Category Archives: labeling

FDA publishes guidance for industry on warnings and precautions and contraindications.

The FDA publishes guidance that is intended to assist applicants and reviewers in drafting the warnings and precautions, contraindications, and boxed warning sections of labelling, as described in the final rule amending the requirement for the content and format of labelling for human prescription drugs and biological products.

The guidance is a set of recommendations is intended to help ensure the labels are clear, useful, informative and to the extent possible consistent in context and format.

Should an IFU for a medical device be user-tested in the same way as a PIL?

Article by associate Consultant Mark Gibson and Maria Mehlin

This article presents a case for evaluation of medical device product information and argues against transferring accepted PIL (Patient information leaflet) user testing methodology to an IFU (Instructions for use) context.

Background

Good quality product information can be a key factor in helping the patient-consumer use a medicine or, in this case, a medical device safely and appropriately. Poorly understood information can have the opposite effect to the one desired: patients may not gain the best use of  the device and could harm themselves as a consequence. This is  particularly so for devices intended for home use, away from healthcare supervision.

Medical device product information commonly comes in the form of Instructions for Use (IFU). Our experience indicates that there can be stark variability in the quality of IFUs, in terms of accessibility of these documents for the lay user. Some Class I devices designed for home use  often do not include any written information, other than the CE Mark  and outer package labelling. Others, such as Class III implantable devices, only provide information for the clinician which is unlikely to  be seen by the patient.

For information design professionals, device information potentially offers huge opportunities. In addition to the vast array of paper-based IFUs, many brochures and educational materials have also been developed to accompany Class III devices, particularly for implanted  devices and home-use equipment to monitor these. Those with  informatics insights can appreciate what the near future could hold for electronic IFU delivery [1] to patients, carers and health care professionals alike. For example, users of devices could be a mouse click away from tailored information available through several electronic channels: multilingual, localised information, availability in audio-visual formats, and so on. This is somewhat ahead of current  pharmaceutical product information provision.

No legislation

Both authors were engaged in PIL user testing before the 2005 legislation came into effect and we cannot help but notice a parallel between the fever pitch of early user testing and the current enthusiasm of those willing mandatory IFU testing into existence. Dozen of testing  companies now list IFU testing as a speculative service and we believe a mismatch between supply and demand has arisen: much of the medical device industry has yet to be convinced of the merits of testing, being chiefly deterred by cost.

There is currently no legislation binding device companies to test their product information, as is the case for pharmaceuticals. We regard this as a blessing because companies who involve consumer evaluation in IFU design do so willingly. By introducing user input in the development  stage of an IFU, medical device companies take the information needs of their users seriously. In our experience, device companies engaging in some form of user involvement in IFU development not only help to improve consumer safety of their products, they also distinguish themselves from their competitors.

Evaluation methods

In Europe, we should not blindly apply the accepted standard EU PIL testing methodology [2] to an IFU context. In the USA, the FDA recommends ‘pretesting’ of device labelling documentation [3], suggesting a number of possible testing methodologies, including  for example, one-to-one interviews. Although leaflets for some drug/device combination products have been tested in accordance with current guidance [2], further consideration needs to be given to borderline products.

An absence of guidance on the testing of IFUs means that testers can be creative: we have a freer hand to apply and combine a whole host of other methodologies that can demonstrate before-andafter iterations by means of involving end users in the information design process. One possible method is to embed an IFU consumer evaluation component in the usability testing process, combining a multidisciplinary approach. Actual users demonstrating the correct use of a device on the basis of clear understanding of the product information can only offer a win-win situation to the device industry. Also, risk factors can be identified and addressed as a result of this process.

Not everything we have learnt from PIL user testing should be  discarded, however. The ability to design information for both the lay user and the healthcare professional is equally applicable to a medical device context. In addition, the concept of ‘bridging’ could be adopted  to harmonise the IFUs of entire product families.

References:

[1] Draft elabelling guidance, European Commission, June 8th 2011
[http://ec.europa.eu/enterprise/tbt/tbt_repository/EEC381_EN_1_1.pdf]
[2] Guideline On The Readability Of The Labelling And Package Leaflet Of Medicinal Products For
Human Use (January 12th 2009)
[http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf]
[3] Guidance on Medical Device Patient Labeling, FDA, April 19th 2001
[http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070
782.htm]

EMA published guideline on core SmPC and package leaflet for radiopharmaceuticals

This new EMA guideline describes the information to be included in the summary of product characteristics (SmPC) and package leaflets for radiopharmaceuticals.

The purpose is to provide applicants and regulators with a harmonised guidance on the information to be included in the summary. The guideline should be read in conjunction with product information templates and all units should be expressed as SI units.

excerpt from the guidance

full text here

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for  Radiopharmaceuticals.

The purpose of this core SmPC and Package Leaflet is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for Radiopharmaceuticals1. This guideline should be read in conjunction with the QRD product information templates and the guideline on Summary of Product Characteristics.
In the SmPC for Radiopharmaceuticals, all units should be expressed as SI unit.

EMA published draft guideline on SMPC for plasma-derived Fibrin sealant

This guideline describes information should be included in the summary of product characteristics (SMPC) for plasma-derived fibrin sealant or haemostatic products. this guidance is being put together so that all products within this group are harmonised guidance on what to include. General guidance has been found in several areas but the DMA felt a single guidance brought it all together would be of value. Specifically sections 4.4 4.8 concerning transmissible agents should be of concern. Also revisions for products recommended for use with gas pressurised fibrin sprayers have been included.

excerpt from draft guidance

full text here

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.

