Pictograms for conveying medicine instructions: comprehension in various South African language groups

The comprehension of medicine instructions is essential for the safe and effective use of medicines. In cases where low literacy constitutes a possible barrier to understanding written medicine information fully, the inclusion of pictograms may facilitate comprehension. Twenty-three internationally available pictograms and 23 corresponding locally developed images were evaluated in 304 low-literate respondents from eight different South African language groups. Demographic data were collected and an English literacy test was administered to those respondents who had stated that they could read English. Interviewees were shown the 46 pictograms in random order and were asked for their interpretation. Preference for either the international or local version was assessed. Correct interpretation of individual pictograms ranged from 14% to 97%. Images which had been developed locally were more successful in eliciting correct interpretations than those obtained from an international source (USP pictograms). Only 2 of the 23 USP pictograms achieved the 85% criterion of the American National Standards Institute compared with 12 of 23 locally developed counterparts. Local pictograms were preferred over the American ones in all cases. Standard of education had a significant influence on interpretation, whereas no significant differences in interpretation could be attributed to cultural diversity between the African language groups. Almost all respondents (98%) reacted positively to the idea of having pictograms on their medicine labels. The success of the local pictograms highlighted the value of a rigorous and consultative design and test process. Results from one African language group can reliably be extrapolated to other groups in South Africa

Development of written information for antiretroviral therapy: comprehension in a Tanzanian population

Objective To design and develop a simple, easily readable patient information leaflet (PIL) for a commonly used antiretroviral (ARV) regimen and to evaluate its readability and acceptability in a Tanzanian population. Method A PIL incorporating simple text and pictograms was designed for the antiretroviral regimen of stavudine, lamivudine and efavirenz. The PIL was designed according to established good design guidelines, modified during a multi-stage iterative testing process and piloted in a South African Xhosa population. The PIL was made available in both English and Kiswahili. Sixty Tanzanian participants who were not taking ARVs were interviewed. They were asked to read the PIL in the language of their choice and were then asked a series of two-part questions; the first part required participants to locate the information in the PIL, after which they were asked to explain the information in their own words. Acceptability was assessed through close-ended questions and open-ended feedback. The influence of selected patient characteristics on comprehension of the PIL was investigated using one-way ANOVA and t-tests for independent samples with a significance level set at 0.05. Main outcome measure Comprehension of the written information in an overall percentage understanding. Results The overall average percentage comprehension of the PIL was 95%. The target set by the EC guideline that at least 80% of participants correctly locate and understand the information was achieved for 19 of the 20 questions. Five of the six instructions illustrated by pictograms were correctly understood by all participants. The only patient characteristics significantly associated with comprehension were educational level and self-reported ease of reading the PIL. Acceptability of the PIL was high and positive comments were associated with simplicity, good design, easy readability and user-friendliness, the latter enhanced by the inclusion of pictograms. Conclusion The PIL designed for this study was shown to be effective in communicating information about ARVs. Patient characteristics must be taken into account when developing written information, and the final document must be tested for comprehension in the target population

Medicine labels incorporating pictograms: do they influence understanding and adherence?

The objective was to determine the influence of medicine labels incorporating pictograms on the understanding of instructions and on adherence. Eighty-seven Xhosa participants attending an outpatient clinic who had been prescribed a short course of antibiotics were randomly allocated to either a control group (41 participants given text-only labels), or an experimental group (46 participants given text + pictogram labels). All participants had a maximum of 10 years of formal schooling. Follow-up home visits were conducted after 3–5 days to assess understanding of instructions and to evaluate adherence. A high adherence of greater than 90% was found for 54% of the experimental group, compared with only 2% of the control group. Average percentages for understanding in the control and experimental groups were 70 and 95%, respectively, and average adherence was 72 and 90%, respectively. The presence of pictograms was found to contribute positively to both understanding of instructions and adherence

The evaluation of pharmaceutical pictograms in a low-literate South African population

