A lesson in prospective drug review: What is your job?

Ken Baker, BS Pharm, JDLaverne DiGiovanni’s physician, Dr. Shastri, had been prescribing lithium for her for almost 10 years. When Laverne needed to control her high blood pressure, Dr. Shastri prescribed Tenoretic. Mrs. DiGiovanni took her Tenoretic prescription to her pharmacist, Dr. Huyuh, who filled the prescription. While doing so, however, pharmacist Huyuh noted that Laverne was regularly refilling a prescription for lithium.

He also noted a possible interaction warning with Tenoretic, which can be found at Drugs.com: “Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such preparations with Tenoretic.”

This case provides a good learning moment for each pharmacist. Before we go on with Mrs. DiGiovanni’s story, ask yourself what the pharmacist should have done at this point. What is the pharmacist’s duty? What is our job?

Prospective review and the law

In 1990, the federal government passed what is generally referred to as OBRA 90, which mandated that states require pharmacists to perform certain services for patients on Medicaid. By 1993, most or all states had passed legislation or regulations implementing these federal requirements. Generally, today these rules apply to all patients.

Arizona law, as an example, requires pharmacists to perform a prospective drug review before dispensing a prescription and to verify the “legality and pharmaceutical feasibility of dispensing a drug based on,” among other items, “a patients’ allergies and incompatibilities with a patient’s currently-taken medications.” Arizona also says a pharmacist should “[I]nterpret the prescription order, which includes exercising professional judgment in determining whether to dispense a particular prescription.”

Unlike many states, Arizona requires a patient to be counseled about all new prescriptions. This includes the name and strength of the drug, indication for use, directions, route of administration, and special instructions - including side effects. Also, “through the exercise of professional judgment. . . . oral consultation “may include . . . common severe adverse effects, interactions, or therapeutic contraindications, and the action required if they occur,” along with other items. Note the rule does not say “shall” include interactions or therapeutic contraindications.

What is the pharmacist's duty?

So using these very abbreviated rules to start our dialogue, let’s discuss our primary question: What is the pharmacist’s duty? What is our job?

Once you have those points of discussion in mind, let’s finish the story. What did pharmacist Dr. Huyuh do - and what did he not do?

The court’s opinion fills in some additional facts. The pharmacist called the physician and talked to him about the potential interaction regarding the lithium and Tenoretic. Dr. Shastri told Dr. Huynh to fill the prescription. Dr. Shastri said “he would monitor the patient.”

Important to our lesson: The pharmacist wrote a note of the conversation and placed it in Laverne’s file. Later, “when Dr. Shastri was questioned during his deposition about a conversation with Dr. Huynh, he indicated that he had no recollection of the conversation.”

Based on the conversation and the assurance the doctor would monitor the patient, Dr. Huynh filled the prescription. There is no indication that the pharmacist counseled the patient about these matters.

Seven days later, another pharmacist, John Glowacki, refilled Laverne’s lithium prescription. Noting the handwritten note in Laverne’s file indicating that the physician was going to monitor her, the second pharmacist refilled the lithium without another call to the physician.

The judge noted one other item. A week after refilling the lithium Rx, “Laverne became ill and was subsequently hospitalized. She later died, allegedly from lithium toxicity.”

In your consideration, note the Lithium/Tenoretic interaction is potential and is a warning, not a direct contraindication.

The physician eventually settled his part of the case with the DiGiovanni estate. The Court ruled that the pharmacy “acted within its duty by notifying Laverne’s physician of the potential drug interaction before filling the prescription.” The duty was “discharged upon notification to the physician or the patient.”

Do you agree with the court?

Resources

1. DiGiovanni v. Albertson’s, Inc., 405 Ill.App.3d 932 (2010), 940 N.E.2d 73, 346 Ill.Dec. 73; “[P]harmacy acted within its duty by notifying customer’s physician of potential drug interaction before filling the prescription.” [Headnotes]

2. Drugs.com:  “Tenoretic® (atenolol and chlorthalidone) is for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol, TENORMIN®) and a monosulfonamyl diuretic (chlorthalidone).” Also, “Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such preparations with Tenoretic.”  https://www.drugs.com/pro/tenoretic.html  (last accessed 7/8/2016.)

3. Omnibus Budget Reconciliation Act of 1990. P.L. 101-508, November 1990

4. Generally, see Fulda, TR, Pugh, MC, Current Status of Prospective Drug Utilization Review, www.amcp.org.Vol. 10, No. 5. September/October 2004 JMCP Journal of Managed Care Pharmacy; (last accessed July 10, 2016)

5. Arizona Board Rules, AACD R-4-402 (A) 5, 6, 7.

6. Arizona Board Rules, AACD R-4-402 (E) & (H).