A PIL is a small, folded sheet of paper enclosed in the package of a medicinal product containing consumer medical information written in the national language of the country where it is available. A PIL represents the communicative situation in which information is exchanged, reviewed and negotiated among drug manufacturers, medical experts and patients. A PIL is the most common practical source of information about medicines (Raynor et al., 2009: 700) aimed at patients for immediate reading. Also referred to as ‘package leaflets’, ‘package inserts’, ‘instruction leaflets’, ‘drug information leaflets’, ‘patient package leaflets’, ‘patient package inserts’ and ‘drug inserts’, PILs are printed documents issued by pharmaceutical companies under the responsibility of Marketing Authorisation (MA) holders that need to fulfil precise European Medicines Agency (EMA) as well as country-specific statutory requirements prior to the registration and licensing of any medication.
In particular, PILs are a simplified version of Summaries of Product Characteristics (SPCs), also known as Product Summaries (PSs), and pharmaceutical company core data sheets, namely specific health education documents required within the EU before any medicinal product is launched on the market, intended for a lay readership (Resurrecció & Davis, 2007: 68). In other words, PILs are an adaptation of both scientific reports on the clinical studies conducted and SPCs directed at competent regulatory assessors for the approval and development of drugs, medical devices, nutritional supplements and vaccines. This summarised variant is designed for the benefit of the patient, who is frequently the end user of the medication itself as well as a lay reader, thus information legibility is of primary importance.
Medicines supplemented by PILs are packaged in labelled medication boxes and released under different brand denominations within the drug distribution system of each EU country. PILs are then made available to the general public as folded package inserts accompanying the medicine, whether prescription-based or sold to the consumer as over-the-counter (OTC) self-medication. EU statutory agencies prescribe that all information contained in SPCs intended for health experts should appear in the corresponding PILs in a detailed and comprehensible form for the prime recipient. Specifically, EU legislation and inter/national regulating authorities guarantee a match between the data dispensed in any PIL and the data disclosed by the drug manufacturers in its equivalent SPC for the purposes of consumer information transparency. This institutional policy is implemented in order to prevent patients from disregarding any crucial information relating to the drug and overlooking the more dangerous drug aspects (especially precautions, warnings and potential adverse effects) which may be deliberately distorted and/or kept from the end users by the pharmaceutical industry in order to avoid alarming the patients themselves, who as a result may become disoriented or intimidated and decide to favour different medication.
The shift occurring from expert information contained in SPCs to patient information communicated in PILs stems from intergeneric (IGT) translation as related by Askehave & Zethsen (2000: 65), whereby the former genre is converted to the latter. However, this transition entails evident linguistic and communicational problems in that EMA requirements are complied with over-zealously by drug manufacturers and medical text producers. In substance, despite the switch between genres, the specialised content and language used in SPCs often end up being preserved in PILs, resulting in a unsatisfactory outcome in terms of document readability and benefit and risk perception.
PILs are the main pharmacological resource aid for medical practitioners involved in primary care. PILs are also used as healthcare education tools by pharmacists, nurses and paramedical caregivers in their capacity of information providers. PILs are aimed at a broad patient population requiring medication for the purposes of prevention, symptom relief or treatment, ranging from patients suffering from temporary medical disorders to those affected by chronic illness. PILs are targeted at a wide range of recipients belonging to either gender also in respect to age group: the elderly, adults, adolescents and children. An accurate grasp of the information perceived in PILs is essential since other population categories may also be affected indirectly such as pregnant and breastfeeding mothers. In such cases observance of drug therapy as per PIL indications, instructions and warnings is paramount since the medication has a potential effect on foetuses and unweaned infants. Medication also has a potential impact on public safety whenever it impairs the ability to operate machinery or drive safely. Hence, the importance of the PIL genre relies on the implications of the user’s interpretation of its contents and ensuing behaviour for human health.
