Pharmacy Regulatory Issues

April 10, 2017  — Department of Health and Pharmacy Commission pilot integrated inspection process

In 2016, the Department of Health (DOH) and the Pharmacy Quality Assurance Commission began piloting an integrated hospital and pharmacy inspection process. The goal is to increase the coordination between these two related inspection processes. The pilot will continue over the couple of months with DOH conducting several unannounced surveys. At the conclusion of the pilot, DOH will conduct an assessment of the new inspection process to determine whether it should be continued.

WSHA has been advocating for new approaches to the pharmacy inspection process and is pleased that DOH is piloting innovative solutions (Ian Corbridge, IanC@wsha.org)

September 26, 2016  — Department of Health advances rulemaking efforts on the use of automated medication dispensing machines

Many of the pharmacy statutes and rules in Washington State our outdated and no longer reflect current practice. The Pharmacy Commission is in the process of updating its rules, with a particular focus on technology. The Commission elected to focus on automated medication dispensing machines as part of its initial effort to modernize its rules.

The Commission released draft rule language in September 2016 for stakeholder input. WSHA submitted comments on the draft language, which sought to simplify the draft rule and clarify components around “emergency” and the process for getting medications from an automated dispensing machine. We will continue to engage on this rulemaking and look forward to the Commission addressing other areas related to technology like telepharmacy. (Ian Corbridge, IanC@wsha.org)

September 25, 2016  — Department of Health finalizes emergency rule on licensing for hospital pharmacy associated clinics

In August, the State Pharmacy Commission adopted an emergency rule in response legislation (SB 6558) WSHA advanced in the 2016 legislative session. The emergency rule allows hospitals to extend their pharmacy license to owned and affiliated clinics for the purposes of transferring drugs and for those clinics to have a license to possess drugs. The emergency rule will be in effect until formal rules are established.

WSHA worked closely with the Pharmacy Commission and Department of Health on the emergency rule. We are pleased with the direction of the emergency rule and look forward to working with the Commission as formal rules are established. (Ian Corbridge, IanC@wsha.org)

April 12, 2016  — WSHA comments on proposed rules for automated drug dispensing devices

A number of the state Pharmacy Commission’s rules and statutes are outdated and no longer reflect current practice. In 2015, the Commission released a pharmacy action plan which outlined steps to update its rules. Those rules impacting pharmacy technology were given first priority. WSHA supports the Commission’s focus on technology and will work to ensure that new rules provide pharmacies and pharmacists new ways of providing high-quality pharmacy services while expanding access and controlling costs. WSHA’s comments on the recent draft rule can be accessed here.

See the Commission’s rulemaking page for more information. (Ian Corbridge, IanC@wsha.org)

August 30, 2015 — New licensure law for hospital clinics

WSHA and a group of pharmacists are meeting with the Department of Health on requirements needed for the new law (SB 5460) that establishes several alternative paths for a hospital clinic to be licensed. (Ian Corbridge, IanC@wsha.org)

August 11, 2015 – Pharmacy Commission issues cumbersome rules on sterile compounding

The Pharmacy Commission released its second draft rule for sterile compounding Aug. 11. The draft rule aims to provide minimum standards for all licensed facilities that compound sterile drugs. The rules are open for comment here through Sept. 30.

WSHA had a number of concerns with the initial draft and worked closely with the Washington State Pharmacy Association to submit joint comments to the Pharmacy Commission in February 2015. Though further review is needed, WSHA is still concerned with the nature and direction of the second draft. We are convening our members and will submit comments. (Ian Corbridge, IanC@wsha.org)

July 22, 2015 – Pharmacy investigations, a concerning trend across the state

We recently became aware of a handful of circumstances in which the Pharmacy Commission and the Washington State Department of Health have opened investigations against a hospital pharmacy license or the license of individual hospital pharmacists’. These investigations could jeopardize access to essential medications and could make it harder for hospitals to attract high-quality pharmacists.

We are extremely concerned about the approach the Pharmacy Commission is taking and the increasing number of pharmacy licenses being investigated across the state. We are working with the Department of Health to further understand its policies on investigations and the recent uptick in investigations against individual pharmacists. (Ian Corbridge, IanC@wsha.org)

May 31, 2015 – Working to influence the practice of pharmacy at a national level

WSHA and the Washington State Pharmacy Association collaborated with a group of hospital pharmacy directors and joined with the American Hospital Association to submit comments to the U.S. Pharmacopeial Convention on its proposed changes to the handling of hazardous drugs. These changes represent a national effort to more tightly control how hazardous drugs are stored, compounded and administered.

While well-intentioned, many of the proposed changes are concerning because of their potential for unintended consequences, including limiting access to medications and driving up health care costs. These unintended consequences would impact both urban and rural hospitals, but would take a greater toll on rural facilities. (Ian Corbridge, IanC@wsha.org)

May 28, 2015 – Potential rulemaking on pharmacists meal and rest breaks and accountability

The Pharmacy Commission is investigating how to enforce meal and rest breaks for pharmacists and technicians in response to a pharmacists workforce survey conducted in 2014. Our policy position on this issue is that the Washington State Department of Labor and Industries has rules and the authority to address meal and rest breaks. We support the L&I current rules.

A rigid system like the one proposed by the Pharmacy Commission would compromise workflow and limit a pharmacist’s ability to manage his or her own meal and rest breaks and provide high-quality care.

We also understand the Pharmacy Commission is also considering adding requirements for the Pharmacist in Charge. The changes under consideration could have a detrimental impact on access while driving up the cost of care.

