Statements Adopted by the Board
Statement on Access to Certain Parenteral Drug Products, including IV Solutions
Adopted October 2024
The Oregon Board of Pharmacy (Board) is committed to protecting the health, safety and welfare of all Oregonians. In response to the public health emergencies issued on or about October 10, 2024, by the Department of Health and Human Services, the FDA issued temporary guidance allowing compounders to produce certain parenteral drug products. That measure is intended to mitigate shortages resulting from the impact of the Hurricane Helene and Milton.
On October 11, 2024, the FDA issued guidance for immediate implementation,Temporary Policies for Compounding Certain Parenteral Drug Products. The FDA guidance affects both federally registered outsourcing facilities and state-licensed pharmacies registered with the Board and is in effect only for the duration of the supply disruption related to the above referenced public health emergency, as directed by the FDA. Please refer to the FDA communications for additional information and updates regarding the FDA guidance and temporary policy requirements.
The Board encourages licensees and registrants to implement strategies to create and receive adequate supplies of parenteral drug products, including IV solutions, to maintain patient care during this period. Pharmacies are required by the FDA to notify the Board prior to providing drug product on the FDA list[1] to a hospital or health system. Please notify the Board by using the Pharmacy Notification Pursuant to October 2024 FDA Guidance Temporary Policies for Compounding Certain Parenteral Drug Products form located on our website. Upon receipt of this form, the Board does not object to licensed pharmacies in good standing providing drug product on the FDA list to a hospital or health system as directed in the FDA guidance Temporary Policies for Compounding Certain Parenteral Drug Products.
In light of the FDA guidance, if a licensee or registrant is in violation of Board statutes or rules in relation to the FDA guidance the Board will not take disciplinary action against Board licensees or registrants if they are acting in accordance with the FDA Temporary Policies for Compounding Certain Parenteral Drug Products up until January 8, 2025, unless otherwise extended by the Board.
During this limited time period the Board may require a licensee or registrant to provide documentation of compliance with the provisions of the FDA temporary guidance policy relied upon by the licensee or registrant and any other documentation required by the Board. Failure to do so may result in disciplinary action.
Resources:
FDA:
United States Pharmacopeia (USP):
- Is providing resources at no charge to support healthcare professionals in addressing shortages of manufactured intravenous (IV) fluids resulting from the damage caused by Hurricane Helene and Hurricane Milton.
- Click here to request access to this information or contact USP Healthcare Quality and Safety staff at CompoundingSL@usp.org with any additional questions.
(1) https://www.fda.gov/media/182634/download
Statement on Access to Buprenorphine for Patients Requiring Medication-Assisted Treatment for Opioid Use Disorder
Adopted October 2023
The Oregon Board of Pharmacy is committed to protecting the health, safety and welfare of all Oregonians. Addressing the opioid epidemic is a critical public health priority, and ensuring access to evidence-based treatments, such as medication-assisted treatment (MAT), is essential to combating this crisis. Buprenorphine, a proven and effective medication, plays a significant role in supporting individuals with opioid use disorder (OUD) on their path to recovery. Recognizing the importance of accessible and convenient care, the Board of Pharmacy encourages all wholesale distributors and pharmacies to maintain adequate supplies of buprenorphine to facilitate access for patents seeking treatment of OUD.
Opioid use disorder is a complex and challenging health issue affecting countless individuals across the US and the State of Oregon. Medication-assisted treatment has demonstrated efficacy in reducing the harms associated with opioid misuse, including overdose and infectious disease transmission, while promoting sustained recovery and improved quality of life. Buprenorphine, a partial opioid agonist, has been shown to be safe and effective in managing withdrawal symptoms and cravings, allowing individuals to regain stability and function within their communities.
Community pharmacies play a vital role in healthcare delivery and are well-positioned to partner in the effective management of OUD by making buprenorphine available to patients seeking treatment. Pharmacies, particularly those in rural and underserved communities, are often the first point of contact for individuals seeking healthcare services, making them a critical and accessible resource for patients requiring MAT. Pharmacists are important members of the healthcare team providing services that help support patients' physical, psychological, and social needs throughout their recovery.
The Board of Pharmacy supports minimizing barriers to accessing buprenorphine and other essential medications for those seeking treatment for OUD. Wholesale distributors and pharmacies are encouraged to make buprenorphine products available to the extent possible to support patients being treated for OUD.
