State Board of Pharmacy: News
- Sunset Review Underway
- Stakeholder Meeting - November 22, 2019
- Permanent Rulemaking Hearing - October 3, 2019
- Pharmacy Technician Q&A
- Listen to PDMP Townhalls
- New Legislation 2019
- Revised Opioid Guidelines Adopted
- Two New Laws Affect Pharmacists
- New Law Affects CO Prescribers, Limits Opioid Prescriptions
- Revised Opioid Guidelines
- PDMP Delegate Training Video
- Mandatory Reporting Reminder
- Important PDMP Updates
- Colorado End-of-Life Options Act
- Free Access to PainNET System for Colorado Providers
- Pharmacist Application Process Speeds Up
- Naloxone Standing Orders
The Colorado Office of Policy, Research and Regulatory Reform is conducting a sunset review of the State Board of Pharmacy. Analysis in a sunset review is performed to determine whether the regulatory program is necessary and should be continued, modified or eliminated. This review will produce a report with recommendations to the Colorado General Assembly and result in subsequent legislation based on the recommendations in the report. Your input is an important component of a successful sunset review. If you would like to submit comments online, please visit COPRRR's website at http://www.dora.state.co.us/pls/real/OPR_Review_Comments.Main
The State Board of Pharmacy held a stakeholder meeting to receive stakeholder input regarding proposed changes to Board Rule 6.00.00 and 17.00.00.
- A copy of the proposed rule changes is available for download.
- Friday, November 22, 2019 at 1:00 P.M. (MST)
The State Board of Pharmacy will hold a permanent rulemaking hearing to consider adopting
the proposed amendments to Rules 1.00.24, 2.01.50, 2.01.52, 2.01.53, 2.01.56, 2.01.80, 3.05.00, 3.00.23, 3.00.30, 6, 7.00.30(c), 11.03.00, 11.07.10, 14.00.05, 14.00.40, 14.00.80, 15.01.11, 15.09.14(a), 17, 19.01.10, 23.00.10, and 23.00.70; and the proposed new Rule 29.00.30. The changes to these rules are being considered to implement new legislation: House Bills 19-1242, 19-1109, and 19-1077; and Senate Bills 19-228 and 19-005.
- A copy of proposed rule changes; House Bills 19-1242, 19-1109, and 19-1077; and Senate Bills 19-228 and 19-005 are available for download.
- Thursday, October 3, 2019 at 8:45 A.M. (MDT)
Ways to Participate
- In Person: Civic Center Plaza, 1560 Broadway, Room 110D (1st Floor), Denver, CO 80202
- By Webinar: Register Here
Public comment and testimony will be allowed at the Permanent Rulemaking Hearing, as this will be the last chance to provide feedback prior to the Board's deliberation on the implementation of the new legislation, and proposed rule changes. If you have any questions or concerns about stakeholder input, please send them to email@example.com. We will accept written comments up to the date of the Hearing. However, to provide the Board adequate time for review and consideration, we ask that you submit your comments as early as possible, and no later than Friday, September 27, 2019.
The Division of Professions and Occupations hosted two Telephone Townhalls on July 15, 2019, that addressed Colorado's requirements for prescribers related to the Prescription Drug Monitoring Program's registration and use. Licensees spanning the Medical, Podiatry, Dental, Optometry, Pharmacy, and Nursing Boards were in attendance.
Robert Valuck, Executive Director of the Colorado Consortium for Prescription Drug Abuse Prevention, was the featured speaker. Among the topics of discussion were the PDMP's structure and purpose; the selection of specialties; prescriber reports, and the use of delegated accounts to inform patient assessments.
Both Townhall recordings are available below for those licensees who were unable to participate in one or both of these sessions. A Q-and-A document also can be accessed that answers many frequently asked questions about the PDMP, its use, benefits, and contact information related to its operation.
