Case Study: Contrastive discussion of the structural, lexical and grammatical properties of the Patient Information Leaflet (PIL) genre in British English and Russian, including cross-cultural differences

INTRODUCTION

The subject of this essay is one of the most common genres in medical communication and translation, the Patient Information Leaflet (PIL). For the purpose of this essay, I have carried out a study of British and Russian PILs with the aim of establishing the general distinctive features of the genre, identifying similarities and differences between the British and Russian PILs, and outlining the potential translation problems this genre may cause. As has been fairly pointed out by Vicent Montalt and Maria Gonzalez Davies, researching medical genres and getting to know their characteristic features, including their communicative purpose, context of situation, participants' motivations and expectations, their structure and form is “a key to successful medical translation” (2007, p.61).

For the purposes of this study, a small comparable corpus was compiled, consisting of seven British and seven Russian original PILs. Both sets of texts were designed for locally manufactured medicines, most of which are commonly used over-the-counter anti-inflammatory drugs such as paracetamol, aspirin, ibuprofen etc. The texts were studied for generic similarities and dissimilarities at the structural, lexical and grammatical levels. Also, the British PIL for the medicine called Tesco Max Strength Cold & Flu Relief Sachets was translated into Russian as a sample ST in an attempt to predict the nature of the problems that may potentially arise during the translation process and see what translation strategies could be adopted for their solution. For the ease of reference, all SL examples are taken from this PIL. The TL examples are taken from the leaflet for the drug Цитрамон П. The SL and TL sample leaflets can be found in Appendix 1 and Appendix 2 respectively. The outcomes of this study are outlined below.

WHAT IS THE PATIENT INFORMATION LEAFLET

Montalt and Gonzalez Davies define the Patient Information Leaflet as “the document enclosed in the outer sales package of a medicinal product and is written in the national language(s) of the country where it is sold” (2007, p.68). PILs are issued by pharmaceutical companies in accordance with the requirements of the drug regulatory agencies in each country. The PIL is an important document which carries information about the drug's name, pharmaceutical form, composition, indications, contra-indications, method of administration and dosage, undesirable effects etc. “Besides providing information required for legal approval, PILs have a vital social function in that they instruct the patient about possible medical treatments and self-therapy” (Cacchiani, 2006, p.28).

Like most other types of text, the PIL is a multifunctional text due to the fact that it has more than one communicative purpose. As shown above, its main communicative purpose is to convey information about the drug as well as when and how it should be used, which is fulfilled, in Newmark's terms, through the informative function (1988, p. 40). The other communicative purpose is to ensure that the patient uses the drug safely and effectively. This communicative purpose is achieved through the vocative function. It is vitally important that the medicine be taken in the right dosage and under certain circumstances, therefore, clarity and accuracy are among the most significant requirements of this genre, especially in the sections devoted to method of administration of the medicine (Montalt, Gonzalez Davies, 2007, p.69).

STRUCTURAL LEVEL

The application of Halliday and Hasan's model of Generic Structure Potential (1989, pp. 63-65) to British PILs has revealed that the genre has the following GSP:

NM ^ (I) ^ WMF ^ BTM ^ TM ^ PSE ^ SM ^ (FI) ^ WMM ^ DLR

The above abbreviations can be decoded as:

NM – Name of Medicine (Heading); I - Introduction; WMF - What the Medicine is for (Indications); BTM - Before Taking this Medicine (Contra-indications); TM – Taking this Medicine (Adults, Children, Overdose); PSE – Possible Side-Effects; SM – Storing this Medicine; FI – Further Information (What is in this Medicine, What the Medicine Looks Like); WMM – Who Makes the Medicine (Marketing Authorisation Holder, Manufacturer); DLR – Date when the Leaflet was Last Revised.

A close examination of the British PILs shows that they have a relatively fixed, but not set in stone structure. They all use the trade name of the medicine as their heading. Most PILs, but not all, start with an introduction that warns the reader of the importance of reading the information contained in the leaflet prior to taking the medicine, as well as keeping the leaflet for further reference etc. Then follows the main body of the leaflet which normally contains five to seven main sections (in bold print above), most of which are further divided into subsections.

