if absent:
>16 consecutive days (must report within 5 days)

>42 days (immediate notice to DCP, no longer is pharmacy manager)

pharmacist manager is responsible for documentation of initial and continuing training of techs

what must documentation include?

documentation must include

1. name of person receiving training

2. dates of training

3. general description of topics

4. signatures of both technician and RX-manager

technicians may:

type rx label

enter rx into computer
enter information into patient file
retrieve medications from stock
place medications in container
place label on container
prepare nursing home medication cards
reconsitute oral liquids
obtain refill authorization for non-controlled drug
compound medications for dispensing

Techs may NOT:
accept oral order for NEW prescription
consult with patient/practitioner about Rx or medical record

identify, evaluate, interpret or clarify a prescription

interpret clinical data

perform professional consultations

verify a prescription order

determine generically or therapeutically equivalent drugs

(may not: consult, clarify *(prescription), interpret (clincial data)

pharmacy to technician ratios

community pharmacy

retail?
IV, unit dose, bulk compounding/dispensing?

retail ratio 2:1 or 3:1*
*One of the technicians must be a certified pharmacy technician, otherwise only 2:1 allowed

Pharmacist may refuse to supervise 3 techs at a time, but refusal must be in writing to manager

IV, unit dose, bulk compounding/dispensing

ratio 3:1

cannot refuse to supervise 3 techs in these instances

pharmacy to technician ratio in institutional pharmacy

outpatient

inpatient

satellite

outpatient -   2:1

up to 3:1 with demonstrated need + petition

inpatient//satellite pharmacy - 3:1

up to 5:1 with demonstrated need + petition

phsyician (MD/DO)

osteopath

dentist

podiatrist

veterinarian

optometrist

physician assistant

APRN

Nurse-Midwife

pharmacist (opioid antagonist)

APRN can prescribe all CII-CV and legend drugs (in scope of practice)
if under written collaborative agreement with a CT licensed physician -- agreement must specify level of C2/C3 that can be prescribed

after 3 years, 2000 hours of practice under agreement, APRN can practice independently

Must have a clinical practice relationship with an OB/GYN based upon medical guidelines and protocols

protocol must contain list of meds that can be prescribed

Physician Assistant Prescriptive Authority

what can they prescribe?

one of the following:

• BS with 10 years of experience or PharmD
• certified by board of pharmaceutical specialties or commision for certification in geriatric pharmacy
• credentialed in disease state management by National Institute for Standards in Pharmacist Credentialing
• In a pharmacy residency (ASHP accredited)
• Successfully completed disease state management certificate program approved by ACPE

1. specific drugs managed by RPh
2. terms and conditions to initiate, modify or discontinue
3. conditions/events that RPH is to report to physician
4. lab tests that may be ordered by RPh
5. drugs that may be administered by RPh

pharmacist must be
1. trained and certified by DCP approed program

2. prescribing done in good faith

3. RPh provides training in the adminstration of the opioid antagonist to the person to whom the drug is dispensed

4. RPh maintains records of dispensing and training

May not delegate or direct anyone else to prescribe the antagonist. may not have someone elser train in the administration of the antagonist

1. name and address of prescriber -- if written, need manual signature
2. name & address of patient (if animal, name and address of owner and species)

3. date prescription was issued

4. drug name, dosage form, and if appliable, strength

5. quantity of medication

6. directions for use

7. any required cautionary statements

8. number of refills (if not control, PRN & Ad lib ok)

9. Date prescription was filled/refilled (on face or back of rx)

10. serial number of prescription

11. Initials of dispensing pharmacist

12. retail price of generic substitute

if control- must incude :

13.  patient age OR status (adult/child)

14. AND prescribers DEA number)

1. name and adress of pharmacy

2. serial number of prescription

3. date of prescrption dispensed (refillde)

4. prescribers full name

5. patients full name (or animal owners name and species)

6. directions for use

7. quantity and expiration date (rx life, or manufacturers date)

8. quantity dispensed

9. any required cautionary statements
(for control RX: needs "CAUTION:Federal law prohibits transfer of this drug to any person other than the patient for whom it is prescribed")

10. if no brand name, generic name and mfr/distributor

(if generic substituted, must include both generic and brand name)

