Iranian Consensus Guideline for Pharmacotherapy with Biologics and Small Molecules Drugs in Adults with Inflammatory Bowel Diseases.

Background: Pharmacotherapy with biologics and small molecules, as the more effective therapies for moderate to severe ulcerative colitis (UC) and Crohn's disease (CD), is complex. Choosing the best methods for their utilization in order to induce and maintain remission are critical for practicing gastroenterologists. We aimed to develop an Iranian consensus on the management of inflammatory bowel disease (IBD) patients with biologics and small molecules. Methods: A Delphi consensus was undertaken by experts who performed a literature summary and voting process. Quality of evidence was assessed using the Grading and Recommendations Assessment, Development, and Evaluation; and an additional risk of bias-protocol. Results: Following an extensive search of the literature, 219 studies were used to determine the quality of the evidence. After three rounds of voting, consensus (defined as≥80% agreement) was reached for 87 statements. Conclusion: We considered different aspects of pharmacotherapy in this consensus. This guideline, along with clinical judgment, can be used to optimize management of IBD patients.

Clinical Role of Silymarin in Oxidative Stress and Infertility: A Short Review for Pharmacy Practitioners.

Silymarin (SMN) as an ancient plant has various therapeutic usage in many diseases. Almost all of its properties attributed to antioxidant and anti-inflammatory properties. Currently, infertility problems impose a heavy burden on many developing countries. As a result, effective infertility treatment is indicated. The role of oxidative stress in both male and female infertility has been revealed. Many studies have shown protective and antioxidative properties of SMN against adverse effects of chemotherapy medications and environmental toxins in sperms and oocytes. The antioxidative and clinical role of SMN in infertility has been reviewed. The use of antioxidants such as SMN can help to improve fertility rate by scavenging free radicals and inhibiting nuclear factor kappa B transcription factor. Animal studies in both male and female have indicated a beneficial effect of SMN on fertility recovery. Further clinical studies are needed considering the phytoestrogenic property of SMN, to determine the right dose and duration of treatment.

Assessment of Orthographic Similarity of Drugs Names between Iran and Overseas Using the Solar Model.

BACKGROUND: The recognition of patient safety is now occupying a prominent place on the health policy agenda since medical errors can result in adverse events. The existence of confusing drug names is one of the most common causes of medication errors. In Iran, the General Office of Trademarks Registry (GOTR), for four years (2010-2014) was responsible for approving drug proprietary names. This study aimed to investigate the performance of the GOTR in terms of drug names orthographic similarity using the SOLAR model. METHODS: First, 100 names were randomly selected from the GOTR's database. Then, each name was searched through pharmaceutical websites including Martindale (the Complete Drug Reference published by Pharmaceutical Press), Drugs.com and Medicines Complete. Pair of drugs whose names look orthographically similar with different indications were identified. Then, the SOLAR model was utilized to determine orthographic similarity between all pair of drug names. RESULTS: The mean of match values of these 100 pairs of drug was 77% indicating the high risk of similarity. The match value for most of the reviewed pairs (92%) was high (≥66%). This value was medium (≥ 33% and <66%) just for 8% of the pairs of drug. These results indicate high risk of confusion due to similarity of drug names. CONCLUSION: The stewardship of the GOTR in patient safety considerations is fundamentally problematic. Thus, as a best practice, we recommend that proprietary names of drugs be evaluated by an entity within the health system. While an entity within the health system should address patient safety considerations, the GOTR is responsible for intellectual property rights.

Incidence of Medication Discrepancies and Its Predicting Factors in Emergency Department.