The purpose of this core SmPC is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.
The QRD product information template with explanatory notes (′QRD annotated template’)1 and the convention to be followed for QRD templates2 provide general guidance on format and text and should be read in conjunction with the core SmPC and the Guideline on summary of product characteristics3. It is very useful to provide information for health professionals on posology and method of administration at the end of the package leaflet since the SmPC is not always readily available. See the QRD annotated template for further guidance on how to present such information.
In addition, for the content of sections 4.4 and 4.8 concerning transmissible agents, refer to the current version of the Note for guidance on the warning on transmissible agents in SmPCs and package leaflets for plasma-derived medicinal products (CPMP/BPWG/BWP/561/03)4.
Timeline history of core SmPC: The original core SmPC (CPMP/BPWP/153/00) came into operation in January 2005. This revision concerns new statements in 4.4 and 6.6 for products recommended for use with gas pressurised fibrin sprayers.

FDA Publish Guidane on Media Fills for PET Drugs

FDA Publish Guidane on Media Fills for PET Drugs

Full Text Here

This guidance is intended to help manufacturers of positron emission tomography (PET) drugs meet the requirements for the Agency’s current good manufacturing practice (CGMP) regulations for PET drugs (21 CFR part 212). Most PET drugs are designed for parenteral administration and are produced by aseptic processing. The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial byproducts, most notably bacterial endotoxins. A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publish Guidance on Time and Extent Applications for NonPrescription Drug Products

FDA Publish Guidance on Time and Extent Applications for Non Prescription Drug Products

Full Text Here

This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-thecounter (OTC) drug monograph system and to describe the process for submitting that information. FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system (21 CFR 330.14). The regulations establish a two-part process. First, to determine whether a drug product is eligible to be considered for inclusion in the OTC drug monograph system, certain information must be submitted in a time and extent application (TEA) to show that a drug product can meet the statutory standard of marketing to a material extent and for a material time.2 Second, if the drug product is found eligible to be considered for inclusion in the OTC drug monograph system, we will publish a notice of eligibility in the Federal Register that requests that interested persons submit data to demonstrate the safety and effectiveness of the drug product for its OTC use(s) (21 CFR 330.14(e) and (f)).

This guidance describes the format and content of a TEA that is used to determine if a drug has been marketed OTC to a material extent and for a material time, and what happens after a TEA is submitted. Drug products covered by this guidance are those OTC drug products that: (1) were initially marketed in the United States after the OTC drug review began on May 11, 1972; or (2) are without any U.S. marketing experience.


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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Key references and local legislation for PIL User Testing: Europe

Key references and local legislation for PIL User Testing: Europe

article by Associate Consultant Mark Gibson

The following document was included in a market analysis report compiled in July 2009. As such, some recent developments, such as the Lithuanian readability testing guidance and the Romanian accreditation guidance are not included.  Neither are any of the guidance published by countries, such as Croatia and Ukraine. All of the above are subjects currently being written up as separate blog articles…so, watch this space!  Nevertheless, a lot of the references included in this article might still be useful.


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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Revisiting the ‘summative’ / ‘formative’ distinction when approaching PIL User Testing

Revisiting the ‘summative’ / ‘formative’ distinction when approaching PIL User Testing

Written by Assocaite Consultant Mark Gibson

The following article is simply a write-up from a recent informal meeting I had with information design specialists working in other industries, a special interest group, I suppose. My role in the meeting was to describe how the PIL Testing industry started off as one thing, developed a life of its own and then went on a Frankensteinian rampage across Europe!

In the context of the above-mentioned meeting with delegates from many other, unrelated sectors where often no legislation is in place for the development and iterative design of instructive texts, it is absolutely clear to me that pan-EU PIL design and testing is the poor relation of the information design industry, despite a legislation being in place. What a great opportunity the pharmaceutical industry had back in 2005 to reach out to their patient audiences in a clear and concise way, yet what a paltry set of circumstances we now find ourselves in. The reason why this is so is clear: the legislation created a business opportunity, a bandwagon and too many under-qualified people carried out the testing. Arguably, the quality of Patient Information Leaflet is the same as pre-legislation: some very good PILs that were co-produced by members of the public and quality testers and some very bad ones that were forced through the testing process in record time and where there is little evidence of the flair, creativity and expertise that the pharmaceutical industry should expect from their PIL Testing providers.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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An exploration of SPC Harmonisation

An exploration of SPC Harmonisation

Article by Associate Consultant Mark Gibson

SPC harmonisation is notoriously regarded as one aspect of regulatory affairs that is seldom fully outsourced. This is for obvious reasons: a bit like the uncertainty I feel when I hand over the keys to my house to people working on my house who I don’t really know while I’m not at home. However, on occasions, SPC harmonisation can be such a tough job, particularly when this involves multilingual input, that there is no other choice but to outsource at least part of the harmonisation process. It is precisely the ‘how to’ aspects of this process that the following article focuses on, both involving monolingual and multilingual SPC Harmonisation processes.


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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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A critique of the linguistic validation process for Patient-Reported Outcomes and Quality of Life instruments.

A critique of the linguistic validation process for Patient-Reported Outcomes and Quality of Life instruments.

Article by Associate Consultant Mark Gibson – Full Text As a Report Available Soon

The linguistic validation process is required to ensure that translated versions of a source text contain conceptual, semantic and pragmatic equivalents to the original source text. Linguistic validation can also assure that the translated content is culturally appropriate, relevant and meaningful for the document to be used in the target countries. Over the past 20 or so years, the linguistic validation process has been implemented in the area of clinical trial documentation, particularly Patient Reported Outcome measures for administration in clinical trials, as pioneered by organisations such as MAPI Research Institute in France. As many large-scale clinical trial programmes are conducted in non-English countries on an increasing basis, the need to translate and adapt clinical trial documentation for use in other than the source language has risen in demand. This is particularly so since most clinical trial documentation, such as PRO measurement tools, originated in the English language.

