105 CMR 700
MLID automatically adopts all ___ rated drug products listed in the ___ this publication is commonly referred to as the "___" it is reprinted by the ___ Volume __ of the ___
"A" rated drug products in the "Approved Drug Products with Therapeutic Equivalence Evaluations" published by the FDA, Department of Health and Human Services "Orange Book" US Pharmacopeial Convention Inc (USP - Volume III - USP DI
what needs to go on an Rx?
"Caution, Federal law prohibits dispensing w/o prescription" - on every manufacturers label?? or every label for an rx? did this change to Rx Only?
when a less expensive generic drug product has been dispensed, what needs to appear on the label? what if less expensive brand? can abbreviations be used?
"Interchange": (Generic name of less expensive drug product dispensed plus manufacturer) same thing but write the generic name and manufacturer or the less expensive brand name and manufacture yes, can use IC for interchange and use the manufacturer's abbreviated names found in the MLID
Upon receiving a prescription for a generic name drug product with no manufacturer specified by the prescriber, the pharmacist may select, regardless of whether or not the prescriber has marked ___ on the prescription, any legally marketed drug product whether or not it appears in the ___, in accordance with the prescriber's intent and the normal exercise of professional judgement.
"no substitution" Massachusetts List of Interchangeable Drugs
emergency situation to dispense schedule II upon oral rx?
(1) That the immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user, and (2) That no appropriate alternative treatment is available, including administration of a controlled substance which is not in Schedule II, and (3) That it is not reasonably possible for the practitioner to provide a written prescription to be presented to the person dispensing the controlled substance prior to the dispensing.
the Generic Drug Law of 76 promoted and regulated the use of generic drugs, created the ___ to develop pa list of interchangeable drug products and also required the use of a ____ to encourage practitioners to prescribe generic drugs what is the standard prescription form?
- DFC (Drug Formulary Commission) - standard prescription form if the prescriber signs the prescription form and writes the words "no substitution) in his own handwriting in the space below the signature, the pharmacist must fill the Rx exactly as indicated, with no interchange permitted (however, if they just sign and don't write that, they can interchange using the MLID)
qualifying pt for an act for humanitarian use of medical marijuana? what is a debilitating medical condition what if UNDER 18?
- MA resident - 18yo - dx by a MA licensed certifying physician as having a debilitating medical condition cancer, glaucoma, HIV, AIDS, hep C, ALS, CD, PD, MS - MA resident - <18 - dx by TWO MA licensed certifying physicians, AT LEAST ONE OF WHOM IS A BOARD-CERTIFIED pediatrician or board-certified pediatric subspecialist, as having a debilitating medical condition that is also a LIFE-LIMITING illness (if not life-limiting, both physicians must agree the benefits outweigh the risks, talk to parents/guardians about risks, and have them sign a consent form?? - check)
all SAMPLES dispensed shall be properly LABELED - a label shall be affixed to the outside of the package and shall include what info? what else should be labeled unless already provided for on the manufacturers' packaging of the sample med? a combination of __, __, __ may used to make sure the pt easily understands the sample what if you have multiple samples being dispensed?
- a registered individual practitioner's name and address (different from what would go on label from a pharmacy, it would just be the name of the practicioner) - date of dispensing - name of the patient, unless a vet product - name, dosage form, strength - clear, simple, and brief directions for use (and any necessary cautionary statements) - date on which the med will expire written info, labeling, and counseling can place the samples in a larger container that has the label containing applicable information
who can hospital pharmacies fill med orders for? what about emergency room patients and discharge patients?
- inpatients - hospital outpatients and employees - can they fill for employees familY? - inpatients of a hospital-based SNF or long-term care facility owned by the hospital may fill rx for them in an amount NOT TO EXCEED 14d supply of the prescribed med
what happens if the Department learns that a participant is utilizing the PMP incorrectly? if after investigation, the Department determines that the participant utilized it incorrectly, the Department may, dependin gon the severity of the violation, do the following?
- may immediately restrict electronic access to the PMP - shall contact the participant to investigate the potential violation (a) Issue a warning letter to the participant; (b) Require the participant to undergo training on the appropriate use of the PMP; (c) Temporarily suspend the participant's access to the PMP;
before commencing such research, the person immediately responsible shall submit to the commissioner 1. satisfactory evidence of compliance with ___ 2. a proposed written "___" 3. a statement of "___" with the requirements for the protection of human research subjects by an ___ 4. a ___describing the research project or study to be undertaken if the Commissioner so requires
1. Federa law 2. "Statement of Informed Consent" 3. "Assurance of Compliance"; Institutional Review Committee 4. protocol
MLID (Mass List of Interchangeable Drug Products) shall consist of... 1. drug products which are considered by the FDA to be ____ to other pharmaceutically equivalent products listed with the same generic or chemical name according to the most recent edition of ____ and its supplements published by the US Department of Health and Human Services 2. the Commission has determined that the ___ is NOT essential, or if the Commission has determined that it is essential, it has been established 3. the list may include the following categories of drug products a. drug products that hold an ___ or ___ approved by the FDA, even if they don't consider them pharmaceutically equivalent b. drug products exempt from the ___ and included in the ___ done by the National Academy of Sciences/National Research Council c. frequently prescribed drug products which were manufactured prior to 38 and meet ___ d. frequently prescribed ___drugs which contain the same amounts of active ingredients, in the same dosage forms, as other drug products with the same generic or chemical name
1. THERAPEUTICALLY equivalent - "Approved Drug Products with Therapeutic Equivalence Evaluations" 2. Bioequivalence - not essential or if it is essential, its been proven a. NDA or ANDAs b. Food, Drug, and Cosmetic Act of 62; Drug Efficacy Study Implementation (DESI) c. FDA GMP requirements d. OTC
In case of an emergency situation, a pharmacist may dispense a Schedule II upon receiving oral authorization of a prescribing individual practitioner; provided that: (1) The quantity prescribed and dispensed is limited to the ___; and (2) The prescription is ___by the pharmacist and contains all information required, except for the ___; and (3) If the prescribing individual practitioner is not known to the pharmacist, he makes ___ to determine that the oral authorization came from a registered individual practitioner, including a___ to the prescribing individual practitioner using ___ or other good faith efforts to insure his identity.
