RI Law

-9 Members

-1 hospital pharmacist

-2 independent retail

-2 chain retail

-2 any field pharmacists

-2 members of the public

-Must have been pharmacist for 5 years in RI prior to appointment

-Under Department of Health

-Appointed by director of health

-Term of 3 years, limit of 3 consecutive terms

$280

-15 hours/calendar year

-Must be retained for 2 years from completion of course

-1 hour must be law

-5 hours must be live

-If immunizing, must do 1 hour of immunization CE

-If in collaborative practice agreement, must do 5 ADDITIONAL hours in an area generally related to CPA

-Can skip CE requirements in first year of licensure following graduation except for immunizations

-1500

-Official Transcript from accredited college of pharmacy

-Preceptor Affidavid of Preceptor Hours

-2x2 passport photo taken within last year

-Copy of driver’s license or state ID

-Copy of current out-of-state pharmacist license

-License verication from each state licensed in

June 30th.

If issued prior to April 21st, will need to renew

-Graduate of or at least 3rd year student of school

-$70

Can only practice under immediate supervision of preceptor

Valid for 1 year, cannot be renewed if not making progress towards graduation

-Yes, except for high school students as part of career exploration programs

-Type 1 - basic

-Type 2 - Also certified by an organization

-18 years

-High school graduate or equivalent or enrolled in a program that awards a degree

-No felonies related to controlled substances

-Pharm Tech 1 - none specified

-Pharm Tech 2 - Ten hours in calendar year, keep documentation for 2 years

$25

-Expires June 30th, must renew same year if given prior to April 21

250 square feet

-Enough to do all duties and functions in a safe and effective manner

Multiple cameras in drug storage area that actively record and store data for at least 30 days

-C-II’s must be stored separately

-C-III’s through V’s should be either in their own location or in a form that is readily retrievable from other prescription records

-Can only be PIC for one pharmacy at a time EXCEPT during transition when you can do at most 2 pharmacies with a max overlap of 60 days

-Top 10 maintenance drugs and cost

-PIC

-Top 10 Opioids or other C-II’s w/ warnings

14 days

14 days

-Type of equipment

-Serial Numbers

-Policies + Procedures

-Name and address of pharmacy

-Manufacturer’s name and model

-Description of how device is used

-Quality assurance protocols

Either located in a wall of a pharmacy or within 20 feet of a licensed pharmacy

Pharmacist must be physically accessible at the address on the license at all times during hours of operation

-May have provision of limited supply of medications for filling urgent orders of medical institution. Must have on-call pharmacist, may be contracted out with another pharmacy.

-Pharmacy must be licensed in RI to mail to a pt in RI, as well as the state it is located

-License becomes null and void if owner changes or location changes

-Can only ship FDA approved meds

-Must provide written documentation that the importation of drugs is in complicate w/ all FDA and federal laws

-Labels must be written in English and meet all other requirements

CANNOT ship the following

-Controlled substance

-Biologic

-Infused drug

-IV drug

-Drug that is inhaled during surgery

-Parenteral drug

-A drug that requires refrigeration during manufacturing, packaging, processing or holding

-Photoreactive drug

Yearly on September 30th

30 days (doesn’t say business days)

No, but can’t have physician own >10%

Also, must be a qualified nuclear pharmacist to open radiopharmaceutical pharmacy

“Sufficient number of pharmacists to operate pharmacy competently, safely and meet the needs of patients”

“Sufficient number of pharmacists to operate pharmacy competently, safely and meet the needs of patients”

Inspection report from BoP from home state or independent organization approved by board. Must be done on initial licensure and annually thereafter

Based on USP standards, documented testing or literature and professional judgment

Pharmacists, interns or technician-II’s

Anyone doing sterile compounding must have documented competencies at least annually for low and medium risk compounding and semi-annually for high-risk level compounding

Must have complete list of active ingredients and assigned BUD

-Codeine, opium tinctures

-May be done by a PHARMACIST (although payment, etc can be done by others)

-No more than 240 mL (8 ounces) or 48 doses of substance containing opium within 48 hour period

-No more than 120 mL (4 ounces) or 24 doses of any other substance within 48 hour period

-Purchaser is 18 years old

-Suitable identification including proof of age, unless purchaser known to pharmacist

-Pharmacist must maintain bound record book of all such dispenses including name and address of purchaser, name and quantity of substance purchased, date of each purchase and name/initial of pharmacist

-3.6 g pseudoeephedrine or ephedrine base/day

-9g pseudoephedrine or ephedrine base/30 days (unless by mail, then 7.5 g/30 days)

-Must be stored in pharmacy

-Prescription not required

-Pharmacist must make available info on safe disposal of hypodermic syringes

Can administer any immunization approved by CDC, ACIP, etc.

Can administer vaccine to patients aged 18+

Can administer to 9+ for influenza

Pharmacy interns who have completed immunization certificate program and are CPR certified under direct supervision of pharmacist

Tech-II same as intern except that pharmacist must be on premises for post-immunization monitoring

Pharmacist can perform only in accordance with instructions in kit. LFTs are tests under Clinical Laboratory Amendments of 1988 (CLIA) as waived tests

Must maintain at minimum:

-Name of test

-Test procedures or site-specific work instructions

-Records of testing materials used, equipment function tests, maintenance

-Test results, including confirmation or supplemental tests required by package insert

-Record of any test system failures, troubleshooting and corrective action

Maintain records for at last 3 years

-To immunize, must have iether written protocol from prescriber or have valid prescription for immunization

Documentation:

-Patient’s name, address, date of birth

-Date of administration and site of immunization

-Name, dose, manufacturer, lot number and expiration date of immunization

-Name and address of patient’s PCP, as identified by patient, if known

-Name or identifiable initials of immunizing person

-Publication date of VIS

-Date that VIS was provided to patient

-Keep records for at least 2 years

-Must report influenza immunizations to people 9-18 years old must be reported to Department within 7 days of administration

Can decline to dispense on ethical, moral or religious grounds only if pharmacist has previously notified the pharmacy owner, in writing of what drugs/class of drugs/devices they object to and the pharmacy owner can, without creating undue hardship provide reasonable accomodation of licensed pharmacist’s objection

This means the owner must have attempted to allow these duties to be performed by someone else but is unable to reasonably accomodate the objections without undue hardship to business

At least:

-Licensed pharmacist

-RN

-Physician

-Admin or adrep

-Ensure that a valid medication or prescription order is received prior to dispensing of any drug

-Ensure that drugs for each patient are kept and stored in originally received containers and that the med of one patient is not trasnferred to another patient

-Ensure that each cabinet, cart or other area utilized for storage of drugs is locked and accessible only to authorized personnel

-Generic or trade name, strength, quantity

-Control number assigned by the pharmacy which corresponds to ID of manufacturer, manufacturer’s expiration date, lot number of drug, quantity repackaged, date repeackaged, and pharmacist responsible for repackaging

-Expiration must be 1 year or expiration date, whatever is earlier

-Can contain schedule IV and V if they are prescribed routinely for patient (NOT schedule II or III)

-Labels must be sufficient size to label each container with all info required by state and federal law

-name of patient

-name of prescriber

-rx number of each prescription

-directions/time of

-name, strength, EXACT PHYSICAL DESCRIPTION, total quantity of drug

-dispensing/preparation date, BUD (no more than 1 year) for each drug

-name, address and telephone number of pharmacy

-Must be designed to prevent it from being re-closed, designed to show evidence of having been opened and designed so that label cannot be altered

-Once labeled and dispensed to patient, if returned, drugs must be treated as adulterated and cannot be returned to pharmacy stock BUT can be redispensed to same patient.

-All events involving contents of ADS must be recorded electronically

Records must include:

-Identity of system accessed

-ID of individual accessing system

-Type of transaction

-Name, strength, dosage form, quantity of drug accessed

-Name of patient for whom drug was accessed

-Additional info as determined by PIC

Must also keep record of medications filled/stocked w/ ID of people filling

-Must have radioactive storage and product decay area. Detailed floor plans shall be submitted to the Department and to RI Radiation Control Agency before approval of license

-Must have approved RI Radiation Control Agency license

-License will only be granted to qualified nuclear pharmacist

-Nuclear pharmacist must be in personal attendance at all times that pharmacy is open for business

-Pharmacist must be licensed in RI or employee of nonresident pharmacy licensed in RI

-Pharmacist has real-time electronic access to prescription records, patient profiles, or other relevant medical info

-Such records are protected from unauthorized access

AKA Central Fill

-Must provide one time written notification to patients informing them that their prescription meds may be processed at an alternate site

-Signage conspicuously displayed at the delivery pharmacy notifying patients that the prescriptions may be processed at an alternate site meets this requirement

-Practitioner may prescribe/administer/dispense controlled substances or may cause controlled substances to be administered by a nurse or intern under their direction and supervision

-A practitioner (seems to be anyone with prescribing privilages) may supply prescriptions samples to their patients

-Controlled substance prescriptions for animals must contain full name and address of the owner and species of the animal

-Under no circumstances can any controlled substance be dispensed to a patient by a practitioner in a hospital ER or ambulatory surgery center

-Any practitioner may provide patient with entire recommended course of PREP if patient had potential exposure to HIV. Must include written instructions regarding use of medications

-If administering a single dose of a medication from a multi-dose unit of use package, a practitioner in a hospital ER, hospital clinic or ambulatory surgical center may distribute any remaining doses to the patient as long as they give the patient sufficient instructions

A non-pharmacist licensed healthcare professional may dispense medications at Block Island Health Center (or another pharmacy licensed in the Town of New Shoreham if BIHC ceases to exist and the medications must be dispensed before it can be delivered to the island

-Must be legend drug included in written policy established by BIHC. Full instruction on the use of the drug must be provided to the patient

-BIHC must keep log of all medications dispensed with this waiver containing:

-Name of prescriber

-Full name of patient

-Name of drug

-Quantity and strength of drug

-Date of dispensing

Must maintain logs for 24 months

Can use an automated data-processing system for record-keeping if:

-System is able to make sight-readable documents of all original and refilled prescription info

-Pharmacist responsible for completeness and accuracy of the entries to the system must provide documentation that prescription info entered into the computer is correct. Either by:

-Maintaining a bound logbook or separate file in which each individual pharmacist involved in the dispensing shall sign a statement each day attesting to the fact that the prescription information entered into the computer that day has been reviewed and is correct. Must maintain this for 2 years

-Provide a printout of each day’s prescription info. That printout shall be verified, dated and signed by the individual pharmacist verifying that the info indicated is correct. Printout must be maintained for at least 2 years

-CII-V for 2 years

-2 years

Only can release to patient or to healthcare profesionnals when it is necessary to protect patient’s health and wellbeing or to governmental agencies authorized by law to receive such confidential info

-Schedule II-V or opioid antagonist

-Within 1 business day of date of dispensing

-If pharmacy has Rhode Island Controlled Substance Registration and does not dispense any controlled substances, they should report “zero fills” every 24 hours

ADRs deemed to be significant by the pharmacist shall be reported to FDA MedWatch or VAERS (if vaccine)

-Documentation of error must be initiated as soon as practical, no more than 3 days from identifying the error.

-Analysis of each error must be performed within 30 days of identification

-Separate record shall be maintained for 12 months from date of analysis including:

-Date analysis was initiated and completed

-Names of participants in analysis

-General description of remedial action taken to prevent or reduce future errors

-Must notify individuals affected in written form by first-class mail or email if the affected individual agreed to such. Must be done without unreasonable delay and in no case later than 60 days after discovery of a breach

-If affecting more than 500 residents of a State/jurisdiction, must also provide notice to prominent media outlets (likely as a press release). Same time frame as above

-Must notify secretary of HHS (Can do online breach report form. Must do in 60 days or less if affecting more than 500 people, or if fewer than 500, can do on annual basis. (no later than 60 days after end of calendar year in which they occurred)

-Full name

-Address

-Telephone number

-Age or DOB

-Gender

-All prescriptions obtained by patient at the pharmacy during the 12 months immediately preceding the most recent entry

-Name and strength of drug

-Prescriptions number

-Quantity and date received

-Name of prescriber

-Pharmacist comments relevant to the individual’s drug therapy and drug allergies

2 years from date of last entry in profile. May be hard copy or computerized form

-Over-utilization and under-utilization

-Therapeutic duplication

-Drug-disease contraindications

-Drug-drug interactions

-Incorrect drug dosage or duration of drug treatment

-Drug-allergy interactions

-Clinical abuse/misuse

-Food-drug interaction

-Must review prior to dispensing a controlled substance prescription for the first time and every three months thereafter

-RECOMMENDED that pharmacists review PDMP prior to dispensing a benzodiazepine or sedating medication

Established FDA

OTC vs Rx

Thalidomide (required efficacy as well as safety to be proven

Child-resistant packaging requirement

-If consists in whole or in part of any filthy, putrid or decomposed substance

-It has been produced, prepared, packed or held under unsanitary conditions by which it may have been contaminated with filth or by which it may have been rendered injurious to health

-If it contains a coal-tar color other than a certified one???

-If it purports or is represented as a drug but its strength differs or quality/purity differs and is not specified on the label

-If it has been cut with something else or is something else entirely

-If labeling is false or misleading in any way

-If missing anything required on label

-Tons of shit related to labeling, I don’t fucking know

Class I: Reasonable probability of expsure to potential serious AE or death

Class II: Temporary or medically reversible AE

Class III: Unlikely to cause AE health consequences

Drug Pricing

Therapeutic Equivalence

International Travel Vaccines

Animal Drug Products

Vaccine-Preventable Diseases

Biological Products

Nonsterile Compounding

Sterile Compounding

Hazardous Drug Handling

-Full name and street address of patient

-Name, address and DEA (if controlled??)

-Date of issuance

-Name, strength, dosage form, quantity of drug prescribed

-Directions for use

-Refills authorized, if any

-If written, prescriber’s signature

-If electronically transmitted, electronic/digital signature

-If hard copy generated from fax, must be on paper that prevents copying/alteration

-Full name and street address of patient

-Name, address and DEA (if controlled??) of provider

-Date of issuance

-Name, strength, dosage form, quantity of drug prescribed

-Directions for use

-Refills authorized, if any

-If written, prescriber’s signature

-If electronically transmitted, electronic/digital signature

-If hard copy generated from fax, must be on paper that prevents copying/alteration

Differences:

-Full name, address, registration number under federal law of prescriber

ICD-10 code for all controlled substances

-Species of animal

-Not specified

-When filling hard-copy C-II, pharmacist must sign full name and write date of filling on face of prescription

-Generic - normal, go for it unless DAW

-Biosimilar - Shall interchange with less expensive product if meets standards for interchangability

-Dosage form - May alter if in professional judgment of the pharmacist, the form dispensed meets the bioequivalency of the dose prescribed and is appropriate for the patient

-Therapeutic subs - Permitted in situations requiring compliance with a formulary from P&T and agreed to by physicians of hospital, NH, etc

-Only valid for 1 year from date of issuance

-May refill prescription from practitioner who has expired or has had license revoked for no more than 90 days, if written before that occurred and has refills

-If unable to readily obtain refill authorization, can fill for up to 90 days if:

-Not for controlled substance

-Essential to maintenance of life or to continuation of therapy for chronic condition

-In pharmacist’s professional judgment, interruption of therapy might reasonable produce undesirable health consequences and the dispensing pharmacist notifies the prescriber within a reasonable time after the dispensing

-Must be located within pharmacy

-In addition to all other info needed on a prescription, must include date of transmission

-Can prescribe CIII-V this way

Can do C II-V

-Must also include date of transmission

-Same info required as written prescriptions

-Oral prescriptions must be promptly reduced to writing and stored either electronically or in hard copy

-Controlled substances must be phoned in by prescriber (not delegated)

-Interns CAN receive prescriptions under immediate supervision of pharmacist

-Tech I - May NOT take new prescriptions

- May take refills, provided no changes

-Tech II - May receive new prescriptions and changes. May request refills

No one else can receive prescriptions

-Transferring person (pharmacist or supportive personnel) must cancel the original, indicate to what pharmacy, date of transfer and name or initials of transferring pharmacist/supportive personnel

-Receiving person must:

-Note that it is a transferred prescription

-Date of issuance of original prescription

-Original number of refills

-Complete refill record of original

-Number of valid refills remaining

-File number of original

-Name of pharmacy and person from who it was transferred

In addition to normal stuff

Transferring:

-Write void on face of invalidated prescription or add to electronic record that invalid and transferred

-Record on reverse of invalidated prescription (or add to electronic record) name, address, DEA # of pharmacy, name of receiving pharmacist

-Record date of trasnfer and name of pharmacist transferring the information

Receiving:

-Write transfer on face of transferred prescription

-Date of issuance of original

-Original number of refills

-Date of original dispensing

-Number of valid refills remaining and date(s) and locations of previous refill(s)

-Pharmacy’s name, address, DEA number, prescription number

-Name of pharmacist transferred

-Pharmacy’s name, address, DEA registration number, prescription number from ORIGINAL fill if different

Must do all of above for electronic transfers too

-Interns under immediate supervision of licensed pharmacist, EXCEPT for controlled

-Tech II’s EXCEPT controlled

For C III-V, can transfer only ONCE, UNLESS electronically sharing real-time online database, then can transfer up to max refills

-Name of prescriber

-Full name of patient

-Name and address of pharmacy

-Name of drug dispensed

-Quantity and strength of drug dispensed

-Date of dispensing

-Prescription number

-Expiration date of prescription

-Instructions

FEDERAL

-”Caution: Federal law prohibits dispensing without a prescription”

-Package insert and reference to that insert for more info

-Storage info

-Lot number

-Manufacturer

-NDC info

-If controlled, what schedule

-New prescription, pharmacist or intern must counsel on matters which will enhance or optimize drug therapy. The offer to counsel may be delegated by the pharmacist.

-Not REQUIRED for a refill

-Must document refusal of counseling in writing

-No REQUIRED topics, list given of things counseling may include

-Unused non-controlled prescriptions may be accepted by pharmacies from which they were purchased for return FROM nursing facilities, ALF, residential care facilities, community health organizations, jails that centrally store prescription drugs within 45 days of dispensing

-May then repackage, restock and redistribute

-Unopened sections of blister pack prescriptions with seal intact

-Unopened unit-dose containers of liquids with safety seal intact

-Unopened unit-dose containers of powders for oral solution with safety seal intact

-Unused injectables with safety seal intact

III

IV

V

III

III

IV

V

III

III

V

IV

C-II?!

IV

-Initial prescription for an opioid for acute pain for someone who has not received opioids in the last 30 days shall not exceed 30 MMEs for a maximum of 20 days

-Cannot be long acting/ER

-Practitioner must review PDMP

90 days from original date of prescription

180 days

C-II: 30 days at a time

C-III: No more than 100 dosage units at one time. Manufacturer prepackages steroids/hormones exempt

C-IV+V: Up to 90 day supply, no more than 360 dosage units at once

C-II: No refils

C-III-V: No more than 5 refills, no more than 6 months

C-II: May write up to 3 separate prescriptions each for up to one-month supply. Signed and dated on date written. Must write earliest date of each subsequent fill

-Can partial fill C-IIs if UNABLE to supply full quantity. Must note quantity supplied on face of prescription. Remaining portion can be filled within 72 hours of first partial filling

-If instead the patient or prescriber request partial fill, can do subsequent fills for up to 30 days from when it was WRITTEN

-C-II for patient with terminal illness OR LTCF may be filled in partials. Must record on prescription whether patient is terminally ill or at LTCF. C-II’s for either of thes are not valid for more than 60 days

Can dispense C-II upon oral authorization if:

-Quantity prescribed and dispensed is limited to amount adequate to treat patient during the emergency period only (any further must be pursuant to written prescription)

-Immediately reduced to retain and contain all required info

-Within 7 days, the practitioner shall make sure a prescritpion is delivered to the dispensing apothecary. Must have written on its face “authorization for emergency dispensing” and date of oral order.

First Letter: A,B,F is a full practioner. X is x-waiver. M is mid-level

Second Letter: First letter of prescriber’s last name

Add 1st, 3rd, 5th number

Add 2nd, 4th and 6th number and multiply by 2

Add both numbers together

7th number of DEA should equal last digit of previous sum

$888

222

106

41

-Can be done on annual basis

-Witnessed by at least two people who can be pharmacist, physician, mid-level, nurse or law-enforcement

Prescriber MUST co-prescribe naloxone if:

-Prescribing opioid when opioids in total are at least 50 MMEs

-Prescribing any dose of an opioid when a benzo has been prescribed in past 30 days or is being prescribed at that time

-Presceribing any dose of an opioid to a patient with a prior history of opioid use disorder or overdose

-All schedules, and methadone (appears to be same authority as physician)

-Hydrocodone products are only C-II allowed. No methadone

-All other C-III-V OK

-May not inject any meds

-Must be used for treatment of conditions of the human eye and its appendages.

-If hydrocodone or C-III, can only be for 72 hours or less

Same as doctor for pedal extremity

Same as doctor

None

Same as doctor?!

RI residents with debilitating medical conditions may use marijuana if physician (licensed in RI, Mass or Connecticut) certifies in writing that the marijuana may alleviate their symptoms and that benefits outweigh risks

IND = investigation new drug. Done before giving to humans, pre - phase 1 clinical trial

NDA = new drug application after phase 3

ANDA = for generics, only have to prove bioequivalence

3500b for nonhealthcare

3500 for healthcare

Generics

5 members of varying backgrounds

-more than one profession

-every effort should be made to mix genders

-at least one scientific area and at least one non

-Should be performed on an every other year basis

Must record:

-Time and date

-Drug, dose, and dosage form

-C III-V can be estimated if package size is < 1000. Exact count necessary if >1000

-C II: Exact count always necessary

-Nonaqueous compounds - 6 months or earliest expiration date of any ingredient

-Water containing oral compounds and refrigerated: 14 day max or earliest of ingredients

-Water containing topical and semisolids: 30 days or earliest expiration

-Aseptic technique w/ ISO class 5 or better (IV hood)

-Only sterile products

-3 or fewer products mixed

-Storage 48 hours RT, 14 days refrig, 45 days frozen

-4 or more sterile products

-Long compounding/special dissolution

-TPN classic example

-Infusion devices that administer over several days

-Storage: 30 hours at room temp, 9 days refrigerated, 45 days frozen

-Nonsterile drugs or devices

-Anything less than ISO class 5

-24 hours RT, 3 days refrig, 45 days frozen

Ceiling -> Back -> Sides -> Devices/Bars- > Main surface

-For all chemo ADMINISTRATION, two pairs of chemo gloves must be worn

-For hazardous injectable ADMINISTRATION must also do chemo resistant gowns

-Can’t re-use gowns

-Description of drug (chemical structure, classication, makeup with both active and inactive ingredients

-Clinical pharmacology

-Indications, usage

-Dosage and administeration

-Boxed warnings

-Contraindications

-Warnings

-AE

-DDI

-Pregnancy, breastfeeding

-Carcinogenesis risk

-Precautions

-Information for patients - important education points

-Lab tests recommended or required

-Overdose info

-How drug supplies

-Reference and clinical studies that are applicable to the drug and FDA approval

September 30th

7 days, should be written communication

IV injection

IV infusion except in codes

Intrathecal

Rectal

Intraocular

Chemo

Controlled substances, except for addiction treatment and hormones

No

Pharmacy DEA number

Patient name, full address, dob

Gender

Prescription number

Ndc

Date written

Date filled

Number of refills

Refill number

Quantity dispensed

Days supply

Code for either 3rd party or cash

Prescriber dea

Pharmacy DEA

Patient full name and full address

DOB

Gender

Prescription number

Date written

Date filled

Refills authorized

Refill number

Ndc

Quantity dispensed

Days supply

3rd party or cash

Prescriber DEA

Chronic pain patients receiving opioids must have one developed within 90 days

No REQUIREMENTS but suggested inclusions

Must be considered for consultation with other professionals once MME is 90. Consideration of consultation must be documented and rationale for deferral if not pursued

Temporary outage

Impractial for patient to pick up, max 5 day supply

Would have negative impact on or delay patient care such as

-complicated prescription

-requires compounding