 

There are two kinds of linguistic validation:

i)                    inter-lingual validation,  that is validation of questionnaires translated into other languages, such as an instrument originating in US English and is to be used in European variants of French, Spanish and Portuguese.

ii)                   intra-lingual validation, that is linguistic validation of questionnaires ‘translated’ into varieties of the same language, such  as a questionnaire originating in US English, to be used in other English-language countries, such the UK, Australia, Jamaica, etc.

 

Both kinds of validation require slightly different processes and methodologies, as are presented below.

Since most PRO and QoL documents originate in US English, for an instrument to be available in other languages, then linguistic validation helps make sure that the foreign language versions address the same concepts in all languages and offer measurable equivalence between languages. This uniformity, or harmonisation, across languages is vital to be able to pool data and compare results robustly across countries in which a given study is taking place. Therefore, the aim of harmonisation is to produce one instrument in numerous languages. Linguistic validation of each language version is the only possible way to make the international interpretation and analyses of results consistent.

Translation is always a highly subjective operation. Therefore, it is no surprise that instruments that have already been translated in other languages and that have not been linguistically validated have caused concern to regulators worldwide, such as the EMA, regarding the validity of measuring the same concepts. With the enlargement of Europe, the need for the linguistic validation of translated documents for clinical studies becomes increasingly more acute. This is not only relevant to the diversity of official languages, such as standard French, Spanish, etc., within the EU’s borders, but also the diversity of community languages spoken by the cultural diverse populations of many EU Member States, such as Turkish as spoken in Germany, Arabic as spoken in France and Bengali as spoken in the UK. For a PRO / QoL instrument to be effective and useful as a means to collect data, it must be appropriate to each cultural, linguistic and ethnic group under investigation. Therefore, to compare results of a PRO / QoL tool across languages, it needs to undergo a process that ensures:

  • that the language versions obtained are conceptually equivalent, both to the original instrument and to one another. Conceptual equivalence is achieved when the answers to the same questions reflect the same concepts and that these concepts are meaningful and relevant in each of the cultures and languages concerned.
  • that the language versions demonstrate item equivalence. This is achieved when the semantic equivalence of each item in the tool survives translation across languages.
  • that each language version is culturally relevant, acceptable and understandable to the target population
  • that the language versions are psychometrically comparable.

There are three approaches to linguistic validation:

i)                    Where the instrument is developed in one language (e.g. US English) within one country (e.g. USA) and the instrument must be translated into one or several other languages.

ii)                   Where the instrument has been developed in a source language and inter-cultural relevance and conceptual equivalence have been considered in the development of the original questionnaire.

Where the instrument has been developed simultaneously in different countries and languages. In this case, a harmonisation process (not dissimilar from a typical SPC harmonisation in the EU) will be necessary.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Advancing the need for cultural localisation of medical device software tools

 Advancing the need for cultural localisation of medical device software tools

Article by Associate Consultant Mark Gibson

Software localisation of medical devices is not a universal regulatory requirement. However, software localisation is vital as a competitive tool to gain a foothold in foreign markets. This potential advantage is not only the case for medical device manufacturers, but also for all software applications that aim to be used outside their native language regions.

Take, for example, a medical device that incorporates a software program that relies on date expression for safe and effective use. The software originates in the USA, whose developers programmed date to be expressed as follows:

02.12.2010 (for 12th February 2010)

The device and software in question is to be marketed in the UK, Spain, Sweden and South Korea. However, date expression differs from country to country, as is illustrated with the example of 12th February 2010 below:

USA UK Spain Sweden South Korea
02.12.2010 12.02.2010 12/02/2010 2010-02-12 2010.02.12

However, the software, in its current iteration, cannot accommodate these cultural date conventions. From this example, it is possible to see at a glance the potential confusion this could bring to a user in each country if the original US format is not localised to the respective countries’ usual formulations of date expression. Another common example is how units of measurement are expressed, such as the UK Imperial system, the US Customary system and the more internationally recognised metric system.

Product localisation and cultural adaptation can help address safety issues related to human factors, such as the risks outlined above with the improper interpretation of date/time information or unit of measurement. Safety issues in medical device development can be identified in trials and resolved in the development process in the initial locale, i.e. where the device was created, before it goes to market. However, the impact of faulty translation and localisation issues that affect safety are not as carefully controlled, verified or validated and many such issues are not identified until after the product has been licensed and marketed. This can often lead to product recalls in the countries in question, which naturally has a direct and negative impact on the manufacturer’s revenues.

Issues also worth considering are

Software localisation and cultural adaptation

Customising software application for use in different target locales will help users in different countries gain maximum benefit from your device. Typically, this would include the translation of accompanying documentation, help files, user interface components, such as screen/display text, buttons, error messages, and so on, as well as ensuring the adaptation of software to the target locale to specific local conventions and requirements, such as date/time formats. The adaptation aspect of the service would involve aspects of user-centred design or human factor testing.

Software verification and validation

The objectives of software verification and validation is to provide evidence that the design outputs of a particular phase in the software development life-cycle meets all the specified requirements for that phase, such as FDA’s General Principles of Software Validation Guidance [1].  Software validation provides insights into the usability of the tool through the provision of objective evidence from a user-centred process that the software specifications conform to user needs and intended uses of the device in question.

