Includes bibliographical references.

Expanded Access Versus Right-to-Try -- Intravenous Magnesium Replacement in Patients With Hypomagnesemia: Time Is of the Essence -- Reply to: Intravenous Magnesium Replacement in Patients With Hypomagnesemia: Time Is of the Essence -- Current Threats to Maintaining a Secure Pharmaceutical Supply Chain in an Online World -- Evaluation of Albumin 25% Use in Critically Ill Patients at a Tertiary Care Medical Center -- The SUP-ICU Trial: Does It Confirm or Condemn the Practice of Stress Ulcer Prophylaxis? -- Awareness About Ebola Virus Disease Among the Health Care Professionals in Karachi, Pakistan -- Intravenous Olanzapine in a Critically Ill Patient: An Evolving Route of Administration -- Current Trends in Hospital Pharmacy Practice in Lebanon -- Pharmacists’ Perceptions on Their Role, Activities, Facilitators, and Barriers to Practicing in a Post-Intensive Care Recovery Clinic -- Intranasal Fentanyl Use in Neonates -- Hyperoncotic Albumin Reduces Net Fluid Loss Associated With Hemodialysis -- Corticosteroids for Septic Shock: Another Chapter in the Saga --

[Article Title: Expanded Access Versus Right-to-Try / Scot Walker, p. 79-81]

Abstract: Expanded Access, also known as compassionate use, has been around for 30 years beginning with access to investigational drugs to treat human immunodeficiency virus (HIV). The program was designed to provide patients who have exhausted all approved treatment options and do not qualify for a clinical trial a way to access investigational drugs. Over the years, the US Food and Drug Administration (FDA) has streamlined the process to improve access, by reducing the size of the application and decreasing the time needed for a decision. Expanded Access for a drug requires a 2-page form, submitted by a physician and approved by an institutional review board (IRB). Over the past 5 years, there have been 9000 Expanded Access Program applications; 99% were approved and 75% were approved in a few days. Manufacturers are permitted to charge patients an FDA-approved price for the investigational drug.

https://doi.org/10.1177/0018578719883801

[Article Title: Intravenous Magnesium Replacement in Patients With Hypomagnesemia: Time Is of the Essence / Zhou Fang and Todd W. Canada, p. 82-83]

Abstract:We read with interest the comparison of short versus prolonged infusion rates of intravenous (IV) magnesium in hospitalized patients with hypomagnesemia.1 The primary outcome was to determine whether there was a difference in the percent of days requiring magnesium replacement out of the magnesium length of stay for these 2 infusion rates. The short infusion rate was 1.8 ± 0.4 g/h, but the actual prolonged infusion rate was not reported. The authors concluded that prolonged magnesium infusion rates did not decrease magnesium replacement requirements, based on the infusion required in 34.8% of days in the short cohort versus 37.5% of days in the prolonged cohort.

https://doi.org/10.1177/0018578719894703

[Article Title: Reply to: Intravenous Magnesium Replacement in Patients With Hypomagnesemia: Time Is of the Essence / Amber B. Clemmons and Shaily Doshi ,p. 84]

Abstract: In response to the Letter to the Editor by Fang and Canada,1 we are including a few clarifications for readers on our article “Prolonged versus short infusion rates of IV magnesium in hospitalized general medicine patients with hypomagnesemia.”2
First, the authors state in their letter “. . . but the actual prolonged infusion rate was not reported.” In our manuscript, page 2 first paragraph of study design section, it is stated, “. . . while those in the prolonged cohort . . . received magnesium after protocol implementation at a standard rate of 0.5 g/h.” Therefore, all patients in prolonged group received intravenous (IV) magnesium at a fixed rate of 0.5 g/h.

Second, the authors comment the therapeutic range of 1.4 to 2.7 mg/dL and “desired” range of 2 to 2.7 mg/dL in our study are not supported by data. Indeed, our hospital’s internal laboratory reference range for upper threshold of 2.7 mg/dL triggering providers to an abnormally high result is above other reported thresholds; however, this only affects the secondary outcome of instances of hypermagnesemia. The lower end of magnesium range (ie, that which defines hypomagnesemia) varies throughout prior literature, often with thresholds of ~1.4 to 2 mg/dL.3,4 Mounting evidence suggests a serum total magnesium concentration of ~2 mg/dL (0.85 mmol/L) is necessary to reduce risk of negative clinical outcomes such as cardiovascular disease, thereby making it a potential goal threshold for providers despite laboratory result not flagging as abnormal within the electronic health record.3 Therefore, we felt it prudent to provide readers with data for both thresholds.

