Longitudinal IV: Pharmacy Law

what is an institutional pharmacy?

pharmacy providing services to licensed healthcare facility (either physical portion of facility or separate that provides centralized services)

fee for new in-state pharmacy/pharmacy services permit?

when does it renew?

$200

even-numbered yrs

fee for renewal in-state pharmacy/pharmacy services permit?

when does it renew?

$100

even-numbered years

fee for change in ownership of pharmacy?

$250

fee for controlled substances in institutional pharmacy?

when does it renew?

$300

even-numbered yrs

how many pharmacies can a supervising pharmacist supervise at a time?

1 (exception is if 2nd pharmacy is institutional pharmacy that's open <15 hrs/wk)

what is the requirement for supervising pharmacist to be on duty?

>50% of operating hours or >30 hrs/wk (whichever is less)

how soon should pharmacist assuming role of supervising pharmacist notify ALBOP of the change?

10 days

within how many days of assuming the role should the supervising pharmacist conduct a controlled substance inventory?

15 days

what is the pharmacist:tech ratio if 2 of them are nationally certified techs?

1:4

what is the pharmacist:tech ratio if 1 of them are nationally certified techs?

1:3

what is the pharmacist:tech ratio if none of them are nationally certified techs?

1:2

who coordinates pharmacy services for facilities w/out a pharmacy?

where are the drugs stored?

a pharmacist (either full or part-time or a consultant)

drug storage area under "competent supervision"

are stop dates required for drugs in hospitals?

yes!!

what should be done if administration errors, ADRs, & incompatibilities are identified within the hospital pharmacy?

reported to attending physician & (if appropriate) the facility's quality assurance program

for hospitals & pharmacy services, what must be provided to professional staff?

drug information source

what must facilities establish for hospitals & pharmacy services?

a formulary !! (sorry this was kind of vague. I didn't know how to word it haha)

what are the required technical equipments for institutional pharmacies?

- up to date Facts & comparisons or other drug info resource (print/electronic)

- hot & cold running water in Rx area

- other equipment needed for its lvl & type of practice

when might after hours access to the pharmacy be necessary?

to get a drug not available from floor supplies or stat medicine cabinet and it's needed to treat IMMEDIATE NEED OF THE PATIENT (the pt's health would be jeopardized w/out it)

what is the required info for form that must be filled out & left with container for pharmacist to see after accessing pharmacy after hours?

pt name, DOB, & Room #

drug name, strength, and quantity obtained

date & time of drug removal from pharmacy

signature of person obtaining removing drug

how many ppl have access to pharmacy after hours?

only ONE supervisory nurse/physician per shift (pre-designated in writing by facility's appropriate committee)

what should be done after obtaining med from pharmacy after hours?

fill out form & leave w/ container for pharmacist to see when next in facility

what is required to access med storage containers (how do you get in them)?

user-specific password, PLUS.. (one or more of below)

- fingerprint

- personal ID badge

- retinal pattern

- etc.

what does ADU stand for?

automated dispensing unit

what is an ADU?

electromechanical system that performs operations/activities related to storage & dispensing of meds

- able to collect, control, & maintain required transaction info & records

what does the ADU store?

unit doses of meds in ready-for-administration form

What does it mean that ADUs are an extension of the managing pharmacy for licensed healthcare facilities w/ a valid ALBOP institutional pharmacy permit?

managing pharmacy = pharmacy department

What does it mean that ADUs are an extension of the managing pharmacy for facilities that are NOT hospitals (like the nursing home)

managing pharmacy = pharmacy that has the contract to provide pharmacy services

who must approve of an ADU for hospital?

ALBOP

what must be done to acquire an ADU?

submit request for approval to ALBP >30 days prior to desired use date

- include copy of all use policy & procedures

what must be done when wanting to relocate an ADU ?

ALBOP approval with request >30 days prior to desired move

what is required to remove a drug from ADU?

valid med order that's reviewed, interpreted, & approved by pharmacist

who can access the ADU?

licensed pharmacist

registered pharmacy techs

licensed nurses

respiratory therapists

other licensed healthcare professionals approved by supervising pharmacist/medical staff

authorized field service personnel for maintenance (under direct supervision by nurse, pharmacist, or pharm tech)

who is responsible for ADU operation?

supervising pharmacist

who must agree upon contents of ADU?

pharmacy, facility Med Director, nursing leadership

who can restock the ADU?

licensed pharmacist or pharmacy tech (other licensed healthcare personnel can restock if approved by ALBOP)

where must drugs go that are delivered to facility but not yet stocked in ADU?

store securely & in compliance w/ policies & procedures

when must on-site inventory of ADU contents occur?

at least quarterly

what are stat medicine cabinets?

cabinet/enclosure containing drugs needed to effectively manage a pt's drug regimen that aren't available from any other authorized source in sufficient time to prevent harm to patient

can controlled substances be in stat medicine cabinets?

