Controlled Substances, Opioid OD Prevention, & Medical Marijuana Flashcards
By which method(s) can unwanted controlled substances be disposed of?
Surrender to the NYDOH or return to the supplier, or request the Department for permission to destroy on premise
If the Department does not grant approval for the person to destroy controlled substances, the person shall surrender the controlled substances to the New York State Department of Health, Bureau of Narcotic Enforcement in the following manner:
(i) the person shall request a surrender date from the bureau on which to surrender the controlled substances to the bureau.
Such a request shall be made on forms provided by the bureau and must include the following information:
(a) . an inventory of all controlled substances to be surrendered;
(b) . the identity of at least two persons who conducted the inventory of the controlled substances to be surrendered. Such persons shall be New York State licensed practitioners, pharmacists or nurses;
(c) . the reason for the surrender of each controlled substance; and
(d) . the proposed date of surrender and an alternative date.
(ii) . a person may surrender controlled substances only after receiving a surrender date in writing from the bureau. The controlled substances must be shipped to the bureau no later than 5 days from the date the bureau has set as the surrender date.
The bureau may set a date different than the date requested by the applicant.
Any record required to be kept under this section shall be kept for a period of 5 years.
Trained overdose responder means any individual not otherwise permitted by law to administer an opioid antagonist, who is either:
(i) . an opioid antagonist recipient as defined in PHL Section 3309 who has successfully completed an opioid overdose prevention training curriculum offered by an authorized opioid overdose prevention program and has been authorized by a registered provider to possess the opioid antagonist;
(ii) . a public safety officer who has completed a curriculum approved by the division of criminal justice services for purposes of intervening in opioid overdoses prior to the arrival of EMS; or
(iii) . a firefighter who has completed a comparable curriculum approved by the department.
The trained overdose responders shall:
(i) . complete an initial training consistent with the program’s opioid overdose prevention training curriculum;
(ii) . complete a refresher training consistent with the opioid overdose prevention training curriculum at least every two (2) years or otherwise demonstrate competence in opioid overdose recognition and response to the satisfaction of the opioid overdose prevention program director or to someone designated by the program director;
(iii) . ensure that EMS has been contacted when encountering a victim of a suspected drug overdose and advise responding emergency medical services personnel if an opioid antagonist has been used;
(iv) . comply with protocols for response to victims of suspected drug overdose consistent with the program’s opioid overdose prevention training curriculum, or, in the case of responders who are public safety or firefighting personnel, comply with policies developed by their local public safety agency or fire department; and
(v) . report all responses to victims of suspected drug overdose to the opioid overdose prevention program director or to someone designated by the program director.
Which of the following statements is/are TRUE about opioid overdose prevention under the New York State Pharmacy Law?
I. A health care professional may prescribe by a patient-specific or non-patient-specific prescription, dispense or distribute, directly or indirectly, an opioid antagonist to an opioid antagonist recipient.
II. A pharmacist may dispense an opioid antagonist, through a patient-specific or non-patient-specific prescription, to an opioid antagonist recipient.
III. An opioid antagonist recipient may possess an opioid antagonist obtained may distribute such opioid antagonist to a recipient, and may administer such opioid antagonist to a person the recipient reasonably believes is experiencing an opioid overdose.
Each medical marijuana product brand, in its final form, shall be defined as having a specific concentration of total:
total Tetrahydrocannabinol (THC) and total Cannabidiol (CBD) and shall have a consistent cannabinoid profile.
The concentration of the following cannabinoids, at a minimum, must be reported on the medical marijuana product:
(i) . Tetrahydrocannabinol (THC)
(ii) . Tetrahydrocannabinol acid (THCA)
(iii) . Tetrahydrocannabivarin (THCV)
(iv) . Cannabidiol (CBD)
(v) . Cannabinadiolic acid (CBDA)
(vi) . Cannabidivarine (CBDV)
(vii) . Cannabinol (CBN)
(viii) . Cannabigerol (CBG)
(ix) . Cannabichromene (CBC)
(x) . Any other cannabinoid component at > 0.2 percent, for which there is a certified standard available at a customary cost.
A registered organization shall use either carbon dioxide (CO2, super-critical) or alcohol for cannabinoid extraction and shall only perform extraction of…
of the leaves and flowers of female marijuana plants. **A registered organization shall obtain prior written approval from the department if it seeks to use other extraction methods.
A registered organization shall only use CO2 that is of a supply equivalent to food or beverage grade of…
at least 99.5 percent purity; and alcohol used shall be of a grade that meets or exceeds specifications of official compendiums.
A registered organization shall only produce such forms of medical marihuana as approved by the department according to the following requirements:
Each registered organization may initially produce up to 5 brands of medical marijuana product with prior approval of the department. These brands may be produced in multiple forms as approved by the commissioner. Thereafter, additional brands may be approved by the department.
