Are you properly documenting prescriber interventions before dispensing opioids to your patients? Documentation must support a pharmacist’s professional judgment with clarity and specificity. 

During a recent Michigan Board of Pharmacy (BOP) inspection, the state inspector advised caution to the pharmacy staff regarding opioid dispensing and documentation of opioid prescription interventions,  referencing MCL 333.7333 and 338.490. During their inspection, they uncovered a pharmacy patient who had received opioid prescriptions for years, stopped getting them for three months, and then restarted treatment. The pharmacy knew the patient, knew the doctor, checked the Michigan Automated Prescription System (MAPS) as appropriate, validated the prescription with the doctor’s office, but failed to document the intervention as to why, after a three-month hiatus, the patient was back on opioids. This failure to document raised a red flag with the state inspector.

The days of merely verifying a controlled substance prescription with either the doctor or the office staff are long over. Under MCL 333.7333 a pharmacist must act in “good faith” before dispensing a controlled substance. For a pharmacist, “good faith” means dispensing a controlled substance after using professional judgment to determine that the prescription was lawfully prescribed.  Professional judgment is now guided by nationally accepted standards for pharmacists. It is expected that, at a minimum, the pharmacist will consider and document the following when making a judgment about whether the prescription is lawful.

• Is there a bona-fide physician-patient relationship?
• Is the prescriber “pattern prescribing” – writing a large number of prescriptions for the same controlled substance for multiple patients?
• Are the quantities for the drug written higher than normally prescribed for this drug by other prescribers? Are the dosages for the opioid unusual? Are the morphine milligram equivalents (MME) reasonable?
• Is there an unusual geographic pattern involving long distances between the prescriber, the pharmacist, and the patient?
• How is the patient paying, Insurance or cash? Is there an appropriate diagnosis?

Inspectors and auditors are looking for appropriate documentation for outlier patients. In the above BOP inspection, the inspector was likely looking to see that the pharmacist spoke with the prescriber or office staff to determine that there was indeed a legitimate reason that the MAPS showed no recent activity for the patient. For example, if a patient was in the hospital, out of the country, or was incarcerated for three months, then there would be no MAPS reporting for opioids.

Appropriate documentation should be legible, entered into the patient’s profile, and address the following questions:

• Who did you speak to, was it the patient, prescriber, or office staff?
• When did you speak to this person (include the time and date)?
• What did you discuss?
• What clarifications were made?
• What follow up is required?

A mock Board of Pharmacy inspection or PBM audit may help avoid unwanted scrutiny and assist pharmacy staff with proper procedures for filling controlled substances under the law. Foley, Baron, Metzger & Juip offers comprehensive assistance to pharmacies and pharmacists seeking to remain compliant with state and federal pharmacy rules and regulations. We also advise clients on related matters including business formation, buying and selling a pharmacy, licensing matters, and audit defense. Contact Pharmacist-Attorney Kim Sveska for more information at 734.742.1800.