Patient Safety

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Patient Safety

Patient safety news, including recalls and safety alerts, important consumer information and updates on safe medication practices.

Applying the Pharmacists' Patient Care Process to Transitions of Care
Devin Schmidt, Pharm.D., BCACP, ambulatory care pharmacist, Mercy Health Muskegon, Muskegon, Mich.

In 2014, the Pharmacists' Patient Care Process was created by the Joint Commission of Pharmacy Practitioners (JCPP) after a need was recognized for a consistent process in the delivery of patient-centered care across various practice settings of the pharmacy profession. Supported by 13 national pharmacy organizations, this process set out to engage patients and caregivers using effective communication to promote comprehensive approaches to deliver care in collaboration with other members of the healthcare team.1 Since the publication of this process, many pharmacists and student pharmacists have begun using these steps to employ consistent patient care to their practices.

Recently, the American Pharmacists Association (APhA) highlighted implementing this process in transitions of care.2 This guide serves to provide specific guidance, directly related to patient care during a healthcare transition, within each of the principles defined in the Pharmacists' Patient Care Process.

Collect - A pharmacist should collect the necessary subjective and objective information to enable safe and efficient care transitions. Collected information should include, but not be limited to, data to optimize medication reconciliation, medication counseling, medication delivery and/or dispensing, and post discharge follow up via telephone or face-to-face visit. Depending on the care transition, this would include a comparison of the existing and previous medication regimens, patient's personal medication list and patient provided history.

Assess - Using the information collected, assessment of the indication, efficacy, safety and ease of adherence for each medication should be performed at each care transition. Assessing both acute and chronic disease states is important during a care transition, even though it may have been an acute concern that lead to this change in level of care. Attention should also be given to health literacy, the patient's social support system, potential barriers, such as transportation or financial barriers, and the need for assistance in setting up follow up care.

Plan - When creating a care plan during various care transitions, each medication related problem needs to be addressed to optimize the patient's medication regimen, prioritizing resolving barriers and ensuring safety. Care plans should align with the therapy goals established by the healthcare team. Engaging the patient with effective communication is important to educate and empower the patient to self-manage their health when discussing the plan.

Implement - Effective collaboration between pharmacists and other members of the healthcare team is imperative to address identified barriers to safe and efficient transitions. Potential collaborations might include utilizing other disciplines to help address barriers with home health, transportation, insurance enrollment, culture, language differences or various levels of health literacy. Pharmacists are uniquely suited to provide patient specific education on their complete medication list at transitions and empower self-management. Providing information to other members of the healthcare team that were not involved in the care transition is also an integral component for implementing a successful plan.

Follow-up: Monitor and Evaluate - Once a patient completes a care transition, it is important that the implemented plans are monitored and evaluated to determine its efficacy, as well as providing effective hand-offs to ensure continuity of care throughout transitions. Follow up phone calls, home or office visits and medication reviews aide in the assessment of adherence and self-care of the implemented plan.

Overall, various care transitions can involve different disciplines, tasks and responsibilities depending on the location of transition. However, utilizing the five steps of the Pharmacists' Patient Care Process provides a framework by which a consistent level of care across the pharmacy profession is provided during healthcare transitions.

References 

1. The Pharmacists' Patient Care Process [Internet]. JCPP. 2014 [cited 2019Feb23]. Available from: https://jcpp.net/patient-care-process
2. American Pharmacists Association. Applying the Pharmacists' Patient Care Process to Care Transitions Services. February 2019.
Posted in: Patient Safety
Narcotic Diversion: Are You or Your Health-System at Risk?

By Julie Schmidt, Pharm.D., BCPS, clinical pharmacist, Bronson Methodist Hospital, Kalamazoo


It is safe to say we have all heard of the opioid epidemic currently happening in our nation and the effects it is having in our communities. If you are not aware of this situation, please refer to our mainstay pharmacy reference, Google, where you will find countless articles regarding the detrimental effects these medications are having on people and communities. What may not be the first article that pops up is an article about a local pharmacist with an opioid addiction, or a nurse caught for pocketingthe fentanyl she pulled from an automated dispensing cabinet that was really supposed to be given to a patient. While you may not exactly find these specific stories on Google, I can assure that you will find plenty that share extreme similarities. While the rest of the nation continues to fight the opioid epidemic in the streets, perhaps we should take a little closer look in our own workplaces.

