Keywords
clinical protocols - prescription drugs - drug classes - instance-based mapping -
clinical decision support - knowledge management
Background and Significance
Background and Significance
Managing prescription renewal requests in the ambulatory care setting is challenging.
Prescription renewals occur when a patient's current prescription either expires or
runs out of authorized refills. In the United States, prescriptions for noncontrolled
substances are valid for up to 1 year; therefore, patients taking chronic medications
for more than 1 year need to renew their prescriptions to continue therapy. Patients
can request a new prescription from their provider during a visit or have the pharmacy
submit a prescription renewal request on their behalf. Responding to these prescription
renewal requests requires a significant amount of clinician and clinic staff time.[1]
[2]
[3]
[4] Excluding requests during patient visits, primary care providers handle approximately
12 prescription renewal requests daily, which commonly include multiple medications.[1] Renewal requests require chart review to assess the patient's current and past medications
and dosages and to determine that appropriate monitoring for side effects occurred.[1]
In recognition of the important role nurses play in ambulatory care, the Vanderbilt
University Medical Center (VUMC) collaborated with the local board of pharmacy to
develop and approve standing prescription renewal orders for VUMC's e-prescribing
system in 2009. The standing renewal orders allowed nurses to authorize prescription
renewal requests when specific conditions were met. These standing renewal orders
reduced resources needed to process prescription renewal requests,[5] helped clinicians determine if a renewal request could be approved, and improved
patient medication adherence by reducing time to appropriate prescription renewals.
Subsequently, many VUMC clinics developed their own clinic-specific standing prescription
renewal orders.
Each legacy standing prescription renewal order contained a header with metadata and
general rules for the standing order. Rules included the requirements that (1) the
medication had to be listed on the patient's active home medication list, (2) nurses
could not renew controlled substances, (3) the patient had to have visited the clinic
in the past 12 months, (4) the licensed nurse could only renew (not alter the prescription),
and (5) medication, dose, route, frequency, quantity, and authorizing prescriber had
to remain unchanged. After the general rules, each clinic's standing order then grouped
medications authorized for renewal with specific renewal criteria for each group ([Fig. 1]). For example, Clinic A's medication group “proton-pump inhibitors (PPIs),” which
included omeprazole, lansoprazole, esomeprazole, etc., had renewal criteria of (1)
patient must have visited in the past 12 months, (2) the patient was not taking clopidogrel,
and (3) the patient did not have a diagnosis of osteoporosis. Clinic A would also
have medication group “asthma medications,” which had a different list of medications
and renewal criteria. The clinic's medical director approved each legacy standing
renewal order, which had been reviewed and approved by the VUMC's Pharmacy and Therapeutics
(P&T) committee.
Fig. 1 Legacy standing prescription renewal order structure.
Maintaining the standing renewal orders quickly became a challenging task. Clinics
had dedicated substantial time and resources to develop the standing orders and to
obtain time-consuming approval. After the development of legacy standing renewal orders,
few resources were allocated for their maintenance and periodic review. As new medications
entered the market and old medications were discontinued, the volume of standing orders
and medications, along with the lack of resources caused many of the standing orders
to become outdated. As clinics were tasked to create and maintain their own standing
renewal orders, many inconsistencies across clinics arose, such as the medication
group name, listed medications, and the specific renewal criteria. To demonstrate
the divergence of standing orders, [Fig. 2] shows that both Clinic A and Clinic B had a medication group “PPIs”. However, the
medication group for Clinic B included ranitidine (not a PPI), and Clinic A had more
detailed renewal criteria than Clinic B.
Fig. 2 Variation across clinic standing renewal orders.
Additional challenges arose due to the creation of the standing renewal orders as
free-text documents that were printed, signed, and scanned into a database as image
documents that were not searchable. The lack of coded or structured medications made
automated enforcement of the standing orders in the e-prescribing system impossible.
After 5 years of using the clinic-specific standing renewal orders, the P&T committee—overwhelmed
by change requests—requested assistance in maintaining standing renewal orders and
converting them from a homegrown electronic health record (EHR) to its commercial
EHR replacement. Ambulatory clinics considered transforming the standing orders to
a new EHR platform a high priority because of the efficiency gains for providers.
