Adaptation and validation of the European Portuguese Communication and Symbolic Behaviour Scales Developmental Profile™ (CSBS DP™) Infant-Toddler Checklist.

BACKGROUND: As delays or disorders in early language and communication are the most prevalent symptom in children with disabilities, early screening is crucial to promote prevention, early diagnosis, and intervention. However, to the best of our knowledge, no screening tool is available for the joint assessment of early language and social communication skills in European Portuguese (EP)-learning children, which is critical for screening, monitoring and enrolment in appropriate early intervention services. AIMS: (1) To adapt and validate the EP version of the Communication and Symbolic Behaviour Scales Developmental Profile™ (CSBS DP™) Infant-Toddler Checklist, a parental report for the screening of early language and social communication skills. (2) To conduct a cross-cultural comparison between the EP adaptation and the original US version. METHODS & PROCEDURES: A total of 611 EP-learning children (ages 6-24 months) were assessed on the CSBS DP Infant-Toddler Checklist. Normative data, psychometric characteristics (i.e., internal consistency and test-retest reliability), and cross-cultural comparison between the EP and the original version were explored. OUTCOMES & RESULTS: Internal consistency ranged from good to excellent and the test-retest reliability was excellent. The performance of the EP and US samples matched on almost all scores. However, EP children performed significantly better than their American peers in the Social compositive at 22 months and in the Symbolic composite at 20 months. No further differences were found. CONCLUSIONS & IMPLICATIONS: These findings showed that the EP CSBS DP Infant-Toddler Checklist seems to be a reliable screening tool of communicative and symbolic behaviours for EP-learning children, which can be particularly relevant for decision-making in clinical practice. WHAT THIS PAPER ADDS: What is already known on the subject Early communication skills are known to be related to later language outcomes. Thus, screening tools for the early identification of children at risk for language and communication impairments, which may lead to monitoring and early intervention, have the potential to promote better outcomes. However, to the best of our knowledge, no screening tool is available for the assessment of early communication abilities in EP-learning children. What this paper adds to existing knowledge This study adapted and validated the EP CSBS DP Infant-Toddler Checklist, the first published parental report checklist for the assessment of early communication skills in EP. It described the psychometric characteristics of the adapted checklist, summarized the newly available normative data for EP-learning infants and toddlers, and compared the performance of EP-learning children with the original standardization sample reported for American English. The results demonstrated that this tool is a reliable instrument for the early screening of language, communicative and symbolic behaviours for EP-learning children between 6 and 24 months of age. What are the potential or actual clinical implications of this work? Given that early screening is crucial to promote prevention, early diagnosis and intervention, the availability of this tool is particularly relevant for children monitoring and their enrolment in appropriate early intervention services, helping decision-making in clinical practice, in line with current guidelines regarding early monitoring and intervention to promote and support better outcomes. Thus, the tool and related normative data will be useful for paediatricians, family doctors, primary healthcare providers, developmental psychologists and speech-language therapists, among other professionals in the healthcare and educational fields, concerned with speech, language, and communication development and impairments.

Development and validation of a parental report of toddlers' prosodic skills.

This study describes the development and validation of Proso-Quest, a parental report of toddlers' prosodic skills that aims to assess early prosodic development in European Portuguese. The development and validation of Proso-Quest proceeded in three phases. Phase 1 was undertaken (a) to establish the structure of the parental report and select the items considering previous work, (b) to collect input from experts on prosodic development, and (c) to revise the report after a pilot study. Phase 2 examined internal consistency, reliability, test-retest reliability, and correlations between Proso-Quest and a valid measure of vocabulary development. Finally, Phase 3 evaluated the discriminant validity of this report in a clinical sample that frequently presents prosodic impairments. The psychometric properties of Proso-Quest indicated an excellent internal consistency, high test-retest reliability, significant correlations with a valid measure of vocabulary development, and sensitivity to identify prosodic delays. This parental report showed evidence of reliability and validity in describing early prosodic development and impairment, and it may be a useful tool in research and educational assessments, as well as in clinical-based assessments.

