MPJE Florida #1

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Pharmacist and Patient counseling

For every prescription offer to counsel verbally and in writing. For delivery the offer shall be in writing and shall provide toll-free access to RPH If a person picks up for another must still offer

Reports of tampered Tylenol leading to deaths in 1982 lead to what?

Laws requiring "tamper-resistant" or "tamper-evident" packaging (NOT tamper-proof)

What meds have been removed from negative formulary?

Levothyroxine, warfarin and digoxin

Explain the Federal Upper Limit (FUL) Reimbursement

Limit for the amount that medicaid reimburses for Multiple Source Drug (MSD- brand with 3 ore more AB generics) Some reimbursed as Estimated Aquisition Cost plus a reasonable dispensing fee

How long after a claim is submitted can a pharmacy be audited?

Limited to 24 months after the claim.

Negative Drug Formulary of Florida What is a "Negative Drug Formulary"?

List of drugs identified by the FL BOP that display therapeutic INEQUIVALENCE *Basically a list of Do Not Substitute*

FL medical marijuana

Low THC Cannabis for Compassionate Use AKA Charlottes Web Law, young girl with refractory seizures >10% CBD, >0.8% THC permitted for patients in state registry Physician orders (not prescribes), must maintain treatment plan and patient must be State resident Pharmacists NOT involved in dispensing/selling/growing

What is required for sterile compounding?

Policy and procedure manual, adequately skilled, educated, instructed, and trained

How much experience is required for licensure by endorsement?

Practicing 2 out of the previous 5 years

Conjugated Estrogens Replacement for?

Premarin= Estrone (50%) + Equilin (15-25%) + Equilenin

If a prescriber and pharmacist collaborate to create a plan of action for a patients therapy and this is formally documented, what is the name of this document?

Prescriber Care Plan

Who is responsible for assuring that FL pharmacy laws are followed in a pharmacy?

Prescription Dept Manager

1962 Kefauver-Harris Drug Effiecacy Amendments to FDCA

Rxs must be profent effective before marketing. Creates NDA and SNDA

*What other Permit can take the place of a SSCP (Special Sterile Compounding Permit)?

SPEP (Special Parenteral & Enteral Permit)--assumes sterile

What PERMIT do you need have in order to perform STERILE compounding?

SSCP (Special Sterile Compounding Permit)*

What will happen to pharmacist license IMMEDIATELY following a phamacists conviction of trafficking/selling/conspiracy to sell controlled substances?

SUSPENSION

Rules for Writing MULTIPLE Rx's involving CS

Same Schedule= yes Different Schedule or 1 schedule + 1 non-schedule= no

What if a practitioner does not have a DEA number but it licensed to prescribe? What should the number be on the script?

The DEA number of the hospital plus a special code

How many types of drugs and how many of each drug can be kept in an institutional type 2b pharmacy?

Unlimited formulary.

What are the maximum pharmacist:intern and pharmacist:technician ratios allowed?

Unlimited pharmacist:intern ratio and 1:3 technicians if compounding sterile products, 1:4 if dispensing, and 1:6 if neither compounding sterile products or dispensing.

DEA Form 106

Unusual or excessive loss, disappearance, or theft

What C5 drugs can pharmacists prescribe without a prescription?

Up to 240mg opium, 120mg codeine, 60mg dihydrocodeine, or 30mg ethylmorphine per 48hrs.

If there is a declared state of emergency, what is the time period allowed for emergency refills?

Up to 30 days (not C-IIs)

How much of the total amount distributed to other registrants may be controlled substances before a pharmacy has to register as a distributer?

Up to 5% in one year

nursing home emergency medication kit

Up to five controlled drugs may be included (with up to three doses of each for 60 beds or less (and an additional three doses for each 60 beds subsequent) Nurse or pharmacist may inventory, replace, and reseal

How far away can a filling machine be located if it is part of a licensed pharmacy?

