ilha do Desterro. A Journal of English Language, Literatures in English and Cultural Studies, 33, 41-55. Retrieved from http://www.periodicos.ufsc.br/index.php/desterro/article/view/9208/9484
Scarpa, F. (1999). Corpus Evidence of the Translation of Genre-Specific Structures. Textus 12(2)
Swales, R. (1990). Genre analysis: English in academic and research settings. New York: Cambridge University Press.
Vermeer, H. (2000). Skopos and commission in translational action. In Venuti, L. (Ed.), The Translation Studies Reader. London: Routledge.