Impact of COVID-19 on Pharmacy Education and Practice: Strategies to Boost Advocacy and Unity among Health Care Organizations.

The global COVID-19 pandemic impacted pharmacy education and changed the pharmacists' scope of practice at the federal and state levels. Based on the Amended Public Readiness and Emergency Preparedness Act, pharmacists were authorized to provide essential services, including testing, treatments, and immunizations at various practice settings. Specifically, the United States Food and Drug Administration issued emergency use authorization for several medications, vaccines, and medical devices. The pandemic also affected the regulatory landscape for pharmacists, pharmacy education, access to care, and delivery of pharmacy services in-person and through telehealth. The pandemic's specific impact on pharmacy education heightened awareness of the well-being of the Academy. This commentary will highlight the impact of COVID-19 on both pharmacy education and practice. It will also provide strategies that educators, researchers, and practitioners can take into future research and action to help promote advocacy and unity among pharmacy organizations.

Review of Best Practices for Diversity, Equity, and Inclusion Committees Within Colleges of Pharmacy.

Objective. To provide a review of best practices for diversity, equity, and inclusion (DEI) committees at United States colleges of pharmacy.Findings. In colleges of pharmacy, DEI committees can play a crucial role in promoting a culture change to ensure pharmacy graduates are equipped to provide equitable and representative care for the patients they serve. There is limited literature available on DEI committee composition, roles, and responsibilities, and their place within a college of pharmacy's organizational structure. A commitment to DEI should be part of the college's strategic plan and embedded and supported at all levels of the college and university to ensure success of DEI-related strategic initiatives. For a DEI committee to be effective, its composition should be intentional to include change agents, campus leaders, and members who are passionate and knowledgeable to execute the DEI goals. For sustainable change, involvement of the entire learning community and an organizational culture change is also important. Thus, DEI committees need to establish active bidirectional collaborations and communication with all key committees, offices, community leaders, and alumni to implement diversity goals.Summary. The DEI committee's established place in the organizational structure of the college is essential to ensure fair and appropriate representation of the community it serves. A clearly defined DEI committee with committee composition, roles, responsibilities, and its association with all constituents of the college and community can help achieve its intended strategic goals.

Colistin induced acute kidney injury in critically ill children: a prospective study utilizing RIFLE criteria.

BACKGROUND: Colistin is one of the last resort antibiotic options for resistant gram-negative pathogens. Renal injury is the most common side effect of colistin. Characteristics of nephrotoxicity are well described in adults. However, this data is sparse in children. OBJECTIVES: In this study we evaluated the incidence, severity, time course and risk factors of colistin nephrotoxicity in a pediatric population. METHODS: In a prospective study over a 9-month period, children who received intravenous colistin for at least 48 h were evaluated for renal side effect by utilizing Risk-Injury-Failure-Loss-End Stage Kidney Disease (RIFLE) criteria. Children receiving renal replacement therapy (RRT) or received a repeated course of colistin were excluded. RESULTS: Thirty-seven children were included. Median age of participants was 4.5 months. Overall, 48.6% of the cases developed AKI and consisted 56% in the Risk, 33% in the Injury and 11% in the Failure categories of RIFLE criteria. AKI was reversible while colistin continued and no one required RRT. Mean ± SD time to AKI development was 10.94 ± 7.51 days. Multivariate logistic regression analysis demonstrated that total cumulative dose of colistin was an independent predictor of nephrotoxicity (standardized ß = 1.024, P = 0.034). CONCLUSION: AKI is a common side effect of colistin therapy in critically ill children developing in nearly half of recipients. However, with the dosage range utilized in this study, in the majority of children, renal injury seemed to be mild to moderate in nature. Given the limited treatment options available in critically ill children with resistant gram-negative pathogens, colistin remains a marvelous therapeutic option. Further studies are required to fully elucidate the risk factors and clinical pictures of colistin-induced nephrotoxicity.

Healthcare students interprofessional critical event/disaster response course.

