We’re predicting there will be changes in the near future and will be updating the status on “pharmacist prescribing in Colorado” as events warrant. (from our email series on Pharmacist Prescribing in Colorado)
What do you mean “Fix the Glitch”?
The title of our 5/13/2018 blog post had a lot of people scratching their heads. What exactly does it mean?
The Value Pharmacists’ “Fix the Glitch” post announced that the Colorado legislature passed a bill that would allow pharmacists to legally prescribe per state wide drug therapy protocols. Since that announcement, a number of questions have come up.
- What was the glitch?
- Why was there a glitch?
- Could pharmacists prescribe before the glitch was fixed?
- Why was HB18-1313 introduced?
- Was HB18-1313 necessary for pharmacists to prescribe under statewide protocols without a collaborative relationship with a physician?
All great questions deserving answers. To get those answers all one needs to do is review the testimony provided by the bill proponents. You can hear the entire testimony in both the House Health, Insurance and Environment Committee on April 10, 2018 and Senate Health and Human Services Committee on April 25 by going to the Colorado State Legislature web page http://leg.colorado.gov. click on “Watch and Listen” then go to the desired committee and date.
In the House Health, Insurance and Environment Committee, the bill sponsor, Representative Ginal explained it this way:
“HB 1313 is another clean-up bill. It was discovered in June 2017 there was a technical glitch which identified pharmacists would not be able to put their name on an authorized prescription order. Current law requires that a practitioner, who is person authorized to prescribe drugs must be on the prescription label but pharmacists are not yet defined as practitioners in existing statute. This is a glitch we are trying to fix. What the bill doses is it clarifies that a licensed pharmacist may serve as a practitioner and have prescriptive authority only under the following circumstances. Number one, over the counter medications under the medical assistance act and for an authorized statewide therapy protocol.”
Co-sponsor Representative Becker, in his opening comments assured the committee with this statement:
“This bill does not allow pharmacists to prescribe independently. It does not change the pharmacist’s scope of practice.”
Emily Zadvorny, Clinical Pharmacy Specialist in Family Medicine – UC Health & CU Skaggs School of Pharmacy and Pharmaceutical Sciences and At Large Member of the Colorado Pharmacists Society, explained the glitch this way:
“In the summer of 2017 awareness was raised that there was an implementation glitch and logistical issues.”
“The bumps in the road are first, the issue of prescriptive authority. In our pharmacy practice act, the only time we are authorized prescriptive authority is the Colorado Medical Assistance Act. So although it talks about us prescribing these pre-authorized medications in the rules and the statewide protocols, there is that kind of inconsistency there. The second bump is every prescription dispensed has to have a label and on the label needs to be the name of the practitioner and the way a practitioner is defined is a person authorized to prescribe drugs. Although pharmacists are recognized as a health care provider, they are not a practitioner.”
“This bill does not change our scope of practice or allow any broad prescriptive authority. It does not increase our scope of practice. We are already doing this great work in this area. Hundreds of pharmacists have been trained, hundreds of patients have already been helped by statewide protocols. “
Why was there a glitch? The original 2016 SB16-135 bill was drafted missing or not addressing a few key points:
- The definition of practitioner is any one licensed to prescribe. The bill did not change the definition of practitioner to include pharmacists.
- No mention was made in the bill to modify the definition of pharmaceutical care which included the statement “does not include prescriptive authority; except that a pharmacist may prescribe only over-the-counter medications to a recipient under the “Colorado Medical Assistance Act.”
- The word prescribe did not appear anywhere in the statute, except in the specific prohibition mentioned above.
- The word prescribe was mentioned in the appendices referenced in the pharmacy rules The appendices contained the statewide protocols approved by the Medical and Nursing board and the Colorado Department of Health and Environment.
Many believed that since the appendices were referred to in rule that was all that was required for pharmacists to prescribe per statewide protocol. However, the Colorado State Board of Pharmacy considered changing the word “prescribe” to “dispense” in all the protocols because of the lack of statutory authority and did not promulgate rules allowing the prescriptive authority. (Refer back to our prior blog post. )
So did we answer our list of questions? Let’s review:
What was the glitch? According to bill proponents it was an oversight that pharmacists were not recognized as “practitioners” and therefore pharmacists could not use their names on the labels attached to the medicines they were prescribing.
