Physicians’ and patients’ valuation of pharmaceutical care implementation in Poznan (Poland) community pharmacies

Implementation of pharmaceutical care (PC) in Poland is of great importance to patients, who, on the one hand, often follow complex pharmacological treatment regimens recommended by several physicians of different specialties, and, on the other, take up the decision on self-treatment due to availability of OTC medications. The aim of the present study was to assess the opinion of both patients and physicians about implementation of PC service in Polish community pharmacies.A cross sectional study was carried out from September 2009 to September 2010 by a pharmacist (author of the study) on the basis of an anonymous questionnaire, where demand of physicians (n = 104) and patients (n = 202) for implementation of PC in a community pharmacy was assessed. The study was planned to determine the relationship between implementation of PC, cost and time of this service and patients’ and physicians’ socio-economic information.Responding patients (85.64%) and physicians (76.92%) unanimously confirmed the need for implementation of PC. Most people convinced of the service implementation were 88.89% of physicians under the age of 35 and all the respondents were over 65 years of age (p = 0.027), just as 93.33% with service lesser than 5 years and 73.68% of respondents working a maximum of 20 years (p = 0.023). Mainly according to 90.00% of physicians with specialty in internal medicine and 92.59% of physicians of the group “Others” (p = 0.012), PC should be implemented in pharmacies. Women more frequently than men reckoned that appointments with a pharmacist should last up to 15 min (p = 0.012). According to 77.78% of the youngest physicians and 83.33% of the oldest ones, appointments should last from 5 to 15 min (p = 0.049), and a similar opinion was shared by 80.77% of physicians without specialty and 77.78% of physicians of the group “Others” (p = 0.0009). According to patients, the mean cost of the visit should be USD 7. Physicians most often assessed the mean cost of the appointment at USD 14.This study provides new data about implementation of PC in Poland. The increased patients’ and physicians’ willingness to benefit from this service provides pharmacists with opportunities to develop PC in community pharmacies.Abbreviation: PC, pharmaceutical care.     

Pharmacists’ and physicians’ perception and exposure to drug promotion: A Saudi study

Introduction

Drug promotion has to contribute to a more rational use of drugs. Concerns arise if promotion negatively influences prescribing/dispensing pattern. It is warranted to assess exposure and attitudes to, and acceptance of, drug promotion among pharmacists and physicians.

Methodology

Adopting a randomized, multiple site and cross-sectional survey study, questionnaires (n = 250) were completed by physicians and pharmacists to investigate the exposure, acceptance or skepticism of Saudi physicians/pharmacists to drug promotion as well as their perception of the appropriateness of gifts and to check if they had any teaching/training about dealing with medical representatives (MRs) and Pharma promotion.

Results

Significantly more pharmacists than physicians (32% vs. 23%; p < 0.05) reported being taught or educated about the ethics of drug promotion. The experience level was significantly associated with the teaching or training that the physicians and pharmacists received. Conference registration fees and drug samples were the most appropriate promotional gift for the physicians (67% and 66%, respectively; p < 0.01) whereas for pharmacists, the drug sample was considered the most suitable donation (79%). More pharmacists perceived drug companies as a useful way to gain knowledge about drugs than physicians (75% vs. 65%; p < 0.01). A higher proportion of both groups were accepting drug promotion than those skeptical about it.

Conclusion

The majority of physicians or pharmacists participating in this study have received gifts from pharmaceutical companies. The drug samples and printed educational materials are the most widely accepted gifts. Recent graduates and those with few years of experience had higher teaching/training than experienced physicians and pharmacists in pharmaceutical promotion ethics and tactics to deal with MRs. On the other hand, experienced healthcare team were more approached and targeted by pharmaceutical companies and MRs. It is highly recommended to implement courses/discussion groups on the ethical interaction between healthcare professionals and pharmaceutical companies in the curriculum of both pharmacy and medicine. Updating the physicians and pharmacists after graduation, as part of continued medical/pharmacy education, will eventually improve the healthcare professionals’ capability to act to the patients’ welfare.     

