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.     

Inter-Rater Reliability of the PIPES Tool: Validation of a Surgical Capacity Index for Use in Resource-Limited Settings

Introduction

In response to the need for simple, rapid means of quantifying surgical capacity in low resource settings, Surgeons OverSeas (SOS) developed the personnel, infrastructure, procedures, equipment and supplies (PIPES) tool. The present investigation assessed the inter-rater reliability of the PIPES tool.

Methods

As part of a government assessment of surgical services in Santa Cruz, Bolivia, the PIPES tool was translated into Spanish and applied in interviews with physicians at 31 public hospitals. An additional interview was conducted with nurses at a convenience sample of 25 of these hospitals. Physician and nurse responses were then compared to generate an estimate of reliability. For dichotomous survey items, inter-rater reliability between physicians and nurses was assessed using the Cohen’s kappa statistic and percent agreement. The Pearson correlation coefficient was used to assess agreement for continuous items.

Results

Cohen’s kappa was 0.46 for infrastructure, 0.43 for procedures, 0.26 for equipment, and 0 for supplies sections. The median correlation coefficient was 0.91 for continuous items. Correlation was 0.79 for the PIPES index, and ranged from 0.32 to 0.98 for continuous response items.

Conclusions

Reliability of the PIPES tool was moderate for the infrastructure and procedures sections, fair for the equipment section, and poor for supplies section when comparing surgeons’ responses to nurses’ responses—an extremely rigorous test of reliability. These results indicate that the PIPES tool is an effective measure of surgical capacity but that the equipment and supplies sections may need to be revised.     

A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT

Objectives

Excisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, non-surgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid™ (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC.

Methods

We conducted a multi-center, open-label, randomized, controlled clinical trial including patients aged 4-55 years with deep partial and full thickness burns covering 5-30% of their total body surface area (TBSA). Patients were randomly assigned to burn debridement with NXB (applied for 4 h) or SOC, which included surgical excisional or non-surgical debridement.

Results

NXB significantly reduced the time from injury to complete débridement (2.2 vs. 8.7 days, P < 0.0001), need for surgery (24.5% vs. 70.0%, P < 0.0001), the area of burns excised (13.1% vs. 56.7%, P < 0.0001) and the need for autografting (17.9% vs. 34.1%, P = 0.01). Scar quality and quality of life scores were similar in both study groups as were the rates of adverse events.

Conclusions

Enzymatic débridement with NXB resulted in reduced need for and extent of surgery compared with SOC while achieving comparable long-term results in patients with deep burns.

Trial registration

: Clinical Trials.gov NCT00324311.     

A new and automated method for objective analysis of detrusor rhythm during the filling phase

Introduction

There is growing acceptance that the detrusor muscle is not silent during the filling phase of the micturition cycle but displays low-amplitude phasic contractions that have been associated with urinary urgency. Unfortunately, there is currently no standardized methodology to quantify detrusor rhythm during the filling phase. Therefore, the purpose of this study was to develop an automated computer algorithm to analyze rat detrusor rhythm in a quick, accurate, and reproducible manner.

Materials and methods

Strips of detrusor smooth muscle from rats (n = 17) were placed on force transducers and subjected to escalating doses of PGE₂ to generate contractile rhythm tracings. An automated computer algorithm was developed to analyze contractile frequency, amplitude, and tone on the generated rhythm tracings. Results of the automated computerized analysis were compared to human (n = 3) interpretations. Human interpreters manually counted contractions and then recounted the same data two weeks later. Intra-observer, inter-observer, and human-to-computer comparisons were performed.

Results

The computer algorithm quantified concentration-dependent changes in contractile frequency, amplitude, and tone after administration of PGE₂ (10^?9–10^?6M). Concentration–response curves were similar for all contractile components with increases in frequency identified mainly at physiologic concentrations of PGE₂ and increases in amplitude at supra-physiologic concentrations. The computer algorithm consistently over-counted the human interpreters, but with less variability. Differences in inter-observer consistency were statistically significant.

Conclusions

Our computerized algorithm accurately and consistently identified changes in detrusor muscle contractile frequency, amplitude, and tone with varying doses of PGE₂. Frequency counts were consistently higher than those obtained by human interpreters but without variability or bias. Refinements of this method may allow for more standardized approach in the study of pharmacologic agents on filling phase rhythmic activity.     

Fibrosis in Hepatitis C Patients Predicts Complications After Elective Total Joint Arthroplasty

Effects of Hepatitis C on total hip (THA) and total knee arthroplasty (TKA) outcomes are poorly understood. Seventy-two hepatitis C patients underwent 77 primary THA or TKA and were retrospectively identified, stratified by fibrosis and thrombocytopenia and compared to matched controls. Overall, Hepatitis C and control patients had similar outcomes. After TKA, fibrotic hepatitis C patients demonstrated a greater average hemoglobin drop than non-fibrotic hepatitis C patients (4.9 versus 3.8, P = 0.023), greater deep infection rate (21% versus 0%, P = 0.047), and rate of cellulitis (21% versus 0%, P = 0.047). Thrombocytopenia showed a trend toward greater infections. Prior to fibrosis, Hepatitis C patients appear to be at no increased risk of complication after joint arthroplasty. Evaluation of fibrosis may predict poor outcome in Hepatitis C patients.