An inability to read and understand written medication instructions may be a major contributory factor to non-compliance in certain patient populations, particularly in countries with a high illiteracy rate such as South Africa. Twenty three pictograms from the USP-DI and a corresponding set of 23 locally developed, culturally sensitive pictograms for conveying medication instructions were evaluated in 46 Xhosa respondents who had attended school for a maximum of 7 years. Respondents were tested for their interpretation of all 46 pictograms at the first interview and again 3 weeks later. The correct meaning of each pictogram was explained at the end of the first interview. Preference for either the Local or USP pictograms was determined. At the follow-up interview, 20 of the Local pictograms complied with the ANSI criterion of ≥85% comprehension, compared with 11 of the USP pictograms. Respondents indicated an overwhelming preference for the Local pictograms

Design and evaluation of a new pharmaceutical pictogram sequence to convey medicine usage

Pictorials may be used to augment textual instructions in the depiction of safety and warning information on medicines. The objective of this study was to design, develop and evaluate a simple and culturally appropriate pictogram sequence for using nystatin suspension, and to assess its understandability in low-literate Xhosa participants. A new pharmaceutical pictogram sequence was designed through focus group discussions and evaluated in a 2-phase process. The results of Phase 1 (30 participants) identified various problems associated with the new pictogram sequence. It was modified accordingly and re-evaluated in Phase 2 with 20 participants. All participants belonged to the Xhosa group, had between 0 and 7 years of formal schooling and had English as their second language. Acceptance of the new pictogram sequence was based on international standards (ANSI and ISO criterion) for evaluating the comprehensibility of pictograms. In Phase 1, the new pictogram sequence was correctly interpreted by 66.7% of the participants and this complied with the ISO criterion of 67% correct. In Phase 2, 95% of the participants were able to correctly interpret the new pictogram sequence. This result complied with the ANSI criterion of 85% correct, therefore, this new pictogram sequence was considered to be acceptable. This study has illustrated the success of using a consultative approach in the design of new pictograms

Phenylpropanolamine hydrochloride

Phenylpropanolamine hydrochloride belongs to the sympathomimetic amine class of drugs and is structurally related to ephedrine hydrochloride. Its synthesis was first reported in 1910 and the first American patent was registered in 1939. The effects of phenylpropanolamine hydrochloride are largely the result of alpha-adrenergic agonist activity resulting from both direct stimulation of adrenergic receptors and release of neuronal norepinephrine. The principal adverse effect of phenylpropanolamine hydrochloride is dose-related hypertension and ventricular arrhythmia has been described. Phenylpropanolamine hydrochloride is widely used as a decongestant and it has been used as an anorectic agent for over 40 years. A report in 1939 described its effect as an hypertensive agent when administered parenterally

Pharmacokinetics of phenylpropanolamine in humans after a single dose study

The pharmacokinetics of phenylpropanolamine have been studied in healthy human volunteers following the oral administration of an aqueous solution of the drug (50 mg/200 ml). Blood and urine samples collected throughout the trial were assayed using HPLC with UV detection. The drug was shown to be rapidly absorbed with a mean tmax of 1.47 ± 0.49 h and a mean elimination half-life of 4.0 ± 0.5 h. Phenylpropanolamine is predominantly excreted via the kidney with a mean renal clearance of 0.646 ± 0.089 liter/kg/h and 90.2 ± 1.7% excreted unchanged in the urine. The data were not well described using conventional one or two body compartment models. However, the incorporation of a discontinuous absorption phase into the models resulted in an improved overall fit with better characterisation of the absorption phase

Determination of phenylpropanolamine in serum and urine by high performance liquid chromatography

A high-performance liquid chromatographic analysis of phenylpropanolamine in human serum and urine without prior derivatization is presented. Using direct UV detection the method is sufficiently sensitive to detect 25 ng of drug/ml of serum or urine; the coefficients of variation at 25 ng/ml and 500 ng/ml were 5.16 and 2.12, respectively, in serum. The method involves serum and urine extraction at a basic pH with chloroform, a single back-extraction, and chromatography on a reverse-phase column. Serum and urine data following administration of a single 150-mg sustained-release tablet of phenylpropanolamine hydrochloride in 6 healthy volunteers demonstrates the suitability of the analytical method