Why was there a glitch? The text of the original 2016 bill was incomplete and did not fully address the desired outcome of the proponents so that the SBOP could promulgate appropriate rules.
Could pharmacists prescribe before the glitch fix? No. The only individuals that could prescribe by law were practitioners. Pharmacists were not practitioners.
Why was HB18-1313 introduced? HB18-1313 passage was necessary to allow pharmacists to prescribe under statewide protocols without a collaborative relationship with a physician.
Was HB18-1313 necessary for pharmacists to prescribe under statewide protocols without a collaborative relationship with a physician? Absolutely! If this bill would not have been passed, the board of pharmacy would need to continue with its efforts to change the word “prescribe” to “dispense” everywhere it appeared in the statewide protocols included in Appendices A & B. Pharmacists would have been required to have a collaborative relationship with a practitioner or group of practitioners to “prescribe” any of the drugs mentioned in the statewide protocols.
Questions? Contact me.
“Fix the Glitch”
Colorado House Bill 2018-1313 has passed the legislature. After final enactment and rules promulgation, pharmacists will be prescribers, under certain circumstances, in Colorado.
Hear testimony in support of CO HB18-1313 (begins at ~9.5 minutes and lasts over 20 minutes).
Proposed Pharmacy Rules Strike the Word “Prescribe”: An Update
Many of you have been requesting an update on prescriber status of pharmacists in Colorado since our blog post “Pharmacist Prescribing in Colorado – Analysis and Status” in which we asked:
- Could it be that all the reports in the media announcing that pharmacists are allowed to prescribe birth control are not accurate?
- Does prescribing per statewide protocol fall under the definition of pharmaceutical care where it clearly states “pharmaceutical care” does not include prescriptive authority?
- Is it true that there is no statutory authority for pharmacists to independently prescribe under statewide protocol?
The answer is yes to all three questions.
On January 22, 2018 the Colorado State Board of Pharmacy (SBOP) held a public stakeholder meeting regarding the implementation of rules related to Senate Bill 16-135. Value Pharmacists was represented by Val Kalnins Executive Director “emeritus” of the Colorado Pharmacists Society.
The central issue of the meeting was to discuss drug therapy management (Rule 6), collaborative practice agreements (Rule 17) and how these rules correlate. Additionally, feedback was solicited on proposed changes. The proposed rule modifications strike the word “prescribe” and replace it with the word “dispense” in every occurrence in Rule 17 Appendices A & B.
When questioned, the SBOP reiterated that according to state statute (law) pharmacists are “not allowed to (independently) prescribe.” State Board of Pharmacy representatives were asked the following questions:
- “Is it true that the pharmacists of Colorado do not have the authority to prescribe?” The SBOP response “yes.”
- “Is that the reason that the word ‘prescribe’ was stricken and replaced with dispense?” Again the answer was “yes.”
- “Can pharmacists legally, under statewide protocols, continue to prescribe independently, that is, no collaboration with a practitioner defined as a person authorized by law to prescribe, and dispense using their name as the practitioner in the labeling of the prescription drug dispensed until these rule changes are adopted or do they need to stop immediately?” The SBOP responded, that will be “up to the Board of Pharmacy.”
Since a ruling from the complete State Board of Pharmacy is pending, we note that it is up to the pharmacist to determine their individual risk.
Should any doubt arise as to the veracity of the law disallowing individual pharmacist prescribing at this time, note that the Colorado Pharmacists Society has acquired sponsors for, and is in process of drafting, legislation during the 2018 session to allow individual pharmacist prescribing. You may want to ask yourself “If prescribing is allowed, why do they need to run a bill to allow prescribing?”
To all our pharmacist friends in Colorado, we advise you to speak with an attorney and/or reconsider independent prescribing per the state-wide protocols set forth in SB16-135 noting that collaborative care agreements were a significant step forward to promote pharmacists as healthcare providers in Colorado.