Graphical content of medicinal package inserts: an exploratory study to evaluate potential legibility issues.

BACKGROUND: The graphical content of the Medicines Package Inserts (MPIs), such as illustrations and typographic features should be legible and appropriate, as required by international pharmaceutical regulations. OBJECTIVES: To study: (1) the frequency and type of MPIs' key graphic elements, (2) their compliance with regulations and (3) how educated people understand them. METHODS: Descriptive study: characterisation of the graphical content of 651 MPIs. Usability study: illustrations and tables (purposively selected) were evaluated with questionnaires in three groups of humanities undergraduates (illustrations only, illustrations plus text and text only). RESULTS: Descriptive study: illustrations and tables were respectively identified in 6.3% and 11.8% of the MPIs. The illustrations were mainly related to how to take/use the medicine. Non-recommended graphical representations were found (e.g. italic or underline). Usability test: legibility issues were identified, especially for the group of isolated illustrations. DISCUSSION & CONCLUSIONS: The scarce use of illustrations and tables possibly affected the legibility of the MPIs. Compulsory legibility tests are needed to guarantee the MPIs' proper use, thus contributing to a safe use of medicines. Overall, this study highlighted the need to carefully revise/assess the MPIs' design and probably increase health information experts' awareness on this issue.

A stress "deafness" effect in European Portuguese.

Research on the perception of word stress suggests that speakers of languages with non-predictable or variable stress (e.g., English and Spanish) are more efficient than speakers of languages with fixed stress (e.g., French and Finnish) at distinguishing nonsense words contrasting in stress location. In addition, segmental and suprasegmental cues to word stress may also impact on the ability of speakers to perceive stress. European Portuguese (EP) is a language with variable stress and vowel reduction. Previous studies on EP have identified duration as the main cue for stress. In the present study, we investigated the perception of word stress in EP, both in nuclear (NP) and post-nuclear (PN) positions, by means of three experiments. Experiment I was an ABX discrimination task with stress and phoneme contrasts, without vowel reduction. Experiments 2 and 3 were sequence recall tasks with stress and phoneme contrasts, vowel reduction being added to the stress contrast only in experiment 3. Results showed significantly higher error rates in the stress contrast condition than in the phoneme contrast condition, when duration alone (PN), or duration and pitch accents (NP), are present in the stimuli (experiments I and 2). When vowel reduction is added, EP speakers are able to perceive stress contrasts (experiment 3). The results show that vowel reduction appears to be the most robust cue for stress in EP. In the absence of vowel quality cues, a stress "deafness" effect may emerge in a language with non-predictable stress that combines both suprasegmental and segmental information to signal word stress. These findings have implications for claims of a prosodic-based cross-linguistic perception of word stress in the absence of vowel quality, and for stress "deafness" as a consequence of a predictable stress grammar.

Do Acoustic Characteristics of Dysarthria in People With Parkinson's Disease Differ Across Languages?

PURPOSE: Cross-language studies suggest more similarities than differences in how dysarthria affects the speech of people with Parkinson's disease (PwPD) who speak different languages. In this study, we aimed to identify the relative contribution of acoustic variables to distinguish PwPD from controls who spoke varieties of two Romance languages, French and Portuguese. METHOD: This bi-national, cross-sectional, and case-controlled study included 129 PwPD and 124 healthy controls who spoke French or Portuguese. All participants underwent the same clinical examinations, voice/speech recordings, and self-assessment questionnaires. PwPD were evaluated off and on optimal medication. Inferential analyses included Disease (controls vs. PwPD) and Language (French vs. Portuguese) as factors, and random decision forest algorithms identified relevant acoustic variables able to distinguish participants: (a) by language (French vs. Portuguese) and (b) by clinical status (PwPD on and off medication vs. controls). RESULTS: French-speaking and Portuguese-speaking individuals were distinguished from each other with over 90% accuracy by five acoustic variables (the mean fundamental frequency and the shimmer of the sustained vowel /a/ production, the oral diadochokinesis performance index, the relative sound level pressure and the relative sound pressure level standard deviation of the text reading). A distinct set of parameters discriminated between controls and PwPD: for men, maximum phonation time and the oral diadochokinesis speech proportion were the most significant variables; for women, variables calculated from the oral diadochokinesis were the most discriminative. CONCLUSIONS: Acoustic variables related to phonation and voice quality distinguished between speakers of the two languages. Variables related to pneumophonic coordination and articulation rate were the more effective in distinguishing PwPD from controls. Thus, our research findings support that respiration and diadochokinesis tasks appear to be the most appropriate to pinpoint signs of dysarthria, which are largely homogeneous and language-universal. In contrast, identifying language-specific variables with the speech tasks and acoustic variables studied was less conclusive.