11. strength of drug if applicable

 
for schedule III and IV - need dates initially filled and refilled

how long must prescription records be kept on file

name of receiving pharmacy

if for LTC inpatient, name of sending facility

if hospice, RX must note it is for hospice patient

"this prescription order is valid only if transmited by means of a facsimile machine"

LTC facilities and hospice, CII-CIV - fax non-fading = original RX)

for non LTC facilities, CII: handwritten original before dispensing, (CIII-CIV, fax non fading = original)

- unable to contact prescriber after reasonable effort

- failure to refil might result in interuption of therapeutic regimen or create patient suffering

- pt/rep informed that script is being dispensed without authorization

- prescriber informed at earliest reasonable time that authorization is required for future refills

- unauthorized refill quantity must not exceed 72 hours

transfer of refills non - controlled (oral and electronic)

transferring pharmacist's record requirements?

name of pharmacy transferred to

date of transfer

cancellation of original RX (unless part of common electronic rx record system (chain)

transfer of refills non - controlled (oral and electronic)

receiving pharmacist's record requirements?

- indicated that RX was transferred

name of transferring pharmacy and pharmacist

original issue date and dispensing date of RX

rx number of original RX

number of refills authorized on original Rx

complete refil record on date of transfer

number of valid refills remaining

NO CII
 CIII - CV can be transfered

Transfer is on a one time basis (one refill)
- except pharmacies sharing electronic real time online database, can transfer up to the maximum # refills prescribed

Must be transferred directly between two licensed pharmacists!

- cancel prescription and write VOID onface of RX

- on back of RX - writename, address, DEA# of receiving pharmacy, + Pharmacists name

Date of the transfer and name of transferring pharmacist

1. write transfer on face of RX record
2. issue date of original prescription
3. original number of refills authorized on original RX
4. date of original dispensing
5. number of valid refills remaining
6. date and locations of prevouis refills
7. transferring pharmacys name, address, DEA #, original RX #

drug name

drug strength

lot number

manufacturer

expiration date, if any

written RX: - Brand Medically Necessary or No Substitution

telephoned RX:  BMN/NS in RpH handwriting (or in e-record)
time RX received

name of persion giving authorization to RPh

electronic Rx: prescriber must select DAW code on certified EHR (the EHR may NOT default to BMN/NS)

Purple Book

FDA approval for same indication and condition of use as reference if:

Same MOA

Route of administration

dosage form

strength
(neuopgen and zarxio)

can hospital ED dispense to non-hospital patient?

if so, how many days supply?

control substance?

Yes if:
NOT a controlled substance

therapeutic needs of pt require immediate medication
24-hour supply
service of licensed pharmacy not available within a 5 mile radius

photo ID not required if:

Pharmacist knows patient
ID not needed in Institutional, LTC faciliy, assisted living, SNF, hosptial

Can compound uip to 20% a CII-CV (aqueous, oleaginous or solid dosage form)

but must be for specific patient/order

if CII - the order must be written

always required 2 employees to witness

1. transfer to person registered or authorized to accept for purposes of destruction

(must witness loading and unloading)

2. transport to registered location

(must accompany transport without unrelated or long stops and witness loading/unloading)

3. transport to non-registered location

(must acompany transport, without unrelated or long stops, & witness both loading/unloading and irretrievable destruction)

4. onsite method

(must witness irretrievable destruction

must contain <= 90mg codeine/dose (tylenol #3) etc

narcotics: <90mg codeine/dose - tylenol #3

buprenoprhine

stimulants (benzphetamine, phendimetrazine, ketamine)

dronabinol

Anabolic steroids (oxadrolone, androgel, etc) and Chorionic gonadotropin

butabital

Narcotics; (propoxyphene, tramadol)

Benzodiazepines (end in Pam or Lam)

Z drugs

modafinil

carisoprodol

meprobamate

phentermine

sibutramine

mazindol

premoline

mephobarbital

prescriber must use at least 2 of the following

password or PIN

biometric data

hard token

prescriber must prove identity to obtain credentials (before can e-prescribe)

CII prescription requirements:

refills?

partial dispensing?

emergency dispensing?

