Pharmacists are being sued more often for “failure to counsel.” In many of these cases, the chart shows a single line: “Any questions?” Plaintiffs’ experts argue that is not counseling, and juries agree. The legal backbone is OBRA ’90. It set a national floor for counseling and prospective DUR. States then expanded it. In court, OBRA ’90 becomes the standard of care, and a weak “offer” turns into evidence of breach. This article explains why “Any questions?” does not protect you, how OBRA ’90 is used against pharmacists, and what reliable counseling and documentation look like in real practice.
What OBRA ’90 Actually Requires
OBRA ’90 ties payment to a professional duty: before dispensing to ambulatory Medicaid patients, the pharmacy must complete a prospective drug utilization review and make an offer to counsel. Most states later applied similar rules to all patients. Courts look to these elements when deciding what a reasonable pharmacist should do.
- Prospective DUR: screen the profile for therapeutic duplication, drug–drug interactions, incorrect dose or duration, clinical abuse/misuse, contraindications/allergies, and unreasonable therapy.
- Offer to counsel by a pharmacist: the pharmacist must provide counseling when accepted. Technicians can relay the offer, but the content must come from the pharmacist.
- Core counseling points typically include: drug name/purpose, dose/route/schedule, how to take, key side effects and what to do, significant interactions, missed-dose instructions, self-monitoring parameters, storage, and refills.
Why it matters: these items define the professional task you must complete. If harm occurs in an area OBRA expects you to address, a plaintiff will argue you breached the standard.
How Plaintiffs Use OBRA ’90 in Court
Every negligence case turns on four things: duty, breach, causation, and damages. OBRA ’90 and state rules help plaintiffs prove the first two.
- Duty: statutes, regulations, and your own policies show you were obligated to screen and counsel.
- Breach: a log entry like “Any questions?” or “Patient declined,” with no detail, makes it easy to argue you did not provide the required counseling or DUR. Corporate metrics and staffing emails can reinforce a “cut corners” narrative.
- Causation: experts testify that if you had warned the patient about the key risk, they would have behaved differently—called the prescriber, refused the drug, or sought care sooner—preventing or reducing harm.
Common fact patterns:
- High-alert drugs: insulin mix-ups, warfarin with interacting antibiotics, methotrexate taken daily instead of weekly, opioids with benzodiazepines.
- New therapy or dose change: no counseling on titration or red flags leads to hospitalization.
- Look-alike/sound-alike: dispensed wrong drug; meaningful counseling would have uncovered the mismatch.
- Known allergy or interaction: alert overridden without documented rationale or prescriber contact.
- Language barriers: “offered” in English to a non-English speaker; no interpreter.
- Drive-thru/mail order: no real-time pharmacist interaction; form letters only.
Why “Any Questions?” Fails
Patients rarely know what they don’t know. A yes/no question shifts work to the patient. It assumes they can spot a risk and ask about it. That is not realistic.
- It’s passive: you didn’t provide information; you put the burden on the patient to request it.
- It’s incomplete: it does not cover OBRA’s core topics. Charts won’t show what was actually taught.
- It’s easy to mishear: in a busy store or drive-thru, patients nod to get going. Plaintiffs call that a “forced decline.”
- It invites bad documentation: “Declined” without context sounds like you avoided counseling rather than offered it meaningfully.
Courts and boards expect an effective offer and substantive counseling on acceptance. “Any questions?” usually demonstrates neither.
What Counts as Adequate Counseling
Practical rule: for every new prescription and every significant change, deliver a short, focused mini-lesson, then confirm understanding.
- Open with purpose: “This is metformin for your blood sugar.” Naming the purpose can also catch wrong-drug errors.
- Give the how: dose, route, timing, titration, and what to avoid (e.g., “Take with food to reduce stomach upset.”).
- Warn on the one or two big risks: the ones that change behavior or trigger urgent care (e.g., “If you have black stools on meloxicam, stop and call us—bleeding is a known risk.”).
- Missed dose: simple, specific advice.
- Teach-back: “Just so I know I explained it well, how will you take this?” This converts counseling into evidence of understanding.
High-alert triggers that warrant extra depth:
- Warfarin: diet consistency, bleeding signs, interactions with TMP-SMX, metronidazole, amiodarone; INR follow-up.
- Insulins: product differences, dosing devices, hypoglycemia symptoms and treatment, storage.
- Methotrexate for RA: weekly dosing, folic acid, mucositis/infection red flags.
- Opioids: sedation, breathing risk, no benzodiazepines/alcohol, naloxone availability.
- Pediatric liquids: correct measuring device, mg vs mL clarity.
- Transplant/chemo/oral oncolytics: adherence, lab monitoring, infection precautions.