OBJECTIVE: Numerous disasters confirm the need for critical event training in healthcare professions. However, no single discipline works in isolation and interprofessional learning is recognized as a necessary component. An interprofessional faculty group designed a learning curriculum crossing professional schools. DESIGN: Faculty members from four healthcare schools within the university (nursing, pharmacy, allied health, and medicine) developed an interdisciplinary course merging both published cross-cutting competencies for critical event response and interprofessional education competencies. SETTING: Students completed a discipline-specific online didactic course. Interdisciplinary groups then participated in a 4-hour synchronous experience. This live course featured high-fidelity medical simulations focused on resuscitation, as well as hands-on modules on decontamination and a mass casualty triage incorporating moulaged standardized patients in an active shooter scenario. PARTICIPANTS: Participants were senior students from allied health, medicine, nursing, and pharmacy. MAIN OUTCOME MEASURES: Precourse and postcourse assessments were conducted online to assess course impact on learning performance, leadership and team development, and course satisfaction. RESULTS: Students participated were 402. Precourse and postcourse evaluations showed improvement in team participation values, critical event knowledge, and 94 percent of participants reported learning useful skills. Qualitative responses evidenced positive response; most frequent recurring comments concerned value of interprofessional experiences in team communication and desire to incorporate this kind of education earlier in their curriculum. Students demonstrated improvement in both knowledge and attitudes in a critical event response course that includes interprofessional instruction and collaboration. Further study is required to demonstrate sustained improvement as well as benefit to clinical outcomes.

Statins Use and Risk of Breast Cancer Recurrence and Death: A Systematic Review and Meta-Analysis of Observational Studies.

PURPOSE: Statins are widely prescribed drugs for lowering cholesterol. Some studies have suggested that statins can prevent breast cancer recurrence and reduce mortality rate. However they are not conclusive. Present systematic review and meta-analysis of published cohort studies was conducted to determine the effects of statins intake and risk of breast cancer recurrence and mortality rate. METHODS: Online databases (PubMed, Embase, Scopus, EBSCO and Cochrane Collaboration) were searched through October 2014. Pooled relative risks and 95 % confidence intervals were calculated with random-effects. RESULTS: A total of 8 cohort studies (4 for recurrence 2 for mortality and 2 for both) involving 124669 participants with breast cancer were eligible. Our results suggest a significant reduction in recurrence (OR= 0.79. I2= 38%) and death (OR = 0.84, I2 = 8.58 %) among statin users. CONCLUSION: Our meta-analysis suggests that breast cancer patients will benefit from statin intake, however from these cohorts we are unable to differentiate between various statins in terms of effectiveness and duration of use. We highly propose conducting randomized clinical trials.

Effectiveness of regular versus glargine insulin in stable critical care patients receiving parenteral nutrition: a randomized controlled trial.

STUDY OBJECTIVE: To compare the effectiveness and safety of two glycemic control regimens in stable critical care patients receiving parenteral nutrition (PN). DESIGN: Prospective, randomized open-label clinical trial. METHODS: Eligible postoperative critical care patients in the ICU began PN on the first to the seventh day of ICU admission. The PN admixture included regular insulin, in doses sufficient to maintain 3 or more goal blood glucose (BG) levels between 110 and 180 mg/dl. After 3 to 5 days of PN containing regular insulin, patients were randomized to 3 more days of regular insulin at the same dose or 80% of their total daily regular insulin dose provided in PN solution as glargine insulin. Capillary BG monitoring was performed every 6 hours. RESULTS: Twenty one patients were randomized to each treatment group. Median APACHE II scores were not significantly different between the two groups within the first 24-hour of ICU admission. There were no significant differences between the two groups at day 3 for mean daily dextrose (306.9 ± 46.2 vs. 305.2 ± 52.2 g; p=0.913) or insulin (18.3 ± 8.8 vs. 19.5 ± 10.0 units; p=0.696) doses. The percentage of BG values in the goal (110-180 mg/dl), hyperglycemic (> 180 mg/dl), and hypoglycemic (< 70 mg/dl) BG levels were similar between the two groups (69.0% vs. 66.7%, p=0.567; 11.9% vs. 11.1%, p=0.780; 0% vs. 1.6%, p=0.124, respectively). Mean daily BG levels were not significantly different between the two groups on each of the 3 study days (day 1: 140 ± 20 vs. 131 ± 25 mg/dl, p=0.194; day 2: 136 ± 20 vs. 140 ± 18 mg/dl, p=0.498; day 3: 142 ± 15 vs. 140 ± 19 mg/dl; p=0.741). CONCLUSION: These data suggest that, compared with regular insulin added to PN, glargine insulin results in similar glycemic control and rates of hyperglycemia and hypoglycemia in stable critical care patients.

A double-blind, randomized, controlled trial on N-acetylcysteine for the prevention of acute kidney injury in patients undergoing allogeneic hematopoietic stem cell transplantation.