Early Word Segmentation Behind the Mask.

Infants have been shown to rely both on auditory and visual cues when processing speech. We investigated the impact of COVID-related changes, in particular of face masks, in early word segmentation abilities. Following up on our previous study demonstrating that, by 4 months, infants already segmented targets presented auditorily at utterance-edge position, and, using the same visual familiarization paradigm, 7-9-month-old infants performed an auditory and an audiovisual word segmentation experiment in two conditions: without and with an FFP2 face mask. Analysis of acoustic and visual cues showed changes in face-masked speech affecting the amount, weight, and location of cues. Utterance-edge position displayed more salient cues than utterance-medial position, but the cues were attenuated in face-masked speech. Results revealed no evidence for segmentation, not even at edge position, regardless of mask condition and auditory or visual speech presentation. However, in the audiovisual experiment, infants attended more to the screen during the test trials when familiarized with without mask speech. Also, the infants attended more to the mouth and less to the eyes in without mask than with mask. In addition, evidence for an advantage of the utterance-edge position in emerging segmentation abilities was found. Thus, audiovisual information provided some support to developing word segmentation. We compared 7-9-monthers segmentation ability observed in the Butler and Frota pre-COVID study with the current auditory without mask data. Mean looking time for edge was significantly higher than unfamiliar in the pre-COVID study only. Measures of cognitive and language development obtained with the CSBS scales showed that the infants of the current study scored significantly lower than the same-age infants from the CSBS (pre-COVID) normative data. Our results suggest an overall effect of the pandemic on early segmentation abilities and language development, calling for longitudinal studies to determine how development proceeds.

(Dys)Prosody in Parkinson's Disease: Effects of Medication and Disease Duration on Intonation and Prosodic Phrasing.

The phonology of prosody has received little attention in studies of motor speech disorders. The present study investigates the phonology of intonation (nuclear contours) and speech chunking (prosodic phrasing) in Parkinson's disease (PD) as a function of medication intake and duration of the disease. Following methods of the prosodic and intonational phonology frameworks, we examined the ability of 30 PD patients to use intonation categories and prosodic phrasing structures in ways similar to 20 healthy controls to convey similar meanings. Speech data from PD patients were collected before and after a dopaminomimetic drug intake and were phonologically analyzed in relation to nuclear contours and intonational phrasing. Besides medication, disease duration and the presence of motor fluctuations were also factors included in the analyses. Overall, PD patients showed a decreased ability to use nuclear contours and prosodic phrasing. Medication improved intonation regardless of disease duration but did not help with dysprosodic phrasing. In turn, disease duration and motor fluctuations affected phrasing patterns but had no impact on intonation. Our study demonstrated that the phonology of prosody is impaired in PD, and prosodic categories and structures may be differently affected, with implications for the understanding of PD neurophysiology and therapy.

European Portuguese-Learning Infants Look Longer at Iambic Stress: New Data on Language Specificity in Early Stress Perception.