Up to half a mile

Special Pharmacy - Limited Community license

dispense remaining multi-dose medications used in the hospital (topical, creams, insulin, eye drops, etc) at discharge (saves the patients money re-ordering these medications)

Must comply with Standards of Practice for Filling Controlled Substances (see 64B16-27.831), that is to use sound professional judgment

dispense valid prescriptions

Military personnel authorized to prescribe controlled substances

do not need a DEA registration number to prescribe in their official duty o Must provide Military Service Number in lieu of DEA number. o Prescriptions written in official duty may be filled by community pharmacy off base even without DEA number

Non-Sterile Compounding 'Good Manufacturing Practices'

efined by USP 795. USP 795 is NOT law

Modified Class II A

eg Methadone clinic, dialysis center Formulary limited to 15 drugs or less <10 Modified Class II registrations Must not have large stock bottles of controlled substances (>100 dosages

Modified Class II B

eg Surgical Center No formulary limitations, drugs can be stored in bulk or unit-dose >90% of Modified Class II registrations

ER Prescribers may dispense drugs for outpatient use.

escribers may dispense drugs for outpatient use. o Smallest duration necessary or 24 hrs. o Only if drug is warranted and community pharmacy services are not available o Records must be made by prescriber and maintained by Consultant Pharmacist o Drug must be properly labeled Controlled Substances okay to dispense

Check expiration dates

every four months (three times a year) and remove expired drugs immediately

It is illegal in FL

for a person to possess prescription drugs without a valid prescription. Florida law recognizes that there are limited instances where the possession of prescription drugs without a valid prescription is warranted. The department is authorized to issue letters of exemption in such cases for certain qualified persons for lawful research, teaching, or testing, and not for resale.

DEA Form 225

New registration

DEA Form 363

New registration

Does spoken word count as labeling?

Is office use of controls allowed

No. Not to be prescribed or dispensed

Can prescriptions for CIIs be given orally?

Only in emergency situations

How long should a supply of a medication prescribed by a pharmacist be limited to?

14 days

How many days worth of emergency drugs can a pharmacist dispense when the governor calls a state of emergency?

30 days.

Immediate use in emergency (ie Code)

discard in 1 hour if administration has not begun (good for 24 hours once hung

Class I Institutional Pharmacy (Nursing Home)

"A pharmacy in which all medicinal drugs are administered from individual prescription containers to the individual patient and in which medicinal drugs are not dispensed on the premises" Must have a consultant pharmacist of record named0

Class II Institutional Pharmacy (Hospital)

"A pharmacy that employs the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution

6 drugs on FL's Negative Drug Formulary?

"CDC gave negative D to PT" 1. Conjugated Estrogens 2. DigiToxin 3. Chlorpromazine 4. Dicumarol 5. Pancrelipase 6. Theophylline

Purchaser Maximums (Sold w/out a Rx; 48 hr window) 1. 5 C-V containing opioids with set maximums in Florida

"OCDde" Opium Codeine Dihydrocodeine Diphenoxylate Ethylmorphine

What unique POSITION must be created if a Sterile Compounding Pharmacy obtains a Special Sterile Compounding Permit?

"Rx Department Manager" (pharmacist internal to organization) or Consultant Pharmacist (outside pharmacist)

What is the exact wording of the federal label for drugs?

"Rx only"

Vaccines & Pharmacists 4 Vaccines that a certified pharmacist can give?

1. Influenza 2. Pneumococcal 3. Shingles 4. Meningitis

What are some products that are exempt from OTC tamper-resistant packaging?

1. Insulin 2. Lozenges 3. Dermatological products 4. Dentifrice products

When can a C-II script be transmitted via fax?

1. LTCF patient 2. Hospice patient

After a 15-day alert report is provided by a manufacturer, how long does the manufacturer have to file a follow-up report?

15 days

How many types of drugs and how many of each drug can be kept in an institutional type 2a pharmacy?

15 different drugs and up to 100 doses of each.

What are the CE requirements for license reactivation?

