law final exam - DPH, Interchangeable, Warfarin, 243 CMR 2.07

Question 1

self-prescribing and prescribing for family members

Answer 1

a licensee is prohibited from prescribing controlled substances in schedules II, III, IV for his own use

except for emergency, a licensee is prohibited from prescribing schedule II substances to a member of his own immediate family, including a spouse (or equivalent), parent, child, sibling, parent-in-law, son/daughter-in-law, step-parent, step-child, step-sibling or other relative residing in the same residence as the licensee.

A licensee who prescribes any CS to a member of his or her immediate family, as defined herein shall maintain a record for such person

Can a doctor prescribed percocet or tylenol with codeine or diazepam for themselves, no. What about amoxicillin, yes schedule VI. Can prescribe for schedule 5 & 6 but comes into ethical issues.
243 CMR 2.07 - 19: except for emergency, cannot prescribe schedule II, but if an emergency then yes. What about schedule III-VI, that is allowed. How do you know if a step parent, child or sibling,
Schedule III CS dispensing: expire 6 months, quantity limits: 5 refills, 30 day time period unless it is implantable pumps then it is 90 days or dextroamphetamine sulphate and methylphenidate hydrochloride then 60 days

Question 2

prescribing anabolic steroid

Answer 2

a licensee is prohibited from prescribing anabolic steroids for the purpose of enhancing a patient’s athletic or performance

Question 3

prescrbing anoretics

Answer 3

a licensee is prohibited from prescribing any CS in schedule II for is anorectic effect

Question 4

Elements of a written prescription

Answer 4

Prescriber:
Name – clearly indicated
(Hospital and clinic forms must contain the name of the facility and a line directly below the signature line for the prescriber to print or type his/her name.)
Address – clearly indicated
(Hospital and clinic forms must contain the address of the facility)
Registration Number (DEA number for Schedules II – V)
Line for Signature on lower portion of form

Supervising Physician:
For mid-level prescribers, the name of the supervising physician must be clearly indicated.

Prescription:
Date of Issuance / Date Written
Date to be Dispensed (In accordance with DEA Rule)

Controlled Substance
Name
Dosage Unit
Strength per Unit
Quantity of Dosage Units to be Dispensed
Directions for Use
Cautionary Statements if Required
Number of Times to be Refilled

Brand/Interchange
Below the signature line or the line provided for the prescriber to type his/her name there shall be a space in which the prescriber may indicate “no substitution.”
Below the space provided for the prescriber to indicate “no substitution,” there shall be printed the words “Interchange is mandated unless the practitioner indicates ‘no substitution’ in accordance with the law.”

Patient
Name (unless veterinary prescription or prescription for expedited partner therapy) For expedited partner therapy, may enter “Expedited Partner Therapy”, “E.P.T.” or “EPT”.
Address (unless prescription for expedited partner therapy) For expedited partner therapy, may leave blank

Question 5

Bioequivalent Drug Products

Answer 5

means drug products whose rate and extent of absorption do not show a significant difference when administered at the same molar dose of therapeutic moiety under similar conditions. Some drug products may be equivalent in the extent of their absorption but not in their rate of absorption and yet may be considered therapeutically equivalent because such differences in the rate of absorption are not essential to the attainment of effective body drug concentrations or are considered medically insignificant for the particular drug product studies.

Question 6

Interchangeable Drug Product

Answer 6

means a product containing a drug in the same amounts of the same active ingredients in the same dosage form as other drug products with the same generic or chemical name.

Question 7

MASSACHUSETTS
LIST OF INTERCHANGEABLE DRUGS

Answer 7

All prescriptions written by generic name can be interchanged if the drug is multi-source. To determine if a prescription written for a brand name drug product is interchangeable in Massachusetts:

1. Look up the drug product by the brand name in the index or by generic name in the”Approved Drug Products with Therapeutic Equivalence Evaluations” (“Orange Book”). The drug products are arranged alphabetically.
2. Compare the dosage form and strength of the drug product prescribed with the dosage form and strength of the same drug product in the “Orange Book”.
3. If the same drug product, dosage form and strength has been assigned an “A” rating by FDA and is not listed on the Exception List contained within 105 CMR 720.050, the drug product is interchangeable.
4. If the drug product is not listed in the “Orange Book”, refer to 105 CMR 720.050(b), the Massachusetts Additional List of Interchangeable Drugs (Additional List).
5. Look up the drug product by the generic name in the Additional List. The drug products are arranged alphabetically.
6. Compare the dosage form and strength of the drug product prescribed with the dosage form and strength of the same drug product listed on the Additional List.
7. If the same drug product, dosage form and strength are listed, the drug product is interchangeable.

