Comparison of Textual Patterns in German and Portuguese Medical Texts¹

0. Introduction

he translation of medical texts represents an interesting and rich area for translation studies. Various sub-domains, such as Terminology or Contrastive Linguistics contribute to the development of the future translators' professional expertise. In the present paper the focus is on the text genre "package insert" ("package leaflet" in BE) and its contrastive textual and pragmatic aspects in the language pair German-Portuguese.

Whereas in Terminology the best strategy for resolving problems consists of the creation of glossaries and specialized dictionaries, the analysis of structural aspects calls for a very profound knowledge of the text genre involved as well as consultation of parallel texts. Therefore, attention was focused on the analysis and the comparison between macro and microstructures of information inserts accompanying drugs (package inserts). This textual genre is mainly characterized by two essential aspects: (1) the legal aspect and (2) the informative aspect. Both aspects influence the pragmatic and textual features used in this genre.

In this paper, we start by characterizing the legal/institutional basis of the package inserts in Germany and Portugal. This part is followed by a brief characterization of the text genre package insert, based on the guidelines of the European Commission. The main section of this paper consists in the corpus analysis, in which we focus on the comparison of package inserts in German and Portuguese, according to certain micro-structural features.

The aim of this analysis is to contribute towards a better understanding of the features of this text genre and, at the same time, to underline similarities and differences between the two languages.

Germany is the third largest pharmaceutical market in the world and the largest in Europe. Until the 1980s Germany was considered 'the pharmacy of the world'.² The roots of this branch go back to the 19th century. More than 1,300 pharmaceutical companies employ approx. 127,000 people, most of them working in small and middle-sized companies.³ Over the last years and due to globalization, the German pharmaceutical market had to face a decline due to company takeovers, such as the latest takeover of Ratiopharm by the Israeli drugmaker Teva Pharmaceutical Industries Ltd. in March 2010. According to current surveys analyzing the main pharmaceutical companies worldwide,⁴ Bayer AG ranks on position 12, followed by Boehringer Ingelheim on position 15 and Merck KG holding rank n°. 25.

The pharmaceutical sector is showing high rates in growth and research investments also in Portugal. It accounts for a turnover of some €1.5 million per year. More than 10,000 people are currently employed in this area (ibid.). The largest Portuguese pharmaceutical companies are Bial, Bluepharma, Laboratórios BASI and Medinfar.

2. Background of German and Portuguese package insert legislation

The German Drug Law (Arzneimittelgesetz) prescribes which information and in which order has to appear on the package insert. Since the beginning of the 90s, the drug law has been regulated on European scale and package inserts have become obligatory all over Europe. There have been many efforts to make package inserts more patient-friendly. One of the considerations made was to divide the information given on package inserts between patients, on the one hand, and physicians and medical staff, on the other hand. In 1998 the EU elaborated a "Readability Guideline",⁵ containing recommendations according readability, comprehensiveness, contents and layout and also providing a "model insert" that was supposed to serve as an example. In the "Readability Guideline" it says: "The package insert should be legible, clear and easy to read in all EEA languages." It continues as follows: "During the drafting of the original package insert every effort should be made to ensure that the package insert can be translated from the original to the various national languages in a clear and understandable way. It is important that the outcome of the user consultation is then correctly translated into the other languages. Strict literal translations from the original language may lead to package inserts which contain unnatural phrases resulting in a package insert which is difficult for patients to understand. Therefore, different language versions of the same package insert should be 'faithful' translations allowing for regional translation flexibility, whilst maintaining the same core meaning." In March 2002 the German Bundesinstitut für Arzneimittel und Medizinprodukte published new regulations for a better readability and comprehensiveness on the basis of the German translation of that "model insert."

In Portugal, the Autoridade Nacional do Medicamento e Produtos de Saúde, in short INFARMED, regulates the contents of a package insert. In 1991 the law n.º 72/91 (Decreto-Lei n.º 72/91) specified regulations concerning layout and contents of package inserts in Portugal for the first time. In the following law amendments it was tried to harmonize EU legislation with the national one.

3. Text genre—Package Insert

The package insert is a subset of healthcare materials and its predominant text function is to inform readers/users about drugs. But, as most texts, is has additional functions such as instruction, warning, and recommendation.