Most sections are obligatory, though the order of their appearance may slightly vary. For example, the 'What is in your medicine' section may be at the beginning of a leaflet or as part of 'Further information' at the end. Same with the 'manufacturer' and 'product licence holder': they can appear either at the beginning of a leaflet or in the conclusion. But, on the whole, the main sections flow in the same progression throughout all the PILs: Indications > Contra-indications > Dosage and Administration > Side-effects > Storing. From leaflet to leaflet, the same sections' headings are worded in the same or similar way, for example:

'Before you take your medicine' = 'Before taking this medicine' = 'Is this medicine suitable for you?';
'How to take this medicine' = 'How to take your medicine' = 'Taking your medicine';
'How to store your medicine' = 'Storing the tablets' = 'Storing your medicine' etc.

As it is extremely important that the information and instructions contained in a leaflet be completely understood by the reader and followed to the letter, structuring of the text and signalling of relevant information play a crucial role in this genre. For this purpose, British PILs use a series of visual devices, for example, various font sizes and font types. To make the main sections stand out more, their headings appear in bold print and larger font than the rest of the text, sometimes in capital letters. The main sections are often numbered. The headings of subsections are in bold print, too, but, in contrast to the main headings, are in smaller font. The text in subsections is arranged in bulleted lists. Some British PILs introduce other colours, like red or blue, along with exclamation marks and crosses on a coloured background to attract the reader's attention to particularly important information. Apart from the headings, bold print can be used for highlighting stretches of text that need special attention of the reader. All of the above works towards the same goal - facilitating readability and accessibility of the leaflet.

Russian PILs are, like their British counterparts, highly structured texts, so this can be considered a characteristic feature of the genre. After applying the GSP model to the Russian leaflets, the following picture emerged:

H ^ RN ^ TN ^ PF ^ C ^ D ^ PTG ^ ATCC ^ PE ^ TI ^ CI ^ AD ^ SE ^ (OD) ^ IOD ^ SW ^ FP ^ SC ^ SL ^ PPT ^ M

H – Heading ('Patient Information Leaflet'); RN – Registration Number; TN – Trade Name; PF - Pharmaceutical Form; C – Composition; D – Description; PTG - Pharmaco-therapeutic Group; ATCC – Anatomical Therapeutic Chemical Classification (ATC) Code; PE - Pharmacological Effect; TI - Therapeutic Indications; CI – Contra-indications; AD - Administration Method and Dosage; SE – Side-effects; OD – Over-dosage; IOD - Interaction with Other Drugs; SW - Special Warnings; FP - Form of Packaging; SC - Storing Conditions; SL - Shelf-Life; PPT - Pharmacy Purchasing Terms; M – Manufacturer.

Here two important observations can be made. First, Russian PILs consist of the same main sections as British PILs, though not necessarily in the same order as in the British ones, hence a considerable overlap of their macro-structures. Second, unlike British PILs, the Russian texts adhere to the same format much more strictly. All sections, except for one, 'Over-dosage', are obligatory, worded in the same or nearly the same way in all the PILs and follow strictly in the same order. British PILs display a more flexible structure than Russian PILs. It is self-evident that this dissimilarity should be taken into consideration and reflected in the translation in order to conform to the generic conventions of the TT.

It should also be noted that the Russian PILs are far less creative in the use of visual devices. Though the headings of the main sections are, like in British PILs, in large font and bold print (usually in centred justification), there is very often no further division into subsections. Only some sections may contain bulleted lists, but in most cases the text is arranged in paragraphs rather than lists. No other colours apart from black and white are used. Small print is used for the entire text with occasional use of italics in subheadings. Normally, bold print is only used for headings but not for highlighting particularly important information.

LEXICAL LEVEL

The main lexical feature of the given genre is the abundance of medical terms, which is not unexpected in a medical text. Whenever possible, the British PILs use everyday vocabulary, familiar to a layperson, thus showing features of terminological simplification. However, the use of specialist terminology cannot be avoided in PILs, as references often have to be made to rare and complex illnesses, conditions, medicines. To facilitate the text comprehension and its accessibility for the consumer, most medical terms are accompanied by explanations, resulting in explicitation. The explanations can be in the form of a phrase or a whole clause like in the following examples from the sample PIL (Appendix 1):

“nasal congestion (blocked nose) and feverishness (high temperature)” (section 1);

“a condition called Raynaud's Phenomenon, which results from poor circulation in the fingers and toes” (section 2);

“barbiturates (for epilepsy or to help you sleep)” (section 2).

A reverse tendency can also be observed when a layperson word is accompanied by a proper medical term in parenthesis, whose purpose might be to educate the reader:

“a pain reliever (analgesic)” (section 1);
“high blood pressure (hypertension)” (section 2).

