Idaho State Regulatory Update April 2019
HB0058: Addition of the provision for the transfer of legend drugs for donation to medically indigent patients.
54-1761. DEFINITIONS. As used in sections 54-1760 through 54-1765, Idaho Code:
Redefines "Donation repository", "legend drug", and "medically indigent patient", "patient assistance program", and "qualified charitable clinic/donor" in the state.
37 54-1762. LEGEND DRUG DONATION.
Legend drugs may be transferred from a qualified donor to a donation repository for donation to medically indigent patients.
Qualified donors may distribute legend drugs in accordance with the following requirements:
Drugs donated by an individual member of the public must be in the manufacturer's original sealed packaging, including those packaged in single unit doses when the outside packaging is open, and the single unit dose packaging is intact; and
Drugs donated by an entity that is a qualified donor must meet either of the following conditions:
- The drugs are in the manufacturer's original sealed packaging, including those packaged in single unit doses when the outside packaging is open and the single unit dose packaging is intact; or
- The drugs are opened or unsealed but have remained under the control and storage of the qualified donor.
Donation repositories may accept drugs in accordance with the following specifications:
- Only drugs that bear a clear and verifiable lot number and expiration date may be accepted and dispensed. Drugs bearing an expiration date fewer than three (3) months from the date the drug is donated shall not be accepted and shall not be dispensed;
- Drugs and other substances provided in schedules II through V of article II, chapter 27, title 37, Idaho Code, shall not be accepted and shall not be dispensed; and
- A drug shall not be accepted or dispensed if the person accepting or dispensing the drug has reason to believe that the drug has been adulterated.
Any donation repository dispensing legend drugs shall:
- Comply with all applicable federal and state laws related to the storage and distribution of drugs;
- Inspect all drugs prior to dispensing to determine that such drugs have not been adulterated;
- Dispense drugs pursuant only to a valid prescription; and
- Separate donated drugs from the donation repository's normal drug stock. Donated drugs may not be resold.
HB 182: Amends existing law to add products that may be prescribed by a pharmacist
Law now includes:
- Tobacco cessation products pursuant to section 54-1733E, Idaho Code;
- Tuberculin purified protein derivative products pursuant to section 54-1733F, Idaho Code
2019 Pharmacy Administrative Rule Changes that become effective in early April 2019:
Rule Chapter 1: General Provisions
Limited service outlet has been expanded to include mobile pharmacies. Standard of care now encompasses acts or omissions within the practice of pharmacy, "which fail to meet the standard provided by other qualified licensees or registrants in the same or similar setting."
Rule Chapter 2: Rules Governing Licensing and Registration.
Chapter 2 is updated so that the Idaho-based Multistate Pharmacy Jurisprudence Examination is no longer a requirement for licensure. This change is consistent with nearly every other Idaho health profession.
Rule Chapter 3: Rules Governing Pharmacy Practice.
For in-state drug outlets, the requirement by the Board to designate a pharmacist-in-charge has been removed from Chapter 3.
Prescription Drug Order: Validity.
There is no longer a specified expiration date for prescription orders on non-controlled substances. Digital image prescriptions may now be accepted, but not for a controlled substance (CS) or if the patient intends to pay cash for the drug in whole.
Prescription Drug Order: Minimum Requirements.
For a non-controlled substance, a prescriber may omit the required drug information and directions if the prescriber makes a clear indication that the pharmacist is to finalize the patient's drug therapy plan.
Filling Prescription Drug Orders: Drug Product Substitution.
Any institutional facility may participate in drug product substitution using a formulary created by its quality assessment and assurance committee. Prescriber-authorized substitution is added under this section. A prescriber must clearly indicate that substitution is allowed by indicating "therapeutic substitution allowed" or a similar designation. The substitution must benefit the patient and is made to either comply with the patient's insurance formulary or to reduce the patient's cost. The patient must opt-in and be informed of the substitution. Notification to the patient's prescriber of the substitution must be given within five business days of dispensing the prescription. Drugs exempt to substitution are biological products, narrow therapeutic index drugs, and psychotropic drugs.
Filling Prescription Drug Orders.