Written RX only (no oral transcription) - and no order for other drugs.devices on the same RX

No refills! - no quantity limit and no time limit to when it must be filled (pharmacist must determine if needed still by patient)

partial and emergency dispensing is allowed

up to a total of 90 day supply

each separate RX is for legitimate medical purpose

provider has written instruction son each RX (for earliest day on which pharmacy may fill)

prescriber concludes there is no undue risk of diversion or abuse

state law permits this *(and CT does)

quantity dispensed on face of Rx (if there is no notation, assumed that entire quantity was dispensed)

remaining portion must be dispensed wtihin 72 hours

no further quantity beyond 72 hours

exceptions:: terminal illness/LTC inpatient

1. rx record for each partial fill (date, quantity dispensed, remaining available & dispensing RPh)

2. Rx must note LTCF patient, or terminally ill

3. RX valid for 60 days

1. immediate administration necessary

2. no appropriate alternative treatment is available,

3. written prescription not reasonably possible prior to dispensing


Requirements

1.  quantity limited to amt adequate to treat during emergency period

2.  Rx order immediately reduced to writing

3.  If prescriber unknown, must make reasonable effort to determine if prescriber is legitimate

4.  Written RX authorizing emergency dispensing must be mailed or delivered within 72 hours (CT) - [ postmarked within 7 days, federal ]

---- signed by prescriber

---- AUTHORIZATION FOR EMERGENCY DISPENSING " written on face of Rx "
5. written authorization prescription must be immediately attached to the pharmacist written oral prescription

written and oral prescription allowed

up to 5 refills!

life or RX = 6 months, OR original + 5 refills (whicher first)

partial dispensing is allowed


for CV - CT doesnt restrict life of prescription to 6 months, or 5 refills, - so no limit, but must be for a medical purpose

quantity dispensed and initials written on back of prescription

partial dispense not to exceed total amount authorized by the prescription

all refills must be within 6 month limit

no CII

CIII-CV only

retail or hospital pharmacy may distribute small quantities to anothe pharmacy if

for immediate needs of patient

<=1 oz of powder/ointment

<= 16 oz liquid

<= 100 tabs, caps, suppostiroies or injections

pharmacist may change patient address:

upon contact with, and verbal permission directly from prescriber - may change

dosage form

drug strength

drug quantity

directions for use

must document - change was authorized, date and time authorized, initials of pharmacist

May not change 1. name of patient, 2. drug (except generic substitution) 3. name of prescriber, 4. date of issuance

pt address, and upon verification with prescriber
dosage form

drug strength

drug quantity

directions for us

issue date (Cant change with CII)

may not change patient name, prescriber or drug name

CII:
written/verbal order countersigned wihtin 24 hours

maximum 7 day order

CIII - CV
written or verbal order countersigned within 72 hours

maximum 30 day order

pharmacy may distribute CS without being registered as a distributor to another pharmacy, or registered practitioner (for dispensing to patients)

Only if

Total number of dosage units of CS DNE 5% of all controlled substances dispensed in a calendar year
whoever receiving the CS Is registered with DEA

documented transfer on DEA form 222 for CII

three separate files

1. CII

2. CIII, CIV, CV
3. all non-controlled

requires prompt filing (in chronological/consecutive ordeR)

(federal law allows two files, CIIs and everything else (wiht CIII-CV having big red C)

date of inventory

- whether taken at beginning or close of busines

-name of each control substance inventoried

- finished form of each (e.g. 10mg tablet)

- number of dosage units of each finished form in commerical container (e.g. 100 tablet bottle)

- number of finished containers of each finished form (e.g., four 100 tablet bottles0
COUNT
if CII-- exact count

CIII-CV, - estimated, unless container is >1000 tablets, than must exact count

-following info on all CII - CV

- dispenser ID & Rx number

- date filled

- new or refill, and number of refills authorized (if any)

- drug name, NDC, amt dispensed

- days supply dispensed

- patients: ID number, first and last name, address (zip too), DOB, Gender

- date of prescription issued,  number of refills authorized, & DEA number of prescriber

- type of payment (cash, insurance)

federal is in response to a prescription - to create a medication taiolred to the medical needs of an individual patient

CT - is in pursuant to a prescription

compound drug for identified individual patient

timing:: after the receipt of a rx

OR

in limimted quantities, in advence of a receipt of a valid RX or order for identified individual patient, but distributed after receipt of the RX

laminar air flow workbenf LAFW

biological safety cabinet

compounding aseptic isolator

compounding aseptic containment isolator

certification of ISO 5,7,8, q 6 months  (as recertification) - and whenever PEC or room is relocated, altered, or major service performed

air sampling for each individual area q 6 months, and in response to identified problems, - and recommended action levels