The importance of the package insert as a text genre has often been underlined in the literature (Hoffmann 1983, Berg-Schmitt 2003:58, Cacchiani 2006, among others), both because of the implications of its readability for people's health and because it is such a common genre. We should keep in mind that package inserts are public consultation documents, and that the correct use of drugs depends on the understanding of the package insert. Misunderstandings may have serious consequences, as we are dealing with human health.

Following Löning's model (Löning 1981) of classification of medical discourse (cf. Table 1), which differentiates four main levels according to the degree of specialization among the communication partners and the aim of the text, package inserts are situated on level 3: communication between professional and layperson.

The asymmetry of the communication and the great diversity and background of readers account for some of the style characteristics of the genre: the use of understandable words, which should be as common as possible; the need to introduce explanations in the text; the consistency of the text structure with clear headings. In addition to this, we should not forget that this kind of written communication has a very heterogeneous readership, and doesn't allow individual explanation (any doubts about the content can only be indirectly cleared by asking a doctor or pharmacist). Therefore the contents should be presented in a conventionalized form, be as specific as possible and exclude ambiguity.

According to Van Vaerenbergh (2003: 213), the package insert is characterized, as a text genre, by revealing a particular macro and microstructure. The macrostructure consists in the structuring of the text in sections and paragraphs (headings, graphic aspects), in its completeness, and in the way the reader is addressed. The microstructure focuses on the linguistic implementation at the lexical level (the use of medical terms and non-specialized words), and the syntactic structures used to convey the different language functions.

The package insert is a highly conventionalized genre and its structure and contents are now determined by European and national regulations, as mentioned above. Therefore it is not possible to characterize its macro and microstructures without referring to the guidelines of the European Commission and to the Product Information Templates⁶ created by the European Medicines Agency.

As far as the macrostructure is concerned, package inserts are structured in the following sections:

0. Introduction—name of the medicine; active substance; strength and pharmaceutical form

1. Description of the medicine and therapeutic indications

2. Warnings and precautions

3. Instructions

4. Description of side effects

5. Description of storage conditions

6. Further information

According to the "Guideline on the Readability of the Labeling and Package Insert of Medical Products for Human Use" (Guideline on the Readability), headings should be bold typed or have a different color, "the use of multiple levels of heading should be considered carefully" and sub-headings should "only be included if these are relevant for the particular medicine." The readership

should be addressed in a clear and direct way.

As we mentioned above, patient inserts have different functions, which are intermingled. The different sections of the insert provide an overview of these functions:

• The preamble, section 1, section 4 (side effects) and section 6 (further information) are mostly descriptive, although some instruction is also available (Read all of this insert ...).
• Section 2 (dedicated to contraindications, precautions and interactions with other products) is characterized by warnings and advice.
• Sections 3 (how to use), 5 (how to store) and 6 (further information) are a mixture of instruction and advice.

These textual functions are conveyed in each language by specific language structures, as will be seen in the corpus analysis.

4. Corpus analysis

This paper presents a corpus-based descriptive analysis of the most common textual and syntactic patterns in both German and Portuguese drug information inserts. The analysis mainly focuses on the micro-structural level, which includes ways of disambiguation that are inherent to this text genre. It will also focus on the ways of expressing warnings, instructions and advice.

On macro-structural level, German package inserts have two ways of addressing the patient—an implicit and an explicit one. In the latter, the patients are referred to as such, by which the reader (patient) gets more confident knowing that the text was written for him and not for medical professionals. In Portuguese inserts patients are addressed by using the formal imperative.

DE:

1. Direct salutation: Liebe Patientin, Lieber Patient! /
2. General form of address: Gebrauchsinformation: Information für den Anwender

PT:

1. Non-existent
2. General form of address: Folheto informativo: Informação para o utilizador

DE:

1. Gebrauchsinformation: Information für den Anwender
2. Benennung des Medikaments
3. Lesen Sie die gesamte Packungsbeilage sorgfältig durch.
   Heben Sie die Packungsbeilage auf.

1. Liebe Patientin, lieber Patient!
2. Bitte lesen Sie die Gebrauchsinformation aufmerksam (...)
3. Benennung des Medikaments

PT:

1. Folheto Informativo: Informação para o utilizador
2. Nome do medicamento
3. Leia atentamente este folheto antes de tomar o medicamento.

DE:

— Emphasis of the structure through headings in bold letters or numbering

— Titles in interrogative form

— Tables and images as visual aids are common

PT:

— Emphasis through bold letters, but headings are not stressed.