Last, the authors correctly point out the limitations of a retrospective chart review methodology. These include inability to analyze items which are often not precisely or consistently documented in medical records (enteral/oral nutrition intake, losses from diarrhea) as well as inability to control for physician driven interventions (threshold to initiate IV repletion, rationale for concomitant oral magnesium supplementation). We strongly advise future researchers to consider these factors in the design of a prospective trial which would better answer the question of optimal infusion rate of IV magnesium. Furthermore, prospective studies are necessary to evaluate the potential increased risks of symptomatic hypermagnesemia and/or hypotension with shorter infusion rates as well as potential correlation of infusion rate to clinical outcomes.

https://doi.org/10.1177/0018578719894705

[Article Title: Current Threats to Maintaining a Secure Pharmaceutical Supply Chain in an Online World / John B. Hertig, Libby Baney and Robert J. Weber, p. 85-89]

Abstract:

Background: Maintaining integrity of the pharmaceutical supply chain is critical to providing medications that are free from adulteration (counterfeit, substandard or unapproved medications), making them safe for patient use. Purchasing pharmaceuticals through the Internet can be associated with a risk of receiving adulterated medicines.

Objective: The objective of this study was to review the current threats to maintaining a secure pharmaceutical supply chain, specifically focused on Internet-based procurement of medications.

Methods: A review of the literature was conducted along with collating important up to date resources and other publications that provide foundational information to understanding the risks and prevention strategies for online purchasing of pharmaceuticals.

Conclusion: The information provided in this article helps to properly inform pharmacy leaders to the resources available to protect against the risks of on-line purchasing of pharmaceuticals.

https://doi.org/10.1177/0018578719868406

[Article Title: Evaluation of Albumin 25% Use in Critically Ill Patients at a Tertiary Care Medical Center / Heather Torbic, Seth R. Bauer, Michael Militello, Sarah Welch, Chiedozie Udeh and Steven Richardson, p. 90-95]

Abstract:

Background: Albumin 25% has been studied and has demonstrated benefit in a limited number of patient populations. The use of albumin 25% is associated with higher costs compared with crystalloid therapy. The aim of this study was to describe the prescribing practices of albumin 25% at a tertiary-care medical center and identify opportunities for restriction criteria related to its use to help generate cost savings. Methods: This evaluation was a retrospective, noninterventional, descriptive study of albumin 25% use between June 2015 and February 2016. Inclusion criteria consisted of patients ≥18 years old and who received at least one dose of albumin 25% while admitted to a Cleveland Clinic main campus intensive care unit (ICU). Inclusion was restricted to 150 randomly selected patients.

Results: A total of 539 albumin 25% orders were placed for the 150 included patients. The cardiovascular ICU more frequently prescribed albumin 25% compared with the medical, surgical, neurosciences, and coronary ICUs (51% vs 23% vs 11% vs 9% vs 6%, respectively). Although the cardiovascular surgery ICU most frequently prescribed albumin 25% compared with other ICUs, the medical ICU prescribed a larger total quantity of albumin 25% compared with the cardiovascular, surgical, neurosciences, and coronary ICUs (8705 g vs 7275 g vs 3205 g vs 2162 g vs 625 g, respectively). The majority of patients (61%) did not have an indication listed for albumin 25% use and only 9% of patients were prescribed for indications supported by primary literature. Of the patients prescribed albumin for other indications not supported by primary literature (30%), the most common reasons for albumin 25% were hypotension, acute kidney injury, and volume resuscitation. The median cost per patient of albumin 25% was $417 with a total cost of $122 164 for the cohort. Only 19% of the total cost aligned with dosing regimens evaluated in primary literature.

Conclusion: Prescribing patterns of albumin 25% at a tertiary academic medical center do not align with indications supported by primary literature. These findings identified a major opportunity for prescriber education and implementation of restriction criteria to target cost savings.

https://doi.org/10.1177/0018578718823727

[Article Title: The SUP-ICU Trial: Does It Confirm or Condemn the Practice of Stress Ulcer Prophylaxis? / Jeffrey F. Barletta, Mitchell S. Buckley and Robert MacLaren, p. 96-101]

Abstract:

Purpose: Stress ulcer prophylaxis (SUP) is routinely administered to critically ill patients for the prevention of stress ulcer–induced, clinically important bleeding (CIB). Recently, the value of SUP has been questioned due to the perceived decline in CIB and the potential for infectious complications secondary to acid suppressive therapy. The SUP-ICU trial is a large, randomized controlled trial comparing intravenous pantoprazole with placebo for the indication of SUP. It is hoped that this trial would answer many of the questions pertaining to the overall value of SUP. This article will provide an in-depth assessment of the SUP-ICU trial in the context of the overall body of literature in this area. Furthermore, applications for clinical practice and recommendations on the provision of SUP are provided.