Adaptation Updates have been made under changes in quantity pertaining to non-controlled substances. Biological products and compounded drugs are also excluded. The change is intended to dispense up to the total amount authorized by the prescriber including refills. The change extends a maintenance drug for the limited quantity necessary to coordinate a patient's refills in a medication synchronization program.
Rule Chapter 4: Rules Governing Pharmacist Prescriptive Authority Pharmacist Prescribing for Minor Conditions.
There are new minor ailments listed that pharmacists can independently prescribe for when following the parameters indicated in Chapter 4. Allergic rhinitis: Prescribing is limited to intranasal drugs only. Mild acne: Prescribing is limited to topical drugs only. Mild cough: Only benzonatate may be prescribed for cough suppression.
Prescribing for these conditions must be in accordance with the general requirements specified in Rule 020 Pharmacist Prescribing: General Requirements. The Board has published template protocols for pharmacists to use as a starting point for allergic rhinitis and mild acne. Some changes were also made to the urinary tract infection (UTI) template, such as removing post-menopause as an exclusion criterion. Pharmacist Prescribing for Clinical Gaps in Care Pharmacist statin prescribing is clarified to include only those who have been diagnosed with diabetes, removing the previous requirement for a current prescription for a drug for diabetes. Pharmacist Prescribing to Supplement an Infusion Order Items have been added to include: Agents for catheter occlusion. Additional supplemental drugs: methylprednisolone, hydrocortisone, diphenhydramine, epinephrine, and normal saline.
Rule Chapter 5: Rules Governing Drug Compounding.
Changes were made to Chapter 5 under Rule 101.02 Dosage Forms Requiring Sterility. Previously, sprays intended to treat bronchial mucosa were exempt from sterile compounding. This has been changed to exempt only sprays and irrigations intended to treat nasal mucosa. The requirement for gloved fingertip sampling has been updated to reflect United States Pharmacopeia Chapter (797). It is required every six months for personnel who compound high-risk sterile preparations and annually for those who compound only low- and medium-risk sterile preparations.
Updated CPE Requirements.
Per Rule 27.01.02.033: Each pharmacist applicant for license renewal must complete fifteen (15) CPE hours each calendar year between January 1 and December 31. 01. ACPE credits must be reported to and documented in CPE Monitor in order to be accepted. No longer must a pharmacist complete a minimum number of live, law, immunization, or sterile compounding credits as a matter of law. No longer will attendance sheet-based documentation be accepted. The link between license renewal and CPE completion is severed, and 15 CPE hours must be obtained each calendar year between January 1 and December 31.
Birth Month Renewal.
The Board is going to birth month renewal. Those pharmacists who renewed on or before June 30, 2018, will renew one more time on or before June 30, 2019.
What does this mean for pharmacists practicing in the state of Idaho?
- If your pharmacy takes part in a drug donation program, be aware of the new regulations surrounding this practice, and ensure that your policy matches those new rules.
- If your pharmacy offers a pharmacist prescriptive authority program, be aware of the many changes that have occurred and be sure that you are using the most up to date prescribing template or protocol.
- Several new rules involve how prescriptions can be dispensed regarding generic substitution and partial filling of non-controlled substance prescriptions. Also included are requirements around non-sterile compounding of nasal sprays. Ensure that your SOP's reflect these changes, and that all staff are trained on these changes.
- Many changes have taken effect around licensure requirements and administrative or supervisory functions of pharmacists. All pharmacists must be aware of these changes and renewal requirements to avoid a lapse in licensure.
Idaho Regulatory Update November 2018
Rule 27-0104-1701: Rules Governing Pharmacist Prescriptive Authority
Requires that for each drug or drug category the pharmacist intends to prescribe, that the pharmacist must maintain a patient assessment protocol based on current clinical guidelines, when available, or evidence-based research findings that specifies patient inclusion and exclusion criteria and explicit medical referral criteria.
Rule 27.01.03.303.03: Rules governing refills when a physician is not available for authorization.
A pharmacist may refill a prescription for a noncontrolled drug one (1) time in a six (6)-month period when the prescriber is not available for authorization. In such cases, a pharmacist may dispense a refill up to the quantity on the most recent fill or a thirty (30)-day supply, whichever is less.
What does this mean for pharmacists practicing within the state of the District of Columbia?
