Evaluating Drug Names for Similarities: Methods and Approaches Public
Meeting

June 26, 2003

Request for opportunity to make a presentation

Suzanne A. Coffman, Pharm.D.

Product Manager

NDCHealth

3 Gamecock Ave Suite 307

Charleston, SC 29407

(843)769-2366 office

(843)729-0151 cell

While I have some comments on several questions, the one I'd like to
have the opportunity to address at the meeting is number 4 about
effective risk management programs and their evaluation. I would like to
have 10 minutes for my presentation and 5 for question/answer.

Responses to questions:

**1: Methods for evaluating drug names**:

\"NDCHealth has created a white paper on a process by which drug names
could be tested prospectively (well before marketing) along with
proposed strengths and sigs in very large sample sizes of actual
practicing pharmacists in an actual outpatient pharmacy practice
environment.\"

**2: Study methodologies for evaluating potential prescription errors**:

a.  We are conducting a study of our error-reduction tool with the
    Medical University of South Carolina College of Pharmacy. For our
    first phase we are relying on prescription data and not doing
    on-site visits. We are comparing serial submissions for the same
    prescription (or same patient if the prescription number changes) to
    detect changes in drug, quantity or days supply that could represent
    correction of a process error/quality related event related to
    prescribing or dispensing. One outcome of our study will hopefully
    be a validation of this methodology.

b.  \"NDCHealth has created a white paper on a process by which drug
    names could be tested prospectively (well before marketing) along
    with proposed strengths and sigs in very large sample sizes of
    actual practicing pharmacists in an actual outpatient pharmacy
    practice environment.\"

**3: What kind of information should be included in studies**:

a.  In addition to drug name, strength, quantity and directions also
    patient age, and weight for pediatric patients, whether or not
    voice-mail was used and whether the prescription was faxed or
    original. Also, studies of electronically transmitted prescriptions
    are needed to determine the extent to which that methodology
    decreases errors and introduces new root causes for error not seen
    with traditional prescribing workflows.

b.  \"NDCHealth has created a white paper on a process by which drug
    names could be tested prospectively (well before marketing) along
    with proposed strengths and sigs in very large sample sizes of
    actual practicing pharmacists in an actual outpatient pharmacy
    practice environment.\"

**4: Risk management programs for confusing drug names**:

> [LASA error prevention alert service]{.underline}: NDCHealth is a
> leading provider of health care EDI and informatics products and
> services. 68% of all retail prescription transactions travel through
> the NDCHealth Intelligent Network. We are connected to 90% of all
> retail pharmacies in the US (and Canada). NDCHealth offers a service
> (RxSafety Advisor) to retail pharmacy outlets using our network that
> evaluates prescriptions for the presence of potential look-alike
> sound-alike drug confusion. The service uses a U.S. patent pending set
> of rules and a database built around the USP/ISMP list of known
> look-alike sound-alike drug pairs, and includes a LASA likelihood
> score developed in conjunction with ISMP. If we detect a prescription
> where the dose is atypical for the drug submitted but typical for a
> look-alike sound-alike product we alert the pharmacist to double-check
> the prescription for a LASA error. In the 5 months since the service
> was launched we have prevented at least 50 potentially clinically
> significant errors with only about 200 stores using the service so
> far. Examples attached at end of report.
>
> [Study using claims data]{.underline}. We are doing a study of the
> impact of our service in the chain pharmacy environment using
> prescription claims data and comparing initial to subsequent
> prescription submissions for the same patient to detect changes that
> could represent correction of a process error. The study will test the
> impact of the service in preventing LASA and other types of errors
> resulting from prescribing, handwriting or phone miscommunications or
> data entry.
>
> [Post-marketing surveillance]{.underline}. If our service were adopted
> by a wider base of pharmacies (80% of retail pharmacy outlets in the
> US use our network---chain, independent, hospital outpatient,
> specialty, and some mail-order) it could be a useful tool for
> post-marketing surveillance in the case of drugs suspected of being at
> risk for name-confusion errors. Not only would our alerts PREVENT some
> of the potential errors, we would track occurrences of how often
> errors occurred with an accurate denominator of total prescriptions
> filled.