The transition also offered an opportunity to review and standardize the standing
renewal orders, develop a knowledge management process with approval and periodic
review, document metadata (e.g., clinical owners, subject-matter experts, review dates),
and improve reporting and compliance. The objective of this project was to review
and restructure the standing prescription renewal orders into a modular and scalable
format for use in the new EHR.
Methods
Legacy Local Standing Orders to a Centralized Standing Order
The P&T committee recommended moving away from clinic-specific standing orders and
creating a main enterprise-wide standing renewal order usable for all clinics. The
novel central prescription standing renewal order consisted of general rules and several
subgroups, each with a medication group, renewal criteria, and clinics for which the
subgroups applied ([Fig. 3]). As a result, a single standing prescription renewal order at the VUMC was created
to combine all the subgroups (medication groups, criteria, and applicable clinics).
Initially, the P&T committee focused on the most common medication renewal groups,
which could be renewed in any clinic. As a result, the initial standing order did
not include location restrictions.
Fig. 3 Revised prescription standing renewal order structure. ARBs, angiotensin II receptor
blockers.
For legacy standing order conversion, pharmacy students manually extracted the metadata
(e.g., title, approval date, date document loaded into e-prescribing system, associated
clinics), medication group names, medication names (normalized to generic ingredients),
and the medication group's renewal criteria from all approved standing prescription
renewal orders to a spreadsheet. Initially, data were extracted by the students together
with the authors, and then each student was assigned a set of documents with random
spot-checking of the extracted data. Medication names were mapped to First Databank
(FDB) medication name codes and RxNorm ingredient codes.
Medication Group Comparison
We evaluated the medication groups, their medications, and their renewal criteria
across all clinic standing orders to identify reoccurring groups or themes. Comparing
the groups lexically was difficult due to the lack of a naming convention (e.g., one
clinic named a medication group “PPIs,” while another clinic named the same group
of medications lexically differently “gastrointestinal [GI] acid reducers”). Therefore,
we did not compare medication groups lexically, but rather compared the medication
groups based on the included medication items, which provided a better comparison
of intent or semantic meaning than the group name alone.[6]
[7] This comparison technique of “instance-based matching” has been used for medication
class matching[6]
[8]
[9]
[10] and compares medication groups in a pairwise manner by calculating a similarity
or equivalence score (ES) between the two groups using a modified Jaccard coefficient
if the groups share at least one common medication.[6] ES values range from 0 to 1, with scores approaching 0 indicating little to no similarity
between the medication groups, and scores approaching 1 representing high similarity.
Using the example above, “PPI” and “GI acid reducers” when compared had one medication
unique to each group (ranitidine, dexlansoprazole) and five shared medications resulting
in an ES of 0.65. For our purposes, we selected an ES greater than 0.3 as indicating
significant similarity based on prior research.[10] In addition to matching by medication groups, we also analyzed the complete clinic
standing orders. All instance-based matching analysis was done with STATA 13 (StataCorp.
2013, College Station, Texas, United States).
Design of New Standing Renewal Order
After identifying common medication groups, we mapped and normalized the medication
groups to FDB Enhanced Therapeutic Classifications (ETC). Several classes were joined
together to create a medication group and the listed medications were filtered by
intended route (e.g., oral, subcutaneous, and inhalation). New medication groups were
named using a precise standard naming convention. For example, the medication group
of hydroxyzine HCl, hydroxyzine pamoate, and buspirone was called “anxiolytics” in
the past. This name neglected that many other medications are used as anxiolytics.
Thus, we expanded the name to “Anxiolytic—noncontrolled substance.” Since these medications
were restricted to the oral route only, we would modify the name to “Anxiolytic—noncontrolled
substance (oral).” For safety reasons, we excluded some medications from medication
groups, per the P&T committee request, by composing the group of ETC classes that
did not include the medication in question. For example, isotretinoin was not included
in the group “Acne therapy (oral),” by not including the retinoids and derivatives
ETC class.
When similar classes were unavailable, we created new medication groups using generic
medication names (similar to RxNorm ingredients) for select antifungals, antibiotics,
and hypoglycemia treatments. Medication groups were instantiated by deriving all dispensable
medication information (medication name + dose form + strength, RxNorm semantic clinical
drugs, and semantic branded drugs) belonging to the medication subgroup and route.
