# NCPS TIPS -- May/June 2006

### Contents: 1. Tablet Splitting

2.  New Directive: Preventing Retained Surgical Items in Surgical
    Procedures

3.  Adverse Events Related to Do Not Resuscitate (DNR) Orders

### Tablet Splitting

### *By Mariscelle M. Sales, Pharm.D., and Francesca E. Cunningham, Pharm.D.* 

**Background**

Tablet splitting is a common practice often recommended by providers and
implemented by healthcare systems.

Splitting a tablet allows for a lower dose than that manufactured by the
pharmaceutical industries, can facilitate administration of large
tablets that patients may find difficult to swallow whole, and can give
patients access to more expensive medications.

Tablet splitting has many benefits, and consideration of both drug and
patient characteristics ensures safe and appropriate use.

Certain physicochemical properties of a drug influence the decision to
split. For example, drugs with enteric coatings, extended-release
formulations, and some combination products can cause adverse outcomes
if split.^1-3^

In one study, elongated tablets scored deeply on both sides broke easily
when manually split.^4^ Tablet splitting devices were shown to perform
best with larger tablets, tablets with flat edges, and oblong tablets
without pointed ends.^5^

Drugs with narrow therapeutic windows should only be split if the
physicochemical properties are adequate and if the optimal therapeutic
response depends on the dose being halved. Also, patients with severe
physical or visual impairments may hinder precision in pill splitting.

Tablets come in all shapes and sizes and require sharp instruments to
divide them. Patients or their caregivers must have good vision, manual
dexterity, and the mental capacity to accurately split a tablet.
Accuracy of tablet splitting also depends on one's technique or device.

An optimal tablet-splitting device should have a hard, steel blade that
goes all the way into the base when the lid is depressed. This will
ensure a clean cut without leaving unusable fragments or crumbs that
break off from the tablet. Additional benefits are provided when using a
non-slip surface with adjustable grips to firmly hold the tablet steady
and an optional magnifying attachment to enlarge the view of small
tablets.

Any alteration of a medication may result in an adverse event or close
call; hence, tablet splitting may cause problems in the medication use
process. Using a good tablet-splitting device, unambiguous directions
listed on the prescription, and identification/recognition of
non-splittable medications comprises steps that can help to prevent
problems from developing.

VA NCPS and the VA Center for Medication Safety Patient Safety Center of
Inquiry (PSCI) embarked on an effort to evaluate potential medication
problems caused by tablet splitting. Data on tablet-splitting events
were evaluated using the NCPS Patient Safety Information System database
(nicknamed "SPOT"). This article describes the results of that analysis.

**Analyzing SPOT Data**

Methods:

NCPS identified tablet splitting entries by querying the SPOT database
for all RCA and safety reports involving tablet splitting from January
2001 to April 2005, forwarding the results to our Patient Safety Center
of Inquiry for analysis. Search terms included: pill splitting, tablet
splitting, half tablet, quarter tablet, ½ tab, and ¼ tab.

Data provided for each event included an anonymized case ID; date
(year); free text description of event details; and record type
(aggregate, safety report, RCA).

A complete evaluation of reports was conducted. Analysis of each
individual case determined:

-   Type of event (actual adverse event, close call, not enough
    information, or "other")

-   Location of occurrence (inpatient or outpatient)

-   Error type (overdose, underdose, incorrect directions, incorrect
    quantity, incorrect day supply, and incorrect strength dispensed)

-   Medication characteristics (correct physicochemical properties, to
    include: non-extended release, no enteric coating and symmetric in
    shape; commercially available strengths; and high alert
    medications^6^)

-   Documented patient outcomes (no harm, minor harm, hospitalization,
    and/or permanent harm/death)

Results:

We found 442 reports in SPOT related to pill splitting. Below are
selected, notable statistics from these events:

-   38% were adverse events

-   66% of the adverse events involved patients receiving more than
    their intended dose

-   65% of the adverse events occurred in outpatient settings

-   51% of the adverse events involved medications that came in
    commercially available strengths

-   28% of the medications were high alert

-   9% of the adverse events resulted in causing harm to a patient, but
    only 2% required hospitalization; no deaths were reported

**Discussion**

Limited literature suggests that manually or mechanically splitting
tablets does not always produce equal portions.^7-14^ The current
evaluation of tablet splitting events within the VA revealed no problems
regarding accuracy in splitting tablets to produce equal halves.

