94C - Controlled Substances
The department of public health shall produce and distribute either in written or electronic form to pharmacies, not including institutional pharmacies, pamphlets for consumers relative to narcotic drugs, specifically opiates, that includes educational information about: A pharmacist shall distribute the pamphlet when dispensing a narcotic or controlled substance contained in Schedule ____.
(i) pain management; (ii) misuse and abuse by adults and children; (iii) risk of dependency and addiction; (iv) proper storage and disposal; (v) addiction support and treatment resources; and (vi) the telephone helpline operated by the bureau of substance abuse services II or III
Persons registered shall keep records and maintain inventories in conformance with the record-keeping and inventory requirements of the Federal ____or any amendment thereof, and the Federal Food, Drug and Cosmetic Act, and with any additional rules or regulations promulgated by the board or commissioner.
''Comprehensive Drug Prevention and Control Act of 1970''
violations of distributing class A-E controls while within ___ of a preschool, headstart facility, elementary, vocational, or secondary school; or ___ of a public park of playgroud punishment? Lack of knowledge of ___ shall not be a defense to any person who violates the provisions of this section.
- 300 feet of the real property (between 5am and midnight) - 100 feet of a public park or playground 2.5 (2?) years-15 years; potentially also a fine of 1000-10,000 school boundaries
who issues administrative inspection warrants warrant directed to the ___ in order to ___ - then return info to the inspecting court within what amount of time?
A district court or justice or superior court (after proper oath/affirmation from the commissioner, police, or board) commissioner (manufacturer) or board (pharmacy, outsourcing facility, wholesale druggist) - to inspect the area - within TEN days of the date of issuance
which schedules should pharmacists dispense a pamphlet regarding pain management, abuse/misuse, dependency/addiction, support, etc WITH THE PRESCRIPTION? who does this NOT apply to?
Schedules II and III institutional (hospital) pharmacies
when doing approved research with scheduled drugs, does the researcher need a written or oral rx in order to dispense the control?
no
a person acting in good faith may receive a naloxone prescription and do what
possess naloxone and administer naloxone to an individual appearing to experience an opiate-related overdose.
schedule VI includes all ___
prescription drugs not in schedules I-V
employees of manufacturers can possess controls w/o registration except for which employees?
salesman, detail man, or other field rep cannot possess any controls I-V What about giving samples tho??? - does the doc need to get the samples shipped to them?
physicians may lawfully dispense controlled substances pursuant to schedule VI to recipients of such services in what quantity? ____ is this different than I-V?
such quantity as needed for treatment exempt from the requirement that such dispensing be in a single dose or as necessary for immediate and proper treatment
A pharmacist dispensing an opioid antagonist under this section shall ____provide to the ____the ____. Reports made pursuant to this section shall not ___ again, very similar to ?
- annually - department - number of times an opioid antagonist is dispensed NOT identify an individual patient, shall be confidential and shall not be public records emergency contraception
A pharmacist dispensing emergency contraception shall ____ (how often?) provide to the ____(who?) the____ (what?). Reports made pursuant to this section shall not___ these laws are very similar to dispensing ___
- annually - department of public health - number of times such emergency contraception is dispensed NOT identify any individual patient, shall be confidential and shall not be public records opioid antagonists
PMP: The department shall ____determine, through the prescription drug monitoring system the ___ and ___ for opiates contained in Schedules __, that mean and median prescription quantities and volumes shall be determined within ___as determined by the department. practitioner's standing shall be expressed as a ____for the practitioner within the practitioner's category. Each practitioner whose prescribing exceeds the mean or median within the practitioner's category shall be ___. Such information shall not be __, __, or ___
- annually - mean and median quantity and volume of prescriptions - II and III categories of practitioners of a similar specialty or practice type percentile ranking sent notice of the practitioner's percentile ranking in a manner determined by the department (a) constitute a public record ; (b) be admissible as evidence in a civil or criminal proceeding; or (c) be the sole basis for investigation by a licensure board
controlled OTCs - pt needs to ___ - preparation not more than ____are dispensed, or sold to a person during any ___period. The pharmacist dispensing such excepted substances shall keep an accurate record book including what 5 things?
- identify himself (18 or older??) - 4 ounces/48 hour period name and address of the purchaser, the name of the preparation, the strength per dosage unit, the quantity dispensed and the date.
An order issued by the commissioner to place a substance in schedule I shall take effect upon the completion of a ____. For the purposes of this section, the notice period shall begin when the order is ____, or by any other means the commissioner may deem necessary. The commissioner shall forward a copy of the order to all ___in the commonwealth, in a form and manner to be determined by the commissioner, to disseminate information regarding the dangers of the substance. also forward copy to ___, ___, ___ guidance to regional boards of health?
-14-day notice period -published on the department of public health's website -acute inpatient hospitals chairs of the joint committee on public health, attorney general of the United States, all local and regional boards of health guidance that possession or distribution of the substance by any food, retail or other commercial establishment shall constitute an imminent health hazard
when the commissioner places a substance in schedule I, how long can this "emergency regulation" remain in effect?
1 year
For the purposes of monitoring the prescribing and dispensing of all schedule II to V controlled substances the department shall promulgate regulations including, but not limited to, (1) a requirement that each pharmacy that delivers a schedule II to V controlled substance or a substance classified as an additional drug by the department to the ultimate user shall submit to the department, ___ and (2) a requirement that each pharmacy collects and reports, for each prescription dispensed, a ___, Each pharmacy shall submit the information in accordance with transmission methods and frequency requirements promulgated by the department; provided, however, that the information shall be submitted at least once every ___. The department may issue a waiver to a pharmacy that is unable to submit prescription information by electronic means. The waiver shall permit the pharmacy to submit prescription information by other means promulgated by the department; provided, however, that all information required in this section is submitted in this alternative format.
