Law - exam 3 (final exam) 247 CMR 9, 10, 11, 12, 16, 21 policies Flashcards
9
List the 19 items provided under the code of conduct for registered pharmacists, pharmacies and pharmacy departments.
Provide an example of each one of the 19 items that could result in a violation of the code of conduct.
1 conduct professional activities according to laws and board regulations
cannot dispense CS to go around the law
observe the standards of the USP
can not dispense any med. which has been previously provided
responsible for the proper preservation and security of all drugs in the pharmacy or pharmacy department
not engage in fraudulent or deceptive acts
cannot agree with any person for dispensing drugs that have been ordered by coded Rx
cannot promise discounts, rebates, refunds, or commissions to a person who operates or manages, or is employed by a hospital, nursing home, or other health facility
cannot aid or abet unlawful practice of pharmacy
cannot give expired, outdated, or substandard drugs or devices to a person who is not licensed or legally authorized to receive drugs or devices
11 may dispense Rx drugs by mail or common carrier in a manner consistent with federal law. Also, have enough info. to contact the patient and prescriber
12 Unless otherwise by law, an RPh who works for a hospital or clinic cannot dispense drugs to any person other than inpatients outpatients, or employees of hospital. or clinic or to the employee’s family
13 an RPh, pharmacy, pharmacy department, pharmaceutical organization or pharmacy corportaion can not give Rx blanks referring to any other pharmacists, pharmacy or pharmacy department
14 shall keep a perpetual inventory of each CS II that has been dispensed, received or disposed of by them. This must be done or reconciled every 10 days
15 Unless otherwise by law, RPh shall not limit their services to a certain segment of the general public
16 shall not refuse to compound customary pharmaceutical preparations except upon extenuating circumstances
17 shall not purchase drug samples for compounding, dispensing or reselling these samples
18 shall comply with mandatory counseling provisions
19 maintain patient confidentiality at all times
9
Describe the process of transferring a prescription listed in schedules III-V.
Rx authorizing refills or schedule III to V CS may be transferred between pharmacies or pharmacy departments on a one-time only basis except as otherwise permitted by law
schedule II can not be transferred!!!!!
9
Who is allowed to conduct the transfer of schedules III-V
pharmacists and CPhT I think
pharmacies and pharmacy departments
9
Describe the process of transferring a prescription listed in schedules III-V.
A: the RPh must record the following info:
- write the word VOID on the face of the invalidated Rx
- record the the reverse of the invalidated Rx the name, address, and DEA registration number of the pharmacy to which it was transferred, and the name of the RPh receiving the Rx info
- record on the written transfer log or by entry into a computerized system, the Rx number, date of transfer, the name or identification of the pharmacist transferring the info, and the name of the pharmacy or pharmacy department to which the Rx is transferred
B: the transferring RPh shall cancel all refills remaining on the transferred Rx
C: the RPh receiving the transferred Rx info shall complete the following
- write the word “transfer” on the face of the transferred Rx
- write all info required by the state and federal law to be on the Rx and include:
- date of issuance of the original Rx
- the original number of refills authorized on the original Rx
- the date of original dispensing
- the number of valid refills remaining and the date of the last refill
- the RPh’s name, address, DEA number, and original Rx from which the Rx info was transferred, and the name of the transferor RPh
D: the RPh receiving the transferred info shall inform the patient that the original Rx’s refills have been canceled at the pharmacy or pharmacy department from which it has been transferred
9
What are the responsibilities of the transferring and receiving pharmacy
A
receiving & transferring
- fill out DEA
- 14-day notice
intending to transfer controlled substances schedules II to VI from one pharmacy to another the board must have the following information at least 14 days before the transfer takes place:
❖ The name, address, telephone number, pharmacy permit number of the transferor and the transferee.
❖ For schedule II, form 222 is required
❖ For schedules III to VI, only the invoice is required
but I thought that they could not be refilled so they cannot be transferred…. Schedule II controlled substances are not able to be transferred at all due to the risk of substance abuse and dependency they pose.