1. amount adequate to treat the patient during the emergency period 2. immediately reduced to writing; except for the signature of the prescribing individual practitioner 3. reasonable good faith effort; callback; his phone number listed in the telephone directory
prior to participation of a patient in the marijuana program (research program), the physician must certify that the pt is eligible by providing th eDepartment with the following info: 1. the patient is threatened by loss of __ or __; if the patient has asthma, that the patient experiences __ 2. other tx? 3. marijuana as an option? 4. that the pt has given in writing his/her ___ based upon information about the nature, duration, and purpose of the research, the method and means by which it is to be conducted, the inconveniences and hazards reasonably to be expected and the effects upon the pts health or person to be expected
1. life or sight; severe respiratory problems or discomfort 2. not responding to or has incurred severe side effects from the admin of conventional controlled substances 3. that the admin of marijuana may have beneficial therapeutic effects upon the pt 4. informed consent
termination of registration a. shall terminate if and when what 4 reasons? what should the person do if change in name or address?
1. person dies/ceases legal existence 2. discontinues business in MA 3. changes his/her name or address 4. or has his/her registration revoked person may apply for a new registration in advance of the effective date of such change
PMP: pharmacy reporting requirements 1. pharmacy shall transmit to the Department the __, __, ___ as specified in the Prescription Monitoring Program Dispensing Guide issued by the Commissioner 2. who does this NOT apply to? 3. a ___ needs to be presented whenever a controlled substance in schedules II-V is dispensed 4. when can a pharmacy dispense a control in schedule II-V WITHOUT a customer identifier? 5. when does this documentation need to be in? 6. if a pharmacy is not able to submit dispensing info by___ means, the Commissioner may issue a waiver to authorize another means of transmission, provided that all info required is submitted in this alternate form
1. pharmacy identifier, customer identification number, and associated info 2. dispensing a control pursuant to a med order to an inpatient in a HOSPITAL 3. customer identifier 4. if the pharmacy has reason to believe that the failure to dispense the control would result in a serious hardship for the ultimate user and documents the reason AND the ultimate use/agent prints his/her name and address on the reverse side of the Rx and signs his/her name thereto (if electronic, provides an electronic signature) 5. by the end of the next business day and shall include data for all controls dispensed since the previous transmission or report or as otherwise specified in guidelines of the Department 6. electronic
60 days supply of medical marijuana corresponds to how many ounces?
10
A certifying physician may determine and certify that a qualifying patient requires an amount of marijuana exceeding the normal amount for a 60d supply which is ____ if so, the physician shall document the ___ in the medical record and in the written certification. For that qualifying patient, that amount of marijuana constitutes a 60-day supply.
10 ounces as a 60-day supply amount and the rationale
written request for a hearing must be submitted within ___ of receipt of notification of suspension, revocation, or refusal to renew a registration
14 d
med marijuana: A certification must indicate the time period for which the certification is valid, and shall not be less than ___ or longer than ___.
15 calendar days - one year
A certifying physician issuing a written certification on or after July 1, 2014, must have completed a minimum of ___ Such program must explain the ___
2.0 Category 1 continuing professional development credits proper use of marijuana, including side effects, dosage, and contraindications, including with psychotropic drugs, as well as on substance abuse recognition, diagnosis, and treatment related to marijuana.
to be a personal caregiver for a medical marijuana patient, you must be how old? personal caregiver cannot be __ can be __
21 cannot be pt's certifying physician can be hospice provider, nursing, medical facility/visiting nurse, personal care attendant, or home health aide
who are the people that can issue Rx for shceudle II-VI that isn't a physician?
3 nurses: certified nurse practitioner, psychiatric clinical nurse specialist, certified registered nurse anesthetist or physician assistant
the amount of time the prescriber should send a written prescription (after oral emergency prescription of a C2)? how long til the pharmacist should contact the nearest office of the Bureau of Narcotics and Dangerous Drugs, U.S. Department of Justice and the Commissioner of Public Health if they don't hear from the prescriber?
72 hours 7 days
Within ___after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. the prescription shall have written on its face "___". The written prescription may be delivered to the pharmacist how?
72 hours (only time it's an EMERGENCY, is for CII - so 72h) "Authorization for Emergency Dispensing" in person or by mail, but if delivered by mail it must be postmarked within the 72-hour period.
difference in illnesses allowed to be treated through the act for humanitarian use of medical marijuana v. the therapeutic research program?
9 debilitating diseases - cancer, glaucoma, HIV, AIDS, hep C, ALS, CD, PD, MS 3 illnesses - pts experiencing nausea and ill-effects of cancer chemo and radiation therapy - glaucoma pts who experience intraocular pressure - pts with asthma who experience sever respiratory problems or discomfort
an rx or med order for an implantable infusion pump containing a schedule II or III control may be filled for a max of ___
90d supply
what can a certified midwife issue?
A certified nurse midwife may issue prescriptions and medication orders for those controlled substances in Schedules II through VI. i don't believe they need a supervising physician - just need to be in a practice/relationship with an obgyn?
what a pt who USED TO HAVE a debilitating medical condition? - can they receive medical marijuana?
A patient who has had a diagnosis of a debilitating medical condition in the past but does not have an active condition, and is not undergoing treatment for such condition is not suffering from a debilitating medical condition for which the medical use of marijuana is authorized - shouldn't receive it unless the symptoms related to such condition are mitigated by marijuana for medical use?? - maybe?
what is automatically adopted into the MLID? what else can be added?
A rated drugs from the "Approved Drug Products with Therapeutic Equivalence Evaluations" or the Orange Book individually reviewed a approved drugs by the DFC and Department - placed in the MA Additional List of Interchangeable Drugs ("Additional List")
med marijuana: when can an initial certification be submitted? what about a renewal?
An initial written certification submitted before a clinical visit is prohibited. (NOT ALLOWED) A renewal written certification may be submitted after a clinical visit or a telephonic consultation, however a clinical visit must occur no less than ONCE PER YEAR.
MLID continued: following the comment period (after Notice of Public Comment Period), the Department shall review all evidence and commentary and shall report its recommendation to the __ the commission shall consider the recommendations, make revisions, and recommend amendments to the list for adoption by the ___
Commission (Drug Formulary Commission?) Commissioner and the Public Health council - so they have the last call?
Notice of Inspection form is supplied by the ___ to the pharmacy; it shall contain... a. name and title of ___, ___, and ___ b. the __ and __ of inspection c. a statement that the Notice of Inspection is given pursuant to ___ d. a reproduction of the pertinent parts of ___ e. the ___ of the inspector f. provision for acknowledgement in writing by the owner has given his/her informed consent of his/her constitutional right ___ g. of his/her right to ___ h. of the possibility that anything of an ___which may be found may be used against him/her I. that he/she has been presented with a __ j. that the consent given by him/her is ___ k. that he/she may ___his/her consent when? __
Commissioner a. registrant, owner (operator or agent in charge), and name/address of controlled premises b. date and time c. M.G.L. c. 94C d. M.G.L. c. 94C e. signature f. NOT to have an administrative inspection of the premises w/o an administrative inspection warrant g. REFUSE such an inspection h. incriminating nature I. Notice of Inspection j. voluntary and w/o threats of any kind k. withdraw ; at any time during the course of inspection
if not registered with the DEA, the person who proposes to manufacturer controlled substances shall file with the Commissioner a copy of ___ he/she shall file a copy thereof at the time ___ or ____, whichever is earlier. does the applicant have to disclose technical detail of the process?
