Pharmacy Professions Inspections

Under the Pharmacy Quality Assurance Commission's new pharmacy inspection rules, pharmacy inspections will follow a notice of deficiency-plan of correction model rather than the point-based classification previously used. The new inspection rules require all pharmacies to conduct an annual self-inspection in March or within 30 days of naming a new pharmacist in charge. The self-inspections are completed on forms the commission provides.

Pharmacy inspections will not change, but the report pharmacies receive will. Once an inspection takes place, pharmacies will receive an inspection report that may include deficiencies found during the inspection. Pharmacies must then submit to the Pharmacy Commission a plan addressing how they will correct deficiencies on the inspection report.

New inspection process

Below you'll find information and resources about pharmacy inspections.

Rules self-inspection worksheets

* All worksheets and addendums are in a .docx fillable format and work best with Microsoft Word. MSWord is not needed/required to complete these forms.

Recorded webinar trainings
  • Pending updates
Inspection frequently asked questions
  • Pending updates
Directives
Inspectors listed by county

Pharmacist inspector supervisor
360-236-4946

Inspection Area 1

Island, King, San Juan, Skagit, Snohomish and Whatcom Counties
360-628-4703

Inspection Area 2

Clark, Cowlitz, King, Lewis, Pacific, Pierce, Skamania, Thurston, and Wahkiakum Counties
360-236-2973

Inspection Area 3

Adams, Asotin, Benton, Columbia, Franklin, Garfield, Grant, Kittitas, Klickitat, Walla Walla, Whitman and Yakima Counties
509-590-5743

Inspection Area 4

Chelan, Douglas, Ferry, Grant, Lincoln, Okanogan, Pend Oreille, Spokane and Stevens Counties
509-329-2206

Inspection Area 5

King County
253-395-6718

Inspection Area 6

King and Snohomish Counties
253-395-6712

Inspection Area 7

King and Pierce Counties
360-480-0986

Inspection Area 8

Clallam, Grays Harbor, Jefferson, King, Kitsap, Mason, Pacific, Pierce and Thurston Counties
360-236-4659

Tips for passing your community pharmacy inspection

Nationally over the past few years, there has been an increase in high-profile adverse events related to pharmacy practice. These adverse events have given rise to a heightened level of scrutiny of pharmacy practice as well as its regulators. During this time, the Washington State Legislature adopted a more stringent set of pharmaceutical compounding standards. Following this overall national trend, the Washington State Pharmacy Quality Assurance Commission (WAPQAC) adopted a more rigorous routine inspection process subjecting pharmacies to a more in-depth and comprehensive standards review.

As part of this process, pharmacies have been cited for violations contained in these new standards. Additionally, repeat violations are cited with higher point deductions when violations from previous inspections have not been corrected. This in-depth and comprehensive process, in some instances, has resulted in some pharmacies receiving lower inspection scores than they had traditionally received in the past.

WAPQAC investigators routinely conduct pharmacy inspections to ensure that all pharmacies in the state meet minimum standards of operation and practice as defined by rule and statute. WAC 246-869-190 states that “(1) all pharmacies shall be subject to periodic inspections to determine compliance with the laws regulating the practice of pharmacy. (2) Each inspected pharmacy shall receive a classification rating which will depend upon the extent of that pharmacy's compliance with the inspection standards.”

The WAC further defines three rating classifications for pharmacy; Class A – for inspection scores of 90 to 100; conditional for inspection scores of 80 to 89; and unsatisfactory for inspection scores 79 and below.

A pharmacy receiving a conditional rating has 60 days to raise their inspection score to 90 or better. A pharmacy receiving an unsatisfactory rating has 14 days to raise its inspection score to 90 or better. If upon reinspection a pharmacy receiving a conditional or unsatisfactory rating on the original inspection fails to receive a rating of 90 or better, then the pharmacy will be subject to disciplinary action by the commission.

Noncompliance with provisions of chapter 18.64A and WAC 246-901 (technician ratio) resulting in a deduction of at least five points will result in an automatic unsatisfactory rating. A standard ratio of one pharmacist to a maximum of three technicians is established for each licensed pharmacy that has an approved ancillary utilization plan on file with the commission. Pharmacies receiving an unsatisfactory rating that represent a clear and present danger to the public health, safety and welfare will be subject to summary (immediate) suspension of their pharmacy license.

The top violations noted in pharmacy inspections from January 1, 2015 through July 15, 2015 are listed below in decreasing order of occurrence. Violations cited under these five WACs represent 68 percent of all violations cited in pharmacy inspection reports.

1. Violations of WAC 246-875: Patient Medication Record Systems (35 percent of all violations)

“Any patient allergies, idiosyncrasies, or chronic condition which may relate to drug utilization. If there is no patient allergy data the pharmacist should indicate none or ‘NKA' (no known allergy) on the patient medication record.”

Pharmacists may use professional judgment to develop multiple methods to collect chronic conditions information from new patients and periodically update existing information for current patients.

Some suggested solutions include but are not limited to:

  • The pharmacists using their education, training and experience to make a professional judgment relating to chronic conditions during the required profile review for new and refilled prescriptions and at final prescription verification.
  • Using the required counseling time on new and updated one-year prescriptions as an opportunity to discuss chronic conditions.
  • Obtaining the information from the prescriber when you request a routine refill. Most prescribers now have easily accessible ICD codes, diagnosis, or indication for use in their patient profiles and can readily communicate these to your pharmacy via fax or telephone.
  • Discussing the patient conditions and diagnoses with prescriber offices when a pharmacist is calling to clarify prescriptions.
  • Questioning the patient regarding allergies, chronic conditions, and idiosyncrasies when collecting new insurance information at the beginning of the year. - Often patients state “I don't have any medical conditions.” When counseling patients, try asking them “what are you taking this medication for?”