However, a potential source for problems was found in a number of areas:
ordering, verifying, filling, and administering medications that require
splitting.

The following examples show recurring issues that occurred due to
splitting tablets in half:

-   Most frequently, patients forgot to split the medication; providers
    often caught this problem when a patient came in early for a refill.

-   Patients did not read the label properly.

-   Healthcare personnel chose the wrong medications or formulations for
    splitting (i.e., enteric-coated, sustained-release, capsules).

-   Complicated entries with strengths and additional instructions from
    providers not placed in the proper fields, resulting in incorrect
    directions, day supply and quantities in the final prescription.

-   Tablet-splitting devices were not ordered or staff did not determine
    if patient had a device at home.

-   Errors in the administration process occurred as staff no longer
    split medications per local policy, and patients did not get their
    correct dose.

Limitations of the analysis include: subjective interpretation secondary
to raw data documented in SPOT; the voluntary nature of safety reports,
potential underestimation of the frequency of adverse events; and the
variability of reporting, resulting in some reports that contain
detailed information and others with minimal data.

**Taking Action to Prevent Harm to Patients**

Although tablet splitting remains a common practice in many settings,
common elements of the cases reviewed demonstrate the need for increased
awareness for both patients and providers. When tablets are split, the
following should be considered:

-   Practitioners must know the types of tablets that should not be
    split, such as: enteric-coated, extended release, and asymmetrical
    agents.

-   Practitioners must be aware of patients or caregivers who are unable
    to split tablets.

-   Practitioners must assure that all patients that are prescribed a
    tablet to split have a proper tablet-splitting device to do so.

-   Provider and pharmacist must counsel patients; patients must have
    clear, concise directions describing how to take their medications
    --- especially for new prescriptions or those with changes.

-   A standardized process for entering prescriptions and directions
    involving tablet splitting should be in place.

-   If pill splitting is desired, the facility's pharmacy and
    therapeutics committee (or equivalent) must instruct the automated
    data processing application coordinator (ADPAC), or designee, to
    ensure that possible dosages are configured appropriately to support
    tablet splitting within VistA Pharmacy Data Management (PDM)
    software.

**Summation**

Local procedures, such as those noted above concerning VistA PDM and
patient counseling, are critical aspects of this patient safety effort.

Only consistent monitoring of tablet-splitting can allow leadership to
assess how well the practice is being carried out at their facility and
allow them to promote systematic improvements when needed.

VA plans to include guidance on tablet splitting in its Formulary
Management Process Handbook, due for release later this year.

References:

1\. Stafford RS, Radley DC. The potential of pill splitting to achieve
cost savings. Am J Managed Care 2002; 8:706-712.

2\. Tablet splitting. Med Lett Drugs Ther 2004; 46(1195):89-91.

3\. Tablet splitting: Evaluating appropriateness for patients. J Am
Pharm Assoc 2004; 44(3): 324-5.

4\. Gupta P, Gupta K. Broken tablets: Does the sum of the parts equal
the whole? Am J Hosp Pharm 1998; 45:1498-9.

5\. Sedrani M, Arnaud P, Fontan JE, Brion F. Splitting tablets in half.
Am J Hosp Pharm 1994; 51:548-550.

6\. ISMP's list of high alert medications. Institute for Safe Medication
Practices. www.ismp.org/Tools/highalertmedications.pdf Accessed
September 2005.