1. by electronic means, information regarding each prescription dispensed 2. customer identification number and other information associated with the customer identification number - so this DOES HAVE CUSTOMER IDENTIFICATION - however, when reporting out of state dispensing of CIIs, i don't think you include names? 24 hours
a prescription shall be: (1) written in ink, indelible pencil or by other means on a ___consistent with federal requirements for ___; or (2) transmitted ___; and (3) ___by the prescriber. A prescription may be transmitted electronically with the electronic signature and electronic instructions of the prescriber, and shall be transmitted directly from the prescriber to the pharmacy designated by the patient without alteration of the prescription information, except that ___.
1. tamper resistant form; Medicaid 2. electronically 3. signed third-party intermediaries may act as conduits to route the prescription from the prescriber to the pharmacy
the commissioner may terminate a research project if he finds (1) that the drug under investigation is __under the conditions of use; or (2) that the investigators lack the necessary __to conduct such research project or study; or (3) that the research protocol contains any ___, provided, that if the commissioner finds that there is an imminent hazard to health he shall order that the research project or study be discontinued upon notice and afford those persons who are undertaking the research the opportunity for an ___. The commissioner may also, after due notice and opportunity for a hearing, order that a research project or study be discontinued if the commissioner finds (1) that the persons who are undertaking the research have failed to establish a system for ___, or have repeatedly or deliberately failed to ___ which are required by the commissioner or the persons undertaking the research project or study have refused to ___; or (2) the methods used in, or the facilities and controls used for the research project or study are ___
1. unsafe 2. training and experience 3. untrue statement of a material fact - expedited hearing 1. maintaining required records - maintain such records or to make reports - permit access to or copying or verification of such records 2. inadequate to safeguard against unlawful diversion of the drug under investigation.
Any person who traffics in fentanyl, by knowingly or intentionally manufacturing, distributing, dispensing or possessing or by bringing into the commonwealth a net weight of more than ____ of fentanyl shall be punished by a term of imprisonment in state prison for not more than ___.
10 grams 20 years
Whoever steals a controlled substance from a registered manufacturer, wholesale druggist, pharmacy or other person authorized to dispense or possess any controlled substance shall be punished by imprisonment in the state prison for not more than __ or in a jail or house of correction for not more than ___ or by a fine of not more than ___
10 years 2.5 years $500
written prescription after oral in how many days for schedule II schedule III-V schedule VI
3 days - federal? 7 days not necessary
A written prescription for a controlled substance in Schedule II shall become invalid _____the date of issuance.
30 days after
if someone uses a false/revoked registration number to dispense/possess controls, what is the imprisonment/fine? Whoever violates this after one or more prior convictions of a violation of this section, or of a felony under any other provision of this chapter, or under a provision of prior law relative to the sale or manufacture of a narcotic drug or a harmful drug shall be punished by imprisonment in the state prison for not more than ___ or in a jail or house of correction for not more than ___, or by a fine of __
4 years (2.5 house of correction) - not more than $20,000 8 years (2.5 years) - 30,000 or both
32K: Any person who knowingly causes, induces or abets a person under the age of 18 to distribute, dispense or possess any controlled substance, or to accept, deliver or possess money used or intended for use in the procurement, manufacture, compounding, processing, delivery, distribution or sale of any such controlled substance shall be punished by imprisonment in the state prison for ___. and a fine of ___
5-15 years 1,000-100,000
if the net weight of marihuana or any mixture is ___ or more, but not less than ___, be punished by a term of imprisonment in the state prison for not less than a mandatory ____ years (max 15 years) or by imprisonment in a jail or house of correction for not less than a mandatory ___ (max 2.5 years) what about 100-2000 pounds >2000 - 10,000 pounds? >10,000 grams?
50 pounds, 100 pounds - 2.5 years - 1 year not less than 2 years and a fine of not less than 2,500 (not more than 15 years) - same for 18-36 grams not less than 3.5 years= nor more than fifteen years; fine not less than 5,000 nor more than 50,000 dollars - same for 36-100 grams Not less than 8 years (not more than 15); fine = 20,000-200,000 - same for 100-200 grams 200+ grams = 12 years imprisonment (not more than 20); 50,000-500,000 dollar fine
Call center (manufacturers of controls) shall be staffed during regular hours of operation every day and not less than ___per week. The phone number shall be affixed to the drug's___notifying prescribed users and practitioners of the fact that the drug is a ___.
6 hours container, alongside the label - compounded drug preparation
If the dispensed quantity is less than the recommended full quantity of a CII (by pts requrest), the pharmacist or a designee shall, within ___, notify the prescribing practitioner of the quantity actually dispensed. The notification shall be conveyed by a notation in the ____ or, if the pharmacist does not have the ability to make a notation in this way, by __, __ or ___.
7 days - interoperable electronic health record of the patient - facsimile, electronic transmission or by making a notation in the patient's record maintained by the pharmacy which shall be accessible to the practitioner by request
When issuing a prescription for an opiate to an adult patient for outpatient use for the FIRST time, a practitioner shall not issue a prescription for more than a____. what about for minors?