The business case for undertaking localisation and cultural adaptation services is supported by legislation. For instance, FDA’s Medical Device Quality System Regulation Part 820:30 (21 Code of Federal Regulations 820:30)[2] states that labelling, whether electronic, paper-based or both, is considered part of the medical device and subject to design control. In Europe, the Medical Devices Directive (MDD) [3], as well as ISO 13485:2003 also requires design control and software validation for medical devices as part of the application for Marketing Authorisation within the EU. Accordingly, as with traditional labelling, the User Interface of medical device software tool can carry vital information about the product in question for safe and effective use. For many products, the User Interface provides the medium for the user’s interaction with device. In some cases, the software is the only way to interact with the device, or with stand-alone tools, the software is the device.  Furthermore, ISO14971: Medical Device Risk Management identifies a lack of product localisation as a possible cause for hazards and recommends, as standard practice, the involvement of an expert in localisation risk for both the labelling of the product and its User Interface.

In addition to the regulatory framework currently in place, the advantages of these are to:

  • Provide medical device developers with a tool to mitigate risk
  • Help to gain an advantage in foreign markets

Help to support a global user base for the product.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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There’s a hole in my bucket: The Circularity of Discussions Around Pictograms

There’s a hole in my bucket: The Circularity of Discussions Around Pictograms

Article by Mark Gibbson

The use of pictograms to convey drug-specific or health-specific information to lay patients has interested me for many years. This article is really just a ‘doodle’ of my thoughts around this subject and the potentialimpasse that we find ourselves in when discussing it at industry and regulatory level. This is of the first of a series of articles on the subject of pictogram design and testing.

In theory, pictograms can serve to provide vital information to people:

·         Who have low literacy skills (up to 20% of the UK population are unable to read or have low literacy skills)

·         Who may have limited competence in English (in the UK, up to 8% of the population speak a first language other than English)

·         Who would be classed as ‘hard-to-reach’, such as people with a learning disability

·         Who are in multilingual environments in extreme circumstances, such as disaster relief.

An inability to access written text can impair an individual’s ability to follow instructions regarding important life issues, such as medicine taking. Alternative methods of provision include recorded spoken information and pictograms. Pictograms in medicine have been developed and deployed around the world, the best known studies having taken place in the USA and South Africa. However, there is evidence that the understanding of pictograms is culture dependent. Other than a handful of isolated pilot studies (with no apparent follow up), there does not seem to have been any significant study in the area of pictogram use and interpretation across cultures.

This is in spite of the fact that the pictogram development is an important issue in the pharmaceutical, medical and surgical device industries, where pictograms are frequently used to convey complex information, such a when to take a medicine or how to administer it.

In fact, in all the discussed about pictograms I have been involved in the UK, France and wider Europe, I have become acquainted with circularity of how pictogram development is treated, as illustrated below:

‘There’s a hole in my bucket’:

i) Notionally, pictograms are a good idea, so…

ii) The realisation that sometimes pictograms may not be interpreted as intended and culture might colour users’ interpretation…

iii) The realisation that poor interpretation of pictograms might be down to poor design…

iv) And we can’t understand why because our marketing department and graphic designers are really good, but…

i) Pictograms are still notionally a good idea (back to the original idea). 

I think the industry can break away from the roundabout discussions in this otherwise important area by discussing the following issues:

·         Pictograms must convey simple information, on a one pictogram – one concept basis

·         For pictograms in EU Patient Information Leaflets, they must also be usability tested as part of the readability test, since they are equally as important to the general message as the written instructions·         As a code for communicating ideas, pictograms that are new and unfamiliar to users must be intuitively understood or easy to learn. For example, we all had to learn that ‘’ = ‘stop’ or ‘◄◄’ = ‘rewind’ on a DVD player·         As far as possible, pictograms must be culturally neutral. For example, to convey ‘take at mealtimes’, would a pictogram such as this:  be intuitively understood by native speakers of Somali, or if a product is to be sold in India or the whole of southern and eastern Asia?

·         Where complex information is being depicted, should photography rather than artistry ought to be considered?

·         Discussion about pictograms in a pharmacy and medical device context ought to be brought back into the field of semiotics, the parent discipline of pictogram communication. Virtually no published research discussing pictograms with a health application displays any awareness of or references to semiotics as the core discipline of this area, yet there is a whole ocean of published pictogram research in semiotics

To answer the following questions:

·         Is it possible to have universally understood pictograms to convey information that could be understood clearly and unequivocally in potentially stressful situations, such as disaster relief? 

·         If there are cross-cultural problems in the understanding of pictograms used in patient education materials, is the problem due to the fact that pictograms have largely been the domain of Anglo-Saxon developers, i.e. viewing the world through Anglo-Saxon eyes? What would Indian, Chinese or African developers of pictograms do differently?

·         Do we know for sure that some pictograms, such as those depicting mealtimes could cause problems of interpretation cross-culturally, or are we simply making this (potentially patronising) assumption, based on a dominant Anglo-Saxon worldview?

·         Presenting pictograms to illustrate how to take an asthma inhaler is one thing, but what about conveying potentially complex information, such as about when and how to take medicines or learning about and managing a newly diagnosed health condition?

·         With the right design, can anything be conveyed in pictogram form? What about other abstract concepts, such as information about energy consumption, carbon footprinting, paying taxes? Can these concepts be represented in pictogram form for people with a cognitive disability, for example?

