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March 4, 2014
Evidence-Based Prescribing and Deprescribing in the Elderly
In our January 28, 2014 Patient Safety Tip of the Week “Is Polypharmacy Always Bad?” we discussed the need to consider polypharmacy in the context of the number of comorbidities a patient has. And we pointed out that some of the adverse consequences traditionally associated with polypharmacy may actually be the result of underprescribing! So we said what we really need to strive for is “eupharmacy”, where patients are treated with medications based upon the medical evidence base.
But one of the problems we have in dealing with the elderly is that the evidence base is limited. Particularly for patients age 80 and older there is often a paucity of evidence because such patients are often excluded from randomized controlled trials. For some preventive medications that absolute risk reduction may be much different at age 80 than it is at age 50 or 60.
So a provocative recent perspective in the journal Evidence-Based Medicine (Byatt 2014) is very timely in that respect. The author looked at the evidence base for medications used to prevent stroke in patients over 80 and noted that by this age hypertension may no longer be an attributable risk factor for stroke. Similarly, the use of statins in this age group has only marginal reduction in stroke risk and modest reduction in overall cardiovascular events.
Byatt notes that the NNT (number needed to treat) with antihypertensives for 2 years to prevent one stroke is 94 and the NNT to prevent nonfatal strokes even higher. For statins, treatment in the elderly reduces the risk of a composite of all strokes or cardiac events but not strokes alone.
The numbers noted by Byatt for antihypertensive therapy come from the HYVET (Hypertension in the Very Elderly Trial) study (Beckett 2008). That study did show that treatment of hypertension in patients age 80 and older resulted in a 30% reduction in the rate of fatal or nonfatal stroke and a 39% reduction in the rate of death from stroke. Also, in contrast to several other studies, it demonstrated a reduction in the rate of death from any cause (21% reduction). But overall the study population in HYVET was relatively healthy. Only 11.8% had a history of cardiovascular disease. So it is very difficult to extrapolate the beneficial effects noted in HYVET to the frail elderly.
For many years we have said that the benefits of statin use are actually more pronounced in the very elderly. But that is where we need to make a distinction between primary and secondary prevention. They may be beneficial in a patient who has already had a cardiovascular event but may have a much more limited benefit when used as primary prevention at this age.
At the same time the Byatt perspective came out another study (Tinetti 2014) was published looking at the impact of antihypertensive therapy on serious fall-related injuries in the elderly. They looked at a nationally representative sample of community-dwelling Medicare patients older than 70, most of whom had multiple comorbidities and were therefore representative of the real world as opposed to the relatively healthy patients in randomized controlled trials. Compared to patients on no antihypertensive medications those with moderate-intensity antihypertensive therapy were 40% more likely to have a serious fall-related injury and those on high-intensity antihypertensive therapy 28% more likely to have a serious fall-related injury. Also, those with a history of a prior fall injury were over twice as likely to suffer a fall-related serious injury. The authors chose serious fall-related injuries (hip fractures, other serious fractures, head injuries, etc.) because the consequences of these are comparable to the consequences of the conditions they are being used to prevent (eg. stroke, cardiovascular conditions).
The Tinetti paper is another reminder that in the real world we need to balance the potential risks against the potential benefits when we consider treatment of various risk factors. What works well in relatively healthy subjects seen in randomized controlled trials may not have the same risk:benefit ratio seen in elderly patients with multiple chronic conditions.
Patients such as those in the Byatt and Tinetti papers are not likely first starting their medications in their 70’s and 80’s. In most cases they have likely been on them for many years. Sometimes it is difficult to ascertain who originally prescribed the medication and why. So the real question is “when should we consider stopping medications?” and the next question is “how do we go about stopping them?”.