7-day supply - check this no more than a 7-day supply at ANY TIME and shall discuss with the parent/guardian of the minor the risks associated with opiate use and the reasons why the prescription is necessary.
if a police officer finds a child present where said officer finds a substance which he reasonably believes to be a controlled substance listed in Class __ kept or possessed, and if the police officer reasonably believes that the child has not reached his___ birthday and that the child knew of the presence of such controlled substance, the police officer may lawfully ___ not to exceed___. A child detained pursuant to the provisions of this section shall not be considered to have been ___
A, B, or C eighteenth take such child into protective custody for a period not to exceed 4 hours arrested or to have a criminal record for any purpose
If a person registered to distribute controlled substances discovers a theft or loss of controlled substances that requires the filing of ___with the United States DEA, the person shall simultaneously file a copy of that form with the ____ and ____
DEA Form 106 police department in the city or town wherein the theft or loss is alleged to have occurred AND to the department of state police ALSO need to send in form A and B (if confirmed) to the Board along with the DEA 106 form within 7d
research: the administering or dispensing directly or prescribing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his dependence upon such drugs in the course of conducting an authorized clinical investigation pursuant to a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term ''in the course of professional practice'' as used in this chapter, provided, that ___approval, if such approval is required, is obtained prior to the initiation of such a program, and satisfactory evidence of such approval is submitted to the commissioner.
FEDERAL
Prior to issuing an extended-release long-acting opioid in a non-abuse deterrent form for outpatient use for the first time, a practitioner shall (i) evaluate the patient's current ___, if any, and current medications; and (ii) inform the patient and note in the patient's medical record that the prescribed medication, in the prescriber's medical opinion, is an ____based on the medical need of the patient. In the event that a practitioner recommends that an extended-release long-acting opioid be utilized during the course of long-term pain management, the practitioner registered shall enter into a ____ with the ___ that appropriately addresses the benefits as well as the risk factors for abuse or misuse of the prescribed substance under guidelines published by the department. Such an agreement shall be filed in the __ or __.
I. condition, risk factors, history of substance abuse ii. appropriate course of treatment written pain management treatment agreement with the patient patient's medical record or included in the patient's electronic health record
voluntary non-opiate directive form: A written prescription that is presented at an outpatient pharmacy or a prescription that is electronically transmitted to an outpatient pharmacy shall be presumed to be valid and a pharmacist in an outpatient setting shall ____of this section for dispensing a controlled substance in contradiction to a voluntary non-opiate directive form, except upon evidence that the pharmacist ___against the voluntary non-opiate directive form.
NOT be held in violation unless they acted knowingly
commissioner may authorize registration for a SPECIFIC activity; who might the commissioner do this with?
NPs, psychiatric nurse mental health clinical specialists - can write rxs for pts pursuant to guidelines mutually developed and agreed upon by the nurse and supervising physician - commissioner shall consult with board of registration in medicine and nursing to determine which schedules the nurses should be registered certified nurse-midwives " nurse anesthetists " - board of registration in nursing, medicine, AND pharmacy PAs " - consult board of registration of PAs, board of medicine pharmacists, CDTM " - board of pharmacy and medicine optometrists - board of registration in optometry
CLASS A distribution to someone under the age of 18? CLASS B CLASS C
No less than a mandatory minimum term of imprisonment of 5 years (no more than 15) and a fine of not less than 1000 dollars nor more than 25,000 dollars not less than 3 years (no more than 15); 1000-25,000 2.5 years (no more than 15); 1000-25,000
commissioner should exclude non-narcotics from any schedule if they are sold ___
OTC (non-narcotics) w/o a prescription - these products are not even schedule VI - have to be an Rx to be a schedule
'sharps collection center'' must meet requirements of federal ____and the federal ___and is marked with the international ___symbol; The program shall be designed to protect the public health and the environment by providing for the safe, secure and accessible collection and disposal of __ and ___.
Occupational Safety and Health Administration; Department of Transportation; biohazard hypodermic needles and lancets
Physicians located in MA - Narcotic CII- ____ - Non-narcotic CII- ____ Physicians located in contiguous states or Maine - Narcotic CII- _____ - Non-narcotic CII- _______ Physicians located outside of contiguous states or Maine - Narcotic CII- _____ - Non-narcotic CII- _____ Midlevel prescriber in MA - Narcotic CII- _____ - Non-narcotic CII- ____ Midlevel prescriber out of state - Narcotic CII- _____ - Non-narcotic CII-______
Physicians located in MA - Narcotic CII- prescription is valid for 30 days - Non-narcotic CII- prescription is valid for 30 days Physicians located in contiguous states or Maine - Narcotic CII- Prescription is valid for 5 days - Non-narcotic CII- Prescription is valid for 5 days Physicians located outside of contiguous states or Maine - Narcotic CII- NOT VALID - Non-narcotic CII- Prescription is valid for 5 days Midlevel prescriber in MA - Narcotic CII- prescription is valid for 30 days - Non-narcotic CII- prescription is valid for 30 days Midlevel prescriber out of state - Narcotic CII- NOT VALID - Non-narcotic CII- NOT VALID
who implements the regulations in regards to emergency contraception? who implements it for opioid antagonist dispensing?
The department of public health, board of registration in medicine, and board of registration in pharmacy shall adopt regulations to implement this section. same people
manufacturers register with the ___ and registration lasts ___ wholesale druggist outsourcing facility pharmacy scientific analysis lab?
