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September 22, 2020  Immunization Quiz Updates/Corrections


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Section 3 Question 18 Answer is Updated.

Answer(a,b,d) is changed to (b,d).

Section 4 Question 46 Answer Choices Are Updated. 

a. True
b. False

a. Live, attenuated vaccine
b. Inactivated vaccine




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March 20, 2020  Montana Pharmacy Law Updates/Corrections


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Section 1 Question21 Explanation and Answer are updated.

A registered pharmacist in good standing may supervise the services of no more than three technicians at any given time.
 
a. True
b. False
 
Answer: (b) False  (a) True, [Administrative Rules Montana Board of Pharmacy 24.174.711].
 
(1). A registered pharmacist in good standing may supervise the services of no more than three technicians at any time. The 1:3 pharmacist to pharmacy technician ratio may be revised by the board at any time for good cause.
 
(2). Registered pharmacists in good standing in the state of Montana may supervise a maximum of three registered pharmacy technicians, provided:
 
(a). in the professional judgment of the pharmacist on duty, the policy and procedures of the pharmacy must allow for safe and accurate filling and labeling of prescriptions;
 
(b). the policy and procedures shall be reviewed annually. All affected supervising pharmacists and pharmacy technicians must be familiar with the contents and any changes made must be reported to the board; and
 
(c). a copy of the policy and procedures must be available for inspection by the board compliance officer.
 
(3). If a pharmacy desires more than three technicians to work under the supervision, direction, and control of one pharmacist, the pharmacy shall obtain the prior written approval of the board.
 
(1). A registered pharmacist in good standing may supervise the services of no more than four pharmacy technicians at any time. The 1:4 pharmacist to pharmacy technician ratio may be revised by the board at any time for good cause. A pharmacist intern does not count against the pharmacist to pharmacy technician ratio.
 
(2). Registered pharmacists in good standing in the state of Montana may supervise a maximum of four registered pharmacy technicians, provided:
 
(a). in the professional judgment of the pharmacist on duty, the policy and procedures of the pharmacy must allow for safe and accurate filling and labeling of prescriptions;
 
(b). the policy and procedures shall be reviewed annually. All affected supervising pharmacists and pharmacy technicians must be familiar with the contents and any changes made must be reported to the board; and
 
(c). a copy of the policy and procedures must be available for inspection by the board compliance officer.
 
(3). If a pharmacy desires more than four technicians to work under the supervision, direction, and control of one pharmacist, the pharmacy shall obtain the prior written approval of the board.




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March 8, 2020  New York Pharmacy Law Updates/Corrections


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Section 3 Question 17 Answer Explanation and Answer Choice are updated.

A patient brings a new prescription for Tylenol No. 3 with 5 eligible refills. The prescription is written on April 1, 2014. The prescription reads:
 
Tylenol No. 3:  1 tablet by mouth at bed time x 30 days. Refills: 5 times
 
A patient has requested medication to be partially filled. Below is the list of partially filled transactions:
 
1. 04/04/2014: 20 tablets
 
2. 05/05/2014: 40 tablets
 
3. 05/25/2014: 18 tablets
 
4. 06/09/2014: 23 tablets
 
5. 06/21/2014: 5 tablets
 
6. 08/11/2014: 35 tablets
 
7. 09/05/2014: 11 tablets
 
8. 10/11/2014: 36 tablets
 
9. 10/28/2014: 21 tablets
 
10. 11/05/2014: 6 tablets
 
Based on above information what shall be the dispensed quantities (legally)?
 
Answer: (b) 137 tablets, [Title 10-NYCRR, Chapter 80, Section 80.69(c)].
 
Answer: (b) 119 tablets, [Title 10-NYCRR, Chapter 80, Section 80.69(g) and 80.74(a),(j) and ].
 
Before we solve this question, we need to make sure three things for schedule III, IV and V controlled substances:
 
1. Prescription must be presented within 30 days of the date such prescription was signed by an authorized practitioner, In our example it was issued on April 1, 2019 and the patient had presented it to a pharmacy on April 4, 2019. So it is valid to be filled.
 
2. Schedule III, IV and V controlled substance may be refilled, provided, however, no such authorization shall be effective for longer than six months from the date the prescription is signed and that not more than five refills are made. When the initial prescription is issued for a quantity of substance in excess of a 30-day supply, the prescription may only be refilled once.
 
3. A pharmacist may partially fill a prescription for a controlled substance provided that:
 
(1). each partial filling is recorded in the same manner as a refill;
(2). the total quantity dispensed does not exceed the total quantity prescribed for a 30-day period.
 
In above example, the prescription expires on 10/01/2019 (six months from an issue date of 04/01/2019). Therefore, all partial filling before this date should be considered legal.
 
The second thing the pharmacist has to observe that the total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed.
 
