Module 5

Filling prescriptions, PPPA. rx counseling and delivery, compounding

what is required of medication profile records?

• maintained with patient info

  • first and last name, address, DOB

  • animal: name/species of animal, last/DOB of owner

  • all Rx info and prescribers

• attempt to obtain

  • allergies

  • ADR

  • chronic conditions

how long are med profiles and rx reocrds maintained for ?

5 years

what must computer systems have for med profile records?

• must be able to print any data requested

• must have a backup system/procedure in case the computer system is down!

What are the aspects of prospective DURs?

at the minimum (OBRA 90)

• over-under utilziation

• therapeutic duplication

• drug interactions

  • drug diseas

What does WI DUR include?

• reasonable utilization and optimum therapeutic outcomes

• therapeutic duplications

• DI with food, beverages, other meds or medical conditions

• known allergies

• reasonable dose, Duration of use, route of administration, considering the age + other factors

• potential abuse or misuse

• rational therapy

• CI

• reasonable directions for use

• potential or actualy DR

what are retrospective DURs?

process that is performed by state Medicaid admin, PBMs, other system or plan administrators or quality improvement initiatives

• looks at multiple patients OVER TIME
  uses medical or claims data

what type of DUR looks at trends to ID patterns of use or misuse and generic utilization?

Retrospective DUR

when can a pharmaists dispense a drug produce equivalent (e.g., generic durg)

• designated therapeutic equivalent by FDA in the orange book

• must be lower in price than OG

• must inform consumer of substitution

• prescribe does indicate no sub no specific wording is required)

can pre-printed statements prohibiting subs be ona prescribers Rx blank?

NO

t/f you can change drug product equivalents when refilling a rx, if you inform consumer

true

what type of patients can have therapeutic alternate drug selection and who can perform those?

patients that are in

• hospital

• nursing facility

• corrections system

MD, DO, APNP, or PAs can do this

therapeutic alternative = subing one drug for another within the same class

what type of stuff do we need to disclose to consumers at a pharmacy?

• post a sign stating the pharmacists ability to sub a med with a l;ess expensive DPE

• make available info on how to access PEBs lsit of top 100 generic drugs, updated annually —> can be a link to PEBs website

• have available a list (updated monthly) of the retail price of the drugs from the PEBs top 100 lists that are available at the pharmacy

  • must include brand, generic, and biolgocs with interchangeable products

what are the required signage and postings in every pharmacy

• professional hours

• WI poison center

• patients right to consultation

• how to file a complaint with the bpard

• description of pharamcists ability to sub less exp generic drugs and biologics

• available info on how to access

  • PEB list of top 100 drugs

  • FDAs lsit of interchangeable biologics

  • retail price for each drug in top 100 brand and generic) ←- updated monthly

What must be present for a biosimilar to be substituted?

• interchangeable (not just biosimilar) per FDA purple book

• must communication with the physician within 5 days as to specific biological product dispensed

  • writer or direct comm

what is the required label info on prescription labels?

• pharmacy name, address, and phone #

• rx #

• fill date

• patient first and last name

• prescribers name

• Rx dir

• drug product name, strength

• quantity of drug

• refills remaining

• BUD for drug produc

T/F a doctors full name has to be on a prescription label

False

• need full name on prescription but not on the patients prescription label

When does a prescription label not need a patient’s first and last name?

• EPT

• opioid antag

• school epi

• animals

what is optional on a prescription label?

• indication for Rx (unless pt requests)

• brand name (unless brand was to be dispensed but generic was dispensed

• drug desriptions

• aux labels

what information must be on a prescription label if CS 3, 4, 5

• date of original fil

what information must be on a prescription label if CS 2, 3, 4

federal caution label must be placed

what must be on presrtiption label for animals?

• name

  • name of animal

  • species

  • owners last name

• if food producing animal

  • withdrawal time of drug

• vets name and address

what is NOT requried for rx label

patient

• address

• DOB

• phone #

prescriber

• address

• phone #

drug

• manu/distributor

date of OG dispensing

• required for CS

date Rx expires

• date of drug product exp is required tho

what must be on repacking for stock labels?

• drug name, form, strength

• BUD

• either

  • NDC + mfr lot number

  • mfr name + mfr lot #

  • pharmacy control number

what must be recorded by pharmacys for repackaging for stock

• drug name, form, strength

• qty per container, # of containers

• NDC or name of mfr

• mfr lot #

• OG exp date, new BUD

• repackager name, verifying RPh

• date of repackaging

• pharmacy control number, if there

For every rx, what parts of the Final check needs pharmacists verify at which steps?

• label is correct and meets all req

• product verification

• DUR completed

who must be put on record for students/interns completing final check?

supervising pharmacists

who can product verif be completed by?

• pharmacists

• pharmacy tech under tech-check-tech

• automated tech

The record must ID the tech or technology (not the pharmacists)

what is the poison prevention packaging act of 1970?