Summary: The SUP-ICU trial revealed no difference in the primary outcome of 90-day mortality with pantoprazole but lower rates of CIB were noted (which was a secondary outcome). Overall, these data provide important insight into the value of SUP along with other questions related to the provision of SUP such as the relationship between CIB and mortality, infectious complications, and enteral nutrition.

Conclusions: The SUP-ICU trial is a landmark trial describing the value of SUP in a modern-day setting of intensive care unit (ICU) practice. The provision of SUP should be continued in high-risk patients. Future studies are ongoing that will add further insight to this routine practice.

https://doi.org/10.1177/0018578719867687

[Article Title: Awareness About Ebola Virus Disease Among the Health Care Professionals in Karachi, Pakistan / Kashif Ali, Syed Omair Adil, Subhana Akber, Shakir Khan, Nand Lal, Zubeda Bhutto and Shehzada Abdullah, p. 102-107]

Abstract:

Background: Ebola virus disease is an acute and life-threatening illness, which, if untreated, is fatal. It was first discovered in 1976, which aware the world with sporadic outbreaks of Ebola in some parts of Africa. According to Centers for Disease Control and Prevention (CDC), the natural reservoir for Ebola virus remains unknown; however, it is yet to be affirmed that the natural habitat is animal-borne where bats are most likely to carry over this virus. Therefore, the aim of this study was to estimate awareness of health care professionals as they serve as the integral part of our health care system.

Methods: A cross-sectional survey was conducted among 149 health care workers (HCWs) in Civil Hospital of Karachi from June 2015 to August 2015. The study participants were randomly selected individuals who were students of and/or were working in the university’s affiliated tertiary care hospital in Karachi, Pakistan.

Results: Baseline characteristics of the study participants are shown in Table 1. Median age of the participants is 21 (range: 17-24) years. Female preponderance was found to be higher (104; 69.8%) as compared with the males (45; 30.2%). Discipline of majority of the study participants was medical technology (80; 53.7%), followed by nurses (38; 25.5%) and doctors (31; 20.8%). Majority of the study respondents were undergraduate medical students (60; 75%) as compared with medical technologist and the nurses (17; 24.6%) with a P value < .001 as shown in Figure 1. The mean for correct responses was 8.43 ± 4.08 (range: 3-17). Appropriate knowledge was observed in 84 (56.4%) responders and inappropriate knowledge was observed in 65 (43.6%) of the study respondents.

Conclusion: Our study concludes that there is an unsatisfactory knowledge about Ebola virus disease among health care professionals. Moreover, public health authorities should signify the importance of prevention against Ebola virus disease not only among the health care professionals but also into the communities through mass media and awareness campaigns which can thus halt the panic and incidence of Ebola virus outbreaks in coming decades.

https://doi.org/10.1177/0018578718817472

[Article Title: Intravenous Olanzapine in a Critically Ill Patient: An Evolving Route of Administration / Michael P. Lorenzo, Jeni Burgess and William Darko, p. 108-111]

Abstract: Purpose: The purpose of the article is to describe the successful use of parenteral olanzapine intravenously (IV) in a critically ill patient with severe agitated delirium.

Summary: A 70-year-old man was admitted to the medical intensive care unit requiring plasmapheresis with platelet counts consistently below 20 000/µL secondary to thrombotic thrombocytopenic purpura (TTP). The patient had experienced agitated delirium requiring treatment, which was complicated by electrocardiogram (EKG) findings of a prolonged QTc interval. The antipsychotics the patient was receiving were believed to be responsible and, as such, the team desired an option that would have a lesser chance of worsening QTc (baseline-corrected QT) interval. Olanzapine was chosen and given IV versus the U.S. Food and Drug Administration (FDA)–approved parenteral route of intramuscular (IM) due to concern of bleeding. The patient’s delirious state responded to treatment to varying degrees and showed no increase in EKG abnormalities. To our knowledge, there is a paucity of published literature regarding this route of administration.