On June 3, 2019, Governor Jared Polis signed HB19-1242 Regulate Pharmacy Technicians. This new law goes into effect on October 1, 2019, and requires pharmacy technicians practicing in Colorado on or after March 30, 2020, to obtain a certification or provisional certification from the State Board of Pharmacy (Board). An applicant for certification by the Board must pass a criminal history record check and provide proof of certification by a board-approved, nationally-recognized organization that certifies pharmacy technicians. To allow time to meet the requirements, the Board may grant a one-time provisional certification of up to 18 months to an applicant who has not satisfied certain requirements for certification. The provisional certification may be extended due to hardships. Pharmacy technicians also must meet continuing education requirements before renewing a certification. The new law states that any pharmacy technician on duty must be certified or have a provisional certification. Finally, the law includes a sunset date of September 1, 2021.
On May 23, 2019, Governor Jared Polis signed SB19-228 Substance Use Disorders Prevention. The law went into effect immediately upon the Governor’s signature and requires certain health care providers with prescriptive authority to complete substance use disorder training as part of the continuing education requirement for professional license renewal on or after October 1, 2019. The new requirements apply to podiatrists, physicians, physician assistants, dentists, advanced practice nurses, optometrists, and veterinarians, and prescribers must be able to demonstrate competency regarding:
- Best practices for opioid prescribing, according to the most recent version of the Division’s Guidelines for Prescribing and Dispensing Opioids;
- Recognition of substance use disorders;
- Referral of patients with substance use disorders for treatment; and,
- Use of the Electronic Prescription Drug Monitoring Program.
The law exempts any provider from the continuing education requirements who meets the following criteria:
- Maintains a national board certification that requires equivalent substance use prevention training; or
- Attests to the appropriate board that the health care provider does not prescribe opioids.
In addition to the continuing education requirements, the new law includes the following provisions:
- Restricts a physician, physician assistant, or advanced practice nurse from accepting any direct or indirect benefits for prescribing a specific medication,
- Allows pharmacies to charge enhanced dispensing fees if they provide counseling concerning the risks of opioids to patients who have not previously received opioid prescriptions,
- Allows medical examiners and coroners to access the prescription drug monitoring program (PDMP) under specified circumstances,
- Requires opioid prescriptions for outpatient use to bear a warning label, and,
- Provides funding for the implementation of several programs for the prevention of opioid and other substance use disorders in the Department of Human Services (DHS), the Department of Public Health and Environment (CDPHE) and local public health agencies (LPHAs), and the University of Colorado.
On May 16, 2019, Governor Jared Polis signed SB19-005 Importation of Prescription Drugs From Canada. The new state law creates the Canadian Prescription Drug Importation Program in the Department of Healthcare Policy and Financing (HCPF) and goes into effect on August 2, 2019. By September 1, 2020, HCPF must submit a request for federal approval of the program. If the program is approved, HCPF is required to begin operating the program no later than six months after receiving federal approval.
HCPF is required to contract with one or more vendors when the program receives federal approval; vendor selection is exempt from the state procurement process for the first three years. Vendors, in consultation with HCPF and other vendors, must annually establish a wholesale prescription drug importation list that identifies the prescription drugs that have the highest potential for cost savings to the state. HCPF is required to ensure these lists meet program requirements every three months.
Vendors must identify Canadian suppliers, verify the supplier meets all legal and program requirements, and contract with or facilitate contracts with suppliers to import prescription drugs under the program. Vendors must follow specific requirements related to:
- developing and administering distribution programs;
- assisting HCPF with annual reporting;
- ensuring safety and quality of imported drugs through requirements for testing and certification;
- laboratory and documentation standards;
- financial reporting;
- surety bonds;
- required participation in applicable legal actions; and
Eligible drugs, importers, and suppliers:
A vendor may import a prescription drug from a Canadian supplier if the drug meets U.S. standards related to the drug's safety, effectiveness, misbranding, and adulteration; importing the drug would not violate federal patent laws; and importing the drug is expected to generate cost savings. Eligible importers include the following:
- licensed Colorado pharmacists;
- pharmacists or wholesalers dispensing to Medicaid recipients;
- pharmacists or wholesalers dispensing to inmates in the custody of the Department of Corrections; and,
- wholesalers approved by HCPF.
