Registration Requirements

1. Who is required to register to access the PMP?

Uploading Requirements

2. Which federal schedules or drugs of concern is a dispenser required to report to the PMP?
3. How often do I have to report?
4. How do I send a Zero Report?
5. Which Web site address should I use to upload my data files?
6. The Delaware PMP requires data submissions using the ASAP 4.2 standard. Please offer some direction to help eliminate file formatting errors.
7. What are the requirements for valid NDC numbers?

Reporting/Frequency of Reporting

8. Which controlled substances must be reported to the PMP?
9. Are there any types of patients for whom reporting of controlled substance prescriptions is not required?
10. Are Methadone clinics required to submit data to the PMP?
11. Is a practitioner who administers a drug to a patient in a clinic, emergency room or other outpatient facility required to report to the PMP when he/she administers a drug, such as an IM injection of meperidine to a patient in an emergency room?

Legal Implications

12. How does the HIPAA Privacy Rule affect the PMP?
13. Are there any legal protections for prescribers, pharmacists and dispensers who report data to the PMP or who access PMP patient profiles?
14. Can I give a patient a copy of his/her own Delaware PMP Recipient Report?

Additional Questions

15. Where do I find more information on my PMP AWARxE Account?

Answers

Who is required to register to access the PMP?

Answer: Registration to access the Delaware PMP is mandatory (16 Del. C. § 4798(u)) for the following:

• Practitioners (other than veterinarians) who hold a valid Delaware controlled substance registration
• Pharmacists who dispense controlled substances in Delaware.

However, certain other practitioners may register although it is not mandatory.  For more information, see Practitioner, Pharmacist and Delegate Registration.

 

Which federal schedules or drugs of concern is a dispenser required to report to the PMP?

Answer: Dispensers are required to report Schedule II, III, IV, and V controlled substances and drugs of concern, as defined by the Office of Controlled Substances. However, controlled substances and drugs of concern are excluded from reporting in these situations:

• Licensed health care facility pharmacies dispense/distribute the drugs for inpatient care
• Emergency departments dispense/distribute the drugs for immediate use
• Any Delaware-licensed pharmacy (in-state or non-resident) or a controlled substance registrant dispenses/distributes less than a 72-hour supply of the drugs (including samples) at the time of a patient’s discharge from emergency department care.

How often do I have to report?

Answer: You must report data daily.

 

How do I send a Zero Report?

Answer: For complete instructions on sending Zero Reports, see section 4.4 of the Dispenser’s Implementation Guide.  Zero Reports must be sent daily.

 

Which web site address should I use to upload my data files?

Answer: For complete data formatting and delivery instructions, refer to the Dispenser’s Implementation Guide.

 

The Delaware PMP requires data submissions using the ASAP 4.2 standard. Please offer some direction to help eliminate file formatting errors.

Answer: Check these items (listed in order of priority) to make sure the software is handling your data properly:

1. Are field and segment separators used correctly?
2. Are the dates formatted correctly?
3. Does the NDC field contain a valid NDC? Is that NDC actually a controlled substance?

 

What are the requirements for valid NDC numbers?

Answer: An NDC is 11 digits in the format 99999-9999-99. They are typically located on the original medication bottle on the top right corner of the label and start with “NDC” followed by a dash and the number. These are the criteria for uploading NDC numbers in PMP:

• Do not include the dashes – for example: 99999999999.
• If the manufacturer leaves off a zero in the NDC, add the 0 where appropriate. Use the following examples as a guideline:
  

  IF the NDC appears this way…	THEN enter…
  1234-5678-90 (missing 0 in first segment)	01234568790
  54321-123-98 (missing 0 in second segment)	54321012398

 

Which controlled substance prescriptions must be reported to the PMP?

Answer: Pharmacies licensed and located in Delaware must report to the Delaware PMP all schedule II, III, IV and V controlled substance prescriptions that they dispense. All such prescriptions must be reported, including those dispensed for non-Delaware residents or mailed/shipped out of state.