Question 8

Schedule I.

Answer 8

consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated

Question 9

Schedule II.

Answer 9

Schedule II. Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated,

Question 10

Schedule III.

Answer 10

Schedule III. Schedule III shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated,

Question 11

Schedule IV.

Answer 11

Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated

Question 12

Schedule V.

Answer 12

Schedule V shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated

Question 13

Schedule VI.

Answer 13

Schedule VI. Schedule VI shall consist of all prescription drugs, which are not included in any other schedule established by the Commissioner.

Question 14

Lisinopril, amoxicillin. Gabapentin are all what schedule drug

Answer 14

schedule VI

Question 15

A school district or private school shall register in order to permit a school nurse to

Answer 15

store and delegate administration of patient-specific controlled substances to trained school personnel

Question 16

pharmacists may issue, modify, or discontinue an Rx or medication order as authorized in

Answer 16

collaborative practice agreement

Question 17

what controlled substance can a retail (community) RPh prescribe

Answer 17

schedule VI only

Question 18

an RPh can issue a Rx provided that it has what

Answer 18

the prescribing pharmacist clearly identifies their name and professional designation to the dispensing pharmacist and provides their registration number, work address, phone number, and the name of the supervising physician.

Question 19

can an RPh prescribe for a patient in a licensed facility

Answer 19

the pharmacist may prescribe a controlled substance for a patient in a licensed health facility, including a hospital, long term care facility, ambulatory care clinic or hospice, through the use of a written medication order entered on the patient’s medical record maintained at the facility, provided that such a written order meets all applicable provisions of 105 CMR 700.000;

Question 20

what healthcare professionals can provide an EPT

Answer 20

a registered physician, physician assistant, certified nurse practitioner, or nurse midwife may provide expedited partner therapy (EPT) for the treatment of chlamydia infection, which is the prescribing or dispensing for immediate treatment of an appropriate therapeutic agent in Schedule VI for the treatment of a sex partner or partners of a patient diagnosed with chlamydia infection, provided that:

Question 21

what practitioners are required to be registered and shall register separately for each business or professional activity

Answer 21

certified NP

CRNA

dentist

nurse-midwife

OD

RPh

physician

PA

podiatrist

psychiatric nurse mental health clinical specialist

researcher

Question 22

is a separate registration required?

Answer 22

Separate Registrations Required for Separate Activities. Each person shall obtain a separate registration for each group of activities in which they engage.

Question 23

inventory Requirements - Every registrant shall take an initial inventory and biennial inventories after that.

Answer 23

Every registrant required to take inventories under federal law and regulations shall follow those requirements, which are deemed to include Schedules I, II, III, IV, and V only.

(2) Every registrant shall take an initial inventory of all their controlled substances in Schedules II through V on the day they first manufacture, distribute, or dispense controlled substances.

(3) Every registrant shall take a new inventory of all stocks of controlled substances in Schedules II through V every two years following the date on which either the Federal or State initial inventory was taken, as applicable:
(a) On the day of the year on which the initial inventory was taken;

(b) On the registrant’s regular physical inventory date, if any, which is nearest to and does not vary by more than six months from the biennial date and which would otherwise apply; or

(c) Any other fixed date which does not vary by more than six months from the biennial date which would otherwise apply.

Answer 24

a registrant who elects to take their biennial inventory on their regular general physical inventory date or another fixed date shall inform the Commissioner of this election and of the date on which they will take his biennial inventory upon request.

Answer 25

Whenever the Commissioner by regulation adds to any schedule a controlled substance which was not immediately prior to that date listed in a schedule on which a registrant was required to keep records, a registrant who possesses that substance shall:

(a) Take, on the effective date of the regulation, an inventory of all stocks of that substance on hand and;

(b) Thereafter, include such substance in each inventory made by such registrant.