Fortunately, some good work has already been done addressing the issue of deprescribing in the elderly. Ian Scott and colleagues (Scott 2012) developed a 10 step conceptual framework for minimizing inappropriate medications in older populations and deprescribing (if you don’t have full access to that journal you can read an interview with Dr. Scott (Brookes 2013) in Medscape):
Deprescribing can be very time-consuming and often requires coordination with many other providers. Scott suggests only deprescribing one medication at a time. Another article on deprescribing in elderly nursing home patients (Liu 2014) also notes you need to observe patients for withdrawal syndromes or discontinuation syndromes when certain medications are tapered or discontinued.
We’ve noted in many of our columns that when we do medication reviews on elderly patients we almost always identify at least 1-2 medications that might be discontinued. In some cases there may be therapeutic duplication. In others it may be a potentially inappropriate medication from Beers’ list or the STOPP list. Those instances are actually the easy ones in which we can begin deprescribing. The tougher ones are those in which the patient is on a preventive medication. That’s when we must determine the patient’s real risk of developing the condition within his/her expected lifespan and whether the evidence is there to suggest the medication truly prevents that condition at this age. We then need to consider the potential adverse effects that medication might have and do an individualized risk:benefit analysis for that patient. We find most patients are willing to consider deprescribing when you have this sort of informed conversation with them. They (and more often the provider) may fear that stoppage of that medication will result in the condition they were trying to avoid. You do have to let them know that is a possibility but when you weigh the potential harms against the potential benefit (using terms they can understand, not statistical terms like “relative risk reduction”!) most are willing to consider coming off even a preventive medication.
So the bottom line: don’t just consider medications as potentially inappropriate if they are on Beers’ list or the STOPP list. Consider all medications as potentially inappropriate in the very elderly and do the sort of analyses noted above to determine whether deprescribing may be an option for your individual patient.
Some of our past columns on Beers’ List and Inappropriate Prescribing in the Elderly:
Patient Safety Tips of the Week:
What’s New in the Patient Safety World columns:
Byatt K. Overenthusiastic stroke risk factor modification in the over-80s: Are we being disingenuous to ourselves, and to our oldest patients? (Perspective). Evid Based Med 2014; doi:10.1136/eb-2013-101646 Published Online First: 26 February 2014
Beckett NS, Peters R, Fletcher AE, et al. for the HYVET Study Group. Treatment of Hypertension in Patients 80 Years of Age or Older. N Engl J Med 2008; 358: 1887-1898
Tinetti ME, Han L, Lee DSH, et al. Antihypertensive Medications and Serious Fall Injuries in a Nationally Representative Sample of Older Adults. JAMA Intern Med 2014; Published online February 24, 2014
Scott IA, Gray LC, Martin JH, Mitchell CA. Minimizing inappropriate medications in older populations: a 10 step conceptual framework. Am J Med 2012; 125: 529–537
Brookes L, Scott IA. Deprescribing in Clinical Practice: Reducing Polypharmacy in Older Patients. An Expert Interview With Ian A. Scott, MBBS, FRACP, MHA
Medscape Internal Medicine. November 26, 2013
Liu LM. Deprescribing: An Approach to Reducing Polypharmacy in Nursing Home Residents. Journal for Nurse Practitioners 2014; 10(2): 136-139
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March 2-8, 2014 is Patient Safety Awareness Week
The National Patient Safety Foundation is sponsoring Patient Safety Awareness Week March 2-8, 2014. Visit the NPSF website for tools to use at your organization to promote patient safety awareness.
We’ve highlighted perioperative handoffs in several columns (see our Patient Safety Tip of the Week for February 11, 2014 “Another Perioperative Handoff Tool: SWITCH” and our What’s New in the Patient Safety World columns for December 2011 “AORN Perioperative Handoff Toolkit” and March 2012 “More on Perioperative Handoffs”). But those have mostly dealt with handoffs of patients coming out of the OR or PACU.