Acute kidney injury (AKI) is one of the complications of hematopoietic stem cell transplantation and is associated with increased mortality. N-acetylcysteine (NAC) is a thiol compound with antioxidant and vasodilatory properties that has been investigated for the prevention of AKI in several clinical settings. In the present study, we evaluated the effects of intravenous NAC on the prevention of AKI in allogeneic hematopoietic stem cell transplantation patients. A double-blind randomized placebo-controlled trial was conducted, and 80 patients were recruited to receive 100 mg/kg/day NAC or placebo as intermittent intravenous infusion from day -6 to day +15. AKI was determined on the basis of the Risk-Injury-Failure-Loss-End-stage renal disease and AKI Network criteria as the primary outcome. We assessed urine neutrophil gelatinase-associated lipocalin (uNGAL) on days -6, -3, +3, +9 and +15 as the secondary outcome. Moreover, transplant-related outcomes and NAC adverse reactions were evaluated during the study period. Statistical analysis was performed using appropriate parametric and non-parametric methods including Kaplan-Meier for AKI and generalized estimating equation for uNGAL. At the end of the trial, data from 72 patients were analysed (NAC: 33 patients and placebo: 39 patients). Participants of each group were not different considering baseline characteristics. AKI was observed in 18% of NAC recipients and 15% of placebo group patients, and the occurrence pattern was not significantly different (p = 0.73). Moreover, no significant difference was observed between groups for uNGAL measures (p = 0.10). Transplant-related outcomes were similar for both groups, and all patients had successful engraftment. Three patients did not tolerate NAC because of abdominal pain, shortness of breath and rash with pruritus and were dropped from the intervention group before transplantation. However, the frequency of adverse reactions was not significantly different between groups. In conclusion, our findings could not show any clinical benefits from high-dose NAC particularly for AKI prevention in allogeneic hematopoietic stem cell transplantation patients.

No Superiority of Granisetron Over Metoclopramide in Prevention of Post-operative Nausea and Vomiting: A Randomized Clinical Trial.

PURPOSE: Post-operative nausea and vomiting (PONV) is considered as one of the most disturbing sequels of surgeries under general anesthesia, which if not controlled appropriately increases post-operative morbidity, nursing burden, and general healthcare costs. In this study, we compared granisetron with its brand Kytril(®) and also with metoclopramide regarding PONV management. METHODS: A total of 180 obstetrics and gynecology patients who underwent surgeries under general anesthesia participated in this prospective study at the Dr. Shariati Teaching Hospital, Tehran, Iran. The patients were randomly assigned to single-dose generic granisetron (40 mcg/kg), Kytril(®) (40 mcg/kg), or metoclopramide (0.2 mg/kg) at the end of the surgery. Two episodes of emetic symptoms (nausea and vomiting) were recorded by a gynecologist who had no knowledge of which treatment each patient had received. This gynecologist observed the patients at three different intervals: 0-6, 6-12, and 12-18 h post-surgery. RESULTS: One hundred and thirty-seven patients (76.1 %) underwent hysterectomy and 40 patients (22.2 %) underwent myomectomy. Each group consisted of 60 patients (33 %). The incidence of vomiting in the first 6, 12, and 18 h post-surgery was 22, 15.2, and 13.3 % for granisetron; 18.6, 10, and 8.3 % for Kytril; and 22, 11.9, and 5 % for generic metoclopramide, respectively. There was no significant difference in the incidence of PONV with any of these agents. CONCLUSIONS: All three anti-nausea and vomiting agents, granisetron, its brand (Kytril), and generic metoclopramide, have a similar effect to manage PONV in obstetrics and gynecological surgeries. Trial registration This trial is registered with www.irct.ir, number IRCT201010134927N1.

An educational intervention to improve nurses' knowledge, attitude, and practice toward reporting of adverse drug reactions.

BACKGROUND: The reporting of adverse drug reactions (ADRs) by nurses in hospitals is very important. AIMS: This study was aimed at investigating the impact of an educational intervention to improve ADR reporting and whether trained nurses had better knowledge, attitude, and practice toward ADR reporting. MATERIALS AND METHODS: A total of 300 nurses in a tertiary care teaching hospital in Tehran, Iran were evaluated with a knowledge, attitude, and practice (KAP) questionnaire regarding ADR reporting in March 2010. After this, an educational program about ADR was provided to nurses. Then the nurses were re-evaluated by the same questionnaire. Comparisons were made of the attitude and knowledge within nurses, before and after education. Data were analyzed using SPSS software. P < 0.05 was considered as significant level. Independent-sample t-test was used to measure the intervention effect. RESULTS: The response rate was 61.3% (N = 184). Knowledge of nurses before the intervention was significantly less than the knowledge after the intervention (P = 0.001). Also, there was a significant effect on attitude (P = 0.002). During the follow-up period of 4 months after the intervention, 26 spontaneous reports were received. CONCLUSION: Continuous ADR educational program, training, and integration of ADRs' reporting into the activities of the nurses would likely improve ADR reporting.