Renewal criteria for each medication group were reviewed and proposed to the P&T committee
for approval ([Fig. 4]).
Fig. 4 ARB standing renewal order. ARBs, angiotensin II receptor blockers.
Standing Renewal Order Integrated in Commercial EHR
A subcommittee of P&T met weekly to review and approve the proposed medication groups
and renewal criteria. The finalized list was implemented by the HealthIT ambulatory
team using clinical decision support tools in the new EHR, which would trigger when
a nurse or provider opened a medication renewal request. The tool would display the
requested medication, its prescription instructions (or directions for use), and the
medication's renewal criteria with a green checkmark for each condition if it was
met or a red “x” if the condition was not met ([Fig. 5]). We provided clinicians with a link to a searchable document, which was similar
in appearance to the legacy standing orders; however, it was autogenerated each time
from querying the standing renewal order content from the EHR data warehouse ([Fig. 4]).
Fig. 5 Example of clinical decision support for standing prescription renewal orders.
Maintenance and Review Process
We established processes for clinics to request new subgroups to be reviewed and approved
by the P&T committee. We also developed a process for the P&T subcommittee to perform
regular review and maintenance of all standing prescription renewal orders using metadata
attached to the subgroup records built in the EHR. Metadata included subgroup subject
matter experts, when the subgroup was last reviewed and by whom, next review date,
the status of the subgroup (i.e., under review, approved, retired), and any additional
notes.
Results
Legacy Standing Orders
Seventy-eight legacy standing prescription renewal orders covered 135 clinics (some
standing orders applied to multiple clinics). The oldest standing order was 7 years
old and had never been reviewed since approved, and the newest was created in the
same month as the analysis was conducted. On average, the time from the last review
or creation was 3 years (median of 4 years).
There were 870 distinct medication groups with 971 distinct medications, of which
656 were listed in multiple legacy standing orders. Seventy-five medications could
not be mapped to FDB or RxNorm codes, of which 47 had been discontinued and 28 were
compounded medications (such as Mary's Magic Mouthwash), ambiguous due to multiple
salt forms or dose forms (e.g., “betamethasone,” “multivitamin,” “calcium,” or “oral
contraceptives”), or were medical supplies (e.g., oxygen or other durable medical
equipment). The standing orders listed seven controlled substances—several since discontinued.
Some standing orders included outdated information on unavailable generic alternatives
(e.g., stating, “there is no generic for Singulair”) as generics had become available
after the standing order was developed. Additionally, there were 12 misspelled medication
names.
The 870 medication group class names mainly represented the therapeutic intent of
the medications (e.g., “analgesics” or “antiemetics”). Some drug class names described
the mechanism of action (e.g., “antihistamines” or “anticoagulants”). Some group names
also included the intended route of administration (e.g., “topical antiacne medications”
or “inhaled corticosteroids”). Two main groups represented chemical structure (e.g.,
“steroids” and “vitamins), and there were two names reflecting an anatomical site
(e.g., “urinary medications” and “GI medications”). Each medication group listed an
average of 12 medications (range, 1–37, median, 11). Some medication groups had nonspecific
names (e.g., “miscellaneous,” “supplies,” “unspecified”).
Instance-Based Matching Analysis
Legacy Clinic Standing Orders
When comparing the clinic standing orders, 46 clinic standing orders had (by our definition)
significant overlap (ES > 0.3). Three clinic standing orders had perfect overlap with
31 shared medications (“Trauma Clinic,” “General Surgery,” and “Emergency General
Surgery”). Two other standing orders overlapped perfectly with 67 shared medications
(“Pediatric Allergy and Immunology” and “Allergy Medication”), and two others had
near perfect overlap with 112 shared medications and 5 unique (“Internal Medicine”
and “HMG-Internal Medicine”). Several other clinic standing orders had close matches,
such as “Mohs” with “Franklin Dermatology” (with 83 shared medications and 16 unique)
and “Green-Hills Internal Medicine” with “Internal Medicine” and “HMG-Internal Medicine”
(with 99 shared medications and 20 unique).