**5: Different evaluation process for prescription vs OTC drugs?** No
comments.

  --------------------------- ------------- ------------ ----------------------------
  Table 1. Examples of LASA                              
  errors corrected to date in                            
  response to RxSafety                                   
  Advisor alerts:                                        

  **Submitted Drug (LASA      **Submitted   **Outcome    **Outcome Drug**
  Pair)**                     Qty/Days**    Qty/Days**   

  [Look-alike Sound-alike                                
  Drug Changes]{.underline}                              

  CLARITIN-D 12 HOUR TAB SA   20/20         20/20        CLARITIN-D 24 HOUR TAB SA
  (Claritin D/Claritin D 12                              
  hr)                                                    

  ISOSORBIDE DN 20MG TABLET   60/5          60/5         PROPRANOLOL 20MG TABLET
  (Inderal/Isordil)                                      

  HYDRALAZINE 50MG TABLET     15/4          15/5         HYDROXYZINE HCL 50MG TABLET
  (hydroxyzine/hydralazine)                              

  HYDRALAZINE 10MG TABLET     100/3         100/4        HYDROXYZINE HCL 10MG TABLET
  (hydroxyzine/hydralazine)                              

  LAMISIL (Lamictal/Lamisil)                             LAMICTAL 25MG TABLET

  GLYBURIDE 5MG TABLET        45/30         45/30        GLIPIZIDE 5MG TABLET
  (glipizide/glyburide)                                  

                                                         

  [Changes in Strength,                                  
  Formulation Quantity or                                
  Days Supply]{.underline}                               

  AZULFIDINE ENTAB 500MG      120/30        120/30       SULFASALAZINE 500MG TABLET

  DITROPAN XL 5MG TABLET SA   45/30         45/30        OXYBUTYNIN 5MG TABLET

  DITROPAN XL 5MG TABLET SA   45/30         45/30        OXYBUTYNIN 5MG TABLET

  PERIOSTAT 20MG CAPSULE      30/30         45/90        DOXYCYCLINE 100MG TABLET

  ALBUTEROL SULF 2MG/5ML SYRP 100/10        60/25        ALBUTEROL 5MG/ML SOLUTION

  CELEXA 20MG TABLET          60/30         30/30        CELEXA 40MG TABLET

  AMITRIPTYLINE HCL 25MG TAB  30/5          30/5         LORAZEPAM 0.5MG TABLET

  AVANDIA 2MG TABLET          15/30         15/30        AVANDIA 4MG TABLET

  SULINDAC 200MG TABLET       20/7          20/10        SULINDAC 200MG TABLET

  VIOXX 25MG TABLET           14/3          14/14        VIOXX 25MG TABLET

  SARAFEM 20MG PULVULE        42/84         42/28        SARAFEM 20MG PULVULE

  AMERGE 2.5MG TABLET         9/5           9/9          AMERGE 2.5MG TABLET

  HALOPERIDOL LAC 2MG/ML CONC 60/30         60/15        HALOPERIDOL LAC 2MG/ML CONC

  HYDROXYZINE PAM 25MG CAP    60/5          60/10        HYDROXYZINE PAM 25MG CAP

  PROPRANOLOL 40MG TABLET     300/75        300/100      PROPRANOLOL 40MG TABLET

  SYNTHROID 100MCG TABLET     45/90         45/30        SYNTHROID 100MCG TABLET

  SYNTHROID 75MCG TABLET      45/90         45/30        SYNTHROID 75MCG TABLET

  TIZANIDINE HCL 4MG TABLET   15/3          15/7         TIZANIDINE HCL 4MG TABLET

  TIZANIDINE HCL 4MG TABLET   15/7          15/14        TIZANIDINE HCL 4MG TABLET

  LISINOPRIL 10MG TABLET      60/30         60/30        LISINOPRIL 40MG TABLET

  PREDNISONE 20MG TABLET      42/12         42/12        PREDNISONE 10MG TABLET

  ATENOLOL 50MG TABLET        15/30         60/30        ATENOLOL 50MG TABLET

  AZULFIDINE ENTAB 500MG      120/30        180/30       AZULFIDINE ENTAB 500MG

  METHOTREXATE 2.5MG TABLET   16/30         48/30        METHOTREXATE 2.5MG TABLET

  GUAIFENESIN 1200 TABLET SA  13/6          20/10        GUAIFENESIN 1200 TABLET SA

  HALOPERIDOL LAC 2MG/ML CONC 120/15        60/30        HALOPERIDOL LAC 2MG/ML CONC

  DIOVAN 40MG TABLET          30/70         12/10        DIOVAN 40MG TABLET

  SARAFEM 20MG PULVULE        42/84         14/28        SARAFEM 20MG PULVULE

  CELEXA 20MG TABLET          15/30         30/15        CELEXA 20MG TABLET
  --------------------------- ------------- ------------ ----------------------------

