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May 31, 2017  West Virginia State Pharmacy Law Updates/Corrections


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Section 5 Question 5 Entire Question Is Replaced With New Question

Which of the following drugs is classified as a Schedule III drug?
 
a. Fioricet
b. Fiorinal
c. Codeine
d. Lorazepam
 
Answer: (b) Fiorinal (Butalbital with Aspirin) is classified as a Schedule III drug, [Section 811(g) (3) (A) of the Controlled Substances Act].
 
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.

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, [http://www.wvbop.com/index.php?option=com_content&view=article&id=67&Itemid=96].
 
West Virginia Regulation:
 
West Virginia has its own controlled substances act and it schedules several things that the DEA exempts.  For example, Fioricet and Fiorinal are treated the same here as controlled drugs, whereas the DEA schedules one but exempts the other. 
 
The Board has fielded several questions recently on state versus federal scheduling of Chlordiazepoxide and Butalbital products.  Federal law has some exemptions for some of these.  However, our state law is tighter. To reiterate and flesh things out:
 
For Butalbital containing products in Schedule III of state statutes, West Virginia Code § 60A-2-208(c)(3) states that any substance which contains any quantity of a derivative of barbituric acid or any salt of barbituric acid is a CIII, and subsection (6) specifically states “Butalbital (including, but not limited to Fioricet)” is included as a CIII. 
 
So, we treat Fioricet and Fiorinal the same under state law since they both contain butalbital, which comes from barbituric acid.
 
For products containing Chlordiazepoxide, regardless of federal exemptions, the state statute for Schedule IV at West Virginia Code § 60A-2-210(c)(8) specifically includes Chlordiazepoxide.
 
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 26, 2017  Arkansas State Pharmacy Law Updates/Corrections


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Section 2 Question 22 Answer Explanation, Answer are Updated.

Each pharmacist on duty in a retail or specialty pharmacy may utilize three pharmacy technicians to assist the pharmacist.

a. True
b. False
 
Answer: False True, [Arkansas State Board of Pharmacy Regulations 03-00-0007(a)].
 
(a). Retail or Specialty Pharmacy Settings
 
(1). Each pharmacist on duty in a retail or specialty pharmacy may utilize two three pharmacy technicians to assist the pharmacist.



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March 3, 2017  Florida State Pharmacy Law Updates/Corrections


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Section 3 Question 7 Answer Choice Is Updated.

The stocking or restocking of a medicinal drug for an Automated Pharmacy System in a Community Pharmacy shall only be completed by a Florida licensed pharmacist.
 
a. True
b. False

Answer: (a) True, (b) False [Florida Administrative Code 64B16-28.141(3)(b)(c)(d)].

The stocking or restocking of a medicinal drug shall ONLY be completed by a Florida licensed pharmacist, EXCEPT as provided in paragraph (c) below.
 
(c). If the automated pharmacy system uses removable cartridges or container to store the drug, the stocking or restocking of the cartridges or containers may occur at a licensed repackaging facility and be sent to the provider pharmacy to be loaded by personnel designated by the pharmacist if:
 
1. A Florida pharmacist verifies the cartridge or container has been properly filled and labeled.
 
2. The individual cartridge or container is transported to the provider pharmacy in a secure, tamper-evident container.
 
3. The automated pharmacy system uses a bar code verification, electronic verification, weight verification, radio frequency identification (RFID) or similar process to ensure that the cartridge or container is accurately loaded into the automated pharmacy system.
 
4. The Florida pharmacist verifying the filling and labeling is responsible if the cartridge or container is stocked or restocked incorrectly by the personnel designated to load the cartridges or containers.


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November 16, 2016  Oregon State Pharmacy Law Updates/Corrections


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Section 1 Question 16 Answer and Explanation Are Updated.

Oregon State Board of Pharmacy consists of how many members?
 
a. 2
b. 5
c. 7
d. 9
 
7 members, 9 members [Oregon Pharmacy Act 689.115].
 
The State Board of Pharmacy consists of seven members nine members appointed by the Governor. All members of the board must be residents of this state. Of the members of the board:
 
(a). Five must be licensed pharmacists.
(b). Two must be licensed pharmacy technicians.
(b). (c). Two must be members of the public who are not licensed pharmacists or a spouse, domestic partner, child, parent or sibling of a pharmacist.


Section 2 Answer, Answer Choice and Explanation Are Updated.

A pharmacist may administer vaccines to persons who are at least:
 
a. 18 years of age.
b. 16 years of age.
c. 21 years of age.
d. 11 years of age. 7 years of age.
 
11 years of age, 7 years of age. [Oregon Pharmacy Act 689.645].
 
(1). A pharmacist may administer vaccines to persons who are at least 11 years of age.
     
(2). The board may adopt rules allowing a pharmacist to prescribe vaccines to persons who are at least 11 years of age. The rules may only be as broad as necessary to enable pharmacists to enroll and participate in the Vaccines for Children Program administered by the Centers for Disease Control and Prevention.
 
(3). The board is authorized to issue, to licensed pharmacists who have completed training accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body, certificates of special competency in the prescription and administration of vaccines to persons who are at least 11 years of age.
 
 (1). In accordance with rules adopted by the State Board of Pharmacy under ORS 689.205, a pharmacist may:

 (a). Administer vaccines:

 (A). To persons who are seven years of age or older; or

 (B). If authorized by the Governor under ORS 433.441 or the Public Health Director under ORS 433.443 or 433.444, to a person three years of age or older.


