Does your pharmacy comply with quality assurance requirements?

Natallia MazinaIf you work at a retail pharmacy, you know that one of the first things an inspector wants to see is your Quality Assurance (QA). If the pharmacy does not have a QA, or has inadequate QA, it is likely to face a disciplinary action. Here are some tips on what constitutes a QA and how to comply with pharmacy law when creating one.

See also: Quality assurance in a post-NECC world

QA for Rx errors

Most state boards require retail pharmacies to have a QA for prescription errors.¹ CMS also requires pharmacies serving Medicare Part D plans to maintain a QA. Nevertheless, some pharmacies still do not have QAs or have created unworkable versions of QA. There could be a number of reasons for that.

Fear of potential legal action or discipline. This could be the primary reason that some pharmacies do not record errors and do not create potential adverse evidence. If you are one of these pharmacists, fear not: Most states have enacted a statutory exemption from discovery for QA records.² The goal behind the QA requirements is not to penalize but to provide pharmacists with the knowledge to improve pharmacy processes and enhance existing procedures, in order to reduce the incidence of medication errors.

Disregard for the gravity of QA. If you are a pharmacist who does not take QA seriously, bear in mind that pharmacy boards regard failure to implement QA as an extremely serious violation. So consider the alternatives: Would you rather risk a disciplinary action, or record an error and determine causes and possible solutions?

Keep in mind that a “medication error” is defined as any variation from a prescription or drug order not corrected before a drug is furnished to a patient (with the exception of generic and dosage form substitutions, which are not errors). So, if you have refilled too soon or dispensed the wrong quantity of medication, this could be considered a variation from the prescription and therefore a medication error.

States vary on how a pharmacy needs to respond to the medication error, but most agree that investigation should commence as soon as possible (usually within two days of discovery), and the pharmacy needs to record basic information about the cause of the mistake, as well as preventive steps. Check your state’s regulations on QA and update your QA as needed.

See also: Will requiring CQA by law actually reduce errors?

Compounding QA

In addition to QA for medication errors, most states require that all compounding pharmacies maintain a written QA designed to “monitor and ensure the integrity, potency, quality, and labeled strength of compounded drug products."³ However, some pharmacies still use compounding manuals that lack QA provisions. A good compounding QA should include:

•  Written procedures for verification, monitoring, and review of the adequacy of the compounding processes

• Written standards for qualitative and quantitative integrity, potency, quality, and labeled strength analysis of compounded drug products

• Written procedure for scheduled action in the event a compounded drug is below minimum standards for integrity, potency, quality, or labeled strength

It follows that your compounding QA should answer the following (not inclusive):

• Do you perform independent review of the compounded products (and keep all the certificates of analysis)?

• Does the pharmacy comply with USP 795 (nonsterile preparations) or USP 797 (sterile preparations)?

• Does the pharmacy perform daily, weekly, and quarterly cleaning to ensure a clean and safe facility?

• Does the pharmacy have staff dedicated exclusively to compounding?

• Does the pharmacy keep documentation indicating that its staff has been trained and understands the standard operating procedures?

• How do you verify the potency of finished compounds through weight, volume, and yield checks? What is your process for handling complaints and errors? How do you investigate sterility failures?

Take a moment to review your QAs, update them, and keep them available for all personnel at all times. Remember, you have created QAs not to please the inspector but to ensure the quality of your drug product, which is your best asset and marketing tool. As Henry Ford once said: “Quality means doing it right when no one is looking.”

References

Twenty states require QA: California, Connecticut, District of Columbia, Florida, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, New Mexico, North Carolina, Oklahoma, Oregon, Rhode Island, Utah, Vermont and West Virginia.

In addition, four states require specific QA pertaining to pharmacy technician ratios or responsibilities: Montana, North Dakota, South Dakota, and Washington.

Some states require a QA program if the pharmacy is using an automated medication system or is acting as a central fill pharmacy: Arkansas, Delaware, Idaho, Illinois, Indiana, Maine, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, and Wyoming.

2. For example, Cal. Bus. & Prof. Code § 4125: “Records generated for and maintained as a component of a pharmacy’s ongoing quality assurance program shall be considered peer review documents and not subject to discovery in any arbitration, civil, or other proceeding” (with limited exceptions).

3. Title 16, Cal. Code of Regulations § 1735.8.

Natallia Mazinais a founding partner of the law firm Carman & Mazina, specializing in pharmacy law and assisting pharmacists and pharmacies with compliance, litigation, audits, and defense proceedings. E-mail her atnmazina@cmpharmlaw.com.