How can controlled substance be stored in pharmacy inventory? Reference?
- Controlled substances may be stored in pharmacy stock in a locked cabinet OR disbursed throughout the non-controlled medication stock.
- IAC 10.13
What changes can be made to a schedule II prescription?
- After consulting with the prescribing practitioner (you must speak directly to the practitioner, not his/her agent), the pharmacist may modify or add the following:
a. Date of issue - may be added but not changed
b. Patient’s address
c. drug strength
d. drug dosage form
e. drug quantity - may be modified in conjunction with change in strength only, not to exceed the original total dosage prescribed
f. directions for use
What changes may a pharmacist never add or change to a Schedule II prescription? (hint: 4)
- A pharmacist may never add or change:
a. the name of the drug (except to generic when appropriate)
b. name of the patient
c. signature of the practitioner
d. ‘do not fill before’ date
Can more than one schedule II medication be included on the prescription blank?
- Yes, there is nothing in Iowa law or federal law that prohibits a practitioner from issuing such a prescription
What are the maximum refills on non-controlled, CIII-CV and CII medications?
`1. Non-controlled: 12 refills in 18 months
- CIII-CV: 5 refills in 6 months
- CII: no refills, however may issue 3x30 day’s supply for prescriptions to have on file at the pharmacy
What are the three ways a Schedule II substance can be partial filled?
- Partial fills may occur if insufficient supply is in stock if the remaining portion is fillled within 72 hours.
- Partial fills for Schedule II medications are allowed in Board of Pharmacy rules for long-term care or terminally ill patients when “terminally ill” or “LTCF” patient” is recorded on the prescription.
- At the request of the patient or prescriber, pursuant to Comprehensive Addictioner and Recovery Act [CARA].
Describe how to fill a partial fill of a schedule II using CARA
- The total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed.
- Except in the case of an “emergency prescription”, the remaining portion of a prescription partially filled may be filled within 30 days of the date the prescription was issued.
Describe how to fill a partial fill of a schedule III-V
- The partial filling of a prescription for a controlled substance listed in Schedule III-V is permissible provided that each partial fill is recorded in the same manner as a refill.
- The total quantity dispensed in all partial fills shall not exceed the total quantity prescribed.
- No dispensing shall occur later than six months after the date of which the prescription was issued.
When an a pharmacist accept a faxed prescription for a schedule II medication?
- A prescription may be faxed to the pharmacy provided the medication is not dispensed until the pharmacy receives the hard copy with signed prescription. Exceptions in which a faxed prescription can be filled without receiving the hard copy include:
a. Long-term care patients (if the address indicates a long-term care facility)
b. Hospice patient (the prescriber must indicate the patient is in hospice on the prescription)
c. Emergency situations, and only in the smallest quantity to meet the needs of the patient during the emergency period. A written prescription must follow within 7 days. The pharmacist must report the prescriber to the Board and DEA if the written prescription is not received.
Reference IAC 23.18 and 10.26
How long after issuance can prescriptions for schedule II medications be considered valid?
- 6 months
- After that period of time, pharmacists should consider the prescription invalid and advise the patient that a new prescription order must be obtained.
What can methadone be dispensed by a pharmacy?
- Methadone can be dispensed by a pharmacy if the indication is for analgesic purposes.
- Feederal regulations do not permit the prescribing of methadone for purposes of detoxifying or maintaining a narcotic addict.
- Prescriptions issued for this purpose are illegal and do not authorize pharmacists to dispense methadone for these purposes.
- The federal regulations require that methadone may only be administered for these purposes by drug treatment programs approved by the FDA.
- Reference: FDA 21CFR 1306.04, 1306.07, and Controlled Substances Act 21 USC 802
What are the quantity restrictions for pseudoephedrine distribution? (hint: state and federal)
1a. Federal daily: 3.6 g
2a. Iowa daily: 3.6 g
1b. Federal 30-day: 9 g
2b. Iowa 30-day: 7.5 g
3a. Federal Mail Order: 7.5 g
3b Iowa Mail order: not applicable
How do Iowa and federal law differ on quantity restrictions of pseudoephedrine distribution?
Iowa has a more stringent 30-day limit at 7.5 g
Which pharmacy staff members can sell pseudoephedrine products?
- Pharmacists and registered pharmacy technicians under the supervision of a pharmacist are able to complete the sales of pseudoephedrine products, verify that the patient is at least 18 years old, review the patient’s photo identification, and verify through the pseudoephedrine tracking system that the patient has not received more than the maximum allowable quantity in the last 24 hours and 30 days.
- reference IAC 10.34
What are the schedule V dispensing limits for ephedrine, pseudoephedrine or phenylpropanolamine?
