Attachment 2 VHA Prescription Label Specifications V1.1.1 Document.pdf

VHA OUTPATIENT PHARMACY

VA Outpatient Label Specifications

Version 1.1.1

January 2019

Contents Version 1.1.1

1.1 Version Control Changes:

1.2 Label Stock:

1.2.1 General Information

1.2.2 Figure 1

1.2.3 Horizontal and Vertical Measurements

1.2.4 Long Sig Label:

1.2.5 Long Sig Horizontal and Vertical Measurements

1.3 General requirements:

1.3.1

1.3.2 1.3.3………………………………………………………………………………………… 8

1.4 Prescription Label Elements:

1.5 Prescription Label Element Specifications:

1.5.1 (Position 1)

1.5.2 (Position 2) 2D Barcode:

1.5.3 (Position 3) Patient Instructions (SIG):

1.5.4 (Position 4) Medication Name:

1.5.5 (Position 5) Prescription Number:

1.5.6 (Position 6) Provider:

1.5.7 (Position 7) Medical Center Address:

1.5.8 (Position 8) Refill Left:

1.5.9 (Position 9) Prescription Quantity:

1.5.10 (Position 10) Item Number:

1.5.11 (Position 11) Medical Center Phone Number:

1.5.12 (Position 12) Prescription Warning Labels:

1.5.13 (Position 13) Divider Line:

1.5.14 (Position 14) NDC:

1.5.15 (Position 15) Fill Date:

1.5.16 (Position 16) Order Refill By:

1.5.17 (Position 17) Discard By:

1.5.18 (Position 18) Product Description:

1.5.19 (Position 19) Linear Bar Code:

1.5.20 (Position 20) Human Readable:

1.6 Attachment A:

1.1 Version Control Changes:

1.2 Label Stock:

1.2.1 There will be (2) two sizes of preprinted label stocks available. The first stock will be on 2 inches by 5.50 inches label stock (Figures 1.2.2, and 1.2.3). Both label stocks will be preprinted with the yellow highlighting, VA Logo, and the Federal Caution Statement. When the patient instructions will not fit on the standard label a long sig label will be utilized. This label will be 2.5 inches by

5.5 inches (Figure 1.2.4 and 1.2.5).

1.2.2 Figure 1

1.2.3 Horizontal and Vertical Measurements

1.2.4 Long Sig Label:

1.2.5 Long Sig Horizontal and Vertical Measurements

1.3 General requirements:

1.3.1 All printed information on the label will be in Sans Serif and font size will be called out on each label element

1.3.2 Certain Segments should print in all capital letters. These sections will be called out in 2.0 Prescription Label Element Specifications.

1.3.3 When the patient instructions will not fit on the standard label a long sig label will be utilized. The Instruction field (Position 3) should always print in 8 point font on the long sig label.

1.3.3.1 Note: CMOP experience is less than 0.1% of prescriptions (10 per 10,000 prescriptions) will require a long sig label.

1.4 Prescription Label Elements:

1.5 Prescription Label Element Specifications:

1.5.1 (Position 1) Patient Name: Should be centered in yellow label area and display in following format first, middle initial, last, and suffix (Example John H. Smith Jr). This section should have dynamic printing. Programmer should try to print in 12 pt font if characters exceed space limitations should slide down to 10pt, and then 8 point font. Patient name should be printed in bold font and printed in all Capital Letters.

1.5.2 (Position 2) 2D Barcode: A 2D Barcode will print in two positions on the PCL.

This 2D Barcode will be used internally and by patient facing applications that are to be developed (at a later date). Here is the specific formatting of what will be contained in the 2D barcode. The first digit will be a possible value of one (1) through nine (9). The digit represents where the data originates and can be used to identify the repository where information can be retrieved, like CDW and/or CMOP, etc.

Value System Origination

1 VistA Pharmacy 2 VistA CMOP 3 Cerner Pharmacy 4 Cerner CMOP 5 Future use 6 Future use 7 Future use 8 Future use 9 Future use

1.5.2.1 For VistA systems the Next component is the RxIndex followed by the tilde (~) identifying the end of the unique prescription identification that can be used to retrieve information about the prescription. The RxIndex is a composite field consisting of the “Parent Site number – Rx Number – Refill Number”. Any information after the tilde (~) should be ignored as this information is used by the system that generated the barcode. There is no grantee that the information will be discernable or related to the prescription information for the Veteran.

1.5.2.2 For Cerner the Next component is the Rx Number – followed by the Disp_History_ID followed by the tilde (~) identifying the end of the unique prescription identification that can be used to retrieve information about the prescription. The Rx Number is a Composite field that is the “internal ID number of the Pharmacy in the Cerner system – Rx Number”. Any information after the tilde (~) should be ignored as this information is used by the system that generated the barcode. There is no grantee that the information will be discernable or related to the prescription information for the Veteran.