 

Data from the American Nurses Association report that about one in 10 nurses are thought to be abusing drugs and may be impaired while taking care of patients. While the overall incidence of drug abuse is about the same in healthcare workers compared to the general population, healthcare workers have some exclusive patterns to their population regarding drug abuse. For example, healthcare workers are more likely to misuse prescription medications as compared to street drugs since prescription medications are often easy to access. While healthcare workers experience every day stressors just like the general population, they are also known to experience stress from handling patient illness and death, long hours and demanding work. Unfortunately, the misuse of these medications not only affects the one abusing them, but they may also directly impact patients. As a result of diversion in a healthcare setting, patients may receive diluted medications, infections from contaminated needles/syringes and potential errors if the healthcare professional is impaired.

 

How do we avoid medication diversion in our own workplace? First off, expect it. This does not mean it is acceptable, but rather it means that steps need to be taken in order to prevent it in the first place. This may include, but is not limited to, ensuring access is only given to necessary personnel, regular auditing and utilizing technology such as automated dispensing cabinets (ADCs). ADCs may be helpful in tracking medication diversion by recording trends, keeping a rolling inventory of medications and ensuring there is a systematic way to document waste. Together with ADCs, hospitals and other healthcare systems should have established policies to identify those responsible for drug diversion, ensure reporting is completed on a routine basis and execute disciplinary action as necessary.

 

In addition to the steps listed above, many helpful resources are available online when evaluating your own workplaces policies and procedures regarding medication diversion. See references below for access to some of these resources. By regulating controlled substances in our workplace and making sure policies and procedures are followed, we can help protect not only ourselves and coworkers from potential misuse, but also our patients from unnecessary negative impacts.

 

References:

  1. Brummond PW, Chen DF, Churchill WW, et.al. ASHP Guidelines on Preventing Diversion of Controlled Substances. Am J Health-Syst Pharm. 2017;74:325-48.
  2. Diversion Central. Omnicell website. https://www.omnicell.com/diversion. Accessed Oct. 1, 2018.
  3. Diversion and Loss Prevention. BD website. https://www.bd.com/en- in/our-products/integrated-analytics-solutions/diversion-and-loss-prevention. Accessed Sept. 30, 2018.
Posted in: Patient Safety
C. difficile: Three Essentials from the New National Guidelines

By Rachel Kenney, Pharm.D., BCPS-AQ ID, pharmacy specialist, antimicrobial stewardship, Henry Ford Hospital, Detroit

 

Clostridium difficile infection (CDI) causes approximately 453,000 infections and 29,000 deaths in the United States (U.S.) annually.1 This reportable healthcare-associated infection is a priority across the entire healthcare continuum, resulting in 159,700 community-onset infections each year.1 New national guidelines for CDI were recently published from the Infectious Diseases Society of America and Society for Healthcare Epidemiology of America.2 Here are three things that all pharmacists should know:

#1. Metronidazole is notably absent as a first line recommendation in new guidelines, after a 2017 study identified imidazole resistance genes in 47.5 percent of positive samples at a U.S. reference laboratory.2,3 Additionally, recent studies demonstrate that metronidazole is inferior to vancomycin for clinical response and associated with increased 30-day mortality, particularly among patients with severe disease.4,5 Therefore, the guidelines recommend that providers consider metronidazole only for patients with a mild to moderate first episode when medication access barriers prevent the patient from obtaining one of the first line regimens.

#2. Fidaxomicin (Dificid®) is recommended in the guidelines as first line therapy for non-severe, severe and first recurrence of CDI.2 A recent Cochrane review concluded that, “moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin” for the treatment of CDI.6 Among patients being treated for a first recurrence, fidaxomicin resulted in reduced second recurrences compared to a 10-day course of vancomycin (19.7 percent versus 35.5 percent, p=0.045).7 However, the cost of fidaxomicin (average wholesale price approximately $4,400) continues to limit the optimal positioning of this medication in many settings, representing an important medication access opportunity for pharmacists.

