Women’s involvement in clinical trials: historical perspective and future implications

The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women’s response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women’s inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue.

Adherence to antiretroviral therapy and its determinants among persons living with HIV/AIDS in Bayelsa state, Nigeria

Background: A high level of adherence is required to achieve the desired outcomes of antiretroviral therapy. There is paucity of information about adherence to combined antiretroviral therapy in Bayelsa State of southern Nigeria. Objectives: The objectives of the study were to determine the level of adherence to combined antiretroviral therapy among the patients, evaluate the improvement in their immune status and identify reasons for sub-optimal adherence to therapy. Methods: The cross-sectional study involved administration of an adapted and pretested questionnaire to 601 consented patients attending the two tertiary health institutions in Bayesla State, Nigeria: The Federal Medical Centre, Yenagoa and the Niger-Delta University Teaching Hospital Okolobiri. The tool was divided into various sections such as socio-demographic data, HIV knowledge and adherence to combined antiretroviral therapy. Information on the patient's CD4+ T cells count was retrieved from their medical records. Adherence was assessed by asking patients to recall their intake of prescribed doses in the last fourteen days and subjects who had 95-100% of the prescribed antiretroviral drugs were considered adherent. Results: Three hundred and forty eight (57.9%) of the subjects were females and 253 (42.1%) were males. The majority of them, 557 (92.7%) have good knowledge of HIV and combined anti-retroviral therapy with a score of 70.0% and above. A larger proportion of the respondents, 441 (73.4%), had > 95% adherence. Some of the most important reasons giving for missing doses include, “simply forgot” 147 (24.5%), and “wanted to avoid the side-effects of drugs” 33(5.5%). There were remarkable improvements in the immune status of the subjects with an increment in the proportion of the subjects with CD4+ T cells count of greater than 350 cells/mm3 from 33 (5.5%) at therapy initiation to 338 (56.3%) at study period (p<0.0001). Conclusion: The adherence level of 73.4% was low which calls for intervention and improvement. The combined antiretroviral therapy has significantly improved the immune status of the majority of patients which must be sustained. “Simply forgot” was the most important reason for missing doses.

Associations between patient factors and medication adherence: a Jordanian experience

Objective: To explore the effect of patient characteristics and health beliefs on their medication adherence. Methods: Patients (n=167) with chronic conditions (mean age 58.9; SD=13.54, 53% males) were recruited from March 2009- to March 2010 using a cross sectional study design. Data collected included patients’ demographics, medical conditions, medications therapeutic regimen, frequency of physician visits and health beliefs. Patient self-reported adherence to medications was assessed by the researcher using a validated and published scale. Treatment related problems (TRPs) were evaluated for each patient by competent clinical pharmacists. Associations between patient characteristics/health beliefs with adherence were explored. Results: About half of the patients (46.1%) were non-adherent. A significant association was found between lower adherence and higher number of disease states (p<0.001), higher number of medications (p=0.001), and higher number of identified TRPs (p = 0.003). Patient adherence was positively affected by older age, higher educational level, and higher number of physician visits per month, while it was negatively affected by reporting difficulties with getting prescription refills on time. Conclusion: This study identified different factors that may negatively affect adherence, including higher number of medications and disease states, higher number of identified TRPs and inability to getting prescription refills on time. Hence, more care needs to be provided to patients with complex therapeutic regimens in order to enhance adherence.