Example:

VistA Pharmacy 1549-4872653F-3~987329430523-2344t243;32454;34543;

Vista CMOP 2549-4872653F-3~00000087654-8965724;2345;23;4;55;

Cerner Pharmacy 311111-76432839-87542638~8756;4234;3425-2344523;440

Cerner CMOP 411111-76432839-87542638~00000087654- 8965724;2345;23;4;55;

1.5.2.3 For VistA there is no need to capture the unique identifier, Vista contains enough information to be able to generate all the unique identifiers as well there is issues have Class One software changed.

1.5.2.4 However, for Cerner, there needs to be a field that does get populated so the unique identifier can be exposed to the VA. Currently the Disp_Hist_ID is not exposed and is not easily exposed. The unique identifier linkage needs to be preserved for use in future VA endeavors. An example of this the Drug Supply Chain Security Act (DSCSA) requirements. in 2020 The pharmacy has to be able to provide to the patient Lot, Expiration date along with where the medication was manufactured and it’s procurement from the manufacturer to the dispensing pharmacy. The complexity is increased with the 2023 requirements where it is at the unit level. Three (3) inhalers are dispensed each inhaler has to have the serialized barcode, it’s Lot, Expiration date along with where the medication inhaler was manufactured and its procurement from the manufacturer to the dispensing pharmacy. Being able to store the unique identifier with the prescription allows VA a way to meet the Federal Mandate and expand VA’s capabilities into the future.

1.5.3 (Position 3) Patient Instructions (SIG): In this area we will print the medication instructions for use. This section should have dynamic printing and consider appropriate word breaks. This element should always be printed in all Capital Letters. Programmer should try to print in 12 pt font if characters exceed space should slide down to 10pt, and then 8 point font.

1.5.4 (Position 4) Medication Name: In this area the Cerner Print Name will be printed. If a VA Print Name is present the Cerner system Cerner will print the VA print name in all but one case. If the DAW option is checked Cerner will always print the Cerner Print Name. This element should always be printed in all Capital Letters. This element should print dynamically in 10 pt font and slide to 8 pt font if needed. The medication name should always print in Bold font.

1.5.5 (Position 5) Prescription Number: In this area Cerner will print “Rx#” followed by the Cerner prescription number which will contain the station identifier followed by the unique number. Programmer should print this in 10 pt font.

The prescription name should always print in Bold font.

1.5.6 (Position 6) Provider: In this area Cerner will print “PROVIDER:” followed by the providers name (Last Name and first initial and period). This element should always be printed in all Capital Letters and the Programmer should print this in 8 pt font.

1.5.7 (Position 7) Medical Center Address: In this area Cerner will print the Medical Center address on two lines. The first line is the Medical Center Name and Station Number and the second line is the state and zip code. This element should always be printed in 8 pt font.

1.5.7.1 : Controlled Medications: In CMOP controlled medications are printed with the CMOP address. However, this should not impact Cerner as it done internally by

CMOP.

1.5.8 (Position 8) Refill Left: In this area Cerner will print “Refills Left:” followed by the number of refills left on this prescription. If there are no refills remaining on the prescription the following should be printed on the label “No Refills Left” in bold font. The Programmer should print this in 8 pt font.

1.5.9 (Position 9) Prescription Quantity: In this area Cerner will print “Qty:” followed by the number of tablets, Grams, MLs, for this label compared to the entire prescription. For example, if the entire 120 tablets can fit in this bottle the field would read “Qty: 120 of 120”. If the prescription requires multiple labels the field would indicate how many tablets are contained in this container. For example, a prescription for 240 that required two bottles would read “Qty: 120 of 240” and the second bottle would also read “Qty: 120 of 240” . The Programmer should print this in 8 pt font.

1.5.10 (Position 10) Item Number: In this area Cerner will print “Item:” followed by the number of containers for this label compared to the entire prescription.

For example, if it is one bottle the fields would read “Item: 1 of 1”. If the prescription requires multiple bottles the field would indicate how containers.

For a prescription requiring two bottles the first label would read “Item: 1 of 2” and the second label would read “Item: 2 of 2”. The Programmer should print this in 8 pt font.

1.5.11 (Position 11) Medical Center Phone Number: The Programmer should print this in 8 pt font in bold font. In this area Cerner will print “Ph:” followed by the Medical Centers Phone Number. The format should be as follows: “Ph: (602) 789-2789”. If the Medical Center phone number contains an extension the following adjustments can be made. If addition space is needed the “Ph:” can be removed and if it still does not fit then the bold font can be removed. For example, “Ph: (602) 789-2789 Ext 1234” or “(602) 789-2789 Ext 1234” or “(602) 789-2789 Ext 1234”.