DEA Form 130 he or she files such form with the DEA or before he/she begins manufacture no, but they must identify each substance used in or resulting from successive stages of manufacture, in order to notify the Commissioner of precursors and byprodcuts
who can be a certifying physician for marijuana?
MA licensed physician (MD or DO)
a reasonably available drug prouct means any interchangeable drug that appears on the ___ and can be obtained within ___
MLID 72 hours or less
MLID?
Mass List of Interchangeable Drug Products
verified financial hardship means an individual is a recipient of __, or ___, or the individuals income down not exceed ___
MassHealth Supplemental Security Income does not exceed 300% of the federal poverty level, adjusted for family size
a first responder may administer epinephrine or naloxone or other opioid antagonist approved by the Department in accordance ___and the Statewide Treatment Protocols;
Massachusetts First Responder Training
what training does a first responder go through?
Massachusetts First Responder Training can administer controlled substances (like EMTs and EFRs who get training thereunder and the Statewide Treatment protocols)
Before issuing a written certification for medical marijuana, a certifying physician must utilize the ___, unless otherwise specified by the Department, to review the qualifying patient's prescription history.
Massachusetts Prescription Monitoring Program
after completing the review of the MLID by the Commission, the Department shall propose amendments to the List of Interchangeable Drug Products by issuing a ___ the Department shall mail this notice to each person who ___ during the period ending ___ before the notice is issued the Departmetn shall also mail thie notice to each person who filed a ____ with the Department during December of the previous year??
Notice of Public Comment Period filed a petition during the period ending 30d before the Notice of Public Comment Period is issued a written request
____: the Commissioner may establish this group to advise the Department in the evaluation of Rx info and clinical aspects of PMP a. members of this group shall be ___ and ___ and, to the extent feasible, at least one member shall be licensed in the ___ as the practitioner whose records are under review b. practitioners serving on this group must have a valid ___
PMP Medical Review Group a. licensed HCPs and pharmacists; same discipline b. Controlled Substances Registration for Schedules II through VI
_____ shall consist of all prescription drugs, which are not included in any other schedule established by the Commissioner.
Schedule VI
___: means the Emergency Medical Service Pre-hospital Treatment Protocols approved by the Department for application statewide whose trained this way?
Statewide Treatment Protocols EFRs and EMTs
Filing of Controls/Rxs in Pharmacies
THREE DIFFERENT FILES 1. schedules I and II separate from all other Rxs (identified as schedules I and II ONLY) 2. schedule III-V filed separately from all other Rxs (identified as III, IV and V ONLY) 3. schedule VI and prescriptions for non-controlled substances filed separately from all other Rxs (identified as schedule VI and non-controlled substances)
who prepares the List of Interchangeable Drug Products and the amendments thereto?
The Drug Formularly Commission
who publishes the Orange Book who decides if bioequivalence is essential ?
US Department of Health and Human Services Commissioner
generic names are listed by the United States ___ and the Unites States ___ in the ___
Unites States Adopted Names Council Unites States Pharmacopeia in the USAN/USP Dictionary of Drug Names
who can be registered for activities involving schedule Is
a person proposing to manufacture schedule Is person proposing to conduct research on human beings in schedule I a person proposing to engage in qualitative or quantitate analysis of schedule Is within a scientific lab
Who may administer epinephrine or naloxone or other opioid antagonist approved by the Department as well as nerve agent antidotes approved by the Department to another authorized public employee?
a public employee of or volunteer to a municipality or an agency, department or authority of the Commonwealth (agency), whose function includes emergency preparedness and response and who is designated by a municipality's or agency's medical director
who is exempt from record keeping?
a registered person doing research or teaching at a registered institution that maintains its own records IF he/she has notified the DEA and the Commissioner of the name, address, and registration number of the institution registered by the DEA also a chemical analyst employed by a scientific lab which maintains its own records - again, the registrant must notify the Commissioner of the name, address, and registration number of the scientific lab
prescription format a. must permit the practitioner to instruct the pharmacist to dispense a brand name drug product by indicating ___ b. if paper-based, rx must be on a form that contains a ___ for the practitioner on the lower portion of the form c. __ and ___prescriptions should have a line directly below the signature line for the prescriber to print or type his/her name d. where does "no substitution" go? e. below this space, what should be indicated?
a. "no substitution" b. signature line c. hospital and clinic d. below the signature line (and below the line with the typed/printed signature in hospitals/clinics) e. "Interchange is mandated unless the practitioner indicates "no substitution" in accordance with the law"
emergency room and discharge patients prescriptions a. days supply? b. refills? c. any exceptions on days supply? d. one other exception?
a. 14d supply (not to exceed) b. may NOT BE REFILLED by the hospital pharmacy c. if the product is only available from the manufacturer in greater than 14d supply quantities - the quantity dispensed can not be larger than the smallest quantity supplied by the manufacturer. d. rare and unusual drugs which are generally not available in a retail pharmacy, a hospital pharmacist may fill the rx for emergency room patients and discharge patients in the amount prescribed by the doc
distribution upon d/c of business a. notify the Commissioner in writing when? b. needs to inform (in the written note of closure) how he/she plans to ___ c. does the commissioner have to respond? when registration expires, the (expired) registrant shall... 1. a. dispose of the controls under the authorization and instructions of the ___by transfer to a person registered to possess the controls or b. by delivery to an agent of the __or c. by delivery to an expressly authorized agent of the ___ d. by destruction of the substances in the presence of an agent of the ___ e. by destruction of the substances in the presence of an expressly authorized agent of the __ f. by such other means as said ___ may determine 2. may __such controls without being registered to do so 3. upon the completion of such disposition, shall file with the __on a form approved or provided by him a __of such disposition
a. 15d before such event (closure, moving place of business) b. dispose of all the controls c. no - if no response before the date the owner said they were going to close, the owner can dispose of the controls in the way they proposed 1. a. Regional Director of the DEA b. DEA c. Commissioner d. DEA e. Commissioner f. Regional Director 2. transfer 3. Commissioner; final report
time for application and term of registration a. any person registered with the Commissioner may apply to be re-registered not more than ___ before the expiration date of his/her registration b. how long does it last? (exceptions?) c. research? d. can you modify your registration?