Question 26

Dispensing and Labeling of Sample Medications by Practitioners

Other than for immediate administration, a practitioner shall not dispense controlled substances to an ultimate user in the course of professional practice, except as follows:

Answer 26

a schedule VI sample medication in a single dose or in such quantity as is in the opinion of the practioner appropriate for the treatment of the patiient but not exceeding a 30-day supply per dispensing; provded, however the this quantity may be increased to a 90-day supply if dispensed as part of an indignent patent drug program and deemed appropriate in the professional judgement of the practioner

a schduele II through V sample med. in a single dose or in such quantity as in the opinion of the practioner is essential for the immediate treatment of the patient

Answer 27

All sample medications dispensed by a practitioner shall be properly labeled.
(1) Whenever a sample medication is dispensed by a practitioner, a label shall be affixed to the outside of the package, and shall include the following information:
(a) a practitioner’s name and address;
(b) date of dispensing; and
(c) name of the patient, unless a veterinary product.

Answer 28

A prescription or medication order for an implantable infusion pump containing a Schedule II or Schedule III controlled substance may be filled for a maximum of a 90 day supply.

Answer 29

A pharmacy that dispenses a controlled substance subject to the requirements in 105 CMR 700.012 must require that a customer identifier is presented whenever a controlled substance in Schedules II through V , or an additional drug is dispensed. The pharmacy may dispense a controlled substance in Schedules II through V or an additional drug without reviewing the customer identifier if the pharmacy has reason to believe that the failure to dispense the controlled substance or additional drug would result in a serious hardship for the ultimate user or agent of the ultimate user, and documents the reason; and the ultimate user or agent of the ultimate user prints their name and address on the reverse side of the prescription and signs their name thereto, or in the case of an electronic prescription, provides an electronic signature; and the pharmacy provides to the Department those informational fields required by the Department.

Question 30

Requirement to Utilize the Prescription Monitoring Program.

Answer 30

A practitioner must utilize the prescription monitoring program:
(a) prior to prescribing a Schedule IV or V controlled substance, as designated in guidance issued by the Department pursuant to M.G.L. c. 94C, § 24A(c), and
(b) prior to prescribing any opoid in Secheule II or III or a benzodiazepine.

Answer 31

(B) A Prescription must enable the practitioner to instruct the pharmacist to dispense a brand name Drug Product by indicating “no substitution”, provided that:
(1) the indication of “no substitution” is not the default indication;

(2) the Prescription indicates that “Interchange is mandated unless the practitioner indicates ‘no substitution’ in accordance with the law”; and

(3) the indication of “no substitution” is a unique element in the Prescription and shall not be satisfied by use of any other element, including the signature.

Question 32

The Prescription shall contain the following information:

Answer 32

The Prescription shall contain the following information:
(1) the registration number of the practitioner;

(2) date of issuance of the Prescription;

(3) name, dosage, and strength per dosage unit of the controlled substance prescribed, and the quantity of dosage units;

(4) name and address of the patient, except in a veterinary Prescription, a Prescription for naloxone or other opioid antagonist approved by the Department, or a Prescription issued pursuant to 105 CMR 721.070(A)(7) or 105 CMR 721.070(A)(12), in which case the name and address may be left blank; provided however, the person taking delivery of the Prescription for naloxone or other opioid antagonist as approved by the Department may, but is not required to, be used in place of the name of the patient;

(5) directions for use, including any cautionary statements required;

(6) a statement indicating the number of times to be refilled; and

(7) if the Prescription is for an opioid substance in schedule II, a notation that the patient

may fill, upon request, the Prescription in an amount less than the recommended full quantity indicated.

