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August 20, 2018  Wisconsin State Pharmacy Law Updates/Corrections


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Section 5 Question 30 Answer and Answer Explanation Are Updated.

According to Wisconsin State Pharmacy Law, which of the following mid-level practitioners may prescribe and/or dispense a Schedule II controlled substance in the course of their professional practices?
 
I. Physician’s assistant
II. Nurse practitioner
III. Optometrists
 
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: (b) I and II only (d) All, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].

4. OD (Optometrists): Schedule III to V controlled substances (prescribe, dispense and administer).

4. OD (Optometrists): Schedule II Hydrocodone containing products and Schedule III to V controlled substances (prescribe, dispense and administer).




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June 19, 2018  Virginia State Pharmacy Law Updates/Corrections


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Section 2 Question 24 Answer and Answer Explanation Are Updated.

RJ came to the pharmacy and said that he could only pay for 30 tablets of Ritalin. The remaining he would collect next week. The pharmacist may tell him:
 
a. Okay, but call us before you come.
b. We cannot dispense this prescription.
c. You have to pay us in advance for the whole supply.
d. No, you cannot do that.
 
Answer: (a) Okay, but call us before you come, [18VAC110-20-310(E)].
 
A prescription for a Schedule II drug may be filled in partial quantities if the partial fill is requested by the patient or by the practitioner who wrote the prescription provided:
 
1. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed;
 
2. The prescription is written and filled in accordance with state and federal law; and
 
3. The remaining portions are filled not later than 30 days after the date on which the prescription is written.


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June 11, 2018  Kentucky State Pharmacy Law Updates/Corrections


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Section 5 Question 22 Answer Explanation Is Updated.

A collaborative care agreement shall:
------------------------------------------------------------
(1). Be in writing;
 
(2). Be signed and dated by the:
 
(a). Individual practitioner;
 
(b). Individual pharmacist; and
 
(c). Patient or care giver;
 
(3). Provide that upon termination of the agreement the individual practitioner or individual pharmacist shall notify the patient in writing;
 
(4). State the method for termination of the agreement; and
 
(5). Contain the information specified by Section 2 of this administrative regulation.
 
A collaborative care agreement shall contain the following information:
 
(1). Patient name;
 
(2). Patient address and telephone number;
 
(3). Protocol, criteria, standing orders, or other method by which services are authorized;
 
(4). The method established for the assessment of patient outcomes, if appropriate; and
 
(5). Lab tests that may be ordered.
 
A collaborative care agreement shall:
 
(1). Be in writing;
(2). Be signed and dated by:
(a). Each practitioner; and
(b). Each pharmacist who is a party to the agreement;
(3). Provide the method for referral of patients to be managed under the agreement; and
(4). State the method for termination of the agreement.
 
The following information relating to a patient managed under the collaborative care agreement shall be maintained by the pharmacist:
 
(1). Name;
(2). Address and phone number;
(3). Emergency notification contact;
(4). Date of birth, weight, height, and gender;
(5). Medical history, including:

(a). Known diseases;
(b). Known allergies;
(c). Reactions and conditions relating to:

1. Prescription medications; and
2. Nonprescription medications;

(d). Current prescription regimen; and
(e). Current nonprescription regimen;

(6). Lab tests ordered, including results of lab tests;
(7). Assessment of patient outcomes;
(8). Notes relating to the care and course of therapy of the patient; and
(9). Documentation of patient consent to receive care under the collaborative care agreement.
 
Documentation relating to the care and course of therapy of the patient pursuant to the agreement shall be documented in the patient’s record maintained by the pharmacist, provided to the collaborating practitioner, and be readily available to other healthcare professionals providing care to the patient.
 
A collaborative care agreement, and information and records required by the provisions of this administrative regulation, shall be maintained:
 
(1). At the pharmacist's practice site; and
(2). For at least five (5) years after termination.

Section 4 Question 8 Question, Answer and Answer Explanation Are Updated.

A pharmacist receives a prescription for a Schedule II drug with a quantity of 120. The patient’s insurance will only cover a quantity of 100. Can the pharmacist fill the quantity of 100 on the insurance on one prescription number and fill the remaining 20 on another prescription number for cash?