- No more than 7.5 g to same purcchaser in 30-day period
2. No more than 3.6 g to same purchaser within single calendar day
What are the schedule V dispensign limits for other substances besides ephedrine, pseudoephedrine or phenylpropanolamine?
A. For other non-prescription schedule V substances (as determined by the Food, Drug and Cosmetic Act) not more than the following quantities may be sold to the same purchaser within any 48 hour period:
- 240 cc (8 oz) of any CS containing opium
- 120 CC (4 oz) of any other CS substance
- 48 dosage units of any CS containing opium
- 24 dosage units of any other CS
What are the pharmacy requirements for Prescription Monitoring Program (PMP) reporting? Reference?
- Each reportable prescription dispensed shall be submitted by each dispenser no later than the next business day following dispensing
- IAC 37.3
If theft or significant loss of controlled substance is found, how long does a pharmacy have to report this to the Board of Pharmacy?
- The controlled substance registrant must report to the Board of Pharmacy on a specific form within 2 weeks of discovery of loss or theft.
- IAC 10.16(124)
How does a pharmacy keep record of controlled substance refills? How long must these records be maintained?
- The pharmacy must print out a list of refills within 48 hours of dispensing and verify, date and sign that hard copy printout.
- Alternatively, the pharmacy can keep a bound logbook of statements that attest that the controlled substance refills have been verified each day, signed by each pharmacist that filled prescriptions that date.
- All records pertaining to controlled substances must be kept two years.
Is the use of electronic prescribing for controlled substances (EPCS) mandatory/
- No. The DEA’s rule “Electronic Prescriptions for Controlled Substances” (EPCS) revises regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically.
- The regulations also permit pharmacies to receive, dispense and archive these electronic prescriptions
- IAC 657-21.8 coincides with the established DEA revision. Practitioners and pharmacies must still meet all the rules and regulations for EPCS established by the DEA prior to introducing electronic prescribing of controlled substances into practice.
- ***Beginning 1/1/2020 all prescriptions issued for a prescription drug shall be transmitted electronically as an electronic prescription to a pharmacy by an electronic prescriber unless excempt per IAC 155 A.27
How will a prescriber be able to determine that an application complies with the DEA’s rule for EPCS?
- For prescribers, dual authentication is necessary for their prescribing applications to be compliant with DEA rules for prescribing CII.
- Furthermore, the applicable provider must provide a copy of the third-party audit/certification report to practitioners who use or are considering use of the electronic prescription applicable to allow them to determine whether the application is compliant with DEA’s requirements.
What requirements must be met for a pharmacy to accept electronic prescriptions for controlled substances?
- A pharmacy will be able to process electronic CS prescriptions when the pharmacy applicable the pharmacy is using complies with the requirements in the final rule.
- A pharmacy cannot process electronic prescriptions for CS until its pharmacy applicable provider issues the third party audit/certification report verifying that the application complies with the DEA requirements.
To whom does the third-party audit/certification apply for EPCS?
- The requirement for a third-party applies to the applicable provider, not to the individual practitioner, institutional practitioner, or pharmacy that uses the application.
- The practitioner or pharmacy is not subject to the requirement unless they have developed their own application.
For pharmacy applications, what must the third-party auditor or certification organization determine in order to be compliant with EPCS?
- The third-party audit or certification must be conducted before the pharmacy application is used to process electronic prescriptions.
- Thereafter, a third-party audit or certification must be conducted whenever a function related to CS prescription requirements is altered, or every 2 years, whichever occurs first. This includes:
a. If the information required in 21 C.F.R. 1306.05(a), the indication that the prescription was signed as required by 21 C.F.R 1311.205(b)(6), and the number of refills as required by 21 C.F.R. 1306.22, cannot be consistently and accurately imported, stored, and displayed, the third-party auditor or certification organization must indicate that the application does not meet DEA’s requirements.
b. If the pharmacy applications accepts prescriptions with the practitioners digital signature, the TPA/CO must indicate that the applicatino does not meet DEA’s requirements if the application does not consistently and accurately import, store and verify the digital signature.
c. If other informatino required under 21 C.F.R parts 1300 through 1321 cannot be consistently and accurately imported, stored and displayed, the TPO/CO must indicate that the application has failed to meet the requirements for the specific information and should be used to process electronic prescriptions that require the additional information.
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Introduction/Background3
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General Regulatory Processes4
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Licensure/Registration/Certification/Operational Requirements16
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Practice Details28
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Long-term Care5
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Emergency Medical Services1
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Healthcare Provider Details19
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Compounding4
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Controlled Substances51
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Technician Product Verification3
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Immunizations9
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Naloxone3
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Miscellaneous13
