Simple, illustrated medicines information improves ARV knowledge and patient self-efficacy in limited literacy South African HIV patients.

Few studies have investigated antiretroviral (ARV) knowledge and self-efficacy in limited literacy patients. Using a randomized controlled study design, we investigated the influence of a simple pre-tested patient information leaflet (PIL) containing both text and illustrations on HIV- and ARV-related knowledge and on self-efficacy over six months in a limited literacy African population. The recruited patients were randomly allocated to either control (standard care) or intervention group (standard care plus illustrated PIL). HIV and medicines-related knowledge was evaluated with a 22-question test at baseline, one, three, and six months. Self-efficacy was assessed using a modified version of the HIV Treatment Adherence Self-Efficacy Scale. Two-thirds of the patients were female, mean age was 39.0 ± 9.6 years and mean education was 7.3 ± 2.8 years. Patients who received the PIL showed a significant knowledge increase over the six-month period (62.0-94.4%), with improvement at each subsequent interview whereas the control group showed no improvement. At baseline, side effect knowledge was the lowest (50-56%) but increased in the intervention group to 92%. Similarly, other medicine-related knowledge at baseline (57-67%) improved significantly (93%) and was sustained over six months. Cohen's d values post-baseline ranged between 1.36 and 2.18, indicating a large intervention effect. Self-efficacy improved significantly over six months in intervention but not control patients. At baseline, patients with ≤ 3 years of education had lower knowledge and self-efficacy but this was not observed post-intervention, which we attribute to the PIL mitigating the effect of limited education. Knowledge and self-efficacy were significantly correlated in the intervention group. In conclusion, a low-cost intervention of a well-designed, pre-tested, simple, illustrated PIL significantly increased both ARV knowledge and self-efficacy in HIV patients with limited education.

Assessing the chronic toxicity of atrazine, permethrin, and chlorothalonil to the cladoceran Ceriodaphnia cf. dubia in laboratory and natural river water.

The majority of ecotoxicological data are generated from standard laboratory-based experiments with organisms exposed in nonflowing systems using highly purified water, which contains very low amounts of dissolved organic matter and suspended particulates. However, such experimental conditions are not ecologically relevant. Thus, there is a need to develop more realistic approaches to determining toxicity, including both lethal and sublethal effects. This research provides information on the effect of natural water constituents, such as suspended particulates and dissolved organic matter, in river water (RW) on the chronic toxicity (7-day reproductive impairment) of the pesticides atrazine, chlorothalonil, and permethrin to the freshwater cladoceran Ceriodaphnia cf. dubia. Standard bioassays were conducted under standard laboratory and more environmentally realistic conditions (using RW). The 7-day IC25 (reproduction impairment) values of atrazine, chlorothalonil, and permethrin to C. cf. dubia ranged from 862.4 to >1000, 51.3 to 66.4, and 0.19 to 0.23 µg/L, respectively. Using the Globally Harmonized System of Classification and Labelling of Chemicals, atrazine is classified as moderately to highly toxic, whereas permethrin and chlorothalonil were both highly toxic. The presence of dissolved organic matter and suspended particles in natural RW did not significantly (p > 0.05) change the toxicity of any of the pesticides to C. cf. dubia compared with that tested in laboratory water (LW). For the tested pesticides, toxicity testing in LW provided an adequate estimate of the hazard posed.

Medicines information and adherence in HIV/AIDS patients.