The final medical marijuana product shall not contain less than 90 percent or more than 110 percent of the concentration of total THC or total CBD indicated on the label and shall have no more than 10mg total THC per dose. However:
(i) Where the total THC concentration is <5 milligrams per dose, the concentration of total THC shall be within 0.5 milligrams per dose;
(ii) Where the total CBD concentration is <5 milligrams per dose, the concentration of total CBD shall be within 0.5 milligrams per dose; and
The registered organization shall offer and make available to patients at least one brand that has…
a low THC and a high CBD content (e.g., a 1:20 ratio of THC to CBD).
The registered organization shall offer and make available at least one brand that has…
approximately equal amounts of THC and CBD.
For each brand offered, the registered organization shall only utilize a distinct name which has been approved by the department, consisting of only letters and/or numbers. The name shall not be…
coined or fanciful, and may not include any “street”, slang or other names. No reference shall be made to any specific medical condition.
Each registered organization shall ensure the availability of at least…
a one year supply of any offered brand unless otherwise allowed by the department
Within 72 hours after authorizing an emergency oral Rx for a controlled substance, the prescribing practitioner shall cause to be delivered to the pharmacist the official New York State prescription. If the pharmacist fails to receive such prescription, he shall…
Notify the NYDOH in writing within 7 days from the date of dispensing the substance.
The commissioner shall publish findings on statewide opioid overdose data that reviews overdose death rates and other information to ascertain changes in the cause and rates of opioid overdoses, including fatal opioid overdoses. The report shall be submitted annually, on or before October first, to..
the governor, the temporary president of the senate, the speaker of the assembly, the chairs of the senate, and assembly health committees. Also, the report shall be made public on the department’s internet website.
The report shall include, at a minimum, the following information on a county basis:
(a) . information on opioid overdoses and opioid overdose deaths, including age, gender, ethnicity, and geographic location;
(b) . data on ER utilization for the treatment of opioid overdose;
(c) . data on utilization of pre-hospital services;
(d) . data on the dispensing and utilization of opioid antagonists; and
(e) . any other information necessary to ascertain the success of the program, areas of the state which are experiencing particularly high rates of overdoses, ways to determine if services, resources and responses in particular areas of the state are having a positive impact on reducing overdoses, and ways to further reduce overdoses.
The commissioner shall provide the current information and data specified in the report to each county every…
3 months
Prior to prescribing for or dispensing to a patient any controlled substance listed on schedule II, III, or IV, every practitioner shall consult the…
prescription monitoring program registry for the purpose of reviewing that patient’s controlled substance history.
The patient’s controlled substance history shall be obtained from the prescription monitoring program registry no more than…
24 hours prior to the practitioner prescribing or dispensing any controlled substance to that patient. A practitioner shall document such consultation in the patient’s medical chart or, if the practitioner does not consult the prescription monitoring program registry, the practitioner shall document in the patient’s medical chart the reason such consultation was not performed.
The duty to consult the prescription monitoring program registry shall not apply to:
(i). veterinarians;
(ii) . a practitioner dispensing pursuant to public health law section 3351(3);
(iii) . a practitioner administering a controlled substance;
(iv) . a practitioner prescribing or ordering a controlled substance for a patient of an institutional dispenser for use on the premises of, or during an emergency transfer from, the institutional dispenser;
(v) . a practitioner prescribing a controlled substance in the ED of a general hospital, provided that the quantity of controlled substance prescribed does not exceed a 5 day supply
(vi) . a practitioner prescribing a controlled substance to a patient under the care of a hospice;
(vii) . a practitioner when:
(a) . it is not reasonably possible for the practitioner to access the registry in a timely manner;
(b) . no other practitioner or designee authorized to access the registry is reasonably available; and
(c) . the quantity of controlled substance prescribed does not exceed a 5 day supply if the controlled substance were used in accordance with the directions for use
(viii) . a practitioner acting in circumstances under which consultation of the registry would, as determined by the practitioner, result in a patient’s inability to obtain a prescription in a timely manner, thereby adversely impacting the medical condition of such patient, provided that the quantity of the controlled substance does not exceed a five-day supply if the controlled substance were used in accordance with the directions for use;
(ix) . a situation where the registry is not operational as determined by the department or where it cannot be accessed by the practitioner due to a temporary technological or electrical failure. In the instance of a temporary technological or electrical failure, a practitioner shall, without undue delay, seek to correct any cause for the failure that is reasonably within his or her control; or
(x) . a practitioner to whom the commissioner has granted a waiver from the requirement to consult the registry. A waiver may be issued by the commissioner based upon a showing by a practitioner that his or her ability to consult the registry in accordance with this section is unduly burdened by:
(a) . technological limitations that are not reasonably within the control of the practitioner; or
(b) . other exceptional circumstance demonstrated by the practitioner.
It shall be unlawful to distribute free samples of controlled substances except by licensees…
licensed under this Part to persons licensed by the department for research, instructional activities or chemical analysis. No such distribution shall be made without giving prior notice to the department regarding the proposed manner of distribution and the names of those persons to whom such distribution will be made. A record of all such distributions shall be made.
Controlled substances may be administered to an addict or habitual user:
I. to relieve acute withdrawal symptoms.
II. Who is a bona fide patient suffering from an incurable and fatal disease such as cancer or advanced tuberculosis.
III. Who is aged, infirm, or suffering from serious injury or illness, and the withdrawal from controlled substances would endanger the life or impede or inhibit the recovery of such person.