Out-of-state pharmacies must report to the Delaware PMP all schedule II through V controlled substance prescriptions that they deliver, ship or mail into Delaware. However, when a Delaware resident travels to a pharmacy outside of Delaware and physically picks up the prescription(s) there, do not report that prescription to the Delaware PMP because that prescription is technically not dispensed in Delaware.

 

Are there any types of patients for whom reporting of controlled substance prescriptions is not required?

Answer: Yes. The law states that a dispenser is not required to submit data on controlled substance prescriptions dispensed for a:

• • Substance Abuse Treatment Program, such as Methadone Clinics and Opioid Treatment Programs (OTP), which are exempt by federal regulations (42 CFR Part 2)
  • Prescriber or other authorized person who administers such controlled substance or drug upon the lawful order of a prescriber
  • Prescriber or other authorized person who, in providing emergency patient care in a healthcare facility, causes the administration of a controlled substance for immediate relief of symptoms arising from an acute condition
  • Prescriber or other authorized person who prescribes less than a 72-hour supply of a controlled substance for on call services or emergency care
  • Veterinarian who prescribes for the purpose of providing veterinary services.

 

Are Methadone clinics required to submit data to the PMP?

Answer: No. The federal regulations at 42 CFR Part 2 concern the confidentiality of alcohol and drug abuse treatment records. Section 2.1 states:

“Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.”

In addition, nothing in 42 CFR Part 2 prevents a physician or pharmacist working for an OTP from registering for access to the PMP, and nothing would prevent a physician or pharmacist working for an OTP from requesting patient profiles from the PMP.

 

Is a practitioner who administers a drug to a patient in a clinic, emergency room or other outpatient facility required to report to the PMP when he/she administers a drug, such as an IM injection of meperidine to a patient in an emergency room?

Answer: No. The administration of a drug does not have to be reported to the PMP. The law states that “dispensing does not include the direct administering of a controlled substance to a patient by a licensed health care professional.” Only drugs that are dispensed to the patient for a 72-hour supply or greater (i.e., given to the patient to take home for later use) must be reported to the PMP.

 

How does the HIPAA Privacy Rule affect the PMP?

Answer: 45 CFR §164.512 provides exceptions to the general rules that require a patient’s consent or authorization before protected health information may be disclosed and used. Specifically, these two exceptions allow information to be disclosed to the PMP:

• • A covered entity, such as a pharmacy, may disclose protected health information for certain public health activities and purposes
• Information may be disclosed to a health oversight agency for oversight activities authorized by law.

 

Are there any legal protections for prescribers, pharmacists and dispensers who report data to the PMP or who access PMP patient profiles?

Answer: Yes. Unless a court of competent jurisdiction makes a finding of gross negligence, malice or criminal intent, the Office of Controlled Substances, any other state agency, any prescriber or dispenser, or any person or entity in proper possession of [PMP] information is not subject to civil liability, administrative action or other legal or equitable relief for any of the following acts or omissions:

• Furnishing information in accordance with 16 Del. C. §4798
• Receiving, using or relying on – or not using or relying on – information received in accordance with 16 Del. C. §4798
• Information that was not furnished to the Office of Controlled Substances.
• Information that was factually incorrect or that the Office of Controlled Substances released to the wrong person or entity.

Pharmacists and prescribers are permitted to request profiles only for patients whom they are currently or prospectively treating. Pharmacists and prescribers are not permitted to look up the profiles of anyone whom they are not currently treating.

 

Can I give a patient a copy of his/her own Delaware PMP Recipient Report?

Answer: No. The Recipient Report for practitioners contains confidential information about the prescriber. Patients can request their own Delaware PMP Recipient Report.

 

Where do I find more information on PMP AWARxE services?

Answer: For more information and frequently asked questions review the AWARxE FAQ page.