The impact of using pictorial aids in caregivers’ understanding of patient information leaflets of pediatric pain medications: A quasi-experimental study

IntroductionPatient information leaflets (PILs) are one of the main sources of information for over-the-counter medications (OTCs). This study aimed to assess caregivers'' understanding of instructions in PILs provided with paracetamol medications and the impact of pictograms use.MethodsA quasi-experimental study was conducted among caregivers of children aged < 13 years recruited in pediatric outpatient clinics at University Medical City in Riyadh. The calculated sample size was 128; at least 64 participants were needed in each group (the text-only group and the text-plus pictograms group). Caregivers'' health literacy was assessed using a validated Arabic version of the Newest Vital Sign scale. Participants’ understanding of PILs instructions was assessed using eight questions on the route of administration, minimal hours between doses, max daily dose, shake medication before use, storage, and reporting adverse events; and was rated based on the number of questions correctly understood. Characteristics of participants were compared by Pearson X² and t-test was used to assess the significance of mean score differences between groups.ResultsA total of 130 caregivers participated in the study; almost half of them were mothers (47%, [n = 61]) and 43% (n = 56) have “a possibility of limited health literacy”. The mean number of correct answers to questions assessing the understanding of PILs instructions was significantly higher among the text-plus pictograms group compared to the text-only group (5.25 ± 1.85 vs. 4.38 ± 1.27; p < 0.001). When results were controlled for age and gender, better health literacy was found to be associated with a better understanding of instructions (B = 0.39, 95 %CI 0.23–0.54).ConclusionLimited comprehension of medications instructions was observed; adding pictorial aids to PILs might enhance the comprehension. Differences in health literacy levels of caregivers should be considered when designing PILs.     

Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference

This article summarizes discussions at the March 2014 conference organized by the University of Florida (UF) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), entitled “Orlando Inhalation Conference: Approaches in International Regulation.” The special focus of the conference was on global scientific and regulatory issues associated with the testing and demonstration of equivalence for the registration of orally inhaled drug products (OIDPs) in the United States, Europe, Brazil, China, and India. The scope included all types of OIDPs throughout their lifecycle, e.g., innovator/brand-name products, generics, modifications due to lifecycle management, device changes, etc. Details were presented for the U.S. “weight of evidence approach” for registration of generic products (which includes demonstration of in vitro and in vivo equivalence, as well as quantitative and qualitative sameness, and device similarity). The European “stepwise” approach was elucidated, and the thinking of regulatory agencies in the major emerging markets was clarified. The conference also highlighted a number of areas that would benefit from further research and discussion, especially around patient/device interface and human factor studies, statistical methods and criteria for demonstrating equivalence, the relative roles of in vivo and in vitro tests, and appropriate designs and metrics for in vivo studies of inhaled drugs.KEY WORDS: bioequivalence, emerging markets, generics, MDIs and DPIs, regulatory science     

Efficacy and safety of silodosin in the medical expulsion therapy for distal ureteral calculi: a systematic review and meta‐analysis

Aims

Using a selective α‐adrenoceptor blocker for medical expulsive therapy (MET) is an effective treatment approach widely used for ureteral stones. The aim of the review was to assess the efficacy and safety of silodosin in medical expulstion therapy compared with placebo and tamsulosin.

Methods

A systematic search was performed in PubMed, Cochrane Library and Embase to identify randomized controlled trials that compared silodosin with a placebo or tamsulosin for ureteral calculi.

Results

Eight publications involving a total of 1048 patients were used in the analysis, which compared silodosin with placebo and tamsulosin. We found that silodosin was effective in treating ureteral calculi in our meta‐analysis and was superior to tamsulosin in its efficacy. The expulsion rate of all ureteral stones (OR 1.59, 95% CI 1.08, 2.36, P = 0.02), the expulsion rate of distal ureteral stones (OR 2.82, 95% CI 1.70, 4.67, P < 0.0001) and the expulsion time (days) of distal ureteral stones (standard mean difference (SMD) −4.71, 95% CI −6.60, −2.83, P < 0.00001) indicated that silodosin was more effective than the placebo. Moreover, expulsion rate (OR 2.54, 95% CI 1.70, 3.78, P < 0.00001), expulsion time (days) (SMD −2.64, 95% CI −3.64, −1.64, P < 0.00001) and pain episodes (P < 0.00001) indicated that silodosin was more effective than the tamsulosin. Even though silodosin had a significant increase in abnormal ejaculation compared with tamsulosin, no significant differences were observed for complications (OR 1.00, 95% CI 0.58, 1.74, P = 1.00).

Conclusions

This meta‐analysis indicated that silodosin was superior to placebo or tamsulosin in the efficacy for distal ureteral calculi with better control of pain. The safety profile of silodosin was similar to tamsulosin though retrograde ejaculation was worse for silodosin use. We conclude that silodosin might have potential as a MET for ureteral stones.     

Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co‐medication interactions

AimThe aim of the present study was to analyse concomitant drug use and its association with outcome in patients (N = 17 701) receiving rivaroxaban or standard of care (SOC) for the prevention of venous thromboembolism after major orthopaedic surgery in the non‐interventional, phase IV XAMOS (Xarelto® in the prophylaxis of post‐surgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study.MethodsConcomitant drug use was at the discretion of the treating physician. Prespecified co‐medications of interest were cytochrome P450 (CYP) 3A4/P‐glycoprotein inhibitors/inducers, platelet aggregation inhibitors (PAIs) and nonsteroidal anti‐inflammatory drugs (NSAIDs). Crude event incidences were compared between rivaroxaban and SOC groups.ResultsCYP3A4/P‐glycoprotein inhibitor/inducer use was infrequent, in contrast to PAI (~7%) and NSAID (~52%) use. Rivaroxaban was associated with a lower incidence of overall symptomatic thromboembolic events compared with SOC, regardless of co‐medication use. In both treatment groups, PAI users, with higher age and prevalence of cardiovascular co‐morbidities, had similar higher (>7‐fold) incidences of symptomatic arterial but not venous thromboembolic events compared with non‐users. NSAID use had no influence on thromboembolic events. However, odds ratios (ORs) for major bleeding events (European Medicines Agency definition) were higher in NSAID users compared with non‐users in rivaroxaban [OR = 1.50; 95% confidence interval (CI) 1.06, 2.13] and SOC (OR = 1.70; CI 1.16, 2.49) groups. In PAI users, ORs for major bleeding events were no different from those of non‐users in both the rivaroxaban (OR = 1.49; CI 0.84, 2.65) and SOC (OR = 1.46; CI 0.82, 2.62) groups.ConclusionsUse of NSAIDs in XAMOS was frequent and associated with a higher frequency of bleeding events in patients receiving rivaroxaban or SOC, although the benefit–risk profile of rivaroxaban compared with SOC was maintained.     

Generic medications for you,but brand-name medications for me

BackgroundBecause generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics.ObjectiveThis study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid).MethodsWe recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications.ResultsThe average age of the women (n = 172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics.ConclusionAwareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers—both physicians and pharmacists—infrequently discussed generic substitution with them.     

Saudi school students’ knowledge,attitude and practice toward medicines

The current study was aimed to assess Saudi school students’ knowledge, attitude and practice about medicines. A pretested self-administered questionnaire was used anonymously among 15–20 year-old adolescents attending tertiary schools in Taif City, KSA. A total of 1022 students completed the questionnaires. Only 15.4% of the respondents knew the medicines’ uses. Most of the students 79.6% affirmed that they used to take medicines after consulting physicians, and 45.1% of the students thought that tablet size affects the medicine’s efficacy. More than half of the students knew that high temperatures affect the efficacy of medicines, there was a significant difference between rural and urban areas (P = 0.005). Physicians (50.6%) and community pharmacists (15.7%), were the main students’ reliable sources of information about medicines. The majority of the students 70.5% were interested in learning more about medicines. The younger students ⩽18 years wish to learn more than the older ones (P < 0.014). The study showed that Saudi school students aged 15–20 years old have poor knowledge, misconception and negative attitudes about medicines. Low level of knowledge may expose adolescents to health-related problems. Educational efforts are important to improve students’ practice toward medicines.     

Community pharmacists’ knowledge,behaviors and experiences about adverse drug reaction reporting in Saudi Arabia

Objective

To assess community pharmacists’ knowledge, behaviors and experiences relating to Adverse Drug Reaction (ADR) reporting in Saudi Arabia.

Methods

A cross-sectional study was conducted using a validated self-administered questionnaire. A convenience sample of 147 community pharmacists working in community pharmacies in Riyadh, Saudi Arabia.

Results

The questionnaire was distributed to 147 pharmacists, of whom 104 responded to the survey, a 70.7% response rate. The mean age of participants was 29 years. The majority (n = 101, 98.1%) had graduated with a bachelorette degree and worked in chain pharmacies (n = 68, 66.7%). Only 23 (22.1%) said they were familiar with the ADR reporting process, and only 21 (20.2%) knew that pharmacists can submit ADR reports online. The majority of the participants (n = 90, 86.5%) had never reported ADRs. Reasons for not reporting ADRs most importantly included lack of awareness about the method of reporting (n = 22, 45.9%), misconception that reporting ADRs is the duty of physician and hospital pharmacist (n = 8, 16.6%) and ADRs in community pharmacies are simple and should not be reported (n = 8, 16.6%). The most common approach perceived by community pharmacists for managing patients suffering from ADRs was to refer him/her to a physician (n = 80, 76.9%).