Section 2 Question 26 Answer Explanation Is Updated.

All, [OAR 855-019-0200(3)].
 
An intern under the supervision of a pharmacist may perform all the duties of a technician and the following:
 
(A). Counseling;
 
(B). Performing DUR;
 
(C). Oral receipt or transfer of a prescription,
 
(D). Immunizations if appropriately trained, and supervised by an immunization qualified pharmacist;
 
(E). Other activities approved in writing by the Board.
 
(2). Only a pharmacist may practice pharmacy as defined in ORS 689.005, to include the provision of patient care services. Activities that require the professional judgment of a pharmacist include but are not limited to:

(a). Drug Utilization Review;
(b). Counseling;
(c). Drug Regimen Review;
(d). Medication Therapy Management;
(e). Collaborative Drug Therapy Management or other post-diagnostic disease state management, pursuant to a valid agreement;
(f). Practice pursuant to State Drug Therapy Management Protocols;
(g). Ordering, interpreting and monitoring of a laboratory test;
(h). Oral receipt or transfer of a prescription; and
(i). Final verification of the work performed by those under their supervision.

(3). A pharmacist may not delegate any task listed in OAR 855-019-0200(2), EXCEPT that a pharmacist may PERMIT an intern to perform the duties of a pharmacist under their direction and supervision, after the intern has successfully completed his or her first academic year, and only after successful completion of coursework corresponding to those duties.

(4). An intern cannot perform final verification.


Section 2 Question 28 Answer Explanation Is Updated.

A pharmacist must notify the Board in writing, within 15 days, of any change in employment location or residence address.
 
True, [OAR 855-019-0205(7)].
 
1. A pharmacist must notify the Board in writing, within 15 days, of any change in employment location or residence address.
 
2. A pharmacist who has reasonable grounds to believe that prescription drugs or records have been lost or stolen, or any violation of these rules has occurred, must notify the Board within 10 days.
 
3. A pharmacist must report to the Board within 10 days if they:
 
(a). Are convicted of a misdemeanor or a felony; or
 
(b). If they are arrested for a felony.
 
(3). A pharmacist must report to the Board within 10 days if they:

(a). Are convicted of a misdemeanor or a felony; or
 
(b). If they are arrested for a felony.

(4). A pharmacist who has reasonable cause to believe that another licensee (of the Board or any other Health Professional Regulatory Board) has engaged in prohibited or unprofessional conduct as these terms are defined in OAR 855-006-0005, must report that conduct to the board responsible for the licensee who is believed to have engaged in the conduct. The reporting pharmacist shall report the conduct without undue delay, but in no event later than 10 working days after the pharmacist learns of the conduct unless federal laws relating to confidentiality or the protection of health information prohibit disclosure.

(5). A pharmacist who reports to a board in good faith as required by section (4) of this rule is immune from civil liability for making the report.

(6). A pharmacist who has reasonable grounds to believe that any violation of these rules has occurred, must notify the Board within 10 days. However, in the event of a significant drug loss or violation related to drug theft, the pharmacist shall notify the Board within one (1) business day.

(7). A pharmacist must notify the Board in writing, within 15 days, of any change in e-mail address, employment location or residence address.


Section 4 Question 9 Answer Explanation Is Updated.

Which of the following statements are NOT TRUE about vaccinations by pharmacists under Oregon State Pharmacy Law?
 
I. A pharmacist may administer vaccines and immunizations to persons who are at least 15 years of age.
 
II. A pharmacist must have completed a course of training accredited by the Centers for Disease Control and Prevention.
 
III. The pharmacist must hold a current basic Cardiopulmonary Resuscitation (CPR) certification issued by the American Heart Association.
 
a. I only
b. I and II only
c. II and III only
d. All
 
I is not true, [Oregon Administrative Rules (OARs) 855-019-0270 and 855-019-0280].
 
A pharmacist may administer vaccines to persons who are at least 11 years (NOT 15 years) of age as provided by these rules. For the purposes of this rule, a person is at least 11 years of age on the day of the person's eleventh birthday.
 
(3). A pharmacist may administer vaccines under Section (1) or Section (2) of this rule only if:
 
(a). The pharmacist has completed a course of training approved by the Board;
 
(b). The pharmacist holds a current basic Cardiopulmonary Resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross or any other equivalent program that contains a hands-on training component and is valid for not more than three years, and documentation of the certification is placed on file in the pharmacy;
 
(c). The vaccines are administered in accordance with an administration protocol written and approved by the Oregon Health Authority (OHA); and
 
(d). The pharmacist has a current copy of the CDC reference, "Epidemiology and Prevention of Vaccine-Preventable Diseases."
 
(4). A pharmacist may not delegate the administration of vaccines to another person.
 
(5). Prior to administering a vaccine to a person who is at least 11 years of age a pharmacist must follow protocols written and approved by the Oregon Health Authority (OHA)for administration of vaccines and the treatment of severe adverse events following administration of a vaccine.
 
(6). The pharmacy must maintain written policies and procedures for handling and disposal of used or contaminated equipment and supplies.
 
(7). The pharmacist must give the appropriate Vaccine Information Statement (VIS) to the patient or legal representative with each dose of vaccine covered by these forms. The pharmacist must ensure that the patient or legal representative is available and has read, or has had read to them, the information provided and has had their questions answered prior to administering the vaccine.
 
(8). The pharmacist must report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient.
 