15 hours of live CE for each year of inactivity, plus usual 30 hours every 2 years

What are the requirements to become a pharmacy technician?

17yo and proof of an approved training program of at least 160 hours within 6 months.

Age limit for sale of Sudafed BEHIND the counter?

18 years old

What are the two ways a drug can be labeled prescription only?

1. Lack of safety for use without medical supervision 2. Request by the manufacturer for this distinction

What is the delinquent fee charged by the BOP and what is the fee for out-of-cycle license changes?

1. Late- $70 2. Out of cycle- $25

Medicare Part D primarily made changes relating to what?

1. MTM 2. Electronic prescribing standards 3. Recordkeeping

2 AntiNAUSEA meds a Pharmacist can write for?

1. Meclizine (Max 25mg)--Dramamine/Bovine/Antivert 2. Scopolamine (Max 1.5mg)--Scopoderm

How long does a passing NAPLEX score stand for licensure by endorsement?

12 years

Statute 893

"THE CONTROLLED SUBSTANCE ACT" - The Criminal Code

Florida Pharmacy Practice Act - FL Statute 465

"THE LAW" Details who is able to do what

Florida Board of Pharmacy Rules -64B16

"THE RULES" 64B16-26 Pharmacists Licensure 64B16-28 General Requirements - Permits 64B16-30 Disciplinary Guideline

The law states that the FDA will approve or deny an NDA within what time period?

180 days

2 criteria that must be met in order for pharmacist to be PDM of more than one store?

#1: 2 pharmacies must be in "close proximity" to one another AND #2: Pharmacist/Pharmacy must prove that the pharmacists "normal duties" will not infringe on his/her ability to fulfill PDM duty

Florida Licensure "License by Endorsement" 1 or 2 criteria that must be met in order to gain Florida licensure through ENDORSEMENT

#1: Proof of pharmacy practice for 2 of last five years + CE Hours (30) completed within last 2 years or #2: Proof of completion of 2 year INTERNSHIP

Fee for license by endorsement?

$100

What is the max cost to get licensed by the FL BOP?

$100

What is the consultant license fee?

$250

What is the renewal fee for licenses?

$250

C-V in FL?

(Lomotil)= Diphenoxylate + Atropine (2.5 mg/25 mcg)

IF ONLY process drugs for other pharmacies and do not compound, dispense, store or sell drugs

, THEN do not require sink, running water, refrigeration, patient consultation area, signs, and daily operating hours

FDCA was passed in ________

1938

Vaccination Certification for Pharmacists 1. # of training hours? 2. Additional certifications required?

1. 20 hours 2. CPRcert

Class II Institutional Pharmacy (Hospital)

-- Has pharmacy onsite *Drugs must be dispensed in unit-dose packages -- Must have consultant pharmacist of record named

Community Pharmacy (Independent/Chain)

-- Prescriptions filled stored and dispensed on an outpatient basis -- typical independent or chain drug store * Each store must have its own permit --May use automated filling systems --May do limited sterile compounding

Class I Institutional Pharmacy (Nursing Home)

-> do not dispense drugs to patients, they administer drugs -- Does not have a pharmacy on premises -- Must have a consultant pharmacist of record named * must provide written, onsite consultation at least once a month

HIPAA pharmacy requirements

-All pharmacy employees must be trained regarding HIPAA --all employees with access to PHI must receive training soon after hiring, documentation must be maintained for 6 years ---if significant changes made all employees affected by changes must receive updated training -Must notify patients about their privacy rights and how their information can be used -- must be publicly available -Designate an individual to be responsible for seeing that the privacy procedures are adopted and followed -Patients have right to access, inspect and correct medical records

What are some pharmaceutical industry tactics?

-Drug samples and seeding use -Development of me too drugs (no ground breaking therapies) - Hiring cheerleaders and medical liaisons to promote -Integrating educational programs with marketing programs -Publishing and exaggerating favorable benefits -Identifying new diseases -Dovetailing on government and academic research

What are some of the special requirements of first time license applicants?