Question 33

what kind of Rx should also have the name of the supervising physician

Answer 33

an Rx issued by a certified NP, psychiatric clinical nurse specialist or CRNA

Question 34

A Failover shall be considered an Oral Prescription, and shall not require a Written or Electronic follow-up Prescription, provided:

Answer 34

(1) The prescription contains all information required by M.G.L. c. 94C, § 20(a) except for the practitioner’s signature, and the Prescription is immediately entered into a compliant electronic pharmacy system or otherwise reduced to writing by the dispensing pharmacist;

(2) if the prescribing practitioner is not known to the dispensing pharmacist, the dispensing pharmacist makes a reasonable good faith effort to determine that the Failover was issued by a prescribing practitioner; and

(3) The prescription is not for an Additional Drug, as defined by 105 CMR 700.001: Definitions.

Question 35

Invalid Prescriptions

Answer 35

(A) A Prescription in a format that does not conform to 105 CMR 721.000 is invalid and shall not be filled.

(B) APrescription that does not meet the security requirements of 105CMR721.000 is invalid and shall not be filled.

(C) An Electronic Prescription transmitted through means other than Electronic Transmission is invalid, except in the event of a Failover, as verified pursuant to 105 CMR 721.020(G).

Question 36

Prescribing More than One Drug Product

Answer 36

Practitioners who wish to prescribe more than one Drug Product, with the same or different dispensing instructions, shall place each Prescription on a separate Prescription form or record. More than one Drug Product may be prescribed in the hospital setting on a single form or record provided, however, the Prescription provides clear directions for the use and interchange of each Drug Product.

Answer 37

within seven business days after authorizing an emergency orally transmitted Prescription, the prescribing practitioner shall cause an Electronic or Written Prescription for the emergency quantity prescribed to be delivered to the pharmacy which must have written on its face “Authorization for Emergency Dispensing” and shall comply with federal and state law. The Written Prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven day period; and

2 days electronic but 7 days hard copy

Question 38

ePrescribing Exceptions

Answer 38

(1)Prescriptions issued by veterinarians;

(2) Prescriptions issued or dispensed in circumstances where electronic prescribing is not available due to temporary technological or electrical failure;

(3) Prescriptions issued by practitioners who have applied for and received a waiver pursuant to 105 CMR 721.075;

(4) Prescriptions issued or dispensed in Emergency Situations in accordance with 105CMR 721.060;

(5) Prescriptions that cannot be issued electronically under federal or state law or regulations, including those issued for a drug for which the U.S. Food and Drug Administration (FDA) requires certain elements that cannot be accomplished with electronic prescribing;

(6) Prescriptions issued outside the jurisdiction of the Commonwealth of Massachusetts;

(7)Prescriptions issued pursuant to 105CMR700.003(J)for expedited partner therapy for treatment of chlamydia, which is intended for dispensing to the patient’s partner;

(8) Prescriptions for Compounded Drug Preparations, subject to standards outlined in Department guidance;

(9) Rx issued for CS in schedule VI

(10) Rx for durable medical equipment

(11) Rx issued prior to 1/1/23 or such later date as determined by the department to residents of level I, II, III LTC facility

(12) Prescriptions issued in response to a declared public health emergency

(13) Rx for the treatment, control and prevention of diseases dangerous to public health, including sexually transmitted infections, or for any other urgent public health matter.

Question 39

Hospital Pharmacies

Answer 39

Hospital pharmacies may fill medication orders for hospital inpatients, prescriptions for hospital outpatients and employees, and medication orders or prescriptions for inpatients of a hospital-based skilled nursing facility or a long-term care facility that is solely owned by a hospital that meets the Federal criteria for a sole community hospital contained at 42 CFR § 412.92 and is located on the hospital premises. Patients of such a hospital-based skilled nursing facility or long-term care facility shall be considered hospital patients for the purposes of receiving pharmacy services.

Question 40

Hospital Pharmacies

Answer 40

Notwithstanding the provisions of 105 CMR 722.090(A), hospital pharmacies and their satellites or branches may fill prescriptions for emergency room patients and discharge patients in an amount not to exceed a 14-day supply of the prescribed medication.

(1) Prescriptions for emergency room patients and discharge patients may not be refilled by the hospital pharmacy.

(2) Drug products that are only available from the manufacturer in greater than 14-day supplies may be dispensed in larger quantities for emergency room and discharge patients. The quantity dispensed, however, may not exceed the smallest quantity supplied by the manufacturer.