August 2023
Board of Pharmacy Statement on Services Provided Under DHHS Guidance
Amended April 22, 2023
On March 17, 2020, the U.S. Department of Health & Human Services (DHHS) issued a Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID-19 to provide liability immunity for activities related to medical countermeasures against COVID-19. There have been 10 amendments as well as various General Counsel advisory opinions and DHHS guidance documents concerning the PREP Act. For a PREP Act emergency determination, the Secretary must specify an end date; in this case, it is currently October 1, 2024, in most cases (although there are some exceptions). On April 14, 2023 DHHS noticed an intent to extend certain provisions of the act to December 31, 2024. Advisory Opinion 20–02 on the Public Readiness and Emergency Preparedness Act and the Secretary's Declaration under the Act, (May 19, 2020), set forth the PREP Act's legal framework for identifying a ''qualified person'' (which include pharmacists, pharmacy technicians, and pharmacy interns) and preemption of state law that is different from, or is in conflict with, that designation.
The Oregon Board of Pharmacy has determined that it will not take disciplinary action against licensees and registrants who act in accordance with DHHS guidance considering DHHS's position that state law is preempted. The Board does not take a position on whether DHHS's position on the preemption of state law is valid. If a complaint is received by the board relating to activities covered under DHHS guidance, the board will expect the licensee and registrant to provide documentation of full compliance with provisions of the PREP Act and DHHS Guidance. Failure to do so may result in disciplinary action.
Safe Pharmacy Practice Statement for Licensees
Adopted February 11, 2022
The Oregon Board of Pharmacy recognizes the hard work and perseverance of pharmacy personnel in all practice settings who have provided essential care to the residents of Oregon during the COVID-19 pandemic. The board also recognizes that pharmacists, technicians, and interns have been challenged by an increase in work demand, a decrease in available staffing and more frequent lapses in civility. In community pharmacy settings, this has adversely impacted pharmacy operating hours, wait times for prescriptions, and opportunities for pharmacists to address their patients’ medication-related questions or concerns. The board continues to receive a high number of complaints from licensees and the public about these conditions.
Sufficient staffing of pharmacies is a critical component of protecting public health and safety. The board is updating rules to facilitate communication with the public about hours of pharmacy operation, to remove barriers to Pharmacy Technician licensure, and to allow alternative methods of prescription dispensing with Remote Dispensing Site Pharmacies and Pharmacy Prescription Lockers. The board has also convened a workgroup of Oregon licensed pharmacists, technicians, and members of the public to solicit feedback on current practice conditions and make recommendations on rule changes.
Pharmacies are encouraged to employ strategies to provide sufficient staffing to assure that the public can receive their medications, vaccinations, counseling, and other patient care services in a safe and timely manner.
Statement Regarding Sterile Syringe Access and Harm Reduction
Adopted February 2018
There is an opioid, heroin and methamphetamine crisis occurring across Oregon and the US. Evidence shows that access to sterile syringes and naloxone are effective strategies to reduce negative health outcomes and the spread of disease related to injection drug use, including HIV, Hepatitis B and C and overdose. Reuse of syringes is common when new syringes are unavailable; this increases intravenous drug users (IDUs) risk of infections and communicable diseases.
Oregon was the first state to squarely face the question of syringe access as a public health measure. Prior to 1987, syringe sales were not regulated. In that year, the legislature passed a paraphernalia law based on the model statute but heeded the advice of state health officials to explicitly exclude syringes from the definition of paraphernalia (
ORS 475.525(3)). In Oregon, it is therefore legal to sell syringes not only in pharmacies but also in other retail outlets, and to distribute them free through Syringe Exchange Programs (SEPs) or other mechanisms. Of note, the sale of syringes in Oregon does not require a prescription. However, a pharmacist must use good professional judgment when selling syringes to minors (individuals less than 18 years of age) see
ORS 475.744. The Oregon approach has minimized the legal barriers to syringe access.
Public health studies have proven legal syringe access reduces syringe reuse and sharing, does not promote injection drug use, and does not increase criminal activity in surrounding areas. When pharmacies or pharmacists choose to directly or indirectly restrict syringe sales to IDUs, or to not carry naloxone, the opportunity to decrease or prevent individual and community harm from addiction and injection drug use are lost.
The Board recommends and encourages pharmacies and pharmacists to increase access of sterile syringes and naloxone to the public. Pharmacies are important public health partners for infectious disease and drug overdose prevention. Existing laws in Oregon have positioned pharmacies and pharmacists to support public health efforts to increase community member access to sterile syringes and naloxone, deliver health education, and refer IDUs to local health care and recovery services. Removing the stigma of selling sterile syringes and prescribing and dispensing naloxone will improve patient care in the short and long term.
