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State of Emergency continues to exist for all counties throughout Washington state as a result of the coronavirus disease 2019 (COVID-19) pandemic. As of April 22, 2020, the House and Senate Leadership extended nine of the Governor’s Proclamations 20-26, 20-27, 20-28, 20-29, 20-30, 20-31, 20-32, 20-33, 20-34, and 20-35. The letter extends the effective date of the statutory waivers and suspensions authorized in the proclamations until May 4th 2020, or until termination of the emergency proclamation, whichever occurs first.
Please check Plan-19 as many waivers e.g., AUPs, License of Location, and Hand Sanitizer, are approaching their expiration dates. We anticipate that many of these waivers may be extended tomorrow. However, if a waiver is not extended, then statutes and rules is reinstituted.
Does a pharmacist have the ability to independently order a COVID-19 tests?
Yes, the Commission adopted HHS’s policy “HHS Statements on Authorizing Licensed Pharmacists to Order and Administer COVID-19 Tests” and the Commission will exercise prosecutorial discretion for those pharmacist engaging in COVID-19 testing.
Does a pharmacist have the ability to administer a COVID-19 tests?
Yes, pharmacists are allowed to administer tests, including COVID-19 tests. This falls under their scope of practice identified in RCW 18.64.011(28) which states "Practice of pharmacy" includes the practice of and responsibility for: Interpreting prescription orders; the compounding, dispensing, labeling, administering, and distributing of drugs and devices; the monitoring of drug therapy and use; the initiating or modifying of drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs; the participating in drug utilization reviews and drug product selection; the proper and safe storing and distributing of drugs and devices and maintenance of proper records thereof; the providing of information on legend drugs which may include, but is not limited to, the advising of therapeutic values, hazards, and the uses of drugs and devices.”
Are retail and community pharmacist required to complete the Sterile Compounding Self-Inspection Worksheet: USP 797 – Sterile Compounding Addendum?
No. At the April 24, 2020 Pharmacy Commission business meeting, the Commission voted to not require the completion of the Sterile Compounding Self-Inspection forms in the retail and community pharmacist setting, when a pharmacist is engaged in low-risk compounding under the immediate use exemption.
Can a pharmacy use transportation network companies (TNCs) such as Uber, Lyft, or Postmates to deliver a patient’s prescription medication?
Possibly--Under Washington law, a TNC could transport a patient’s prescription medication if they are a “common carrier” or “contract carrier” (see RCW 69.41.030(1) and RCW 60.50.302(c)(2)). If a TNC is a “common carrier” or “contract carrier” the TNC would have to obtain a permit from the Washington State Utilities and Transportation Commission (UTC) unless they are exempt.
Pharmacies should contact the UTC to verify the status of a “common carrier” or “contract carrier”. The contact information for the UTC, and a searchable database of common carriers can be found here.
Pharmacies should consider other applicable laws and other regulators e.g. United States Drug Enforcement Administration, before using TNCs to ship a patient’s prescription medications. For example, the DEA has stated registrants are responsible for selecting common or contract carriers that will provide adequate security against in-transit losses or thefts.
Non-resident Pharmacies
Policy Statement For nonresident pharmacies who are required to renew their nonresident pharmacy licenses by May 31, 2020, the Pharmacy Commission will treat a letter from an approved inspection program, that complies with the criteria below, as meeting the requirement in RCW 18.64.360(1)(b)(i) and (ii) of providing an inspection report conducted by an approved inspection program within the last two years. The letter from the approved inspection program must state: (1) an inspection of the nonresident pharmacy has not been conducted within the last two years, and (2) an inspection cannot be conducted at this time because of the COVID-19 pandemic. A list of approved inspection programs can be found here.
This statement does not affect obligations of applicants for nonresident pharmacy licenses. These applicants will still need to provide an inspection report conducted by an inspection program approved by the Pharmacy Commission that has been issued within two years. A letter that meets the criteria in the paragraph above will not be acceptable for new applicants of nonresident pharmacy licenses.
Background The Pharmacy Commission has had regulatory authority over nonresident pharmacies that operate in Washington since 1991 (see Pharmacies – Licensing of Nonresident Pharmacies, Laws of 1991, ch. 87). RCW 18.64.350 through RCW 18.64.420 delineates the Pharmacy Commission’s regulatory authority for nonresident pharmacies. The Pharmacy Commission can take enforcement action, among other things, when a nonresident pharmacy fails to comply with any requirement of RCW 18.64.350 through RCW 18.64.400 (see RCW 18..64.390).
As part of the 2019 legislative session, the Legislature passed HB 1412 and amended RCW 18.64.360(1)(b) to require nonresident pharmacies to submit a copy of an inspection report as part of their initial application and renewal. The inspection had to be conducted by “an inspection program approved by the commission as having substantially equivalent standards to those of the commission” and the inspection report must have been “issued within two years of application or renewal.” RCW 18.64.360(1)(b)(i) and (ii). The Pharmacy Commission has issued a directive identifying those inspection programs that conduct inspections based on equivalent standards to those of the commission.
Due to the COVID-19 pandemic, nonresident pharmacies have informed the Pharmacy Commission they will be unable to meet the requirement to provide a copy of an inspection report because in-person inspections are not currently being conducted. At its April 24, 2020, business meeting the Pharmacy Commission discussed this issue and stated that for nonresident pharmacies who are required to renew their nonresident pharmacy licenses by May 31, 2020, the Pharmacy Commission will treat a letter, that meets the criteria below, from an approved inspection program as meeting the requirement in RCW 18.64.360(1)(b)(i) and (ii) of providing an inspection report conducted by an approved inspection program within the last two years. The letter from the approved inspection program must state: (1) an inspection of the nonresident pharmacy has not been conducted within the last two years, and (2) an inspection cannot be conducted at this time because of the COVID-19 pandemic. This action does not affect obligations of applicants for nonresident pharmacy licenses. These applicants will still need to provide an inspection report conducted by an inspection program approved by the Pharmacy Commission that has been issued within two years.
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