(9). The pharmacist must make available the Adolescent Well Visit Referral document, provided by the OHA, to a patient aged 11 through 18 years of age or their legal representative.
 
(10). The pharmacist may administer or dispense an oral vaccine as established by written protocols approved by OHA.
 
(2). A pharmacist may administer vaccines to persons who are at least 7 years of age as provided by these rules. For the purposes of this rule, a person is at least 7 years of age on the day of the person's seventh birthday.

(3). A pharmacist may administer vaccines under section (1) or section (2) of this rule only if:

(a). The pharmacist has completed a course of training approved by the Board and maintained competency;
(b). The pharmacist training includes, injection site, and Cardiopulmonary Resuscitation (CPR) specific to the age and population the pharmacist treats;

(c). The pharmacist holds active CPR certification issued by the American Heart Association or the American Red Cross or any other equivalent program intended for a healthcare provider that contains a hands-on training component and is valid for not more than three years, and documentation of the certification is placed on file in the pharmacy;

(d). The vaccines are administered in accordance with an administration protocol written and approved by the Oregon Health Authority (OHA); and

(e). The pharmacist has a current copy of the CDC reference, "Epidemiology and Prevention of Vaccine Preventable Diseases."

(4) A pharmacist otherwise in compliance with section three of this rule may, during a declared emergency, administer a vaccine to a person who is at least three (3) years of age when;

(a). The Governor declares a state of public health emergency and authorizes the reduced age limitation;

or

(b). The Public Health Director, during a declared disease outbreak, authorizes a reduction in the age limit.

(5). A pharmacist may not delegate the administration of vaccines to another person.

(1). Prior to administering a vaccine to a person who is at least 7 years of age a pharmacist must follow protocols written and approved by the Oregon Health Authority (OHA) for administration of vaccines and the treatment of severe adverse events following administration of a vaccine.

(2). A pharmacist during a declared emergency may administer a vaccine to a person who is at least three (3) years of age when;

(a). The Governor declares a state of public health emergency and authorizes the reduced age limitation;

or

(b). The Public Health Director, during a declared disease outbreak, authorizes a reduction in the age limit.

(3). The pharmacy must maintain written policies and procedures for handling and disposal of used or contaminated equipment and supplies.

(4). The pharmacist must give the appropriate Vaccine Information Statement (VIS) to the patient or legal representative with each dose of vaccine covered by these forms. The pharmacist must ensure that the patient or legal representative is available and has read, or has had read to them, the information provided and has had their questions answered prior to administering the vaccine.

(5). The pharmacist must report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient.

(6). The pharmacist may prescribe, administer or dispense immunizations, including oral vaccines, as established by written protocols approved by OHA.


Section 5 Question 27 Answer Is Changed.

Physician assistant and licensed nurse practitioner, All,

[http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].



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November 8, 2016  New York State Pharmacy Law Updates/Corrections


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Section 1 Question 27 Entire Question Is Updated.

Which of the following is/are treated as Schedule II controlled drug(s) under the New York State Pharmacy Law?
 
I. Oxazepam
II. Zaleplon
III. Estazolam
 
a. I only
b. I and II only
c. II and III only
d. All
 
All, [Title 10-NYCRR, Part 80 Section 80.67(a)].
 
Please note under New York State Pharmacy Law, all schedule IV benzodiazepines shall be treated as schedule II controlled substances.
 
Which of the following is/are treated as Schedule II controlled drug(s) under the New York State Pharmacy Law?
 
I. Oxazepam
II. Estazolam
III. Zaleplon
 
I and II only, [Title 10-NYCRR, Part 80 Section 80.67(a)].
 
Please note under New York State Pharmacy Law, all schedule IV benzodiazepines shall be treated as schedule II controlled substances. Non-Benzodiazepine Zaleplon (Sonata), Zolpidem (Ambien), Zopiclone (Imovane) and Eszopiclone (Lunesta) are NOT TREATED as Schedule II controlled drugs.
 
All such benzodiazepines shall be issued on the official New York State prescription form and shall not be refilled.



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November 4, 2016  Massachusetts State Pharmacy Law Updates/Corrections


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Section 2 Question 25 Entire Question Is Updated.

Under Controlled Substances Act (CSA), what changes may a pharmacist make to a prescription written for a controlled substance in schedule II after verbally consulting with a practitioner?
 
I. The dosage form of the drug
II. The name of the controlled substance
III. The quantity prescribed
 
a. I only
b. I and II only
c. II and III only
d. All
 
None of the above, [http://www.deadiversion.usdoj.gov/faq/general.htm and http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm].
 
On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921).
 
In the preamble to that Rule, DEA stated that "the essential elements of the prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed, and--in the case of multiple prescriptions under this Final Rule--the earliest date on which the prescription may be filled) may not be modified orally."
 
The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber.
 
DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking.  Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.
 
What changes may a pharmacist make to a prescription written for a controlled substance in schedule II after verbally consulting with a practitioner or practitioner agent?
 
I. The dosage form of the drug
II. The drug strength  
III. The quantity prescribed
 
a. I only
b. I and II only
c. II and III only
d. All
 
All can be changed, [http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/pharmacy-joint-policy-2012-01-
prescrip-changes.pdf ].
 
For All schedules (Schedule II – Schedule VI) the following prescription information may NEVER be changed or added (a new prescription would require).
 
a. Patient’s name
b. Drug product (except for permitted generic substitution)
c. Prescriber’s name
d. Prescriber’s signature
e. Issue date/earliest date to be filled***
 
***Earliest date to be filled
 
In the rule response to public comments, DEA affirmed that no oral modifications may be made to the earliest date that a schedule II prescription may be filled.
 
