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Patient Safety Tip of the Week
August 15, 2023
Problems with
Newer Diabetes Drugs
Many patient safety
issues in diabetic patients involve insulin. Moreover, some of the most serious
patient outcomes stem from incidents involving insulin. But over the past several
years we’ve been inundated by a variety of new drugs for treating diabetic
patients, including both oral agents and injectable agents. So, it should be no
surprise that we are beginning to see medication errors involving these newer
diabetes drugs.
ISMP Canada recently published a safety alert about
incidents with such drugs (ISMP
Canada 2023). ISMP Canada found 441 reports of incidents involving these
drugs. The majority of incidents were reported as near
misses or as having resulted in no harm. As opposed to incidents involving
insulin, only a small proportion (3.6%) of the incidents with the newer
diabetes drugs were reported as having caused harm to the patient.
They found 3 main themes in these incidents:
·
Complex medication regimens
·
Look-alike/Sound-alike (LASA) issues
· Product
packaging and storing issues
Frequent adjustments of diabetes drugs are common.
These may include dose modifications, addition of an agent from a different
medication class, or a switch in medications. This is where the “copy and
paste” issue becomes problematic. A pharmacist or a prescriber may copy a prior
order, intending to alter the dose after pasting into a new order but then
forgetting to make that change. ISMP Canada therefore recommends limiting the
“copy” function to prescriptions that are unchanged from the previous
prescriptions. It also recommends encouraging prescribers to prominently indicate
medication and dose changes on the prescription (e.g., STOP [previous medication];
INCREASE dose).
Another problem is complex dose titrations. In such
cases, ISMP Canada suggests inputting each step in the titration as a separate
prescription (instead of inputting the multi-step titration on one prescription
and refilling this prescription). Note that this necessitates patient
counselling with each step. If a refill approach is used, they recommend incorporating
a flag in the system to ensure the pharmacist speaks with the patient at each
dose change. Another suggestion is to number each step in the titration (i.e.,
Step 1, Step 2) for clarity. Another tip is to provide a personalized calendar
to support the patient’s understanding of the dosing titration (and scan a copy
of the
calendar into the prescription file).
Certain products are available in different pack sizes,
with capability of delivering different doses, which
may lead to the dispensing of incorrect quantities. ISMP Canada therefore
recommends:
·
Incorporate an independent double check into the
dispensing process to confirm calculations for the dose and quantity to dispense.
·
Develop educational materials to inform staff about
these product pack sizes and dose delivery options, and to provide a quick
reference in the pharmacy.
Unfortunately, those are 2 interventions we always include
lower in our hierarchy of effective interventions. But we don’t have any better
recommendations.
And it’s not just diabetes drugs being confused with each
other. Synjardy (empagliflozin/metformin) has also
been confused with Synthroid (levothyroxine). We don’t know of a safe TALLman lettering format to help with that one, but including
the indication for the drug would go a long way to avoid that error.
Moreover, packages may look alike, particularly
packages of different doses of the same drug. Regarding look-alike packaging,
ISMP Canada recommends:
·
Incorporate barcode scanning into pharmacy
processes, including inventory management and
dispensing.
·
Separate look-alike medication packages using a
shelf divider or individual bins.
Newer antidiabetic medications for
injection (eg. semaglutide
[Ozempic], liraglutide [Victoza], and dulaglutide [Trulicity]) are stored in
the refrigerator. We all know about the risks of taking the wrong
medication from refrigerators. It’s not different with these injectable
diabetes drugs. ISMP Canada recommends the following regarding those
medications requiring storage in refrigerators:
·
Organize filled, refrigerated prescriptions
alphabetically by patient surname.
·
Position filled products in the refrigerator in
a way that makes the label with the patient’s name visible.
Issues with new diabetes drugs are
not only causing concern for pharmacists and ordering physicians. There are
issues raised by anesthesiologists given the tsunami of patients taking semaglutide (Ozempic). In particular,
there is considerable confusion about what to do with this drug prior to
anesthesia. The key issue is that semaglutide and
other glucagon-like peptide-1 (GLP-1) receptor agonists can reduce gastric
emptying, possibly increasing the risk for aspiration.