The third and final things needs to be considered by the pharmacist that no partial filling may exceed more than 30 day supply worth of medication under New York State Pharmacy Law.
 
Therefore, 30 tablets shall be filled on 05/05/2019 and 08/11/2019 instead of 40 and 35 respectively. Also, the prescription cannot be partially filled on 05/25/2019 for 18 tablets since we have already partially filled 30-day supply for the month of May (e.g on 05/05/2019 30 tablets were filled).
 
The prescription is written for 180 tablets, 1 tablet by mouth qd x 30 days with additional 5 refills. When adding all the partial filling starting from 04/04/2019 to 09/05/2019 (excluding 10 tablets count for 05/05, 5 tablets count for 08/11 and 18 tablets for 05/25), the total quantities that the pharmacist can dispense legally come about 119 tablets.




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February 14, 2020  Federal Pharmacy Law Test 1 Updates/Corrections


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Section 2 Question 20 and 21 Are Updated.

Q. 20 Which of the following pregnancy categories shows the highest risk to the developing fetus?

a. Labeling does not require pregnancy risk categories letters.
b. Category B
c. Category D
d. Category X
 
Answer: (a), Labeling does not require pregnancy risk categories letters.  [Pregnancy and Lactation Labeling Rule of December 2014].
 
On December 13, 2014, the FDA published the Pregnancy and Lactation Labeling Final Rule (PLLR), which changed the labeling requirements for the pregnancy and lactation sections for prescription drugs.
 
The final rule removed the pregnancy letter categories, and created descriptive subsections for pregnancy exposure and risk, lactation, and effects to reproductive potential for females and males.
 
Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs using the labeling changes immediately. Previously approved drugs from June 30, 2001 will switch to the new labeling gradually.

Q. 21 The FDA published the Pregnancy and Lactation Labeling Final Rule does not apply to the labeling of:
 
I. Prescription drugs
II. Biological products
III. OTC products 

a. I only
b. III only
c. II and III only
d. All
 
Answer: (b) OTC drugs, [Pregnancy and Lactation Labeling Rule of December 2014].
 
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drug and biological products.
 
The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling.
 
For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation.
 
The final rule eliminates the "Labor and delivery" subsection because information about labor and delivery is included in the "Pregnancy" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential.
 
The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential.





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January 24, 2020  New York State Pharmacy Law Updates/Corrections


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Section 4 Question 4 Answer Is Updated.

Pharmacy interns may administer immunizations in New York State.
 
a. True
b. False
 
Answer: (b) False (a) True, [NY Rule 63.9(b)(4)]. [http://www.op.nysed.gov/prof/pharm/pharmimmunizationfaq.htm Question 7].
 
Pharmacy interns CANNOT administer immunizations in New York State. The law restricts administration of immunizations to certified licensed pharmacists only.
 
With the exception of a certified pharmacy intern, a certified pharmacist shall not delegate the administration of immunizations to another person. For purposes of this section, a certified pharmacy intern shall mean a pharmacy intern who is certified to administer immunization as specified in section 6806 of the Education Law and has completed the requirements set forth in subdivision (d) of section 63.4 of this Part. Such a certified pharmacy intern may only administer immunizations under the immediate personal supervision of the certified pharmacist.
 
No licensed pharmacist shall administer immunizing agents without a certificate of administration issued by the Department.
 
A certified pharmacist shall be authorized to administer to:
 
(i). patients 18 years of age or older, immunizing agents to prevent influenza, pneumococcal, acute herpes zoster, meningococcal, tetanus, diphtheria or pertussis disease, pursuant to a patient specific order or a non-patient specific order; and
 
(ii). patients between the ages of two and eighteen years of age, immunizing agents to prevent influenza, pursuant to a patient specific order or a non-patient specific order.




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November 26, 2019 The procedure for filling DEA Forms 222 has been changed since September 30, 2019


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(a). A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form.
 
(b). A supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number and the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser.
 
If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section.
 
(c). The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the DEA Form 222, except as specified in paragraph (f) of this section.
 
(d). The supplier must retain the original DEA Form 222 for the supplier's files in accordance with §1305.17(c). Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under §1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to DEA.Orderforms@usdoj.gov.
 
The copy must be forwarded at the close of the month (not the close of next month) during which the order is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires.
 
(e). The purchaser must record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.
 
(f). DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.


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January 2, 2019  Wisconsin State Pharmacy Law Updates/Corrections


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Section 4 Question 6 is updated.

Which of the following information related to controlled substances shall be submitted to Wisconsin prescription drug monitoring program (PDMP)?
 
I. The NDC number of the monitored prescription drug.
 
II. The estimated number of days of drug therapy.
 
III. The classification code for payment type.
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: (d) All, [Wisconsin Administrative Code Chapter CSB-4 CSB 4.04].
 
A dispenser shall compile dispensing data that contains information about each time he or she dispenses a monitored prescription drug to a patient.
 