Regarding the rule, Federal regulations 21 CFR 1306.14(e) states:
 
"When a prescription that has been prepared in accordance with section 1306.12 contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the schedule II prescription before that date."
 
Schedule II prescription information that a pharmacist MAY change or add after consultation with prescriber or prescriber’s agent
                                                                
1. Prescriber’s address
2. Patient’s address*                                                    
3. Prescriber’s DEA No. **
4. Directions for use                                                                     
5. Dosage form                                      
6. Refill Information                                                           
7. Drug strength                                    
8. Generic substitution (as permitted by state law)  
9. Quantity prescribed 
            
*   A patient’s address may be:
 
(a). Added if not included on the original prescription, without consultation with the prescriber or agent;
 
OR
 
(b). Changed after consultation with the prescriber or agent. 
 
** A Prescriber’s DEA No. may be added to a valid prescription without consultation with the prescriber or agent.
 
Methods for prescriber to communicate Schedule II prescription information changes or additions:
 
(a) Written: A prescriber may provide written changes or additions by mail or electronic transmissions, including e-mail and facsimile. The pharmacist must attach the written changes, including notation of the receiving changes, on the original prescription. In addition, the pharmacist must document the date and name of the prescriber authorizing the changes to the prescription.
 
(b) Oral:
 
A prescriber may orally communicate changes or additions to the pharmacist. The pharmacist must document the date, changes or additions and the name of the authorizing prescriber on the front or back of the original prescription.



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October 21, 2016  South Dakota State Pharmacy Law Updates/Corrections


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Section 3 Question 7 Answer and Answer Explanation Are Updated.

According to South Dakota State Pharmacy Law, the ratio of pharmacy technicians to pharmacists that may be on duty in a pharmacy at a given time is two technicians for every pharmacist.
 
True, False [South Dakota Administrative Rule 20:51:29:19 and 20:51:29:19.01].
 
The ratio of pharmacy technicians to pharmacists that may be on duty in a pharmacy at a given time is two technicians for every pharmacist.
 
A pharmacy intern does not count in this ratio. The maximum ratio of pharmacy technicians to pharmacists that may be on duty in a mail service pharmacy is four technicians for every pharmacist on duty.
 
Exception for mail service pharmacy:
 
Technicians above a 2:1 ratio must have completed a board-approved pharmacy technician education program or have passed a pharmacy technician certification examination that is accredited by the National Commission for Certifying Agencies (NCCA).
 
The ratio of pharmacy technicians to pharmacists that may be on duty in a pharmacy at a given time is three technicians for every pharmacist. A pharmacy intern does not count in this ratio.


Section 4 Question 1 Answer and Answer Explanation Are Updated.

The MAXIMUM ratio of pharmacy technicians to pharmacists that may be on duty in a retail, hospital, and long-term care pharmacy is three technicians for every pharmacist on duty.
True, [South Dakota Administrative Rule 20:51:29:19.02].
 
Rule 20:51:29:19 says: The ratio of pharmacy technicians to pharmacists that may be on duty in a pharmacy at a given time is two technicians for every pharmacist.
 
Rule 20:51:29:19.02 says: The maximum ratio of pharmacy technicians to pharmacists that may be on duty in a retail, hospital, and long-term care pharmacy is three technicians for every pharmacist on duty.
 
False, [South Dakota Administrative Rule 20:51:29:19.02].
 
The maximum ratio of pharmacy technicians to pharmacists that may be on duty in a hospital, mail order, and long-term care pharmacy will be determined by the pharmacist in charge. However, all of the following requirements must be met:

(1). Medication is dispensed pursuant to a legal prescription;

(2). The technology includes tablet or product imaging and or bar code scanning, or both, to insure accuracy in the prescription filling process;

(3). A role-based access software automation system that places stop points within the prescription filling process is used, which requires a pharmacist's intervention before allowing the prescription to move to the next step in the prescription dispensing process;

(4). Pharmacy software that screens and detects drug allergies, identifies drug interactions, and checks age appropriate dosage ranges is used;

(5). A pharmacist reviews clinically significant computer warnings of drug interactions, therapy duplications, and contraindications;

(6). Electronic surveillance technology is used to control access or to provide continuous monitoring of all areas where drugs are stored or dispensed or both;

(7). All non-pharmacist personnel who input patient drug information into a computer or whose duties include receiving, packaging, shipping of drugs, or who have access to any areas where drugs are dispensed are registered as pharmacy technicians and meet the requirements in chapter 20:51:29;

(8). In hospital and long-term care pharmacies, nursing personnel in facilities served by the pharmacy have telephone access to a pharmacist 24 hours a day, 7 days a week. In mail order pharmacies, a patient has access to a pharmacist 24 hours a day, 7 days a week on a dedicated pharmacist staff line;

(9). Drug information, both electronic and hard copy, is readily available to pharmacists;

(10). A quality assurance program that identifies and evaluates dispensing errors, accompanied by a continuous quality improvement program that assures very high dispensing accuracy rates in place;

(11). There are written policies and procedures for all pharmacy functions -- clerical, supportive, technical, and clinical;

(12). There are written policies and procedures for training personnel, including on-going training programs for all personnel and documentation of that training for each employee;

(13). There is a strict monitoring program designed to prevent diversion of controlled substances. This includes perpetual inventory of all schedule II controlled drugs as well as selected high-risk schedule III, IV, and V drugs. Routine audits are conducted to review purchases versus dispensing of controlled drugs to deter and detect diversion.