> Intro: Good morning ladies and gentlemen. I am grateful for the
> opportunity to address such an esteemed group of experts. My name is
> Suzanne Coffman, and I am a product manager with NDCHealth. My area of
> responsibility is solutions for clinical issues facing retail pharmacy
> today, including medication errors.
>
> Hook: NDCHealth is a leading provider of health care EDI and
> informatics systems and services. 68% of all retail prescription
> transactions travel through the NDCHealth Intelligent Network. We are
> connected to 90% of all retail pharmacies in the US (and Canada).
>
> MO: If all retail pharmacies used our RxSafety Advisor alert service
> thousands of look-alike sound-alike dispensing errors and near misses
> could be prevented each month.
>
> Point 1: RxSafety Advisor alerts pharmacists to double-check the
> prescription when the dose they submit is atypical for the drug
> submitted but typical for a look-alike sound-alike drug.
>
> Point 2: We have prevented at least 50 potentially clinically
> significant errors in our first few months on the market with only
> about 200 stores live.
>
> Point 3: RxSafety advisor could prevent errors and near misses from
> potentially confusing drugs as a post-marketing surveillance tool.
>
> Point 1: RxSafety Advisor alerts pharmacists to double-check the
> prescription when the dose they submit is atypical for the drug
> submitted but typical for a look-alike sound-alike drug.

-   We determine whether the dose is typical for the submitted drug or
    any of its LASA drugs using a database built on top of the USP/ISMP
    list of LASA pairs and updates published in the Medication Safety
    Alert newsletter

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-   Even though atypical doses may be within the safe range for a drug,
    they can be an indicator that something is wrong

-   We determine typical doses for every strength of every drug from
    analyzing millions of de-identified prescriptions

-   We also use a scoring system for the likelihood of look-alike
    sound-alike confusion developed with the assistance of ISMP

-   The alerts can be turned on at NDCHealth with the flip of a switch
    as soon as the store or chain agrees

> Point 2: We have prevented at least 50 potentially clinically
> significant errors in our first few months on the market with only
> about 200 stores live.

-   Currently conducting a randomized controlled trial in a 115-store
    chain to determine the true impact of RxSafety Advisor alerts.

-   Comparing prescription transactions immediately before and after the
    alert was sent to identify any changes in drug, quantity or days
    supply that could indicate that a process error was corrected.

-   The study will test the impact of RxSafety Advisor in preventing
    LASA and other types of errors resulting from prescribing,
    handwriting, or phone miscommunications, lapses during data entry,
    or confirmation bias.

> Point 3: RxSafety advisor could prevent errors and near misses from
> potentially confusing drugs as a post-marketing surveillance tool.

-   For products with potentially confusing names, especially
    newly-approved drugs, RxSafety Advisor could be a valuable tool for
    post-marketing surveillance

-   Our alerts would PREVENT many of the errors and near misses

-   We can categorize the data by new vs refill, by prescription volume
    of the store, by day of the week, by different strengths of the
    product in question, or by the action taken by the pharmacist in
    response to the alert.

> MO: If all retail pharmacies used our RxSafety Advisor alert service
> thousands of look-alike sound-alike dispensing errors and near misses
> could be prevented each month.
>
> Point 1: RxSafety Advisor alerts pharmacists to double-check the
> prescription when the dose they submit is atypical for the drug
> submitted but typical for a look-alike sound-alike drug.
>
> Point 2: We have prevented at least 50 potentially clinically
> significant errors in our first few months on the market with only
> about 200 stores live.
>
> Point 3: RxSafety advisor could prevent errors and near misses from
> potentially confusing drugs as a post-marketing surveillance tool.
>
> *I'm a pharmacist, and I've made look-alike sound-alike dispensing
> errors (never harmed anyone). I would love to get alerts telling me
> that an odd-looking prescription could indicate I'm making a
> look-alike sound-alike error.*