2. Violations of WAC 246-869-230: Child-resistant containers - 9 percent of all violations

All legend drugs shall be dispensed in a child-resistant container as required by federal law or regulation, including C.F.R. Part 1700 of Title 16, unless:

  • Authorization is received from the prescriber to dispense in a container that is not child-resistant.
  • Authorization is obtained from the patient or a representative of the patient to dispense in a container that is not child-resistant.

Authorization from the patient to the pharmacist to use a regular container (nonchild-resistant) shall be verified in one of the following ways:

  • The patient or the patient's agent may sign a statement on the back of the prescription requesting a container that is not child-resistant.
  • The patient or the patient's agent may sign a statement on a patient medication record requesting containers that are not child-resistant.
  • The patient or the patient's agent may sign a statement on any other permanent record requesting containers that are not child-resistant.

No pharmacist or pharmacy employee may designate himself or herself as the patient's agent.

  • WAC 246-869-230 states that all legend drugs intended for oral use shall be dispensed in a child-resistant container (CRC) as required by federal law or regulation, unless authorization to use a non-CRC is obtained from the prescriber, patient or patient's representative. Authorizations to dispense in non-CRC shall be verified by having the patient or his agent sign a statement on a patient medication record requesting containers that are not child resistant. Remember having a patient or patient's agent sign a statement acknowledging that their prescriptions are dispensed in non-safety caps does not fulfill the requirement of 246-869-230 stating that the patient must authorize the use of non-safety caps.

Some suggested solutions include but are not limited to:

Have the patient or patient's representative sign and date a statement such as one of the following:

  • “I request that my prescriptions be filled in non-child resistant containers”.
  • “I authorize (name of pharmacy) __________ pharmacy to fill my prescriptions in non-child resistant containers”.

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3. Violations of WAC 246-869-150: Physical Standards for Pharmacies – Outdated Stock (9 percent of all violations)

“Dated items—all merchandise which has exceeded its expiration date must be removed from stock.

All stock and materials on shelves or display for sale must be free from contamination, deterioration and adulteration”Some suggested solutions include but are not limited to:

  • Stickering or otherwise marking stock bottles that are short-dated in a manner that is readily recognizable by all staff members.
  • Monthly sweeps of all drug stock within the pharmacy, and in the case of retail pharmacies nonprescription OTC drugs in the OTC area.
  • Assigning staff-specific areas within the pharmacy and OTC drug areas to check for outdates and require staff members to sign a log sheet when completed.
  • When removing outdates, place them in a designated sealed container or locked drawer until they can be permanently removed from the pharmacy.This will prevent outdated stock from being reintroduced to the active stock areas of the pharmacy.It is also best practice to label this sealed container or locked drawer with “Expired” or something similar to clearly identify its contents.

4. Violations of WAC 246-869-210: Prescription Labeling (8 percent of all violations)

“To every prescription container, there shall be fixed a label or labels bearing the following information: All information as required by RCW 18.64.246. To every box, bottle, jar, tube or other container of a prescription which is dispensed there shall be fixed a label bearing the name and address of the dispensing pharmacy, the prescription number, the name of the prescriber, the prescriber's directions, the name and strength of the medication, the name of the patient, the date, and the expiration date of the drug. The security of the cover or cap on every bottle or jar shall meet safety standards adopted by the commission,” provided that in determining an appropriate period of time for which a prescription drug may be retained by a patient after its dispensing, the dispenser shall take the following factors into account:

  • The nature of the drug;
  • The container in which it was packaged by the manufacturer and the expiration date thereon
  • The characteristics of the patient's container, if the drug is repackaged for dispensing;
  • The expected conditions to which the article may be exposed;
  • The expected length of time of the course of therapy; and
  • Any other relevant factors.

“The dispenser shall, on taking into account the foregoing, place on the label of a multiple unit container a suitable beyond-use date or discard-by date to limit the patient's use of the drug. In no case may this date be later than the original expiration date determined by the manufacturer.”

The majority of violations related to this WAC involve drug expiration dates on the label exceeding the actual expiration date of the drug stock bottle/package and/or incorrect beyond use dates placed on labels of compounded products.

Please note that the expiration date on the prescription label must be either the lesser of: (1) one year from date of dispensing or (2) the expiration date on the manufacturers' package or stock bottle.

Some suggested solutions include but are not limited to:

  • Visually confirming that the expiration date on the prescription label does not exceed the manufacturers' date on the manufacturers' stock bottle/package. An expiration date must be placed on the prescription label. References on the prescription label such as “refer to expiration date on manufacturers' package” are not allowed.
  • For compounded prescriptions follow USP requirements for beyond-use dating and conduct all end product testing as required.
  • For other repackaging activities including but not limited to compliance packaging, unit dose etc., follow USP requirements for beyond-use dating.

5. Violations of WAC 246-869-100: Prescription Record Requirements (7 percent of all violations)

“Records for the original prescription and refill records shall be maintained on the filled prescription or in a separate record book or patient medication record. Such records must be maintained for a period of at least two years and shall be made available for inspection to representatives of the board of pharmacy.”

Some suggested solutions include but are not limited to:

  • Print out all faxed prescriptions, process and retain as you would any hardcopy. Under RCW 69.50.312 faxed prescriptions do not qualify as electronic communication and therefore may not be stored electronically.
  • Ensure hardcopy and electronic prescriptions contain required information including serial number, date of dispensing and initials of the responsible pharmacist verifying the prescription.

While this is a brief outline of the more common violations found in inspections as well as some suggested solutions, it is by no means all-inclusive. Your pharmacist investigator is always available to assist you with ways to ensure that violations are at a minimum and patient safety is maximized at your pharmacy. Please contact the investigators with any questions you have regarding the inspection process.