a. 60 days b. 1 year (other than registration to conduct research with schedule Is or a registration to dispense automatically) c. not to exceed 1 year - how is this different? d. any person who is registered may at any time apply for a modification of his/her registration on a form supplied by the Commissioner
A certified nurse practitioner, psychiatric clinical nurse specialist, certified registered nurse anesthetist or physician assistant may issue prescriptions and medication orders for Schedule II through VI controlled substances provided that the following requirements are met a. 3 nurses meet what requirements? b. PA meets what? c. registers with? d. the listed nurses and PAs must also practice in accordance with ___ d2. scope of practice consistent with __ and __ e. the nurses and PA may order controlled substances in Schedule__ from a drug wholesaler, manufacturer, laboratory or distributor. f. For the purpose of dispensing medication in Schedules II through V for immediate treatment, the nurses and PA may obtain such medication how? g. the nurses and PA may issue prescriptions provided that the person issuing the prescription clearly identifies ___ to the pharmacist and provides his or her ____. h. the nurses and PA may prescribe controlled substances for a patient in a health facility or other setting through use of ___entered on the patient's medical record maintained at the facility
a. Advanced Practice Registered Nursing b. Board of PA: Purpose, Authority and Definitions; Registration of Individual Physician Assistants; Scope of Practice and Employment of Physician Assistants c. Department's Prescription Monitoring and Drug Control Program and with the Drug Enforcement Administration (DEA) d. written guidelines governing the Rx of medication mutually developed and agreed upon beteween them and a supervising physician d2. nurses: Advanced practice registered nursing for nurses practicing in the expanded role PA: Scope of Practice and Employment of PA e. VI f. ONLY as supplied by the supervising physician, obtained through a written Rx for the patient, or in the case of certified registered nurse anesthetist, as supplied by a practitioner for immediate treatment of a patient, in accordance with guidelines of the Board of Registration in Medicine. g. his or her name and professional designation AND registration number, work address, phone number, and the name of the supervising physician h. written medication orders
every applicant for activities in schedule I must demonstrate to the satisfaction of the Commissioner the following a. he/she is registered by the ___ to do what? b. he/she never had an application ____ by the DEA c. his/her ___ are specifically approved by the DEA d. that in the case of an application to conduct research with schedule Is, his/her ___is attached to his/her application
a. DEA to manufacture, or conduct research involving schedule Is b. denied or suspended or revoked c. physical security controls d. protocol
a controlled substance in schedule V may be dispensed by a pharmacist w/o a prescription to a purchaser provided that a. the compound, mixture or prep containing the control is not a ___ b. the compound, mixture or prep contains not more than ___ no more than ___ of such preparation can be dspensed or sold to a person during any ___ period when dispensing, the pharmacist must keep an accurate record book including the __, __, __, __, and ___
a. NOT a prescription drug b. NOT more than 100mg of opium/100ml or /100g 4 ounces in any 48 hour period name and address of pruchaser, the name of the preparation, the strength per dosage unit, the quantity dispensed, and the date
evidence of compliance with applicable federal law (for research) a. any of the following might be required by the FDA? b. a copy of the ___of each person required to be registered by the DEA
a. Notice of Claimed Investigational Exemption for a New Drug (Form FD 1571) Statement of Investigator (clinical pharmacology) (Form FD 1572) Statement of Investigator (Form FD 1573) b. DEA Registration
Drug Product Problem Reporting Program a. operated by? b. utilized by __, __, or __ c. to report any product problems encountered when using __ d. product oriented, what is NOT requested? e. can the reporter be anonymous? f. who should reports be sent to?
a. USP and FDA b. pharmacists, physicians, or consumers c. drugs INTERCHANGED under the MA generic drug law d. patient identification NOT REQUIRED e. yes, indicated to the USP and your name will be withheld from the manufacturer and the FDA f. USP
required to utilize PMP when.. a. MUST utilize the PMP prior to prescribing __, __, ___ for the FIRST TIME b. effective Oct 15, 2016, a registered practitioner must utilize the PMP EVERY time the practitioner issues an Rx to a patient for ___ c. what about VI? d. what about patients in the ER? e. what about hospital inpatients? f. immediate treatment? g. what if the PMP is not operational d/t temporary technological or electrical failure? h. age limit?
a. a narcotic drug in schedule II or III (first and all times); a BZD; or a schedule IV or V controlled substance, as designated in guidance to be issued by the Department b. ANY NARCOTIC DRUG IN SCHEDULE II AND III c. not necessary for samples? d. not if the practitioner doesn't think they'll need an Rx for a schedule II-V e. not necessary f. not required g. PMP requirements dont apply during this time h. practitioner doesnt need to report if treating a pt younger than 96 months old (8 years old)
certification and review of pts for participation in the therapeutic research program (marijuana) a. who reviews all certification forms (forms filled out by physician certifying the pt to participate)? b. the panel will accept or reject the pt's participation in a timely manner; all certification forms shall be kept on file where?
a. a panel of 3 physicians appointed by the Commissioner b. kept on file at the Department and a copy included in the patients medical record this is all with the department, not the board
a request for a waiver from PMP utilization shall include a description of the following a. the participant's history of ___; (b) A substantial hardship created by a ___ beyond the control of the participant; (c) ____ limitations not reasonably within control of the participant; or (d) ___limitations within the control of the participant that will be rectified within ___
a. compliance with laws and regulations related to controlled substances b. natural disaster or other emergency c. Technological d. Temporary technological; six months.
Dispensing and Labeling of Sample Meds by Practioners a. schedule VI samples? b. schedule II-V samples?
a. doc can dispense a singe dose sample OR a quantity the doc thinks is reasonable but NOT to exceed a 30d supply - this quantity can be increased to a 90d supply if dispensed as part of an indigent patient drug program and deemed appropriate in the professional judgement of the practitioner b. single dose or in such quantity as in the opinion of the registered individual practitioner that is essential for the immediate tx of the patient
confidentiality of trade info: unless the owner consents in writing, NO INSPECTION SHALL EXTEND TO... A. ___ data b. ___ data, other than shipping data c. ___ data d. technical details of __
a. financial b. sales c. pricing d. production processes
once registered by the Department, a certifying physician will retain INDEFINITELY a registration to certify a debilitating medical condition for a qualifying patient UNLESS a. the physician's ___or ___ is suspended or revoked b. the physician has ___ of a debilitating medical condition c. The physician has certified a qualifying patient for a debilitating medical condition on or after July 1, 2014, without appropriate completion of continuing___ d. The physician surrenders his or her__.