Section 4 Question 9 Answer and Answer Explanation Are Updated.

Which of the following information is/are TRUE about a ratio of pharmacy technician to pharmacist in Remote Pharmacy?
 
I. The pharmacist on duty at a central pharmacy may supervise no more than two pharmacy technicians.
 
II. The total number of allowed technicians may be divided between the central pharmacy and the remote pharmacy in any manner.
 
III. Each remote pharmacy must have at least one pharmacy technician or pharmacy intern on duty when it is open.
 
a. I only
b. I and II only
c. II and III only
d. All

All, II and III only, [South Dakota Administrative Rule 20:51:30:13 and 20:51:29:19].
 
Section 20:51:29:19: The ratio of pharmacy technicians to pharmacists that may be on duty in a pharmacy at a given time is two technicians THREE technicians for every pharmacist.
 
The pharmacist on duty at a central pharmacy may supervise no more than the number of technicians allowed in accordance with § 20:51:29:19.
 
The total number of allowed technicians may be divided between the central pharmacy and the remote pharmacy in any manner.
 
However, each remote pharmacy must have at least one pharmacy technician or pharmacy intern on duty when it is open.



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September 26, 2016  Mississippi State Pharmacy Law Updates/Corrections


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Section 1 Question 3 Answer Explanation Is Updated.

Which of the following statements is/are TRUE about renewing a pharmacist license?
 
I. Every pharmacist shall renew his license annually.
 
II. Any pharmacist who has defaulted in license renewal may be reinstated within 2 years upon payment of renewal fees and presentation of evidence of the required continuing education.
 
III. Any pharmacist defaulting in license renewal for a period in excess of 2 years shall be required to successfully complete the examination taken by the board before being eligible for reinstatement as a pharmacist in Mississippi.
 
All, [Mississippi Pharmacy Act 73-21-91].
 
(1). Every pharmacist shall renew his license annually. To renew his license, a pharmacist shall:
 
(a). Submit an application for renewal on the form prescribed by the board;
 
(b). Submit satisfactory evidence of the completion in the last licensure period of such continuing education units as shall be required by the board, but in no case less than one (1) continuing education unit in the last licensure period.
 
(c) (i) Pay any renewal fees as required by the board, not to exceed One Hundred Dollars ($ 100.00) for each annual licensing period, provided that the board may add a surcharge of not more than Five Dollars ($ 5.00) to a license renewal fee to fund a program to aid impaired pharmacists or pharmacy students. Any pharmacist license renewal received postmarked after December 31 of the renewal period will be returned and a Fifty Dollar ($50.00) late renewal fee will be assessed before renewal.

(ii) The license fee for a pharmacy benefit manager shall be set by the board, but shall not exceed Five Hundred Dollars ($ 500.00). Any license renewal received postmarked after December 31 of the renewal period will be returned and a Five Hundred Dollar ($ 500.00) late renewal fee will be assessed before renewal.
 
(2). Any pharmacist who has defaulted in license renewal may be reinstated within 2 years upon payment of renewal fees and presentation of evidence of the required continuing education.
 
(3). Any pharmacist defaulting in license renewal for a period in excess of 2 years shall be required to successfully complete the examination taken by the board before being eligible for reinstatement as a pharmacist in Mississippi.
 
OR
 
(4). Shall be required to appear before the board to be examined for his competence and knowledge of the practice of pharmacy, and may be required to submit evidence of continuing education.
 
If the person is found fit by the board to practice pharmacy in this state, the board may reinstate his license to practice pharmacy upon payment of all renewal fees.

Section 1 Question 15 Answer Explanation Is Updated.

Each pharmacist shall renew his/her license annually.
 
1. To renew his/her license, a pharmacist shall:
 
A. Submit an application for renewal on the form prescribed by the Board or through the online process found at the Mississippi Board of Pharmacy webpage;
 
B. On the application, indicate and certify the number of continuing education hours earned for Licensure: One (1) continuing education unit (10 hours) is required for each licensure period.
 
Each newly licensed pharmacist, effective May 1, 2013, in the State of Mississippi be required to attend a Mississippi Association of Recovering Pharmacists(MARP) sponsored seminar consisting of a minimum of six (6) continuing education contact hours once during his/her first five (5) years of licensure.
 
This requirement will only apply to Mississippi licensed Pharmacists who actively engage in the practice of pharmacy in the State of Mississippi.
 
iii. A pharmacist licensed by the Mississippi Board of Pharmacy must be a registered user of the Prescription Monitoring Program.
 
D. Any pharmacist license renewal application postmarked after December 31 of the renewal period or submitted online after 11:59 P.M. CST shall be returned or rejected and a fifty dollar ($50.00) late renewal fee shall be assessed prior to renewal.
 
E. Any license not renewed by January 15th may be considered invalid and may be subject to disciplinary action by the Board.


Section 1 Question 17 Answer Explanation Is Updated.

The Pharmacy Board shall by regulation determine the classification of permit(s) that shall be required. The biennial fee for an original or renewal permit shall not exceed Three Hundred Dollars ($300.00) Five Hundred Dollars ($500.00).
 
Any Pharmacy permit renewal application postmarked after December 31 of the renewal period shall be returned and a fifty ($50.00) late renewal fee shall be assessed prior to renewal.


Section 2 Question 6 Answer Explanation Is Updated.