An eligible Canadian supplier may only export prescription drugs into Colorado if the supplier is in full compliance with Canadian law and submits proof of a registered agent in the U.S. Canadian suppliers and eligible importers participating under the program must comply with the tracking and tracing requirements of federal pharmaceutical distribution supply chain law; and may not distribute, dispense, or sell prescription drugs imported under the program outside of Colorado. In addition, both entities are required to submit certain information to the vendor related to drug type, quantity, point of origin and destination, price, and shipping information as applicable.
HCPF must immediately suspend the importation of specific drugs or the importation of drugs by specific eligible importers if it discovers that any drug or activity is in violation of any federal or state law or regulation. HCPF may revoke the suspension if, after conducting an investigation, it determines that the public is adequately protected from counterfeit or unsafe drugs being imported into this state.
HCPF must designate an office or division that must be a licensed pharmaceutical wholesaler or that must contract with a licensed pharmaceutical wholesaler to:
- set a maximum profit margin;
- exclude generic products if their importation would violate U.S. patent law;
- comply with federal laws regarding pharmaceutical distribution supply chains; and
- determine a method for covering the administrative costs of the program, which may include a fee imposed on each prescription drug sold through the program, as long as the fee amount does not significantly reduce consumer savings.
HCPF is required to report on program operations to the Governor and the General Assembly by December 1 of each year starting in 2021. The report must include information about participants, prescription drugs imported and dispensed, methodology, and estimated cost saving.
On March 21, 2019, Governor Jared Polis signed HB19-1077 Pharmacist Dispense Drug Without Prescription in Emergency. The new law went into effect immediately upon signature and allows pharmacists to dispense to a patient an emergency supply of a chronic maintenance drug without a current valid prescription if the following conditions exist:
- the pharmacist has made every reasonable attempt to obtain an authorization for a refill;
- the pharmacist has a record of the prescription or has been presented proof of a recent prescription or, in the pharmacist's professional judgement, refusal to dispense the drug would endanger the patient's health;
- the amount dispensed does not exceed the most recent prescription or the standard quantity of the drug;
- the pharmacist has not dispensed an emergency supply of the chronic maintenance drug to the same patient in the previous 12 months; and
- the prescriber has not indicated that no emergency refills are authorized.
A chronic maintenance drug is defined as one prescribed to a patient to take on a recurring basis or is used as a lifesaving rescue drug for a chronic condition, but is not an opioid or controlled substance that is prohibited from being dispensed without a prescription under federal law. In accordance with Section 12-280-125.5, Colorado Revised Statutes, the State Board of Pharmacy has adopted rules, in consultation with the Colorado Medical Board and the State Board of Nursing, to establish standard procedures for pharmacists. In addition, the pharmacist, pharmacist's employer, or the original prescriber is not civilly liable for an act or omission in connection with the dispensing of a chronic maintenance drug unless there is negligence, recklessness, or willful or wanton misconduct.
On May 6, 2019, Governor Jared Polis signed SB 19-201 Open Discussions About Adverse Health Care Incidents. This new law creates the "Colorado Candor Act” and establishes a process for the communication between a patient and a healthcare provider or health facility after an adverse health care incident. Under the new law, if an adverse health care incident occurs, a health care provider involved with the incident, either individually or jointly with the facility involved, may request that the patient enter into an open discussion concerning the incident. The request must include certain components listed in the law.
If an offer of compensation is made, the new law requires certain processes for payment and financial resolution to be followed. If a health care provider or health facility determines that no offer of compensation is warranted, the health care provider or health facility shall orally communicate that decision with the patient.
A health care provider or facility may provide de-identified information about an adverse health care incident to any patient safety centered nonprofit organization.
On March 15, 2019, Governor Jared Polis signed SB19-081 Repeal of the “Colorado Cancer Drug Repository Act.” The legislation repeals a section of statute that established a state cancer drug repository program. There is a broader drug repository program for all types of unused medication in state law, making this limited provision obsolete.
On March 14, 2019, the revised Guidelines for Prescribing and Dispensing Opioids were adopted by all six of Colorado’s prescribing and dispensing Boards: the Colorado Dental Board, the Colorado Medical Board, the State Board of Nursing, the State Board of Optometry, the Colorado Podiatry Board, and the State Board of Pharmacy, and endorsed by the State Board of Veterinary Medicine.
