By Michael D.I. Siget, JD, MPA, PAMED’s Legislative & Regulatory Counsel
On Nov. 2, Gov. Wolf signed four bills into law relating to opioids and prescribing practices. Those questions are included below and have been updated to reflect any changes that will occur due to the four bills.
1. Are there situations where prescribers are exempt from having to query the PDMP system?
This has been the most frequently asked question in the past few weeks. In one word, no, there are no exemptions for prescribers to query the system.
Where the confusion arises is the list of exemptions for dispensers having to enter dispensing information into the system. In that list of exemptions, there are scenarios where prescribers, who are dispensing, are exempt from having to report the dispensing of a controlled substance to the PDMP system.
However, that does not relieve a prescriber from having to query the system if one of two conditions occurs: the first time a controlled substance is prescribed to a patient for purposes of establishing a baseline and a thorough medical record; or, if the prescriber believes, or has reason to believe, using sound clinical judgment, that the patient may be abusing or diverting drugs.
A list of the exemptions can be found here under the definition of "dispenser."
More information on this issue can be found here.
Beginning Jan. 1, 2017, if a patient has been admitted to a licensed health care facility or is in observation status in a licensed health care facility, the prescriber does not need to query the system after the initial query (for each patient the first time the patient is prescribed a controlled substance by the prescriber for purposes of establishing a baseline and a thorough medical record) as long as the patient remains admitted to the licensed health care facility or remains in observation status in a licensed health care facility.
Under Act 122 and beginning Jan. 1, 2017, health care practitioners who are providing medication to a patient in the course of treatment while the patient is undergoing care in an emergency department are not required to query the PDMP system.
2. Is querying the PDMP system dependent on the type of facility, such as a physician's office versus a nursing home or inpatient versus outpatient facility?
No. Querying the system is dependent upon the factors listed in the answer to question No. 1, not the type of facility.
3. I am a licensed physician but I don't prescribe controlled substances. Am I still required to register with the PDMP system?
Yes. Registering for the system is separate from having to query and is not dependent on prescribing to patients. As the Department of Health (DOH) stated on its PDMP website: "A prescriber who does not prescribe controlled substances still needs to register for the system and is required to query the system if they believe or have reason to believe, using sound clinical judgment, that a patient may be abusing or diverting drugs."
4. Are physicians required to query for only narcotics or all controlled substances?
Physicians are required to query the PDMP system for all Schedule II through V controlled substances as follows:
- For each patient the first time the patient is prescribed a controlled substance by the prescriber for purposes of establishing a baseline and a thorough medical record;
- If a prescriber believes, or has reason to believe, using sound clinical judgment, that the patient may be abusing or diverting drugs; or
- Each time a prescriber prescribes an opioid or benzodiazepine to a patient. (This additional query requirement was added by Act 122 and goes into effect on Jan. 1, 2017.)
5. Are there penalties against my license for failing to query the system when required?
Possibly. The law states that "a prescriber or dispenser violating provisions of this act shall also be subject to sanctions under the prescriber's or dispenser's professional practice acts and by the appropriate licensing boards."
Ultimately, what sanctions, if any, may be imposed against a physician's license will rest with the State Board of Medicine or Osteopathic Medicine.
6. Are there other penalties in the law?
Yes. There are both civil and criminal penalties in the law for obtaining or using information from the system for purposes other than those specified in the law. Those penalties can be found here.
7. When I queried the system for a patient, I noticed that prescriptions I have written for the patient several months ago are not listed. Why is that?
Dispensers were required to start reporting all schedule II through V controlled substances into the PDMP system as of June 24, 2016. Previous to the PDMP system being transferred to the Department of Health (DOH), only schedule II prescriptions were required to be reported to the Office of Attorney General.
8. If I am prescribing a controlled substance (not for the first time) to a patient and I don't believe the patient is abusing or diverting drugs, am I required to query the system?
It depends. As discussed in answer #4 above, prescribers are now required to query the PDMP each time they prescribe an opioid or benzodiazepine to a patient.
For querying related to abuse or diversion, if a prescriber does not believe that a patient is abusing or diverting controlled substances, the prescriber shall not be in violation of the PDMP law for not seeking or obtaining information from the system prior to prescribing so long as the prescriber is otherwise in compliance.
9. May prescribers assign someone else to query the system on their behalf?
Yes. There are two requirements if a prescriber is going to assign designees:
- A designee must be an employee of the prescriber.
- In assigning a designee, a prescriber shall give preference to a professional nurse licensed by the State Board of Nursing.
DOH's policy on assigning designees can be accessed here.
10. Are there other instances when I may query the system even if querying in those instances is not required?
Yes. A prescriber may query the system for an existing patient and for prescriptions written using the prescriber's own DEA number.
11. If I am licensed in Pennsylvania but do not practice in Pennsylvania, do I need to register for the program?
Yes. As of Jan. 1, 2017, all licensed prescribers who are lawfully authorized to distribute, dispense, or administer a controlled substance in the Commonwealth of Pennsylvania are required to register with the program. This does not include veterinarians.
12. When am I required to record information from the PDMP in a patient's medical record?
A prescriber is required to indicate the information obtained from the system in the patient's medical record if:
- the individual is a new patient; or
- the prescriber determines a drug should not be prescribed or furnished to a patient based upon the information from the system.
13. Will I receive notification if the PDMP system is down or undergoing routine maintenance?
If there are any maintenance, downtimes or unplanned technical issues, Appriss (PMP AWARxE) will notify all PMP AWARxE users by posting a message to the application's login page within 30 minutes of them having recognized an issue or the planned technical downtime. Appriss will continue to provide an update to the PA PDMP office at DOH in 30 minute intervals of the status if the unplanned technical issue is still on-going.
Regardless of the causes, the PA PDMP website will be updated of the downtime followed by status updates every 30 minutes. There will also be mass mailings going out to all the users about the downtime.
14. Where can I find a copy of the entire law?
You can obtain a copy of the law here.
Acts 122 and 124-126, which are deal with opioids, can be found here.
PAMED will answer more questions as needed regarding a physician's responsibilities under the law in future blog postings. If you have questions about your responsibilities under the law, please contact PAMED's Knowledge Center at 855-PAMED4U (855-726-3348) or by filling out this form.