Now a new study highlights vulnerabilities in handoffs in the opposite direction: from the ICU to the operating room (Evans 2014). The authors cite several case vignettes of problems with patient care emanating from poor handoffs as patients go to the OR from the ICU. They note the inability of the patient to provide history in many cases (altered mental status, sedation, intubation, etc.) increases the need for a detailed clinician-to-clinician handoff.
They also note that most of the standardized handoff formats we’ve discussed in our many columns on handoffs (see list below) don’t work well for this “reverse” perioperative handoff. So they developed their own checklist for this type of handoff and this could be completed on paper or electronic format. This checklist includes not only those items you’d expect in a handoff (demographics, current illness, past medical history, medications, allergies, lab results, etc.) but also specifics about various lines and catheters, DNR status, hemodynamic trends, airway problems, ventilator settings, antibiotic regimens, infusions, cardiac implantable devices, etc.
The authors appropriately note that a mandatory verbal handoff still needs to take place. We’ve stressed on numerous occasions that the combination of written and verbal handoff almost always outperforms handoffs that only use either the written or verbal format. Again, we stress that performing the verbal handoff in a venue free of distractions and interruptions works best and that handoffs are “two-way” where adequate opportunity must be present for the recipient to ask questions and get clarifications.
Read about many other handoff issues (in both healthcare and other industries) in some of our previous columns:
May 15, 2007 “Communication, Hearback and Other Lessons from Aviation”
May 22, 2007 “More on TeamSTEPPS™”
August 28, 2007 “Lessons Learned from Transportation Accidents”
December 11, 2007 “Communication…Communication…Communication”
February 26, 2008 “Nightmares….The Hospital at Night”
September 30, 2008 “Hot Topic: Handoffs”
November 18, 2008 “Ticket to Ride: Checklist, Form, or Decision Scorecard?”
December 2008 “Another Good Paper on Handoffs”.
June 30, 2009 “iSoBAR: Australian Clinical Handoffs/Handovers”
April 25, 2009 “Interruptions, Distractions, Inattention…Oops!”
April 13, 2010 “Update on Handoffs”
July 12, 2011 “Psst! Pass it on…How a kid’s game can mold good handoffs”
July 19, 2011 “Communication Across Professions”
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
December 2011 “AORN Perioperative Handoff Toolkit”
February 14, 2012 “Handoffs – More Than Battle of the Mnemonics”
March 2012 “More on Perioperative Handoffs”
June 2012 “I-PASS Results and Resources Now Available”
August 2012 “New Joint Commission Tools for Improving Handoffs”
August 2012 “Review of Postoperative Handoffs”
January 29, 2013 “A Flurry of Activity on Handoffs”
December 10, 2013 “Better Handoffs, Better Results”
February 11, 2014 “Another Perioperative Handoff Tool: SWITCH”
Evans AS, Yee M-S, Hogue CW. Often Overlooked Problems with Handoffs: From the Intensive Care Unit to the Operating Room. Anesthesia & Analgesia., POST AUTHOR CORRECTIONS, 9 January 2014
The American Society for Gastrointestinal Endoscopy has revised its guidelines for safety in the gastrointestinal endoscopy unit (Calderwood 2014). The guideline focuses on multiple facets of patient and staff safety: facilities, staffing, infection control, and sedation.
The section on facilities focuses on ensuring adequate space and equipment are provided to facilitate the procedures, patient recovery, storage, and infection control measures. More complex procedures should be assigned to larger procedure rooms with space for more specialized equipment and additional staff. One thing we like is their position that there should be a written plan for traffic patterns within the unit.
The section on infection control discusses hand hygiene, use of PPE, safe medication practices, and topics related to safe handling of potentially contaminated equipment, reusable medical equipment, and terminal cleansing issues. It is recommended that a qualified staff member must be responsible for implementation of a specific infection prevention plan. The section on safe medication practices focuses heavily on infection prevention.
They have recommendations for staffing before, during and after endoscopic procedures and for qualifications and training of staff.