Determinants of self-medication with NSAIDs in a Portuguese community pharmacy

Background: Non-steroid anti-inflammatory drugs (NSAIDs) are a widely used therapeutic group in the world, and particularly in the Portuguese population. Objective: To compare NSAID’s use by prescription and self-medication acquisition and to determine the pattern of indication of NSAIDs, their usage profile and possible implications for patients’ safety. Methods: A cross-sectional design was used where individuals presenting at a community pharmacy requesting NSAIDs during the study period (one month) were invited to answer a face-to-face interview where socio-demographic characteristics, the indication pattern and previous experience of side effects were assessed. A follow-up interview was performed one week later to assess the incidence of adverse effects. The study was ethically approved. Results: A sample of 130 NSAIDs users was recruited, comprising mostly women (n=87; 66.9%), actively employed (n=77; 59.2%) and presenting a mean age of 49.5 years old (SD=20.49). An equal proportion of individuals acquired NSAIDs by self-medication and with medical prescription (n=65; 50%). Over 4/5 of patients (n=57; 87.7%) acquiring NSAIDs without a prescription were self-medicated by their own initiative, and only 10.8% (n=7) had been advised by the pharmacist. The most commonly acquired active substances were ibuprofen and diclofenac. Self-medicated users more frequently resorted to topical NSAIDs following short term treatments. The major underlying condition motivating NSAIDs sought were musculoskeletal disorders (45.0%), regardless of the regimen. An important proportion of prevalent users of NSAIDs reported previous experience of adverse effects (11.3%). One week after initiating NSAID therapy, a small proportion of patients reported incidence of adverse effects. Conclusion: Self-medication with NSAIDs is sought for numerous medical conditions. Reported adverse effects (prevalent and incident) confirm the need for a more rational use of NSAIDs and ongoing pharmacovigilance.

Predominant learning styles among pharmacy students at the Federal University of Paraná, Brazil

Background: Learning styles are cognitive, emotional, and physiological traits, as well as indicators of how learners perceive, interact, and respond to their learning environments. According to Honey-Mumford, learning styles are classified as active, reflexive, theoretical, and pragmatic. Objective: The purpose of this study was to identify the predominant learning styles among pharmacy students at the Federal University of Paraná, Brazil. Methods: An observational, cross-sectional, and descriptive study was conducted using the Honey-Alonso Learning Style Questionnaire. Students in the Bachelor of Pharmacy program were invited to participate in this study. The questionnaire comprised 80 randomized questions, 20 for each of the four learning styles. The maximum possible score was 20 points for each learning style, and cumulative scores indicated the predominant learning styles among the participants. Honey-Mumford (1986) proposed five preference levels for each style (very low, low, moderate, high, and very high), called a general interpretation scale, to avoid student identification with one learning style and ignoring the characteristics of the other styles. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 20.0. Results: This study included 297 students (70% of all pharmacy students at the time) with a median age of 21 years old. Women comprised 77.1% of participants. The predominant style among pharmacy students at the Federal University of Paraná was the pragmatist, with a median of 14 (high preference). The pragmatist style prevails in people who are able to discover techniques related to their daily learning because such people are curious to discover new strategies and attempt to verify whether the strategies are efficient and valid. Because these people are direct and objective in their actions, pragmatists prefer to focus on practical issues that are validated and on problem situations. There was no statistically significant difference between genders with regard to learning styles. Conclusion: The pragmatist style is the prevailing style among pharmacy students at the Federal University of Paraná. Although students may have a learning preference that preference is not the only manner in which students can learn, neither their preference is the only manner in which students can be taught. Awareness of students’ learning styles can be used to adapt the methodology used by teachers to render the teaching-learning process effective and long lasting. The content taught to students should be presented in different manners because varying teaching methods can develop learning skills in students.

Medication reconciliation at patient admission: a randomized controlled trial

Objective: To measure length of hospital stay (LHS) in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620). The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety.

Reliability assessment of a peer evaluation instrument in a team-based learning course

Objective: To evaluate the reliability of a peer evaluation instrument in a longitudinal team-based learning setting. Methods: Student pharmacists were instructed to evaluate the contributions of their peers. Evaluations were analyzed for the variance of the scores by identifying low, medium, and high scores. Agreement between performance ratings within each group of students was assessed via intra-class correlation coefficient (ICC). Results: We found little variation in the standard deviation (SD) based on the score means among the high, medium, and low scores within each group. The lack of variation in SD of results between groups suggests that the peer evaluation instrument produces precise results. The ICC showed strong concordance among raters. Conclusions: Findings suggest that our student peer evaluation instrument provides a reliable method for peer assessment in team-based learning settings.