1.5.12 (Position 12) Prescription Warning Labels: Cerner should print Multum warning labels in same order as Multum content. If the warning labels exceeds the space allocated then it should print warning labels that can fit in space and then print warning statement “SEE PATIENT INFORMATION SHEET FOR ADDITIONAL WARNINGS”. All warning should then reprint on PMI.

Programmer should print in 8 pt font.

1.5.12.1 First Warning Label To long to print: If the first warning label is too long to fit on the label along with the warning statement “SEE PATIENT INFORMATION SHEET FOR ADDITIONAL WARNINGS” then the next warning that can fit should be printed and then all warning labels should be printed on the paper work.

1.5.13 (Position 13) Divider Line: Cerner will print a horizontal solid black line to separate the warning labels from the rest of the information.

1.5.14 (Position 14) NDC: In this area Cerner will print “NDC:” followed by the NDC used for this fill. The format should be as follows: “NDC: 12345-1234-12”.

The Programmer should print this in 8 pt font.

1.5.15 (Position 15) Fill Date: In this area Cerner will print “Filled:” followed by the day the label was printed for fulfillment. The format should be as follows:

“Filled: 01/30/2019”. The Programmer should print this in 8 pt font.

1.5.16 (Position 16) Order Refill By: In this area Cerner will print “Order Refills By:”

followed by the date the prescription is valid until. The format should be as follows: “Order Refills By: 06/30/2019”. If there are no refills left (item 8) then this field should read “Contact Provider For Refills” The Programmer should

1.5.17 (Position 17) Discard By: In this area Cerner will print “Discard After:”

followed by the date the prescription is useable to. This will be one day less than one year from the fill date or if the expiration date is less than one year it will be on the day before the manufacture’s expiration date. The format should be as follows: “Discard After: 06/30/2019”. The Programmer should

1.5.18 (Position 18) Product Description: In this area Cerner will print “Rx Desc:”

followed by the MIL image description. The MIL descriptors will be printed in the following order with a “/” between each field: Front Imprint/Back Imprint/Shape/Scored (will say scored if > 0)/Dosage Form/Color. If all the information cannot fit on the label the label will leave of the descriptors in reverse order. The Programmer should print this in 8 pt font.

1.5.18.1 Once Cerner gets access to the MIL data in CDW the SQL Code in Attachment A (1.5) can be used to obtain the proper information for (Position 18).

1.5.19 (Position 19) Linear Bar Code: The linear bar code is intended for internal pharmacy purposes it should contain the same information as after the tilde (~) in the 2D barcode. This is an optional field.

1.5.19.1 Please note: CMOP increments the label instance printed and it is contained in the 2D, linear, and human readable. For example, the first label printed will be a “A” instance.

If the label is reprinted the label instance will increment to instance “B”. If the “A” instance is reprinted to a “B” instance CMOPs software will call out that the “A” instance is no longer valid if scanned.

1.5.20 (Position 20) Human Readable: The human readable contains information internal to Pharmacy. First it contains the same information as the linear barcode. Next it contains the location where the medication was filled from and then it contains the printer the label was generated on. The Programmer should print this in 6 pt. font as it is for internal use.

1.5.20.1 Example break down of CMOP’s human readable:

1.5.20.1.1 Example Human Readable: V00000126234333.001002B212-A10023/E4 Order Number: V00000126234333 Line Number: 001 Item Number: 002 Label Instance: B Location: 212-A10023 Printer: E4

1.6 Attachment A:

SELECT TOP 10

LTRIM(RTRIM(ai.[NDC])) AS [NDC] LTRIM(RTRIM(ai.[VAProductID])) AS [ProductCode] , LTRIM(RTRIM(ai.[VAPrintName])) AS [VAPrintName] , COALESCE(STUFF(