In contrast, Russian PILs do not seem to be making any effort in facilitating accessibility of the text, as they very rarely provide explanations for medical terms. They commonly use specialised terminology that only a medical expert would be familiar with. As previously explained by Cacchiani, these dissimilarities are explained by the cultural differences as well as different legal requirements to the content of PILs in the two countries, along with different assumptions regarding the text receiver and their background knowledge (2006, p.28). While British PILs are aimed at any possible including the uninformed reader, Russian PILs are designed, in the first place, for an expert reader (a doctor or pharmacist), hence the abundance of specialised terms. The reason why Russian PILs are mainly designed for a medical professional lies in the fact that patients in Russia have always been discouraged by medical authorities to use any medicines without a doctor's prescription or advice.

GRAMMATICAL LEVEL

Syntax

As noted by Cacchiani, British PILs “exhibit a strong preference for short asyndetic sentences” (2006, p.32). Our corpus shows that this observation is true, particularly in relation to the sections of instructional nature, like those concerning the administration and storing of a medicine. This is explained by the necessity to keep the instructions maximally short and clear, for example:

“Do not exceed the stated dose” (section 3).
“Go to your nearest hospital casualty department” (section 3).

Another important feature is syntactic parallelism, which occurs both on a sentence and sub-sentence level and is particularly prominent in bulleted lists:

“paracetamol which is …
phenylephrine which is …”(section 1);

“Do not give to …
Do not exceed …
Do not take … “ (section 3).

The corpus analysis shows that parallelism is a characteristic feature of sentence structure in British PILs. The main purpose for using parallelism is again to ensure maximum clarity and readability of the text. This feature also helps readers “remember information more easily”(Byrne, 2006, p. 89).

The use of elliptical sentences is another specific feature of this genre. Its necessity is caused by spatial constraints as well as the communicative purpose of the genre to render information in a concise manner:

“Contains paracetamol” (section 2);
“May be harmful for people with …” (section 2);
“To be taken into consideration by ...” (section 2).

In Russian PILs, sentences are much longer (can be up to five - six lines long) and often have a complex structure. Ellipsis is used only occasionally, mainly in the sections concerned with the packaging, storing and shelf-life of a medicine, for example (Appendix 2):

“Усиливает действие гепарина...” ('Interaction with Other Medicines' section).
[BT: Increases the effect of heparin ….]

“В сухом … месте” ('Storing' section).
[BT: In (a) dry … place.]

Parallel syntactic structures are found in Russian PILs only occasionally and seem to be accidental.

Mood and Modality

Contrastive analysis shows a striking difference between British and Russian PILs in terms of mood and modality. British PILs are designed to complement the doctor's information, thus displaying features of “spoken rather than written discourse” (Cacchiani, 2006, p. 32). Written in an informal style, the British PILs “attempt to mime face-to-face doctor/patient interactions” (Cacchiani, 2006, p. 37). They contain questions that patients might want to ask themselves or their doctor or pharmacist. The reader is addressed directly, hence the abundance of first- and second-person pronouns:

“...helps reduce your temperature when you have a fever” (section 1).

Along with declarative sentences, British PILs contain a significant number of interrogatives and imperatives, for example:

“Is this medicine suitable for you?” (section 2);
“Do not take this medicine ...” (section 2).

Due to the nature of the genre, British leaflets use a great number of modal verbs:

“… you still need to use this product carefully ...” (Introduction);
“Keep this leaflet as you may need to read it again” (Introduction);
“This should be taken into account...” (section 2).

The main means of expressing epistemic modality is the modal 'may', while deontic modality is usually conveyed through the modal 'should' and semi-modal 'need', and only in special cases 'must'.

Imperatives are a distinctive feature of British PILs and express either strong commands or polite requests, often accompanied by 'please':

“Read all of this leaflet carefully ...” (Introduction);
“Please see your doctor ...” (section 2);
“Do not drink alcohol ...” (section 2);
“... stop taking this medicine immediately ...” (section 4).

Russian PILs show a totally different picture in terms of mood choices and modality. The leaflets are written in a formal style, reflecting a written discourse, in which there is no direct address to the reader, therefore, no first- or second-person pronouns, no imperatives or interrogatives.

Like in British PILs, there are a lot of instances of the use of modals, but they have a much higher degree of obligation. The most frequently used modals are the deontic '(не) следует' ['should (not)'], 'должен' ['must'], 'необходим(о)' ['necessary']. For epistemic modality, the modal verb 'может' ['may'] and modal adjective 'возможен' ['possible'] are used. Apart from that, a striking distinctive feature of modality in Russian PILs is the extensive use of impersonal sentences with a modal as part of the predicate:

“...необходимо немедленно обратиться за врачебной помощью” ('Over-dosage' section).
[BT: ...(it is) necessary immediately to seek for medical help.]