This is DIFFERENT from just the registration, this is the controlled substances registration!!! commissioner, 1 year board, 1 year, also every year for registration (Nov. 1) board, TWO years for registration (Dec 31 of every odd year) board, TWO YEARS (2), also for registration (Dec 31 of every odd year) commissioner, 1 year
No controlled substance in Schedule II may be dispensed without the written prescription of a practitioner, except that a. In ____, drugs in said Schedule II may be dispensed upon oral prescription of a practitioner, reduced promptly to ____ b. what about Schedule III, IV, V or VI?
a. - emergency situations - writing and filed by the pharmacy b. can be dispensed via written OR oral prescription (no emergency required?)
heroin fines/imprisonment a. 18g-36g b. 36-100g c. 100-200g d. 200+ grams
a. 3.5-30 years; 5,000-50,000 b. 5-30 years; 5,000-50,000 c. 8-30 years; 10,000-100,000 d. 12 years; 50,000-500,000
PMP a. department will require participants to utilize the prescription monitoring program when? ___ b. The department may require participants to utilize the prescription monitoring program prior to the issuance, to a patient for the first time, of ___ or __, which is commonly abused and may lead to physical or psychological dependence or which causes patients with a history of substance dependence to experience significant addictive symptoms. c. The regulations may also specify the circumstances under which ___may use the prescription monitoring program on behalf of a registered participant. d. When promulgating the rules and regulations, the department shall also require that pharmacists be trained in the use of the prescription monitoring program as part of the___mandated for licensure by the board of registration in pharmacy e. The department shall also study the feasibility and value of expanding the prescription monitoring program to include ___prescription drugs.
a. prior to the issuance, to a patient for the first time, of a prescription for a narcotic drug that is contained in schedule II or III - i thought every time for schedules II and III? b. benzodiazepines or any other schedule IV or V prescription drug c. support staff d. continuing education requirements e. schedule VI
if, in the professional medical judgment of a practitioner, more than a 7-day supply of an opiate is required to treat the adult or minor patient's ____or is necessary for the treatment of __, ___, or ___, then the practitioner may issue a prescription for the quantity needed to treat such condition. The condition triggering the prescription of an opiate for more than a 7-day supply shall be____. who does this not apply to?
acute medical condition, chronic pain management, pain associated with a cancer diagnoses or for palliative care documented in the patient's medical record and the practitioner shall indicate that a non-opiate alternative was not appropriate to address the medical condition - is this only for the FIRST TIME the pt is receiving this med - if its other than the first they don't have to do this right? medications designed for the treatment of substance abuse or opioid dependence.
for most controlled substances imprisonments, any person servicing will be up for parol when? UNLESS WHAT?
after serving 1/2 of the maximum term of the sentence UNLESS: (i) the defendant used violence or threats of violence or possessed a firearm, rifle, shotgun, machine gun or a weapon or induced another participant to do so, during the commission of the offense; (ii) the defendant engaged in a course of conduct whereby he directed the activities of another others who committed any felony (iii) the offense was committed during the commission or attempted commission of a violation of section 32F (dispensing to minors) or section 32K (involving a kid <18) of chapter 94C.??
PMP: The department shall submit an ___ (how often?) report on the EFFECTIVENESS of the PMP with the who? (4 departments)
annual clerks of the house and senate, the chairs of the joint committee on public health, the chairs of the joint committee on health care financing and the chairs of the joint committee on public safety and homeland security
what should a nurse do with unused controlled substances?
any unused portion of the controlled substance which is no longer required by the patient
A licensed dental hygienist who has obtained a controlled substance from a practitioner for dispensing to an ultimate user shall return to such practitioner ___ this also applies to who?
any unused portion of the substance which is no longer required by the patient. nurses who don't use all controlled substance on patients
A practitioner may have a ___ give an immunization under the practitioner's direction
certified medical assistant
possession of 1 ounce or less of marihuana shall only be a ___, subjecting an offender who is 18 years of age or older to a civil penalty of ____and forfeiture of the marihuana, but not to any other form of criminal or civil punishment or disqualification. what if < 18? - who else is involved if <18? If an offender under the age of eighteen fails within 1 year of the offense to complete both a __ and ___, the civil penalty may be increased to ___ and the offender and his or her parents shall be jointly and severally liable to pay that amount. but overall, this individual will not be deprived of ___
civil offense $100 same forfeiture and civil penalty provisions ($100), provided he or she completes a drug awareness program (32M) - The parents or legal guardian are notified drug awareness program AND the required community service - $1000 financial aid, right to drive a car, etc.
who makes the regulations for emergency situations (when oral rxs are allowed for schedule IIs)
commissioner acting jointly with the board
fee for registration for manufacturing, dispensing, possessing controls is determined by the __ how often?
commissioner annually
PMP: The department may contract with another agency or with a private vendor, as necessary, to ensure the effective operation of the PMP. A contractor shall be bound to comply with the provisions regarding ___
confidentiality of prescription information
The board of registration in pharmacy shall promulgate regulations requiring pharmacies located in areas with high incidents of opiate overdose, as determined by the board in consultation with the department of public health, to maintain a ___ or ___.
continuous supply of naloxone rescue kits or opioid antagonist medications
The pharmacist filling a written or oral prescription for a controlled substance shall package the controlled substance in a container, affixing to the container a label showing what info?
date of filling the pharmacy name and address the filling pharmacist's initials - I thought for controls you needed to sign your name ??? the serial number of the prescription the name of the patient, unless it is a veterinary prescription - what about address??? the name of the prescribing practitioner the name of the controlled substance directions for use and cautionary statements if tablets or capsules - the number in the container
voluntary non-opiate directive form -form shall be posted on the _____. -how does an individual revoke this form?
department's searchable website any reason and may do so by written or oral means
Authority to control schedules shall not extend to ___, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1954.
distilled spirits, wine, malt beverages, or tobacco
Whenever the commissioner, the board of registration in pharmacy, or the commissioner of mental health has substantial reason to believe that a registrant has committed a criminal violation of any provision of this chapter, he or it shall promptly report all pertinent facts to the ___ or the the __
district attorney in the county where the violation is believed to have occurred, or to the attorney general.
failure to accept pharmacists offer to counsel should be ___
documented
An offender under the age of eighteen is required to complete a ___ within ___ of the offense for possession of 1 ounce or less of marihuana. In addition to the civil penalties, the failure of such an offender to complete such a program may be a basis for delinquency proceedings for persons under the age of 18 at the time of their offense. The drug awareness program must provide at least ___ and ___. who enforces this?