1. 3 hours of AIDS/HIV coursework 2. 2 hours of med error coursework

What are the CE requirements?

1. 30 hours every 2 years 2. 1 hour must cover HIV/AIDS (every other biennium the licensee may complete end-of-life instead of HIV) 3. 2 hours of med errors

Incentive/Penalty

-Report 25 separate prescribing events during reporting period to receive incentive (2012) -10 by June 30 2012 to avoid 2013 penalty - if unsuccessful for reporting period, fee schedule shall be reduced by 1% 2012, 1.5% 2013 and 2.0% 2014 and each subsequent year

*Whenever you see "Class II Institutional Pharmacy"--it is referring to a very specialized pharmacy that CANNOT operate like a normal retail pharmacy

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C-V Codeine/Dihydrocodeine/Ethylmorphine/Opioid

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Central Filling Pharmacies in FL

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Prescriptions PHARMACISTS can/can't WRITE for in FL *Write= write an actual prescription without prescriber

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Pseudoephedrine (Sudafed) Laws in FL

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Question 15?? Federal law requires that C-II's be kept SEPARATE from all other prescriptions

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Sterile Compounding

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How long does the Modified Class II Institutional Pharmacy have to return DEA Form 41 to DEA office?

1 Day! (not "immediately")

CE Hours If a pharmacist is earning SEMESTER HOURS thorugh an approved post-doc training program AT a College/School of Pharmacy, how many CE Hours per 1 Semester Hour

1 Semester Hour= 5 CE Hours!

How long after a license is revoked must a registrant wait to apply for a new license?

1 year

How long must a patient be an addict before gaining admission to OTP?

1 year

Maximum LENGTH a pharmacist may ORDER Fluoride for a patient?

1 year

Oral Analgesics Pharmacists can write for: 1. 4 drugs? 2. Max day supply?

1) 1. Ibuprofen 2. Naproxen 3. ASA 4. Mag Citrate or Mag/Choline Salicylate 2) 6 days

National Drug Codes (NDC) serve as a universal (unique) product identifier for human drugs o Every distinct drug, package has a unique ten digit, three segment number (11 digit HIPPAA standard

1) Manufacturer or Labeler 2) Drug Product 3) Package Size • 4-4-2, 5-3-2, or 5-4-1 configurations

Controlled substances may be stored in one of three methods in the pharmacy

1) Stored in locked container 2) Dispersed throughout the pharmacy 3) Combination of 1 and 2 o No requirement for CII's to be locked up; they can be dispersed among inventory

Must substitute generic drugs unless

1) patient requests otherwise 2) prescriber mandates "Medically Necessary" or 3) drug is on negative formulary. o Must give patient right to refuse, inform patient of substitution and price difference o Must pass full savings on to patient Handwritten Rx-medically necessary handwritten Verbal Rx-expressly indicates medically necessary Electronic Rx-overt act indicates medically necessary

Fill out of state/ out of jurisdiction (country) prescriptions only

1) valid order 2) licensed prescriber in that state/jurisdiction and 3) for chronic or recurrent condition only.

How much does it cost to become a CE provider? What is the cost of providing just one program?

1. $150 2. $50

What are the initial requirements to becoming a consultant pharmacist?

1. 12 hours of coursework 2. 40 hours of hands-on training under a preceptor

What is the breakdown related to the members of the FL BOP?

1. 7 must be practicing RPh (minimum of 4 years) 2. 1 RPh in community, 1 in Class II institution 3. Remaining 2 members must be in no way connected to pharmacy 4. One member must be at least 60 years old

What if: 1. >2,000 Pounds/Plants (but <10,000 Pounds/Plants)? 2. >10,000 Pounds/Plants?

1. 7 years prison + $50 K 2. 15 years prison + $200K

Florida BOP Members 1. Total # of members? 2. # of Pharmacists? 3. # of each type of Pharmacist?