Conclusion: Intramuscular olanzapine used IV may be a safe and effective option for the treatment of acutely agitated, delirious, critically ill patient.

https://doi.org/10.1177/001857871882

[Article Title: Current Trends in Hospital Pharmacy Practice in Lebanon / Nibal Chamoun, Ulfat Usta, Lamis R. Karaoui, Pascale Salameh, Souheil Hallit, Patricia Shuhaiber, Anna-Maria Henaine, Youssef Akiki, Rony M. Zeenny and Katia Iskandar, p. 112-118]

Abstract: Objectives: For decades, the role of hospital pharmacists has been instrumental in elevating pharmacy practice worldwide. Recently, the Hospital Pharmacy Section of the International Pharmaceutical Federation (FIP), the European Association of Hospital Pharmacists (EAHP), and the American Society of Health-System Pharmacists (ASHP) updated their statements about the future role and responsibilities of the pharmacy executive in hospitals and health systems. A series of surveys were conducted around the globe to better understand the current state of hospital pharmacy practice. The purpose of these surveys was to identify challenges in hospital pharmacy practice and to develop improvement strategies. The objective of this national survey is to evaluate hospital pharmacy practice in Lebanon.

Methods: A cross-sectional observational study was performed among pharmacists working in hospital settings in Lebanon, from January through June 2016. Based on a literature review, a questionnaire to elicit Lebanese hospital pharmacists’ practice was developed.

Results: The results showed a nonsignificant difference between university teaching and nonuniversity teaching hospitals in the processes of drug procurement, preparation, dispensing, and drug administration. However, statistically significant differences were observed between university teaching and nonuniversity teaching hospitals with respect to having clinical pharmacists (P < .001) and highly qualified personnel (P < .005). Pharmacy services in teaching hospitals seemed to be more advanced cooperating with affiliated medical schools. Furthermore, teaching hospitals were more likely to have pharmacists providing information about the safety of the medications used (P = .029). Although not statistically significant, there was a higher trend toward having a designated champion for medication safety (P = .052).

Conclusion: The results of our survey showed that teaching hospitals were more compliant with the International Statements of Hospital Pharmacy Practice compared with nonteaching hospitals. There is room for improvement especially if the application of the accreditation standards for safe hospital pharmacy practice becomes mandatory for all hospitals, which is expected to standardize pharmacy practice and secure both medication and patient safety.

https://doi.org/10.1177/0018578718823733

[Article Title: Pharmacists’ Perceptions on Their Role, Activities, Facilitators, and Barriers to Practicing in a Post-Intensive Care Recovery Clinic / Antoinette B. Coe, Rebecca E. Bookstaver, Andrew C. Fritschle, Michael T. Kenes, Pamela MacTavish, Rima A. Mohammad, Robert J. Simonelli, Jessica A. Whitten and Joanna L. Stollings, p. 119-125]

Abstract:

Background: Complex medication regimen changes burden intensive care unit (ICU) survivors and their caregivers during the transition to home. Intensive care unit recovery clinics are a prime setting for pharmacists to address patients’ and their caregivers’ medication-related needs. The purpose of this study was to describe ICU recovery clinic pharmacists’ activities, roles, and perceived barriers and facilitators to practicing in ICU recovery clinics across different institutions.

Methods: An expert panel of ICU recovery clinic pharmacists completed a 15-item survey. Survey items addressed the pharmacists’ years in practice, education and training, activities performed, their perceptions of facilitators and barriers to practicing in an ICU recovery clinic setting, and general ICU recovery clinic characteristics. Descriptive statistics were used.

Results: Nine ICU recovery clinic pharmacists participated. The average number of years in practice was 16.5 years (SD = 13.5, range = 2-38). All pharmacists practiced in an interprofessional ICU recovery clinic affiliated with an academic medical center. Seven (78%) pharmacists always performed medication reconciliation and a comprehensive medication review in each patient visit. Need for medication education was the most prevalent item found in patient comprehensive medication reviews. The main facilitators for pharmacists’ successful participation in an ICU recovery clinic were incorporation into clinic workflow, support from other health care providers, and adequate space to see patients. The ICU recovery clinic pharmacists perceived the top barriers to be lack of dedicated time and inadequate billing for services.