7\. Uniformity of dosage units. United States Pharmacopeia 24/National
Formulary 19. Rockville, MD: United States Phamacopeia Convention, Inc.;
1999; 2000-3.

8\. Carr-Lopez SM, Mallett MS, Morse T. The tablet splitter: Barrier to
compliance or cost-saving instrument? Am J Health-Syst Pharm 1995; 52:
2707-8.

9\. Rosenberg JM, Nathan JP, Plakogiannis F. Weight variability of
pharmacist-dispensed tablets. J Am Pharm Assoc 2002; 42: 200-5.

10\. McDevitt JT, Gurst AH, Chen Y. Accuracy of tablet splitting.
Pharmacotherapy 1998; 18(1): 193-7.

11\. Peek BT, Al-Achi A, Coombs SJ. Accuracy of tablet splitting by
elderly patients. JAMA 2002; 288 (4): 451-452.

12\. Teng J, Song CK, Williams RL, Polli JE. Lack of medication dose
uniformity in commonly split tablets. J Am Pharm Assoc 2002; 42:195-9.

13\. Cook TJ, Edwards S, Gyemah C, Shah M, Shah I, Fox T. Variability in
tablet fragment weights when splitting unscored cyclobenzaprine 10mg
tablets. J Am Pharm Assoc 2004; 44(5):583-586.

14\. Boggie DT, Delattre ML, Schaefer MG, Morreale AP, Plowman BK.
Accuracy of splitting unscored valdecoxib tablets. Am J Health-Syst
Pharm 2004; 61:1482-3.

**2. New Directive: Preventing Retained Surgical Items in Surgical
Procedures**

#### By Noel Eldridge, MS, NCPS executive officer, and Ed Dunn, MD, MPH, NCPS director of policy and clinical affairs

During a surgical procedure, surgical teams employ standard "tools of
the trade," usually described in three categories: instruments, sharps,
and sponges.

Infrequently, one of these items can be accidentally left inside a
patient after a surgical procedure is concluded. Referred to as
"retained items" or "retained foreign bodies," they can become the
source of infection, pain, or other serious issues. In many cases,
another surgical procedure is required to remove a retained item.

Information on the incidence of retained surgical items in the VA
varies, but available data suggest that it has happened from
approximately 10-to-70 times annually in recent years. Efforts to
prevent this type of adverse event have varied, but there has been no
standardized approach to solving this problem across VHA. The same is
true for private sector health systems.

Our review of RCA reports submitted by VAMCs to NCPS, 2000 to present,
indicates that 80 percent of the retained items were sponges, 8 percent
were towels, and 12 percent were other items, such as retractors. The
post-operative count of items could be determined for two-thirds of
these events: 48 percent of the reports ended with a "correct" count, 28
percent ended with an "incorrect" count, and 24 percent with the
retained item excluded from the count.

To standardize a basic set of preventative procedures, NCPS collaborated
with the VA Office of Patient Care Services to draft a new directive,
Prevention of Retained Surgical Items. This directive was pilot-tested
at six VAMCs.

The directive is based primarily upon previous work of experienced
clinicians, processes established at VAMCs, standards established by the
Association of Perioperative Registered Nurses (AORN), and root cause
analysis findings submitted by VAMCs to NCPS.

The basic requirements of the directive are as follows:

-   In every case, a methodical wound exploration must be performed
    before closing the surgical wound.

-   Specific methods, following AORN standards, should be implemented
    for counting instruments, sharps, and sponges.

-   During normal working hours, radiologists must interpret radiographs
    taken in the OR to locate a missing item, and provide findings to
    the surgical team within 30 minutes of the request.

-   During other times, such as off-duty hours or weekends, VA
    radiologists may be provided electronic access to radiographs by
    VAMCs. Another option that may be provided is interpretation of a
    radiograph from a remote location by a radiologist who is not
    connected to a particular VAMC. (Increased capabilities for
    interpretation of radiographs from consolidated centers during
    off-hours has been approved by the National Leadership Board, but
    implementation will take time.)