On May 11, 2018, Governor John Hickenlooper signed House Bill 18-1307 Limit Access To Products With Dextromethorphan. It will go into effect August 8, 2018. The new state law makes it unlawful to sell or knowingly dispense medication containing any quantity of dextromethorphan to a person under the age of 18. Anyone selling a medication containing dextromethorphan must obtain proof of age as specified in the bill, unless he or she reasonably believes the purchaser is at least 25 years old. This bill does not require:
- restrictions on consumer access to medication containing dextromethorphan,
- transaction record keeping.
It does not apply to medication sold pursuant to a valid prescription. The Colorado State Board of Pharmacy encourages licensees to read the bill to better understand its new requirements. If you have questions, please send them to firstname.lastname@example.org.
Cost of Prescription Drugs Purchased at a Pharmacy
Patient Drug Costs Savings Act
On April 30, 2018, Governor John Hickenlooper signed House Bill 18-1284 Disclosure Of Prescription Costs At Pharmacies. The new state law allows pharmacies/pharmacists to disclose to patients the cost share for the covered prescription drug on his or her insurance, and the clinical efficacy of a more affordable alternative drug that is therapeutically equivalent, if available. In addition, pharmacies must charge the patient the retail price of a medication if that price is less than the copay for that drug. The new law goes into effect August 8, 2018.
The Colorado State Board of Pharmacy encourages all licensees to read the bill to better understand how it affects pharmacies and pharmacists. If you have questions, please send them to email@example.com.
Note: The prescribing and dispensing Boards are reviewing Senate Bill 18-22 Clinical Practice for Opioid Prescribing, and considering its impact, if any, on the Guidelines for Prescribing and Dispensing Opioids. Please check back for updates.
On Monday, May 21, 2018, Governor John Hickenlooper signed Senate Bill 18-22 Clinical Practice for Opioid Prescribing. The bill went into effect immediately upon the Governor’s signature. This new state law limits the number of opioid pills a healthcare provider can prescribe and affects physicians, physician assistants, advanced practice registered nurses with prescriptive authority, dentists, optometrists, podiatrists, and veterinarians.
Under the new law, a prescriber must limit a patient’s initial prescription of an opioid to a seven-day supply, if the prescriber has not written an opioid prescription for the patient in the last 12 months. The prescriber may exercise discretion in including a second fill for a seven-day supply. These limits do not apply, if, in the judgment of the prescriber, the patient:
- Has chronic pain that typically lasts longer than 90 days or past the time of normal healing, as determined by the prescriber, or following transfer of care from another prescriber who prescribed an opioid to the patient;
- Has been diagnosed with cancer and is experiencing cancer related pain; or
- Is experiencing post-surgical pain, that, because of the nature of the procedure, is expected to last more than 14 days.
- Is undergoing palliative care or hospice care focused on providing the patient with relief from symptoms, pain and stress resulting from a serious illness in order to improve quality of life. (This exemption is allowed for physicians, physician assistants and advanced practice registered nurses only.)
After the first prescription, the prescriber is required to check the Prescription Drug Monitoring Program (PDMP) database before prescribing any additional opioids for the same patient. Failure to check the PDMP constitutes unprofessional conduct if the prescriber repeatedly fails to comply with this new requirement. The second fill requirement to check the PDMP does not apply when a patient:
- Is receiving the opioid in a hospital, skilled nursing facility, residential facility, or correctional facility;
- Has been diagnosed with cancer and is experiencing cancer related pain; or
- Is undergoing palliative care or hospice care;
- Is experiencing post-surgical pain, that, because of the nature of the procedure, is expected to last more than 14 days;
- Is receiving treatment during a natural disaster or during an incident where mass casualties have taken place; or has received only a single dose to relieve pain for a single test or procedure.
After the second opioid prescription, the law has no further restrictions on the healthcare provider’s prescribing practices. The new law does require a healthcare provider, or the provider’s designee, to specify the provider’s specialty upon the initial query of the PDMP. It also states a violation of the new requirements does not constitute negligence or contributory negligence per se and does not create a private right of action or serve as the basis of a cause of action.