— No interrogative forms in titles

— Tables and images as visual aids are rare

The analysis of the microstructure will mainly focus on how medical terms can be disambiguated in package inserts (1). Moreover, we will also compare the different ways of expressing warnings (2), instructions (3) and advice (4).

(1) Disambiguation

Although disambiguation of medical terms is present in both German and Portuguese inserts, it is more frequently used in German texts. This is due to the duplication of the term in its erudite form (of Latin or Greek origin) and its popular form (of German origin). In Portuguese, as in other Romance languages, this difference is not so evident.

DE: bei Patienten mit Zuckerkrankheit (Diabetes mellitus)

PT: ... que são usadas para tratar a diabetes mellitus

The simplification of medical terms is explicitly referred to in the European Guidelines as an important means of making it possible for the layperson to understand the message. An interesting phenomenon is the reverse strategy: The common word or expression is used unmarked in the text, but it is followed by the specific term in brackets, so that the specialist term is an extra-information for the reader. This may be understood as a part of "education" of the layperson.

DE: Clarification/Simplification of medical terms (specific -> common):

I—a specialized medical term is clarified by a general term in brackets:

— Dermatitis (Ekzem)

— Furunkel (Eiterbeulen)

II—a specialized medical term is clarified by a paraphrases in brackets:

—Megakolon einschließlich eines toxischen Megacolons (Dickdarmerweiterung als Komplikation

z.B. einer chronischentzündlichen Darmerkrankung)

III—a specialized medical term is explained by adding an example in brackets:

—Arzneimittel, die die Magen- und Darmtätigkeit dämpfen (z.B. Morphin-haltige Schmerzmittel)

IV—a specialized medical term is introduced by sogenannt (so called) or wird bezeichnet als

(is designated as) and clarified by a general term in brackets:

—Diclofenac-ratiopharm Gel enthält einen Wirkstoff aus der Gruppe der sogenannten nicht-

steroidalen Antiphlogistika/Analgetika (Entzündungs- und Schmerzhemmer)

—Elidel behandelt spezifisch eine Entzündung der Haut, die als atopische Dermatitis (Ekzem)

bezeichnet wird.

V—a common word is specified by a medical term in brackets:

—Schlaf-, Beruhigungs- und Narkosemitteln (Hypnotika, Sedativa und Narkotika);

—Schmerzmitteln (Analgetika wie z. B. Dextropropoxyphen und Opiate)

—Darmverschluss (Ileus)

—Pilzerkrankungen (Mykosen)

VI—a paraphrase with common words is specified by a medical term:

—akute Unterzuckerungserscheinungen (Hypoglykämien)

VII—a common word is specified by a medical term in brackets, introduced by sogenannt :

—bestimmte Medikamente, die eine vermehrte Harnausscheidung bewirken (sogenannte

Aldosteronantagonisten und Schleifendiuretika)

PT: Clarification/Simplification of medical terms (specific -> common):

I—a specialized medical term is clarified by a general term in brackets [not very often in PT]:

—flatulência (gases intestinais)

—náuseas (enjoos)

II—a specialized medical term is clarified by a paraphrases in brackets [common in PT]:

—diuréticos (comprimidos para urinar)

—hipocloridria (secreção insuficiente de ácido gástrico)

III—a specialized medical term is explained by adding an example in brackets:

— sintomas de eczema ligeiro ou moderado (por ex. vermelhidão e prurido)

IV—a specialized medical term is introduced by denominado/a and clarified by a general term

in brackets:

—Elidel creme trata especificamente uma inflamação da pele denominada dermatite atópica

(eczema).

V —a common word is specified by a medical term in brackets:

— assadura (dermatite)

— comichão (prurido)

VI—a paraphrase with common words is specified by a medical term

— descida abrupta e acentuada dos níveis de açúcar do sangue (choque hipoglicémico)

VII—a common word is specified by a medical term, introduced by conhecido como:

— pertencente a um grupo de substâncias conhecidas como "antifúngicos"

I—modal verb dürfen + nicht

— Glucobay 50 darf nicht eingenommen werden, wenn ...

— Imodium akut darf nicht eingenommen werden, wenn Sie überempfindlich gegenüber Loperamid sind.