Another characteristic feature of Russian PILs is the infinitival constructions with a present or elliptical modal:

“Не использовать по истечении срока годности ...” ('Shelf-Life' section).
[BT: Not to use on completion (of) period (of) validity....]

TRANSLATING PILS FROM ENGLISH INTO RUSSIAN

The contrastive analysis of the British and Russian PILs described above proved to be an important preliminary stage in the translation process. It has shown that the genre of the PIL is highly conventionalised and extremely structured in both languages. At the same time, there are cross-cultural generic differences between them at structural, lexical and grammatical levels, which have to be taken into consideration during the translation process.

After carrying out the analysis, I translated the sample British PIL into Russian in order to establish the most significant potential translation problems that may arise and see what guidance could be offered to translators in terms of useful strategies for solving these problems. In the following, I will describe briefly the nature of the main problems and their solutions.

Structure

As we have seen earlier, the structure of Russian PILs has a number of differences regarding the layout, the number of sections and their arrangement, the use of visual devices such as bulleted lists etc. Therefore, to meet the expectations of the target audience, the TT requires redesigning in accordance with the structural conventions of Russian PILs.

Due to the fact that Russian leaflets adhere strictly to the established format, the redesigning of the TT involves a lot of omission of information contained in the ST. For example, the introductory part inviting the patient to read the leaflet carefully and keep it for later reference has to be abandoned altogether as it does not fit in the Russian format. On the other hand, some information such as the registration number and ATCC (Anatomical Therapeutic Chemical Classification Code) has to be added. This type of information needs to be obtained from the translation initiator.

It is important to bear in mind that the format of the Russian PIL cannot be changed. Instead, the translator is expected to use the ST as a source of new information for the new audience. It is pertinent here to remind us of Jody Byrne's statement regarding the specificity of technical translation (2006, p. 11):

The purpose of technical translation is, therefore, to present new technical information to a new audience, not to reproduce the source text, per se, or reflect its style or language. Technical translation is a communicative service provided in response to a very definite demand for technical information which is easily accessible ….

British headings (usually in the form of a question) should be replaced by the conventional Russian headings, which, unlike the English, have the form of a noun or a nominal phrase. Let us consider the heading of section 1 of the sample PIL:

1. What is this medicine and what is it used for?

The first part of this section enlists the ingredients and their pharmacological effect, while the second part deals with the cases when the drug can be used. In accordance with the format of Russian PILs, this information should be given in two different sections, one followed by the other. Therefore, section 1 of the ST should be split into two sections in the TT, and its heading gets transformed in the TT into two Russian ones:

ФАРМАКОЛОГИЧЕСКОЕ ДЕЙСТВИЕ [BT: Pharmacological Effect]
ПОКАЗАНИЯ К ПРИМЕНЕНИЮ [BT: Therapeutic Indications]

It is obvious that before even starting the translation, the translator should know the exact format of the Russian PIL, in what order the sections are arranged and the precise formulation of the headings.

The next issue to be addressed is concerned with the ST's visual devices. For example, bulleted lists are a characteristic feature of British PILs but are not very common in Russian PILs, therefore, they have to be rearranged into paragraphs in the TT. Due to space restrictions, I can show here only one point from a bulleted list:

ST:
• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever (section 1)
TT:
Парацетамол оказывает жаропонижающее, обезболивающее действие.
[BT: Paracetamol exerts fever-reducing, pain-relieving effect.]

Lexico-syntactic features

The problems concerning layout and structure are more of a technical nature and are relatively easy to solve provided the translator is familiar with the TT structural conventions of the genre. Working on the translation has proved that the main problems are caused by the lexical and stylistic choices that have to be made. As shown earlier, Russian PILs use a much more formal style compared to British PILs and, therefore, are full of complex medical terms. This means that along with switching to a formal style, the translator is expected to replace the ST's everyday vocabulary by proper medical terminology in the TT. This type of work may require of the translator either having a medical background or carrying out extensive medical research. But the most realistic solution, in my view, for the translator without a medical background is to seek a second opinion from a medical expert. Switching to a formal style also requires a removal of the direct address to the reader and with it of the first- and second-person pronouns:

ST:
Do not take this medicine if you:
• are allergic to paracetamol, phenylephrine or any of the other ingredients
• have a serious heart condition … (section 2).

