Ley's Partial Model of Compliance suggests that patients who understand information given to them are more likely to remember the information and are more likely to be satisfied with the information. The model then suggests that these components will lead to greater patient compliance with medication regimens. To test the model, Patient Package Inserts (PPIs) describing thiazide diuretics from the American Association of Retired Persons, the American Medical Association, the Canadian Pharmaceutical Association, the Food and Drug Administration, the National Association of Retail Druggists, the United States Pharmacopoeial Convention and a Test PPI written by the Principal Investigator were used. The SMOG Readability Formula was used to determine the grade levels at which PPIs were written. One hundred thirty-six adults enrolled in GED classes in Tucson and other communities and 107 adults enrolled in remedial reading classes at Tucson's Pima Community College were administered the Zip Scale reading placement test and blocked by their reading abilities. Within each of the three blocks, subjects randomly received one of the seven information sheets or no sheet. Subjects took a multiple-choice test based upon information common to all of the PPIs, a cloze comprehension test based upon the PPI which they read, and completed a satisfaction survey which asked subjects to rate the PPI which they read. Subjects also read five vignettes describing fictitious patients taking thiazides who were confronted with different barriers to compliance. Subjects indicated how likely the fictitious patients were to overcome the barriers to compliance. Among this sample of remedial-reading adults, the Test PPI emerged as clearly superior to the others for any of the variables measured. This result would behoove providers of PPIs to rewrite PPIs, reducing the difficulty of these documents as much as possible. Ley's Partial Model of Compliance did not accurately describe the associations between Understanding, Memory, Satisfaction and Compliance for this sample. A New Model emerged describing different associations between these components and between subject reading ability and PPI readability.

No description available.

Thesis (MMed)--Stellenbosch University, 2014. / ENGLISH ABSTRACT: OBJECTIVE The aim of this study is to establish the frequency of unlicensed and off label drug use in infants admitted to the neonatal intensive care unit (NICU) in Tygerberg Hospital. METHOD This was a prospective descriptive survey conducted over 3 consecutive months (September 2011-November 2011) of all medicine charts of neonates admitted during this time period to the NICU. Data collected included demography, diagnoses, medicines prescribed according to dose, frequency, route of administration and indication. Medicine use was defined as unlicensed, licensed or off label use according to the latest South African Medicines Formulary (2012) and the manufacturer’s package insert. Unlicensed drug use is per definition a drug not registered with South African Medicine Control Council (SA MCC) for children and off label drug use is where the use is outside of its authorized license with SA MCC. RESULTS There were 112 neonates enrolled in the study, of whom 51% were preterm and 49% term infants. The most common diagnoses on admission for the preterm babies were hyaline membrane disease (33%) and sepsis (21%), while it was hypoxic ischemic encephalopathy (42%) and post-operative care (22%) for term infants. There were 759 drug events of which 37% were licensed and followed all the licensing terms, 51% were prescribed in an off label manner and the remaining 12% were of unlicensed drugs. The most common reasons off label drug use were for weight (74%), followed by age (44%), frequency (44%), indication (21%), or a route not described in the licensing terms (13%). There was a lack of pediatric data for 9% of the drugs prescribed. In 203 drug events (27%) a drug was used in an off label manner for more than one reason. Sixty one percent of the drugs used had no information on the use of the drug in neonates. CONCLUSION This is the first study conducted in an African NICU, according to our knowledge and the results are similar to studies conducted in Europe and America. Neonates are exposed to a significant proportion of unlicensed and off label drugs. Neonatal clinical trials should be conducted to address the need for proven safe and efficacious treatment for neonates.