Conclusion

The majority of community pharmacists in Riyadh have poor knowledge of the ADR reporting process. Pharmacovigilance authorities should take necessary steps to urgently design interventional programs in order to increase the knowledge and awareness of pharmacists regarding the ADR reporting process.     

Measuring the rate of therapeutic adherence among outpatients with T2DM in Egypt

Background and objective

The promotion of therapeutic adherence is considered as an integral component of pharmaceutical care practice and patient healthcare. It has been shown that despite effective methods of treatment, 50% of diabetic patients fail to achieve satisfactory glycemic control, which leads to accelerated development of complications and increased mortality. Clinical experience indicates that no improvement of metabolic control is possible without patients’ adherence to medications. This study sought to examine the rate of medication adherence and different factors affecting it among Type 2 diabetic patients in Egypt.

Methods

A total of 226 Type 2 diabetic patients who fulfilled the inclusion criteria were recruited in the current study. Adherence to the treatment was evaluated during patients’ hospitalization in the Outpatient Clinics of Internal Medicine Department at University of Mansoura, Egypt. The medication adherence has been assessed during a personal interview with each patient using a multiple-choice graded questionnaire.

Results

In the study population, the adherence rates to medication, dietary/exercise and appointment were observed to be suboptimal. The most important social factors that were significantly affecting adherence rate to the prescribed oral hypoglycemic agent(s) included marital status (P < 0.01), family support (P < 0.01), and socio-economical level (P < 0.01). Other patient factors that were significantly affecting therapeutic adherence were patient knowledge about the disease (P < 0.01), patients’ beliefs and motivation about prescribed drugs (P < 0.01), and regularity of patients’ self monitoring of blood glucose level (P < 0.01). Among drug factors which found to affect significantly the rate of medication adherence are the number of drugs taken (P < 0.05), complexity of drug regimen (P < 0.01), and the presence of drug side effects (P < 0.01). Economical factor played an equally important role. Direct and indirect care costs in relation to patients’ income were significantly affecting the rate of adherence to medication (P < 0.01).

Conclusions

An improvement with the adherence to oral hypoglycemic agent(s) may be achieved through continuing patient education about diabetes, improvement of patients’ economical levels as well as a reduction in the cost of medication. Pharmaceutical companies have to be involved and pharmacists have to be payed for helping chronically ill patients to take their medicines correctly for improving clinical outcomes.     

Impact of a pharmacist led diabetes mellitus intervention on HbA1c,medication adherence and quality of life: A randomised controlled study

Malaysia is situated in Western Pacific region which bears 36.17% of total diabetes mellitus population. Pharmacist led diabetes interventions have been shown to improve the clinical outcomes amongst diabetes patients in various parts of the world. Despite high prevalence of disease in this region there is a lack of reported intervention outcomes from this region. The aim of this study was to evaluate the impact of a pharmacist led intervention on HbA1c, medication adherence, quality of life and other secondary outcomes amongst type 2 diabetes patients. Method: Type 2 diabetes mellitus patients (n = 73) attending endocrine clinic at Universiti Kebangsaan Malaysia Medical Centre (UKMMC) were randomised to either control (n = 36) or intervention group (n = 37) after screening. Patients in the intervention group received an intervention from a pharmacist during the enrolment, after three and six months of the enrolment. Outcome measures such as HbA1c, BMI, lipid profile, Morisky scores and quality of life (QoL) scores were assessed at the enrolment and after 6 months of the study in both groups. Patients in the control group did not undergo intervention or educational module other than the standard care at UKMMC. Results: HbA1c values reduced significantly from 9.66% to 8.47% (P = 0.001) in the intervention group. However, no significant changes were noted in the control group (9.64–9.26%, P = 0.14). BMI values showed significant reduction in the intervention group (29.34–28.92 kg/m²; P = 0.03) and lipid profiles were unchanged in both groups. Morisky adherence scores significantly increased from 5.83 to 6.77 (P = 0.02) in the intervention group; however, no significant change was observed in the control group (5.95–5.98, P = 0.85). QoL profiles produced mixed results. Conclusion: This randomised controlled study provides evidence about favourable impact of a pharmacist led diabetes intervention programme on HbA1c, medication adherence and QoL scores amongst type 2 diabetes patients at UKMMC, Malaysia.     

An evaluation of consumers’ knowledge, perceptions and attitudes regarding generic medicines in Auckland

Objectives The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. Methods A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. Results A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers’ willingness to use generics. Conclusion Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.     