— Kinder unter 2 Jahren dürfen nicht mit Loperamid-haltigen Arzneimitteln behandelt werden.

II— modal verb dürfen without negative particle + nur

— Diese darf ebenfalls nur nach ärztlicher Verordnung mit Loperamidbehandelt werden.

III—sein + adjective (Besondere Vorsicht ist erforderlich...)

— Besondere Vorsicht bei der Anwendung von Elidel ist erforderlich,

IV—imperative

— Nehmen Sie ... nicht, wenn Sie...

V—können (relates to possible risks and effects of the drug

— ... kann die Wirkung von folgenden Mitteln verstärken/abschwächen

I—Negative imperative form

—Não tome Glucobay, caso ...

II modal verb dever + não + passive voice

— Glucobay não deve ser usado caso sofra de: ...

II—imperative + especial cuidado

— Tome especial cuidado com Elidel creme

I —modal verb müssen meaning "necessity"

When applied in the non-epistemic sense, this necessity results from the highly conventionalized character of the text genre package insert.

— Wenn sich Ihr Krankheitsbild verschlimmert oder nach 2 Tagen keine Besserung eintritt, müssen Sie einen Arzt aufsuchen.

— Wenn eine akute Infektion schwerwiegend ist oder nicht auf die Behandlung innerhalb weniger Tage anspricht, muss Mirena unverzüglich durch Ihre Ärztin/Ihren Arzt entfernt werden

— Wie alle öligen Lösungen muss Nebido auf jeden Fall intramuskulär und sehr langsam injiziert werden.

II—modal verb sollen

— Danach soll nach jedem ungeformten Stuhl die Wiederholungsdosis eingenommen werden.

— Die Hartkapseln sollen unzerkaut mit ausreichend Flüssigkeit eingenommen werden.

"sollen" im Konjunktiv II

— Die Einnahme von Loperamid sollte unter diesen Umständen nur nach ärztlicher Verordnung erfolgen.

III—imperative

— Informieren Sie Ihren Arzt oder Apotheker, wenn Sie Nebenwirkungen bemerken, die nicht in dieser Packungsbeilage aufgeführt sind.

— Verwenden Sie diese Packung nach diesem Datum nicht mehr!

IV—sein zu + infinitive form

— Bei Anwendung von wesentlich zu großen Mengen oder versehentlicher Einnahme von Diclofenac-ratiopharm Gel ist der Arzt zu benachrichtigen.

V—sein + adjective

— Besondere Vorsicht ist erforderlich...

VI—modal verb dürfen

— Sie dürfen das Arzneimittel nach dem auf dem Umkarton und auf der Tube angegebenen Verfallsdatum nicht mehr verwenden.

VII—infinitive form

— Arzneimittel für Kinder unzugänglich aufbewahren.

VIII—Making a request

The German uses a more polite language than the Portuguese. In German it is normal to use bitte even in the package insert, whereas for Portuguese speakers it is common to use the imperative form without adding por favor.

— Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, wenn Sie den Eindruck haben, dass die Wirkung von Diclofenac-ratiopharm Gel zu stark oder zu schwach ist.

I—modal verb dever meaning "necessity"

— Mirena deve ser retirado se houver infecções pélvicas recorrentes ou infecções da camada que reveste a cavidade uterina, ou se uma infecção aguda for grave ou não responder a tratamento dentro de poucos dias.

— Deverá dar-se especial atenção de forma a evitar injecções intravasculares.

— Tal como em todas as soluções oleosas, Nebido deverá ser injectado estritamente por via intramuscular e muito lentamente.

II—imperative

— Se algum dos efeitos secundários se agravar ou se detectar quaisquer efeitos secundários não mencionados neste folheto, informe o seu médico ou farmacêutico.

III —infinitive form

— Manter fora do alcance e da vista das crianças.

DE:
I—modal verb sollen in its subjunctive form sollte

The subjunctive form sollte expresses an advice or a suggestion which is why instructions given in this mode are non-binding (Berg-Schmitt 2003: 120).

— Falls die Creme versehentlich auf diese Bereiche aufgetragen wurde, sollte sie sorgfältig abgewischt und/oder mit Wasser abgespült werden.

— Da der Wirkstoff in die Muttermilch übergeht, sollte eine Anwendung von Imodium akut in der Stillzeit nicht erfolgen.