Conclusions: The ICU recovery clinic pharmacists address ICU survivors’ medication needs by providing direct patient care in the clinic. Strategies to mitigate pharmacists’ barriers to practicing in ICU recovery clinics, such as lack of dedicated time and adequate billing for pharmacist services, warrant a multifaceted solution, potentially including advocacy and policy work by national pharmacy professional organizations.

https://doi.org/10.1177/0018578718823740

[Article Title: Intranasal Fentanyl Use in Neonates / Sonia Kaushal, Jennifer L. Placencia, Salvador R. Maffei and Corrie E. Chumpitazi, p. 126-129]

Abstract:

Background: The recent addition of intranasal medication options for procedural sedation and analgesia has decreased the need for additional painful procedures such as intravenous lines for medication administration. Intranasal fentanyl (INF) has been used in the prehospital setting, as well as in the emergency department for several years, and is increasingly utilized in other locations such as the neonatal intensive care unit (NICU). A paucity of data exists in these smallest children, so we sought to explore trends in INF use in our NICU.

Objective: The objective of the study was to describe INF use in the NICU from December 2014 to December 2017.

Design/Methods: A retrospective cohort study was conducted of patients receiving INF in the NICU of a large free-standing quaternary inner-city children’s hospital from December 2014 to 2017. Demographic data were abstracted from the medical record including gestational age on administration, post-menstrual age, day of life on administration, sex, medication initial and total dose, reported indication, and documented adverse events. This study was approved by our local institutional review board.

Results: A total of 54 patients received a total of 67 INF administrations: 32 women (59%), median day of life on administration = 57.1 (interquartile range [IQR] = 33.7-110.4), median weeks gestation = 26.0 (IQR = 24.1-36.1), post-menstrual age = 38.1 weeks (IQR = 33.1-45.4). Initial doses of medications were 1.49 µg/kg/dose INF (range = 0.5-2 µg/kg).

Conclusions: Intranasal adjuncts are increasingly used in the NICU. Starting dose of INF is 1.5 µg/kg/dose, and typically, one dose is given.

https://doi.org/10.1177/0018578719828335

[Article Title: Hyperoncotic Albumin Reduces Net Fluid Loss Associated With Hemodialysis / Mitchell S. Buckley, Brian L. Erstad, Jake M. Lansburg and Sumit K. Agarwal, p. 130-134]

Abstract:

Purpose: The purpose of this study was to compare the volume of fluid removal associated with and without 25% albumin administration in conjunction with hemodialysis.

Methods: This retrospective, cohort study was conducted at a large academic medical center over a 6-month period to compare the net fluid amount removed (mL) during hemodialysis between patients administered 25% albumin and those without albumin.

Results: A total of 238 patients consisting of 973 unique hemodialysis sessions were evaluated. The mean overall net fluid removed by hemodialysis in the 25% albumin and no albumin groups were 1242 mL and 1899 mL, P < .001, respectively. No albumin group had significantly higher mean fluid losses compared with 25% albumin for a total dose of either 25 g (P = .001) or 50 g (P = .001). There were no significant differences in mean fluid loss between the no albumin group and patients receiving 75 g or 100 g of albumin. Post hoc analysis failed to demonstrate a dose-dependent response in those patients receiving 25% albumin and no albumin.

Conclusion: Hyperoncotic albumin administered during hemodialysis sessions reduced net fluid loss associated with hemodialysis. The findings of this study do not support the routine use of 25% albumin to improve fluid removal during dialysis.

https://doi.org/10.1177/0018578719828331

[Article Title: Corticosteroids for Septic Shock: Another Chapter in the Saga / Jason Yerke, Kyle Strnad and Seth R. Bauer, p. 135-142]

Abstract: The use of corticosteroids in the management of septic shock has been a highly debated topic for quite some time. Corticosteroids have the ability to combat hyperinflammatory and exaggerated vasodilatory responses, as well as to sensitize adrenergic receptors to decrease the duration of shock. While helpful clinically, this has not translated to consistent mortality benefits. Conflicting results from 2 landmark trials published in 2002 and 2008 have led to varying clinical practices, and a clearly defined role of corticosteroids in septic shock is lacking. A decade later, an influx of new data derived from 2 more large trials continues to echo diverging viewpoints regarding patient mortality. In combination with fluctuating study designs (eg, adjunctive therapies and shock management) and patient populations (eg, illness severity), generalized conclusions are still difficult to draw. Despite these challenges, this review critically analyzes recently published data in the context of historical debate to provide an updated comment on the role of corticosteroids in septic shock. In summary, hydrocortisone therapy is likely to demonstrate maximal benefit when initiated on patients with septic shock and organ failure refractory to vasopressor therapy and should be used judiciously in other settings as it comes without a demonstrated benefit in mortality and increased potential for adverse effects.

https://doi.org/10.1177/0018578719829416