9
Who is allowed to conduct the transfer of schedules VI
RPh
intern
certified Pharm. tech
9
Describe the regulations relating to the advertising of prescription medication prices
- RPh shall not utilize false, deceptive, or misleading advertising
- whenever an RPh advertises the consumer price for a particular Rx drug, said advertisement shall not contain any representation, either expressed or implied, concerning that drug’s safety, effectiveness, or indications for use
- any RPh who advertises a Rx drug in a manner which provides price info. to consumers shall include the following info:
- the proprietary name if any
- the establish or generic name if any
- the quantity of active ingredients per dosage unit of the Rx drug producr whenever the Rx contains a single active ingredient
- the strength of the Rx whenever said product contains more than one active ingredient by a relevant strenght that can be associated witht he product without indicating each active ingredient; the established name and quantityt of each active ingredient shall not be required whenever said product contains more than 1 active ingredient
- the dosage form
- the price charged for filling a Rx
a RPh who advertises Rx drugs in a manner which provdies price info to consumers may idenfity professional or convenience services provided by the pharmacy of pharmacyy department or may include other written, printed or graphic matter, provided that no info included in such advertsisng shall be flase, deceptive or misleading
whenever a RPh adverists Rx drugs in a manner that provides price nfo to consumers, any stated price with respect to a particular Rx drug shall include all charges to the consumer. These charges
yeah yeah
9
Describe the requirements for dispensing and refilling prescriptions
if drug is distributed only as generic name then RPh should record on the Rx the name of the manufacturer or if the manufacturer’s name is not available then the name of the distributor, packet or repacker
affixed label must be clearly printed
only RPh, intern and certified tech with approval of PIC, can receive new Rx over the phone from prescriber or authorized agent
if filling CS III-VI, RPh must record:
- the date of dispensing
amount of the drug dispensed
his or her initials
if a dispensing RPh does not indicate the quantity of a drug dispensed on the back of the Rx that the RPh has refilled shall be deemed to have dispensed a refill for the full face amount of the Rx
data-processing system may be used for the storage and retrieval of info. pertaining to the refilling of Rx for CS in III-VI
cannot collect Rxs at industrial plants, places of business, other sites where specific groups of people are regularly employed or affiliated
cannot give hydrocodone ER unless:
- stored in locked cabinet
dispensed with child-proof container or within a locked box
the prescriber has given a letter of medical necessity
RPh gives counseling that includes review of written warnings
9
What information needs to be placed on the pharmacy label
the product name and purpose
Dosage and use instructions
Specific instructions for demographics, such as pregnant women and children.
Ingredients, both active and inactive.
Warnings and potential adverse side effects.
9
What information is needed for proper records keeping when dispensing and refilling prescriptions
for CS III-VI:
date of dispensing
amount of drug dispensed
initials
9
Describe the process and requirements of handling hydrocodone-only extended release medications
cannot give hydrocodone ER unless:
- stored in locked cabinet
- dispensed with child-proof container or within a locked box
- the prescriber has given a letter of medical necessity
- RPh gives counseling that includes review of written warnings
can only be done by RPh & intern
9
How are prescriptions files maintained
CS II are separated from other records
CS III-V are separate and identified as such
CS VI, Rx for non-controlled substances, Rx for syringes and instruments adaptable to hypodermic admin. shall be separate from all other records
9
Describe the procedures for verifying a practitioner’s prescriptive authority
good RPh judgement determines:
- Rx is issued according to valid patient-prescriber relationship
Rx is authentic
dispensing is according to 94C
9
How are patient records maintained, what is the name and abbreviation of the federal law relating to patient health information
patient record system that identifies previously dispensed meds.
may be computerized
kept for more than 12 months from date of last entry in the profile record
record includes
- name
- address
- phone #
- DOB
- gender
- history
- drug allergies/rxns
- list of meds ever dispensed
- comments relevant to drug therapy
abbreviation: PHI confidential under HIPAA
9
What information needs to be collected in regards to patient records
record includes
- name
- address
- phone #
- DOB
- gender
- history
- drug allergies/rxns
- list of meds ever dispensed
- comments relevant to drug therapy
9
Describe how a pharmacist shall conduct a prospective DUR
- Before each Rx is dispensed or delivered to a patient
identifies - over-utilization or under-utilization
- therapeutic duplication
-drug-disease contraindication
-drug-drug interaction
-incorrect drug dosage or duration of drug treatment
-drug-allergy interactions
-clinical abuse or misuse
-any significant change in drug, dose, or directions
-ensures proper care of patient and may call prescriber to do so
9
What needs to be done in the event of identifying a an issues with the prospective DUR
offer to counsel
talk to prescriber
9
Describe when counseling needs to be performed
for new Rx or if patient requests
9
When is the offer to counsel made, just new prescription, just refills, both new and refills
new
9
What is done in real life regarding the offer to counsel, does it differ from the legal requirements
for any meds for anyone
9
Describe the process of what needs to be included when counseling a patient
name and description of med
dosage form, dosage, ROA & duration of therapy
special directions for prep. admin and use
common severe side and adverse effects
techniques for monitoring drug therapy
proper storage
Rx refill info
action to be taken if you miss a dose or adverse rxn
9
What happens if the patient does not pick up their prescription, do you need to provide a written offer to counsel
yes
9
What is the difference between the following, drug information sheet, prescription drug insert, patient drug information sheet, medication guide.
A
drug information sheet
- gives you important information about your medication.
prescription drug insert
- details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug.
patient drug information sheet
- gives you important information about your medication.
medication guide
- paper handouts that come with many prescription medicines
10
Under what circumstances might the Board impose disciplinary action against and individual or other entity licensed by the Board?