A pharmacist receives a prescription for a Schedule II drug with a quantity of 120. The patient’s insurance will only cover a quantity of 100. Can the pharmacist fill the quantity of 100 based on the approval provided by an insurance company and fill the remaining 20 on the same prescription number for cash?

Answer: (b) No (a) Yes, [Kentucky State Pharmacy Board News Letter September 2013 and 2017].

The only way the patient can obtain the 120 quantity is for the pharmacist to use the same prescription number for both the 100 quantity and 20 quantity and the total quantity has to be dispensed the same day.

The new law permits the partial filling of a Schedule II CS for patients who are not terminally ill or a resident of an LTCF. The partial filling must be requested by the patient or the prescribing practitioner, and no additional dispensing may occur beyond 30 days from the date of issuance of the prescription. This would allow for partial dispensing of a Schedule II CS in two different scenarios in the community pharmacy setting:

1) the pharmacy is unable to fill the prescription and has 72 hours to complete the filling, or

2) the patient or prescribing practitioner request a partial fill and the pharmacist may do so for up to 30 days.

Therefore, the pharmacist can fill the total 120 quantities for the schedule II controlled drug by recording the partial transaction for the rest 20 quantities that have not been covered by the third party insurance company.

However, in order to do the partial fill for the remaining 20 qty, the pharmacist must receive a request from the patient to partially fill the remaining supply for the cash.



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June 8, 2018  Nevada State Pharmacy Law Updates/Corrections


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Section 4 Question 27 Answer and Answer Explanation Are Updated

Answer: (b) False (a) True, [Nevada Administrative Code (NAC)-453.440].
If the registration number of the prescribing practitioner, the address of the prescribing practitioner or the address of the patient is not on the prescription, before filling the prescription, the pharmacist shall write the missing registration number, address or addresses on the prescription.
 
If the address or addresses are immediately available to the pharmacist by an alphabetical card file, computer, patient profile system or any other system approved by the Board, the pharmacist need not write the address or addresses on the prescription.
 
If the pharmacist writes the missing registration number, address or addresses on the prescription, he shall place his initials near the registration number, address or addresses.
 
If the addresses are immediately available to the pharmacist, he shall place on the prescription his initials and a notation indicating the addresses are immediately available, including, without limitation, “RA,” “readily available,” “in files,” “on computer” or any other similar notation.
 
A pharmacist is NOT authorized to add or change the DEA registration number of a practitioner on a prescription for any controlled substance.



Section 4 Question 13 Answer Explanation Is Updated

(4). The date that the prescription was issued.
(4). Date prescription was issued can be corrected, if written in error, but not changed.
(5). Days supply
(6). ICD-10 code; and
(7). Date of birth of the patient



Section 5 Question 8 Answer Explanation Is Updated

Nevada State Pharmacy Law does not limit the quantity that a practitioner can prescribe for CII prescriptions for CNS stimulant drugs or for any drug.

Nevada State Pharmacy Law does not limit the quantity that a practitioner can prescribe for CII prescriptions for CNS stimulant drugs. However, Nevada law does specify the limits for an initial prescription of a CS listed in Schedule II, III, or IV for the treatment of acute pain. 



Section 3 Question 16 Entire Question Is Updated

Which of the following information is/are TRUE ABOUT the initial controlled substance prescriptions prescribed for an acute pain?
 
I. The initial prescriptions must NOT be intended to be used for more than 14 days.
 
II. The initial prescriptions must NOT exceed 90 morphine milligram equivalents (MMEs) daily for opiate naive patients.
 
III. The initial prescriptions must be limited to either 30 tablets or capsules.
 
a. I only
b. I and II only
c. All
d. None of the above
 
Answer: (b) I and II are true, [Nevada April 2018 NewsLetter].
 
Pharmacists should also be aware of some prescribing limits on an initial prescription for a CS. An initial prescription is defined as “a prescription . . . for a new patient of a practitioner . . . or a new prescription to begin a new course of treatment for an existing patient”. These limits are for an initial prescription of a CS listed in Schedule II, III, or IV for the treatment of acute pain and are as follows:
 
1. Must be intended to be used for no more than 14 days, and
 
2. Must not exceed 90 morphine milligram equivalents (MMEs) daily for opiate naive (never received an opioid prescription or most recent course was completed more than 19 days prior to initial prescription).
 