a. license to practice medicine in MA OR MA Controlled Substances Registration b. fraudulently issued a written certification c. professional development credits d. registration
the FDC (Formulary Drug Commission) determines drug products to be interchangeable only when they meet certain criteria a. the drug is available from ___ b. its manufacture is __ c. when essential to therapeutic outcome, the manufacturer of the drugs has documented __
a. more than one source with the same active ingredient in the same dosage form and strength b. approved by the FDA c. bioequivalence
all registered individual practitioners shall include the following in their inventories for schedules II-V a. for each controlled substance in finished form, they need to include the __, __, and __ b. for each controlled substance NOT in finished form, they need to include the __ and ___
a. name of the substance, the size of each finished form in weight or volume, and the number of units or volume of each b. the name of the substance and the total quantity of the substance to the nearest metric unit of weight
research involving controls a. who can do research with schedule IIs?
a. no one UNLESS he/she supplies the Commissioner with satisfactory evidence of compliance with Federal law, and with such information regarding the research project/study as the Commissioner requires
the List (MLID) does NOT include a. drugs that are protected by __ b. many _ and __ drug products since they may not consistently deliver the same quantities c. those drugs for which the Commission had any significant __ d. any drug for which bioequivalence is considered __but for which bioequivalence has not been demonstrated
a. patent b. controlled-release and enteric coated c. doubt about safe interchange between manufacturers d. essential
rx shall contain the following info a. the ___ of the practitioner b. the ___ of the Rx c. the __, __ and __ per dosage unit of the control prescribed, and the __ of dosage units d. __ of the patient e. when is d not required? f. ___ for use, including cautionary statements required g. a statement indicating the number of ___
a. registration number b. date of issuance c. name, dosage, and strength; quantity d. name and address of the patient e. EXCEPT if vet rx or an rx for EPT (expedited partner therapy) f. directions g. refills
the therapeutic research program approved by the Department to conduct research and monitor experimentation in the use of marijuana as a therapeutic modality in which aspects of health?
alleviating nausea and ill-effects of cancer chemo and radiation in decreasing intraocular pressure in pts with glaucoma in decreasing airway resistance in pts with asthma
a physician who wishes to issue a written certification (for marijuana card) for a qualifying pt shall have at least one established place of practice in MA and shall hold what 2 things?
an active full license, with on prescribing restriction, to practice medicine in MA a MA Controlled Substance Registration from the Department
reporting for the therapeutic research program (marijuana): the Department shall file a(n) ___ report of the activities of the program with the __ and ___
annual Governor and General Court
time to keep records? is registrant allowed to use central record keeping?
at least 2 years form the date of preparation - every report, inventory, and record if registrant holds a valid permit to keep central records issued by the DEA and notifies the Commissioner thereof.
Upon receipt of the written prescription (within 72 hours of emergency oral prescription for a C2) the dispensing pharmacist shall ___ to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the ___ and ___ if the prescribing individual practitioner fails to deliver a written prescription to him within ___
attach the prescription nearest office of the Bureau of Narcotics and Dangerous Drugs, U.S. Department of Justice and the Commissioner of Public Health - seven days.
every registrant shall take an initial inventory and ___inventories thereafter. a. which drugs? b. what day is the initial day? c. when is the next inventory? (more specific) d. a registrant who elects to take his/her biennial inventory on his/her regular general physical inventory date or another fixed date, shall ___ of this election and of the date on which he/she will take his biennial inventory upon request e. if the Commissioner adds any drug to a schedule that was not prior to that date listed in a schedule on which a registrant was required to keep records, a registrant who possesses that substance shall what?
biennial (every 2 years) a. II-V b. on the day he/she first engages in the manufacture, distribution, or dispensing of controls c. on the day exactly 2 years after initial inventory, on the registrants regular physical inventory date that does not vary by more than SIX MONTHS from the biennial date or any other fixed date that doesn't vary by more than 6 months from the biennial date d. inform the Commissioner e. take an inventory on the EFFECTIVE DATE OF REGULATION, of all stocks of that substance on hand
___ drug: drug whose rate and extent of absorption do not show a significant difference when administered at the same molar dose what if not similar in rate but similar in extent of absorption?
bioequivalent drug therapeutically equivalent
A qualifying patient who is under 18 years of age and has been diagnosed by two Massachusetts licensed certifying physicians, at least one of whom is a ____, with a debilitating ____ illness, may receive a written certification, what if NOT a life-limiting illness: physicians must determine that the ___. - This must include a discussion of the potential negative impacts on ___ with the ___ of the qualifying patient, ____ of the parent or legal guardian, and documentation of the rationale in the medical record and the written certification.
board-certified pediatrician or a board-certified pediatric sub-specialist LIFE-LIMITING benefits of the medical use of marijuana outweigh the risks - neurological development with the parent or legal guardian - written consent of the parent/legal guardian
Debilitating Medical Conditions (under an act for humanitarian use of medical marijuana)?
cancer glaucoma HIV AIDS hep C ALS CD PD MS
marijuana means the plant ___
cannabis sativa L, tetrahydrocannabinol, or a chemical derivative or synthesis of tetrahydrocannabinol
A person involved in the qualitative or quantitative analysis of controlled substances within a scientific laboratory is required to register as an individual ____; in addition to the requirement that the ___also register.
chemical analyst scientific laboratory however, the chemical analyst does not have to keep records as long as lab does and as long as the chemical analyst notifies the department? of the fact that he/she will not be maintaining records
requirement of confidentiality: records maintained by researchers, included the informed consent, shall be ___
closed to the public, and shall not be used in the criminal prosecution of any research subject in connection with his/her participation as a research subject
info collected via PMP shall be kept ____ by the Department the Department can provide data collected to... a. an individual authorized and registered to prescribe or dispense controls, for the purpose of ___ b. a person authorized to act on behalf of an entity provided the request is in connection with a bona fide (real) specific controlled substance or additional drug-related___, and further provided that such entity is... 1. a ___ that supervises or regulates a profession that may prescribe or dispense controlled substances; 2. a local, state or federal law enforcement agency or prosecutorial office working with the ____ engaged in the administration, investigation or enforcement of criminal law governing controlled substances; 3. the Executive Office of Health and Human Services, acting with regard to a ___recipient; 4. the ___; 5. the ___; or 6. the ____. ugh.. many other reasons (page 30ish of 105 CMR 700 - http://www.mass.gov/courts/docs/lawlib/104-105cmr/105cmr700.pdf
confidential a. providing medical or pharmaceutical care to a pt b. investigation 1. state board or regulatory agency 2. Executive Office of Public Safety 3. MassHealth program 4. United States Attorney 5. Office of the Attorney General 6. office of a District Attorney
what dosage forms may not be listed in the MLID
controlled-release and enteric coated
the term opiate does not include the ____. It does include its ____ forms
dextrorotatory isomer of 3-methoxy-n-methyl-morphinan and its salts, dextromethorphan - does not include racemic and levorotatory forms - does include
if a prescription has a brand name on it and does NOT include the "no substitution", what does the pharmacist need to do?