TT:
ПРОТИВОПОКАЗАНИЯ
Повышенная индивидуальная чувствительность к компонентам препарата, сердечная недостаточность …
[BT:
COUNTER-INDICATIONS
Increased individual sensitivity to (the) components (of the) preparation, cardiac deficiency ...]

The ST's interrogative and imperative sentences also need to be addressed. Due to the change of style and register, they should be replaced by infinitival constructions and impersonal sentences with a present or elliptical modal, for example:

ST:
Do not take with any other paracetamol-containing products (section 2).

TT:
Не принимать в сочетании с другими парацетамолсодержащими лекарствами.
[BT: Not to take in combination with other paracetamol-containing drugs.]

ST:
Do not drink alcohol (beer, wine, spirits etc) while taking this product (section 2).

TT:
Во время лечения следует отказаться от употребления алкогольсодержащих напитков.
[BT: During treatment (you) should refrain from consumption (of) alcohol-containing beverages.]

The last example also demonstrates that redundancies in the ST such as intra-textual glosses are not transferred into the TT and are simply omitted.

CONCLUSION

The main aim of this essay has been to compare British and Russian PILs within a comparable corpus in terms of their similarities and differences and establish potential problems that may arise in English - Russian translation as well as their solutions. The most important conclusion to be drawn is that the genre is highly culture-specific in both languages, well structured and extremely conventionalised, therefore, in order to produce functionally adequate translations, it is required of translators to be familiar with the genre conventions and its most distinctive rhetorical features in both languages. Translators should bear in mind that shifts are unavoidable in terms of style, register, lexis, syntax, mood choices and modality.

CORPUS
E1 – E7: British PILs:
E1: Anadin Original, tablets, Wyeth Lederle S.p.A, leaflet last revised May 2008;
E2: Benylin, Cold & Flu Max Strength Capsules, Wrafton Laboratories Ltd., leaflet last revised June 2009;
E3: Aspirin, Dispersable 300 mg tablets, Aspar Pharmaceuticals Ltd., leaflet last revised March 2004;
E4: Extra Power Pain Reliever Caplets, Wrafton Laboratories Ltd., leaflet last revised August 2007;
E5: Ibuprofen, 200 mg caplets, Galpharm International Ltd., leaflet last revised March 2007;
E6: Lemsip Cold & Flu Lemon, sachets, Reckitt Benckiser Healthcare (UK) Ltd., leaflet last revised April 2006;
E7: Tesco Max Strength Cold & Flu Relief Sachets, Wrafton Laboratories Ltd., leaflet last revised October 2008.
R1 – R7: Russian PILs:
R1: Анальгин - УБФ, таблетки, ОАО "Уралбиофарм";
R2: Ацетилсалициловая кислота МС, таблетки 500 мг, ОАО "Уралбиофарм";
R3: Ибупрофен, таблетки, ОАО "Татхимфармпрепараты";
R4: Парацетамол - УБФ, таблетки, ОАО "Татхимфармпрепараты";
R5: Пентафлуцин, гранулы, ОАО "Уралбиофарм";
R6: Таблетки от кашля, таблетки, ОАО "Татхимфармпрепараты";
R7: Цитрамон П, таблетки, ОАО "Уралбиофарм".


REFERENCES

• Byrne, J. (2006). Technical Translation. Usability Strategies for Translating Technical Documentation. Dordrecht: Springer

• Cacchiani, S. (2006). Dis/Similarities Between Patient Information Leaflets in Britain and Italy: Implications for the Translator. New Voices in Translation Studies 2(2006), 28-43.

• Halliday, M.A.K. and Hasan, R. (1989). Language, Context, and Text: Aspect of Language in a Social-Semiotic Perspective.(2nd edn.). Oxford: Oxford University Press

• Montalt, V. and Gonzalez Davies, M. (2007). Medical Translation Step by Step. Learning by Drafting. Manchester: St. Jerome Publishing

• Newmark, P. (1988). A Textbook of Translation. New York and London: Prentice-Hall
• Tesco Max Strength Cold & Flu Relief Sachets, Patient Information Leaflet, Wrafton Laboratories Ltd., last revised October 2008.
• Цитрамон П, таблетки, Инструкция по медицинскому применению препарата, ОАО "Уралбиофарм". [ Citramon P, tablets, Patient Information Leaflet, Uralbiopharm Plc, n.d.].