Medication Groups
From 870 distinct medication groups, 839 (96.4%) shared at least one medication with
another group. The remaining 31 medication groups, which included 55 medications,
were excluded from this analysis; however, they were manually reviewed and seven of
the medication groups were included in the proposed final medication group list. There
were 696 legacy medication groups with significant overlap (ES > 0.3), which were
reviewed and narrowed down to 54 themes and then subdivided based on the proposed
renewal criteria into 132 medication groups. The remaining 143 legacy medication groups
had poor overlap with others; however, we were able to reduce them to 26 medication
groups not previously included.
Design of a New Standing Renewal Order
The 165 proposed medication groups were mapped to FDB ETC classes (Pharmaceutical
Subclasses in Epic). Six medication groups with poor matching were created manually.
The proposed renewal criteria had 379 distinct legacy refill criteria, which were
narrowed by analyzing for common themes to 21 criteria rules. The resulting medication
groups and renewal criteria underwent iterative review and approval first by the P&T
subcommittee and then the full P&T committee. Of the 165 proposed subgroups, 13 (7.9%)
were not approved by the subcommittee and removed (e.g., “decongestants,” “monoamine
oxidase inhibitors,” certain antibiotics, “dopamine receptor agonists”). Additionally,
12 subgroups were added after gaps in the proposed list were identified by clinics
(e.g., melatonin, supplements including calcium and magnesium, medications to treat
allergic anaphylaxis). In total, 164 prescription renewal subgroups were approved
for build ([Fig. 6]). A sample list of medication groups is provided in [Appendix A].
Fig. 6 Flow diagram for medication groups. P&T, Pharmacy and Therapeutics Committee; EHR,
electronic health record.
Standing Renewal Order Build in Commercial EHR
The build estimate for the standing order decision support implementation in the new
EHR was over 480 hours; however, structured and coded format of the subgroups allowed
us to import most of our design directly into the commercial EHR after some minor
transformations to comply with the import specifications. All 164 subgroups were built
prior to the impending go-live of the new EHR in approximately 10 hours. Building
the criteria and testing the decision support were also completed in a fraction of
the estimated time. Next, we created a Structured Query Language (SQL)-based Crystal
report containing the medications used for building the prescription renewal subgroups
and composed a searchable document of the new enterprise-wide standing prescription
renewal order, which we hosted on our local intranet and available within the EHR
with monthly updates.
Maintenance and Review Process
Similar to a new medication formulary request, any new medications, criteria, or subgroup
requests are submitted to the P&T committee using a request form that includes the
required information to review and add new requests. To assure maintenance, subgroups
are continually reviewed. Any time a change is made to a subgroup, the P&T subcommittee
reviews the medications and criteria included in the subgroup. If new safety concerns
are identified, the P&T committee will address them without waiting for a scheduled
review. To track review and approval of the subgroups, we created searchable metadata
records associated with each subgroup. Adherence to the standing order is monitored
by the P&T committee using reporting tools from the EHR. Using the standing order
decision support, nursing staff send approximately 4,300 prescriptions per week in
our system (615/day average). Additionally, providers use the standing order decision
support for approximately 3,000 prescriptions per week (an average of 428/day).
Discussion
Summary
In this article, we describe a methodology for standardizing and scaling standing
prescription renewal orders at an enterprise level. Prescription renewals are a common,
time-consuming burden for ambulatory care clinics. The management of standing prescription
renewal orders (electronic or on paper) presents many challenges to the enterprise.
We redesigned our legacy standing orders to allow nurses to authorize prescription
renewals from within the EHR workflow. Using instance-based matching techniques, we
were able to identify, standardize, consolidate, and subsequently build 164 medication
groups with standardized renewal criteria.
Variations across clinics and practice sites for prescription renewals are common.
A study by Guirguis-Blake et al surveyed 11 family medicine residency practices within
the University of Washington Family Medicine Residency Network.[11] All sites had a process for handling prescription renewals; however, no two sites
had the same procedure, and only four of the sites could identify a written protocol.
A written protocol was associated (nonsignificantly) with more frequent chart review
prior to authorization and lower likelihood that the renewal request would be forwarded
to another provider.