Like any procedure, a “timeout” for verification of correct patient and procedure is necessary. Actual marking of the site is not required for endoscopic procedures because endoscopy does not involve lateral right-left distinction levels such as those found in spinal procedures or those done on multiple structures such as fingers or toes. Before starting an endoscopic procedure, the patient, staff, and performing physician should verify the correct patient and procedure to be performed.
The section on sedation discusses equipment, medications, monitoring, and staffing. Regarding personnel during moderate sedation, a nurse should monitor the patient and can perform interruptible tasks. If more technical assistance is required, a second assistant (nurse, licensed practical nurse [LPN], or unlicensed assistive personnel [UAP]) should be available to join the care team.
The ASGE position on use of capnography is that there is inadequate data to support the routine use of capnography when moderate sedation is the target. Our own warning is that the “target” of moderate sedation is often overshot and some patients inadvertently receive deep sedation. While the evidence base for use of capnography in this setting may be limited, it only takes one case of a disaster related to oversedation to destroy whatever other good work you’ve done. Capnography is rapidly becoming a standard of care whenever patients are being given intravenous sedation or opioids.
Lastly, they have a section on management of emergencies and need for a plan for transfer of patients to higher level facilities where necessary.
Calderwood AH, Chapman FJ, Cohen J, et al for the ASGE Ensuring Safety in the Gastrointestinal Endoscopy Unit Task Force. Guidelines for safety in the gastrointestinal endoscopy unit. Gastrointestinal Endoscopy 2014; article in press published 30 Jan 2014
Just as The Leapfrog Group has released its most recent report showing dramatic reductions in medically unnecessary C-sections and inductions before 39 weeks, another study raises questions about the ideal time for repeat C-sections in patients having multiple C-sections.
For several years now there has been a campaign to reduce non-medically indicated labor inductions prior to 39 weeks of gestation (see our February 8, 2011 Patient Safety Tip of the Week “Inducing Too Early”). That campaign, originally sponsored by the March of Dimes, Leapfrog Group, California Maternal Quality Care Collaborative and the California Department of Public Health; Maternal, Child and Adolescent Health Divisions, and later adopted by the American College of Obstetricians and Gynecologists (ACOG) highlighted the risks to newborns delivered prior to 39 weeks of gestation and provided tools to help avoid “elective” inductions prior to 39 weeks. We’ve been on board for that campaign.
The Leapfrog Group has been publicly reporting hospital rates since 2010, though hospital reporting has been voluntary. This month The Leapfrog Group published the rates for 2013 and they demonstrate a continued striking improvement trend. The national average of 4.6 percent in 2013 stands in sharp contrast to the national average of 17 percent in 2010. Moreover, in 2013, 71 percent of the reporting hospitals met Leapfrog’s early elective deliveries target rate of less than 5 percent, compared to 46 percent of hospitals in the 2012 survey.
While the public reporting likely got more hospitals involved, the real reason for the improvement has been that hospitals have done a good job educating both pregnant women and providers about the benefits of avoiding early induction. Most hospitals we’ve worked with have simply not allowed scheduling of elective inductions in cases lacking a medical indication (though simply requiring the provider to give a medical reason and then doing audit and feedback also successfully reduced rates of inappropriate early inductions).
But a new study, presented as an abstract at the 2014 Society for Maternal-Fetal Medicine Annual Meeting, seems to challenge delaying repeat C-sections in some women who have had prior C-sections (Hart 2014). The researchers studied over 6000 women with prior cesarean section deliveries who lacked medical or obstetrical indications for early delivery during their current pregnancy. They found that for women with 2 prior cesarean section deliveries the risk of adverse maternal outcomes increased three-fold with a concomitant increase in the risk of adverse perinatal outcomes between 38 to 39 weeks. In women with ≥ 3 previous cesarean section deliveries, the risk of maternal complications increased four-fold between 37 to 38 weeks. They conclude that their findings suggest the optimal time for scheduled delivery of women with 2 previous cesarean section deliveries is between 38 wks 0 and 38wk 6 days and between 37 wks 0 and 37 wks 6 days for women with ≥ 3 previous cesarean section deliveries.