In vitro-in vivo evaluation of a sustained release phenylpropanolamine oral dosage form

There is increasing interest in measuring pharmacokinetic parameters of phenylpropanolamine (PPA), a sympathomimetic amine used in over-the-counter nasal decongestants and anorectic formulations. A high pressure liquid chromatographic (HPLC) procedure was developed to enable direct ultraviolet detection of PPA, after extraction from serum and urine, without prior derivatization of the drug. This method was used to assay samples obtained from a bioavailability study of BUBtained-releasePPA tablets. The mean serum and urine profiles obtained are presented. The sustained-release tablets were subjected to dissolution testing utilizing the United States Pharmacopoeia (USP XIX) rotating basket method. An internal standard was incorporated into the dissolution fluid to enable direct analysis of the samples by HPLC. A comparison of three different dissolution fluid regimens was carried out to determine if release of the drug was affected by the change in pH of the medium and to select the most convenient method for the final dissolution studies. Some preliminary observations relating to correlations between rate of drug release from the sustained-release dosage form and percent drug absorbed are presented

Improving assessment and risk-based management of freshwater salinisation

Salinisation is a common and increasingly threatening environmental stressor to freshwater ecosystems globally. Despite this, there is a lack of environmentally relevant data on the effects of salinisation for freshwater macroinvertebrates. This is a problem because in order to manage and mitigate effects caused by freshwater salinisation, we first need to more fully understand how salinity affects freshwater biota. This thesis comprises a series of papers that aim to improve salinity risk assessment and water quality guideline derivation for lotic freshwater ecosystems by contributing empirical data to knowledge gaps and suggesting future research directions. Trade-offs between data quality and quantity in salinity risk assessment using species sensitivity distributions (SSDs) were investigated. The dominant taxonomic group was the prime determinant of protective concentrations (PCs), and decreases in data quantity decreased community representativeness. There is a need to compile SSDs that reflect natural biotic assemblages; however, there are insufficient ‘high quality’ data to do this. Until more data become available, the use of right-censored data in SSDs is recommended. The use of such data can provide a more representative sample of species from which to estimate ecologically relevant PCs, and cannot result in under protective concentrations. Salinity is composed of multiple major ions, yet typically studies have used representative single salts (e.g. NaCl) or artificial sea water to determine its toxicity. This thesis researched the use of representative salts, finding that site specific and whole effluent toxicity testing produces more environmentally realistic salinity risk assessment of saline wastewaters. The thesis investigates mechanisms of salinity toxicity in two model species, Paratya australiensis (Decopoda) and Austrophlebiodes pusillus (Ephemeroptera), and their experience of temporally varying salinity. Mortality in P. australiensis co-occurred with osmoregulartory breakdown. However, latent (or delayed) mortality effects occurred when P. australiensis are returned to ambient waters, despite haemolymph salinity returning to a normal baseline level. This indicates that a rise in haemolymph salinity is not the sole cause of mortality from increased salinity in this species. Latent effects are not currently considered in salinity risk assessment, and are not incorporated into current water quality guideline derivation protocols; thus the effects of salinity may be underestimated. In A. pusillus osmoregulartory breakdown did not precede death irrespective of the temporal course of the salinity increase. Furthermore, significant mortality occurred well below the isotonic point. This finding contrasts with common osmoregulatory theory which implies no mortality below the isotonic point, and has not been previously reported. Thus, this research challenges the extent of our current understanding of the relationship between osmoregulation and mortality. Further studies are urgently needed on the osmoregulation of other salt sensitive species. Current salinity risk assessment and water quality guideline derivation protocols likely underestimate the effects of salinity on freshwater macroinvertebrates. Salinity risk assessment and water quality guideline derivation protocols need to compile SSDs that are more representative of the communities they aim to protect, and use ionic proportions of the salt source. Further research is required on the implications of temporally varying salinity and latent mortality effects, and into the physiology of osmoregulation for salt sensitive species