A study by Ferrell et al surveyed five clinics and also found significant variations.[3] Three of the five sites had medical assistants or nurses involved in the decision-making
process for authorizing prescription renewals; however, only two sites had a written
protocol. The two clinics with protocols were more likely to send requests to the
providers for review, possibly due to strict protocols, varying nurse experience levels,
or random chance due to small sample size. They found that medical assistants and
nurses were capable of making accurate decisions for the majority of renewal decisions
and determined that the renewal process needed to be standardized across all clinics
and experience levels via protocol.
In contrast, some organizations manage prescription renewals centrally, for example,
by pharmacy.[4]
[12]
[13] Rim et al described a centralized renewal authorization program within an academic
health system with two pharmacists and two pharmacy technicians.[4] The program consisted of a collaborative practice agreement that authorized the
pharmacists to approve the prescription renewal requests. On average, the program
processed 12,000 renewal requests monthly for 10 clinics. Given the number of unique
clinics at VUMC exceeds 800 (with more than 30,000 renewal requests monthly), a distributed
model of nurses in the individual clinics reviewing and approving the renewal requests
represented a more scalable approach. However, our approach required the standing
renewal order to be standardized across the many sites to reduce the maintenance burden
and the risk of errors.[14] Nevertheless, the methodology we describe for standardizing and scaling standing
prescription renewal orders should be applicable to these varied organizational management
strategies (i.e., centralized pharmacy-managed vs. distributed clinic-managed).
Benefits of New Standing Renewal Order Design
The centralization and modularization of the VUMC's standing prescription renewal
order governance and build has provided standardization and consistency across the
enterprise. Our approach decreased the management burden on local clinic staff, improved
the ease of standing renewal order maintenance, and has helped to ensure timely review
and update of standing order content. The centralized and modular format allows the
standing prescription orders to be scalable because they do not need to be built by
each of our clinics and can be implemented across the entire enterprise. The modular
format is also extensible because the medication groups were built using medication
classes maintained by our medication data vendor (FDB), and medication classes are
less likely to be added or removed compared with individual medications. Additionally,
using a SQL query to generate the list of medications allowed for renewal by standing
order reduces the task of maintaining that list of medications and ensures the EHR
decision support correlates with the standing order. Furthermore, our implementation
facilitated build integration of the standing renewal order directly in a vendor EHR,
which supports existing vendor clinical decision support tools. The implementation
displays clinical data relevant to the triggered renewal subgroup which we anticipate
to decrease nurse chart review time (not measured). Monitoring and reporting of nurse
compliance with standing renewal order criteria are vastly improved since all data
are now discrete. Furthermore, an automated drug database update-driven process is
now in place that indicates when a subgroup must be revised due to medications being
added to or removed from the market, or becoming available in generic form. Finally,
our approach is valuable in that it is scalable and sharable among health care organizations.
Challenges of New Standing Renewal Order Design
Standardization of standing renewal orders, by definition, means the loss of individualization
across the enterprise. A nontechnical challenge we encountered in this process was
defining and gaining consensus for acceptable enterprise-level renewal criteria, which
took several months for analysis, review, and approval. For some clinics, standardization
meant the loss of approved specialty-specific use cases or medications (such as pulmonary
antihypertensives). However, we plan to extend the functionality of our implementation
in the future to handle these situations and we currently have a process in place
for new subgroup requests.
Reconciling varied medication groupings as we moved to a standardized model also presented
unique challenges. Our approach was to avoid unnecessary custom medication groupings
by using existing higher-level concepts, such as medication classes, provided by our
drug database vendor. We used custom groupings sparingly due to their inherent increased
maintenance costs.
As with any implementation in a vendor environment, our approach is limited by the
expected workflow and specified functionality of the EHR. For example, the standing
renewal order rules are triggered when medication renewal requests come from pharmacies
(via Surescripts requests), a specific mechanism from the patient portal, or if a
specific message-type is created by a clinician within the EHR. Requests originating
from other means, such as from phone calls or other mechanisms, could bypass the standing
renewal order decision support. Ultimately, we can standardize the standing prescription
renewal orders, clinical decision support, and reporting functionality but we cannot
change the prescription renewal workflows, ways that clinics receive renewal requests
(such as via phone, which would bypass the decision support), or the implementation
of certain decision support elements within the EHR.