A conversion chart for MMEs can be found at https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf.




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June 5, 2018  Alabama State Pharmacy Law Updates/Corrections


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Section 3 Question 11 Explanation Is Updated

Only in an emergency situation is an oral order for a schedule II controlled substance permitted. The physician must provide a hard copy of the prescription within 72 hours 7 days. If the prescriber does not provide said hard copy, the pharmacist is responsible for contacting the DEA.




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May 30, 2018  Kentucky State Pharmacy Law Updates/Corrections


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Section 2 Question 25 Entire Question Is Updated

Which of the following drugs is/are classified as Schedule III controlled drug(s)?
 
I. Fiorinal
II. Fioricet
III. Codeine
 
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: (b) I and II only. Both Fiorinal and Fioricet are classified as Schedule III drugs, [Kentucky State Pharmacy law section 902 KAR 55:025].
 
Kentucky Regulation:
------------------------------------
 
Under the Kentucky Pharmacy Law, all barbituric acid derivatives are classified as Schedule III controlled substances.
 
 
Federal Regulation:
-------------------------------
 
Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.
 
Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.
 
The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet. Interesting to note that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.
 
The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophen) is added.
 
The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg.
 
The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.




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May 9, 2018  Florida State Pharmacy Law Updates/Corrections


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Section 5 Question 22 Answer Explanation Is Updated.

Each time a controlled substance is dispensed to an individual, the controlled substance shall be reported to the department through the system as soon thereafter as possible, but not more than 7 days the close of the next business day after the day the controlled substance is dispensed unless an extension is approved by the department for cause as determined by rule.
 
A dispenser must meet the reporting requirements of this section by providing the required information concerning each controlled substance that it dispensed in a department-approved, secure methodology and format. Such approved formats may include, but are not limited to, submission via the Internet, on a disc, or by use of regular mail.



Section 5 Question 29 Entire Question Is Updated.

Which of the following drugs is/are classified as Schedule III controlled drug(s)?
 
I. Fiorinal
II. Fioricet
III. Codeine
 
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: (b) Both Fiorinal and Fioricet are classified as Schedule III drugs, [Florida Comprehensive Drug Abuse Prevention and Control Act 893.03(3)(a)(1)].
 
Florida Regulation:
 
*Please Note: Under the Florida State Pharmacy Law, Fioricet and Fiorinal are classified as Schedule III controlled drugs.
 
Section (3)(a): Any substance which contains any quantity of a derivative of barbituric acid, including thiobarbituric acid, or any salt of a derivative of barbituric acid or thiobarbituric acid, including, but not limited to, butabarbital and butalbital.
 
Federal Regulation:
-------------------------------
 
Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.
 
Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.
 
The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet. Interesting to note that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.
 
The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophen) is added.
 
The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg.
 
The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.



Section 4 Question 2 Answer Choice and Explanation Are Updated

Which of the following information is/are TRUE ABOUT Pharmacist to Registered Pharmacy Technician ratio?
 
I. Any pharmacy or any pharmacist engaged in sterile compounding shall not exceed a ratio of up to three (3) registered pharmacy technicians to one (1) pharmacist (3:1).
 
II. Any pharmacy or any pharmacist may allow a supervision ratio of up to four (4) registered pharmacy technicians to one (1) pharmacist (4:1), as long as the pharmacist or pharmacy is not engaged in sterile compounding.
 
III. Any pharmacy which does not dispense medicinal drugs, and the pharmacist(s) employed by such pharmacy, may allow a supervision ratio of up to twelve (12) registered pharmacy technicians to one (1) pharmacist (12:1), as long as the pharmacy or pharmacist is not involved in sterile compounding.
 
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: (b) I and II are true, (a) I only true [Florida Administrative Code 64B16-27.410(4),(5) and (6)]**
 
(4). Three to One (3:1) Ratio: Any pharmacy or any pharmacist engaged in sterile compounding shall not exceed a ratio of up to three (3) registered pharmacy technicians to one (1) pharmacist (3:1).
 