COALESCE('/' + NULLIF(LTRIM(RTRIM(ai.[FrontImprint])), ''), '') + COALESCE('/' + NULLIF(LTRIM(RTRIM(ai.[BackImprint])), ''), '') + COALESCE('/' + NULLIF(IIF(LEN(ai.[Shape]) <= 1, UPPER(RTRIM(ai.[Shape])), UPPER(SUBSTRING(LEFT(RTRIM(ai.[Shape]), PATINDEX('%[ ;-]%', RTRIM(ai.[Shape]) + ';') - 1), 1, 1)) + LOWER(SUBSTRING(LEFT(RTRIM(ai.[Shape]), PATINDEX('%[ ;-]%', RTRIM(ai.[Shape]) + ';') - 1), 2, 200)) + IIF(PATINDEX('%[ ;-]%', RTRIM(ai.[Shape])) > 0, SUBSTRING(RTRIM(ai.[Shape]), PATINDEX('%[ ;-]%', RTRIM(ai.[Shape])), 1), '') + UPPER(SUBSTRING(LTRIM(RTRIM(REVERSE(LEFT(REVERSE(RTRIM(ai.[Shape]) + ' '), PATINDEX('%[ ;-]%', REVERSE(RTRIM(ai.[Shape]))))))), 1, 1)) + LOWER(SUBSTRING(LTRIM(RTRIM(REVERSE(LEFT(REVERSE(RTRIM(ai.[Shape]) + ' '), PATINDEX('%[ ;-]%', REVERSE(RTRIM(ai.[Shape]))))))), 2, 200))

+ IIF(COALESCE(CAST(NULLIF(COALESCE(NULLIF(ISNUMERIC(ai.[Score]), 0), -1), 1) AS REAL), ai.[Score]) > 1, '/Scored', '')

+ COALESCE('/' + NULLIF(IIF(LEN(RTRIM(ai.[DosageForm])) <= 1, UPPER(RTRIM(ai.[DosageForm])), UPPER(SUBSTRING(LEFT(RTRIM(ai.[DosageForm]), PATINDEX('%[ ;-]%', RTRIM(ai.[DosageForm]) + ';') - 1), 1, 1)) + LOWER(SUBSTRING(LEFT(RTRIM(ai.[DosageForm]), PATINDEX('%[ ;-]%', RTRIM(ai.[DosageForm]) + ';') - 1), 2, 200))

+ IIF(PATINDEX('%[ ;-]%', RTRIM(ai.[DosageForm])) > 0, SUBSTRING(RTRIM(ai.[DosageForm]), PATINDEX('%[ ;-]%', RTRIM(ai.[DosageForm])), 1), '') UPPER(SUBSTRING(LTRIM(RTRIM(REVERSE(LEFT(REVERSE(RTRIM(ai.[DosageForm]) + ' '), PATINDEX('%[ ;-]%', REVERSE(RTRIM(ai.[DosageForm]))))))), 1, 1)) + LOWER(SUBSTRING(LTRIM(RTRIM(REVERSE(LEFT(REVERSE(RTRIM(ai.[DosageForm]) + ' '), PATINDEX('%[ ;-]%', REVERSE(RTRIM(ai.[DosageForm]))))))), 2, 200))

+ COALESCE('/' + NULLIF(IIF(LEN(RTRIM(ai.[Color])) <= 1, UPPER(RTRIM(ai.[Color])), UPPER(SUBSTRING(LEFT(RTRIM(ai.[Color]), PATINDEX('%[ ;-]%', RTRIM(ai.[Color]) + ';') - 1), 1, 1)) + LOWER(SUBSTRING(LEFT(RTRIM(ai.[Color]), PATINDEX('%[ ;-]%', RTRIM(ai.[Color]) + ';') - 1), 2, 200)) + IIF(PATINDEX('%[ ;-]%', RTRIM(ai.[Color])) > 0, SUBSTRING(RTRIM(ai.[Color]), PATINDEX('%[ ;-]%', RTRIM(ai.[Color])), 1), '') + UPPER(SUBSTRING(LTRIM(RTRIM(REVERSE(LEFT(REVERSE(RTRIM(ai.[Color]) + ' '), PATINDEX('%[ ;-]%', REVERSE(RTRIM(ai.[Color]))))))), 1, 1)) + LOWER(SUBSTRING(LTRIM(RTRIM(REVERSE(LEFT(REVERSE(RTRIM(ai.[Color]) + ' '), PATINDEX('%[ ;-]%', REVERSE(RTRIM(ai.[Color]))))))), 2, 200)) , 1, 1, ''), '') AS [MILDescription] LTRIM(RTRIM(ai.[FrontImprint])) AS [FrontImprint] , LTRIM(RTRIM(ai.[BackImprint])) AS [BackImprint] , LTRIM(RTRIM(ai.[Shape])) AS [Shape] IIF(COALESCE(CAST(NULLIF(COALESCE(NULLIF(ISNUMERIC(ai.[Score]), 0), -1), 1) AS REAL), ai.[Score]) > 1, 'Scored', '') AS [Scored] , LTRIM(RTRIM(ai.[DosageForm])) AS [DosageForm] , LTRIM(RTRIM(ai.[Color])) AS [Color]

FROM

[MIL].[AcceptedImageMetadata] AS ai

WHERE

ai.[Imagestatus] IN (3, 5)

1.6 Attachment A: