NH MPJE 2027 ANSWERS AND QUESTIONS SET A+
✔✔Compounding a commercial drug during drug shortage - ✔✔May compound only in
this instance
✔✔Collaborative practice agreement - ✔✔NH RPh license
1million liability coverage
PharmD or 3yr experience
5 hrs CE/yr
✔✔Collaborative practiced allowed in: - ✔✔Hospitals
Long term care fac
Hospice
Amb care clinics
✔✔RPh vaccine administration - ✔✔NH RPh license
1 million liability cov
Vaccination training
✔✔Restrictions on vaccine admin - ✔✔Influenza - general public
Pneumococcal/Zoster - 18 or older
✔✔On pharmacy label - ✔✔Name/address pharmacy
Name/initials RPh
Rx #
Date dispensed
Any directions
Prescriber name
Patient name
Auxiliary labels
Name, strength and quantity of drug
✔✔Labeling exemptions - ✔✔Institutionalized pt
,✔✔Oral Rx requirements - ✔✔Patient name
Name/strength/quantity of drug
Directions
Prescriber name
Date ordered
RPh name
✔✔Electronic Rx requirements - ✔✔Patient name
Name/strength/quantity of drug
Directions
Prescriber name
Dated and e-signed on day issued
✔✔Durham-Humphrey Amendment of 1951 - ✔✔- amendment to FDCA
- established legend and OTC drugs
- required adequate directions of use
- provided for oral prescriptions and refills
✔✔Kefauver-Harris Amendment of 1962 - ✔✔- adopted over thalidomide concerns
- also referred to as Drug Efficacy Amendment
- required not only safe but effective
- placed authority for regulating drug advertising with FDA
✔✔Investigational New Drug Application (IND) - ✔✔- 1st form submitted to FDA before
drug administered to humans
- FDA has 30 days to decide if suitable for testing
- includes all preclinical info
✔✔Phase 1 trial - ✔✔Small group of healthy individuals
- evaluate toxicology, pharmacokinetic, pharmacological properties
- assess safety in humans
✔✔Phase 2 trial - ✔✔- patients with the disease given the drug
- determine effectiveness of drug
- obtain info on dosing, safety and adverse effects
✔✔Phase 3 trials - ✔✔- involve large groups of people
- obtain data concerning drugs effectiveness compared to placebo
- double blind study
✔✔Treatment IND - ✔✔Allow admin of IND to patients not enrolled if patient has
imminent need of drug
✔✔"Phase 4" trials - ✔✔Post marketing surveillance
- health professionals report problems esp. Adverse effects
, ✔✔Abbreviated NDA - ✔✔Generic drug form
- prove bio similar to brand
✔✔Supplemental NDA - ✔✔Manufacturer wants changes to synthesis, production or
location, packaging or labeling
✔✔USAN - ✔✔Responsible for designating generic name for a new drug
✔✔Secretary of HHS - ✔✔Grants final approval of any drug name
✔✔Waxman/Hatch Amendment - ✔✔Granted longer patent protection, easier approval
for generics
✔✔Generic drug co. - ✔✔Must show bio equivalence, do not have to wait until drug off
patent to start studies
✔✔NDC code - ✔✔10 or 11 digits
Manufacturer-drug ID-package ID
✔✔NDC number - ✔✔No federal law requiring NDC on labels, prescriptions, individual
dosage units
✔✔Inactive ingredients on labels - ✔✔Alphabetically by name but separate from active
ingredients
✔✔Coloring agents - ✔✔Prohibited in ophthalmic and parenteral dosage forms
✔✔Labeling of manufacturers containers - ✔✔- name/address of manufacturer, packer
or distributor
- name of drug
- quantity in package
- weight of each active ingredient in each dosage form
- RX only
- specific route of administration if not PO
- special storage directions
- manufacturer lot #
- expiration date
✔✔FD&C yellow 5 - ✔✔Tartrazine, must disclose presence of this agent
✔✔Aspartame - ✔✔Phenylketuronics
✔✔Sulfites - ✔✔Must contain allergy warning
✔✔Compounding a commercial drug during drug shortage - ✔✔May compound only in
this instance
✔✔Collaborative practice agreement - ✔✔NH RPh license
1million liability coverage
PharmD or 3yr experience
5 hrs CE/yr
✔✔Collaborative practiced allowed in: - ✔✔Hospitals
Long term care fac
Hospice
Amb care clinics
✔✔RPh vaccine administration - ✔✔NH RPh license
1 million liability cov
Vaccination training
✔✔Restrictions on vaccine admin - ✔✔Influenza - general public
Pneumococcal/Zoster - 18 or older
✔✔On pharmacy label - ✔✔Name/address pharmacy
Name/initials RPh
Rx #
Date dispensed
Any directions
Prescriber name
Patient name
Auxiliary labels
Name, strength and quantity of drug
✔✔Labeling exemptions - ✔✔Institutionalized pt
,✔✔Oral Rx requirements - ✔✔Patient name
Name/strength/quantity of drug
Directions
Prescriber name
Date ordered
RPh name
✔✔Electronic Rx requirements - ✔✔Patient name
Name/strength/quantity of drug
Directions
Prescriber name
Dated and e-signed on day issued
✔✔Durham-Humphrey Amendment of 1951 - ✔✔- amendment to FDCA
- established legend and OTC drugs
- required adequate directions of use
- provided for oral prescriptions and refills
✔✔Kefauver-Harris Amendment of 1962 - ✔✔- adopted over thalidomide concerns
- also referred to as Drug Efficacy Amendment
- required not only safe but effective
- placed authority for regulating drug advertising with FDA
✔✔Investigational New Drug Application (IND) - ✔✔- 1st form submitted to FDA before
drug administered to humans
- FDA has 30 days to decide if suitable for testing
- includes all preclinical info
✔✔Phase 1 trial - ✔✔Small group of healthy individuals
- evaluate toxicology, pharmacokinetic, pharmacological properties
- assess safety in humans
✔✔Phase 2 trial - ✔✔- patients with the disease given the drug
- determine effectiveness of drug
- obtain info on dosing, safety and adverse effects
✔✔Phase 3 trials - ✔✔- involve large groups of people
- obtain data concerning drugs effectiveness compared to placebo
- double blind study
✔✔Treatment IND - ✔✔Allow admin of IND to patients not enrolled if patient has
imminent need of drug
✔✔"Phase 4" trials - ✔✔Post marketing surveillance
- health professionals report problems esp. Adverse effects
, ✔✔Abbreviated NDA - ✔✔Generic drug form
- prove bio similar to brand
✔✔Supplemental NDA - ✔✔Manufacturer wants changes to synthesis, production or
location, packaging or labeling
✔✔USAN - ✔✔Responsible for designating generic name for a new drug
✔✔Secretary of HHS - ✔✔Grants final approval of any drug name
✔✔Waxman/Hatch Amendment - ✔✔Granted longer patent protection, easier approval
for generics
✔✔Generic drug co. - ✔✔Must show bio equivalence, do not have to wait until drug off
patent to start studies
✔✔NDC code - ✔✔10 or 11 digits
Manufacturer-drug ID-package ID
✔✔NDC number - ✔✔No federal law requiring NDC on labels, prescriptions, individual
dosage units
✔✔Inactive ingredients on labels - ✔✔Alphabetically by name but separate from active
ingredients
✔✔Coloring agents - ✔✔Prohibited in ophthalmic and parenteral dosage forms
✔✔Labeling of manufacturers containers - ✔✔- name/address of manufacturer, packer
or distributor
- name of drug
- quantity in package
- weight of each active ingredient in each dosage form
- RX only
- specific route of administration if not PO
- special storage directions
- manufacturer lot #
- expiration date
✔✔FD&C yellow 5 - ✔✔Tartrazine, must disclose presence of this agent
✔✔Aspartame - ✔✔Phenylketuronics
✔✔Sulfites - ✔✔Must contain allergy warning