References

Abdullah R, Huebner R, Pictograms, Icons & Signs: A Guide to Information Graphics, Thames and Hudson, 2006

Dowse R, Ehlers M, Pictograms for conveying medicine instructions: comprehension in various South African language groups, South African Journal of Science 100, November/December 2004

Dowse R and Ehlers MS, The evaluation of pharmaceutical pictograms in a low-literate South African population. Patient Educational and Counseling 2001; 45: 87-99

Dowse, R, Ehlers, MS, Pictograms in pharmacy. International Journal of Pharmacy Practice 1998; 6: 109-18

Price S, Raynor DK, Knapp P, Developing effective medicine pictograms for the UK, HSRPP Conference, Leeds, March 2003

‘There’s a hole in my bucket’ [URL: http://en.wikipedia.org/wiki/There’s_a_Hole_in_My_Bucket]

United States Pharmacopoeia. [URL: http://www.usp.org/information/programs/pgrams/describe.htm]



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publish Guidance on Tablet Scoring: Nomenclature, Labeling and Data Evaluation

FDA Publish Guidance on Tablet Scoring: Nomenclature, Labeling and Data Evaluation.

Full Text Here

This guidance provides recommendations to sponsors of new drug applications (NDAs) and 1 abbreviated new drug applications (ANDAs) regarding what criteria should be met to facilitate the evaluation and labeling of tablets that have been scored. (A scoring feature facilitates the practice of tablet splitting.2) Specifically, this guidance recommends:

• Guidelines to follow, data to provide, and criteria to meet and detail in an application to approve a scored tablet.

• Nomenclature and labeling for approved scored tablets.

This guidance does not address specific finished-product release testing, where additional requirements may be appropriate for scored tablets.

The Agency has previously considered tablet scoring as an issue when determining whether a generic drug product is the same as the reference listed drug (RLD). One characteristic of a tablet dosage form is that it may be manufactured with a score or scores. This characteristic is less than a full tablet is desired for a dose. Although there are no standards or regulatory requirements that specifically address scoring of tablets, the Agency recognizes the need for consistent scoring between a generic product and its RLD.

Consistent scoring ensures that the patient is able to adjust the dose, by splitting the tablet, in the same manner as the RLD. This enables the patient to switch between products made by different  manufacturers without encountering problems related to the dose. In addition, consistent scoring ensures that neither the generic product nor the RLD has an advantage in the marketplace because one is scored and one is not.

CDER’s Drug Safety Oversight Board considered the practice of tablet splitting at its October 52 2009 and November 2010 meetings. During those meetings, they discussed how insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients’ dose or as a cost-saving measure. Because of this, the Agency conducted internal 55 research on tablet splitting and concluded that in some cases, there are possible safety issues, especially when tablets are not scored or evaluated for splitting. The Agency’s concerns with splitting a tablet included variations in the tablet content, weight, disintegration, or dissolution, 58 which can affect how much drug is present in a split tablet and available for absorption. In 59 addition, there may be stability issues with splitting tablets.

Tablet splitting also is addressed in pharmacopeial standards. The European Pharmacopeia (EP) currently applies accuracy of subdivision standards for scored tablets—and has at various times also included standards for content uniformity, weight variation, and loss of mass—while the United States Pharmacopeia published a Stimuli article in 2009 proposing criteria for loss of mass and accuracy of subdivision for split tablets.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EU PIL Testing: A 2011 Commentary – Possible Learnings and References

EU PIL Testing: A 2011 Commentary – Possible Learnings and References

Article By Mark Gibbson

Possible Learnings

- PIL Testers and assessors from Competent Authorities should consider commentaries from domain specialists such as Sless and Lentz regarding the summative and formative distinction and compare this with their own service offering / assessment practices, regardless of whether you have completed 800 or 8 tests  

- Document Design expertise needs to be placed at the forefront of the testing process, not as a  ‘nice to have’ component to the overall service 

- If the abuse of testing practices, as described in the last section, is as rife as rumours (and in many of cases, actual evidence) suggests, let us – as an industry – seek out the truth and expose them.   

References

Amongst the references that influenced the series of EU PIL Testing: A 2011 Commentary articles are:

Consultation with Target Patient Groups – Meeting the requirements of Article 59(3) without the need for a full test – recommendations for bridging, CMDh, October 2007 [URL: http://www.hma.eu/uploads/media/patient_consultation_bridging.pdf]       

Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use. Revision 1, European Commission, Brussels, 12th January 2009 [URL: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/2009_01_12_readability_guideline_final.pdf ]

Guidance concerning consultations with target patient groups for the package leaflet, European Commission, May 2006 [URL:http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/user_consultation_200605.pdf ]

Guidance and checklist for the review of User Testing results, European Medicines Agency, London, 2007

Operational procedure on  Handling of “Consultation with target patient groups” on Package Leaflets (PL) for Centrally Authorised Products for Human Use, European Medicines Agency, London, 20th October 2005 [URL:http://www.emea.europa.eu/htms/human/qrd/qrdplt/27737805en.pdf ] 

Improving the usability of Patient Information Leaflets, Pander Maat, H; Lentz L, Patient Education and Counseling,  Vol. 80, Iss. 1, 113-119, July 2010

Package Leaflets: Testing and harmonisation in relation to the overall business process in regulatory procedures – An example of the impact of changing regulatory requirements, Sommer S, Published Masters’ Thesis, [URL:http://www.dgra.de/studiengang/masterthesis.php ]

PIL Testing: misapplied and out of context,  Sless D, Regulatory Rapporteur, September 2007 

PIL Testing: possible futures, Sless D, Dialog zum User Testing, BfArM, Bonn, 11thSeptember 2007

Snake oil and PILs, David Sless’ Soap Box, Sless D,  September 29th 2007 [URL:http://www.communication.org.au/dsblog/?p=18 ]



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EU PIL Testing: A 2011 Commentary – Better “Policing” of PIL Testing

EU PIL Testing: A 2011 Commentary – Better “Policing” of PIL Testing

Article By Mark Gibbson

Synopsis for Busy People: Let’s face it, abuse is rife and we all know it.