The ASA has just released its “American Society of
Anesthesiologists Consensus-Based Guidance on Preoperative Management of
Patients (Adults and Children) on Glucagon-Like Peptide-1 (GLP-1) Receptor
Agonists” (Joshi
2023). It applies to patients taking medications like Ozempic® (semaglutide), Trulicity® (dulaglutide), and other
glucagon-like peptide-1 (GLP-1) receptor agonists. The guidance reads:
“ASA’s Task Force on Preoperative Fasting suggests the
following for patients taking GLP-1 agonists for type 2 diabetes or weight loss
who are having elective procedures. It is also calling for further research to
be done regarding GLP-1 agonist medications and anesthesia.
The evidence to provide guidance for preoperative management
of these drugs to prevent regurgitation and pulmonary aspiration of gastric
contents is sparse limited only to several case reports. Nevertheless, given
the concerns of GLP-1 agonists-induced delayed gastric emptying and associated
high risk of regurgitation and aspiration of gastric contents, the task force
suggests the following for elective procedures. For patients requiring urgent
or emergent procedures, proceed and treat the patient as ‘full stomach’ and
manage accordingly.
For patients scheduled for elective procedures consider
the following:
Day(s) Prior to the Procedure:
·
For patients on daily dosing consider holding
GLP-1 agonists on the day of the procedure/surgery. For patients on weekly
dosing consider holding GLP-1 agonists a week prior to the procedure/surgery.
·
This suggestion is irrespective of the
indication (type 2 diabetes mellitus or weight loss), dose, or the type of
procedure/surgery.
·
If GLP-1 agonists prescribed for diabetes
management are held for longer than the dosing schedule, consider consulting an
endocrinologist for bridging the antidiabetic therapy to avoid hyperglycemia.
Day of the Procedure:
·
If gastrointestinal (GI) symptoms such as severe
nausea/vomiting/retching, abdominal bloating, or abdominal pain are present,
consider delaying elective procedure, and discuss the concerns of potential
risk of regurgitation and pulmonary aspiration of gastric contents with the
proceduralist/surgeon and the patient.
·
If the patient has no GI symptoms, and the GLP-1
agonists have been held as advised, proceed as usual.
·
If the patient has no GI symptoms, but the GLP-1
agonists were not held as advised, proceed with ‘full stomach’ precautions or consider evaluating gastric volume by
ultrasound, if possible and if proficient with the technique. If the stomach is
empty, proceed as usual. If the stomach is full or if gastric ultrasound
inconclusive or not possible, consider delaying the procedure or treat the patient as ‘full stomach’ and manage accordingly.
Discuss the concerns of potential risk of regurgitation and pulmonary
aspiration of gastric contents with the proceduralist/surgeon and the patient.
·
There is no evidence to suggest the optimal
duration of fasting for patients on GLP-1 agonists. Therefore, until we have
adequate evidence, we suggest following the current ASA fasting guideline
Yes, the plethora of new drugs is good for diabetes
management but, at the same time, brings with it a variety of potential patient
safety issues.
References:
ISMP Canada. Newer Classes of Medications for Diabetes
Treatment: A Multi-Incident Analysis of Reports from the Community Pharmacy
Setting. ISMP Canada Safety Bulletin 2023; 23(4): April 26, 2203
ASA (American Society of Anesthesiologists). Patients Taking
Popular Medications for Diabetes and Weight Loss Should Stop Before Elective
Surgery, ASA Suggests. ASA Press Release 2023; June 29, 202
Joshi GP, Abdelmalak BB, Weigel
WA, et al. for the American Society of Anesthesiologists (ASA) Task Force on
Preoperative Fasting. American Society of Anesthesiologists Consensus-Based
Guidance on Preoperative Management of Patients (Adults and Children) on
Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists. ASA 2023; June 29, 2023
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