#3. Vancomycin tapered, pulsed therapy is recommended for a first recurrence of CDI.2 The burden of recurrent CDI is on the rise and approximately one in five patients will experience at least one recurrence.8 Due to the important role of the gut microbiome in protecting against CDI, vancomycin given as a tapered, pulsed regimen is proposed to treat recurrent CDI and allow the normal gut microbiome to recover (weak, low quality evidence recommendation).2 In one study of 100 consecutive patients, recurrent CDI was managed with an average duration of 11 weeks of vancomycin oral taper-pulse.9 Overall, clinical cure at 90-days was 74 percent. Patients who concluded their taper-pulse regimen with vancomycin oral every other day followed by vancomycin oral every 72 hour dosing had improved cure when compared to patients who concluded their regimen with every other day dosing.9

Overall, the new guidelines result in very major changes to standard of care treatment for CDI. Pharmacists have an important role to play to ensure optimal CDI management, particularly until all prescribers are familiar with these new recommendations.

 


Summary of Guideline Recommendations for C. difficile infection

Non-severe

Severe*

First Recurrence

Fulminant CDI** (formerly severe, complicated)

Vancomycin 125 mg oral every six hours for 10 days

OR

Fidaxomicin 200 mg oral twice daily for 10 days

Vancomycin 125 mg oral every six hours for 10 days

OR

Fidaxomicin 200 mg oral twice daily for 10 days

Vancomycin 125 mg oral every six hours x 10 days followed by a taper-pulse

OR

Fidaxomicin 200 mg oral twice daily for 10 days

Vancomycin 500 mg oral every six hours + metronidazole 500 mg IV every eight hours + vancomycin 500 mg every six hours as a retention enema

*Severe is defined as leukocytosis with a white blood count of 15,000 cells/mL or more, OR a serum creatinine greater than 1.5 mg/dL. **Fulminant is defined as the presence of hypotension, shock, ileus or toxic megacolon due to CDI.

 

References

1.      Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372:825-834.

2.      McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):987-994.

3.      Barkin JA, Sussman DA, Fifadara N, Barkin JS. Clostridium difficile infection and patient-specific antimicrobial resistance testing reveals a high metronidazole resistance rate. Dig Dis Sci. 2017;62(4):1035-1042.

4.      Johnson S, Louie TJ, Cornely OA, et al. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014;59:345-54.

5.      Stevens VW, Nelson RE, Schwab-Daugherty EM, et al. Comparative effectiveness of vancomycin and metronidazole for the prevention of recurrence and death in patients with Clostridium difficile infection. JAMA Intern Med. 2017;177(4):546-553.

6.      Nelson RL Suda KJ, Evans CT. Antibiotic therapy for Clostridium difficile-associated diarrhoea in adults. Cochrane Database Syst Rev. 2017; Issue 3 Art. No.: CD004610.

7.      Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012;55(Suppl 2):S154–61.

8.      Kelly CP and LaMont JT. Clostridium difficile – more difficult than ever. New Engl J Med. 2008;359:1932-1940.

9.      Sirbu BD, Soriano MM, Manzo C et al. Vancomycin taper and pulse regimen with careful follow-up for patients with recurrent Clostridium difficile infection. Clin Infect Dis. 2017;65: 1396–1399.

Posted in: Patient Safety
Injectable GLP-1 Agonists & Combination Products: Review for Inpatient Use

By Matthew Hecker, Pharm.D., PGY1 pharmacy practice resident, Sparrow Hospital, Lansing

 

Glucagon-like-peptide-1 (GLP-1) receptor agonists are a class of injectable and oral medications used in the treatment of type II diabetes. Injectable agents that are currently approved for use in the United States are: albiglutide (Tanzeum®), dulaglutide (Trulicity®), exenatide extended release (Bydureon®), exenatide immediate release (Byetta®), lixisenatide (Adlyxin®), and liraglutide (Victoza®). Combination products containing long acting (basal) insulin include: insulin degludec/ liraglutide (Xultophy®, and insulin glargine/lixisenatide (Soliqua®). GLP-1 agents are associated with increased glucose-dependent insulin secretion, decreased inappropriate glucagon secretion, increased B-cell growth and replication, slower gastric emptying and decreased food intake.


GLP-1 agonists have been shown to lower the hemoglobin (Hb) A1C in type II diabetes by one to 1.5 percent, which is only surpassed by the lowering effects of insulin therapy. In addition to its glucose lowering effects, the results from the LEADER trial (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) have demonstrated that liraglutide (Victoza®) can provide additional cardiovascular benefits in patients with type II diabetes.4  The overall benefits of these agents in patients with type II diabetes is seen in their outpatient utilization.