On March 16, 2018, the revised Guidelines for Prescribing and Dispensing Opioids were adopted by all six of Colorado’s prescribing and dispensing Boards: the Colorado Dental Board, the Colorado Medical Board, the State Board of Nursing, the State Board of Optometry, the Colorado Podiatry Board, and the State Board of Pharmacy, and endorsed by the State Board of Veterinary Medicine.
This revised Policy is a product of the collaboration between the seven Boards and a robust stakeholder engagement process. Stakeholder views, opinions and comments were essential in the revision of the 2014 Policy for Prescribing and Dispensing Opioids.
A training video is available to show prescribers and pharmacists how to set up delegate accounts for the PDMP. Any prescriber or pharmacist can create up to three delegate accounts for trained individuals who can check the PDMP on the prescriber or pharmacist's behalf. You can utilize the PDMP more frequently to get the most complete medical history possible.
Did you know you are a mandatory reporter? Under Colorado law, more than 40 professions are required to report suspected child abuse and elder abuse. These professions include many regulated through the Division of Professions and Occupations (DPO) at DORA, such as:
- Physicians (including physician assistants and physicians in training);
- Dentists and dental hygienists;
- Nurses (including registered nurses, licensed practical nurses, and nurse practitioners);
- Nursing home administrators;
- Occupational therapists;
- Physical therapists;
- Mental health professionals (including psychologists, social workers, professional counselors, marriage and family therapists, registered psychotherapists and all candidates for licensure);
Online trainings help mandatory reporters recognize and report abuse, neglect and exploitation. Licensees of the regulatory boards at DPO may accrue credit towards continuing education and continuing competency requirements for completing the trainings (should they exist for their profession).
Section 19-3-304, C.R.S. outlines the persons required by law to report child abuse and/or neglect. To assist mandatory reporters, a training is available on the Colorado Department of Human Services website at http://coloradocwts.com/mandated-reporter-training.
Section 18-6.5-108, C.R.S outlines the persons required by law to report abuse and exploitation of at-risk elders and at-risk adults with intellectual and developmental disabilities. Further information and an online training can be found on the Colorado Department of Human Services website at http://www.coloradoaps.com/about-mandatory-reporting-update.html.
If you have further questions regarding these requirements, please contact the Colorado Department of Human Services.
For questions regarding mandatory reporting of at-risk elders and at-risk adults with intellectual and developmental disabilities, please contact the Office of Community Access and Independence’s Division of Aging and Adult Services at firstname.lastname@example.org.
As we work together to tackle prescription drug misuse, abuse and diversion, we see PDMP utilization rates continue to increase as the database continues to serve as an important tool for meeting the standard of care for safe prescribing.
We are pleased to announce a new and improved PDMP website: colorado.gov/dora-pdmp. We listened to your challenges and ideas and hope you’ll find the new website easier to navigate and more relevant to your needs. You will be able to link to your PDMP account and access other information directly from the homepage. We also selected a new vendor, APPRISS, and will be utilizing the PMP AWARxE system. The database interface will look different and make PDMP queries easier and quicker. We encourage your continued feedback for ongoing improvement efforts.
New State Law Improves Access to PDMP
To make the PDMP more accessible and easier for health professionals to incorporate into daily use, the Colorado General Assembly passed legislation in 2017. On April 6, 2017, Governor John Hickenlooper signed Senate Bill 17-146 Access To Prescription Drug Monitoring Program, which clarifies health professionals' access to the PDMP database by:
- Allowing a health care provider with prescribing authority to query the PDMP about a current patient, including checking on drug interactions and side effects, thus making the PDMP an even more useful tool for health professionals in their clinical decision-making for patients;
- Allowing a veterinarian with prescribing authority to query the PDMP about a current client if the veterinarian has a reasonable basis to suspect the client has committed drug abuse or has mistreated an animal; and
- Allowing a pharmacist to query the PDMP about a current patient for whom the pharmacist is dispensing any prescription drug, rather than only patients receiving controlled substances.