Controlled substances can be given to addicts who are aged and infirm, or severely ill and it is determined that withdrawal of controlled substances would be dangerous to life, provided that:
(i) . such determination has been confirmed by adequate consultation;
(ii) . complete records of treatment, administration or dispensing of controlled substances including patient’s name, date and type and quantity of controlled substance administered or dispensed are kept;
(iii) . adequate safeguards have been taken against diversion of the controlled substances from the intended use; and
(iv) . the patient is carefully supervised;
Controlled substances can be given to addicts to relieve acute withdrawal symptoms, except that:
(i) only the amount of controlled substances essential for relief of such acute symptoms shall be administered; and
(ii) administration shall be in an institutional or other setting reasonably certain to provide a drug-free environment;
Manufacturers or distributors may destroy controlled substances on their premises providing that federal DEA approval is obtained and a copy of such approval is filed with the Department…
within 30 days of the receipt of such approval. Any record required to be kept under this section shall be kept for a period of 5 years.
A practitioner may authorize a designee to consult the prescription monitoring program registry on his or her behalf, provided…
that the ultimate decision as to whether or not to prescribe or dispense a controlled substance remains with the practitioner and is reasonably informed by the relevant controlled substance history information obtained from the registry.
A practitioner may only appoint a designee to consult the prescription monitoring program registry on his or her behalf if:
(i) . such designee is located in the state of NY when accessing the prescription monitoring program registry;
(ii) . the designee is employed by the same professional practice or is under contract with such practice.
(iii) . the practitioner takes reasonable steps to ensure or has actual knowledge that such designee is sufficiently competent in the use of the registry and that such designee is aware of and conforms to all relevant federal and state privacy statutes;
(iv) . the practitioner remains responsible for ensuring that access to the registry by the designee is limited to authorized purposes and occurs in a manner that protects the confidentiality of the information obtained from the registry, and the practitioner remains responsible for any breach of confidentiality; and
(v) . the practitioner selects and maintains all active designees authorized to access the prescription monitoring program registry in a format acceptable to the department.
Upon a designee’s relinquishment or termination of employment or authorization as a designee, a designating practitioner or pharmacist shall…
immediately notify the department, in a fashion deemed appropriate by the commissioner, of the revocation of the designee’s authorization to access the prescription monitoring program registry on the designating practitioner’s or pharmacist’s behalf.
A pharmacist may designate another pharmacist or a pharmacy intern to consult the prescription monitoring program registry on the pharmacist’s behalf, provided that:
(i) such designee is located in the state of New York when accessing the prescription monitoring program registry and is employed by the same pharmacy or is under contract with such pharmacy; and
(ii) the designating pharmacist selects and maintains all active designees authorized to access the registry in a format acceptable to the department.
A Rx for a controlled substance may be issued only by a practitioner who is:
(1) authorized to prescribe controlled substances pursuant to his licensed professional practice; and
(2) either registered under the Federal Controlled Substances Act and in possession of a registration number from the DEA, United States Department of Justice, or its successor agency, or exempted from such registration as an exempt official
A practitioner issuing an electronic prescription for a controlled substance shall:
(1) use an electronic prescribing application that is consistent with federal requirements; and
(2) register the certified electronic prescribing application with the NYDOH, BNE
Independent out-of-hospital health facilities, such as clinics, may qualify to obtain official New York State institutional prescription forms required for prescribing schedule II controlled substances under the New York State Controlled Substances Act by complying with the following:
(1) Obtain an operating certificate from the NYDOH or license by the New York State Department of Mental Hygiene
(2) Obtain a registration as a clinic from the Drug Enforcement Administration (schedules II, III, IV and V), United States Department of Justice, or its successor agency.
Pharmacy providers and dispensing practitioners must submit schedules II-V controlled substance dispensed prescription data to the Bureau of Narcotic Enforcement (BNE) no later than…
24 hours after the substance was delivered.
If a patient develops a new condition that would warrant the issuance of a Rx for a controlled substance, a practitioner may issue such Rx prior to performing an examination if:
(i) . the prescribing practitioner has a previously established practitioner/patient relationship with the patient; and
(ii) . an emergency exists; and
(iii) . the prescription does not exceed a 5-day supply as determined by the directions for use
The pharmacist filling a controlled substance prescription shall endorse upon the prescription his/her…
signature (initials are unacceptable), the date of filling, and the Rx # under which it is recorded in the pharmacy prescription file.
A licensed, registered pharmacist, or a pharmacy intern acting thereunder in a registered pharmacy, may, in good faith and in the course of his/her professional practice, sell and dispense controlled substances provided that:
a. they are dispensed pursuant to an official New York State prescription and delivered within 30 days of the date such prescription was signed by the authorized practitioner;
b. an out-of-state prescription or an electronic prescription delivered within 30 days of the date such prescription was signed by the authorized practitioner OR
c. an oral prescription where permitted delivered within 30 days of the date such prescription was signed by the authorized practitioner or an oral prescription where permitted.