While concerns exisit for therapy in all patients, inpatient concerns for GLP-1 agonists include their use in patients with renal impairment, hypersensitivity reactions to any GLP-1 products, a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, and pancreatitis. The most commonly reported adverse drug effects are hypoglycemia, diarrhea, nausea and injection site reactions.1

 

Table 1: Characteristics of Injectable GLP-1 Agonists/Combination Products 1,2

Agent

 

Effect on HbA1C

Weight Loss

Hypoglycemia

Diarrhea

Nausea

Injection Site Reactions

Albiglutide

~1%

~1 kg

3-17%

13%

11%

18%

Dulaglutide

~1.5%

~2.5 kg

3-6%

9-13%

12-21%

0.5%

Exenatide ER

~1.5%

~2.5 kg

4-11%

1-20%

11%

17%

Exenatide IR

~1%

~2 kg

4-11%

11%

11%

13-17%

Liraglutide

~1.5%

~2.5 kg

16%

10-12%

20%

18%

Lixisenatide

~1%

~2 kg

n/a

8%

25%

18%

Degludec/ Liraglutide

~1% more than insulin degludec

~2.5 kg

 

Refer to Individual Agents

 

Insulin Glargine/ Lixisenatide

~0.5% more than insulin alone

~1.4 kg

 

Refer to Individual Agents

 

 

According to the American Diabetes Association (ADA), a review of anti-hyperglycemic medications concluded that GLP-1 receptor agonists show promise in the inpatient setting; however, proof of safety and efficacy await the results of randomized controlled trials. 3 There are potential administration concerns that could arise as a result of nursing staff’s unfamiliarity with these agents and their ability to cause hypoglycemia. Furthermore, cost of the medication may also be prohibitive in the inpatient setting.  Medication-related concerns such as renal impairment and gastrointestinal symptoms pose unique challenges in the acutely ill patient.


Although studies have shown that patients are able to improve glycemic control while taking these agents, there is relatively low benefit to using these agents in the acute inpatient setting.3 Patients can be sufficiently controlled with the use of basal and bolus insulin. Because of the potential risks associated with the GLP-1 agonists, the Pharmacy & Therapeutics Committee at Sparrow Hospital has classified these agents as non-formulary (Do Not Stock/Do Not Dispense). An automatic hold on GLP-1 agonists for the duration of hospitalization will occur, and providers will be prompted to utilize the basal and bolus insulin order set. Patients on combination products will be converted to basal insulin products based upon the recommended conversions provided in Table 2.

 

Table 2: Converting Combination Products to Long Acting Insulin Regimens at Sparrow 1

Combination Product

Conversion to Insulin Only Regimen

Degludec/ Liraglutide (Xultophy®)

Convert current insulin degludec dose to equivalent insulin detemir dose (Levemir®) 1:1 conversion of degludec to detemir

Insulin Glargine/ Lixisenatide (Soliqua®)

Convert current insulin glargine dose to equivalent insulin detemir dose (Levemir®) 1:1 conversion of degludec to detemir

 

 

References:

  1. Lexi-Drugs. Lexicomp Online. Hudson, OH: Wolters Kluwer Clinical Drug Information Inc. http://online.lexi.com. Accessed December 20, 2017.
  2. Therapeutic Research Center. Comparison of GLP-1. http://pharmacistsletter.therapeuticresearch.com/pl/ArticlePDF.aspx?&DocumentFileID=0&DetailID=340201&SegmentID=0. January 2017.
  3. American Diabetes Association (ADA). 14. Diabetes care in the hospital. Diabetes Care. 2017c;40(suppl 1):S120–S127.
  4. Marso SP, Daniels GH, Brown-Frandsen K et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311-22.
Posted in: Patient Safety
Managing Violent Psychiatric Patients in the Emergency Department

By Steven Zhang, Pharm.D., PGY-1 pharmacy resident, Sparrow Hospital, Lansing

 

A major emerging issue in emergency medicine practice is the boarding of psychiatric patients awaiting placement. Boarding is defined as a patient remaining in the emergency department after admission to the facility, but has not been transferred to an inpatient unit. The American College of Emergency Physicians considers the boarding of patients to be a failure of inpatient bed management that contributes to decreased patient safety and lower quality of care.1 While boarding may occur with any patient, psychiatric patients are frequently affected because of dwindling availability of inpatient psychiatric beds.2 For psychiatric patients that present with psychotic, aggressive or violent behavior, the emergency department may not be able to provide the specialized psychiatric care necessary.

