What a Pharmacy Is Supposed to Check Before It Fills a Prescription

Answer first: there is a written description, and it was written for a payment program

Advice to take a question to a pharmacist is easy to give and hard to act on. It assumes the person on the other end has something in front of them. What that is, and what they are expected to do with it, is rarely spelled out anywhere a buyer can read.

Federal law does spell it out, in one place. A Medicaid statute requires a state to run a drug use review program, and a regulation fills in the detail. Between them they describe a screen before the fill, an offer to talk, and a record the pharmacy keeps.

The scope has to come first, because it is easy to over-read. The statute states its own purpose: a state provides the program so that prescriptions are appropriate, are medically necessary, and are not likely to result in adverse medical results. The regulation ties the program to federal financial participation for covered outpatient drugs.

So this is a condition attached to a payment program, not a rule that reaches every pharmacy transaction in the country. Reading it is still worth the time, because it is the most detailed published account of the counter that exists, and one clause inside it points outward into state law.

Seven things a screen is supposed to look for

The timing is fixed. The regulation requires a review of drug therapy before each prescription is filled or delivered, and describes it as point-of-sale or point-of-distribution review. The statute uses the same moment and adds that the review typically happens at the point of sale or point of distribution.

The screen has a named list. It covers therapeutic duplication, drug-disease contraindication, adverse drug-drug interaction, incorrect drug dosage, incorrect duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.

Each of those is defined rather than left to intuition. Therapeutic duplication is the prescribing and dispensing of two or more drugs from the same therapeutic class such that the combined daily dose puts the beneficiary at risk of an adverse medical result. Drug-disease contraindication runs two ways: a disease altering the effect of the drug, or the drug affecting the disease.

One definition is arithmetic rather than judgment. The regulation defines incorrect drug dosage against predetermined standards, and states that dosage is the strength multiplied by the quantity dispensed divided by day's supply.

The statute widens one item in a way worth carrying. Its version of the screen names drug-drug interactions and adds, in a parenthesis, serious interactions with nonprescription or over-the-counter drugs.

Eight subjects the conversation is supposed to cover

The counseling half is a list too, and it is short enough to read in full. The statute names the name and description of the medication, and the route, dosage form, dosage, route of administration and duration of therapy.

Then it names special directions and precautions for preparation, administration and use by the patient. Then common severe side or adverse effects, interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur.

The last four are the ones people never expect to be on a federal list. Techniques for self-monitoring drug therapy. Proper storage. Prescription refill information. Action to be taken in the event of a missed dose.

Read that list beside the questions people actually arrive with, and it is close to the same list. The eight subjects are not obscure. They are the things a person wants settled in the first week of a new medication, and a statute has already named them as the content of one conversation.

It is an offer, and the text says what an offer does not include

The duty is framed as an offer to discuss, not as a lecture. The pharmacist must offer to discuss those matters with each person presenting a prescription, or with that person's caregiver. The offer is made in person whenever practicable, or through access to a telephone service that is toll-free for long-distance calls.

The content is filtered through judgment. The statute says the pharmacist covers the matters that, in the exercise of the pharmacist's professional judgment and consistent with state law respecting the provision of such information, the pharmacist deems significant. Other matters the pharmacist considers significant may be added.

Two limits sit in the closing sentence of the same clause. Nothing in it requires a pharmacist to provide consultation where the person or caregiver refuses it. Nothing in it requires verification of the offer, or of a refusal of the offer.

The regulation then hands five questions to the state to answer. Whether the offer is required for new prescriptions only or for refills too. Whether pharmacists must make the offer or auxiliary personnel may. Whether only a refusal must be documented or every offer. Whether documentation of the counseling itself is required. And what happens where a patient's representative is not available to receive either the offer or the counseling.

That last question is the one that decides how any of this looks to a person who never stands at a counter.

Two clauses written for a shipment rather than a counter

The regulation does not assume the transaction is face to face. It requires a state's counseling standards to address special situations where the patient or the patient's representative is not readily available. That covers the case where neither the offer to counsel nor the counseling itself can reach them, and the regulation supplies its own example: prescriptions delivered offsite or through the mail.

The second clause is blunter and shorter. After the general rule about a toll-free telephone service, and after a carve-out for a pharmacist whose primary patient population is reachable through a local exchange, the regulation adds one sentence. Mail order pharmacies are required to provide toll-free telephone service for long distance calls.

Both clauses sit inside the same Medicaid scope as everything else here. What they establish is narrower than it looks, and more useful than it sounds.

They establish that the distance was anticipated. A drafter in the early nineteen nineties already saw that a prescription could arrive by mail with nobody in the room, and wrote the reachability question into the rule rather than leaving it out.

