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:

Pharmacies (both in-state and non-resident) with a permit from the Maryland Board of Pharmacy that are also registered with the federal Drug Enforcement Administration (DEA) and the Maryland Division of Drug Control to dispense CDS; and
Healthcare practitioners that are registered with DEA and the Maryland Division of Drug Control AND have a prescription drug dispensing permit issued by their licensing board.

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:

Licensed hospital pharmacies that only distribute CDS for direct administration to an inpatient of the hospital. Please note that hospital-based pharmacies that dispense any CDS on an outpatient basis are not exempt from reporting. These pharmacies must report all outpatient dispensing to the PDMP. However, distribution of CDS drugs to licensed healthcare practitioners for direct administration to hospital inpatients should not be reported. Also, hospital-based outpatient dispensing of CDS drugs by healthcare practitioners (e.g., dispensing of ?URoestarter doses?UR? to patients treated and released from an emergency department) must be reported to the PDMP. This is considered practitioner dispensing and should be reported under the practitioner?UR(TM)s DEA number.
Pharmacies issued a waiver permit under COMAR 10.34.17.03 by the Maryland Board of Pharmacy (?URoewaiver pharmacies?UR?) that provide pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities. Please note that specialty pharmacies that only serve these types of facilities but do not have a waiver permit are NOT exempt from reporting. To verify if your pharmacy has a waiver permit, please call the Board of Pharmacy at 410-764-4755.
Opioid maintenance programs that are licensed under Health-General Article § 8-404, Annotated Code of Maryland and comply with Code of Federal Regulations 42, Part 8 and COMAR 10.47.02.11.
Veterinarians licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland when dispensing controlled substances for animals in the usual course of providing professional services.

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:

Direct administration of CDS to a patient.
Provision of patient drug samples (in accordance with Health Occupations Article, Section 12-102(d), Annotated Code of Maryland). Please note that samples must be packaged and distributed in compliance with federal requirements to meet the reporting exception. "Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug (21 CFR 203.3). Drug samples are usually pre-packaged by the manufacturer, and distributed to prescribers by the manufacturer's representatives.
Inpatient Hospice Dispensing: Pharmacies that dispense CDS to patients in an inpatient hospice facility may apply to DHMH for a waiver from reporting PDMP data on dispensing to hospice inpatients. This waiver only applies to dispensing to inpatients in facilities that are currently licensed as a ?URoegeneral license hospice?UR? by the DHMH Office of Health Care Quality (OHCQ) AND have a valid ?URoeCertificate of Need?UR? issued by the Maryland Health Care Commission (MHCC). Pharmacies issued an inpatient hospice waiver will still have to report all other CDS dispensing (i.e., outpatient dispensing). To apply for a waiver, pharmacies must provide information on how they will differentiate dispensing to hospice inpatients from other dispensing required to be reported and also will be subject to unannounced, on-site inspections by the DHMH to verify reporting on dispensing that is not to hospice inpatients. Waivers shall be effective for 2-year periods and may be renewed.

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.

11. How do I report?

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:

Secure FTP over SSH: sftp://mdpdmpreporting.hidinc.com
Encrypted File with OpenPGP Via FTP: ftp://mdpdmpreporting.hidinc.com
SSL Website: https://mdpdmpreporting.hidinc.com
Universal Claim Form (UCF) Submission: https://mdpdmpreporting.hidinc.com

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?

NDCs are 11 digits and use the format 99999-9999-99.
When adding an NDC, do not include the dashes, for example, 99999999999.
NDCs are typically located on the original medication bottle on the top right corner of the label, prefaced with ?URoeNDC-?UR? and followed by the number.
Manufacturers often leave off a zero in the NDC. In these instances, you should add the 0 where appropriate, using the following examples as a guideline:

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.