Tag Archives: colorado pharmacy law
Under a new statewide protocol based on Senate Bill 16-135, only Colorado-licensed pharmacists that have completed an Accreditation Council for Pharmacy Education (ACPE) accredited educational training program related to the prescribing of contraceptives by a pharmacist, may dispense hormonal contraceptive patches and oral hormone contraceptives to patients who are at least 18 years of age.
Additionally, for new patients requesting contraceptive services, a participating pharmacist must:
- Obtain a completed Colorado Self-Screening Risk Assessment Questionnaire;
- Utilize and follow the Colorado Standard Procedures Algorithm to perform the patient assessment;
- Prescribe, if clinically appropriate, the hormonal contraceptive patch or self-administered oral hormonal contraceptive, or refer to a healthcare practitioner;
- Provide the patient with a Visit Summary;
- Advise the patient to consult with a primary care practitioner or women’s health care practitioner;
- Refer any patient that may be subject to abuse to an appropriate social services agency; and
- Ensure that the pharmacy provides appropriate space to prevent the spread of infection and ensure confidentiality.
Colorado Board of Pharmacy Approved Protocols include:
Hormonal Contraception Protocol A (includes Standard Procedures Algorithm and the Self-Screening Risk Assessment Questionnaire)
Smoking Cessation: currently being addressed the Colorado Board of Pharmacy (watch for updates)
On June 6, 2016, Colorado Governor John Hickenlooper signed into law Senate Bill 16-135 which amends the Colorado Pharmacy Practice Act and the Colorado Insurance Code to expand practice opportunities for pharmacist and provide a pathway for reimbursement of pharmacy services. The Bill is expected to go into effect in early August 2016.
The Bill includes the following:
- Providers reimbursement opportunities for pharmacies that provide healthcare services otherwise provided by a physician or advanced practice nurse;
- Calls on insurance plans to include pharmacists in their network of providers;
- Expands collaborative practice agreements to one or more patients cared for by the collaborative physician or advanced practice nurse;
- Expands collaborative practice agreements to treat a protocol rather than a single drug;
- Provides for the development of Statewide Drug Therapy Protocols to be jointly developed by the Boards of Medicine, Pharmacy and Nursing in collaboration with the Colorado Department of Public Health and Environment.
Baer Law will continue to keep you updated.
As discussed previously on the Baer Law Blog, corresponding responsibility remains one of the most misunderstood or unknown concepts found in the Drug Enforcement Administration’s (DEA) regulations. The DEA’s regulations (21 CFR 1306.04) regarding corresponding responsibility state:
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
Many states, including Colorado, have incorporated similar language into their own Board of Pharmacy Rules and Regulations. The Colorado State Board of Pharmacy (Board), for example, uses the following language addressing both medical need and corresponding responsibility issues:
3.00.20 Medical Need. No license or registrant shall compound, dispense, deliver or distribute any drug to any person in such quantity or in any situation where the licensee or registrant knows or reasonably should know said drug has no recognized medical utility or application. Violation of this rule shall constitute prima facie proof of violation of CRS 12-42.5-123, or unprofessional conduct and ground for discipline.
3.00.21 A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued on the basis of an internet-based questionnaire, an internet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.
In a recent Colorado case, both issues were addressed. Pharmacists did not make reasonable efforts to ensure prescriptions for Schedule III controlled substances or other compounds were issued for a legitimate medical purpose by an authorized prescriber and had a recognized medical utility.
The facts of the case are as follows:
During a routine inspection of a registered, in-state prescription drug outlet (Pharmacy) in mid-2014, the Board identified over 20 prescriptions that were dispensed pursuant to orders based on Skype internet-based consultations from a Naturopathic Doctor (ND) in California.
The identified prescriptions included the following:
- Human Chorionic Gonadotropin (HCG), a schedule III Controlled Substance in the State of Colorado;
- “B Lipo,” a vitamin B supplement compounded as a sterile product at the Pharmacy
- “Garcinia,” a plant that is presumed to control appetite and fat storage in the body when properly compounded and ingested.
In California, a ND can prescribe a legend and Schedule IV-V controlled substances under MD/DO supervision and prescribe Schedule III drugs under a patient-specific protocol checked by a supervising MD or DO. In this case, pharmacists did not verify the ND was practicing under a supervising MD/DO or that a valid patient-practitioner relationship existed as the relationship appeared to be based only on an internet-consulatations. Due to the many Federal and State violations, the Pharmacy was cited by the Board and the has since voluntarily relinquished its license to practice pharmacy. Cases against the pharmacists involved are still pending and could be severe.
This case should remind all pharmacists to use due diligence when verifying all prescription orders, especially in light of the reclassification of hydrocodone containing products (HCPs) as Schedule II controlled substances.
Pharmacists are expected to exercise sound professional judgment when making a determination about the legitimacy of all prescriptions, not just controlled substance prescriptions. It is no longer sufficient for a pharmacist to accurately fill a prescription if the prescription is unreasonable on its face. In fact, under the corresponding responsibility rule, a pharmacist who deliberately ignores a questionable prescription where there is reason to believe the prescription was not issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner for knowingly and intentionally distributing controlled substances.
Ultimately, pharmacists should continue to monitor prescriptions for “red flags,” closely scrutinize all prescriptions, and ensure that valid MD/DO supervisory relationships exist when checking any controlled substances, especially Schedule II HCPs as there will likely be much confusion over the next few weeks as practitioners adjust to the new rule.
All Colorado licensed pharmacists and registered DEA prescribing practitioners are required to register an individual user account with Colorado’s Prescription Drug Monitoring Program (PDMP) pursuant to CRS 12-42.5-403 of the Pharmacy, Pharmacy Businesses and Pharmaceuticals Practice Act. The following due dates for each profession are:
- Pharmacists and DEA-registered Advanced Practice Nurses: September 30, 2014
- DEA-registered Dentists, Veterinarians, Optometrists and Podiatrists: October 31, 2014
- DEA-registered Medical Board licensees: November 30, 2014
For more information pharmacists and practitioners should use the following link to create a PDMP account prior to the above due dates: http://www.hidinc.com/copdmp