1. Who qualifies as a dispenser?
2. I qualify as a dispenser. What am I required to do?
3. What CDS drug schedules are monitored?
4. Are there any exceptions to the reporting requirement?
6. Can I apply for a waiver from the reporting requirement?
7. What information do I have to report?
8. How often do I have to report?
9. Is there a fee to report data?
10. When do I need to start reporting?
12. What data submission format will I use?
13. Do I need to send a zero report if I do not dispense CDS drugs during the reporting period?
14. Will I receive a submissions report?
15. What are the requirements for valid NDC numbers?
17. What errors do I need to correct and resubmit beginning with my August 20, 2013 submission?
18. What if I have forgotten the upload account user name or password?
19. Who should I contact with questions?
20. I am a pharmacist. How do I access PDMP data for patient care?
1. Who qualifies as a dispenser?
In general, dispensers are persons or entities authorized to dispense controlled dangerous substances (CDS) to a patient or a patient?UR(TM)s agent in Maryland. This includes:
However, certain types of pharmacies, clinics and practitioners are NOT considered as a dispenser for PDMP purposes and are therefore EXEMPT from reporting to the Program. These include:
2. I qualify as a dispenser. What am I required to do?
Dispensers are required by law to electronically report data on CDS prescription drugs dispensed to a patient or a patient?UR(TM)s agent in the State. Dispensers must register with and report to Health Information Designs (HID), the State?UR(TM)s authorized agent for PDMP data collection. For details on registration, see ?URoeChapter 4: Data Submission?UR? in the MD PDMP Dispenser?UR(TM)s Implementation Guide or contact the MD PDMP Help Desk by email at mdpdmp-info@apprisshealth.com or call 855-729-8920.
3. What CDS drug schedules are monitored?
The MD PDMP is required by law to monitor the prescribing and dispensing of prescription drugs that contain a Schedule II, III, IV, or V CDS as designated under Title 5, Subtitle 4 of the Criminal Law Article, Annotated Code of Maryland.
With few exceptions, Maryland?UR(TM)s CDS schedules parallel those in federal law.
The Maryland Division of Drug Control maintains a list of drugs included in the Maryland CDS schedules that are not included in the federal schedules. This list is routinely updated and posted on the DDC website: http://dhmh.maryland.gov/laboratories/drugcont/SitePages/Home.aspx.
Note: Additions or deletions of other drugs specified by Maryland law may happen periodically. These changes must go through the legislative process in order to be added or deleted. You will be notified of any changes that are made in the future.
4. Are there any exceptions to the reporting requirement?
For information on the types of pharmacies, clinics and practitioners that are exempt from the PDMP reporting requirement, see ?URoeWho qualifies as a dispenser??UR?
Additionally, certain types of drug delivery are not required to be reported, including:
5. I dispense small quantities of CDS drugs to patients being discharged from the hospital. Do I need to report this?
Unless the drug meets the definition of a sample the dispensing must be reported (see ?URoeAre there any exceptions to the reporting requirement??UR? above). There is no exception from the reporting requirement for small drug quantities.
6. Can I apply for a waiver from the reporting requirement?
No. The Maryland PDMP cannot issue blanket waivers from the reporting requirement to pharmacies or practitioners that are not otherwise exempt by law (for exemptions, see ?URoeWho qualifies as a dispenser??UR?). All pharmacies and practitioners that meet the definition of ?URoedispenser?UR? are required to register with the Program. However, once registered, dispensers that do not actually dispense any CDS prescription drugs are not required to report anything. The PDMP does not require dispensers to issue ?URoezero?UR? or ?URoenull?UR? reports when no dispensing activity takes place.
7. What information do I have to report?
For each prescribed CDS drug that is dispensed in Maryland, the dispenser must report identifying information for the drug, patient, prescriber and dispenser. For a complete list of required data elements, see ?URoeChapter 3: Data Collection and Reporting Requirements?UR? in the MD PDMP Dispenser?UR(TM)s Implementation Guide.
8. How often do I have to report?
Dispensers are required to report within three (3) business days of dispensing a CDS prescription drug. However, dispensers are encouraged to report more frequently if possible. Please note that ?URoebusiness day?UR? means any day except Saturday, Sunday, or a holiday on which State offices are closed.
9. Is there a fee to report data?
No.
10. When do I need to start reporting?
The PDMP reporting requirement became effective on August 20, 2013. DHMH has requested that dispensers report data on CDS dispensing from January 1, 2013.