dispense a less expensive med (generic)
DFC? how many members of DFC? - appointed by?
drug formulary commission: prepares the MLID (MA List of Interchangeable Drugs) along with the Department of Public Health 9 members - governor
the following are EXCLUDED from the MLID (MA List of Interchangeable Drug Products)
drugs where bioequivalence IS ESSENTIAL, but for which bioequivalence has not been established drug products which are the subject matter of PATENT RIGHTS issued by the US Patent office, for which provision by other than the patent holder would violate the patent drug products available from only ONE MANUFACTURER at one price
the Notice of Inspection and acknowledgement of informed consent shall be made in ___
duplicate and one copy shall be retained by the Commissioner and the duplicate shall be given to the person inspected
EMS? EFR -what can they do? EMT? - "
emergency medical services EMS First responder - authorized to administer controlled substances Emergency Medical Technician - can also administer controlled substances pursuant to his/her training and the Statewide Treatment Protocols
who gets automatic authorization to utilize PMP?
every registered individual practitioner (except a vet) who holds a valid MA Controlled Substance Registration will automatically, be granted authority to utilize the prescription monitoring program what about midlevel - PA, advanced nurses, pharmacists - they have to apply right?
Form FD 1571, 1572, 1573 might be required for?
evidence of compliance with applicable federal law when doing research with controls
a registered physician, physician assistant, certified nurse practitioner, or nurse midwife may provide ___ for the treatment of chlamydia infection provided that: a. prescribing is ___ b. if given directly to patient, therapeutic agent shall be provided to the patient in a ___ c. if written rx, there shall be a separate rx for the sex partner, which includes on the prescription form, where the name and address of the pt is noted, either the ___ d. the physician, physician assistant, certified nurse practitioner, or nurse midwife __ the pt on EPT and provides pt with an ___
expedited partner therapy (EPT) a. in scope b. separate, properly labeled container for the sex partner to be given the therapeutic agent c. name and address of the sex partner or the words "Expedited Partner Therapy", "EPT", or "E.P.T." d. counsels information sheet for the sex partner
After registering to be a certifying physician under the act for humanitarian use of medical marijuana, a certifying physician is responsible for notifying the Department, in a form and manner determined by the Department, within ___after any changes to the physician's information.
five business days
___: dental assistant, school teacher, school nurse, school aide or school volunteer.
fluoride program monitor
Dental hygienists and fluoride program monitors (dental assistant, school teacher, school nurse, school aide or school volunteer) employed by or affiliated with a registered school may administer ____ to school children at what age? things that need to happen first: a. school registered? b. child's parent or guardian? c. tablets/mouth rinse is administered by ? d. the fluoride program monitor has been ___ e. all fluoride mouth rinse and tablets possessed by the registered school are __ f. the registered school maintains ___
fluoride tablets or fluoride mouth rinse to school children 3-18 years old a. with the Department by sending a letter of intent to administer fluoride tx to the Division of Dental Health b. informed in writing of the nature, dose and effects of fluoride and has consented in writing c. physician or dentist employed by or associated with a local Board of Health or school d. trained to admnister and store fluoride tabs and mouthrinse in accordance with a training program designed by the Commissioner e. stored securely under lock and key f. maintains records and files concerns fluoride program as the Commissioner may require
common name
generic
non-proprietary name
generic. also common name
A certifying physician shall not issue a written certification for ___. what about co-workers?
himself or herself or for his or her immediate family members they can but they need to do so in accordance with all other patients - conduct a clinical visit, complete and document a full assessment of the pts medical hx, and current medical condition, explaining the potential benefits and risks of marijuana use and maintaining a role in the ongoing care and tx of the pt
Notice of Inspection - Commissioner will present what things when doing an inspection does the commissioner need consent?
his/her purpose his/her credentials and if requested, presenting a Notice of Inspection to the owner yes, after the owner consents to the notice?
community residences, group homes, shelters, and hospice settings are examples of ___ settings?
home care setting
____: a long-term care facility or unit thereof that is an integral and subordinate part of the hospital, is operated with other departments of the hospital under common governance and professional supervision such that the facility and the hospital are subject to the bylaws and operating decisions of a common governing board, is fully integrated with all other services of the hospital and is financially integrated with the hospital
hospital-based Skilled Nursing Facility
does the practitioner have to write "interchange" on a prescription in order to substitute?
i thought no, but 720.010 says you need the word "interchange"
when can a pharmacist switch for a generic? when can they not?
if the practitioner simply signs the signature line if he/she signs the signature line and writes the words "no substitution" in his/her own handwriting in the space provided below the signature line
when can a pharmacist dispense a generic if the doc writes "no substitution"? what if "no sub" is NOT written but there is no generic available what should the pharmacist do after?
in a medical emergency if the particular brand is not in stock can dispense brand name written in a medical EMERGENCY situation must record the date, hour, and nature of the medical emergency on the back of the Rx and the person purchasing the drug product must indicate acceptance of this deviation from the law by legibly writing his/her signature on the Rx
therapeutic research program (marijuana): a pt may NOT use the marijuana when?
in the presence of persons under the age of 18 in a moving vehicle in a public place or in any manner inconsistent with the requirements of the program
prior to the implementation of any study protocol pusuant to the therapeutic research program (marijuana), the protocol shall undergo the review and approval of an __
institutional review board
A teacher in a teaching institution using controlled substances for ___ is required to register what about the teaching institution?
instructional purposes not required to register for teaching purposes. - so teacher has to register to teach but not the institution?
record keeping requirements for schools registered for fluoride programs
keep for 2 years (fluoride tabs and mouthrinse) - Commissioner may require
who can use electronic transmission of PMP Info?
limited to the users authorized (authorized end user?)
