Suggest Compliance Plan for Prescribing Professionals
I. Purpose and Introduction
The purpose of this suggested compliance plan is to provide guidance and best practices for prescribers of opiates and benzodiazepines. Compliance with OARRS is required. In addition, urine drug testing (UDT) among pain management physicians, OBGYNs, psychiatrists, and orthopedics is a useful tool that can not only assist in diagnostic and therapeutic decision making, but can also be used as a personal risk reduction tool for those physicians prescribing pain medications. Please ensure proper compliance with your state’s requirements regarding continuing education, registration, licensing, and all other activities associated with pain management clinics. This compliance plan is limited to best practices for UDT only; it should not be construed as legal advice.
II. Obtain a Patient Treatment Agreement
Obtain a signed agreement with the patient requiring the patient to submit to occasional drug screens. This agreement should clearly state that no prescriptions will be written without drug testing upon request. This agreement should also include a representation and warranty on behalf of the patient that all prescription medications will be taken only as prescribed and directed and that in no event should any medication be shared, sold, or otherwise given to a third party.
III. Follow All OARRS Requirements
The Ohio State Board of Pharmacy maintains the Ohio Automated Rx Reporting System (OARRS), a prescription monitoring program designed as a treatment tool to assist healthcare professionals in identifying and preventing the misuse of controlled substances. OARRS is a web-based system available to prescribers, pharmacists, and their delegates. Prior to initially prescribing or personally furnishing an opioid analgesic or a benzodiazepine, the prescriber must request an OARRS report that covers patient information for at least the previous year. Further, the prescriber must make periodic requests for patient information from OARRS if the treatment continues for a period greater than ninety days. These periodic requests must be made in intervals not exceeding ninety days and must continue until the course of treatment ends. Upon retrieval of the OARRS report, the prescriber is required to assess the information and make a notation in the patient’s medical record that the report was received and assessed. In the unlikely event that an OARRS report is unavailable, the prescriber must make a notation in the patient’s medical record the date that the report was requested and unavailable.
The following prescribers are subject to OARRS requirements: physicians authorized to practice medicine, osteopathic medicine, or podiatry; dentists; advanced practice nurses holding certificates to prescribe; and physician assistants holding certificates to prescribe. Optometrists holding a therapeutic pharmaceutical agents certificate are required to register for OARRS, but are only required to run an OARRS report if they have reason to believe that a patient may be abusing or diverting drugs. Those prescribers who practice primarily in an Ohio county that adjoins Kentucky, West Virginia, Indiana, or Michigan must also request the adjoining state’s information through OARRS. A delegate may run an OARRS report on behalf of the aforementioned prescribers in order to satisfy the requirements of the law. Delegates are required to have their own OARRS account as running a report under the prescriber’s name is prohibited. It is important to note that delegates may not interpret results of an OARRS report.
Because an OARRS report contains Personal Health Information (PHI), it must be used and stored in a manner that ensures appropriate confidentiality by all healthcare professionals. An OARRS report may be shown to the patient; however prescribers may not provide patients with a copy. Patients who wish to have a copy of their OARRS report may obtain one directly from the Ohio State Board of Pharmacy. Prescribers may also discuss the report with another health care professional who is treating the patient or dispensing a prescription to the patient; nevertheless, the report cannot be given to another healthcare professional.
The only OARRS requirement for the patient’s medical record is a notation that the record was received and assessed. Therefore, prescribers may choose to view the report through the web-based system, save the report electronically, or print it. If a report is saved or printed, it may be incorporated into the patient’s medical record, stored in a separate file in the medical office, or shredded.
The following scenarios are exceptions where a prescriber is not required to run and assess an OARRS report:
- An advanced practice registered nurse, physician assistant, or physician is prescribing or personally furnishing the drug to a hospice patient or any other patient who is diagnosed as terminally ill;
- An advanced practice registered nurse, physician assistant, or physician is prescribing or personally furnishing the drug for the treatment of cancer (or a condition associated with cancer);
- An advanced practice registered nurse, physician assistant, or physician is prescribing or personally furnishing the drug in a residential care facility, hospital, or nursing home;
- A physician is prescribing or personally furnishing the drug to treat acute pain stemming from a surgical or invasive procedure or delivery;
- The drug is prescribed or personally furnishing in an amount indicated for a period of one week or less; or
- The OARRS report is unavailable.