BACKGROUND: This study was conducted to evaluate the incidence of medication discrepancies and its related factors using medication reconciliation method in patients admitted to the emergency department of Tehran University of Medical Sciences hospitals. METHODS: In this cross-sectional study, 200 adult patients with at least one chronic disease that used two regular prescription medications were included in 2015. After 24 h of admission, demographic data and patient's home medications were collected. Medication discrepancies were assessed through comparison of a best possible medication history list with the physician's orders. RESULTS: Out of 200 patients (mean age, 61.5 yr; 86 males, 114 women), 77.5% of patients had one or more medication discrepancies. The most common discrepancies were medication omission (35.49%), change (14.22%) and substitution (10.97%), respectively. The relationship between number of comorbid conditions (P=0.025), regular home medications (P=<0.001), high-risk medications (P=0.032), medications pharmacological classes (P=<0.001) and medication discrepancies were statistically significant. Cardiovascular drugs compared to other medications classes showed the highest discrepancies (36.2%). Multiple logistic regression showed that the drug groups, including anti-infective for systemic use (OR=8.43; 95%CI 2.5-28.2; P=0.001), Antineoplastic and Immuno-modulator Agents (OR=0.49; 95%CI 0.27-0.87; P=0.016), Blood and Blood-Forming Organs (OR=0.33; 95%CI 0.21-0.52; P<0.001), Muscular-Skeletal System (OR=2.4; 95%CI 1.13-5.1; P=0.022), Nervous-System (OR=2.75; 95%CI 1.7-4.4; P<0.001), Respiratory-System (OR=0.38; 95%CI 0.22-0.67; P=0.001) were associated with the drug discrepancy. CONCLUSION: A medication discrepancy occurs commonly at hospital emergency department. Understanding the type and frequency of discrepancies with using structured medication reconciliation process can help clinicians to prevent them.

The establishment of the Drug Naming Committee to restrict look-alike medication names in Iran: A qualitative study.

BACKGROUND: Medication errors is a prominent issue on the health policy agenda due to its significant human and financial costs; confusing drug names are one of the most common causes of them. This issue necessitates the adoption of a mechanism to restrict such a confusion before approving drug names. OBJECTIVE: Following the establishment of a committee and developed relevant criteria as mechanisms to address the issue of drug names similarity Iran, there were problems in this process. This study explores the process of adopting this mechanism. METHODS: This qualitative study was conducted using date gathered through documents, observation and 31 semi-structured interviews. Ethical approval was achieved from the Research Ethics Committee in TUMS. Confidentiality was ensured at all the interviews. The interviews were recorded verbatim, transcribed and coded, using the MAXQDA ver.12 software. Data were analyzed utilizing the Health Policy Triangle Framework. RESULTS: High rate of medication errors and warning from the WHO about drug names in Iran pushed the issue of drug proprietary names to the FDO agenda. A National Drugs Naming Committee was established and relevant criteria were developed by the Food and Drug Organization (FDO). This committee was dissolved for four years; the function was delegated to the General Office of Trademarks Registry. However, the committee was reestablished and resumed functioning. Finings mainly indicated a higher rate of medication errors during dissolving the committee. CONCLUSION: Health policy-makers have a public responsibility for making a decision and the consequences. Regarding the process of naming drugs, it is important for policy makers to consider two issues: patient safety and trademarks rights. However, the Iran FDO adopted an approach to address these issues, a more multifaceted, integrated approach to initial naming of drugs is suggested. The committee' function is seen to hold the most promise. However the function is partially complete to ensure patient safety. Given the change experienced by altering relevant organizational authorities in the FDO, the sustainability of the committee cannot hope to be guaranteed. Yet, the need for such a guarantee is particularly important.

Training and Validation of Standardized Patients for Assessing Communication and Counseling Skills of Pharmacy Students: A Pilot Study.

