Legislation and patient information leaflets (PILs) : editing perspectives on South African and German common-cold medication PILs for children

Schobel, Zoe Bisbisiane (2018-03)

Thesis (MA)--Stellenbosch University, 2018.

Thesis

ENGLISH ABSTRACT: For many people the first port of call when a cold is contracted is either the local convenience store, pharmacy or to purchase medication online. Often medication is bought with the responsibility of gaining information about the medication dosage and contra-indications firmly reliant on the user via means of a patient information leaflet (PIL). When it comes to children however they rely on their parents selecting the correct medication, familiarising themselves with important information contained in it and then medicating the child as indicated. The question now is: are these PILs understood by the parents in the first place? This study investigated the importance of consumer-oriented (focusing on effectively communicating) PILs for common cold medication for children in South Africa and Germany. The investigation showed that a substantial amount of research is being done on improving PILs for consumers, as consumers still struggle to fully comprehend PILs, which leads to misunderstanding and can potentially be fatal to the consumer. Focus was turned to the legislation governing the creation of PILs in the individual countries to investigate whether they facilitate the creation of effective PILs. Eight PILs were evaluated with a framework created by Garner, Ning and Francis (2011) specifically for PILs. This was followed by an evaluation of the legislation of both countries, which were compared to the results of the framework; and lastly it was investigated how the fields of editing, document design and multimodality can aid in improving the legislation and thus PILs. Recommendations were then created from these results. Results show that current legislation for the creation of PILs do not allow consumer-oriented PILs to be created. Specific problems were found with the legislation of both countries, restricting creators of PILs to create ideal PILs. Recommendations for legislation of both South African and Germany are thus given. These recommendations come from both the researcher as well as respondents in a survey that was part of the research. South African legislation recommendations entail the suggestion to amend clauses relating to content, layout, format, language and typography. Additional clauses are recommended: PILs must be available in every official language; test groups must be formed; prescribe headings are obliged; every target audience must have distinct PILs; explanation of medical terms and ingredients must be given; use of colour is encouraged; use of pictograms is obligatory; and a PIL must be revised with the CCC Model by Renkema. German legislation recommendations entail the same amendment suggestions as the South African legislation. In addition, it is recommended that the following clauses be added: test groups must be used to study reading level; every target audience needs their own PIL; use of colour is encouraged; use of pictograms is obligatory; an alternative way of giving medication must be presented (if applicable); and a PIL must be revised with the CCC Model by Renkema.

AFRIKAANSE OPSOMMING: Wanneer die meeste mense ʼn verkoue opdoen, is die plaaslike geriefswinkel, apteek of selfs aanlyn winkel dikwels die eerste plek waar hulle aanklop om medikasie te bekom. Die verbruiker se lees en begrip van die medisynevoubiljet wat saam met die medikasie verskaf word, is die faktor wat bepaal of inligting oor die dosis en kontra-indikasies bekom word. In die geval van kinders, vertrou hulle op hul ouers of ander versorgers om die korrekte medikasie te kies, met die beskikbare inligting vertroud te raak en die korrekte dosis aan die kind toe te dien. Hierdie studie het daarom ondersoek ingestel of hierdie medisynevoubiljette deeglik begryp word deur die ouers en versorgers wat dit gebruik – en ook of die betrokke land se wetgewing die nodige ondersteuning aan die skrywers van voubiljette en medisyneverbruikers bied. Die studie het die belangrikheid van effektiewe verbruikergeoriënteerde kommunikasie deur middel van medisynevoubiljette vir verkouemedikasie vir kinders in Suid-Afrika en Duitsland ondersoek. Deur analise en vraelyste aan verbruikers is daar aangetoon dat, ten spyte van heelwat navorsing wat die verbetering van hierdie voubiljette ten doel het, verbruikers steeds moeite het om die biljette volledig te begryp. Die fokus is daarna verskuif na die wetgewing wat die vormgewing aan medisynevoubiljette in dié twee lande onderlê, ten einde vas te stel of hulle die skep van korrekte en effektiewe biljette bevorder. Agt voubiljette (vier in elke land) is geëvalueer met behulp van ʼn raamwerk wat deur Garner, Ning en Francis (2011) geskep is, asook met behulp van aanlyn vraelyste aan ʼn steekproef voubiljetgebruikers. Dit is gevolg deur ʼn oorsig van die wetgewing van beide lande, en die resultate hiervan is met die resultate van die evaluasie met behulp van die raamwerk vergelyk. Laastens is daar gekyk na hoe die onderskeie terreine van redigering, dokumentontwerp en multimodaliteit die wetgewing kan help verbeter. Die resultate toon dat medisyneverbruikers moeite het om die instruksies in – en die inhoud van – medisynevoubiljette te begryp. Die huidige wetgewing in albei lande vereis ook nie dat agente volledig effektiewe biljette skep wat verbruikersgeoriënteerd ten opsigte van verskillende groepe teikenverbruikers is nie. Aanbevelings wat ten doel het om effektiewe interaksie tussen die skrywers en die eindverbruikers van die biljette te bewerkstellig, is vervolgens gemaak – telkens binne ʼn bemagtigende wetsraamwerk. Dit sluit in wetgewing wat maklik verstaanbare biljette met korrekte en helder instruksies en inligting wat in ʼn aantreklike en maklik leesbare formaat aangebied word, en wat die verskillende behoeftes van verskillende verbruikersgroepe in ag neem. Die studie het bevind dat daar heelwat ruimte vir verbetering is wat die ontwerp en inhoud van medisynevoubiljette vir verkouemedikasie vir kinders in sowel Suid-Afrika as Duitsland is. Dieselfde geld vir die kommunikasie tussen die agente wat vir produksie van die biljette verantwoordelik is en die verbruikers wat op die biljette moet vertrou, en ook binne die wetgewing wat die inhoud en uitleg van medisynevoubiljette bepaal. Daar is ten slotte ʼn behoefte aan meer diepgaande land- en verbruiker-spesifieke navorsing wat veral gerig is op die verbetering van die wetgewende raamwerke van die twee lande.

Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/103479
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