The dispensing data shall contain all of the following information:
 
(a). The dispenser's full name.
 
(b). The dispenser's DEA registration number.
 
(c). The date dispensed.
 
(d). The prescription number.
 
(e). The NDC number of the monitored prescription drug.
 
(f). The quantity dispensed.
 
(g). The estimated number of days of drug therapy.
 
(ge). The classification code for payment type.
 
(gm). The number of refills authorized by the prescriber.
 
(gs). The refill number of the prescription.
 
(h). The practitioner's full name.
 
(i). The practitioner's DEA registration number.
 
(j). The date prescribed.
 
(L). The patient's full name or if the patient is an animal, the animal's name and the owner's last name.
 
(m). The patient's address, or if the patient is an animal, patient's owner's address, including street address, city, state, and ZIP code.
 
(n). The patient's date of birth, or if the patient is an animal, patient's owner's date of birth.
 
(o). The patient's gender.
 
(p). The name recorded.



Section 4 Question 7 is updated.

The board shall exempt a dispenser from compiling and submitting dispensing data and from submitting a zero report to PDMP if the dispenser provides evidence sufficient to the board that the dispenser does not dispense monitored prescription drugs.
 
a. True
b. False
 
Answer: (a) True, [Wisconsin Administrative Code Chapter CSB-4 CSB 4.08].
 
(1). The board shall exempt a dispenser from compiling and submitting dispensing data and from submitting a zero report as required under this chapter until the dispenser is required to renew its license, or until the dispenser dispenses a monitored prescription drug, if the dispenser satisfies all of the following conditions:
 
(a). The dispenser provides evidence sufficient to the board that the dispenser does not dispense monitored prescription drugs.
 
(b). The dispenser files with the board a written request for exemption on a form provided by the board.
 
(2). A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is administered directly to a patient.
 
(2m). A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is compounded, packaged, or labeled in preparation for delivery but is not delivered.
 
(3). A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is a substance listed in the schedule in s. 961.22, Stats., and is not a narcotic drug, and is dispensed pursuant to a prescription order for a number of doses that is intended to last the patient 7 days or less.



Section 4 Question 8 is updated.

Which of the following information about dispensing data submission to PDMP (Wisconsin Prescription Drug Monitoring Program) is/are TRUE?
 
I. A dispenser shall submit dispensing data to the board within 10 days of dispensing a monitored prescription drug.
 
II. If a dispenser does not dispense a monitored prescription drug for 10 days, the dispenser shall submit a zero report to the board.
 
III. If a dispenser is not able to submit dispensing data within 10 days of dispensing a monitored prescription drug, the board may grant an emergency waiver to a dispenser.
 
a. I only
b. I and II only
c. All
d. None of the above
 
Answer: (d) None of the above are true, [Wisconsin Administrative Code Chapter CSB-4 CSB 4.06].
 
(1). A dispenser shall submit dispensing data to the PDMP no later than 11:59 p.m. of the next business day after the monitored prescription drug is dispensed.
 
(2). If a dispenser does not dispense a monitored prescription drug on a business day, the dispenser shall submit no later than 11:59 p.m. of the next business day a zero report to the PDMP that accounts for each business day on which the dispenser did not dispense a monitored prescription drug.
 
(3). If a dispenser is not able to submit dispensing data zero report before 11:59 p.m. of the next business day as required by subs. (1) or (2), the board may grant an emergency waiver to a dispenser who satisfies all of the following conditions:
 
(a). The dispenser is not able to submit dispensing data or a zero report because of circumstances beyond its control.
 
(b). The dispenser files with the board a written application for an emergency waiver on a form provided by the board prior to the required submission of dispensing data or zero report.
 
Note: The application for an emergency waiver may be obtained online at www.dsps.wi.gov or obtained at no charge from the Department of Safety and Professional Services, 1400 East Washington Avenue, P.O. Box 8366, Madison, WI 53708.
 
(4). Unless otherwise specified by the board, an emergency waiver granted under sub. (3) shall only be effective for 7 days.
 
(5). The board may refer a dispenser and dispenser delegate that fail to submit dispensing data or a zero report as required by subs. (1) and (2), or be granted an emergency waiver under sub. (3), or a dispenser and a dispenser delegate that submit false information to the PDMP to the appropriate licensing or regulatory board for discipline.



Section 4 Question 9 is updated.

If a dispenser discovers omissions or inaccuracies in previously submitted dispensing data or other PDMP information, the dispenser shall notify the board in writing within 72 hours and submit documentation that identifies the erroneous information and includes the correct information.
 
a. True
b. False
 
Answer: (b) False, [Wisconsin Administrative Code Chapter CSB-4 CSB 4.07].
 
A dispenser shall electronically correct dispensing data in the PDMP system within 5 business days of discovering an omission, error, or inaccuracy in previously submitted dispensing data.




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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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