Documentation That Holds Up
If it isn’t documented, it’s hard to prove you did it. Good notes make or break defense.
- Record the offer: “Pharmacist offered counseling; patient accepted/declined.” Note who offered and how (in-person, phone, video).
- Summarize content: list the key points taught and any teach-back confirmation. Short bullets are fine.
- Refusals: include the patient’s reason or context. Distinguish “declined now, requested call later.” Avoid vague “counseling declined.”
- Interpreter use: language, modality, interpreter ID or service name.
- Alerts: document interaction checks, prescriber discussions, clinical rationale for overrides.
- Follow-up: for mail order or unreachable patients, record attempted contacts and messages.
Sample phrases you can adapt:
- “RPh offered counseling; accepted. Covered purpose (BP), dose (10 mg qAM), side effects (dizziness/cough), when to call. Pt teach-back accurate.”
- “RPh offered; pt declined due to time, requested call after 5 pm. Called 5:30 pm; reviewed directions and red flags. Pt verbalized understanding.”
- “Spanish interpreter used via phone; reviewed insulin pen priming and hypoglycemia plan; pt repeated steps correctly.”
- “Flagged TMP-SMX + warfarin; spoke with Dr. Lee; dose plan: hold 1 dose, check INR in 3 days. Pt counseled on bleeding signs.”
Deposition Traps and How to Avoid Them
In deposition, plaintiffs test your habits. They want absolutes they can use to impeach you.
- Avoid “I always/I never”: habits vary with context. Say, “My standard practice is…” and tie it to your documented workflow.
- Do not guess: if you lack independent recollection, say so and refer to records and policy.
- Own your role: “Technicians make the offer; I perform the counseling.” Do not imply techs counsel in your place.
- Explain clinical judgments: when asked about an override, state the factors you consider and that you documented rationale or prescriber input.
Risk Points by Setting
- Community/drive-thru: noise and haste degrade communication. Use a simple script and slow the interaction. Offer private consults for sensitive meds.
- Telepharmacy: ensure synchronous video or phone access to a pharmacist at time of dispensing. Log the encounter time and content.
- Mail order: real-time counseling is still required when accepted. Include a prominent, direct phone number in the package and proactively call for new high-risk meds. Document attempts.
- Language access: use certified interpreters. Avoid relying on family members for clinical content. Document interpreter use.
Practical Workflow That Survives Scrutiny
- Intake: confirm allergies, conditions, current meds. Update profile every visit.
- Verification: perform DUR; resolve alerts; contact prescriber as needed; document decisions.
- Identify counseling triggers: new Rx, dose/form change, interaction resolved with plan, high-alert list, adherence concerns.
- Offer to counsel: tech offers, pharmacist named and available now. If declined, offer a callback and record time preference.
- Deliver focused counseling: 60–120 seconds covering purpose, how, big risk, and teach-back. Provide a written med guide when applicable.
- Document: checkboxes plus free text for key points and teach-back.
- Follow-up: for complex starts (warfarin, insulin), schedule a quick call in 48–72 hours; note in profile.
Quick Scripts You Can Use Tomorrow
- Offer: “I’m the pharmacist. I’d like to go over how to take this safely—it’ll take about a minute. Is now okay?”
- Open: “This is sertraline for mood. Start with one each morning.”
- Big risk: “In the first weeks you may feel nausea or sleep changes; that’s common and settles. If you have thoughts of self-harm, call us or go to the ER right away.”
- Teach-back: “Just so I explained it clearly, when will you take this and what side effect should you watch for?”
- Refusal: “No problem. I can call you later today or tomorrow. What time works?”
How Corporate Policies Help or Hurt
Policies are double-edged. If they mirror OBRA ’90 and you follow them, they validate your practice. If they look good on paper but your workflow prevents compliance—high quotas, no breaks, chronic understaffing—plaintiffs use them to show systemic negligence.
- Align metrics with safety: measure documented counseling rates on new/high-alert meds, not just wait times.
- Staffing: document requests for coverage when volume spikes. It explains why you delayed, not skipped, counseling.
- Training: keep records showing techs know how to offer counseling and escalate to the pharmacist.
Bottom Line
“Any questions?” is not counseling. It is a missed chance to prevent harm and weak protection in court. OBRA ’90 and state rules define what you must do: review the therapy prospectively and provide meaningful, pharmacist-led counseling when the patient accepts. Use simple, active scripts, teach-back, and targeted warnings. Document the offer, the substance, and the circumstances. Build a workflow that works in busy, real settings. These steps protect patients first—and, by doing so, protect you.
This article is general information for pharmacists and does not replace legal advice. Consult your state board regulations and your counsel for jurisdiction-specific guidance.
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com