-   VAMC management, purchasing, and logistics personnel will make
    available whenever possible:

    -   X-ray-detectable sponges, laparotomy pads, towels, or other
        related materials for all surgical procedures

    -   Adequate radiology department staffing to support timely
        intra-operative radiographs with interpretations reported to
        surgical team in the OR as required

    -   Access to teleradiology for OR support when necessary

In the past, the primary responsibility for preventing retained items
has resided with OR nurses. The directive does not remove the OR nurses
primacy in maintaining an accurate record and counting of surgical
items. However, it does make clear that surgeons, radiologists, and
administrators share the ultimate responsibility with nursing to prevent
retained surgical items.

For instance, the directive indicates that surgeons have a
responsibility to perform a methodical wound exploration prior to
closing the surgical wound and again whenever an incorrect count is
reported by the circulating nurse. When there is an incorrect count, the
surgeon must support the circulating nurse's request for an
intraoperative radiograph to be performed and interpreted in a timely
fashion.

The surgeon must also perform an initial review of an intraoperative
radiograph during times when interpretations of radiographs are not
available from the radiology department.

The surgeon must also allow adequate time for OR nurses to count and
accurately record counts of surgical items prior to a procedure, before
closing a wound, and after wound closure.

It should also be noted that VAMC directors have an important
responsibility to prevent retained surgical items. In particular, they
must ensure adequate staffing in radiology departments and to provide
the OR with surgical sponges, instruments, and towels that are
detectable by a radiograph whenever possible.

The directive allows for rare exceptions, such as for an unstable
patient or when a surgeon decides it is in the best interest of a
patient to expedite a procedure by forgoing final counts.

In summation, only a standardized approach that is consistently applied
throughout VHA, as defined in the directive, can improve the accuracy of
the counting process and reduce the incidence of retained surgical
items.

The directive became effective on April 3, 2006. It can be viewed
online:
[*ww1.va.gov/vhapublications/*](http://ww1.va.gov/vhapublications/)

**3. Adverse Events Related to Do Not Resuscitate (DNR) Orders**

*By Carol Samples, BGS, NCPS program analyst*

DNR orders come with strong ethical implications. We would never want to
withhold resuscitation when a patient and family have chosen to have
resuscitation attempted. We also don't want to put patients and their
families through the unnecessary stress of a code when DNR decisions
have been conscientiously reached and agreed upon.

After reviewing reports in NCPS' Patient Safety Information System,
nicknamed "SPOT," it appears it is sometimes difficult for us to
determine a patient's DNR status: codes are called unnecessarily when
patients are DNR, or not called when there is no active DNR order.

To clarify the term "DNR," the VA National Ethics Conference Call on
June 28, 2005, noted the following guidelines:

> "A DNR order is a medical order written by a healthcare provider that
> applies immediately. When the DNR order is entered into CPRS, the
> record is marked to alert other healthcare staff that the patient does
> not want CPR. A DNR order is clear and unequivocal. It instructs
> healthcare personnel not to initiate CPR in situations where the
> patient has no pulse. Personnel \[are\] to withhold CPR, which
> includes various types of interventions, but only when they are used
> in the setting of cardiopulmonary arrest. It is important to remember
> that a DNR order does not mean 'do not treat' or do not do other
> things beyond the setting of cardiopulmonary arrest and CPR
> interventions. Appropriate medical treatment and care is never
> withheld or withdrawn from a patient simply because a DNR order has
> been entered."

This article summarizes a search of SPOT using the free text term "DNR."
The search uncovered 25 RCAs and 55 safety reports pertaining to this
issue. In addition to the events mentioned above, reports indicated the
following:

-   Delays in decisions regarding care when DNR orders were incomplete,
    such as when no note accompanied an order; or, when a note was
    written but not accompanied by an order.