 

In 1955, over 500,000 inpatient psychiatric beds existed nationwide. By 2012, that number decreased to just over 50,000 beds.3 During that same time frame, the national population nearly doubled, from 165 million to 325 million. The reason for this decline in beds is in part due to reports of patient abuse at psychiatric facilities, which prompted the president of the American Psychiatric Association in 1958 to describe psychiatric hospitals as “morally bankrupt beyond remedy” and advocated for their closure “as rapidly as can be done.” This, along with reduced funding and the emergence of antipsychotics which allowed for more outpatient management of previously hospitalized patients, contributed to the deficiency of psychiatric bed availability. In Michigan, 47 percent of inpatient psychiatric beds were closed between 2005 and 2010, leaving a total of 5.4 beds per 100,000 people, fourth fewest among states in the country.3 The impact of this trend has been widespread, but has presented significant problems for emergency departments in particular. A nationwide survey of 6,000 hospitals in 2012 found 70 percent of emergency departments reported boarding psychiatric patients for “hours to days,” with 10 percent reporting boarding of individuals in psychiatric crisis for one week or longer.3

 

The medical management of patients presenting with psychotic, aggressive or violent behavior in the emergency department is challenging. There are few studies or guidelines that offer conclusive evidence on how these patients should be treated. Chemical restraints such as antipsychotics, benzodiazepines and ketamine can be given as needed; in severe cases, physical restraints may be used.4,5 While rescue doses are effective for an acute escalation in patient behavior, the relatively short duration of action of these agents leaves open the possibility of re-emergence of the psychotic, aggressive or violent behavior once effects of the medication have worn off. Emergency physicians may be less likely to start scheduled antipsychotics in boarded patients, as they anticipate a psychiatrist will take over care upon inpatient admission. However, with more of these patients remaining boarded in the emergency department for longer periods of time, a stronger emphasis should be placed on not allowing the patient’s behavior to escalate to the point of requiring stat or IV injections. Every instance where a rescue dose of an antipsychotic, benzodiazepine or ketamine is required is an indication of an unsafe situation that poses a risk to the patient and hospital staff. The prevention of these situations should be a priority in boarded psychiatric patients exhibiting behavioral issues that may escalate. Pharmacists can make an impact by identifying and intervening on appropriate patients to recommend scheduling an antipsychotic regimen. The agent, dose and frequency chosen will vary based on patient factors, adverse drug reactions and the clinical judgment of the pharmacist and physician, but the overall objective is to avoid resorting to rescue injections to restrain a patient, thereby indicating a decrease in the number of risky situations. More studies are needed moving forward to give more conclusive evidence on the clinical impact of these interventions.  

 

Psychiatric patients presenting with psychotic, aggressive or violent behavior while boarded in emergency departments present a major challenge for health-systems and healthcare professionals. Because the trend of declining inpatient psychiatric beds shows no indication of reversing, the medical treatment of these patients in the emergency department should be optimized by pharmacists with the goal of reducing the need for rescue injections of chemical restraints. Using antipsychotics in a scheduled regimen for these patients may be an effective method of reducing the risk of physical injury to patients and staff.

 

References

1. American College of Emergency Physicians. Boarding of admitted and intensive care patients in the Emergency Department. Policy statement. ACEP website. https://www.acep.org/patient-care/policy-statements/boarding-of-admitted-and-intensive-care-patients-in-the-emergency-department/#sm.000kxp1n7154messs1i200bq8xdid. Last revised June 2017.

2. Fuller D, Sinclair E, Geller J, et al. Going, going, gone: trends and consequences of eliminating state psychiatric beds. Treatment Advocacy Center. 2012.

3. Torrey E, Fuller D, Geller J, et al. No room at the inn: trends and consequences of closing public psychiatric hospitals. Treatment Advocacy Center website. http://www.treatmentadvocacycenter.org/storage/documents/going-going-gone.pdf.

4. Wiler J, Brown N, Chanmugam A, et al. Care of the psychiatric patient in the emergency department – a review of the literature. American College of Emergency Physicians website. https://www.acep.org/globalassets/uploads/uploaded-files/acep/clinical-and-practice-management/resources/mental-health-and-substance-abuse/psychiatric-patient-care-in-the-ed-2014.pdf.

5. Yildiz A, Sachs G, Turgay A. Pharmacological management of agitation in emergency settings. J Emerg Med. 2003;20:339-46.

Posted in: Patient Safety
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