64B16-27.831 Standards of Practice for the Filling of Controlled Substance Prescriptions; Electronic Prescribing; Mandatory Continuing Education.

All rules/laws/regulations are subject to interpretation and this new standards for Pharmacists in Florida in regards to filling controlled substances is no different. Interpretations can be by the BOP, chain employers, individual Pharmacists… meaning that there still may be no cold/hard standard.

For the most part AG Bondi and the DEA are MIA as this new standard evolved

Keep in mind that Pharmacist are not required to have the new mandatory continued education until the later  part of 2017… so can the BOP just keep their hands folded until all the Pharmacists have been known to have completed this new requirement ?

Below is a copy of the new standards and I will be inserting my observation/opinion within the text.

The Board of Pharmacy recognizes that it is important for the patients of the State of Florida to be able to fill valid prescriptions for controlled substances. In filling these prescriptions, the Board does not expect pharmacists to take any specific action beyond exercising sound professional judgment. Pharmacists should not fear disciplinary action from the Board or other regulatory or enforcement agencies for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice.

This was promulgated by the FL BOP and since Pharmacists are not licensed by the DEA.. They can’t promise that the Pharmacist’s employer could not be sanctioned/fined by another regulatory agency. Given the rapidly growing surplus of Pharmacist, generally being the cause of your employer getting fined.. will mean that you will get fired.

Every patient’s situation is unique and prescriptions for controlled substances shall be reviewed with each patient’s unique situation in mind. Pharmacists shall attempt to work with the patient and the prescriber to assist in determining the validity of the prescription.
(1) Definitions: For purposes of this rule the following definitions shall apply:
(a) Valid Prescription. A prescription is valid when it is based on a practitioner-patient relationship and when it has been issued for a legitimate medical purpose.
(b) Invalid Prescription. A prescription is invalid if the pharmacist knows or has reason to know that the prescription was not issued for a legitimate medical purpose.

For the Pharmacist to KNOW is presumed to be a FACT… a Pharmacist’s who’s belief that he/she KNOWS is based on the influence of personal phobias, biases or some other intangible reason ?  Who is going to go to bat for the pt, when a Pharmacist’s decision is based on the later and not the former ?
(c) Validating a Prescription. Validating a prescription means the process implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose.
(2) General Standards for Validating a Prescription: Each prescription may require a different validation process and no singular process can fit each situation that may be presented to the pharmacist. There are circumstances that may cause a pharmacist to question the validity of a prescription for a controlled substance; however, a concern with the validity of a prescription does not mean the prescription shall not be filled. Rather, when a pharmacist is presented with a prescription for a controlled substance, the pharmacist shall attempt to determine the validity of the prescription and shall attempt to resolve any concerns about the validity of the prescription by exercising his or her independent professional judgment.
(a) When validating a prescription, neither a person nor a licensee shall interfere with the exercise of the pharmacist’s independent professional judgment.

Does this mean that corporate policies like Walgreen’s “good faith policy” is to be rescinded or is not considered to be “interference “. If a Pharmacist states that they can’t fill a Rx because of company policy.. does that suggest that the Pharmacist’s independent professional judgement is being interfered with ?
(b) When validating a prescription, the pharmacist shall ensure that all communication with the patient is not overheard by others.

This appear to remind the Pharmacist that there is a Federal HIPAA regulation. Which was enacted TWENTY YEARS AGO ! Does this mean that if a Pharmacist does speak loud enough for other to hear that would permit the pt to file a complaint with the BOP for violation of this standard.  Another reason why pts should video all interaction with the Rx dept staff.

(c) When validating a prescription, if at any time the pharmacist determines that in his or her professional judgment, concerns with the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.
(3) Minimum Standards Before Refusing to Fill a Prescription.
(a) Before a pharmacist can refuse to fill a prescription based solely upon a concern with the validity of the prescription, the pharmacist shall attempt to resolve those concerns and shall attempt to validate the prescription by performing the following:
1. Initiate communication with the patient or the patient’s representative to acquire information relevant to the concern with the validity of the prescription;
2. Initiate communication with the prescriber or the prescriber’s agent to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(b) In lieu of either subparagraph 1. or 2., but not both, the pharmacist may elect to access the Prescription Drug Monitoring Program’s Database to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(c) In the event that a pharmacist is unable to comply with paragraph (a) due to a refusal to cooperate with the pharmacist, the minimum standards for refusing to fill a prescription shall not be required.

We may see the phrase “I’m not comfortable” .. with.. ” I don’t have the medication in stock..  Of course, Pharmacies are required to maintain a perpetual inventory of C-II meds.. If your Rx is declined you will need to note the date/time and it may take a court order to validate the presence of inventory at the time you were denied.  That leaves the question if the BOP will consider lying to pts unprofessional conduct ?
(4) Duty to Report: If a pharmacist has reason to believe that a prescriber is involved in the diversion of controlled substances, the pharmacist shall report such prescriber to the Department of Health.
(5) Electronic Prescriptions: All controlled substances listed in Schedule II through V may be electronically prescribed pursuant to the provisions of Section 456.42(2), F.S. (2015), and pursuant to applicable federal law. For more information related to the federal requirements, access http://www.deadiversion.usdoj.gov/ecomm/index.html.
(6) Mandatory Continuing Education: All pharmacists shall complete a Board-approved 2-hour continuing education course on the Validation of Prescriptions for Controlled Substances. The course content shall include the following:
(a) Ensuring access to controlled substances for all patients with a valid prescription;
(b) Use of the Prescription Drug Monitoring Program’s Database;
(c) Assessment of prescriptions for appropriate therapeutic value;
(d) Detection of prescriptions not based on a legitimate medical purpose; and,

Is the BOP now instructing the Pharmacist to diagnose (second opinion)  the pt’s health issue, without the necessary training background, without doing a in person physical exam .. as any prescriber would be required to do before writing a prescription
(e) The laws and rules related to the prescribing and dispensing of controlled substances. All licensed pharmacists shall complete the required course during the biennium ending on September 30, 2017. A 2-hour course shall be taken every biennium thereafter. The course shall count towards the mandatory 30 hours of CE required for licensure renewal. All newly licensed pharmacists must complete the required course before the end of the first biennial renewal period.
(7) Summary Record: Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by any law enforcement personnel entitled to request such summary under authority of Section 893.07(4), F.S. Such summary shall include information from which it is possible to determine the volume and identity of controlled substances being dispensed under the prescription of a specific prescriber, and the volume and identity of controlled substances being dispensed to a specific patient.
Rulemaking Authority 456.013, 465.005, 465.0155, 465.009, 465.022(12) FS. Law Implemented 456.013, 456.42, 456.43, 465.0155, 465.003, 465.009, 465.016(1)(i), (s), 465.017, 465.022(12), 893.04 FS. History–New 8-29-02, Amended 2-24-03, 11-18-07, 12-24-15.

Filed under: General Problems