- If the pharmacist or pharmacy initiates participation in services utilizing prescriptive authority, they must ensure that they have a protocol in place that provides up to date clinical guidance for practice. Ensure that your pharmacy's standard operating procedures includes the training on and proper use of a standard protocol that meets the state requirements.
- A pharmacist can provide one refill of a non-controlled medication to a patient in the event that the prescriber cannot be contacted for authorization, avoiding an interruption in critical therapy.
Idaho State Regulatory Summary- 2018
The following regulations were enacted during the 2018 Legislative Session, and can be found in detail at theIdaho Board of Pharmacy or in the Idaho March Board of Pharmacy Newsletter.
Rule 021.03 Pharmacy License Renewal Periods
The Board of Pharmacy will transition from a June 30 license renewal deadline to a birth month renewal model: individuals would renew their license by the last day of their birth month beginning with 2019 renewals.
Rule 030.03 - Controlled Substance Registration Exemption for Pharmacists
Pharmacists are exempt from obtaining a controlled substance registration in addition to their pharmacist license. Pharmacists are still required to maintain compliance with the Idaho Uniform Controlled Substances Act.
Rule 033 Pharmacists Continuing Education Completion Requirement
Pharmacists must complete 15 hours of continuing education annually between January 1 and December 31. Specific category requirements have been removed.
Rule 036 Pharmacy Extern and Intern Licensure Consolidation
Pharmacy "externs" and "interns" are now placed into a single category named "pharmacist interns."
Rule 041 Pharmacy Technician and Training Registration
Technician-in-training registration category is now a one-time registration with a two-year duration. The employer requirement is eliminated. Current technicians in-training will not be required to renew.
Rule 042 New Student Technician Category
This rule creates a "student technician" registration category for individuals who are enrolled in a school-supervised program and who do not otherwise meet the requirements for registration as a technician-in-training or certified technician.
Rule 101 Pharmacist Delegation of Duties to Technicians or Interns
Pharmacists retain full discretion over what tasks to delegate and to which individuals under their supervision, but they must first consider whether the task is commensurate with the education, skill, and experience and whether the unique professional judgment of the pharmacist is necessary for the task.
Rule 202 Required Steps to Prescription Dispensing
The rule specifies the five steps that must occur, unless exempted, when dispensing a prescription drug:
- obtain a valid prescription drug order;
- perform prospective drug review;
- affix label meeting specific requirements;
- verify dispensing accuracy; and
- counsel the patient.
Rule 203 Off Site Dispensing Requirements
Rule 203 allows each of the activities in Rule 202 to be performed off site if specific parameters are met.
Rule 303 - Emergency Refill Authority
A pharmacist may refill a prescription for a non-controlled drug one time in a six-month period for the quantity on the most recent fill or a 30-day supply, whichever is less.
Rules Governing Pharmacist Prescriptive Authority
Rule 020.03 Patient Assessment Protocols
The rule requires a pharmacist to use a patient assessment protocol for each drug he or she intends to prescribe. The protocol must be based on current clinical guidelines or evidence-based research findings and must specify patient inclusion and exclusion criteria, as well as explicit medical referral criteria.
Rule 020.06 PCP Notification of Prescribing
Requires the pharmacist to notify the patient's primary care provider of any drug prescribed within five business days.
Rules 021-026 - Drugs, drug categories, and devices that pharmacists may independently prescribe
Conditions for which pharmacists can prescribe within certain parameters. Refer to the full regulation for a complete list of covered conditions.
What do these new regulations mean for pharmacists practicing within the state of Idaho?
- Many changes take effect concerning pharmacist and technician registration. Ensure that all are aware of these changes and that employees maintain proper licensure through this transition and avoid potential non-compliance risks.
- All pharmacists must understand the allowances and limitations with all new technician and intern designations, and assign tasks as allowed.
- Practicing pharmacists must become familiar with all new rules of practice, including emergency refill rules and record-keeping, along with all new prescriptive authority allowances.
- With greater ability comes a great responsibility; ensure that all pharmacy team members fully understand the new requirements, complete all competency training, and have operating procedures in place to provide patient care in compliance with the Idaho Board of Pharmacy.
- All pharmacists must also review their corporate policies, as those policies may be stricter than the above policies and take precedence.
For full regulatory language, refer to the Idaho Board of Pharmacy