 - at beginning of each work shift-

- before each batch preparation is started

- every 30 minutes during continuous compounding periods of individual CSPs

-when there are spills

-when surface contamination is know

Always high risk when:
compounding with non-sterile raw materials
putting sterile products into non-sterile container

Also:  exposing sterile materials to room air quality worse than ISO class 5 for > 1 hour
non sterile water preparations are stored for >6 hours before being sterilized

purity of components is assumed but cannot be verified by documentation (using bulk containers)

must be administered <= 1 hour from start of compounding
(and labeled 1 hour BUD if not administerd right away)

simple transfer <= 3 commercially manufactured, non-hazardous products

<=2 entries into any container

compounding is continuous and completed in less than 1 hour

aseptic technique used

no hazardous drugs

must be administered within 12 hours of preparation (or earlier)
CSP is prepared under physician order for specific patient

for low risk level CSPS where a PEC cannot be located under ISO class 7 clean room

immediate use :: RT 1 hour
low risk w/ 12 hr bud (12 hours in RT or fridge)

low-high risk - freezer is 45 days

low risk RT - 48 hours

medium risk RT - 30 hours

high risk RT - 24 hours

low risk fridge -14 days

medium risk fridge 9 days

high risk fridge 3 days

perform annual review of list

also every time a new HD or dosage form is added

3.6 grams daily limit

9gram monthly limit  (not to <=60mg of sales)

OTC only

all non rx must be in blister packs or unit doses

mail order - 7.5gram max

product name, quantity sold, name and address of purchaser, date and time of sale _-- purchaser must show ID and sign logbook

non control:: - need online retrieval at least 6 months from last dispensing --
must retain original and refill history for 3 years!! (need accessible within 48 hrs from DCP notice)

document non-control refill data by either

1. daily printout (made within 72 hours of dispensing) - verified and signed by dispensing pharmacist asap
2. electronic record, with rpH name and initials as dispensing pharmacist



must give 30 day advance notice to DCP if starting use, changing system, or discontinuing system

same as non control -- 6 months from last dispensing, and retained for 3 years - (but also needs DEA number of prescriber in information)

Documentation of refills is either

1. daily printout, made within 72 hours - signed by RPH asap (same as non-control)

OR

2.  bound log book or separate file signed by dispensing RPh on date of dispensing *but no later than RPHs first work date after dispensing) - by signing, the RPH is verifying they reviewed the refil info entered into the computer, and it is correct

confidentiality of pharmacy records:

General rule: no disclosure of patient information without patients consent

Exceptions (no consent required?)

When is patient authorization not required?

patient, prescriber ( or agent), 3rd party payer, government agency with staturory authority, valid subpoena, entity with written agreement ot access data that does not identify specific individuals

patient authorization is not required for
Treatment

payment, healthcare operations

family/friends involved in pt care/payment

public health and safety

to prevent less/imminent danger

facility directories

how the CE may use and disclose an individuals PHI

the patients rights regarding the PHI, and how patient may make a complaint

the CEs duties regarding the PHI (and how must maintain privacy by law)

whom the patient may contact for more info

kept for 3 years, filed by date

made available upon request within 48 hours

7 commissioners
5 full time pharmacists (at least 2 community (1 independent, 1 chain) - at least 1 hospital
2 public members

term is coterminous wiht gvernor, or until successor is chosen (which ever is later)

must be:

locked

equipped with alarm

may have a one way drop box (accessible to authorized personnel only)

NO SALE of prescriptions when closed

deliveries (when closed) to be in secure, locked area, until RPH available to supervise processing

pt name

pt address

physician name

physician address

drug name

dosage

strength

quantity

number of refills

date prescription issued

cautionary statements

directions for use
date prescription fillde

serial number of prescription
pharmacist initials
generic price

DEA # phsyciian

age or if child/adult

patient name

pharmacy name

pharmacy address

prescriber full name

name of drug (or generic and mfr ) unless prescriber says no (if generic substitute, need generioc amd nramd_

if generic, and no brand name, need generic name, name of mfr, med watch # and internet site

quantity dispensed

directions for use

strength

date of refill

expiration date!!!

serial number rx

requried cautionary statements

pt name

pharmacy name/address

phsyician name

drug name, strength, quantity dispensed

date of script filled

directions for use

cautionary statements

expiration date

prescription number