Impact of clinical pharmacist-based parenteral nutrition service for bone marrow transplantation patients: a randomized clinical trial.

PURPOSE: Parenteral nutrition (PN) is a well-documented supportive care which maintains the nutritional status of patients. Clinical pharmacists are often involved in providing PN services; however, few studies have investigated the effect of a clinical pharmacy-based PN service in resource-limited settings. METHODS: We designed a randomized clinical trial to compare the clinical pharmacist-based PN service (intervention group) with the conventional method (control group) for adult patients undergoing hematopoietic stem cell transplantation in Shariati Hospital, Tehran, Iran (2011-2012). In the intervention group, the clinical pharmacists implemented standard guidelines of nutrition support. The conventional method was a routine nutrition support protocol which was pursued for all patients in the bone marrow transplantation wards. Main study outcomes included nutritional status (weight, albumin, total protein, pre-albumin, and nitrogen balance), length of hospital stay, time to engraftment, rate of graft versus host disease, and mortality rate. Patients were followed for 3 months. RESULTS: Fifty-nine patients were randomly allocated to a study group. The overall intake (oral and parenteral) in the control group was significantly lower than standard daily needed calories (P < 0.01). Patients in the intervention group received fewer days of PN (10.7 ± 4.2 vs. 18.4 ± 5.5 days, P < 0.01). All nutritional outcomes were either preserved or improved in the intervention group while the nutritional status in the control group was deteriorated (P values < 0.01). Length of hospital stay was significantly shorter in the intervention group (P < 0.01). Regarding PN complications, hyperglycemia was observed more frequently in the intervention group (34.5 %, P = 0.01). Two patients in the control group expired due to graft versus host disease at the 3-month follow-up. CONCLUSION: A clinical pharmacist-based nutrition support service significantly improved nutritional status and clinical outcomes in comparison with the suboptimal conventional method. Future studies should assess the cost effectiveness of clinical pharmacists' PN services.

Vancomycin Pharmacokinetic Parameters in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT).

BACKGROUND: Vancomycin is used abundantly in patients undergoing HSCT, especially during neutropenic fever. Despite its widespread use little is known about vancomycin pharmacokinetics in HSCT patients. We conducted this study to investigate vancomycin pharmacokinetic parameters in our HSCT patients and to evaluate current dosing regimen based on trough vancomycin concentrations measurement. METHODS: Vancomycin serum concentration at steady-state was determined prospectively in 46 adult HSCT patients who received vancomycin as empirical treatment of neutropenic fever. Individual steady-steady pharmacokinetic parameters were also determined in 20 patients who had two vancomycin levels from an administered dose, assuming one-compartment model. Acute kidney injury was also evaluated in our patients during vancomycin therapy. RESULTS: Mean (±SD) apparent volume of distribution (L/kg) and clearance (mL/min) were 0.6 (± 0.33) and 109.7 (± 57.5) respectively. With mean (±SD) total daily dose of vancomycin 31.9 (±10.5) mg/kg/day that was administered, more than 90% of measured vancomycin trough concentrations were outside the range of 15-20 mg/L and 54.3% of patients had trough concentrations below 10 mg/L. Of 46 patients, 21 patients (45.7%) developed acute kidney injury (AKI) during vancomycin therapy; among them 19 patients were receiving nephrotoxic drug(s) concomitantly. CONCLUSION: Current vancomycin dosage regimen could not lead to recommended therapeutic serum concentrations in our patients. Large variation in vancomycin pharmacokinetic parameters observed among patients of this study along with difference of vancomycin pharmacokinetics in our study and other similar studies further explain the need for therapeutic drug monitoring and individualization of vancomycin dosing.

Evaluation of treatment with Oseltamivir during the 2009 H1N1 (swine flu) pandemic: the problem of incomplete clinical information.

During the H1N1 (swine flu) pandemic of 2009, the World Health Organization (WHO) confirmed more than 14,000 deaths globally; this included a death toll of 147 in Iran. In order to evaluate (a) the appropriateness of the Oseltamivir dose through calculation of a patient's creatinine clearance (CrCl) and (b) the quality of data in the medical charts, we conducted a retrospective study at the Shariati Hospital in Tehran. All admissions to the hospital between the dates 1 October 2009 and 31 January 2010 were evaluated, amounting to a total of 51 patients' charts, including 8 outpatient charts. Of these 51 charts, 26 (51%) contained all the information necessary to evaluate the CrCl. However, there was at least one piece of information missing (e.g. the patient's weight; serum creatinine) from each of the remaining 25 charts (49% of the sample), which made it impossible for us to evaluate the dose. These results demonstrate how crucially important it is to ensure that all the necessary patient information is correctly registered at the time of admission in order to minimise medication errors.