The ability to perceive lexical stress patterns has been shown to develop in language-specific ways. However, previous studies have examined this ability in languages that are either clearly stress-based (favoring the development of a preference for trochaic stress, like English and German) or syllable-based (favoring the development of no stress preferences, like French, Spanish, and Catalan) and/or where the frequency distributions of stress patterns provide clear data for a predominant pattern (like English and Hebrew). European Portuguese (EP) is a different type of language, which presents conflicting sets of cues related to rhythm, frequency, and stress correlates that challenge existing accounts of early stress perception. Using an anticipatory eye movement (AEM) paradigm implemented with eye-tracking, EP-learning infants at 5-6 months demonstrated sensitivity to the trochaic/iambic stress contrast, with evidence of asymmetrical perception or preference for iambic stress. These results are not predicted by the rhythmic account of developing stress perception, and suggest that the language-particular phonological patterns impacting the frequency of trochaic and iambic stress, beyond lexical words with two or more syllables, together with the prosodic correlates of stress, drive the early acquisition of lexical stress. Our findings provide the first evidence of sensitivity to stress patterns in the presence of segmental variability by 5-6 months, and highlight the importance of testing developing stress perception in languages with diverse combinations of rhythmic, phonological, and phonetic properties.

Validation of a new tool for evaluating subjects' satisfaction with medicine package leaflets: a cross-sectional descriptive study.

BACKGROUND: Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce. OBJECTIVE: To validate a new tool for assessing subjects' satisfaction with medicine package leaflets (LiS-RPL). DESIGN AND SETTING: Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre). METHODS: 503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett's sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler's Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability. RESULTS: Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler's Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous. CONCLUSION: LiS-RPL is a validated tool for evaluating subjects' satisfaction with medicine package leaflets.

The Sense of Sounds: Brain Responses to Phonotactic Frequency, Phonological Grammar and Lexical Meaning.

Two outstanding questions in spoken-language comprehension concern (1) the interplay of phonological grammar (legal vs. illegal sound sequences), phonotactic frequency (high- vs. low-frequency sound sequences) and lexicality (words vs. other sound sequences) in a meaningful context, and (2) how the properties of phonological sequences determine their inclusion or exclusion from lexical-semantic processing. In the present study, we used a picture-sound priming paradigm to examine the ERP responses of adult listeners to grammatically illegal sound sequences, to grammatically legal sound sequences (pseudowords) with low- vs. high-frequency, and to real words that were either congruent or incongruent to the picture context. Results showed less negative N1-P2 responses for illegal sequences and low-frequency pseudowords (with differences in topography), but not high-frequency ones. Low-frequency pseudowords also showed an increased P3 component. However, just like illegal sequences, neither low- nor high-frequency pseudowords differed from congruent words in the N400. Thus, phonotactic frequency had an impact before, but not during lexical-semantic processing. Our results also suggest that phonological grammar, phonotactic frequency and lexicality may follow each other in this order during word processing.

Short Assessment of Health Literacy (SAHL) in Portugal: development and validation of a self-administered tool.

The goal of this study was to adapt, improve and validate a short, self-administered health literacy assessment tool for European Portuguese-speaking adults. Health literacy tools are of great importance to health authorities and professionals, as low or inadequate health literacy, that is, a limited capacity to handle health-related information, is associated with higher morbidity and mortality. The 18-item Short Assessment of Health Literacy for Brazilian Portuguese-speaking adults (SAHLPA-18) was adapted into European Portuguese. The European Portuguese tool (SAHLPA-23) includes five additional items. The SAHLPA-23 was tested in a convenience sample of 503 participants from two Portuguese regions. Socio-demographic data, literacy and cognitive indicators were collected. Participants also completed a questionnaire on comprehension of written health materials. Construct validity was assessed through correlations between SAHLPA-23 scores and education, literacy, and cognitive variables and score on the comprehension questionnaire. The psychometric properties of the new tool were compared with those of the SAHLPA-18. The mean SAHLPA-18 and SAHLPA-23 scores were 13.9 (77.2%; SD=2.9) and 18.3 (79.6%; SD=3.8), respectively. Both tools showed adequate reliability (Cronbach's α>0.7). SAHLPA-23 was more highly correlated with all study variables than SAHLPA-18. Although both instruments displayed acceptable discriminative power, SAHLPA-23 had better accuracy than SAHLPA-18 (DeLong's method: ΔAUC=0.09, Z=3.36; P<0.001). The SAHLPA-23 is an independent, feasible and innovative tool for estimation of health literacy in the Portuguese adult population.