1. 9 2. 7 3. a) Community= 2 b) Hospital= 2 c) Any= 3

Trafficking Cannabis Punishments *Trafficking= Selling, Purchasing, Manufacturing, Delivering 1. Baseline for "Trafficking Cannabis" violation? 2. General punishment for any Trafficing Cannabis?

1. >25 (but <2,000) pounds OR >300 (but <2,000) plants--> 3 years prison + $25 K 2. FIRST Degree Felony

What are the CE rules for members of the military and their spouses?

1. Active duty, no requirements until 6 months after return 2. Spouses, exempt if due to military commitments

What is the formula to check DEA numbers?

1. Add 1st, 3rd, and 5th numbers together 2. Add 2nd, 4th, and 6th numbers together and double the result and add this to the first sum 3. Compare the number in the ones column of that result to the 7th number in the DEA number

What are the drugs an RPh can prescribe?

1. Any OTC 2. Any drug in the process of going to OTC status 3. Any drug containing an antihistamine or decongestant 4. Any drug containing fluoride 5. Any drug containing lindane 6. Topical anti-infectives (except ear/eye)

What is required of addicts under the age of 18 before long-term maintenance therapy is provided?

1. At least two failed attempts at short-term detox or drug-free periods 2. Parental consent

Butalbital containing drugs 1. Butalbital + APAP 2. Butalbital + APAP + Caffeine 3. Butalbital + APAP + Caffeine + Codeine 4. Butalbital + ASA 5. Butalbital + ASA + Caffeine + Codeine 6. Butalbital + Ergotamine + Caffeine + Belladonna

1. Axocet/Bucet/Bupap/Cephadyn/Dolgic/Phrenilin/Sedapop 2. Fioricet 3. Fioricet #3 with Codeine 4. Axotal 5. Fiorinal #3 with Codeine 6. Cafergot

Prescription Obesity Drugs in FL 1 of 2 criteria used to determine legitimacy of Rx for weight loss?

1. BMI (>30 or >27 + 1 co-morbidity) or 2. % body fat (>30% female; >25% male)

3 Unique C-IV in FL

1. Barbital 2. Carisoprodol (Soma) 3. Butorphanol

What are the requirements related to controlled substance inventories?

1. Be kept separate from other files 2. Be readily available 3. Be kept for a minimum of 2 years

Repackaged drugs must be labeled with (R-E-P-A-C-K 6 Requirement

1. Brand or generic name. 2. Strength. 3. Dosage form. 4. Name of the manufacturer. 5. Expiration date. 6. Lot number: a. Manufacturer's lot number, or b. Number assigned by the dispenser or repackager which references the manufacturer's lot number. o Prepacking in Class II pharmacy / Community pharmacy must follow documented procedures as set up be Consultant Pharmacist on Record / Prescription Department Manage

Repackaged drugs must be labeled with (R-E-P-A-C-K 6 Requirement

3Unique C-III in FL

1. Buprenorphine (Butrans) 2. Buprenorphine + Naloxone (Suboxone) 3. Dronabinol (Marinol)

C-IIIs 2 Barbiturates?

1. Butalbital 2. Butabarbital (Butisol)

When do newly licensed pharmacists have to renew their license and what is the cost?

1. By July 31st of the first odd-numbered year after licensure 2. Cost is $190

Counterfeit-Resistant Prescription Blanks in Florida 1. What are these Rx's intended to be written for? 2. T/F: DEA # of practitioner must be pre-printed? 3. T/F: Rx blanks like these CANNOT be transferred?

1. C-II to C-V 2. False 3. True

Originating Pharmacy responsibilities What must be written on the CS prescription before sent to the central fill pharmacy?

1. CENTRAL FILL (written on front) 2. Name + Address + DEA Registration # (of originating pharmacy 3. Name of PHARMACIST 4. Date of transmittal

Pharmacy Technicians Do/Dont's in FL 2 tasks a PharmTech cannot do?

1. Call to prescriber to CHANGE DIRECTIONS 2. Take verbal orders over the phone

Specific rules for Central Filling Pharmacies filling C-II and sending back to Original Pharmacy 5 unique pieces of information that must be AFFIXED to the package containing the C-II?