Question 41

Midstream interchange means

Date of listing means

Answer 41

the first time an interchangeable drug product is dispensed pursuant to a prescription written prior to the date of listing on which the drug changed from sole source to multi-source.

the date on which a drug product listing first appears in print in the Massachusetts List of Interchangeable Drugs.

Question 42

Date of listing is:

Answer 42

for drug products listed pursuant to 105 CMR 720.050(a), the date the edition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) is postmarked or posted electronically, whichever is first, by the United States Department of Health and Human Services;

for drug products listed under 105 CMR 720.050(b), the date the Additional List is published by the Secretary of State in the Massachusetts Register; or

for drug products listed pursuant to 105 CMR 720.080, the date the Exception List is published by the Secretary of State in the Massachusetts Register.

The effective date of interchangeability means not later than 90 days after the date of listing of a drug product in the Massachusetts List of Interchangeable Drugs.

Question 43

what is the EXCEPTIONS LIST

Answer 43

Orange Book “A” rated drug products not approved for interchange.

There are currently no products designated to be listed on the Exception List.

no drugs on exception list
so if on exam then put none of the above

Question 44

Drug Interchangeability

Answer 44

According to Massachusetts law, pharmacists must dispense a less expensive, reasonably available, interchangeable drug product provided that (a) the drug product is listed in the Massachusetts List of Interchangeable Drugs (MLID) and (b) the prescriber has not indicated “no substitution”.

A pharmacist shall interchange accordingly when dispensing a new prescription or a prescription refill presented after the effective date of interchangeability.

Question 45

Midstream Interchange

Answer 45

With respect to midstream interchange, open communication among pharmacists, patients, and prescribers is important because there may be factors other than bioequivalence or interchangeability, including patient concerns, that may affect drug product selection.

Therefore, a pharmacist presented with a new prescription or prescription refill that requires midstream interchange shall notify the patient and prescriber of said requirement in those cases in which such notification is, in the pharmacist’s professional judgment, reasonably indicated for the proper care of the patient.

Such notification may be written or oral and may be conveyed by telephone, facsimile, electronic transmission or other approved means. To prevent a midstream interchange, the prescriber must issue a new prescription that indicates “no substitution”.

Midstream interchange means the first time an interchangeable drug product is dispensed pursuant to a prescription written prior to the date of listing on which the drug changed from sole source to multi-source.

Answer 46

The above policy permits a pharmacist up to 90 days after a drug product is published as interchangeable to put into effect the requirement for interchange. This affords pharmacists the time to continue filling the prescription as originally dispensed while making the necessary administrative changes and communicating with patients and prescribers. There is no requirement to wait the full 90 days to initiate an interchange.

Answer 47

Communication with patient and prescriber may be particularly important for interchange on prescriptions written prior to the date of listing of a drug that has changed from sole source to multi-source. In such cases, called midstream interchange, the prescriber and patient may not have been aware at the time the prescription was written that the drug would become multi-source and interchangeable. This applies whether the change to ongoing drug therapy occurs at the filling of a new prescription or refill.

Answer 48

Publication of the MLID serves as public notification of the requirement for interchange, but is not patient specific. Therefore, the pharmacist must use professional judgment to determine whether there is a need to communicate about the midstream interchange with prescriber and patient. Once notification is provided, there is no requirement for an acknowledgment or response from the patient or prescriber. However, a prescriber may at any time issue a new prescription that indicates “no substitution”. A copy of the notification or a notation that it was provided should be maintained in the pharmacy record.

Question 49

warfarin is bioequivalent to coumadin tablets

Answer 49

The U.S. Food and Drug Administration (FDA) stated on March 26, 1997 that Warfarin Sodium Tablets manufactured by Barr Laboratories, Inc. are “bioequivalent and therefore, therapeutically equivalent to the listed drug (Coumadin® Tablets)” manufactured by DuPont Merck Pharmaceutical Co.

On the matter of equivalence determinations for drugs with narrow therapeutic ratio, the FDA has stated that “because of FDA’s strict bioequivalence criteria, we believe that drugs do not fall into discrete groups that would allow one to consider NTI [narrow therapeutic index] drugs as being clearly different from other drugs for purposes of therapeutic substitution.”

okay soo….. what’s wrong with warfarin?