(5). Four to One (4:1) Ratio: Any pharmacy or any pharmacist may allow a supervision ratio of up to four (4) registered pharmacy technicians to one (1) pharmacist (4:1), as long as the pharmacist or pharmacy is not engaged in sterile compounding.
 
(5) Six to One (6:1) Ratio: Any pharmacy or any pharmacist may allow a supervision ratio of up to six (6) registered pharmacy technicians to one (1) pharmacist (6:1), as long as the pharmacist or pharmacy is not engaged in sterile compounding.
 
(6). Six to One (6:1) Ratio: (a). Non-dispensing pharmacies. Any pharmacy which does not dispense medicinal drugs, and the pharmacist(s) employed by such pharmacy, may allow a supervision ratio of up to six (6) registered pharmacy technicians to one (1) pharmacist (6:1), as long as the pharmacy or pharmacist is not involved in sterile compounding.
(6). Eight to One (8:1) Ratio:
 
(a). Non-dispensing pharmacies. Any pharmacy which does not dispense medicinal drugs, and the pharmacist(s) employed by such pharmacy, may allow a supervision ratio of up to eight (8) registered pharmacy technicians to one (1) pharmacist (8:1), as long as the pharmacy or pharmacist is not engaged in sterile compounding.
 
(b). Dispensing pharmacies. A pharmacy which dispenses medicinal drugs may utilize an eight to one (8:1) ratio in any physically separate area of the pharmacy from which medicinal drugs are not dispensed. A “physically separate area” is a part of the pharmacy which is separated by a permanent wall or other barrier which restricts access between the two areas.




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May 8, 2018  Texas State Pharmacy Law Updates/Corrections


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Section 2 Question 7 Answer Choice and Explanation Are Updated.

Within how many days after the date a controlled substance prescription is dispensed, a pharmacy must electronically submit controlled substance prescriptions information to the board?
 
a. 1 day
b. 2 days
c. 7 days
d. 15 days

Answer: (c) 7 days, (a) 1 day [Texas Administrative Code Title 22, Part 15, Chapter 315, 315.6].

Within seven days after the date a controlled substance prescription is dispensed, a pharmacy must electronically submit to the board the following data elements from all dispensed controlled substance prescriptions:

Effective September 1, 2017, Texas-licensed pharmacies are required to report all dispensed controlled substances records to the Texas PMP no later than the next business day after the prescription is completely filled. Pharmacies, who fail to report, are subject to an administrative, civil, or criminal penalty.




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January 14, 2018  North Carolina State Pharmacy Law Updates/Corrections


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Section 4 Question 9 Answer and Answer Explanation Are Updated.

The dispenser shall report the information required under the controlled substances reporting system no later than three business days after the day when the prescription was delivered.
 
a. True
b. False
 
Answer: (a) True (b) False, [NC Controlled Substances Act and Regulations  90-113.73(a)].
 
The Department shall establish and maintain a reporting system of prescriptions for all Schedule II through V controlled substances. Each dispenser shall submit the information in accordance with transmission methods and frequency established by rule by the Commission.
 
The Department may issue a waiver to a dispenser who is unable to submit prescription information by electronic means. The waiver may permit the dispenser to submit prescription information by paper form or other means, provided all information required of electronically submitted data is submitted.
 
The dispenser shall report the information required under this section no later than the three business days after the day when the prescription was delivered (begin counting the next day after the delivery date); however, dispensers are encouraged to report the information no later than 24 hours after the prescription was delivered.
 
The dispenser shall report the information required under this section no later than the close of the next business day after the prescription is delivered; however, dispensers are encouraged to report the information no later than 24 hours after the prescription was delivered.
 
The information shall be submitted in a format as determined annually by the Department based on the format used in the majority of the states operating a controlled substance reporting system.



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December 24, 2017  Georgia State Pharmacy Law Updates/Corrections


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Section 1 Question 1 Explanation IS Changed.

The Georgia State Pharmacy Board consists of seven pharmacist members and one consumer member.



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