drug awareness program within one year 4 hours of classroom/group discussion AND 10 hours of community service police department: function as a liaison between the department and persons providing drug awareness programs
The labeling provisions of controls shall apply to the compounding and dispensing of drugs on the oral or written prescription of a licensed and registered prescriber. All drug preparations compounded, made or formulated by a pharmacy licensed by the board of registration in pharmacy shall have affixed to their container by the compounding pharmacy a label notifying prescribed users and practitioners that the drug is ___ or ___.
either a sterile or non-sterile compounded drug preparation
who doesn't need to be registered and may lawfully possess and distribute controlled substances?
employee of a manufacturer/distributor/dispenser (besides field/sales reps) public official/law enforcement officer (acting in regular performance of his official duties) registered nurse, licensed dental hygienist, graduate of a school for nurses, therapist, technician, medical student (supervision of a practitioner) duly licensed optometrist who utilizes diagnostic pharma agents for the purpose of conducting an eye exam - needs to provide the wholesale distributor or pharmacist with the number of optometrist's certification of qualification to administer such dx pharma agents an ultimate user/research subject
If the commissioner determines that a research subject or patient is receiving a controlled substance ___, said commissioner shall so notify the___ who have dispensed the controlled substance.
from more than one source and in quantities which he determines to be harmful to the health of such research subject or patient practitioners
Prior to issuing a prescription for an opioid contained in Schedule II, a practitioner registered shall: (i) consult with a the patient regarding the ___ and the option to ___; and (ii) inform the patient of the ___associated with the opioid prescribed.
i. quantity of the opioid and a patient's option to fill the prescription in a lesser quantity ii. risks
when does an optometrist not need to be registered to possess/dispense controls?
if he/she is a duly licensed optometrist who utilizes diagnostic pharma agents for the purpose of conducting an eye exam - needs to provide the wholesale distributor or pharmacist with the number of optometrist's certification of qualification to administer such dx pharma agents
opioid agonist therapy: A corporate entity doing business in the commonwealth shall be LICENSED by the department and shall comply with requirements established by the department to limit the diversion of opioid drugs and ensure patient safety if they have more than __ patients receiving tx for opioid dependency in the form of opioid agonist therapy? The department shall issue best practice guidance related to __, __, and ___for practitioners who provide opioid agonist therapy in the commonwealth. Practitioners shall adhere to said best practices promulgated by the department.
if more than 300 patients receiving treatment for opioid dependency - confusing bc federally you can only have 30 patients first year, and 100 second year routine toxicology screenings, maximum take home dosages and behavioral health referrals
when can the commissioner place a substance in schedule I
imminent hazard to public safety necessary for preservation of public health/safety NOT listed in any other schedule NOT excluded under subsection c of section 2 (distilled spirits, wine, malt beverages, or tobacco)
possession of MORE than 1 ounce of marihuana? what else has this same imprisonment/fine? any person who is convicted for the FIRST time under this section for the possession of marihuana or a controlled substance in Class E and who has not previously been convicted of any offense pursuant to the provisions of this chapter, or any provision of prior law relating to narcotic drugs or harmful drugs shall be ___ unless such person does not consent, or unless the court files a written memorandum stating the reasons for not so doing. Upon successful completion of said probation, the case shall be dismissed and records shall be___.
imprisonment in a house of correction for not more than 6 months or a fine of 500, or both possession of class E controls without an rx placed on probation - sealed
Whoever knowingly or intentionally violates any provision of this section (research with controls) shall be punished for each offense by ___
imprisonment in a jail or house of correction for not more than one year or by a fine of not more than one thousand dollars, or both.
Any person who knowingly or intentionally manufactures, distributes, dispenses, or possesses a controlled substance in Class A shall be punished by ___ or ___, or by both such fine and imprisonment. what if they do it again? Up for parole when? - UNLESS
imprisonment in the state prison for not more than 10 years or in a jail or house of correction for not more than two and one-half years or by a fine of not less than 1000 nor more than 10,000 dollars (same for class B) - no more than 5 years; 500-5000 (C) - no more than 2 years; 500-5000 (D) - not more than 9 months; 250-2500 (E) No sentence imposed shall be for less than a mandatory minimum term of imprisonment of 3 and 1/2 years and a fine of not less than 2500 nor more than 25,000 may be imposed but not in lieu of the MANDATORY minimum 31/2 year term of imprisonment (mandatory minimum term imprisonment is 2 years for class B; 2.5 years if certain section of B; some is the same as A - 3.5 years); (not less than 18 months for C); (not less than 1 year for D); (not more than 1.5 years; not less than 500-5000 E) after serving half of the max time (same for B, C) - UNLESS the defendant used violence/threats or possessed a firearm/weapon during the offense - UNLESS the defendant directed the activities of another who committed any felony - UNLESS the offense was committed during the commission or attempted commission of a violation of 32F (dispensing to minors) or 32K (involving a kid <18) parole may be enhanced supervision (wearing a gloal posisitioning satellite tracking device) - same for B, C
can the board (retail drug business, wholesale druggist or outsourcing facility) or the commissioner (all other cases) suspend/refuse renewal without a hearing? but he/she has to promptly afford the registrant an ____ when shall the suspension be dropped?
may without hearing suspend or refuse to renew any registration if he finds that there is an imminent danger to the public health or safety which warrants this action opportunity for a hearing The suspension shall continue in effect until the conclusion of the proceedings including judicial review thereof, unless sooner dissolved by a court of competent jurisdiction, or withdrawn by the board of registration in pharmacy in the case of a retail drug business, wholesale druggist or outsourcing facility, or withdrawn by the commissioner in any other case.