1. Central Fill Pharmacy DEA # 2. Prescription # 3. Patient Name 4. Prescriber Name 5. Cautionary Statement + Directions for Use

2 drugs on FL's Negative Drug Formulary that are ORAL dosage form specific?

1. Chlorpromazine (solid oral dosage) 2. Pancrelipase

C-III Opioids (amount/concentration dependent) 4 C-III opioids that CAN be C-III

1. Codeine (C-II straight; C-III cut in tablet; C-V cut in soln) 2. Dihydrocodeine (always cut with something) 3. Ethylmorphine (C-II straight; C-III cut in tablet; C-V cut in soln) 4. Morphine Hydrocodone? (any combination is now a C-II)

C-III Codeine 1. Maximum conc? 2. Maximum #?

1. Codeine 1800 mg/100 mL 2. Codeine 90 mg per tablet

Opioids combinations= C-III classification 1. Codeine 2. Dihydrocodeine 3. Morphine 4. Ethylmorphine 5. Hydrocodone?

1. Codeine-combination with less than or equal to: a) 1800mg per 100mL b) 90mg per dosage unit 2. Dihydrocodeine-combination with less than or equal to: a) 1800mg per 100mL b) 90mg per dosage unit 3. Morphine-combination with less than or equal to: 50mg per 100mL 4. Ethylmorphine-combination with less than or equal to: a) 300mg per 100mL b) 15mg per dosage unit 5. Hydrocodone-combination with less than or equal to: a) 300mg per 100mL b) 15mg per dosage unit

What are the criteria that would cause the FDA to investigate a compounding pharmacy for manufacturing?

1. Compounding massive quantities prior to receiving an Rx 2. Compounding drugs that have been removed from the market for safety reasons 3. Compounding drugs that do not contain FDA approved ingredients 4. Receiving, storing, or using drugs/ingredients that may have been adulterated by the supplier 5. Using commercial scale equipment to compound 6. Compounding drugs that are intended to be sold for resale 7. Compounding copies of FDA approved drugs

3 drugs that are listed without regard to dosage FORM?

1. Conjugated Estrogens 2. Dicumarol 3. DigiToxin (not Digoxin)

Prescriptions must be legible and contain the following

1. Date of issue (month spelled out) 2. Patient's full name 3. Patients address 4. Practitioner's name (species if controlled substance for an animal) 5. Practitioners address 6. Drug name 7. Drug strength 8. Dosage form 9. Quantity prescribed (in numeric and textual form) Number of refills (if any) authorized 10. Directions for use 11. Manual signature of prescribe

What are the drugs on the negative formulary?

1. Digitoxin 2. Conjugated estrogen 3. Dicumoral 4. Chlorpromazine 5. Theophylline 6. Levothyroxine 7. Pancrelipase

FL maintains a Negative drug formulary-

1. Digitoxin (note this is NOT digoxin) 2. Conjugated Estrogen (ie Premarin, Cenesta, Enjuvia) 3. Dicumarol (note this is NOT warfarin) 4. Solid Oral Dosages of Chlorpromazine (Can substitute syrup, injection, and suppository) 5. Controlled Release Theophylline (Can substitute immediate release formulations) 6. Oral Pancrelipase

FL maintains a Negative drug formulary- the following generic drugs cannot be substituted for a brand drug

DigiToxin 1. Replacement for? 2. Brand name?

1. Digoxin 2. Digitaline

C-III Dihydrocodeine 1. Maximum conc? 2. Maximum #?

1. Dihydrocodeine 1800 mg/100 mL 2. Dihydrocodeine 90 mg per tablet

What can a pharmacy tech NOT call a physicians office to clarify or change on a script?

1. Directions 2. Dosage

CV Only rules

1. Do NOT need to write the # in addition to the numerical notation

Name some classes of drugs that require patient inserts:

1. Estrogens 2. Progestational drugs 3. Oral contraceptives

C-III Ethylmorphine 1. Maximum conc? 2. Maximum #?