Revisiting Stress "Deafness" in European Portuguese - A Behavioral and ERP Study.

European Portuguese (EP) is a language with variable stress, and the main cues for stress are duration and vowel reduction. A previous behavioral study has reported a stress "deafness" effect in EP when vowel quality cues are unavailable. The present study recorded both event-related potentials (ERPs) and behavioral data to examine the stress processing by native EP speakers in the absence of the vowel quality cues. Our behavioral result was consistent with previous research, showing that when vowel reduction is absent EP speakers demonstrated a stress "deafness" effect similar to that found in speakers of languages with fixed stress or without any lexical stress marking. In the ERP task, both the trochaic and iambic conditions yielded mismatch negativity (MMN) and late negativity, suggesting that EP speakers are able to discriminate the two stress patterns without vowel reduction at the pre-attentive stage. Moreover, the ERP and behavioral data revealed compatible results regarding the pattern of stress bias in EP. In the EPR task, the MMN and late negativity components were more negative and span over a larger temporal window in the iambic condition than in the trochaic condition, indicating a higher sensitivity for the iambic stress pattern. In the behavioral task, EP speakers responded more accurately and more quickly to the iambic stress. These results match recent developmental findings in the acquisition of stress, but speak against the dominant view in EP phonological literature which assumes penultimate stress to be the regular stress pattern. In addition, both the ERP and the behavioral data showed that EP speakers' stress processing was influenced by their working memory (WM) capacity. The participants with high WM capacity outperformed the participants with limited WM capacity in the iambic condition. In sum, our results broaden the current knowledge on stress processing by EP speakers at both the pre-attentive and attentive levels.

Evaluation of brand names of medicines: linguistic and format issues.

OBJECTIVES: Focusing on the shape of brand names of medicines in the Portuguese market, the aims of this study were: to evaluate the number of words, syllables and letters, to identify the combinations of letters that are not found in Portuguese words and to characterize the use of capital letters in these names. METHODS: A descriptive study was conducted using 474 randomized brand names of medicines, approximately 25% of all over-the-counter and prescribed medicines available in Portugal. The number of words, syllables and letters was automatically determined with a dedicated software. The combinations of letters that are not found in Portuguese and the use of capital letters were quantified through visual inspection. KEY FINDINGS: The 474 names were formed by 615 words. 74.5% of the words comprised three or less syllables, the most common number of syllables in the Portuguese words (91%). As recommended, 81% (n = 385) names were formed by just one word, 59.2% (n = 281) of the names were composed of 5-8 letters, and 83.1% (n = 394) presented the first letter in capitals or all letters in upper case. Contrary to recommendations, 22% of the names comprised combinations of letters that are not commonly found in Portuguese words. CONCLUSIONS: Given the current readability requirements, some of the Portuguese brand names of medicines should be reduced in length, adapted to the native language or capitalized. Equivalent studies are recommended in other European countries, because many brands of medicines are internationally marketed, while their development and approval should be beyond general marketing rules.

Grammar and frequency effects in the acquisition of prosodic words in European Portuguese.