B. Practice Recommendations
While prescribers are allowed to incorporate the OARRS report into patients’ medical records, it is not recommended due to the risk of inadvertent disclosure. Medical records are often duplicated for other medical professionals, insurance companies, patients, and even law firms. Such duplication with an OARRS report could place the employee or the medical office at risk for criminal prosecution. If an office does choose to keep OARRS reports with patients’ medical records, the office should use care to avoid including the OARRS report in any medical record duplications. These offices should use a filing mechanism that either flags the OARRS report or segregates it completely. Offices should also take steps to ensure that if a patient is shown an OARRS report, the patient does not leave the office with it. Finally, offices should not release copies of OARRS reports to law enforcement officers. Law enforcement officers can obtain their own report.
IV. Drug Testing Best Practices
A. Test Upon Initial Consultation
Evidence based practice and case studies suggest that all pain patients should be subject to UDT upon the initial visit. The purpose of this UDT is fourfold: (i) results will provide physicians with objective information of drug misuse prior to prescribing any medications; (ii) initial drug testing can be used to reduce “physician shopping behaviors”; (iii) results may identify the need for further assessment; and (iv) to obtain a baseline result for future compliance testing.
B. Drug Screening Upon Change of Medication or Dosage
Prior to adjusting a patient’s dosage or medication, it is recommended to test the patient to ensure compliance with the first line of treatment. Use results to assist with clinical decision making.
C. At Unannounced Intervals
Perhaps one of the most important tools for checking the patient’s adherence to his or her prescribed medications is the unannounced UDT. This should be done at least twice a year at a follow-up visit. Results should be monitored for consistency with the patient’s prescribed medication. This UDT should be performed prior to issuing a prescription for continuation of treatment.
Please note that abnormal results may have multiple meanings and will require additional follow-up. A UDT that is negative for prescribed medication may indicate diversion, but it could also indicate several other scenarios: (i) the patient ran out of medication prior to the UDT due to increasing the dosage or frequency of administration; (ii) the patient is taking less medication than originally prescribed; or (iii) the patient may have tampered with the sample to cover up illegal drugs or illegally obtained prescriptions. A UDT that is positive for medications and substances that have not been prescribed can signal patient related issues and may require referral to an addiction specialist if this is not the prescriber’s area of expertise. Always run a check with your state’s prescription monitoring program or prescription tracking tool anytime you receive an abnormal or unexpected result.
V. Consider Licensing Implications
Physicians must take care to conduct an appropriate examination, arrive at a diagnosis and purpose for which a controlled substance is utilized, document the examination, diagnosis, and the purpose of the prescription in the patient’s record, as well as record the medication, dosage, and frequency of administration. Failure to follow federal and state regulations related to prescribing of controlled substances and failure to properly document a patient’s record may result in discipline, up to and including, loss of your professional license. As such, it is recommended that physicians regularly utilize UDT as a tool to ensure that patients are not misusing, abusing, or selling their prescriptions. Regular UDT is a best practice to help protect your professional license.
For more information, contact the Healthcare Law team.
“Personally furnish” means the distribution of drugs by a prescriber to the prescriber’s patients for use outside the prescriber’s practice setting. This does not include the administration of drugs.
Currently, physician assistants holding certificates to prescribe and advanced practice registered nurses are not permitted to personally furnish controlled substances. See R.C 4723.481(E)(3) and 4730.43(A)(3)
Pennsylvania does not currently have an active prescription drug monitoring program. If such a program becomes available, providers in counties adjoining Pennsylvania must also request information from Pennsylvania. In Kentucky, a physician assistant is not considered a prescriber. As a result, any Ohio physician assistant that needs to access the prescription monitoring program in Kentucky will need to do so through a delegate account.
Currently, physician assistants holding certificates to prescribe and advanced practice registered nurses are not permitted to personally furnish controlled substances.
O.R.C. 4729.99(J)(1) reads: “Whoever violates division (A)(1) of section 4729.86 of the Revised Code is guilty of a misdemeanor of the third degree. If the offender has previously been convicted of or pleaded guilty to a violation of division (A) (1), (2), or (3) of section 4729.86, that person is guilty of a misdemeanor of the first degree.” O.R.C. 4729.86(A)(1) states “No person in divisions (A)(1) to (10) or (B) of section 4729.80 of the Revised Code shall disseminate any written or electronic document the person receives from the drug database, except as necessary in the investigation or prosecution of a possible or alleged criminal offense.
See generally (Chou, et al, 2009; Cone, et al 2008), (Antoin and Beasley, 2003), Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care (Gourlay, Heit, and Caplan).