Next Steps…
Planned future enhancements of our implementation include adding clinic or location
specificity and expanded scope for requested medications not currently covered by
our existing standing order. We also plan to refine the monitoring and reporting functionality
to enhance operational support of standing renewal order compliance. Finally, we hope
to work with our EHR vendor to expand the number of workflows in which renewal content
can be displayed to the end user and to improve the overall quality of clinical decision
support delivered in the prescription renewal workflows.
Conclusion
Managing prescription renewal requests in the ambulatory care setting is a challenge.
We describe a methodology for standardizing standing prescription renewal orders and
scaling it at the enterprise level by utilizing knowledge management.
Clinical Relevance Statement
Clinical Relevance Statement
By centralizing the clinic-specific standing prescription renewal orders into a single
standing order, nurses are provided with consistent and sustainable clinical decision
support based on an enterprise-wide standing prescription renewal order. This approach
helps reduce the burden of prescription renewals for ambulatory providers.
Multiple Choice Questions
Multiple Choice Questions
-
Which of the following is a benefit of using a modular and enterprise-wide approach
to a prescription standing renewal order?
-
Increased personalization by clinics.
-
Decreased maintenance over time.
-
Supported by all EHR workflows.
-
Easier to gain consensus from clinics.
Correct Answer: The correct answer is option b. Having the standing order document generated based
on EHR content deceases the burden of maintaining the document and keeps the document
and EHR build in sync. It is also easier to review and maintain 164 subgroups versus
870.
-
Which of the following methods efficiently compares medication groups based on their
membership (representative medications)?
Correct Answer: The correct answer is option c. Instance-based matching compares medication groups
in an automated and pairwise manner calculating a similarity or equivalence score
(ES) between the two groups if the groups share at least one medication in common.
-
Which RxNorm term types represent dispensable medications used in clinical decision
support?
-
Ingredient.
-
Semantic clinical drug.
-
Clinical drug component.
-
All of the above.
Correct Answer: The correct answer is option b. Dispensable medications require a medication name,
dose form, and strength, similar to the RxNorm semantic clinical drugs, and semantic
branded drugs term types. In this project we instantiated our medication groups to
a list of dispensable medications for the clinical decision support in the EHR.
-
In this study, how were medications grouped or classified?
-
By frequency.
-
By therapeutic intent.
-
Alphabetically.
-
By shelf life.
Correct Answer: The correct answer is option b. There are many different ways to group medication,
each depending on the use case and area of interest of the terminology or ontology.
Some are grouped by therapeutic intent (e.g., “analgesics” or “anti-emetics”), mechanism
of action (e.g., “antihistamines” or “anti-coagulants”), chemical structure (e.g.,
“steroids” and “vitamins”), anatomical site (e.g., “urinary medications” and “GI medications”),
or even combinations of the above (e.g., “tricyclic antidepressants”).
Sample list of medications for Standing Prescription Renewal Orders (not a complete
list)
ACE inhibitors (oral)
Acne (topical)
Acne therapy (oral)
Alpha-glucosidase inhibitors (oral)
Anaphylaxis therapy (injection)
Anticonvulsants
Antiemetics
Antigout agents (oral)
Antihistamines
Antimigraine
Antiparkinson
Antipyretics
Antivirals - HSV (oral)
Anxiolytic - noncontrolled substance (oral)
ARBs (oral)
Bile acid sequestrants (oral)
Calcium supplements (oral)
Contraceptives (oral, vaginal, transdermal)
Corticosteroids (inhaled)
Diabetic supplies
Digestive enzymes (oral)
DPP-4 inhibitors (oral)
Expectorants (oral)
Fibrates (oral)
H2 receptor inhibitors (oral)
Hypoglycemia treatment
Infant formulas (oral)
Intraocular pressure reducing agents (ophthalmic)
Long-acting β-adrenergic agonists (inhaled)
Magnesium supplements (oral)
Melatonin (oral)
Multivitamins (oral)
Prenatal vitamins and minerals (oral)
Proton-pump inhibitors (oral)
Short-acting β-adrenergic agonists (inhaled)
Smoking cessation products
Statins (oral)
Thyroid hormones (oral)
Vitamin D analogs (oral)