This paper investigates the acquisition of prosodic words in European Portuguese (EP) through analysis of grammatical and statistical properties of the target language and child speech. The analysis of grammatical properties shows that there are solid cues to the prosodic word (PW) in EP, and the presence of early word-based phonology in child speech shows that EP children are aware of these cues. It is thus hypothesized that grammatical properties could play a role in the development of the PW by promoting the early production of the different word shapes found in the language. The analysis of statistical properties of the input, namely word shape frequencies in adult speech and child-directed speech, shows that they constrain early word shapes in child speech in ways similar to recent reports on other languages: a fairly high frequency of monosyllabic shapes, and especially of monosyllabic CV shapes, in the input agrees with the production of subminimal words in child speech; a fairly high frequency of trisyllabic and larger shapes in the input (adult speech in particular) matches the early development of words larger than a binary foot. These patterns, together with the co-occurrence of truncation to subminimal shapes in the initial and later stages, as well as the presence of prosodic fillers regardless of word size, support the claim that early words in EP are not constrained by minimality or maximality requirements. The potential interaction of grammar and frequency effects in PW acquisition is discussed in the light of the present findings and comparable data available in the literature for English, French, Spanish and Catalan.

Factors influencing subjects' comprehension of a set of medicine package inserts.

Background Package inserts (PIs) should promote the safe and effective use of medicines. The comprehension of PIs is related to socio-demographic features, such as education. Objectives To evaluate the participants' comprehension of a sample of PIs and to build an explanatory model of subjects' understanding of the content of these documents. Setting The data were collected from municipalities, city halls, firefighters, the military, schools and charities from two Portuguese regions. Methods Cross-sectional descriptive survey: 503 participants, homogeneously distributed by education and gender. The self-administered tool comprised questions on socio-demographic data, literacy tasks and comprehension evaluation of 12 purposively selected PIs. A logistic regression analysis was used. Main outcome measures Scores of numeracy tasks and comprehension. Results The average comprehension score for the PIs was 63 % (±32 %), with 48 % (n = 239) of the participants scoring <75 %. The most important predictors in explaining a comprehension score ≥75 % were having >12 years of education and correctly performing a numeracy task [respectively, OR 49.6 (CI 95 %: 22.8-108) and OR 2.48 (CI 95 %: 1.5-4.2)]. Conclusion An explanatory model of subjects' knowledge about the content of the tested PIs was built. Given that a high level of education and literacy were found to be the most relevant predictors for acceptable comprehension rates, PIs should be clearly written to assure that they are understood by all potential users, including the less educated. The evaluated PIs may thus need to be simplified.

Dysarthria in individuals with Parkinson's disease: a protocol for a binational, cross-sectional, case-controlled study in French and European Portuguese (FraLusoPark).

INTRODUCTION: Individuals with Parkinson's disease (PD) have to deal with several aspects of voice and speech decline and thus alteration of communication ability during the course of the disease. Among these communication impairments, 3 major challenges include: (1) dysarthria, consisting of orofacial motor dysfunction and dysprosody, which is linked to the neurodegenerative processes; (2) effects of the pharmacological treatment, which vary according to the disease stage; and (3) particular speech modifications that may be language-specific, that is, dependent on the language spoken by the patients. The main objective of the FraLusoPark project is to provide a thorough evaluation of changes in PD speech as a result of pharmacological treatment and disease duration in 2 different languages (French vs European Portuguese). METHODS AND ANALYSIS: Individuals with PD are enrolled in the study in France (N=60) and Portugal (N=60). Their global motor disability and orofacial motor functions is assessed with specific clinical rating scales, without (OFF) and with (ON) pharmacological treatment. 2 groups of 60 healthy age-matched volunteers provide the reference for between-group comparisons. Along with the clinical examinations, several speech tasks are recorded to obtain acoustic and perceptual measures. Patient-reported outcome measures are used to assess the psychosocial impact of dysarthria on quality of life. ETHICS AND DISSEMINATION: The study has been approved by the local responsible committees on human experimentation and is conducted in accordance with the ethical standards. A valuable large-scale database of speech recordings and metadata from patients with PD in France and Portugal will be constructed. Results will be disseminated in several articles in peer-reviewed journals and in conference presentations. Recommendations on how to assess speech and voice disorders in individuals with PD to monitor the progression and management of symptoms will be provided. TRIAL REGISTRATION NUMBER: NCT02753192, Pre-results.

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.