NO NO NO

for a facility w/ in-house pharmacy, a stat medicine cabinet or other enclosure used to provide drugs when the pharmacy is not attended by a pharmacist is located where?

outside of pharmacy area (must consult pharmacist for use though)

for a facility w/out a pharmacy, a stat medicine cabinet's access is limited to...

authorized personnel who can access by key or combo

in regards to stat medicine cabinet, the supervising pharmacist & facility's appropriate committee must develop/determine...

1. list of drugs/inventory included

2. who has access

3. written policies & procedrues

what are requirements of stat medicine cabinets?

1. drugs properly labeled

2. only stock pre-packaged drugs (no stock bottles)

3. only stock quantity sufficient for immediate therapeutic requirements

4. valid written med order to access cabinet

5. proof of use provided for any drug removed

6. inventories at least every 30 days

7. complete audit of all activity occurs at least once per month

when must stat medicine cabinets be inventoried?

at least every 30 days

when must a complete audito of all stat medicine cabinet activity occur?

at least once per month

for facilities w/out in-house pharmacy, how many stat medicine cabinets can they have?

one (can get more w/ permission from AL state Board of health)

for facilities w/out in-house pharmacy, how often should the pharmacist review the need for medications included in stat medicine cabinets?

annually

for facilities w/out in-house pharmacy, who must approve the list of contents included in stat medicine cabinets?

pharmacist & facility's appropriate committee

for facilities w/out in-house pharmacy, how often must a pharmacist inspect the stat medicine cabinet? what do they do?

at least monthly

- replace outdated drugs

- reconcile all use in last month

- use this info to prepare monthly report

what should the list of contents for a stat medicine cabinet contain if facility doesn't have in-house pharmacy?

1. drug name & strength

2. quantity of each drug name by strength

3. expiration date

recordkeeping requirements for stat medicine cabinets in facilities w/out in-house pharmacy?

1. amt of drug stocked in cabinet

2. name of pt for which a drug is removed

3. how much drug removed for pt

4. prescribing physician

5. time of drug admin

6. name of person removing / administering drug

7. quantity on hand after drug removal

what are emergency kits?

Kit containing drugs needed to effectively manage a critical care incident of need of a patient

can controlled substance be included in emergency kits?

YES YES YES

where should kits in long-term care facilities be acquired from?

DEA-registered pharmacy

what is the max day supply of any controlled substance that be stocked in emergency kit?

3 DS

what should emergency kits containing controlled substances have?

double locks

what should be done regarding telephone med orders when using emergency kits?

they must be signed ASAP

general requirements for emergency kits

• A copy of a list of contents must be maintained by both the institution and the supplying pharmacy (if different)

• Must be provided and sealed by a licensed pharmacist (in Alabama)

• Supplying pharmacist and facility’s medical staff jointly determine drugs (including quantity) included

• Must be securely stored to prevent unauthorized access

• Must be stored in an environment that preserves contents (does not lead to damage or adulteration)

• Labeled to indicate clearly that it is an emergency drug kit and should be used for emergencies only

• Label must list the drugs inside kit – including name, strength, and quantity of those drugs

• Label must have an expiration date – earliest expiration of any drugs in kit

• Label must list name, address, and telephone number of supplying pharmacist

• Nothing is removed from kit without a valid med order (can be verbal)

any time an emergency kit is opened, when must the pharmacist be notified? why?

within 72 hours

to restock & reseal kit

requirements for pharmacists preparing sterile products in AL?

registered w/ ALBOP

minimum 8 hours course that includes didactic & hands-on training

take a written exam

obtain 2 CE hours each renewal cycle

who is responsible for verifying parenteral certifications?

supervising pharmacist

what is an additional requirement for pharmacists who prepare compounded sterile products from "one or more non-sterile starting components"?

addnl 4 hour course + other requirements (8 hr training course)

required contents on hospital drug labels

pharmacy name/address

drug name

drug strength per dosage unit

directions for proper storage, handling, safety, or use

manufacturer's mixture of ingredients or one w/ common name (like "GI cocktail") --> can use "prescriber's mixture" if compounded product or absence of common name

what can be excluded on labels for in-patients' meds? why?

directions for use

-- these are included on electronic/printed med administration record

what is NOT required on individual unit dose units or floor stock med controlled w/ proof of use sheets?

institutional name

t/f: hospitals are allowed to repackage OTC drugs for use w/in facility?

TRUE!

a drug is not considered "manufactured" ( isn't subject to FDA requirements for manufacturers) if it is...