Evaluation and monitoring of isotretinoin use in Iran.

BACKGROUND: Isotretinoin (13-cis retinoic acid) is used for treatment of nodular cystic acne unresponsive to conventional therapy. It is an expensive, potent teratogenic drug with serious adverse drug reaction (ADRs). Recently, use of this drug has increased in Iran. To date, there are no published data about the use of isotretinoin in Iran; therefore, this study aims to assess its use in this country. METHODS: This was a prospective, drug utilization evaluation (DUE) study conducted in an institutional community pharmacy affiliated with Tehran University of Medical Sciences (TUMS). Drug prescription, administration, and evaluation of appropriateness were recorded and compared with standard protocols. Collected data were analyzed by SPSS software. RESULTS: A total of 274 outpatients treated with isotretinoin enrolled in the study. Of these, 51.3% were prescribed isotretinoin under the usual recommended daily doses of 0.5mg/kg/day. Data also indicated that 33.5% of the patients were given total doses of less than 100 mg/kg (72.4 ± 17.2 mg/kg) and 12.2% received more than 150 mg/kg. With regards to the teratogenic effects of isotretinoin, only 6.8% of couples simultaneously used two methods of contraception (P = 0.001). In addition, we detected improper use of isotretinoin for mild and moderate acne in about 20% of cases. CONCLUSION: The most important finding of this study is that the doses of isotretinoin are incorrect in many cases. Incorrect dosages would decrease drug efficacy and increase the risk of relapse. In addition, patients have not been adequately counseled about isotretinoin's teratogenicity and the seriousness of its adverse effects.

Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting.

BACKGROUND: Adverse drug reactions (ADR) are ranked as some of the major causes of patient morbidity and mortality. Spontaneous reporting of ADRs has remained the cornerstone of pharmacovigilance and is important in maintaining patient safety. This study was conducted to assess the nurses' knowledge and attitude towards pharmacovigilance, reasons for not reporting ADRs, and their pharmacovigilance practice. MATERIALS AND METHODS: A questionnaire was prepared to investigate knowledge, attitude and practice (KAP) of nurses regarding ADR reporting. In November 2009, the questionnaires were given to 500 nurses of a teaching hospital in Tehran. FINDINGS: Knowledge and practice of participants were not satisfying; however, their attitude towards pharmacovigilance was at a high level. About 91% of the nurses had never reported an ADR. Most nurses liked to report the ADRs to the physicians (87.1%) and pharmacists in hospital's ADR center (1.8%) rather than the ADR National Center. The main cause of under-reporting of the suspected ADRs was unawareness about the existence of such a national center. Among nurses who had reported ADR for at least once, the majority preferred using phone (10 out of 50) or Yellow Cards (7 out of 50). Only 1 person out of 50 preferred using internet for submitting the reports. CONCLUSIONS: Since the nurses in this study had little knowledge and poor practice regarding the pharmacovigilance and spontaneous reporting system, interventions such as holding pharmacovigilance workshops in the hospitals focusing on the aims of pharmacovigilance, completing the Yellow Card and clarifying the reporting criteria are strongly recommended.

The effect of zinc sulfate in the prevention of high-dose chemotherapy-induced mucositis: a double-blind, randomized, placebo-controlled study.

The purpose of this study was to evaluate the effect of oral zinc sulfate in the prevention of chemotherapy-induced mucositis in patients undergoing hematopoietic stem-cell transplantation (HSCT). This study was a double-blind, randomized, placebo-controlled design, with 60 patients undergoing HSCT, divided proportionally in experimental group who received zinc sulfate, and in placebo group. They all had received high-dose chemotherapy conditioning regimen for allogenic transplantation. Oral mucositis assessed was based on World Health Organization (WHO) oral mucositis scale. There were no significant differences in the development of mucositis between the two groups. Severity of mucositis was not significantly different between the two groups either. The same result was obtained regarding the duration of mucositis. Zinc sulfate did not show any significant adverse effects in experimental group. In conclusion, Zinc sulfate did not have any clinical benefits in prevention or reduction of severity, and duration of high-dose chemotherapy-induced mucositis in patients undergoing HSCT.