what should a practitioner write on a written prescription for a control?
name, address and registration number of the practitioner the date of delivery (?) of the prescription the name, dosage and strength per dosage unit of the controlled substance the name and address of the patient unless it is a veterinary prescription the directions for use and any cautionary statements required a statement indicating the number of times to be refilled
Upon receiving an ORAL prescription for a RADIOPHARMACEUTICAL drug from an authorized practitioner, the nuclear pharmacist shall immediately reduce the prescription to writing and shall record the ____.
name, address and registration number of the practitioner (and the name of any expressly authorized representative) the date of the prescription the name and the dose of the radiopharmaceutical drug the serial number assigned to the prescription by the dispensing nuclear pharmacy the name of said nuclear pharmacy the name and address of the patient any specific instructions required
can a person carry out a research project with a schedule II?
no, unless he supplies the commissioner with satisfactory evidence of compliance with any applicable federal law, and, if the commissioner so requires, with a protocol describing the research project or study to be undertaken.
fine/imprisonment for possessing a control without a prescription for it? what if it's heroin (1st and 2nd offense?) nor more than five years or by a fine of not more than five thousand dollars and imprisonment in a jail or house of correction for not more than two and one-half years.
not more than 1 year not more than 1000 or both 1st: house of correct not more than 2 years OR by fine of not more than 2,000 (or both) 2nd: 2.5 years - 5 years; or by fine not more than 5000 AND imprisonment in a correction for 2.5 years
Any person who knowingly or intentionally creates, distributes, dispenses or possesses a counterfeit substance shall be punished by imprisonment in a jail or house of correction for not more than ___or by a fine of not less than ___, or both such fine and imprisonment.
not more than 1 year at least 250 nor more than 2500
Any person who is knowingly present at a place where heroin is kept or deposited in violation of the provisions of this chapter, or any person who is in the company of a person, knowing that said person is in possession of heroin in violation of the provisions of this chapter, shall be punished by imprisonment for __ or ___, or both
not more than 1 year or by a fine of not more than $1000
how does a practitioner note the option for a pt to fill LESS of a CII than prescribed?
notation ON THE PRESCRIPTION: a lesser amount of the the prescription in an amount not to exceed the recommended full quantity indicated also tell the pt this
No prescription for a controlled substance shall be refilled unless the ___ and ___
original prescription provides for such refilling AND unless the number of refills has been specified in said prescription.
The department shall enter into reciprocal agreements with ___that have compatible prescription drug monitoring programs to share ____information among the states.
other states prescription drug monitoring
The commissioner may gather __and__ data if available from objective sources and review community retail drug business-based collaborative drug therapy management (CDTM). If the commissioner finds that sufficient data and funding sources exist to conduct a valid study, he shall conduct a study within ___after that finding. The study shall include representatives of the board of registration in ___ and ___. In conducting the study, the commissioner shall hold at least 1 ___to receive testimony from the public, including representatives of pharmacy and medicine and other concerned parties.
patient outcome and cost-savings 2 years medicine and pharmacy public hearing
every person who manufactures, distributes or dispenses, or possesses with intent to manufacture, distribute or dispense any controlled substance within the commonwealth shall upon ___, register with the commissioner of public health, in accordance with his regulations, said registration to be effective for ___from the date of issuance. which facilities shall register with the board of registration in pharmacy instead of the commissioner?? - how long does their registration last?
payment of a fee ONE year (unlike 3 with the DEA?) Every wholesale druggist and outsourcing facility and pharmacy - wholesale druggist and outsourcing facility: annual - pharmacy: every 2 years (biennial)
The department shall, upon request, provide data from the prescription monitoring program to the following?
persons authorized to prescribe/dispense controls individuals who request THEIR OWN prescription monitoring info persons authorized on behalf of state boards and regulatory agencies local/state/federal law enforcement or prosecutorial officials executive office of health and human services regarding Medicaid program recipients US attorney personnel The department may provide de-identified information to a public or private entity for statistical research or educational purposes.
every registration for a location holding/possessing/dispensing controlled substances lasts ONE YEAR except?
pharmacies - lasts 2 years
Hypodermic syringes or hypodermic needles can be sold by what 3 facilities?
pharmacist or wholesale druggist , a manufacturer of or dealer in surgical supplies or a manufacturer of or dealer in embalming supplies
a licensed pharmacist may dispense an opioid antagonist (naloxone) in accordance with written, standardized procedures or protocols developed by an actively practicing physician registered with the commissioner to distribute or dispense a controlled substance, if such procedures or protocols are filed at the __ and ____ this law is very similar to the law for ___
pharmacist's place of practice and with the board of registration in pharmacy before implementation. emergency contraception
If the board of registration in pharmacy or the commissioner suspends or revokes a registration, all controlled substances which are affected by such suspension or revocation shall be ___. No disposition may be made of substances under such embargo until ____unless a court, upon application therefor, orders the ___. Upon a revocation order becoming final, all controlled substances may be __ The board or commissioner shall promptly notify the ___of all orders suspending or revoking a registration and all forfeitures of controlled substances.
placed under embargo - the time for taking an appeal has elapsed or until all appeals have been concluded - UNLESS - sale of perishable substances and the deposit of the proceeds of the sale with the court forfeited to the commonwealth bureau
No person shall sell, possess or purchase drug paraphernalia, knowing, or under circumstances where one reasonably should know, that it will be used to ____ a controlled substance Whoever violates any provision of this paragraph shall be punished by imprisonment in jail or house of correction for ___, or both. what if sold to a minor (<18)?
