Pharmacists have a legal duty to counsel patients. It’s a core philosophy drilled into every pharmacy student.

When I was in pharmacy school, it was repeatedly and strongly emphasized that this duty went beyond a pharmacy technician asking the patient, “Do you have any questions for the pharmacist?” But, how many pharmacists today are actually performing this professional obligation?

Several years ago, I went to pick up a new prescription at a large retail chain. The pharmacy student providing me the prescription simply told me to “sign here.” I signed where I was directed and paid for the medication.

As I was leaving, I told the student he’d just broken a federal law. The look of shock on his face was unforgettable. When I tried to explain the law that mandates pharmacist counseling, the student looked dumbfounded and said he’d never heard of such a requirement. I suppose he never looked at the descriptions of the columns in the logs where the patients sign for their prescriptions.

Over the years, I’ve picked up many new prescriptions for myself and my family. I started using a smaller pharmacy where the pharmacists know I’m a member of the profession, and I haven’t thought much about the lack of counseling offered.

However, when I went to pick up a prescription at a different large retail chain a few weeks ago, the individual handing me the medication had never seen me before. I was simply told to “sign the receipt.”

The “receipt” was actually a small slip of paper that had written out (in what I estimated to be size 6 font) 2 statements by checkboxes that I was either refusing counseling or requesting it. I didn’t check either box, but dutifully signed the slip and returned it.

As I left the pharmacy, I wondered how often the counseling emphasized during pharmacy school is actually being provided in pharmacy settings.
The Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90) held special provisions that forever changed the practice of pharmacy.1,2 Along with regulations later implemented by the Centers for Medicare and Medicaid Services, it requires states to establish standards of patient counseling requirements in order to continue to receive federal funding for Medicaid.

OBRA ‘90 details what information the pharmacist should provide to the patient using professional judgement. Its components have become the gold standard in prescription counseling over the last 25 years. Although the federal law primarily applies to Medicaid patients, almost every state responded by developing laws or regulations on pharmacist counseling applicable to all patients.

Nevertheless, not long after OBRA ’90’s passage, it was suggested that the offer to counsel wasn’t being extended.3 
The Department of Health and Human Services Inspector General reported that as early as the mid- to late 1990s, pharmacists weren’t counseling on severe and potentially fatal drug interactions, and the offer to counsel was only being made by <42% of pharmacists. The report listed lack of reimbursement for counseling and suboptimal staffing as the main barriers to compliance. 

When challenged about pharmacists’ duty to counsel, the courts have offered mixed opinions about negligence, and they’ve even varied on the extent of the obligation. Some items thought to be routine are dosing, administration requirements with food or water, serious side effects, drug interactions, and contraindications. But let’s consider important counseling points that don’t easily fit on an auxiliary sticker or prescription leaflet.

It’s currently summer and a number of medications cause photosensitivity. The tetracyclines and sulfamethoxazole/trimethoprim are frequently associated with this adverse effect, but many other common medications can increase the skin’s sensitivity to the sun, like loop diuretics, amiodarone, and amitriptyline.

A growing number of heart failure patients are on angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and aldosterone antagonists, both of which potentially cause hyperkalemia. These patients may have been instructed to follow a reduced sodium diet, which can be bland in taste. To compensate, many patients may add salt substitutes that include potassium for flavor, further increasing their risk for increased potassium levels.
 
The need to take bisphosphonates with a full glass of water to avoid esophageal irritation has been widely disseminated to patients, but few know it’s just as important to drink a glass of water with clindamycin for the same reason. Additionally, more states are increasing access to naloxone and epinephrine for emergencies, and counseling is key for these medications. Pharmacists must counsel patients on proper administration techniques, what to expect after administration, and to call 911 anytime they use the medication. It’s unknown how many patients picking up these medications will request counseling, so it’s not enough to assume they’ll ask questions.

Medication counseling isn’t an exclusive role for pharmacists. Physicians and other health care professionals are expected to participate, but many of them may be lax because they assume the pharmacist will more thoroughly counsel the patient. Others may just be unaware of the important counseling points.

Not every patient will want counseling, and that’s okay. However, we can’t neglect our duty and direct our patients to sign a log without telling them what they’re signing away.  

References
1. CMS. Drug diversion toolkit: patient counseling–a pharmacist’s responsibility to ensure compliance. cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/drugdiversion-patientcounseling-booklet.pdf. Accessed June 30, 2016.
2.  Vivian JC. Fink JL. OBRA ’90 at sweet sixteen: a retrospective review. US Pharm. 2008;33:59-65.
3.  Brown JG. State Pharmacy Boards’ Oversight of Patient Counseling Laws. Department of Health and Human Services Office of Inspector General Report. 1997:OEI:01-97-00040.