Prescription drug samples may only be distributed to licensed practitioners or to the retail pharmacies, the pharmacies of hospitals or other health care entities upon the written request of a licensed practitioner.
a. True b. False
Prescription drug samples may only be distributed to licensed practitioners or to the retail pharmacies, the pharmacies of hospitals or other health care entities upon the written request of a licensed practitioner.
a. True b. False
Answer: (b) False, [21 CFR 203.3 and Section 503(d) of the Act].
Under section 503(d) of the FFDCA, prescription drug samples may only be distributed to licensed practitioners or to the pharmacies of hospitals or other health care entities upon the written request of a licensed practitioner.
A “health care entity” means any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy (21 CFR 203.3(q)).
A health care entity cannot simultaneously also be a retail pharmacy.
If a pharmacy of a health care entity operates as part of the health care entity, it is eligible to receive prescription drug samples from a manufacturer or authorized distributor of record, if the drug samples are obtained pursuant to a written, signed request of a licensed practitioner affiliated with the health care entity.
“Affiliation” is interpreted to mean that the requesting practitioner sees patients at the health care entity. A retail pharmacy that has no relationship to a health care entity is not permitted to receive prescription drug samples (21 CFR 203.3 and Section 503(d) of the Act).
(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......
(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 [email protected].
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.
The 2016 CDC guideline for prescribing opioids suggests to reassess the evidence of “individual benefit and risk” when increasing daily dose to above ____ morphine milligrams equivalent per day.
a. 30 b. 50 c. 90 d. 120
The 2016 CDC guideline for prescribing opioids suggests to reassess the evidence of “individual benefit and risk” when increasing daily dose to above ____ morphine milligrams equivalent per day.
a. 30 b. 50 c. 90 d. 120
Answer(b): The 2016 CDC guideline for prescribing opioids suggests to reassess the evidence of “individual benefit and risk” when increasing daily dose to above 50 morphine milligrams equivalent per day, and avoidance of doses greater than 90 MME per day.
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
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
Answer: 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.
Pharmacists in Indiana are allowed denying the sale of ephedrine or pseudoephedrine products.
True or False
Pharmacists in Indiana are allowed denying the sale of ephedrine or pseudoephedrine products.
True or False
Answer: True. Pharmacists in Indiana may refuse to sell ephedrine or pseudoephedrine to a purchaser if the pharmacist determines that the drugs are not medically necessary, according to a recently passed law that goes into effect July 1, 2016. The pharmacist is provided with civil immunity for denying the sale, under Senate Bill 80 (SB 80).
The law states an individual who has a relationship on record with a pharmacy may purchase pseudoephedrine or ephedrine. However, if the purchaser does not have a relationship on record with the pharmacy, the pharmacist is required to determine whether there is a legitimate medical or pharmaceutical need for the ephedrine or pseudoephedrine.
A person who is denied the sale of a pseudoephedrine or ephedrine product may obtain pseudoephedrine or ephedrine pursuant to a prescription. SB 80 also adds ephedrine and pseudoephedrine to the definition of “controlled substance” for purposes of the Indiana Scheduled Prescription Electronic Collection and Tracking program. The Indiana Board of Pharmacy is required to adopt emergency rules that are effective July 1, 2016, under the bill.
Prescribing authority shall be allowed, under the medical direction of a supervising physician, for an advanced practice nurse recognized by the Oklahoma Board of Nursing in one of the following categories: advanced registered nurse practitioners, clinical nurse specialists, or certified nurse-midwives.
The advanced practice nurse may write or sign, or transmit by word of mouth, telephone or other means of communication an order, for drugs or medical supplies that is intended to be filled, compounded, or dispensed by a pharmacist.
The supervising physician and the advanced practice nurse shall be identified at the time of origination of the prescription and the name of the advanced practice nurse shall be printed on the prescription label.
According to Oklahoma State Pharmacy Law, every registered pharmacist or assistant pharmacist shall, within ten (10) days after discontinuing or changing his or her place of practice, remove his or her certificate and notify the Executive Director of the Board of his or her new place of practice.
True or False
According to Oklahoma State Pharmacy Law, every registered pharmacist or assistant pharmacist shall, within ten (10) days after discontinuing or changing his or her place of practice, remove his or her certificate and notify the Executive Director of the Board of his or her new place of practice.
Every person upon receiving a certificate of licensure pursuant to the Oklahoma Pharmacy Act, or who has heretofore received a certificate of licensure in this state, shall keep such certificate conspicuously displayed in the pharmacy where such pharmacist is actively engaged in the practice of pharmacy or in such a location as is otherwise prescribed by the State Board of Pharmacy.
The current receipt for licensure shall be attached to the lower left corner of the original certificate.
According to Oklahoma State Pharmacy Law, every registered pharmacist or assistant pharmacist shall, within ten (10) days after discontinuing or changing his or her place of practice, remove his or her certificate and notify the Executive Director of the Board of his or her new place of practice.