(c). Not later than fifteen (15) days after the date the pharmacy benefit manager actually receives an electronic claim, the pharmacy benefit manager shall pay the appropriate benefit in full, or any portion of the claim that is clean, and notify the pharmacist or pharmacy (where the claim is owed to the pharmacist or pharmacy) of the reasons why the claim or portion thereof is not clean and will not be paid and what substantiating documentation and information is required to adjudicate the claim as clean.
 
Not later than thirty-five (35) days after the date the pharmacy benefit manager actually receives a paper claim, the pharmacy benefit manager shall pay the appropriate benefit in full, or any portion of the claim that is clean, and notify the pharmacist or pharmacy (where the claim is owed to the pharmacist or pharmacy) of the reasons why the claim or portion thereof is not clean and will not be paid and what substantiating documentation and information is required to adjudicate the claim as clean.
 
Any claim or portion thereof resubmitted with the supporting documentation and information requested by the pharmacy benefit manager shall be paid within twenty (20) days after receipt.
 
(4). If the board finds that any pharmacy benefit manager, agent or other party responsible for reimbursement for prescription drugs and other products and supplies has not paid ninety-five percent (95%) of clean claims as defined in subsection (3) of this section received from all pharmacies in a calendar quarter, he shall be subject to administrative penalty of not more than Twenty-five Thousand Dollars ($ 25,000.00) to be assessed by the State Board of Pharmacy.


Section 2 Question 15 Answer and Answer Explanation Is Updated.

True False, [Mississippi Pharmacy Regulations Article: XL Section:(4),(A)].
 
It has been determined by the Board that two (2) three (3) technicians on duty performing technician related work directly related to the dispensing of medications are sufficient for each licensed pharmacist on duty.
 
Support personnel used solely for clerical duties such as filing prescriptions, delivery and general record keeping need not be included in the ratios of the functions performed by a pharmacy technician.


Section 3 Question 1 Answer and Answer Explanation Are Updated.

False True, [Mississippi Pharmacy Regulations Article: VIII Section:(1),(C),(5)].
 
A pharmacist shall not be assisted by more than two pharmacy technicians three pharmacy technicians.
 
In the dispensing of drugs from a pharmacy, it shall be the responsibility of the supervising pharmacist to prevent the pharmacy technician from performing those functions relative to dispensing which are functions based on a judgment for which the pharmacy technician has not been prepared by education or authorized by law or regulation.



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September 25, 2016 Washington State Pharmacy Law Updates/Corrections


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Section 2 Question 17

Recently, Washington State Pharmacy Law has dispose of the entire section regarding Schedule V controlled substance OTC dispensing. Following questions on our quiz are affected and completely replaced with new questions.

Section 2: Q.17 and Q.22
Section 3: Q.9, Q.10, Q.12 and Q.30
Section 4: Q.10 and Q.11
 
Which of the following information about Introductory trade or stock packages is/are TRUE?
 
I.  The package shall be invoiced by the drug manufacturer as a no charge sale.
 
II. The product shall be distributed by the manufacturer to the pharmacy by mail or common carrier.
 
III.  The manufacturer shall be limited to distributing one introductory package of each dosage strength of a product on a one-time basis to a pharmacy in order to familiarize.
 
a. I only
b. I and II only
c. II and III only
d. All
 
All, [Washington Administrative Code WAC 246-883-025].
 
Introductory trade or stock packages may be distributed by registered drug manufacturers to licensed pharmacies under the following conditions:
 
(1). The package shall be invoiced by the drug manufacturer as a no charge sale.
 
(2). The product shall be distributed by the manufacturer to the pharmacy by mail or common carrier.
 
(3). The drug's package shall not be marked as a sample or with any other labeling that is inconsistent with the claim that the manufacturer intended the package for sale.
 
(4). The manufacturer shall be limited to distributing one introductory package of each dosage strength of a product on a one-time basis to a pharmacy in order to familiarize and assure that a company's new product will be available in pharmacies. The quantity shall not be larger than one hundred solid dosage units or sixteen liquid ounces.



Section 2 Question 22

No prescription in Washington State can be filled by the pharmacist if prescriber DOES NOT sign under the line stated "Dispense As Written" or "Substitution Permitted".
 
True, [Revised Code of Washington RCW-69.41.120(1)].
 
(1). Every drug prescription shall contain an instruction on whether or not a therapeutically equivalent generic drug or interchangeable biological product may be substituted in its place, unless substitution is permitted under a prior-consent authorization.
 
If a written prescription is involved, the prescription must be legible and the form shall have two signature lines at opposite ends on the bottom of the form. Under the line at the right side shall be clearly printed the words "DISPENSE AS WRITTEN." Under the line at the left side shall be clearly printed the words "SUBSTITUTION PERMITTED."
 
The practitioner shall communicate the instructions to the pharmacist by signing the appropriate line. No prescription shall be valid without the signature of the practitioner on one of these lines.
 
In the case of a prescription issued by a practitioner in another state that uses a one-line prescription form or variation thereof, the pharmacist may substitute a therapeutically equivalent generic drug or interchangeable biological product unless otherwise instructed by the practitioner through the use of the words "dispense as written," words of similar meaning, or some other indication.


Section 3 Question 9

In case of oral prescription is involved, only the practitioner and NOT the practitioner's agent may instruct the pharmacist as to whether or not a therapeutically equivalent generic drug or interchangeable biological product may be substituted in its place.
 
False, [Revised Code of Washington RCW-69.41.120(2)].
 