1. Ethylmorphine 300 mg/100mL 2. Ethylmorphine 15 mm per tab

When can a faxed C-II script serve as the original?

1. For an IV infusion 2. For a LTCF resident (NOT terminally ill patients...)

Name the C-Is

1. Heroin 2. LSD 3. Marijuana 4. Qualones

When is provider EXEMPT from inputting for Prescription Drug Monitoring Program?

1. Hospital/Nursing Home/Hospice/Dept of Corrections 2. Dispensing to a person UNDER the age of 16 3. Filling a Emergency Prescription

Newly licensed pharmacist 1. When would a newly licensed pharmacist be EXEMPT from CE hours? 2. How many CE hours needed if not exempt (therefore date of issuance is >/ 12 months from date of required RENEWAL

1. If the date of ISSUANCE of license is <12 months from date of Required RENEWAL 2. 15 hours

How would you classify a drug that does not meet imprint requirements?

1. Misbranded 2. Adulterated 3. Unapproved new drug

What rules are in place for dispensing non-legend controlled drugs?

1. Must be done by a RPh (can be rung up by non-RPh) 2. At least 18 years of age 3. Pt should be known to the RPh 4. Book with name/address should be maintained

What is required to appear on the label of a drug that is dispensed to a patient?

1. Name and address of dispenser 2. Rx number and date of its filling 3. Name of prescriber 4. Name of patient 5. Directions for use 6. Cautionary statements if necessary

All dispensed outpatient prescriptions must be LABELED/LABELING with the following

1. Name of pharmacy 2. Address of pharmacy 3. Date of dispensing. 4. Serial (prescription) number. 5. Name of the patient (or if the patient is an animal, the name of the owner and the species of animal) 6. Name of the prescriber. 7. Name of the drug dispensed (except where the prescribing practitioner specifically requests that the name to be withheld). 8. Directions for use. 9. Expiration date (FL uses a 1 year beyond-use date (discard aftyer date / do not use after date) from date filled or manufacturers expiration date if earlier) * note what is NOT REQUIRED on the label - patient address, date prescription was written, address of prescriber, quantity, dosage form, number of refills remaining, formulation, telephone number of the pharmacy.

All dispensed outpatient prescriptions must be LABELED/LABELING with the following (9/11) items

Controlled Substance Prescriptions for ANIMALS 2 unique criteria about CS Rx's for Veterinary purposes?

1. Name/Address of OWNER and 2. SPECIES of animal

What requirements are made of legible handwriting on Rxs?

1. No cursive, must be print or typewriting 2. Quantities in numbers and letters

What rules surround partial filling of C-IIs?

1. Notate amount supplied 2. Fill remainder within 72 hours or notify prescriber that you cannot 3. LTCF or hospice patients may get partial fills through 60 days from the date of prescription, they don't have to be finished in 72 hours

Controlled Substance Rx Requirements in FL (C-V?) 1. Quantity 2. Date

1. Numerical + Textual 2. 7/26/2015 or Jul 26 2015 or July 26 2015

Give some examples of mid-level practitioners:

1. Nurse practitioners 2. Midwife 3. PA 4. Anesthetic specialist

Class I Institutional Pharmacy 1. Example? 2. Primary limitation (vs. Clalss II)?

1. Nursinghome 2. CANNOT dispense medications internally

2 types of OTIC (ear) products Pharmacist can write for?

1. Otic Analgesics 2. Otic antibacterial/fungals

What are the requirements of a graduate of a non-US COP to get licensed in FL?

1. Pass the Test of English as a Foreign Language 2. Past the Test of Spoken English 3. Have 500 approved hours under a pharmacist

What are the two random C-IIs?

1. Pentobarb 2. Codeine

Who must witness the destruction of controls?

1. Pharmacist 2. DEA inspector OR Agency for Health Care Administration inspector OR Health and Rehabilitative Services inspector

What are the requirements surrounding emergency C-II prescriptions?