Which of the following organizations promotes the Prescription Drug Safety Program?
a. AWARxE b. RXSafety c. StopRxAbuse d. RXDisposal
Which of the following organizations promotes the Prescription Drug Safety Program?
a. AWARxE b. RXSafety c. StopRxAbuse d. RXDisposal
Answer: AWARxE, [NABP News Letter 2015].
AWARxE was originally created and implemented by the Minnesota Pharmacists Foundation in 2007 in memory of Justin Pearson, who died following an accidental drug overdose involving prescription drugs he purchased online.
In 2010, the NABP Foundation TM purchased the program to take AWARxE’s message to a national audience.
Prescription drug abuse in the United States has reached epidemic levels, with Centers for Disease Control and Prevention reporting over 22,000 overdose deaths in 2012 alone.
Although data from many states indicate that prescription drug overdose deaths are decreasing, there has also been a large increase in the use of heroin. Most experts now believe that these issues are connected.
In response to these trends, AWARxE has expanded efforts to raise awareness at both the national and community levels. In 2012, AWARxE launched its biweekly electronic AWARxE Prescription Drug Safety News which is sent to over 16,000 subscribers.
The AWARxE® Prescription Drug Safety Program has served as an information source for consumers nationwide, providing authoritative resources about medication safety, prescription drug abuse, medication disposal, and safely purchasing medications online.
As AWARxE celebrates this milestone, the program will continue to share vital information through the AWARxE website, electronic newsletter, social media pages, public service announcements (PSAs), and community events.
When a pharmacy changes ownership, the original license becomes void and must be surrendered to the board, and a new license obtained by the new owner or owners. A change in ownership for the purposes of this rule shall be deemed to occur when more than _______ % of the equitable ownership of a business is transferred in a single transaction or in a related series of transactions to one or more persons or any other legal entity.
a. 10% b. 20% c. 40% d. 50%
When a pharmacy changes ownership, the original license becomes void and must be surrendered to the board, and a new license obtained by the new owner or owners. A change in ownership for the purposes of this rule shall be deemed to occur when more than _______ % of the equitable ownership of a business is transferred in a single transaction or in a related series of transactions to one or more persons or any other legal entity.
a. 10% b. 20% c. 40% d. 50%
Answer: 50%, [Administrative Rules Montana Board of Pharmacy 24.174.804].
(1). When a pharmacy changes ownership, the original license becomes void and must be surrendered to the board, and a new license obtained by the new owner or owners. The owner shall submit a new license application at least 30 days prior to the change in ownership. The application must be reviewed by the board or its designee before the license may be issued.
(2). A change in ownership for the purposes of this rule shall be deemed to occur when more than 50 percent of the equitable ownership of a business is transferred in a single transaction or in a related series of transactions to one or more persons or any other legal entity.
(3). The board must be notified in writing when five to 50 percent of the equitable ownership of a business is transferred in a single transaction or in a related series of transactions to one or more persons or any other legal entity.
Previously checked medication refills may be handed to patients or their agents by registered technicians in the pharmacist's absence.
True or False
Previously checked medication refills may be handed to patients or their agents by registered technicians in the pharmacist's absence.
True or False
True, [Administrative Rules Montana Board of Pharmacy 24.174.403].
(1). In any pharmacy staffed by a single pharmacist, the pharmacist shall take a meal/rest break for a period of up to 30 minutes per shift without closing the pharmacy and removing support personnel, provided the pharmacist reasonably believes that the security of prescription drugs will be maintained in the pharmacist's absence.
(2). The time of the meal/rest break will be conspicuously posted in clear view of patients approaching the prescription area.
(3). In the pharmacist's absence a sign indicating that no pharmacist is on duty will be conspicuously displayed in clear view of patients approaching the prescription area.
(4). The pharmacist will remain on the premises if the prescription area is to remain open, and be available for emergencies.
(5). When authorized by the pharmacist, only registered technicians and interns directly involved in the process of filling prescriptions may remain in the prescription department to perform nondiscretionary duties as delineated by the pharmacist.
(6). Upon returning, the pharmacist shall review any work performed in the pharmacist's absence.
(7). In the pharmacist's absence there may be no dispensing of NEW prescriptions that the pharmacist has checked and that are waiting to be picked up, nor may counseling be provided.
(8). At the discretion of the pharmacist, previously checked medication REFILLS may be handed to patients or their agents by registered technicians in the pharmacist's absence, and the technicians must offer the patient counseling by the pharmacist. If the patient desires counseling, the patient may wait for the pharmacist to return or may leave a telephone number for the pharmacist to call upon return.
(9). Telephoned new prescriptions must not be accepted by support personnel in the pharmacist's absence.
(10). New hardcopy prescriptions may be accepted and processed by registered technicians in the pharmacist's absence. These prescriptions may not be dispensed until the pharmacist has performed prospective drug review and completed the final check.
(11). If two or more pharmacists are on duty, the pharmacists shall stagger their breaks so that the prescription department is not left without a pharmacist on duty.
(12). The pharmacist-in-charge shall develop written policies and procedures for operation of the prescription department in the temporary absence of the pharmacist.