The record: three things a profile is supposed to hold

The pharmacy-side record has its own name in the regulation, and it is called a patient profile. The state agency must require that the pharmacist make a reasonable effort to obtain, record and maintain one.

Its minimum contents are three items. First, name, address, telephone number, date of birth or age, and gender. Second, individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices. Third, the pharmacist's comments relevant to that person's drug therapy.

The second item is the one that matters when a medication list is spread across several places. A comprehensive list of medications sitting at the pharmacy is a different object from a list held by a prescribing practice, and neither one updates the other automatically.

The standard is also an effort standard rather than a guarantee. Both the statute and the regulation ask for a reasonable effort to obtain, record and maintain the information. What a pharmacy holds depends partly on what it was told.

Where the standards behind a screen come from

A screen has to measure against something, and the regulation calls that something predetermined standards. It requires the program to assess drug use information against them. It then names where they may come from: developed by the state or its contractor, obtained through contracts with commercial vendors, obtained from independent organizations, or any combination.

Their source material is specified. It must be consistent with peer-reviewed medical literature, which the regulation defines in a parenthesis as publications in which original manuscripts are published only after critical review by unbiased independent experts. Three compendia are then named individually.

Two of the three are the same books the payment side of the statute names, and the third is not. The regulation's list ends with American Medical Association Drug Evaluations. A separate part of the statute, the one that decides which uses a program will pay for, names a different third title. Two lists, one section, and they are not identical.

Three further requirements are worth having. The standards must be clinically based and scientifically valid. They must be non-proprietary and readily available to providers of services, although the systems and algorithms using them may remain proprietary. And they must have been tested against claims data before adoption, to validate the level of possibly significant therapeutic problems without undue levels of false positives.

Then the disclosure clause. On adoption, predetermined standards must be available to the public, and pharmacists and physicians must be informed that they exist and how to obtain copies of them.

What the same subpart does after the fill

Prospective review is only one third of the program. The regulation also requires retrospective review: an ongoing periodic examination, no less frequently than quarterly, of claims data and other records.

Its target is patterns rather than individual fills. It looks for patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care among physicians, pharmacists and beneficiaries, or associated with specific drugs or groups of drugs. It monitors nine things, including therapeutic appropriateness, overutilization and underutilization, and the appropriate use of generic products in conformity with state product selection laws.

The third part is education, and it names its own instruments. Dissemination of information about the review board's duties and powers. Written, oral or electronic reminders carrying patient-specific or drug-specific information and suggested changes in prescribing or dispensing practices. Face-to-face discussions with selected prescribers and pharmacists. And intensified review or monitoring of selected prescribers or dispensers.

None of that reaches a person who bought a medication with a card. It is included because it shows what the drafters thought the counter was for: a checkpoint whose output feeds back into prescribing.

Read the scope a second time

The regulation's own general paragraph is the boundary. It conditions federal financial participation for covered outpatient drugs on the state having the program in operation. It states the program's goal as ensuring appropriate drug therapy, while permitting sufficient professional prerogatives to allow for individualized drug therapy.

There are carve-outs inside the program too. Drugs dispensed to residents of nursing facilities complying with separate drug regimen review procedures are outside prospective and retrospective review. Covered outpatient drugs dispensed by a hospital using drug formulary systems and billed at no more than purchasing cost are outside the subpart, and so are drugs dispensed by health maintenance organizations.

One clause does point outward, and it is the reason any of this is visible in ordinary pharmacy life. The regulation says applicable State law, including state board policy incorporated into that law by reference, must establish standards for counseling. It also requires the state to give pharmacies detailed information on complying, including guidelines on counseling, profiling and documentation.

What each state did with that instruction is fifty separate answers, and nothing here says what any of them says. The federal text names the subject and hands it over.

Confidentiality is handled the same way. The agency must establish policies on the confidentiality of patient-related data. Those policies are to be consistent with applicable federal confidentiality requirements, the State Pharmacy Practice Act, and guidelines adopted by the State Board of Pharmacy or other relevant licensing bodies.

What this makes askable

The value of a document written for one payer is that it supplies vocabulary for a question anyone can put to any program. None of the questions below requires a company to disclose anything confidential.

Which entity holds the medication list, and is it the pharmacy or the practice. Whether there is a telephone number reaching a pharmacist rather than a support queue, and whether the call costs anything. Whether a conversation is offered on a refill or only on a first fill.

One more question follows from the profile clause. When a program changes the pharmacy that fills an order, the profile at the old pharmacy does not travel by itself, and asking where the record sits is cheaper before a switch than after.

A program that answers all four has described its own arrangement in terms a person can compare. A program that answers none of them has also told a reader something.