MIP?
marijuana-infused product (intended for use/consumption)
MIH?
mobile integrated health care - health care program approved by the department that utilizes mobile resouces to deliver care and services to patients in an out-of-hopsital environment
MLID: all rxs written by generic name can be interchanged if the drug is ___ to determine if a rx written for a brand name drug product is interchangeable in MA the following needs to occur 1. look up the drug product by the brand name in the index or by generic name in ___. the drug products are arranged how? 2. compare the ___and ___ of the drug product prescribed compared to the one in the Orange Book 3. if the same drug product, dosage form, and strength has been assigned an ___ rating by FDA and is NOT listed on the ___, the drug product is interchangeable 4. if the drug product is not listed in the "Orange Book" refer to the ___ 5. look up the drug product by the ___ name in the Additional List (alphabetically organized) 6. compare the ___ of the drug product prescribed with the that on the Additional List 7. If the same __, __, and ___is listed, the drug product is interchangeable
multi-source 1. "Approved Drug Products with Therapeutic Equivalence Evaluations" ("Orange Book") - alphabetically 2. dosage form and strength 3. "A"; NOT LISTED on the Exception List 4. MA Additional List of Interchangeable Drugs (Additional List) 5. generic 6. dosage form and strength 7. drug product, dosage form, and strength
a registered individual practioner and pharmacist shall maintain on a current basis, separately for each registration he/she possess a record of each substance in shcedules II-V received, distributed, administered, dispensed, and otherwise disposed of as follows?
name size of each finished form number of units/volume of each finished form received from other persons, the date received, the name/address/aDEA admin registration number of the person from whome the substance was received name, dose, strength per dosage unit of each control dispensed or administered; the name and address of each person for whome the control was administered/dispensed and how (delivery or dispensed by prescription); the date of admin; and the typewritten name or initials of the person who admin the substance the number of units/volume of such finished forms disposed of in any other way by the registrant (including the date and manner of disposal)
when a certified nurse practioner, psychiatric clinical nurse specialist, certified registered nurse anesthetist, PA or pharmacist are applying for registration to dispense controls, they must include the ___ the above must tell the Department promptly if any change is made to ?
name and address of supervising physician, general description of physicians scope of practice, and the signature of the supervising physician any termination of employment, change of address, or change of supervising physician
to register a certifying pt (for a marijuana card), the physician must submit what 3 things?
name and business address license # issued by the MA Board of Registration in Medicine MA Controlled Substance Registration # any other info required
records for schedule VI is this different than II-V??
name, dose strength volume of units date of dispensing name/address of the person to whom the med was dispensed
A Paramedic, or a Paramedic student may administer only those controlled substances, in quantity and kind, that are ___ established by? - same goes for a ? a paramedic may dispense by administration what vaccinations?
necessary for the performance of his or her duties Emergency Medical Services System and the Statewide Treatment Protocols oR in accordance with his or her duties as authorized by clinical protocols in a Department-approved MIH program or community EMS program - advanced EMT or EFR influenza and other immunizations designated by the Department to persons 18+ as authorized by clinical protocols in a Department-approved MIH program or community EMS pogram
can a certified physician delegate the right to certify a patient?
no
can you transfer Certificate of Registration?
no
if registrant ceases legal existence, discontinues business, or changes his name/address as shown on the certificate of registration, what do they need to do? what if the registrant dies?
notify the Commissioner at least 30d before such event and shall surrender his/her certificate of registration by mailing it to the Commissioner on the day of such event - i think this is different than pharmacy, outsourcing, and wholesale (registered by the board) - they need to do this 14 days prior?; send in the stuff within 10 days?? the executor of the estate of any deceased registrant shall surrender the deceased Certificate of Registration by mailing it to the commissioner as soon as feasible
can mid-levels ORDER CSs? what about one's they can't order, how do they get them to the pts?
only CVI - these can be dispensed for immediate use (up to 30 days?) CII-V = cannot order - they can prescribe them - nurse anesthetists can receive them from doc for immediate admin - what else?
what drugs would be in the Exception List of the MLID?
orange book "A" rated drugs that are NOT approved for interchange currently no products in this list
exemptions from requirement to register
owners of corporate businesses? employee of a registered business (manufacturer/distributor), public official/law enforcement officer, ultimate user or research subject, registered nurse or licensed practical nurse students enrolled in school for nurses certain persons engaged in interstate or foreign commerce intern/fellow/medical officer/alien physician/registered nurse/licensed practical nurse/or other authorizd person may disepsne controls under the registration of the hospital pharmacist/pharmacist intern (may admin influenza vaccine and other immunization) to persons 9+
A school district or private school may register solely for the purpose of ___
permitting trained school personnel to administer controlled substances
____ drug products: products that contain the same active ingredients, and are identical in strength or concentration, dosage form, and route of admin?
pharmaceutically equivalent - might have different characteristics such as shape, scoring configuration, RELEASE MECHANISMS, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling. how is this different than therapeutically equivalent? - FDA classifies as therapeutically equivalent those products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; and (5) they are manufactured in compliance with Current Good Manufacturing Practice regulations.
automatic registrations: The Commissioner shall automatically issue a registration to dispense controlled substances other than for research to any __,__,__ or ___ who is duly authorized to practice his or her profession in the Commonwealth, provided that, any such physician, dentist, podiatrist, or veterinarian shall only be registered for ___ and for the same schedules as he or she is registered with the ___.
physician, dentist, podiatrist, or veterinarian Massachusetts Schedule VI - so when prescribing schedule VIs, put your MCSR number on script, but if prescribing controls II-V, put the DEA number Drug Enforcement Administration (DEA)
___: physician, dentist, veterinarian, podiatrist, scientific investigator or other person registered to distribute, dispense, prescribe, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research in the commonwealth 2 other practitioners include?
practitioner pharmacy, hospital, institution registered to distribute, dispense, conduct research with respect to or to administer controls in the course of professional practice or research an optometrist
need to establish a reasonable and appropriate level of the following for rxs?
practitioner and dispenser authrentication technical non-repudiation content integrity confidentiality
PMP: a person authorized to receive info shall ___ the Department of any potential violation of confidentiality or use of the data in a manner contrary to standards
promptly notify
who is eligible for the therapeutic research program with marijuana?
pts experiencing nausea and ill-effects of cancer chemo and radiation therapy glaucoma pts who experience intraocular pressure pts with asthma who experience sever respiratory problems or discomfort
who can hold/be issued a registration card (for marijuana) under the act for humanitarian use of medical marijuana?
qualifying pt (18), personal caregiver (21), or dispensary agent (21)
RMD?
registered marijuana dispensary - aka medical marijuana treatment center
report of theft, loss or suspended tampering time and type of form?
report to designated agent of the Commissioner within 24 hours of discovery by submitting to the Commissioner a copy of the Departments "Drug Intake Form"
___: mean a unit of prescription drug distributed by the manufacturer or distributor to practitioners in the original package from the manufacturer, not repackaged and given free of charge to patients.
sample medication
what are the personnel security requirements for security requirements?
screenings of new employees - document this for Commissioner requests no registrant shall knowingly emply any employee who has had an application for registration denied or revoked for violation of any law
in the Additional List of the MLID, only drug products grouped under ____ are to be interchanged under the generic names are listed are the various multisource dosage forms in which a drug product is available. only ___of identical drugs are interchanged next to the "Manufacturers" heading are all approved manufacturers for the drug product; these manufacturers have met all legal requirements including ___ - approved manufactures hold current ___ or ___ when required by law - abbreviation in the MLID?
single headings (720.20) identical dosage forms and strengths FDA GMPs - NDAs or ANDAs - 3 letter/number manufacturer abbreviations (if name changes, the new name is in parenthesis?)
