Updated Model Act Addresses Quality and Safety in Patient Care

Originally published in the September 2010 NABP Newsletter

To assist the boards of pharmacy as they work to protect the public health, NABP recently amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) to reflect the increased utilization of computer technology and, more importantly, improved quality and safety measures in patient care. These changes were incorporated as a result of the Executive Committee-approved recommendations of the Task Force on Electronic Prescribing Software Standards and Data Storage, the Task Force on Prescription Monitoring Program Standards, and the Committee on Law Enforcement/Legislation.

Task Force on Electronic Prescribing Software Standards and Data Storage

Amendments recommended by the Task Force on Electronic Prescribing Software Standards and Data Storage included two additions to the required components of a valid prescription drug order. These additions to the prescription drug order include the patient’s date of birth as well as inclusion of the prescribing practitioner’s professional title. Due to the fact that written, paper prescription drug orders have always provided the prescriber’s title, it was decided that it should also be included on e-prescriptions to assist pharmacists in determining the validity of a prescription and whether it is within the purview of the prescriber’s scope of practice.

For clarification, the Committee on Law Enforcement/ Legislation further revised the Model Act and changed the prescribing practitioner’s professional title to prescribing practitioner’s license designation, to avoid the possibility that it could be construed to mean an individual’s title of employment rather than his or her field of practice, such as MD, DVM, or DDS. Members agreed that “practitioner’s license” was a more precise term to clearly state what information is required on a prescription drug order.

Task Force on Prescription Monitoring Program Standards

Model Act amendments to increase public safety, resulting from recommendations of the Task Force on Prescription Monitoring Program Standards, were specifically premised on ensuring that prescription monitoring programs (PMPs) serve two critical purposes:

  1. assist the pharmacist and prescriber in assessing patient information and providing appropriate patient care, and 
  2.  assist law enforcement efforts in identifying and acting in regard to instances of drug abuse and diversion.

The task force also recommended that NABP work collaboratively with the Alliance of States with Prescription Drug Monitoring Programs (Alliance) to develop one model act that can be utilized by the states. 

First, the revised Model Act includes a change to the title of Appendix G, from Model Prescription Monitoring Act, to Model Prescription Monitoring Program Act. Additionally, certain language from the NABP Model Act was eliminated in order to be consistent with the Alliance Model Act. Specifically, since the Model Act was amended to instate the boards of pharmacy as having the authority to establish and maintain PMPs, the current Section 6, Advisory Board, and Section 9, Education and Treatment, were removed, and other sections renumbered accordingly. Additional references to an “advisory board” or “education and treatment” throughout Appendix G were also removed.

Additionally, the definition of dispenser was revised to include institutional facilities as a reporting exception, whereas wholesale distributors and the dispensing of prescriptions for controlled substances at the time of discharge were removed from the reporting exceptions.

A definition for drugs of concern was also added and the Model Act was revised to provide for the monitoring of all controlled substances in Schedules II through V, all state-specified controlled substances, and state-specified drugs of concern.

Further, to reflect the language found in the National All Schedules Prescription Electronic Reporting Act of 2005, the section of NABP’s Model Prescription Monitoring Act entitled Reporting of Prescription Monitoring Program Information, was amended to require that the following data must be reported by the dispenser to the board of pharmacy.
 

  1. Drug Enforcement Administration Registration Number of Dispenser
  2. Drug Enforcement Administration Registration Number and name of the practitioner who prescribed the drug
  3. Name, address, and telephone number of the ultimate user
  4. Identification of the drug by a national drug code number
  5. Quantity dispensed
  6. Number of days supplied
  7. Number of refills ordered
  8. Whether drug was dispensed as a refill or as a new prescription
  9. Date of dispensing
  10. Date of the original prescription
  11. Such other information as may be required by state law

The revised Model Act also addresses access to PMP data, particularly the importance of determining appropriate types or levels of access. In the section entitled Access to Prescription Monitoring Information/Confidentiality, it is specified that practitioners, dispensers, and law enforcement agents who access PMP data must certify, under procedures designated by the state, that the requested information is for the purpose of providing medical or pharmaceutical treatment or evaluating the need for such treatment to a bona fide current patient, or that the requested information is related to an individual investigation or proceeding involving the unlawful diversion or misuse of a reportable substance. State licensing, certification, or regulatory agents that license, certify, or regulate health care professionals, patients who need to review their records, and other entities determined by the board of pharmacy may also access PMP information under the Model Act revisions. A comment was added to clarify that the language in this section is intended to allow boards of pharmacy to evaluate PMP information and determine appropriate information to provide to law enforcement entities. It is not intended to allow law enforcement officials open access to all data.

As mentioned previously, it was decided that the boards of pharmacy should be the entities responsible for overseeing PMPs, thus Section 5, Establishment of a Prescription Monitoring Program, was modified as follows: “The Board of Pharmacy shall establish and maintain an electronic system for monitoring all controlled substances in Schedules II through V, all State-specified controlled substances in Schedules II through V, and State-specified Drugs of Concern dispensed in the State.” The revisions also allow a state board of pharmacy to contract with a vendor to establish and maintain an electronic monitoring system. Lastly, Section 8 of NABP’s Model Prescription Monitoring Act entitled Unlawful Acts and Penalties was revised to add “a person who knowingly accesses or uses Prescription Monitoring Program Information without authorization in violation of this Act shall be subject to (insert appropriate administrative, civil, or criminal penalty)” as a punishable offense. The updated Model Act is available in the Publications section of the NABP Web site at www.nabp.net/ publications/model-act.
 

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