The PIL overview above provides the groundwork for a brief comparative outlook on the legislative and regulatory status of PILs in the EU, the UK and Italy. PILs started circulating in Europe towards 1977 and for some time were regulated by the national laws in force in each country. However, standardised patient information became compulsory in the EU in 1992 via the issuing of the ‘Council directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets’ laid out by the EMA, as amended by Directive 2001/83/EC and Directive 2004/27/EC. The ‘Guideline on the readability of the labelling and package leaflet of medicinal products for human use, revision 1, 12 January 2009’ ensures that PILs are drawn up in compliance with SPCs, geared to the safe and appropriate use of medicines.
In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) has converted EU legislation relating to PILs into a country-specific guidance. This transposition process has taken place via the issuance of the guidelines entitled ‘Always Read the Leaflet – getting the best information with every medicine’ published by the MHRA, underlining the criteria according to which PILs should be made more usable in order to foster an enhanced understanding of patient information.
The situation in Italy is more complicated, as two PIL types currently complement medicinal products. Only a small number of Italian PILs referring to centrally approved drugs follows the statutory requirements established by the EMA, whereas almost all printed patient information is authorised by the Agenzia Italiana del Farmaco (AIFA) [Italian Drug Agency] and approved by the ‘Ministero della Salute’ [Ministry of Health] pursuant to 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. Furthermore, the ‘Linee guida su foglio illustrativo ed etichettatura dei medicinali di automedicazione’ [Guidelines on patient information leaflets and labelling of self-medication products] issued by the Commissione Unica del Farmaco (CUF) [Drug Commission] refer to OTC products for self-medication only but date back to 1997, thus lack harmonisation with the updated regulations made available by the EMA.
Considering the gaps stemming from legislative and cross-cultural inconsistencies, issues of PIL readability and usability and dissimilarities in patient information provision across the EU, the UK and Italy, it is felt that further in-depth inquiry into PILs and institutional schemata in the EU, the UK and Italy is required.
BIBLIOGRAPHY and RESOURCES
Agenzia Italiana del Farmaco. (n.d.). Retrieved from the AIFA website http://www.agenziafarmaco.gov.it/
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
Askehave, I. & Zethsen, K. (2000). Medical texts made simple – dream or reality? Hermes, Journal of Linguistics 25, 63-74. Retrieved from http://pure.au.dk/portal/files/9939/H25_05.pdf
Decreto Legislativo 24 aprile 2006, n. 219 [Legislative Decree of April 24, 2006, n. 219]. Retrieved from http://www.aimn.it/lex/DLgs_219_2006_medicinali.pdf
Decreto Legislativo 30 dicembre 1992 n.540. Attuazione della direttiva 92/27/CEE concernente l’etichettatura ed il foglietto illustrativo dei medicinali per uso umano [Legislative Decree n. 540 of December, 30, 1992. Implementation of directive 92/27/EEC on the labelling of medicinal products for human use and on package leaflets]. Retrieved from http://www.salute.gov.it/imgs/C_17_normativa_579_allegato.pdf
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
Linee guida su foglio illustrativo ed etichettatura dei medicinali di automedicazione [Guidelines on patient information leaflets and labelling of self-medication products]. (1997, October 16). Ministero della Salute, Circolare n. 13 del 16.10.1997. [Ministry of Health, Circular No. 13, October 16, 1997]. Retrieved from http://www.normativasanitaria.it/jsp/dettaglio.jsp?id=20548
Medicines and Healthcare products Regulatory Agency (MHRA). (n.d.). Retrieved from http://www.mhra.gov.uk/#page=DynamicListMedicines
Ministero della Salute. (nd). Retrieved from http://www.salute.gov.it/
Raynor, D.K., & Dickinson, D. (2009). Key principles to guide development of consumer medicine information – content analysis of information design texts. The Annals of Pharmacotherapy, 43(4), 700-706.
Resurrecció, V. M., & Davies, M.G. (2007). Medical translation step by step – Learning by doing. Manchester: St. Jerome Publishing.
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