(2). If an oral prescription is involved, the practitioner or the practitioner's agent shall instruct the pharmacist as to whether or not a therapeutically equivalent generic drug or interchangeable biological product may be substituted in its place. The pharmacist shall note the instructions on the file copy of the prescription.
 
(3). The pharmacist shall note the manufacturer of the drug dispensed on the file copy of a written or oral prescription.
 
(4). The pharmacist shall retain the file copy of a written or oral prescription for the same period of time specified in RCW 18.64.245 for retention of prescription records.


Section 3 Question 10

Unless the prescribed biological product is requested by the patient or the patient's representative, if "substitution permitted" is marked on the prescription, the pharmacist must substitute an interchangeable biological product that he or she has in stock for the biological product prescribed if the wholesale price for the interchangeable biological product to the pharmacist is less than the wholesale price for the biological product prescribed and at least 60 percent of the savings shall be passed on to the purchaser.
 
False, [Revised Code of Washington RCW-69.41.120(2)].
 
Unless the prescribed biological product is requested by the patient or the patient's representative, if "substitution permitted" is marked on the prescription as provided in RCW 69.41.120, the pharmacist must substitute an interchangeable biological product that he or she has in stock for the biological product prescribed if the wholesale price for the interchangeable biological product to the pharmacist is less than the wholesale price for the biological product prescribed.
 
Minimum of 60 percent of the savings shall be passed on to the purchaser is only for medication and NOT FOR Biological Product.


Section 3 Question 12

In this state, ephedrine is classified as a:
 
a. Schedule II controlled drug
b. Schedule III controlled drug
c. Schedule IV controlled drug
d. Schedule V controlled drug
 
Schedule II controlled drug, [Washington Administrative Code WAC 246-887-150].
Under Washington State Pharmacy Law, schedule II immediate precursors such as ephedrine and pseudoephedrine are classified as Schedule II controlled drugs.


Section 3 Question 30

Who may sale OTC ephedrine containing products to a purchaser older than 18 years of age?
I. A pharmacy licensed by the department of health.
 
II. A  shopkeeper registered with the department of health.
 
III.  An  itinerant vendor registered with the department of health.
 
a. I only
b. I and II only
c. II and III only
d. All
 
All, [Revised Code of Washington RCW-69.43.105(5)].
 
A pharmacy licensed by, or shopkeeper or itinerant vendor registered with, the department of health, or an employee thereof, a practitioner as defined in RCW 18.64.011, or a traditional Chinese herbal practitioner may sell any product containing any detectable quantity of ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or salts of isomers, to a person that is at least eighteen years old.
 
For purposes of this section, "traditional Chinese herbal practitioner" means a person who is certified as a diplomate in Chinese herbology from the national certification commission for acupuncture and oriental medicine or who has received a certificate in Chinese herbology from a school accredited by the accreditation council on acupuncture and oriental medicine.


Section 4 Question 10

Under Washington State, Buprenorphine is classified as:
 
a. Schedule II controlled drug
b. Schedule III controlled drug
c. Schedule IV controlled drug
d. Schedule V controlled drug
 
Schedule V controlled drug**, [Washington Administrative Code WAC 246-887-190 and https://www.deadiversion.usdoj.gov/drug_chem_info/buprenorphine.pdf].
 
The Washington state board of pharmacy finds that buprenorphine has a low potential for abuse relative to substances in Schedule IV; has currently accepted medical use in treatment in the United States; and the substance has limited physical dependence or psychological dependence liability relative to the substances in Schedule IV, and hereby places that substance in Schedule V.
 
**Please Note under Controlled Substance ACT (DEA) buprenorphine is classified as Schedule III controlled drug.


Section 4 Question 11

According to Washington State Pharmacy Law, which of the following information about Electronic Prescriptions for Controlled Substances (EPCS) is/are TRUE?
 
I.  Electronic signatures are required on all electronically communicated prescriptions.
 
II. The prescription that is generated electronically and transmitted via fax shall follow the ECPS rules.
 
III. An ECPS cannot be used to prescribe Schedule II controlled substance.
 
a. I only
b. I and II only
c. II and III only
d. All
 
I only is true, [Washington State Pharmacy Law July 2016 News Letter]
All 50 states, including Washington State, have rules in place allowing electronic prescriptions for controlled substances (EPCS), including Schedule II medications.
 
Pharmacies and practitioners wishing to use EPCS must first select software that meets the requirements of Title 21 Code of Federal Regulations (CFR) §1311. The software application provider must be approved by the federal Drug Enforcement Administration (DEA), and in Washington State it must also be approved by the Commission. Practitioners may not transmit, and pharmacies may not receive, EPCS until their software provider obtains a third-party audit or certification review that determines that their software application complies with DEA’s requirements and provides the audit/certification report to the practitioner/pharmacy.
 
Under Title 21 CFR §1300.03, electronic prescription is defined as a prescription that is generated on an electronic application and transmitted as an electronic data file. Therefore, an electronic prescription does not include prescriptions transmitted by facsimile, even if generated electronically and transmitted via fax, or printed on a computer printer.
 
An electronic signature is defined as a method of signing an electronic message that identifies a particular person as the source of the message and indicates the person’s approval of the information contained in the message.
According to DEA, electronic signatures are required on all electronically communicated prescriptions and are not allowed on CS prescriptions delivered by fax or hard copy to the pharmacy. CS prescriptions sent from fax to fax, computer to fax, printed on a computer printer, or manually written must all contain a manual signature. A manual, or wet, signature means the practitioner directly signs the prescription by hand using ink or indelible pencil.
 