As of this date, according to the Colorado State Board of Pharmacy, Colorado pharmacists are NOT allowed to independently prescribe based on rules implemented per SB16-135. Value Pharmacists maintains our position to educate pharmacists fully in understanding state laws, rules and regulations.
You’ve read the headlines:
“Access to birth control widens as Colorado pharmacists prepare to prescribe oral contraceptives“
“Colorado Pharmacists to Prescribe Women Birth Control”
“Colorado Is Third State Allowing Pharmacists to Prescribe Birth Control“
“Colorado pharmacists can now prescribe contraception”
Are all these reports true? What are the caveats?
Colorado law says …
Colorado Revised Statutes, Title 12 – Health Care – Article 42.5-102 (27) includes the definition of pharmaceutical care which states:
“”Pharmaceutical care” means the provision of drug therapy and other pharmaceutical patient care services by a pharmacist intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient’s symptoms, or arresting or slowing of a disease process. In addition to the preparation, dispensing, and distribution of medications, “pharmaceutical care” may include assessment and evaluation of the patient’s medication-related needs and development and communication of a therapeutic plan with defined outcomes in consultation with the patient and the patient’s other health care professionals to attain the desired outcome. This function includes efforts to prevent, detect, and resolve medication-related problems for individual patients. “Pharmaceutical care” does not include prescriptive authority; except that a pharmacist may prescribe only over-the-counter medications to a recipient under the “Colorado Medical Assistance Act” as authorized pursuant to section 25.5-5-322, C.R.S.” (our emphasis)
Colorado SB16-135, the bill permitting collaborative agreements and statewide protocols as passed by the legislature and signed by the governor, did not affect this definition.
Furthermore, Rule 17 addressing Collaborative Pharmacy Practice specifically defines
“Prescriber”, for the purpose of this Board Rule 17.00.00, means a physician who is actively licensed by the Colorado Medical Board or an advanced practice registered nurse who is actively licensed by the Colorado State Board of Nursing.
Pharmacist is not mentioned in the Rule 17 prescriber definition. Does prescribing per statewide protocol fall under the definition of pharmaceutical care? If it does, what about the part “does not include prescriptive authority?” March 17, 2017 Colorado Pharmacy Rules
Answer: According to Colorado pharmacy law, you must be a “practitioner” defined in Colorado pharmacy law as a
“person authorized by law to prescribe any drug or device, acting within the scope of such authority.”
The question that needs to be asked – are pharmacists authorized by law to prescribe and can they now be considered practitioners?
Previously, we included these definitions as they appear in Colorado pharmacy law and rule.
- 12.45.2-102 (27) Pharmaceutical care – “means the provision of drug therapy and other pharmaceutical patient care services by a pharmacist intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient’s symptoms,…… “Pharmaceutical care” does not include prescriptive authority.“
- Rule 17.00.10 Definitions “Prescriber” means “a physician who is actively licensed by the Colorado Medical Board or an advanced practice registered nurse who is actively licensed by the Colorado State Board of Nursing.“
In both the Colorado pharmacy law and rule, there is no mention of pharmacists prescribing, being a prescriber or a practitioner. Rule 17 does mention Appendices A & B and in Appendix A, for example, it is clearly stated that:
Appendix A – “This collaborative pharmacy practice statewide protocol authorizes qualified Colorado-licensed pharmacists (“Pharmacists”) to perform the pertinent physical assessments and prescribe hormonal contraceptive patches and oral contraceptives under the conditions of this protocol and according to and in compliance with all applicable state and federal laws and rules.” (Value Pharmacists emphasis)
Both appendices A and B include a section on the maintenance of proper records referring back to Rule 17 in SBOP rules. In Rule 17.01 the requirement for records refers to Rules 2, 3, 11, the previously mentioned definitions of “practitioner” and the agreement and “protocol entered into with a prescriber or prescribers.”
Do appendices have force of law?