- compounded for individual pts

- by licensed pharmacist

- in limited quantities

- w/ bulk substances that comply w/ standards of USP or NF monograph

Written policies and procedures are required to ensure that finished products have the ____, ____, ____, ____ that they are supposed to contain

identity, strength, quality, and purity

pharmacist responsibilities & requirements for compounding:

•Be proficient in compounding and continually expand their knowledge through continuing education

• Verify all prescriptions

• Direct the preparation of the compound when a written procedure is not on file with the pharmacy

• Verify the weight or volume of all active ingredients

• Approve or reject all components of the compounded product, drug product container, closures, or labeling

• Prepare and review all compounding records and ensure no errors have occurred in the compounding process

• Ensure proper maintenance, cleanliness, and use of all equipment involved in compounding

• Ensure only personnel authorized by Supervising Pharmacist are in the immediate vicinity of the compounding operation

t/f: pharmacy techs can NOT assist pharmacist in prep of compounds

false!!

YAY WE LOVE OUR TECHS <3

requirements for compounding area

• Be clean, sanitary, and in good condition

• Have adequate lighting and ventilation

• Have cleanable surfaces including walls, ceilings, and floors

• Have portable (e.g. drinkable) water under continuous positive pressure with a plumbing system free from defects

it is not permittable to administer pt's own meds UNLESS...

they're precisely identified (most facilities require pharmacist to do this)

what are the requirements to give pts their own meds in the hospital?

- they're precisely identified

- a facility prescriber's orders (even if they have an outpatient prescription)

what should be done w/ the patient's own meds they bring to hospital?

- return to adult member of pt's immediate fam or removed from facility

- store in manner that follows written policy

what are inpatient investigational drugs?

drugs that aren't FDA approved & are being evaluated as part of clinical trial -- store & dispense from pharmacy only

define "emergency" dispensing for institutional facilities

prescribing/providing necessary meds to patients treated by institutional facilities w/in physicial facility or to be taken w/ patient upon discharge

what is "emergency" dispensing allowed for?

- bulk meds for a single patient use (like an inhaler)

- meds deemed necessary w/ ALBOP approval

minimum labeling requirements for "emergency" dispensing in institutional facilities

1. Facility name and address

2. Directions for use

3. Drug name as dispensed

4. Strength per dosage unit

5. Any additional (true) information essential for proper storage,

handling, safety, and/or use of the medication

any pharmacy wishing to use centralized services must notify _____ BEFORE Services approved

ALBOP

what can authorized centralized services do for pharmacies?

1. Preparing unit dose packages (for single administration) from bulk containers

2. Preparing non-sterile or sterile compounded unit dose drugs for patient administration

3. Warehouse bulk supply medications and supplies

4. Perform off-site order entry

5. Other fuctions approved by ALBOP

what are requirements of a pharmacy involved in centralized services?

1. Either:

-- Be owned by the same person/entity as the originating pharmacy

-- Have a written contract with the originating pharmacy that outlines what services will be provided and what the responsibilities are of each pharmacy in fulfilling the contract

2. Shares a common electronic file or has appropriate technology to allow access to sufficient information needed to process medication orders

3. Maintains a record of all pharmacies (including name, address, and DEA number) to which they provide services

4. The pharmacy and all pharmacy personnel must comply with all pharmacy laws and regulations

pharmacies using centralized services must maintain a policy & procedure manual that contains...

• Appropriate records to identify the pharmacists responsible in performing centralized services

• A mechanism for tracking a prescription drug order during each step and in all process

• A description of adequate security to protect the integrity of and prevent illegal use of disclosure of protected health information

• A description of drug storage and security in compliance with all applicable federal and state statutory regulatory requirements

• A continuous quality improvement program

• A documented annual review

how many schedules for controlled substances are there?

5!

what is the codeine requirement for schedule III drugs?

<90 mg codeine per dosage unit

for testosterone products to be schedule III drugs, they must be no more than ____ mg

90

for schedule V, diphenoxylate <____ mg per 100 mL or 100 grams

200 mg

t/f: a separate DEA registration is required for each pharmacy owned/operated by same entity

TRUE

what is required for every pharmacy that dispenses a controlled substance?

DEA registration

hospital DEA registration is issued as...

"institutional practitioner"

what must be obtained before applying for DEA registration?

state pharmacy license

what is the DEA form for initial registration?

DEA form 224

when is DEA registration renewed?

using what?

every 3 years

using DEA form 224a

Multiple entities involved in controlled substance dispensing require a controlled substance license/permit issued by ALBOP. What is the fee for a pharmacist?

$100 (after 50 yrs of practice = $25)

Multiple entities involved in controlled substance dispensing require a controlled substance license/permit issued by ALBOP. What is the fee for a pharmacy?

$300

Multiple entities involved in controlled substance dispensing require a controlled substance license/permit issued by ALBOP. What is the fee for a facility?

$600 (renewed annually)

when must DEA renewal occur for multiple entities involved in controlled substance dispensing require a controlled substance license/permit issued by ALBOP?

december 31st

any change in operation impacting controlled substance registration of a pharmacy must be reported to ALBOP within ____ days

10

T/F: in AL, a separate controlled substance license is required for both pharmacists & pharmacies in order to dispense controlled substances

true

who maintains complete and accurate records for each controlled

substance purchased, received, stored, distributed, dispensed, or disposed of?

pharmacist! Yay!