I have been told by several leading assessors at three different Competent Authorities that they only really trust User Testing reports that are submitted from at the most 5 companies. I’ve heard this so many times over the years and have had this reported to me by other industry specialists that it begs the question: why is PIL Testing not being subjected to more scrutiny, more policing?

With the benefit of ‘historical insight’, I know that the disparities in the quality of PIL testing / development between companies has been present from even before 2005. What is more, the majority of these companies were in operation and had dozens of PILs tested before many of the Competent Authorities were themselves up to speed with the legislation and actively assessing PIL test reports. In other words, in the early years, some Competent Authorities had to catch up with the industry to some extent. Unfortunately, some member state countries still have not caught up.

I strongly believe that the quality of PIL testing ought to be policed centrally, working in liaison with individual Competent Authorities. Romania, for example, stated last year that PIL testers must be accredited before operating in the country and present a whole list of criteria for accreditation. This is a step I completely support and applaud.

The reasons for extra policing are also because I firmly believe that there has been a degree of abuse in the testing process. Here is a selection of bad practices that are reported to have taken hold – some minor and can be addressed through refresher training, others are much more serious:

  • Questionnaires being subtly designed in a way that skirts around the difficult aspects of leaflets, so as to increase a PIL’s chances of passing
  • Leaflets tested in Word formats only, without any consideration for layout and other presentational aspects
  • Pictograms that are ignored in the testing process, even though they are equally as crucial to the general message as the written text
  • Client pressure to ‘adapt’ participant data to make a leaflet pass
  •  Participants repeatedly drawn from small expatriate communities, which potentially abuses the 6 month no-repeat rule in the EU Guidance (4 months in other countries)
  • PIL testers flouting in-country participant selection practices and in-country data collection and protection procedures
  • Interviewers from non-healthcare professional backgrounds who attempt to counsel participants about medicines during interviews
  • Poor interviewer training resulting in interviewer bias during the testing
  • Participants being placed under undue pressure during interviews by testers pushing through up to three full-length leaflets during one interview
  • Participants not being recruited or interviewed at all and the data simply invented.

Over the past three years, this last point on the list, which if true amounts to serious research fraud, crops up persistently, all over Europe, and always relates to one testing company in particular. Maybe it originated as a thinly disguised sabotage from a nearby competitor (as I partly suspect), or maybe there is genuine truth to the accusation.

Either way, all of the points on the above list deserve some kind of attention from Competent Authorities.If all the above is commonplace amongst some testers:a) it is unfair to the majority of decent testers who genuinely seek to do a good job, and b)it completely devalues the whole testing initiative.

The question is: what are we going to do about it?


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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EU PIL Testing: A 2011 Commentary – The Profile of PIL Testers

EU PIL Testing: A 2011 Commentary – The Profile of PIL Testers

Article By Mark Gibbson

Synopsis for Busy People: three types of specialist in the field, offering varying degrees of expertise

We have established that leading experts such as Sless and Lentz state that a sound understanding of the principles of document design is what is really needed for successful leaflet development and testing.  So, who are the people who currently test PILs in Europe? Do they have experience in document design?

In 2010, I systematically compiled a profile of as many PIL testing companies as I could find in Europe, from Portugal to Finland and Cyprus to Ireland. As of October 2010, I found 85 testing companies. On average, PIL testing companies have 7 members of staff – some are much larger and some one-person companies. In addition (according to LinkedIn anyway), there are an estimated 70 individual consultants offering PIL testing as part of their service portfolio. So, we have a minimum of 660+ people claiming to specialise in PIL testing in Europe.   As part of this exercise, I looked into the backgrounds and skill-sets of key personnel of these companies. I found that the amount of individuals – not companies – whom I believe offer genuine document design expertise cannot be counted on more than two hands.

So, 7 or 8 people as a maximum across the whole continent and located in Germany, Austria, UK, Netherlands and Belgium.

This is not to say everyone else – more or the less the whole industry – is poor. Not at all. But what I am saying is that many purveyors of PIL Testing plainly have an absence of document design expertise and filling this function would only make their testing service all the stronger.

One of the most common backgrounds of a PIL tester is regulatory affairs and medical writing. This is logical and understandable, given that PILs originate in, and the whole process outsourced and managed by, regulatory affairs departments of pharmaceutical companies. This background is important for some aspects of PIL testing, such as understanding the regulatory ‘rules’ and it is crucial for other activities. For example, I would not dream of tackling something as complicated as SPC Harmonisation without a regulatory affairs consultant helping me. With an intimate knowledge of the QRD Template, what can and cannot be done to a PIL, PIM and the full array of regulatory insights, PIL Testers from a regulatory background don’t do a bad job at all. I’ve worked with some of the best of them.

In addition, they know all about quality procedures, working by SOPs, Best Practice Guides and strict version controlling procedures, mirroring their counterparts’ working practices in the pharma industry. Testers from other backgrounds are not necessarily audit-driven in the same way.

However, there are also huge variations in the quality of the documents – the leaflets – produced by regulatory affairs specialists. As discussed in the article ‘The two parallel vocabularies of English’, it is perilous to make the assumption that a medical writer or regulatory affairs professional can write adequately for lay audiences. This skill has to be acquired. I have seen PIL testers who know the QRD Template in their sleep and can produce brilliant PILs, but who, once out of this comfort zone, made a complete debacle of writing instructive texts for medical devices or other patient education materials. Some show a disregard at worst, or a misreading at best, of the purpose of the legislation. As an example of this, I paraphrase from the front page of the website of one UK company whose founder is a regulatory affairs professional: “there is no need to conduct reviews of your PILs, they are probably good enough to pass as they are.”  The whole point of testing is completely missed.