OBJECTIVE: The objective of this study is to describe the process of training valid simulated patients (SPs) for assessing communication and counseling skills of pharmacy students' performance. METHODS: This is a cross-sectional and correlational study. Psychometric properties of checklist and SPs' portrayals and their filling of the checklist regarding assessing pharmacy students were assessed. Five SPs who were working in the simulated patient's pool were volunteered to take part in the project, which one of the SPs failed. Three scenarios, along with corresponding checklists, were developed based on the usual medications of different diseases consisting of asthma, respiratory infections, and osteoporosis. The SPs' role-play performance was video-recorded and rated independently by two experts according to an observational rating scale to assess validity. The role-play was repeated after 1 week with the same scenario and the same doctor, to assess test-retest reliability. The inter-rater agreement between SPs and experts was determined by calculating the intraclass correlation coefficient and kappa coefficient. FINDINGS: The four eligible SPs were all women, with an average age of 37 years. The correlation between mean scores of raters and mean scores of SPs was 0.91 and 0.85, respectively. The Pearson's correlation between mean scores of raters with SPs was 0.75. The checklists' reliability, Cronbach's alpha, was calculated to be 0.72. The measured weighted Cohen's kappa for the ratings of by each SP, and the gold standard was between 0.53 and 0.57, indicating a moderate agreement. The inter-rater reliability kappa coefficient between raters was 0.75 (P = 0.01). CONCLUSION: The authors have demonstrated the technique of using standardized patients to evaluate communication and counseling skills of pharmacy students. The findings indicated that trained SPs can be used as an effective tool to assess pharmacy students' communication and counseling skills.

A randomized, double blinded, placebo-controlled clinical trial of silymarin in ulcerative colitis.

OBJECTIVE: To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients. METHODS: A randomized double blinded placebo-controlled clinical trial was conducted in 80 UC patients whose disease had been documented and were in remission state between September 2009 and October 2010. Patients were assigned to silymarin group (42 cases) and placebo group (38 cases) using a random number table. Either silymarin (140 mg) or placebo (lactose mono-hydrate, corn starch magnesium stearate) tablets were given once daily for 6 months along with their standard therapy. The efficacies were assessed by disease activity index (DAI), frequency difference of the disease flare-up, and paraclinical data. RESULTS: Ten patients (4 in the silymarin group due to nausea and 6 in the placebo group due to disease flare-up and abdominal pain) discontinued the study. An improvement in hemoglobin level (11.8±1.6 g/dL vs. 13.4±1.2 g/dL,P<0.05) and erythrocyte sedimentation rate (23.7±11.5 mm/h vs.10.8±3.2 mm/h,P<0.05) was observed in the silymarin group but not in the placebo group. DAI significantly decreased in the silymarin group and reached from 11.3±3.5 to 10.7±2.8 (P<0.05). Thirty-five out of 38 patients in the silymarin group were in complete remission with no flare-up after 6 months as compared to 21 out of 32 patients in the placebo group (P=0.5000). CONCLUSION: Silymarin as a natural supplement may be used in UC patients to maintain remission.

Antioxidants and infertility treatment, the role of Satureja Khuzestanica: A mini-systematic review.

BACKGROUND: The use of antioxidants in the treatment of infertility has been suggested and recent studies have indicated that oral administration of Satureja Khuzestanica essential oil (SKEO) to rats induces significant antioxidative effects. OBJECTIVE: This systematic review was conducted to evaluate the effectiveness of antioxidants in infertility and also to assess the effectiveness of Satureja Khuzestanica in infertility management. MATERIALS AND METHODS: Pubmed, Scopus, and Cochrane Library were searched for relevant trials published from respective database inception dates to August 2010. Study selection, and data extraction were performed by authors. RESULTS: Fifteen trials on evaluation of antioxidants in infertility and seven studies on the effectiveness of Satureja Khuzestanica were identified. Only 4 of the 15 trials were with application of allocation concealment and three studies were done in in-vitro environment. Despite the methodological and clinical heterogeneity of the trials, 14 of the 15 (93.33%) trials showed an improvement in either sperm quality or pregnancy rate after antioxidant therapy. The human and animal studies of Satureja Khuzestanica showed a significant antioxidative potential of the plant and its effectiveness for infertility improvement. CONCLUSION: The use of oral antioxidants in infertility could improve sperm quality and pregnancy rates. Improved fertility observed by SKEO in rats might be due to its antioxidative effect. Further studies and clinical trials in humans are necessary to evaluate SKEO effectiveness in fertility disturbances.