Category Archives: Pharmacy

Pharmacy

What’s With Those Capital Letters In Drug Names?

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Call me slow. I’ve subconsciously seen those capital letters in drug names for years. But I never really paid attention or thought much about them. For whatever reason, I just now realized that they are EVERYwhere!

So I decided to investigate. Technically, they are called tall man letters. Here are some examples:

Certain parts of the drug name are capitalized to highlight differences from a drug with similar spelling. Note the similarities of the drugs in each row, and how the capital letters set them apart.

Studies from 20 years ago have shown that drug names are easier to distinguish using tall man letters. From a practical standpoint, fewer medication errors occur when tall man letters are used.

This technique is now used on preprinted pharmacy labels, and in electronic medical record systems.  Surveys have shown that half of respondents have used tall man lettering in conjunction with pharmacy labels and medical records. Those found on labels were considered most effective, and those on preprinted order forms was least effective.

The use of tall man characters is now so pervasive that they are just part of the background. But a very important part. Now you (and I) know!

Reference:Tall man letters are gaining wide acceptance. P T. 2012 Mar;37(3):132-48. PMID: 22605902; PMCID: PMC3351881.

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Abstracts, Pharmacy

Best Of AAST #5: Door-To-Prophylaxis Time

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Today’s abstract continues the theme of VTE prophylaxis. The authors introduce another timing parameter in this one: the “door-to-prophylaxis” time. Just as it sounds, this is the time interval between admission to the ED and initiating chemo-prophylaxis. Just like some centers struggle with how long to wait to start it after a solid organ injury (see previous post here), many find it challenging to get it ordered in the first place.

The authors retrospectively reviewed their registry data over four years. They compared adult patients who arrived as a highest-level of activation and received blood during their resuscitation. They were divided into two groups: those with DVT or pulmonary embolism (VTE group) and those without (no VTE group). The door-to-prophylaxis time was defined as the time from hospital arrival to the first dose of medication.

Here are the factoids:

  • Just over 2,000 patients met inclusion criteria, with 106 experiencing VTE and 1,941 without it
  • VTE patients had higher ISS (29 vs. 24), higher lactate levels (4.6 vs. 3.9), and more post-ED blood transfusions (8 vs. 2)
  • There was no difference in the need for dose adjustment or missed doses between the groups
  • Door-to-prophylaxis time was significantly longer in the VTE group (35 vs. 25 hours)
  • When controlling for age, sex, ISS, lactate, and post-ED transfusions, each hour of delay increased the likelihood of VTE by 1.5%

The authors concluded that the door-to-prophylaxis time was significantly associated with increased incidence of VTE. They suggest that the door-to-prophylaxis time should be utilized as a performance improvement metric for this condition.

Bottom line: Unfortunately, we need a lot more information here. There was not enough room for details about the statistical analysis in the abstract, but they will be essential to know. And the authors remind us that this study shows association, not causation. 

Severe injury and blood transfusion are already known to be associated with a higher likelihood of VTE. The fact that the longer door-to-prophylaxis group had more frequent VTE may very well be due to their higher ISS and greater number of transfusions. Those events themselves may have led to the hesitation in starting a heparin.

Early prophylaxis is certainly a desirable goal in any trauma patient. But we need more than a new metric. We need more concrete information on the specific reasons for the delay and to prove that it is safe to give the drug early in patients who have those potential delaying factors.

Reference: “Door-to-prophylaxis” time as a novel quality improvement metric in preventing venous thromboembolism following traumatic injury. AAST 2023, Plenary paper #38.

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Abdomen, Abstracts, Pharmacy

Best Of AAST #4: Starting VTE Prophylaxis After Solid Organ Injury

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Venous thromboembolic disease (VTE) continues to be a major issue in trauma patients. Most trauma centers have prophylaxis guidelines to try to reduce this problem. These guidelines typically recognize specific injuries that increase the risk of bleeding if anticoagulants are given. Typical ones include hemorrhagic injuries to the brain, pelvic and spine fractures, and solid organ injuries.

Typically, VTE prophylaxis starts immediately upon admission. But when these high-risk injuries are present, it is usually delayed for a period of time. Unfortunately, that period may be highly variable. Many centers have adopted 2-3 days to delay administration of low molecular weight heparin in patients with solid organ injury.

The AAST initiated a prospective multi-institutional trial comparing early (<48 hours after admission) and late (>48 hours) administration of prophylactic agents. Patients were older than 16 years, had any number of liver, spleen, or kidney injuries, and were initially treated nonoperatively. Patients who were transferred, died in the ED, were pregnant, had a bleeding disorder, or were taking anticoagulants or platelet inhibitors were excluded. A power analysis was performed, and more than the needed number of patients were enrolled.