1 - violating any of the duties and standards set out in board regulations
2 - violating any provision or any provision of. state or federal statutes or rules or regulations promulgated thereunder related to the practice of the profession
3 - failing to submit an acceptable plan of correction
4 - failing to remedy or correct a violation cited in a deficiency statement by the date specified in the plan of correction submitted. Plans of correction as accepted or modified by the board, unless the pharmacy or pharmacy department demonstrates to the satisfaction of the board that such failure was not due to any neglect of duty and occurred despite his/her good faith attempt to remedy or correct the violations(s) by the specific time
5 - engaging in misconduct in the practice of the profession
6 - engaging in conduct beyond the authorized scope of a pharmacist, pharmacy intern, or pharmacy technician
7 - practicing the profession while the ability to practice is impaired by illness, use of alcohol, drugs, chemicals, or other type of substances, or as a result of any mental or physical condition
8 - engaging in abuse or illegal use of Rx drugs or controlled substances
9 - continuing to practice the profession after registration is lapsed, suspended, or revoked
10 - violating the terms of a consent agreement, final decision, order, surrender agreement, or any other issued by o agreement entered in with the board
11 - engaging in conduct that has the capacity or potential to place the public health, safety, or welfare at risk
12 - engaging in conduct that has the capacity or potential to deceive or defraud
13 - knowingly permitting, aiding, or abetting an unlicensed person to perform activities requiring a license or registration
14 - being convicted of any crime, entering a plea of guilty to any time, entering a plea of nolo contendere to any crime, or admitting to sufficient facts to warrant a finding of guilty of any crime
15 - fraudulently procuring a license or registration or its renewal
16 - providing false info on an application for a license or registration or its renewal
17 - failing without cause to cooperate with any request by the board to appear before it or to provide requested info; failing to respond to a board subpoena or failing to furnish the money to which the board is legally entitled
18 - engaging in conduct that demonstrates a lack of good moral character
19 - cheating on or attempting to compromise the integrity of any licensing or registration examination
20 - having been disciplined in another jurisdiction in any way for reasons substantially
21 - engaging in conduct which undermines public confidence in the integrity of the profession
22 - committing an act that violates recognized standards of pharmacy practice
23 - failing to comply with recognized ethical standards of the profession, including but not limited to, standards of practice of pharmacists, interns, pharmacies, and pharmacy departments
24 - violation of 94C or any rules or regulations promulgated thereunder
25 - failing to report or failing to accurately report to the board within 7 business days, in a manner and format determined by the board
26 - failing to report to the board in writing within 30 days any pending criminal charge or conviction of a registrant or licensee in MA
27 - duty to comply with reporting requirements, the duty to report certain factors of pharmacy operations
28 - violation of, or failure to comply with an order issued by the commissioner of the Department of pH
10
What is a Plan of Correction?
A specific plan of what will be or was done to correct the problem after inspection;
b. A description of what will be done to prevent the recurrence of this problem or problems of this type;
c. Designation of the individual(s) who will be responsible for monitoring the correction to ensure the problem does not recur; and d.
10
Describe the Summary Cease and Desist process? When is it conducted?
- if, based upon affidavits or other evidence, the board or board president determines that a registrant or licensee or the products prepared by a registrant or licensee are an immediate or serious threat to the public health, safety or welfare, the board or board president may:
a - issue a cease and desist notice and/or quarantine notice, requiring non-disciplinary cessation or restriction of any and all pharmacy operations, and prohibiting the use of medications prepared by or in possession of a pharmacy or,
b - issue a cease and desist notice placing non-disciplinary restrictions on a board registrant or licensee, to the extent necessary, to avert a continued threat, pending final investigation results
2 - requirements of the cease and diss notice and/or quarantine notice shall remain in effect until the board or board president rescinds or amends such requirement for until such time as the board takes final action on any related pending complaint and the board issues a final decision
3 - a hearing limited to the determination of the necessity of notices issued pursuant to blah blah blah shall afforded the registrant or licensee within 15 business days of the board or board president’s action
10
What happens if there is disciplinary action against a Massachusetts registrant or licensee taken in another state?
this may be the basis for initiation by the board of disciplinary action against the MA registrant or licensee provided that the conduct disciplined in another state or jurisdiction constitutes a violation of MA law
adjudicatory hearing
means a formal administrative hearing held by the board conducted to determine the truth and validity of complaints filed against a registrant or licensee.
complaint
means a communication filed with the board or the division of health professions license which the board determines, after investigation, merits further consideration or action
conviction
shall include any guilty verdict or finding of guilt and any admission to or finding of sufficient facts to warrant a finding of guilt, regardless of adjudication, a continuance without a finding, and any pleas of guilty or nolo contendere, of to a crime in any jurisdiction, which has been accepted by the court, whether or not a sentence has been imposed. A conviction of any person licensed or registered by the board shall be conclusive evidence of the commission of the crime in any disciplinary proceeding against such person based upon the conviction
invetsigative confernece
means an informal discussion relating to a complaint held with the board
order to show cause
means a document served by the board upon a registrant ordering the registrant or licensee to appear before the board for a formal adjudicatory hearing
11
Why is a Massachusetts Controlled Substance Registration issued?
The Massachusetts Controlled Substance Registry’s primary aim is to ensure controlled substances are handled responsibly and safely within Massachusetts while adhering to rigorous compliance standards when it comes to storage, distribution, and dispensing of controlled substances.
11
To whom are they issued to?
Pharmacy
Outsourcing Facility
Wholesale Druggist
every person who manufacturers, distributes, prescribes, administers, dispenses or possesses controlled substances in Schedules II-V to be registered