Then there are PIL testers who have emerged from a rag-bag of backgrounds: professional sales people, translation managers, event organisers, lawyers, market researchers and random entrepreneurs. These are the people who have exploited the low barriers for entry into the PIL testing scene and who do not necessarily have the insights into health information design, the research skills to carry out a readability test competently or respect the ethics of the whole exercise. These are the organisations who do the PIL Testing equivalent of ‘painting by numbers‘, who test according to the minimum requirements of individual countries’ own stipulations and nothing much more beyond that. And these form the majority of PIL Testing companies across Europe.


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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publishes Implementation Plan for QRD and Package Leaflets

EMA Publishes Implementation Plan for QRD and Package Leaflets

Full Text Here

The European Medicines Agency and the Quality Review of Documents (QRD) Group have revised the
Human Product Information templates with a special focus on the package leaflet.
This revision is the result of 5 years experience with “user testing” and is based on the feedback
received in various forms and through various sources, i.e. National Competent Authorities,
Pharmaceutical Industry, Academia, Companies involved in user testing, Patient and Consumer groups.
In addition, the revised QRD template has now introduced the concept of benefit (based on the report
on benefit-risk of medicines carried out by the European Medicines Agency), new requirements related
to paediatric information and modifications introduced in relation to conditions to the marketing
authorisation in the Annex II.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EU PIL Testing: a 2011 Commentary – A critique of the gold-standard methodology

EU PIL Testing: a 2011 Commentary – A critique of the gold-standard methodology

Article by Mark Gibbson

Synopsis for Busy People: The mainstream methodology may not be wholly appropriate for PIL testing and development 

The ‘Early Years’

As a sociolinguist, I am naturally interested in finding ways to tailor complex information to appropriate audiences, as well as exploring concepts such as Audience Design and Document Design. I was switched onto readability issues in health information provision in 1999 whilst figuring out how to provide usable multilingual health information for dominant UK migrant communities. Shortly after, I became a fan of the work undertaken by Prof. Theo Raynor and Dr. Peter Knapp at the University of Leeds and developed a keen interest in readability testing for package leaflets. I blagged my way into their team in 2003 and we founded LUTO Research Ltd. in the following year.

During this time, leading PIL testers assumed a relatively high profile in terms of disseminating what User Testing was and holding training sessions and masterclasses for regulatory affairs teams, as well as for Competent Authorities themselves. In the latter case, some of us managed to have both a direct and indirect influence on the content of national and EU-wide PILTesting guidance in subjects such as PIL editing, participant selection and interviewing, bridging analysis and report content.

Sless…

I was always slightly unhappy about the way the gold-standard EU methodology was being applied to PIL testing. In a previous role, I had managed aspects of large-scale usability tests of clinical decision support systems and even co-developed and published a new method of capturing doctor-patient-computer interactions. So, I had an interest in the iterative nature of product design, and whether the product is an IT system, a package leaflet or a toaster, the process of iterative design, or user-centred input, of consumer evaluation ought to be the same.

However, I felt that the way the EU method was being applied, PILs were certainly being submitted to a great deal of testing and lay participants were certainly present at the proceedings, but the iterative nature of document design seemed to have been stripped away from the process. I felt the standard methodology required improvement.It didn’t need to be improved though, because it was already present in the Australian method, as developed by David Sless, probably the world expert in English-language document design. In the autumn of 2007, Sless publicly stated in conferences and in articles (see references below) that the EU standard method for PIL testing had been misapplied and was being used out of context. Sless cited a number of reasons for his stance, but what interested me most was precisely what was bothering me since embarking on commercial PIL testing.

He stated that EU testing was being used virtually en masse to produce summativeresults, where the objective is, of course, for leaflets to achieve the pass mark. Nothing wrong with that, surely? Set a high benchmark and good leaflets will reach it, right? But when you consider that the Sless methodology is really designed for formative assessment of the document being studied, i.e. to identify and fix the weaknesses of a leaflet through consumer consultation, then you have to concede that there has indeed been a large-scale misapplication and misinterpretation of how to use this methodology.

Sless’ 2007 comments went down like a lead balloon amongst many in the PIL testing community, which by then had become a whole continent-wide industry. No one was prepared to admit that we had it ever-so-slightly wrong. It was Sless who was the heretic, everyone else was conducting testing in the correct way. The EU legislators could not possibly be wrong. The PIL testing machine had been set in motion – in both legislation and execution – and there was no going back. For me, however, seeing Sless at the BfArM event, Dialog zum User Testing, September 2007, was the first instalment of a two-part epiphany.

The second instalment came at another conference in Bonn in June 2008, where I listened to Mette Lykkebo, then of the Danish Medicines Authority, demonstrate how PILs were not being improved through the user testing method. Showing examples of ‘before testing’ and ‘after testing’, Mette concluded that PILs were pushed through the testing process and that any ‘improvements’ to the leaflets she discussed were negligible. Then Professor Leo Lentz, a document design expert from the University of Utrecht, again underlined the summative misapplication of the methodology. He and colleague, Henk Pander Maat, have conducted their own rigorous usability tests on Patient Information Leaflets – on a non-commercial basis – and have highlighted in publications the need for PIL testers to do the sensible thing and shift from the summative to the formative approach.