A hospital or other health facility is required to register if: (a) It is not registered with the Board of Registration in Pharmacy and (b) It possesses controlled substances which are safeguarded for or intended to be dispensed to any patient. ?
so hospital itself registers with commissioner?? and hospital pharmacy with the board??
what is it called when the Commissioner immediately suspends a registration WITHOUT A HEARING d/t the public health or safetybeing endangered? written notice of the reasons for the suspension shall promptly be issued by the ___ the affected person shall also be notified in writing of the right to an adjudicatory hearing and shall be promptly afforded an opportunity for a hearing provided that written request for a hearing is submitted within ___ after notification of suspension
summary suspension? department 14 days
an rx issued by a nurse practitioner, psychiatric nurse, nurse anesthetist or pharmacist shall also provide the name of the ___
supervising physician what about PA?
as of july 1, 2013, a rx must be written on a __ form consistent with federal requirements for ___
tamper-resistant Medicaid
___: means that parties to the generation, transmission, receipt or storage of an electronic prescription cannot reasonably deny having participated in said activities
technical non-repudiation
Request to Inspect Protocol: if a request is made to inspect and/or release one of the protocols on file with the Department, the Department shall promptly notify the researcher (pharma company) sponsoring the clinical trial of the request how? when should this notification occur?
telephone, followed up by written notification by certified mail at least 8 calendar days prior to inspection
schedule of drug established by?
the Commissioner
after the Drug Formulary Commission reviews the public comment and makes amendments, who finalizes those amendments of the MLID?
the Commissioner and the Public Health Council - they adopt the amendments
for the therapeutic research program (marijuana) the department shall contract with the __, __, and ___ for the receipt of a supply of analyzed marijuana in accordance with all applicable state and federal laws
the national Institute on Drug Abuse the National Cancer Institute or other manufacturer, distributor or analytical lab
should "no substitution" be marked on an oral rx?
the pharmacist shall ascertain whether or not the prescriber wishes "no substitution" to be marked on the Rx and record this info with all other required info on his/her prescription log
difference between therapeutic and bioequivalence
ther: same extent of absorption bio: same extent AND RATE of absorption - more important for narrow therapeutic/toxic dosage range
according to section 1.6 of the Orange Book, drug products with the same NDA are ___
therapeutically equivalent
____ drug products: products which are pharmaceutically equivalent (same active ingredients, and are identical in strength or concentration, dosage form, and route of admin); meet applicable standards for strength, quality, purity, identity; are bioequivalent in that... a. they do not present a known or potential bioequivalence problem, and they do meet an acceptable___ b. if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standards matching both ___ and ___; are adequately ___; and are manufactured in compliance with current ___ regulations
therapeutically equivalent a. in vitro standard b. - rate and extent of absorption - labeled - GMP
what should a person do if a drug product they want on the MLID is not on the list?
they can file a written petition with the Department to amend the List Department shall be submit the petition to the Drug Formulary Commission; this commission will make the decision
which volume of the USP DI is the Orange Book?
third volume volume III
which drugs need bioequivalence (rate and extent) not just therapeutic equivalence (just extent, different rates)?
those whose bioequivalence would have therapeutic significance (ie. use of different brands of the same drug product or different batches of the same drug product would result in therapeutic failure or a hazard to the patient) - most critical in drugs that have a narrow therapeutic toxicity range which requires careful pt titration and monitoring for safe and effective use
what do manufacturers need to report/submit?
to the Commissioner a quarterly report, on or before the 15th day of the month succeeding the period for which such report is submitted account for all stocks of non-narcotic controls appearing in schedules I, II, and III on hand at the beginning and at the end of the quarter, and for all receipts, dispositions, manufacturing, and packaging of such controls similar form to the Federal reporting requirements for narcotic controls in I, II, III - each manufacturer shall make available to the commissioner the required federal reports for NARCOTIC controls in I, II, and III
exceptions to "every separate location needs its own registration"?
warehouse holding controls that only distributes them back to their registered location from which they received them? office used by an agent of a registrant where sales of controls are solicited, but which neither contains such substances, nor serves as a distribution point for filling sales orders - not actually distributing, just selling office or registered hospital or other registered health facility which is used by a registered individual practitioner, pharmacist or optometrist who is registered at another location which is his principal place of professional practice, provided that NO CONTROLS ARE MAINTAINED by such practitioner at any place where he/she is not registered
can the MLID be updated? the Department and the Commission should review this how often?
yes, based on the most recent edition of "Approved Drug Products with Therapeutic Equivalence Evaluations" - this approved list is updated by US Department of Health and Human Services the Drug Formulary Commission and Department should review this at least once a year and revise as necessary the list of interchangeable drugs - drugs can be added or deleted
can practitioners prescribe more than one drug product at once?
yes, but they shall place each prescription on a SEPARATE prescription form or record however, more than one drug product may prescribed in the hospital setting on a single form or record provided that the rx provides clear directions for use and interchange of each product
can a primary account holder for PMP have other people use the PMP? a request for delegate sub-accounts must include an attestation that the primary account holder will do what things?
yes, by authorizing support staff as delegates to use the pMP on beahlf of the participant when the participant SUBMITS A REQUEST to create DELEGATE SUB-ACCOUNTS (a) Ensure that delegates comply with the prescription monitoring program Sub-account User Terms and Conditions; (b) Monitor delegate use of the PMP and inform the Department when a delegate has violated the Sub-account User Terms and Conditions or is no longer authorized by the participant to be a delegate within one business day; and (c) Take reasonable steps to ensure that the delegate is sufficiently competent in the use of the PMP.
can the DFC and Department remove drugs from the MLID even if they are A rated?
yes, drug products assigned an A rating by the FDA that are deleted from the MA List are placed in the EXCEPTION List - none on this list yet
if you are a researcher and a physician, do you need 2 regisrations?
yes: Persons required to be registered for controlled substances shall register separately for each one of the following business or professional activities applicable to him or her. must register separately for location AND activity (whereas DEA registration just is required to have multiple at different locations - not different activities)