• prevent accidental poisoning of children <5

• mandates child-resisted closure on ALL Rx for oral admin, UNLESS exception is request or an exempted drug

T/F a patient may request a blanket waiver for on-child-resistant closures for all prescriptions?

true

• may explicitly state for ALL Rxs

T/F a provider may request a blanket waiver for on-child-resistant closures for all prescriptions?

false

• only per prescriptions basis

can glass rx vials be re-used?

yes

can plastic closures be re-used?

NO - those must be replaced with each rx

what medications are exceptions to compliant packaging?

• nitroglycerin

• mnemonic packaging

  • OCs, steroids

• powders

• inhalers

• topicals

tamper-evidents seasl are required on all __ ___ products

oral OTC

flavored baby chewale aspirin is limited to what count per bottle?

36 due to accidental ingestion

when is counseling required?

• new medication for patient

• change in therapy

• request by patient or patients agent

• when necessary, based on pharmacists professional judgement

when is cousneling is NOT required?

• med is admin by an individual with a scope of practice that includes admin of drugs (home nurse or hospital patient)

• patient or patients agent refuses consultation

what are some counseling pts

• name and description of drug

• form, dose, route of admin, duration of therapy

• intended use and expected action

• directions/precautions for pre and admin

how should counseling be provided to patients?

• verbally when pharmacists’ professional judgement determeins its is in the best interest

• Drug education monographs must be provided with each required consultation

• can occur before or after the delivery of prescription

• board approved sign stating patietns right to consultation

• copy of info stating a patient’s right to RPh consultation and how to file a complaint to board

T/F CS can be mailed

true

what is required when shipping/mailing CS rx?

• When mailing cs, at least one party must be registered with the DEA

  • patients cannot mail CS to each other

  • CS may NOT be shipped to another country unless registered with the DEA as an exporter

• valid signature upon delivery

  • state ID is waived

• outer wrapper must not indicate ocntents in anyu way

when shipping a Rx, what is required?

• notify patients right to counseling

• delivery method is appropriate to prevent drug adulteration

• provided a way to notify the pahramcy is any irregularity in the delivery is observed

if an Rx is compromised or lost while being delivered, what should the pharmacy do?

• replaced by pharmacy at no additional cost

• if time needed to replace the drug will affect patient care, a RPH is required to take steps in order to prevent patient harm

what are 503A compounding pharmacies, and what can they do?

traditional, community pharmacy

• no separate license or notiication to PEB required

may copound human drug products

• pursuant to pateint -sepcific prescriotion OT

• limited quantities ahead o time, based on hx of reciving Rx for those compounded products

may not compound in bluk for office use

• unless for vet use

Substances used in compounding must have USP/NF monograph, on FDA bulk drug list or otherwise approved by FDA
- BUD assigned based on internal or external data

what are 503B compounding facilties and what can they do?

aka outsourcing facilties

• may or may not reistered as a pharmacy

may compound human drug products in bulk or with a patient-specific prescription (if a pharmacy)

• larger amts of sterile preps for offices around the country

• may be compounded for office use

requirements of 503B facilties?

• registered with FDA as an outsourcing facilty at one location

• comply with current CMP regulations

• submit to FA inspections

• demonstrate quality and stability of all products made

• use only bulk drugs approved by FDA for 503B compounding

• report product list to FDA biannually

• label each product per FDCA requirements

what CANNOT be compounded by both 503A/B?

• drugs that have been withdrawn from markets

• products that are essentially copies of commercially available drugs

• drugs that are difficult to compound which this difficulty affects the safety or efficacy of the drug

location of 503A vs B?

A: retail

B: dedicated compounding facility (may be a pharmacy)

licensing/registration of 503A vs B?

a: regualr pharmacy registration

B; voluntarily registers with FDA as outcosuring, may license as pharmacy too

typesof compound of 503A vs B?

A: only for patient speciif Rx or limited quanitity based on past rx volume and dispense sitll per pt-specific rx

b: large quanitites of sterile or non-steorl preps for office use

BUD determination of 503A vs B?

A: use BUD based on lit or USP info or internal info

B: must demonstrate quality and stability in house of all products compounded

cuurent GMP practices of 503A vs B?

A: does not have to conform

B: must conform and submit to FDA inspections

can we compound animal drugs

only if the source of active ingredients is a finished FDA approved drug

What must be on rx labels for compounded products?

in additiona to other labeling requriements

• stroage reqi

• BUD

• any speical handeing

• indication that prescirption is compounded

for a non-sterile compound, non-aqueous formulations at room temp’s BUD is what?

6 mo

for a non-sterile compound, aqueous semi-solid at room temp’s BUD is what?

35 days

for a non-sterile compound, aqueous oral in Fridge BUD is what?

14 days

what is required for non-patient specific orders (not an Rx)

• practitioner’s name and address

• drug name, strength, quantity

• purpose of compound

label requirements for non-patient specific compounding

• practitioner’s name

• statement: “ for practitioner admin only - not for dispensing or distribution)

• for single-use compounds: single dose only

what must pharmacists record for all non-patient specific compounding distribtued to practitioner

• name and address of lcoation to which distributed

• BUD

• lot #

T/F recons or mixing of pre-pack ingredients is compounding

FALSE