So, I became a ‘formative testing’ evangelist. But, trust me, apart from a handful of like-minded people in Europe, including my old mates at LUTO, I feel like a preacher in the desert. While opinions from the likes of Sless, Lentz and Pander Maat are fairly well known, the user testing machine has largely continued onward, unfazed and unchanged, with very few testers reflecting on their own processes.   Why? Perhaps because they don’t want to admit to their own clients that the 700 or so PILs they have tested on their behalf did not follow diagnostic testing best practice and, besides, they are complying with the EU regulations. So, if it ain’t broke, there’s no need to fix it.

In fact, some testers I’ve spoken to about this subject are not even certain about the distinction between the two approaches. In my opinion, this betrays so much about their own lack of expertise in consumer evaluation research methods, a solid knowledge of which ought to be presupposed before embarking on the PIL development and testing process, or at least one would like to think this would be the case.

I generally use the summative – formative distinction as a kind of shibboleth to distinguish between a competent readability tester and someone who has just been winging it for years. The pharma industry can use this litmus test too – call your own testing providers without warning and ask them about the difference between summative and formative assessment, which they think they are engaging in with their own readability testing service and why they chose to adopt one form of assessment and not the other. The quality and confidence of the answer will tell you everything you need to know.  

An easy fix

The most fundamental issue regarding the misapplication of the methodology is that, in six years, we have seen a well-intentioned Council Directive be reduced to little more than a bureaucratic hurdle. With PILs being forced through the process without rigorous document design input, the voice of the patient has often been muffled in the midst of the pressure of testing and the all-consuming desire to reach the ‘pass mark’. So, as a result, we’re left with a bizarre pre-2005 situation, where leaflets are still largely written by scientists in a scientific style, only now with a tokenistic patient consultation step inserted parenthetically between internal composition and external submission.

The real tragedy is that there is no great secret about how to fix this situation: high quality formative testing can be done by anyone by introducing a miniscule tweak to the EU standard methodology, as well as a tiny shift of emphasis and mentality in the way readability tests are conducted throughout Europe. There is no question that when the formative approach is applied correctly, it inevitably leads to a better, more understandable and more usable leaflet.

And with the situation as it is, we’re potentially neglecting to capitalise on a golden opportunity for the pharma industry – that of reaching out to their users through education, allowing them to be a core part of the process of making instructive texts even better and potentially motivating them to increase product compliance through clear and effective information.


For Assistance with PIL Development Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EU PIL Testing: A 2011 Commentary – Why it was Introduced

EU PIL Testing: A 2011 Commentary – Why it was Introduced

SBP (Synopsis for Busy People): Frankly, much of it is a complete mess and it’s upsetting.

The readability testing legislation, Council Directive 2004/27/EC (Medicines review 2001), is now entering its sixth year since it first came into effect. This article examines how PIL testing started, how it has evolved over the past 6 years and what can be done to enhance the process.

Rationale behind the legislation

Let’s go right back to the beginning: the legislation was introduced because PILs prior to 2005 were not generally written or presented in a way that was useful to the patient. In other words, PILs were sometimes so glaringly bad that the EU had to introduce a law to ensure they would be improved, that they would be readable and that lay members of the public – the patients, the users and consumers of medicines – would be given an active role in making the leaflets better.

Prior to 2005, the written style of PILs were typically biomedical in character, as if scientists were writing for other scientific audiences, seemingly leaving out patients’ interests – the real ‘clients’ of the pharma industry – completely out of the equation.  The problems with PILs were repeatedly documented in academic research. Some of this research, such as that carried out at the University of Leeds, fed into the initial development of the directive, whose aim was to place the voice of the patient firmly in the centre of PIL development.

So, if PILs were good enough to be understood by the average punter in the first place, there would have been no need for the Council Directive.

The User Testing Method

The most commonly used PIL Testing method is not really adequate or appropriate for iterative PIL development.

The method recommended by the EU to undertake patient consultation, i.e. User Testing, or Readability Testing is supposed to be an adaptation of an older methods of Diagnostic Testing or Performance-based Testing.

There are examples of PIL Testing companies across Europe who apply methods other than the standard EU methodology, drawing on interesting approaches from psychology, social sciences and business research methods. This article does not treat these other testing methods, but focuses on how testing has evolved in the mainstream, for the bulk of tested PILs.


For Assistance with PIL Development Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Improves Package Leaflets

EMA Improves Package Leaflets

Full Text Here

The European Medicines Agency has updated the template for package leaflets for human medicines, to make the information easier for patients to understand and to include new sections on medicines’ benefits and their uses in children.

The Agency introduced these changes to contribute towards the safe and effective use of medicines. They address the feedback from five years of user testing and from a range of stakeholders, including patient and consumer groups, national medicines regulatory agencies, the pharmaceutical industry and academics.

This feedback included concerns that the package leaflet needed to be more readable with fewer rigid standard statements, and that patients needed more information on the benefits that medicines can bring and on their uses in children.

The update also takes the Agency’s report on the expectations of patients, consumers and healthcare professionals regarding benefit-risk information into account, as well as the requirements of the paediatric regulation.

The Agency’s Working Group on Quality Review of Documents introduced these changes as part of the latest revision of the human product information templates.

In addition to the package leaflet, the revision included changes to the templates for the summary of product characteristics, labelling, and ‘annex II’, the section of the product information covering the conditions imposed on marketing authorisations.

The updated templates are available in all official European Union languages, as well as Icelandic and Norwegian, together with an implementation plan. Versions of the templates showing the latest updates as ‘tracked changes’ are also available.


For Assistance with Leaflet Design Translation and Readability Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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