Whether you answer “yes” or “no,” in order to be in compliance with all applicable state and federal laws and rules when dispensing an oral contraceptive (as required within the appendix), the pharmacist also must consider:
- A prescription order is required to dispense a prescription drug. (Rule 2) Nothing in Colorado pharmacy law permits dispensing without a prescription order.
- A prescription order requires a doctor or nurse’s signature or oral communication. (An “authorized practitioner” per Rule 3.00.21 Dispensing)
- A prescription drug needs to be properly labeled; name of the doctor or nurse need to appear on the label. Colorado pharmacy law specifically states “any drug dispensed pursuant to a prescription order must bear a label prepared… stating…the name of the practitioner…”
How can pharmacists meet these legal requirements if they are not authorized by law to prescribe?
Establish a true collaborative agreement with a practitioner. With a practitioner signed collaborative practice agreement in hand, each of these issues is addressed!
Compare Colorado to Oregon’s Law & Rules
Actually Colorado and Oregon differ from the git-go. Oregon statute specifies pharmacists are prescribers. (Remember Colorado Revised Statutes do not.)
In O.R.S. 689.005, the definition of the “practice of pharmacy” includes:
- The prescribing and administering of vaccines and immunizations and the providing of patient care services pursuant to ORS 689.645 (Power to administer and prescribe vaccines, provide approved patient care services);
- The prescribing and dispensing of hormonal contraceptive patches and self-administered oral hormonal contraceptives pursuant to ORS 689.683 (Prescription and dispensation of certain contraceptives).
Nevertheless, Colorado’s “Appendix A” was derived, in part, from Oregon protocols. In Oregon, the authority to prescribe flows from law to rule to the protocol. In Colorado, the reverse has been attempted but is not supported by C.R.S. or State Board of Pharmacy rules.
Recently, Oregon has enacted further legislation expanding prescribing capabilities.
“In May, Oregon Governor Kate Brown signed into law a bill that allows pharmacists to prescribe and dispense drugs or devices without a physician’s prescription, provided that a health professional has already made a relevant diagnosis and the drugs or devices are on a formulary to be established by an executive committee of allied health professionals. The law expands the previous Public Health Advisory Committee and renames it the Public Health and Pharmacy Formulary Advisory Committee to reflect the inclusion of three pharmacists along with two physicians and two nurse practitioners.
Under the law, pharmacists will also be able request that the committee add a drug or device to the formulary. The committee may recommend drugs or devices to the Board of Pharmacy for inclusion, and the board may add them via rule, rather than go through the state legislature to create and pass laws.” )
Our intent has been to illuminate the intricacies of Colorado pharmacy law, perhaps clarifying some misperceptions about Colorado pharmacist prescribing, especially in comparison to the clear Oregon laws which specifically allow pharmacists to “prescribe and dispense.”
All is not lost just because pharmacists in Colorado can’t prescribe without an agreement with a physician or nurse. There is a silver lining.
Colorado Senate Bill 16-135 DID recognize collaborative agreements in pharmacy law, so it was certainly a step in the right direction. In fact, we believe there is a model in Colorado of the statewide protocol in practice for dispensing oral contraceptives.
Although Colorado pharmacists do not have prescriptive authority in the legal sense, they now have statutory authority to collaborate with physicians to provide evidence-based health care services according to a specific treatment protocol.
As defined in Rule 17,
“Evidence-based healthcare service” means a healthcare service provided by a Colorado-licensed pharmacist pursuant to a statewide protocol or an agreement and protocol with a Colorado-licensed prescriber or prescribers which is guided by or based on current, objective, supportive scientific evidence as published in scientific literature as opposed to anecdotal observations.
If pharmacists want to be able to independently prescribe per statewide protocol and use their own names on the prescription order and the prescription label, it will necessary to go back to the legislature and add the word prescribe in the definition of the “practice of pharmacy.” Sounds simple but we predict there will be a lot of lobbying necessary to overcome the opposition.
Until then, Value Pharmacists suggests expanding your collaborative agreements with physicians and nurse practitioners.
As additional information becomes available, we’ll be emailing or blogging about it. Stay tuned for more on pharmacist prescribing in Colorado!