Comparative in vitro dissolution study of carbamazepine immediate-release products using the USP paddles method and the flow-through cell system

Dissolution profiles of four carbamazepine immediate-release generic products (200 mg tablets) and the reference product Tegretol® were evaluated using the USP paddles method and an alternative method with the flow-through cell system, USP Apparatus 4. Under official conditions all products met the Q specification, dissolution profiles of generic products were similar to the dissolution profile of the reference product (f₂ > 50) and model-independent parameters showed non significant differences to the reference product except mean dissolution time for product A (p < 0.05). On the other hand, when the flow-through cell system was used, none of the products met the pharmacopeial specification at 15 min and product A did not reach dissolution criteria at 60 min, dissolution profiles of all generic products were not similar to the reference product profile (f₂ < 50) and all model-independent parameters showed significant differences compared to the reference product (p < 0.05). Weibull’s model was more useful for adjusting the dissolution data of all products in both USP apparatuses and Td values showed significant differences compared to the reference product (p < 0.05) when USP Apparatus 4 was used. These results indicate that the proposed method, using the flow-through cell system, is more discriminative in evaluating both, rate and extent of carbamazepine dissolution process from immediate-release generic products.     

Evaluating factors affecting the implementation of evidence based medicine in primary healthcare centers in Dubai

Objectives

To assess the current evidence based medicine (EBM) knowledge, attitude and perceptions of physicians at Dubai Primary Health Care Sector (PHCS). Further to evaluate barrier and facilitator factors toward implementing the EBM practice.

Methodology

A cross-sectional study, at Dubai PHCS, UAE between June and August 2010. The survey was composed of two phases. The first phase was a self administrated questionnaire employed for data collection and the second phase was qualitative method, which was in the form of individual interviews. Statistical Package for Social Sciences (SPSS) was used for data analysis.

Results

In total 48 participants responded to the survey questionnaire and 13 responded to individual interviews. The response rate was 70.0%. Mean age was 42.18 (SD 10.46). The majority were females (64.6%). The physicians who attended EBM courses reported 70.30% using EBM and showed statistical significance (p = 0.002) from those who did not attend the EBM courses. 65.0% believe that 50–75% of the patients are capable of participating in clinical decision while 71.8% disagreed that the concept of EBM is not applicable to their culture. In addition they showed significance (p = 0.03) between physician beliefs with regard to patient capacity to take decision. About 67.0% of the family physicians were knowledgeable and followed systematic review as the strongest evidence. They had no access to the EBM resources (37.0%) and had no time to practice the EBM (38.0%). Nearly 40.0% interviewees reported lack of encouragement to attend EBM courses. EBM activities (22.0%) and active audit (18.0%) were top rated facilitating factors.

Conclusions

EBM is not fully utilized by indefinite physicians in the Dubai PHC sector. Factors associated with non-utilization of EBM in the PHCS are lack of encouragement to attend EBM courses, senior physicians resist adoption of EBM, lack of time and insufficient dissemination process for implementing the clinical guideline.     

In Vitro Stability Evaluation of Different Pharmaceutical Products Containing Meropenem

Background:

Meropenem is a beta-lactam antibiotic for treating multidrug-resistant gram-negative bacilli infections. The expiry of the drug’s patent (Merrem) allowed the production of generics to be commercialized by a few companies, including Hospira and Hikma. The stability of these medicines after reconstitution as reported on a data sheet report is 6 hours for Merrem and 1 hour for generics.

Objectives:

The aim of this work was to evaluate the stability profile of 3 products in 0.9% sodium chloride until 6 hours.

Methods:

Six polyolefin bags (2 for each drug, stored in the light and in the dark) were prepared for every test run (n =10) at concentrations of 4 and 10 mg/mL. All solutions were stored at controlled room temperature (25°C ± 3°C) and sampled immediately after preparation and at every hour until 6 hours had passed. The concentrations, pH changes, and the visual clarity were used as stability and compatibility indicators.

Results:

All 3 drugs retained over 95% of the initial concentration at 3 to 4 hours. At the sixth hour, all the concentrations decayed 8% to 10%. No statistical differences were observed in the percentage deviation values of the stability profile between generics and the branded drug.

Conclusion:

The stability profile of the products in polyolefin bags, at 4 and 10 mg/mL, was superimposable during the period of analysis and seems to show small values of deviation (1%-2%). These data do not affect the pharmacokinetics because these variations could be attributed to the intra- and interindividual variability between patients. The products showed the same stability, and consequently they could be used interchangeably in hospital pharmacy.