— Falls eine Behandlung der Ursache des Durchfalls möglich ist, sollten Sie diese—soweit sinnvoll—durchführen.

II—empfehlen

— Die Anwendung eines luftdichten Verbandes (Okklusivverband) wird nicht empfohlen.

— Wegen möglicher Beeinträchtigung des Sehvermögens empfiehlt es sich, die Salbe nur nachts anzuwenden.

I—modal verb dever

— Em caso de aplicação acidental nestas áreas, o creme deve ser bem limpo e/ou lavado com água.

II—ser aconselhável

— Antibiophilus® Cápsulas não é aconselhável durante o aleitamento, salvo indicação médica contrária.

The aim of this study was to compare the text genre package information insert both in German and Portuguese. Given the highly conventionalized text genre and the introduction of so-called Readability Guidelines (Directive 2001/83/EC) by the EU, it could be observed that there are hardly any differences in readability and user-friendliness between German and Portuguese package inserts. The differences encountered are more linked to socio-cultural characteristics of the two countries. On a micro-structural level, the different ways of disambiguation in both languages were exemplified and further functions, such as warnings, instructions and advice, were included in the research to show the high degree of conventions used in this text genre.

¹ This paper was presented at the Conference "Emerging Topics in Translation and Interpreting" at the Università degli Studi di Trieste, 16-18 June 2010.

² Cf. http://www.atlantic-times.com/archive_detail.php?recordID=465.

³ http://www.einstieg.com/infos/berufswahl/berufswelten/medizin-gesundheitswesen/key/f71bfde147a76ad190cd37f1de75afbf/artikel/markt-der-moeglichkeiten-3974.

⁴ http://www.pharmazeutische-zeitung.de/index.php?id=33059.

⁵ http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol2/c/2009_01_12_readability_guideline_final_en.pdf

⁶ http://www.ema.europa.eu/htms/human/qrd/docs/Hannotatedtemplate_highlighted_consultation.pdf .

Berg-Schmitt, Jutta (2003): Wissenstransfer Arzneimittel. Untersuchungen zu Packungsbeilagen. Trier: Diss.

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

Deutsch, Edwin / Lippert, Hans-Dieter (2006): Kommentar zum Arzneimittelgesetz (AMG). Heidelberg: Springer.

Hoffmann, Ludger (1983): „Arzneimittel-Gebrauchsinformationen: Struktur, kommunikative Funktionen und Verständlichkeit", in: Deutsche Sprache 2, 138-160.

Löning, Petra (1981): „Zur medizinischen Fachsprache. Stilistische Gliederung und Textanalysen", in: Muttersprache 91, 79-92.

Neubach, Constanze (2009): Deutsche und französische Packungsbeilagen. Vergleichende Fachtextanalysevon Packungsbeilagen der deutschen und französischen Sprache zwischen 1991-2007. Hamburg: Dr. Kovač.

Van Vaerenbergh, Leona (2003): Fachinformation und Packungsbeilage: Fachübersetzung oder Technical Writing?, in: Schubert, Klaus (ed.): Übersetzen und Dolmetschen. Modelle, Methoden, Technologie. Tübingen: Gunter Narr Verlag.

Wiese, Ingrid (2000): „Textsorten des Bereichs Medizin und Gesundheit", in: Text- und Gesprächslinguistik / Linguistics of Text and Conversation. Antos, G. / Heinemann, W. / Sager, S. (eds.). Berlin - New York: de Gruyter, 710-718.

http://www.ema.europa.eu/htms/human/qrd/qrdtemplate.htm

http://www.ema.europa.eu/htms/human/qrd/docs/Hannotatedtemplate_highlighted_consultation.pdf

http://www.ema.europa.eu/htms/human/qrd/docs/Hannotatedtemplate_consultation.pdf

http://www.ema.europa.eu/htms/human/qrd/ReferralSPC/Hreferralspcpt.doc (template in PT)

http://www.ema.europa.eu/htms/human/qrd/ReferralSPC/Hreferralspcde.doc (template em DE)

http://www.einstieg.com/infos/berufswahl/berufswelten/medizin-gesundheitswesen/key/f71bfde147a76ad190cd37f1de75afbf/artikel/markt-der-moeglichkeiten-3974/

http://www.pharmazeutische-zeitung.de/index.php?id=33059

http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol 2/c/2009_01_12_readability_guideline_final_en.pdf