Inclusion of salt form on prescription medication labeling as a source of patient confusion: a pilot study

Background: It has been estimated that 10,000 patient injuries occur in the US annually due to confusion involving drug names. An unexplored source of patient misunderstandings may be medication salt forms. Objective: The objective of this study was to assess patient knowledge and comprehension regarding the salt forms of medications as a potential source of medication errors. Methods: A 12 item questionnaire which assessed patient knowledge of medication names on prescription labels was administered to a convenience sample of patients presenting to a family practice clinic. Descriptive statistics were calculated and multivariate analyses were performed. Results: There were 308 responses. Overall, 41% of patients agreed they find their medication names confusing. Participants correctly answered to salt form questions between 12.1% and 56.9% of the time. Taking more prescription medications and higher education level were positively associated with providing more correct answers to 3 medication salt form knowledge questions, while age was negatively associated. Conclusions: Patient misconceptions about medication salt forms are common. These findings support recommendations to standardize the inclusion or exclusion of salt forms. Increasing patient education is another possible approach to reducing confusion.

Pharmacy students’ knowledge and attitudes about antibiotics in Kosovo

Objective: The main objective of this study was to assess the knowledge and attitude among Pharmacy students of the University of Prishtina in regards to the antibiotics. Methods: 144 pharmacy students at the University of Prishtina were recruited in this study to complete a self-administered questionnaire. The total number of questions in this questionnaire was eight (8), covering two (2) major themes: self-report of the current and past antibiotic use and behavior; and anticipated prescription behavior of antibiotics upon graduation. The data was statistically analyzed through using SPSS for Windows. Descriptive analysis was employed, and the results were expressed in frequency and percentages. Results: The results showcased a good knowledge of antibiotic among students. The most common answer of students' knowledge about antibiotics was good or moderate (82 %), while 63.2% of the subjects used antibiotics by self-decision, most of them (45 %) for sore throat. Upon graduation, 56.9 % of the students will not sell antibiotics without prescription and 85.4% think that module for rational use of antibiotics is very necessary to be inside the pharmacy syllabus. Conclusion: The study showed good and moderate knowledge of pharmacy students regarding the antibiotics. Half of them use antibiotics by self-decision but the majority of them stated that they will not serve the antibiotics without medical prescription. Specific modules and training for proper antibiotic use should be implemented within the Pharmacy program in The Faculty of Medicine.

Inter-professional education unveiling significant association between asthma knowledge and inhaler technique

Objectives: To explore whether an association exists between health care professionals’ (HCPs) asthma knowledge and inhaler technique demonstration skills. Methods: HCPs’ asthma knowledge and inhaler technique demonstration skills were assessed at baseline at an inter-professional educational workshop focusing on asthma medication use. Asthma knowledge was assessed via a published questionnaire. Correct inhaler technique for the three inhalers, the Accuhaler, Turbuhaler and pressurized Metered Dose Inhaler (pMDI) was assessed using published checklists. Results: Two hundred HCPs agreed to participate: 10 specialists (medical doctors specialized in respiratory diseases) (5%), 46 general practitioners (23%), 79 pharmacists (39%), 15 pharmacists’ assistants (8%), 40 nurses (20%) and 10 respiratory therapists (5%). Backwards stepwise multiple regression conducted to determine predictors of HCPs’ inhaler technique, showed that out of many independent variables (asthma knowledge score, profession, age, gender, place of work, years in practice and previous personal use of the study inhaler/s), asthma knowledge score was the only variable showing significant association with inhaler technique (R²=0.162, p<0.001). Conclusion: This study revealed significant associations between asthma knowledge and inhaler technique scores for all HCPs. Providing inter-professional workshops for all HCPs involved integrating education on asthma knowledge and practice of inhaler technique skills are looked-for.