plant, propagate, cultivate, grow, harvest, manufacture, compound, convert, produce, process, prepare, test, analyze, pack, repack, store, contain, conceal, ingest, inhale, or otherwise introduce into the human body 1-2 years, fine of 500-5000 3 - 5 years prison 1,000-5,000 or both - This section shall not apply to the sale of hypodermic syringes or hypodermic needles to persons over the age of 18
A person who, in good faith, seeks medical assistance for someone experiencing a drug-related overdose shall not be charged or prosecuted for ___ same goes for? The act of seeking medical assistance for someone who is experiencing a drug-related overdose MAY be used as a MITIGATING (to make less severe) factor in a criminal prosecution under the ___ Nothing contained in this section shall prevent anyone from being charged with trafficking, distribution or possession of a controlled substance with ___.
possession of a controlled substance if the evidence for the charge of possession of a controlled substance was gained as a result of the seeking of medical assistance. if the person in trouble calls for him/herself Controlled Substance Act intent to distribute
A pharmacy registered in the commonwealth to dispense schedule II, III, IV or V prescription drugs shall make available ____for sale at each store location. Pharmacies shall make customers aware of the availability of these by displaying a sign on or near the pharmacy counter that: (i) is at least___; and (ii) includes the following statement in legibly printed font: "___"
prescription lock boxes I. 4 inches by 5 inches ii. ''Lock boxes for securing your prescription medications are available at this pharmacy''
Upon obtaining or renewing a registration to posses controls, a practitioner who prescribes controlled substances shall automatically and without further action be registered as a participant in the ___. The department shall provide each participant with a unique __ and ___for the program. For the purposes of this section, a practitioner shall not include a ___; provided, however, that a practitioner shall include a __, __,__authorized by the board of registration in nursing to practice in an advanced practice nursing role.
prescription monitoring program user name and access code veterinarian - shall NOT include physician assistant, nurse anesthetist or a registered nurse - shall include
to use a human being when studying/researching with controls, the patient must ___
provide in writing his INFORMED CONSENT based upon information about the nature, duration and purpose of the investigation; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon the subject's health or person which may reasonably be expected to come from his participation.
If a person elects delivery of a prescription drug at a location other than a pharmacy, the requirements of this section may be satisfied by ____. - this number shall be printed___
providing such person with access to a toll-free telephone service to facilitate communication between such person and the pharmacist - on a label affixed to EACH container of a prescription drug dispensed
oral rx If the prescribing practitioner is not known to the pharmacist, he shall make a _____.
reasonable effort to determine that the oral authorization came from a registered practitioner
Upon receiving an oral prescription for a controlled substance or instrument from an authorized practitioner, the pharmacist shall immediately reduce the prescription to writing: what should be on the prescription form?
record the name, address and registration number of the practitioner (and the name of any expressly authorized representative) the date of the prescription the name, dosage and strength per dosage unit of the controlled substance the serial number assigned to the prescription by the dispensing pharmacy the name of said pharmacy??? - didn't think this would have to be there? the name and address of the patient (unless it is a veterinary prescription) the directions for use and any cautionary statements required and a statement indicating the number of times to be refilled
Clinic pharmacies operated by a health maintenance organization may ___prescriptions which have been previously dispensed by another health maintenance organization clinic pharmacy, provided that prior to dispensing a refill, the pharmacy refilling the prescription ___.
refill verifies the appropriateness of the refill through a centralized database
A written prescription for a controlled substance in Schedule II shall not be ___and shall be kept in a ___file.
refilled separate
If the radiopharmaceutical drug is not administered, it shall be ____ the nuclear pharmacist shall note on the prescription form the ____
returned to the nuclear pharmacy to be disposed of the amount of the radiopharmaceutical drug that has been returned and disposed of as required.
which schedules does the department need to annually report a mean and median quantity and volume of prescriptions for opiates?
schedule II and III
Whenever a practitioner dispenses a controlled substance by oral prescription, such practitioner shall, within a period of not more than ____ or such shorter period that is required by federal law cause a written prescription for the prescribed controlled substance to be delivered to the dispensing pharmacy. The prescription may be delivered to the pharmacy how? Upon receipt, the dispensing pharmacy shall ___. The requirements of this subsection shall not apply to ____
seven days in person or by mail, but if delivered by mail the envelope shall be postmarked within the seven-day period or such shorter period that is required by federal law. (3 for schedule II?) attach said prescription to the oral prescription which the pharmacy has reduced to writing controlled substances in Schedule VI - don't need a written rx for schedule VI
A physician, PA, dentist, podiatrist, optometrist, certified nurse midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist or veterinarian may dispense by delivering to an ultimate user a controlled substance in a ____. The amount or quantity of any controlled substance dispensed under this subsection shall not exceed the quantity of a controlled substance necessary for the ___ of the patient until it is possible for the patient to have a ___. who does this not include?
single dose or in a quantity that is essential for the treatment of a patient immediate and proper treatment - prescription filled by a pharmacy - manufactures dispensing controls to the patient dispensed in the package from the manufacturer at no charge to the patient - optometrists dispensing/selling in-office therapeutic contact lesnes
On any premises where tobacco rolling papers are sold, the person in control of such premises shall display in a prominent place a printed warning that ____. Whoever violates the provisions of this subsection shall be punished by a fine of not less than ___.
such papers shall not be used in conjunction with the possession of a controlled substance the possession of which is punishable by a fine or imprisonment 50-200 dollars
who has jurisdiction over the board and commissioner?