It’s not the first time there has been a challenge to the campaign. In our October 2013 What’s New in the Patient Safety World column “Challenging the 39-Week Campaign” we noted a study by researchers at the Oregon Health & Science University (Darney 2013) that found no difference in the risk for severe lacerations, operative vaginal delivery, perinatal death, NICU admission, respiratory distress, or macrosomia between the groups at any week studied. There was an increased risk of hyperbilirubinemia in infants with inductions lacking medical indication at 37 and 38 weeks of gestation and an increased risk of shoulder dystocia at week 39.
Note also that another study (Stock 2012) had found that elective induction of labor between weeks 37 and 40 was associated with decreased odds of perinatal mortality compared to expectant management and did not increase the risk of cesarean sections. Admissions to a neonatal unit were, however, increased in those cases having elective induction prior to 41 weeks.
The studies highlight the importance of ensuring that recommendations are evidence-based. The Hart study would seem to indicate that adherence to the 39-week “rule” might actually have some unintended consequences in some cases.
The Leapfrog Group. Hospital Rates of Early Scheduled Deliveries. March 2014
Hart L, Refuerzo J, Sibai B, Blackwell S. Abstract 40: Should the “39 week rule” apply to women with multiple prior cesarean deliveries? American Journal of Obstetrics & Gynecology 2014; 210(1 Supplement): S27, January 2014
Darney BG, Snowden JM, Cheng YW, et al. Elective Induction of Labor at Term Compared With Expectant Management: Maternal and Neonatal Outcomes. Obstetrics & Gynecology 2013; published ahead of print 6 September 2013
Stock SJ, Ferguson E, Duffy A, et al. Outcomes of elective induction of labour compared with expectant management: population based study. BMJ 2012; 344: e2838 Published 10 May 2012
In several of our prior columns on use of oxygen (see our Patient Safety Tips of the Week April 8, 2008 “Oxygen as a Medication” and January 27, 2009 “Oxygen Therapy: Everything You Wanted to Know and More!”) we have commented that in the past we often routinely gave oxygen to patients with myocardial infarction or stroke. But such use was more reflexive in nature and not evidence-based.
In our What’s New in the Patient Safety World columns for July 2010 “Cochrane Review: Oxygen in MI” and February 2012 “More Evidence of Harm from Oxygen” we discussed the lack of evidence to support the routine use of oxygen in the acute MI patient and the possible deleterious effects in these and some other cardiac patients.
Now another new study (Rincon 2014) shows that hyperoxia was independently associated with in-hospital death as compared with either normoxia or hypoxia in ventilated stroke patients admitted to ICU’s. Their data underscore the need for studies of controlled reoxygenation in ventilated critically ill stroke populations. They recommend that, in the absence of results from clinical trials, unnecessary oxygen delivery should be avoided in ventilated stroke patients.
As we’ve recommended before, hospitals need to look at their existing protocols (and actual practices) for managing a variety of medical conditions where oxygen use may be considered. How many of you have standardized order sets that directly (or indirectly by poor use of checkboxes) encourage inappropriate use of oxygen in MI or stroke patients? Going back to our Patient Safety Tips of the Week April 8, 2008 “Oxygen as a Medication” and January 27, 2009 “Oxygen Therapy: Everything You Wanted to Know and More!” we strongly support facilities doing audits of their oxygen practices. You’ll probably be surprised at the opportunities you uncover to improve practices (and save money at the same time!).
And don’t forget that in many cases high doses of oxygen are administered by the pre-hospital emergency response teams. Making them aware of the potential dangers is also important.
Rincon F, Kang J, Maltenfort M, et al. Association Between Hyperoxia and Mortality After Stroke: A Multicenter Cohort Study. Critical Care Med 2014; 42(2): 387-396
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