Signing a signature pad on a computer so the prescription is printed or faxed with the signature image, or stamping the prescription with a signature stamp, does not meet DEA requirements for manual signatures. This also applies to EPCS where the electronic transmission fails and the prescription is returned to the practitioner by the intermediary.
 
These prescriptions must be manually signed by the prescriber before being faxed to the pharmacy, even if they include an electronic signature. Pharmacists should recognize they are responsible for ensuring CS prescriptions meet DEA signature requirements and contacting the prescriber whenever necessary.


Section 5 Question 30 Explanation And Answer Are Updated.

I and II only, All, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].
 
5. OD (Optometrists): Schedule III to V controlled substances and Schedule II Hydrocodone containing products.



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August 28, 2016 New Hampshire Pharmacy Law Part-2 Updates/Corrections


  View Updates/Corrections

Section 4 Question 18 Explanation Is Updated.

Registered pharmacy technician duties shall include:
 
(a). The processing of refill request orders;
 
(b). The retrieval of prescription files, patient files and profiles and other such records pertaining to the practice of pharmacy;
 
(c). The counting, weighing, measuring, pouring and reconstitution of prescription medication or stock legend drugs and controlled substances; and
 
(d). The data entry of prescription orders without supervision providing they annually complete a board approved data entry module.
 
Certified Pharmacy Technician Duties. Registered certified pharmacy technician duties shall include:
 
(a). Accepting a new oral telephone order;
 
(b). Accepting an oral refill authorization from a provider;
 
(c). Communicating a prescription transfer for a non-control medication to or from another pharmacy that does not maintain a common database;
 
(d). Communicating orally or in writing, any medical, therapeutic, clinical, or drug information, or any information recorded on a patient profile that does not require professional judgment;
 
(e). Performing the data entry of a prescription or medication order into the computer without supervision;
 
(f). The task of reducing to writing a prescription left on a recording or message line. Prescription order can only be deleted by pharmacist on duty;
 
(g). Preparing or compounding sterile and non-sterile compounds after completing board approved compound training;
 
(h). Stocking or replenishing of an automated dispensing machine or other stock location. A certified pharmacy technician may check the medications pulled by a pharmacy technician or certified pharmacy technician against the delivery report prior to the refill of the automated dispensing machine or other stock location. A licensed health professional shall check the medication before administering to the patient. The facility shall employ bar coding, radio frequency identification (RFID), or another form of electronic bedside verification.


Section 4 Question 22 Entire Question Is Updated.

The filling/restocking of an automated electronic emergency drug kit may be performed by a registered pharmacy technician.
 
True, [New Hampshire State Pharmacy Administrative Rules Section 705.02(e)(4)(a)].
 
Automated electronic emergency drug kits shall meet the following conditions:
 
(1). Real time electronic communication to the provider pharmacy;
 
(2). For access, employ at least but not limited to:
 
a. Bio-Identification; and
 
b. Unique individualized password protections assigned by the provider pharmacy;
 
(3). Automatically generate notice to the provider pharmacy whenever the kit is accessed and provide at least the following information:
 
a. Name of individual accessing the kit;
b. Date and time the kit was accessed;
c. Name, strength and quantity of drug removed; and
d. Name of patient for whom the drug was administered; and
 
(4). Upon restocking the automated electronic emergency drug kit the following conditions shall be met:
 
The filling/restocking of an automated electronic emergency drug kit shall be performed by a licensed pharmacist, physician, physician assistant, advanced practice nurse, registered nurse and registered pharmacy technician.
 
The placement of controlled substances in automated electronic emergency drug kits in non-federally registered long term care facilities and other health care institutions shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970 provided that:
 
a. Controlled substances shall be selected and stored in the automated electronic emergency drug kits in quantities deemed necessary and jointly approved by the pharmacist in charge and the consultant pharmacist, medical director and the director of nursing services;
 
b. Only the director of nursing services, registered nurse on duty, licensed practical nurse on duty, pharmacist, registered pharmacy technician or practitioner shall have access to controlled substances stored in an automated electronic emergency drug kit;
 
c. Controlled substances in automated electronic emergency drug kits shall be administered to patients only by authorized personnel and only as expressly authorized by an individual practitioner and in compliance with the provisions of 21 CFR 1306.11 and 1306.21; and
 
d. When an automated electronic emergency drug kit is utilized, notification of usage shall be reported in accordance with Ph705.02 (e) (3).


Section 5 Question 4 Question and Explanation Are Updated.

Who may witness the destruction of controlled substances?
 
I. An agent of the court. A pharmacist
II. The director of nursing.
III. The director of New Hampshire Department of Health and Human Services. The charge nurse.
 
(c).  Witnesses may include:
 
(1). The practitioner, including a pharmacist;
 
(2). The administrator or assistant administrator;
 
(3). The director of nursing, nursing supervisor or charge nurse;
 
(4).  An agent of the court;
 
(5).  A law enforcement officer;
 
(6).  The director, New Hampshire department of health and human services or his or her designated agent or agents; and
 
(7).  A county attorney.


Section 5 Question 23 Answer and Explanation Are Updated.

All I and II only, [New Hampshire State Pharmacy Administrative Rules Section 706.03, OBRA-90 and 42USC 1396r-8(g)(2)(B)].
 
Only a pharmacist may counsel. A pharmacist or a pharmacist-intern may counsel.



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