-   Problems also included limited availability of unequivocal code
    status, and confusion over colored wristbands. (Facilities used an
    array of colored arm bands to denote DNR status. See references.)

-   Application of the DNR order was questioned when patients fell, were
    found choking, or experienced changes, such as cardiac or
    respiratory distress following falls.

-   DNR status was erroneously communicated or not communicated during
    transfer within or between facilities.

-   Discrepancies existed between various forms of documentation: paper,
    electronic, wristbands, and stickers.

-   DNR and fall risk lists were posted side by side, causing confusion.

-   DNRs were not promptly removed from the medical record when patients
    were discharged.

-   DNR forms developed in a palliative care unit were inappropriate for
    other areas.

In response to the events listed above, RCA teams reinforced the
standards and practices outlined in VHA policy on DNR orders and
suggested other actions:

-   A DNR order, its progress note, and signing of said progress note
    must conform to policy and be written by the attending physician (or
    with the attending's concurrence by house staff/resident for up to
    24 hours).

-   A progress note must accompany the DNR order.

-   Flag records with a visual prompt as to DNR status and/or make DNR
    first on the active order list when an electronic record is
    accessed.

-   Develop clinical reminders for inpatient admitting physicians to
    verify or re-verify the advanced directive and treatment wishes of
    the patient.

-   Add a "Do Not Resuscitate" and/or "Advanced Directive" status
    template to interdisciplinary team treatment notes.

-   Include a copy of the most current DNR order when nursing home
    patients are transferred.

-   Standardize the documentation process: have the same person who
    verifies the order place any patient identifiers and confirm that
    these are, in fact, the patient's or family's wishes, as
    appropriate.

-   When possible, make the patient and family aware of the purpose of
    the wristband when it is placed and confirm their understanding of
    it.

-   Review mock codes routinely to include medical/surgical residents
    and medical students.

-   Implement guidelines for verification of patient identification
    prior to reviewing the medical record with the code team.

A DNR order does not mean that a patient is not offered or provided
other medical treatment and/or comfort care. It does not mean "do not
treat." A DNR order is only applicable when there is no pulse. For
example, should a DNR patient fall or choke, appropriate medical care
must be initiated if there is a pulse.

Patient status should be addressed and documented whenever there is a
transfer from unit to unit, person to person, specialty to specialty, or
department to department. If wristbands are used, they should have
patient-specific information for quick verification. Any color used to
identify DNR status must be consistent throughout the facility.

The DNR status must always be updated with each admission, discontinued
with each discharge, and changed as appropriate with the patient's
condition.

Advance directives drafted by patients do not replace DNR orders
initiated by physicians, yet advance directives, where legal, can help
determine a patient's wishes "in case the patient loses decision-making
capacity."

Standardized practices involving DNR orders are critical because staff
must know what action to take. Patients, families, and caregivers also
must feel secure about the decisions they have so painstakingly reached.

References:

Advance Health Care Planning, VHA Handbook 1004.2, July 31, 2003.

What Does 'DNR' Really Mean?\
National Ethics Teleconference, June 28, 2005.
[www1.va.gov/vhaethics/download/Transcripts/NET.6.28.05.doc](http://www1.va.gov/vhaethics/download/Transcripts/NET.6.28.05.doc)

Do Not Resuscitate (DNR) Orders -- FAQ\
July 2005\
[vaww1.va.gov/vhaethics/download/DNR_FAQ.pdf](http://vaww1.va.gov/vhaethics/download/DNR_FAQ.pdf)

PA-PSRS Advisory.\
Use of Color-Coded Patient Wristbands Creates Unnecessary Risk, December
14, 2005,
<http://www.psa.state.pa.us/psa/lib/psa/advisories/v2_s2_sup_advisory_dec_14_2005.pdf>

*Special Note:*

*Many thanks to Barbara Chanko, RN, MBA, Medical Ethicist, National
Center for Ethics in Health Care, for consulting with us on this
article.*