Maintaining access to high-quality health care while controlling costs is a priority for WSHA. On April 29, 2015, we submitted a letter to the commission outlining our position and concerns with the Pharmacy Commission’s inquiry on meal and rest breaks.

February 15, 2015 – WSHA and WSPA Submit Comments on the Draft Pharmacy Compounding Rule

WSHA and the Washington State Pharmacy Association (WSPA) submitted joint comments to the Washington State Department of Health (DOH) expressing concerns with the Pharmacy Quality Assurance Commission’s draft pharmacy “Compounding Practice Rule.”

We identified both high-level concerns and targeted comments. High-level concerns addressed the lack of alignment between the draft rule and national standards, the unnecessary increase in burden and cost to hospital pharmacies, and the potential impact of these draft rules on access to drug products in rural communities. Specific comments focused on adding clarity or addressing inconsistencies.

The two associations collaborated to convene members from across the state and submit joint comments reflecting our mutual interests and common concerns. Having identified preliminary concerns, WSHA and WSPA requested that the Commission provide a crosswalk between the draft rule and national standards governing the practice of pharmacy. The crosswalk was only released days before the comment period expired, which made it difficult for an in-depth analysis.  We look forward to convening another joint meeting of our members in June or July after the DOH releases its second draft.

WSHA and WSPA are committed to advancing the practice of pharmacy and will continue to work collaboratively to address the concerns around pharmacy compounding practice rules in Washington State. Please have your pharmacy director contact Ian Corbridge if they are interested in participating in these discussions. (Ian Corbridge, IanC@wsha.org)

February 15, 2015 – WSHA and WSPA Submit Comments on the Draft Pharmacy Compounding Rule

WSHA and the Washington State Pharmacy Association (WSPA) submitted joint comments to the Washington State Department of Health (DOH) expressing concerns with the Pharmacy Quality Assurance Commission’s draft pharmacy “Compounding Practice Rule.”

We identified both high-level concerns and targeted comments. High-level concerns addressed the lack of alignment between the draft rule and national standards, the unnecessary increase in burden and cost to hospital pharmacies, and the potential impact of these draft rules on access to drug products in rural communities. Specific comments focused on adding clarity or addressing inconsistencies.

The two associations collaborated to convene members from across the state and submit joint comments reflecting our mutual interests and common concerns. Having identified preliminary concerns, WSHA and WSPA requested that the Commission provide a crosswalk between the draft rule and national standards governing the practice of pharmacy. The crosswalk was only released days before the comment period expired, which made it difficult for an in-depth analysis.  We look forward to convening another joint meeting of our members in June or July after the DOH releases its second draft.

WSHA and WSPA are committed to advancing the practice of pharmacy and will continue to work collaboratively to address the concerns around pharmacy compounding practice rules in Washington State. Please have your pharmacy director contact Ian Corbridge if they are interested in participating in these discussions. (Ian Corbridge, IanC@wsha.org)

April 29, 2014 – WSHA Sends Letter to Pharmacy Quality Assurance Commission Outlining Concerns with Emergency Rule

WSHA submitted a letter to the Pharmacy Quality Assurance Commission (Commission) outlining concerns with the emergency rule for WAC 246-873-060 – Emergency Outpatient Medications. The letter addresses:

  1. The Commission’s confusing methodology used to determine dispensing eligibility; and
  2. The lack of any validation effort on behalf of the Commission to ensure data accuracy.

The emergency rule greatly expands the number of Washington hospitals that can dispense pre-packs of controlled substances in their emergency department from 10 pre-packs to approximately 43. However, the emergency rule has unintended consequences for some hospitals, limiting their dispensing privileges.

WSHA continues to work with the Commission to expand dispensing privileges and improve this WAC which has not been uniformly enforced or updated for decades. As of Tuesday, April 29, 2014 the Commission had not posted the emergency rule. For more detailed information on the emergency rule, contact Ian Corbridge, ianc@wsha.org or (206) 216-2514.

March 25, 2014 – WSHA Submits Revised Language for WAC 246-873-060 to the Pharmacy Commission

WSHA submitted revised language on the Washington Administrative Code (WAC) 246-873-060 – Emergency Outpatient Medications to the Pharmacy Quality Assurance Commission on March 24, 2014. WSHA’s revisions aim to allow hospitals to distribute emergency pharmaceuticals, including controlled substances, when normal pharmacy services are not available. These revisions will be considered by the Pharmacy Commission who has agreed to emergency rulemaking for this WAC.

WSHA worked with our membership to revise and update this WAC, which currently prohibits some hospitals from distributing controlled substances when normal pharmacy services are not available. This WAC has not been uniformly enforced or updated for decades and its enforcement severely limits a provider or hospital’s ability to deliver compassionate, evidence-based, and cost-effective care. For more information, contact Ian Corbridge, IanC@wsha.org or (206) 216-2514.

March 12, 2014 – Pharmacy Commission Approves Emergency Rulemaking

The Pharmacy Quality Assurance Commission approved emergency rulemaking for Washington Administrative Code (WAC) 246-873-060 – Emergency Outpatient Medications. The emergency rulemaking will allow hospitals to prescribe and distribute a limited supply of a controlled substance in an emergency setting when normal pharmacy services are not available. The approval for emergency rulemaking was in direct response to a formal request by the Washington State Hospital Association (WSHA), Island Hospital, and Skagit Valley Hospital.

WSHA is actively working with our membership to revise and update the WAC. Current revisions can be accessed here: (clean draft) (track changes draft). WSHA will submit edits to the Pharmacy Commission who has agreed to expedite the emergency rulemaking process. For more detailed information or to provide edits on this WAC, contact Ian Corbridge, IanC@wsha.org or (206) 216-2514.

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