Here are the factoids:

  • A total of 1173 patients were enrolled, and there were 589 liver injuries, 569 spleen injuries, and 289 kidney injuries
  • About 75% of patients (864) had early prophylaxis
  • Patients were younger (median 34 years), and two-thirds were male, with a median ISS of 22
  • Early VTE prophylaxis patients had significantly lower rates of VTE (3% vs. 7%)
  • There was no significant difference in failure of nonoperative management (5% early vs. 7% late)
  • The early prophylaxis group received fewer units of blood after prophylaxis started (17% vs. 23%)
  • Patients receiving VTE prophylaxis after 48 hours were 2.2x more likely to develop VTE

The authors concluded that early VTE chemoprophylaxis was associated with lower rates of VTE with no increase in complications. They recommended that it should become the standard of care for these patients.

Bottom line: Seeing such a well-designed and nicely executed study is refreshing. If the facts are borne out in the final manuscript review, this should become the standard of care for VTE prophylaxis in patients with solid organ injuries. 

I wish the authors would have stipulated that the chemoprophylaxis was required to be low molecular weight heparin. Unfortunately, there are still more than a few centers using unfractionated heparin. There could be a difference in efficacy and failure rates between the two. This could complicate the statistical analysis. Hopefully, the presenter will address this during the meeting.

I would also like to see a breakdown of when the early VTE prophylaxis actually started. Were they all close to 48 hours? Or were there enough at 24 hours to show this is also safe and effective?

It’s time for everyone to review their VTE prophylaxis guidelines. Get ready to make some major changes in your patients with solid organ injury!

Reference: When is it safe to start VTE prophylaxis after blunt solid organ injury? A prospective AAST multi-institutional trial. AAST 2023, Plenary paper #23.

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Abstracts, Pharmacy

Best of AAST #1: Aspirin Vs Low Molecular Weight Heparin For VTE Prophylaxis

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The 82nd Annual Meeting of the American Association for the Surgery of Trauma begins next week. As is my custom, I will be reviewing some of the more interesting (to me) oral presentation abstracts until the last day of the meeting.

When reading abstracts, keep in mind that you are seeing just a snippet of a finished manuscript. The authors are given very little print space to fully describe their research idea, their methods, and their results’ significance. Sometimes, what is seen in the abstract varies significantly from what is actually heard at the meeting. But mercifully, this does not happen often. The abstract is usually an intriguing look at some new and exciting work.

Having said all that, an abstract should not be a reason to change your practice! It is usually early work and needs to be fully vetted at peer review. Even then, it needs to be taken in context with past, similar research before trickling down to patient care.

The first abstract is fascinating. Our orthopedic surgery colleagues have been trying to use aspirin for venous thromboembolism (VTE) prophylaxis for decades. Frequently, they are thwarted by the trauma surgeons, who are thoroughly indoctrinated in the low molecular weight heparin (LMWH) camp.

This work comes from the Shock Trauma Center in Baltimore and is a follow on to a paper published in the New England Journal of Medicine earlier this year. The paper demonstrates that aspirin is not inferior to LMWH when used for VTE prophylaxis of patients. There was no difference in death from all causes, VTE occurrence, wound complications, or bleeding events.

The abstract is a follow-on to that manuscript. The authors performed a secondary analysis of the initial data to see if aspirin provided the same apparent level of protection in patients with high risk for VTE as measured by the Caprini score.

Here are the factoids:

  • A total of 12,211 patients were enrolled in this multi-center, and the same outcomes listed above were monitored for 90 days
  • Of the total group, 3052 were judged to be high risk: 46% had a femur fracture, 42% had a pelvic/acetabular fracture, 48% had a thoracic injury, 39% had a spinal injury, and 35% had a head injury
  • There was no difference in death, deep venous thrombosis, pulmonary embolism, or bleeding in the two groups
  • Patient-reported satisfaction was significantly better by 68% in the aspirin group

The authors concluded that outcomes for aspirin vs. LMWH are similar, even in patients at high risk for VTE.

Bottom line: This is an intriguing abstract, pointing me to the original paper published in NEJM. This multi-center study was performed in conjunction with the research coordinating center at Johns Hopkins, which designs some top-notch research. This study was no exception.

I am fascinated with this work because it shows that our orthopedic colleagues were right! They’ve been trying to get us to use aspirin for a long time. It’s very cheap compared to LMWH, by a ratio of about 50,000:1. 