The law became effective immediately, and the Division is working with the appropriate Boards to implement the new law including rulemaking, outreach and education. If you have questions about the Colorado PDMP, please contact Division staff at 303-894-5957 or email@example.com. If you need technical assistance with the PMP AWARxE system, please contact the vendor help desk at 1-855-263-6403.
In 2016, Colorado voters approved Proposition 106, “Access to Medical Aid In Dying,” which amends Colorado statutes to include the Colorado End-of-life Options Act at Article 48 of Title 25, C.R.S. This Act requires licensed physicians or pharmacists prescribing or dispensing aid-in-dying medication to provide the Colorado Department of Public Health and Environment (CDPHE) with certain information as outlined in the respective forms below.
Rules 6 CCR 1009-4 have been adopted by the Board of Health within CDPHE describing these reporting requirements.
The Division of Professions and Occupations (Division) advises any licensed physician or pharmacist who participates in this practice to comply with all applicable provisions of the Act and corresponding rules implemented by CDPHE. The Division further recommends that you seek the advice of your employer, insurance carrier and private counsel for matters related to this law.
Additionally, the Medical Board has provided guidance to physicians in Policy 40-6.
The Colorado Department of Health Care Policy and Financing (HCPF) has worked with the vendor of its Project ECHO Pain Management Program, Community Health Center, to expand access to the program website known as PainNET.
The PainNet website is an online learning community that aims to improve pain care expertise among primary care providers. The website is also now available to other Health First Colorado (Colorado’s Medicaid Program) primary care medical providers (PCMPs) for free.
The PainNET learning community enables PCMPs to develop expertise to treat patients with complex chronic pain through a combination of archived Project ECHO Pain case presentations, resource libraries, community forums and expert consultations. Providers and specialists are able to communicate through discussion boards, chat rooms and direct messaging.
This is a great resource for Colorado providers to access resources that can increase their knowledge on how to manage chronic pain more effectively.
Learn More About PainNET
- Download the PainNET Access flyer.
- Watch the Introduction to PainNET video.
- Sign up for access by contacting Agi Erickson at firstname.lastname@example.org.
- Contact JD Belshe, Consultant/Policy & Program Analyst for HCPF, at email@example.com for any other questions about the PainNET program.
We want to make sure all Pharmacy Interns know about some exciting changes in our application process for aspiring pharmacists. These changes streamline the process and allow new grads to enter the workforce more quickly.
Beginning May 1, 2016, applicants for a pharmacist license in Colorado will apply directly to the National Association of Boards of Pharmacy (NABP) to take the NAPLEX and MPJE (Colorado) exams without first needing to apply for a Colorado pharmacist license. The new process allows graduates to schedule and take the licensing exams without waiting on prior approval from DPO. NABP will now evaluate your eligibility for the exams and determine the documentation needed to prove you have graduated from an approved school of pharmacy. To have NABP determine your eligibility, complete the NAPLEX/MPJE Eligibility Request Form and submit to NABP with the one-time $85 processing fee. NABP will also be evaluating any requests for testing accommodations. To make an accommodation request, complete and submit to NABP the Accommodation Request Form. For more information about NABP's process, see the NAPLEX - MPJE Registration Bulletin.
Additionally, a new online application provides a more user-friendly and intuitive pathway, replacing the cumbersome paper applications. Once you have passed the NAPLEX and MPJE (Colorado) and completed your 1500 experiential intern hours, you may apply for your Colorado pharmacist license. To apply, complete the PHA - Original License Score Transfer application and submit with the required fee.
We look forward to helping you join Colorado’s healthcare workforce. If you have questions, please contact us at firstname.lastname@example.org.
In April 2015, Colorado passed a new law, Senate Bill 15-053, expanding access to the life-saving drug naloxone, which is used to reverse overdoses to narcotic drugs, such as certain prescription medications and heroin. As a result of the new law, a physician — or any medical professional with prescriptive authority — can write a standing order for naloxone that can be dispensed by other designed individuals (such as pharmacists and harm reduction organizations).
With these standing orders, pharmacists and harm reduction organizations can now provide naloxone to those who might benefit from it the most, including:
- A family member, friend or other person in a position to assist a person at risk of overdose
- An employee or volunteer of a harm reduction organization
- A first responder
- An individual at risk of overdose