superior court
schedule II A registered pharmacist filling a prescription shall determine that such prescription is authentic and valid; and shall verify such prescription by ____. A pharmacist shall not fill a prescription for which said verification cannot be obtained. A pharmacist shall not be held liable for refusing to fill such prescription for which said verification cannot be obtained; provided, however, that ___were made to determine the authenticity and validity of such prescription. This paragraph is only for the purpose of authorizing the filling of prescriptions within the commonwealth, issued within the ____, and shall not authorize such practitioner to possess, administer or dispense controlled substances. a pharmacist filling a schedule II prescription shall within ___after the filling of such prescription deliver to the department a copy of each such Schedule II prescription; provided, however, that such copy shall not include the ___ and shall not ____
telephone or other means documented good faith efforts preceding five days (ISN'T IT 30 NOW) - CHECK thirty days shall not include the name and address of the patient for whom the prescription is issued and shall not be deemed to be public record
schedule III-V It is the duty of the registered pharmacist who is filling a prescription,, that such prescription is authentic and valid; provided, however, that if the substance is in schedules III to V, the registered pharmacist shall verify the prescription by____ - A pharmacist shall not fill a prescription for which said verification cannot be obtained. The pharmacist shall not be held liable for REFUSING to fill a prescription for which said verification cannot be obtained, provided that ____. This paragraph shall be valid only for the purpose of authorizing the filling of prescriptions, issued within the _____. In the case of any oral prescription for a schedule III through V substance, the pharmacist shall record that he has requested that the practitioner _____ or such shorter period required by Federal law.
telephone or other means documented good faith efforts were made to determine the authenticity and validity of the prescription preceding thirty days deliver or mail to the dispensing pharmacy a written prescription for the controlled substance within seven days (what's federal??)
Upon the request of an elderly person or a person visually impaired, directions on the label affixed by the pharmacist to a container of a prescription drug shall be typed in a print size allowing no more than ____
ten characters per inch
if federal registration is suspended or revoked to manufacture, distribute, dispense, administer or possess controlled substances; what does the state do?
the board may suspend/revoke the registration
who gets automatic issuance of registration from the commissioner upon receipt of the fee ? When would this not happen?
the commissioner shall, upon receipt of the fee, automatically issue to any PHYSICIAN, DENTIST, PODIATRIST, OR VETERNARIAN who is duly authorized to practice his profession in the commonwealth a registration to dispense unless the registration of such physician, dentist, podiatrist, or veterinarian has been suspended or revoked,
what RECORDS should every physician, physician assistant, dentist, podiatrist, certified nurse midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist and veterinarian keep?
the names and quantities of any controlled substances in schedules I, II or III received by the practitioner; the name and address of each patient to whom such controlled substance is administered or dispensed; the name, dosage and strength per dosage unit of each such controlled substance; and the date of such administration or dispensing. NOTICE: NO RECORDS FOR WHAT IS PRESCRIBED
A practitioner who dispenses by DELIVERING to an ultimate user a controlled substance which is NOT for immediate administration shall package the controlled substance in a container, affixing to the container a label bearing what info?
the practitioner's name and address (NO REGISTRATION # LIKE A WRITTEN RX? - not on label either tho) the date of dispensing the name of the patient unless it is a veterinary prescription the name, dosage and strength per dosage unit, of the controlled substance directions for use and any necessary cautionary statements NO REFILL INFO LIKE A WRITTEN RX GOING TO A PHARMACY
In regard to a controlled substance in Schedule II or III, no prescription shall be filled for more than a ___day supply of such substance upon any single filling; exceptions? - 60 - 90
thirty-day supply - dextro amphetamine sulphate and methyl phenidate hydrochloride, a prescription may be filled for up to a 60-day supply of such substance upon any single filling if said substance is being used for the treatment of minimal brain dysfunction (ADHD) or narcolepsy - implantable infusion pumps consisting of Schedule II or Schedule III controlled substances may be filled for a maximum of 90 days.
Before dispensing an opioid antagonist pursuant to this section, a pharmacist shall complete a ___approved by the commissioner on opioid antagonists. this shall include, but not be limited to, __ and ___ regulations regarding dispensing opioid antagonists is very similar to that of ___
training program proper documentation and quality assurance. emergency contraception
Before dispensing emergency contraception, a pharmacist shall complete a ____, which shall include but not be limited to ___. these laws are very similar to dispensing ?
training program approved by the commissioner on emergency contraception proper documentation, quality assurance, and referral to additional services, including appropriate recommendation that the patient follow-up with a medical practitioner opioid antagonists
All prescriptions for controlled substances shall be kept for___by the pharmacy and shall be subject to inspection pursuant to the provisions of this chapter.
two years
what physician doesn't need to participate in PMP?
vets
a licensed pharmacist may dispense emergency contraception in accordance with ____ if such procedures or protocols are filed at the ___ and ___before implementation. filed where before dispensed? these laws are very similar to dispensing ?
written, standardized procedures or protocols developed by an actively practicing physician registered with the commissioner to distribute or dispense a controlled substance in the course of professional practice filed: pharmacist's place of practice AND with the board of registration in pharmacy opioid antagonists
can an oral prescription issued by a practitioner be communicated to a pharmacist by an expressly authorized employee or agent of the practitioner?
yes
do practicioners have to complete training to get and renew registration to possess/dispense controls? what does this training involve?
yes, BESIDES VETS training relative to: (i) effective pain management; (ii) the risks of abuse and addiction associated with opioid medication; (iii) identification of patients at risk for substance use disorders; (iv) counseling patients about the side effects, addictive nature and proper storage and disposal of prescription medications; (v) appropriate prescription quantities for prescription medications that have an increased risk of abuse; and (vi) opioid antagonists, overdose prevention treatments and instances in which a patient may be advised on both the use of and ways to access opioid antagonists and overdose prevention treatments.
can an individual who has elected for voluntary non-opiate directive appoint a duly authorized guardian or health care proxy to OVERRIDE a previously recorded voluntary non-opiate directive form?
yes, the department shall promulgate regs for the implementation of this