If you’ve followed me for a long time, you would know I have been skeptical of the VTE prophylaxis establishment. Looking historically at its evolution over the last 40+ years, the incidence of DVT and fatal PE have changed very little despite the introduction of heparin, low molecular weight heparin, and anti Factor Xa monitoring. But it’s been established practice, so we’ve had to abide by the rules. Now, a cheaper alternative to all of this is being shown to be just as (in)effective. 

I suspect that if others bear out this work, we will be able to use a cheaper prophylaxis drug that does not require injection. But we still need to work on figuring out the basis for this problem to hopefully reduce it to near zero someday.

References: 

  • Risk-stratified thromboprophylaxis effects of aspirin versus low-molecular-weight heparin in orthopaedic trauma patients. AAST 2023 Plenary Paper 3.
  • Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture. N Engl J Med 2023; 388:203-213.
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Abstracts, Pharmacy, Solid organ

Best Of EAST 2023 #10: Early VTE Prophylaxis In Adolescents With Solid Organ Injury

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Chemoprophylaxis against venous thromboembolism (VTE) is routine in trauma care. In most cases, it can be initiated shortly after admission in most trauma patients. However, there are a few major exceptions, including eye injuries and brain injuries with intracranial hemorrhage.

Solid organ injury used to be cause for concern when considering prophylaxis, but most trauma centers are now comfortable beginning within 24 to 48 hours after injury. Having said that, those numbers are for adult patients. What about the younger ones?

The University of California Irvine group queried the TQIP database (3 recent years) to examine outcomes for adolescent patients (12-17 years old) given VTE prophylaxis after injury to liver, spleen, and/or kidney. They excluded patients who had TBI, anticoagulation or coagulopathy, immediate laparotomy, transfers in, and patients who died or were discharged within 48 hours. They matched patients for age, comorbidities, grade of injury, overall severity of injury, and hypotension/need for transfusion.

Eligible patients who received chemoprophylaxis early  (within 48 hours) vs. late were reviewed to identify any differences in complications, length of stay, failed non-op management, and mortality.

Here are the factoids:

  • A total of 1,022 cases were isolated from the TQIP database, and 417 adolescent cases were matched to adults
  • VTE rate was statistically the same, 0.6% in the early group vs. 1.7% in the delayed group
  • Failed non-op management was identical at 5.9% vs. 5.6%
  • There was one death in the delayed group and none in the early group (not significant)
  • ICU LOS was the same at 3-4 days
  • One item not mentioned in the body of the abstract: hospital length of stay was significantly longer in the early group: 9 days vs. 6 days

The authors concluded that early VTE prophylaxis in adolescent trauma patients did not increase failure of nonoperative management, nor did it decrease the incidence of VTE.

Bottom line: This is a study that needed to be done. Due to IRB restrictions, it is typically more challenging to perform actual studies on children and adolescents. Retrospective use of databases helps overcome this problem, although it always introduces a few unwanted wrinkles.

We frequently assume that adolescents behave physiologically like adults. Although often true, you can’t always count on it. Those of us who take care of children and young adults know that they tend to do better than adults by most measures. But again, this is an assumption and needed to be studied.

This database study was limited to three years of data and only produced 417 matched cases for study. This is a small number, and I always worry about statistical power. If the results of such a study are negative, one is left wondering if a proper power analysis was done.

One puzzling result left me wondering about the power question. Patients who received early prophylaxis had exactly the same rate of VTE as those who received it late. Adult data indicates that early use should decrease this complication. Is this another indication of a statistical power problem? Would the inclusion of more patients have shown a real difference?

The other result that struck me (and was not commented upon in the body of the abstract) was the statistically significant 50% increase in hospital length of stay for the early prophylaxis group. Is there some unknown variable that was not matched that caused it? This is one of the known pitfalls of these retrospective database studies.

Here are my questions and comments for the presenter/authors:

  • Broken record question: Did you have enough cases to provide adequate statistical power? This study showed a negative result. Did you have enough matched cases to actually be able to detect a difference if there was one? Why not add a few more years of data and recalculate?
  • How do you explain the failure of early VTE prophylaxis to protect these patients from DVT or PE? Is this also a statistical power problem?
  • Why is the hospital length of stay significantly longer in the early prophylaxis group?

This intriguing paper follows my bias toward treating these patients exactly the same as adults with early chemoprophylaxis. I just need a few of the loose ends tied up.

Reference: SIMILAR RATE OF VENOUS THROMBOEMBOLISM AND FAILURE OF NON-OPERATIVE MANAGEMENT FOR EARLY VERSUS DELAYED VTE CHEMOPROPHYLAXIS IN ADOLESCENT BLUNT SOLID ORGAN INJURIES: A PROPENSITY-MATCHED ANALYSIS. EAST 2023 Podium paper #27.

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