Dispensers are required to report to the program by electronic means. If you are a chain pharmacy, your data will likely be submitted from your home office. Please verify this with your home office. If you are an independent pharmacy or dispensing practitioner that works with a pharmacy or practice management system vendor, please forward the reporting requirements to your software vendor. System changes may be necessary to create the data file, and they may be able to submit the data on your behalf.
Appriss Health is the State?UR(TM)s authorized agent for PDMP data collection. HID offers dispensers with a number of electronic reporting options, including Secure FTP over SSH, Encrypted File with OpenPGP Via FTP, SSL Website and data entry into the Universal Claim Form. For details on data submission options, see ?URoeChapter 4: Data Submission?UR? in the MD PDMP Dispenser?UR(TM)s Implementation Guide.
Based on the delivery method you wish to use, you will use one of the following addresses to upload your data files:
12. What data submission format will I use?
Maryland requires that dispensers submit reports using the American Society for Automation in Pharmacy (ASAP) Standard for Prescription Monitoring Programs Version 4.2 (2011). If you have any questions, contact your pharmacy vendor, or you may contact the MD PDMP Help Desk at mdpdmp-info@apprisshealth.com or 1-855-729-8920.
For more information regarding specifications or to acquire the full Implementation Guide for the ASAP4.2 Standard, contact the American Society for Automation in Pharmacy at www.asapnet.org. The Implementation Guide includes field lengths, acceptable attributes, and examples. You can purchase the 2011 ASAP Version 4.2 Standard at the following website: http://asapnet.org/bookstore.html
13. Do I need to send a zero report if I do not dispense CDS drugs during the reporting period?
The MD PDMP does not require dispensers to submit ?URoezero?UR? or ?URoenull?UR? reports when no CDS prescription drugs have been dispensed during a given period. However, RxSentry® does allow dispensers to submit these reports if desired. For documentation purposes, dispensers should consider submitting zero reports during periods when no CDS prescription drugs have been dispensed.
14. Will I receive a submissions report?
Yes. You will receive your report via the method specified when you created your account, either e-mail or fax. If you submit data via FTP/SFTP, a report will be placed in your home directory on the FTP server.
15. What are the requirements for valid NDC numbers?
If the NDC appears this way ?UR? |
Enter it this way ?UR? |
1234-5678-90 (missing 0 in first segment) |
01234568790 |
54321-123-98 (missing 0 in second segment) |
54321012398 |
16. Since NDC Number is a required field, what do I use for compounded drugs that do not have an NDC number?
You should use all 9?UR(TM)s in the NDC field for compounded drugs and then use the fields in the CDI segment. This will allow you to put the NDC numbers that you used to make the compound in the CDI segment. In the NDC field for the DSP segment you will just need 99999999999.
17. What errors do I need to correct and resubmit beginning with my August 20, 2013 submission?
A single record may be rejected if it has a fatal error. All fatal errors must be corrected and resubmitted. For minor and serious errors, we strongly recommend you change them in your system but don?UR(TM)t resubmit them. That will prevent the same errors from occurring on future data submissions. In addition, an entire batch may be rejected if ALL records have fatal or serious errors, more than 10% of records have fatal errors, or more than 20% of records have serious errors. In these cases the errors need to be corrected and the entire batch must be resubmitted. The Dispenser?UR(TM)s Implementation Guide will show you the edit definitions describing what is considered a fatal, serious, or minor error in the system.
18. What if I have forgotten the upload account user name or password?
Please contact the MD PDMP Help Desk by email at mdpdmp-info@apprisshealth.com or call 1-855-729-8920.
19. Who should I contact with questions?
If you need technical assistance, please contact the MD PDMP Help Desk by email at mdpdmp-info@apprisshealth.com or call 1-855-729-8920. Technical assistance is available Monday through Friday (except for holidays) from 9:00 a.m. ?UR" 5:00 p.m. Eastern Standard Time.
If you have non-technical questions regarding the Maryland PDMP, please send an email to dhmh.pdmp@maryland.gov or call 410-402-8686.
20. I am a pharmacist. How do I access PDMP data for patient care?
Pharmacists will register with CRISP and access data through the CRISP Health Information Exchange query portal. Pharmacist registration is scheduled to begin in November, 2013. For up-to-date information, please see CRISP's website. To receive notification when a date for open registration has been established, send an email to dhmh.pdmp@maryland.gov with "Send me PDMP updates" in the Subject line.
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