BACKGROUND: Providing written medicines information is being legislated in an increasing number of countries worldwide, with the patient information leaflet (PIL) being the most widely used method for conveying health information. The impact of providing such information on adherence to therapy is reportedly unpredictable. Therapy for human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and related opportunistic infections usually involves polytherapy and complex regimens, both of which are risk factors for non-adherence. The objective of this study was to assess the impact of medicines information on adherence to chronic co-trimoxazole therapy in low-literate HIV/AIDS patients. METHODS: Two different PILs were designed for co-trimoxazole tablets and were available in both English and isiXhosa. Participants were randomly allocated to a control group (receiving no PIL), group A (receiving a "complex PIL") and group B (receiving a "simple PIL" incorporating pictograms). At the first interview, demographic data were collected and the time, date and day that the participant would take his/her first tablet of the month's course was also documented. In a follow-up interview adherence to therapy was assessed using two methods; self-report and tablet count. RESULTS: The medicines information materials incorporating simple text and pictograms resulted in significantly improved adherence to therapy in the short term, whereas a non-significant increase in adherence was associated with the availability of the more complex information. This was shown by both the self-reported assessment as well as the tablet count. CONCLUSION: This research suggests that appropriately designed written material can have a positive impact in improving adherence and, together with verbal consultation, are essential for enabling patients to make appropriate decisions about their medicine taking.

Comprehension and Acceptability of a Patient Information Leaflet (PIL) for Antiretroviral Therapy

The patient information leaflet (PIL) is recognised as playing a key role in informing patients about their medicines. The objectives of this research were to evaluate the read- ability and understanding of a PIL for the first-line ARV (antiretroviral) regimen available in the South African public health sector; and investigate its acceptability in the target Xhosa population. The study took place between August 2003 and July 2004. A PIL was designed for the antiretroviral regimen of stavudine; lamivudine and efavirenz; using established usability guidelines. South African legal requirements concerning PILs were incorporated and the PILs were available in both eng and isiXhosa. Sixty Xhosa participants between the ages of 18 and 61 years old; with varied levels of education; ranging from no schooling to tertiary level education; were interviewed and demographic data were collected. All participants had stated that they could read. They were asked to read the PIL and a series of questions was asked to assess its comprehension and acceptability. The overall average rate of understanding was 80. Six of the 20 questions were located and understood by all participants; and only two questions resulted in less than an 85 correct response.The PIL was rated as difficult to read by only three participants. Physical appearance and quantity of information were highly rated and all partici- pants were enthusiastic about the inclusion of pictograms

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.

In vitro release of amoxycillin from lipophilic suppositories.

The in vitro release characteristics of amoxycillin from different lipophilic suppository bases were investigated using the USP rotating basket method. Suppositories containing 250 mg amoxycillin were prepared in theobroma oil and in the semi-synthetic bases Witepsol W35, Suppocire A32, Novata BD, and Novata 299. Both freshly prepared and 1-month-old suppositories were tested. Analysis of amoxycillin was performed using a validated high-performance liquid chromatographic (HPLC) technique. Release profiles differed significantly between bases, with the greatest amount of amoxycillin being released from both newly made and 1-month-old Novata BD bases (87.57 +/- 8.18 and 99.66 +/- 6.63%, respectively), and the lowest amount released from the newly manufactured theobroma suppositories (8.82 +/- 0.75%) and the 1-month-old Suppocire A32 suppositories (7.78 +/- 0.27%).

Pharmacokinetics of oral decongestants.

Only three drugs are commonly used as oral decongestants--phenylpropanolamine (PPA), pseudoephedrine (PDE), and phenylephrine (PE). They are all chiral drugs that exist as stereoisomers. It is possible that each enantiomer can reflect significant enantioselective differences with regard to both pharmacokinetic and pharmacodynamic effects. Both PPA and PDE are readily and completely absorbed, whereas PE, with a bioavailability of only approximately 38%, is subject to gut wall metabolism and is thought to be absorbed erratically. Peak concentrations are reached between 0.5 and 2 hours after administration. All three drugs are extensively distributed into extravascular sites (apparent volume of distribution between 2.6 and 5.0 L/kg). No protein-binding data in humans are available. Whereas PPA and PDE are not substantially metabolized, PE undergoes extensive biotransformation in the gut wall and the liver. Elimination of PPA and PDE is predominantly renal, with urinary excretion being pH dependent. Half-lives are relatively short, approximately 2.5 hours for PE, 4 hours for PPA, and 6 hours for PDE. Elimination of PPA and PDE may be rapid in children, and the agents should be used with caution in patients with renal impairment. In addition, PPA increases caffeine plasma levels and decreases theophylline clearance. Reduced metabolism of PE occurs with concurrent administration of monoamine oxidase inhibitors. No direct relationship between nasal decongestant effect and plasma concentration has been established.

Outpatient compliance with theophylline and phenytoin therapy.

Poor compliance with prescribed medication is a significant problem in chronic disease states and is often responsible for the apparent failure of therapy. The determinants and extent of non-compliance are commonly incorrectly perceived by doctors. During routine therapeutic drug monitoring of epileptic and asthmatic outpatients at a local day hospital, non-compliance was identified as a significant problem. A compliance study was conducted on 80 epileptic and asthmatic patients to determine the nature and extent of this problem. Non-compliance was measured using four different methods, which were then compared using chi 2 tests. Overall incidence of non-compliance was found to be 63%. Age, sex, standard of education and duration of disease were found to have no association with non-compliance. The most clinically significant finding was that almost half the patients were unaware of the necessity of taking their medication on a continuous basis. No significant differences existed between assessing non-compliance using tablet counts, patient interview and clinic attendance, whereas the method using blood levels gave significantly different results from all the other methods used.

Serum concentrations of phenylpropanolamine and associated effects on blood pressure in normotensive subjects: a pilot-study.

This study was undertaken to investigate the effects of racemic phenylpropanolamine (PPA) on blood pressure (BP) in normotensive human subjects following the administration of three different dosages of PPA (25 mg, 50 mg and 100 mg) as single doses and to determine whether any relationship existed between the serum concentrations of PPA and its possible effects on BP. Blood was sampled and BP measured at specified times. Phenylpropanolamine was determined by HPLC with UV detection. No significant changes in BP occurred following the 25 mg dose (5 +/- 7/6 +/- 6 mm Hg), whereas statistically significant changes were found after the two higher doses of 50 mg (26 +/- 16/12 +/- 13 mm Hg) and 100 mg (30 +/- 13/15 +/- 8 mm Hg). Increases in systolic pressure following the 50 mg and 100 mg doses appeared to show a better correlation with peak serum concentrations of PPA than did diastolic effects. Although serum concentrations of PPA increased linearly with increasing dose, no clear-cut correlation could be found between serum concentrations and BP effects. The pressor effects, however, became more noticeable following the 50 mg dose and were markedly increased following the 100 mg dose. Side-effects which were reported were relatively minor even at the higher doses.

Steady state pharmacokinetics and dose-proportionality of phenylpropanolamine in healthy subjects.

The pharmacokinetics of phenylpropanolamine (PPA) were studied in five healthy male volunteers after single oral doses of 25, 50 and 100 mg of the drug as well as at steady state after seven, 4-hourly doses of PPA. The peak serum concentrations and AUC infinity values increased linearly with an increase in dose, whereas the time to reach peak serum concentrations did not vary significantly between doses. The half-life remained relatively constant with an increase in dose (t1/2 = 3.8 to 4.3 hours), as did renal clearance (ClR = 0.41 to 0.44 l/kg/h). The percentage of unchanged PPA excreted in the urine over a 14 hour period was 64%, 63% and 73% for the 25, 50 and 100 mg doses, respectively. The pharmacokinetics of PPA were found to be linear in the dosage range 25 to 100 mg. Steady state serum concentrations were significantly higher than single dose concentrations, with the mean peak serum concentration increasing from 113 ng/ml after a single dose to 183 ng/ml at steady state. The time at which these were attained decreased from 1.47 hours after a single dose to 0.73 hours at steady state. Both clearance and volume of distribution were significantly different after a single dose compared to steady state (P less than 0.05), whereas no significant differences were found between the other parameters.

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-phrase column. Serum and urine data following administration of a single 150-mg sustained-release tablet of phenylpropanolamine hydrochloride in six healthy volunteers demonstrates the suitability of the analytical method.