Statement Regarding Cultural Competency Continuing Education
Adopted August 2014
The Oregon Board of Pharmacy is charged with preserving and protecting the health of our state’s citizens in the delivery of pharmacy related healthcare. Oregonians are growing increasingly diverse, and inequities in access to quality health care are apparent according to the Oregon Health Authority’s Office of Equity and Inclusion. The Office has identified that racial and ethnic populations, lesbian, gay, bisexual and transgender communities, low literacy level individuals and rural Oregonians experience health disparities. The Board believes that increasing understanding and awareness of the necessity to provide culturally competent health care is a patient safety priority.
The National Institutes of Health (NIH) speaks to the critical importance of healthcare practitioner’s awareness and competency in equal care given to patients across cultural lines. The NIH provides the following background to define Cultural Competence:
- Culture is often described as the combination of a body of knowledge, a body of belief and a body of behavior. It involves a number of elements, including personal identification, language, thoughts, communications, actions, customs, beliefs, values, and institutions that are often specific to ethnic, racial, religious, geographic, or social groups. For the provider of health information or health care, these elements influence beliefs and belief systems surrounding health, healing, wellness, illness, disease, and delivery of health services. The concept of cultural competency has a positive effect on patient care delivery by enabling providers to deliver services that are respectful of and responsive to the health beliefs, practices and cultural and linguistic needs of diverse patients.
Cultural competency continuing education is a life-long process of examining values and beliefs while developing and applying an inclusive approach to health care practice in a manner that recognizes the context and complexities of provider-patient interactions and preserves the dignity of individuals, families and communities. Continuing education in cultural competency should teach attitudes, knowledge and skills to care effectively for patients from diverse cultures, groups and communities. The Office of Equity and Inclusion states that such training enables health care providers to work effectively in cross-cultural situations.
The Board recommends and encourages licensees to pursue ongoing continuing education opportunities for cultural competency. For purposes of maintenance of licensure, the Board considers continuing education (CE) in cultural competency to be relevant to the current practice of all licensees, and licensees may use this type of continuing education toward satisfying the required CE hours for license renewal. The Board will document licensees’ voluntary participation in cultural competency CE through the license renewal process beginning in 2015.
In order for Oregon to achieve the triple aim of improving health, improving care, and lowering cost, providers must be responsive to the needs of diverse populations. Cultural competency training for health care providers is one method for helping Board licensees adapt to the needs of Oregon’s socially and culturally diverse communities.
Statement Regarding Optimizing Patient Safety & Reducing Medication Errors in Oregon
Adopted October 2008
Beginning in 2000, in response to the number of medication errors and medication distribution issues, state boards of pharmacy across the country began to convene committees and work groups to research and report back to the boards about ways to reduce medication errors. In response to the Oregon Board of Pharmacy’s interest in promoting an awareness of and ultimately a decrease in medication errors, the Board convened its Medication Error Reduction – Patient Safety Research Council.
The charge of Oregon’s 12-member multi-disciplinary Research Council was to investigate procedures designed to reduce medication errors and evaluate the role the Board currently plays in supporting medication error reduction efforts. The Research Council was also asked to recommend measures the Board could take to improve patient safety through medication error reduction programs in the state. The Research Council has developed a document that reflects optimum standards for providing patient care in today’s pharmacies. While the document is not intended to be a comprehensive list of goals that are completely achievable on a continual basis, it does suggest a number of specific procedures that can be implemented in pharmacy practice settings in an effort to enhance existing quality improvement programs. This list is not exclusive of other improvements and may be supplemented by the Board from time to time.
Optimizing Patient Safety and Reducing Medication Errors, the 23-point document developed by the Research Council, was based on a review of current literature and work done in other states. The recommendations have been modified and edited specifically for use in Oregon pharmacies. The Board would like to acknowledge the work done by the National Association of Boards of Pharmacy’s 2007-08 Task Force on Continuous Quality Improvement, Peer Review, and Inspecting for Patient Safety, the Massachusetts Board of Registration in Pharmacy, and The Institute for Safe Medication Practices.
It is the Board’s position that all pharmacies and pharmacists should review these recommendations as a high priority and should consider implementation of those measures that are appropriate to the particular pharmacy setting. The Board believes that adoption and institution of these practices will lead to optimal patient safety through enhanced pharmacy medication delivery systems, improved performance generally and, ultimately, a significant reduction in medication errors.