1. Pharmacist must immediately transfer to writing a verbal authorization 2. Amount is limited to that necessary to treat during time of emergency 3. RPh must attempt to verify identity of prescriber 4. Within 7 days a written Rx from the prescriber must be received or postmarked, if not the DEA should be notified

Who can samples be distributed to?

1. Practitioners who make a written request 2. Pharmacies at the written request of a practitioner

Who may communicate a new prescription to a pharmacist?

1. Prescriber 2. Prescribers agent 3. Employee of the prescriber

Only 2 things a PHARMACIST can add to a C-II to C-IV prescription (if missing)

1. Quantity 2. Date Written

What patients may have the 1 year minimum addiction clause waived by the director for entry in OTP?

1. Recently released inmates (6 months or less) 2. Pregnant patients 3. Recently treated patients (within 2 years)

Controlled prescriptions in Florida, Pharmacist must

12. Practitioners DEA registration 13. Initial the prescription 14. Write date filled 15. Note the prescription numbe

H2 Receptor Blockers Pharmacists Prescribing Max DAYS pt can take before calling MD (if sx persist)

14 days

What are the renewal fees for licensed pharmacists (not newly licensed) including renewal or inactive licenses and activation/deactivation of licenses?

1. Renewal of license- $245 2. Deactivation of license- $245 3. Reactivation of license- $70 3. Renewal of inactive license- $140

Destruction of Controlled Substances for Modified Class II Institutional Pharmacy 2 "options" for witnesses?

1. Rx Dept Manager or Consultant Pharmacist AND DEA Agent or 2. Rx Dept Manager or Consultant Pharmacist AND Medical Director OR Nursing Director OR Sworn LAW Officer

What sort of information must accompany an NDA?

1. Safety 2. Efficacy 3. Patent status

Which two drugs are animal control shelters allowed to obtain for euthanizing animals?

1. Sodium pentobarbitol 2. Sodium pentobarbitol with lidocaine

Dihydrocodeine combinations: 1. Dihydrocodeine + ASA + Caffeine 2. Dihydrocodeine + Chlorpheniramine + Phenylephrine 3. Dihydrocodeine + APAP + Caffeine

1. Synalgos-DC 2. Tusscough-DHC/Coldcough-PD/Novahistine-DH 3. Trezix

Chlorpromazine 1. Brand Name 2. Drug Class?

1. Thorazine 2. Typical Antipsychotic

2 examples of 3rd Degree Felonies associated with Drug Paraphernalia?

1. Transporting 2. Manufacture/Deliver= 3rd Degree Felony (if delivery to minor= 2nd Degree Felony)

When must you request permission to destroy controls?

1. When using an officer of the law 2. DEA Form 41 must be received by the DEA two weeks prior to the proposed date of destruction

What are the three ways a prescription may be authorized by a prescriber?

1. Writing 2. Verbally 3. Written or verbal refill

What are the primary objectives of HIPAA?

1.) Assure health insurance portability by eliminating job-lock due to pre-existing medical conditions 2.) Reduce healthcare fraud and abuse 3.) Enforce standards for health information 4.) Guarantee security and privacy and health information

What the the meaningful use components and what does it do for eligible professionals and hospitals?

1.) use of a certified EHR in a meaningful manner, such as e-prescribing (at least 50%) 2.) use of EHR for electronic exchange of health information to improve quality of healthcare 3.) use to submit clinical quality and other measures Provides incentive payments as they adopt, implement, upgrade or demonstrate meaningful use in their first year and demonstrate meaningful use for up to five remaining years

How much codeine may be present in a mixture for it to be considered a C-III?

1.8 grams per 100cc

How long after a change in consultant pharmacist of record does a LTCF have to notify the BOP?

10 days

How long after changing pharmacy managers does a pharmacy have to notify the BOP?

10 days

PDM Change How many DAYS in advance to inform the FL BOP that the PDM has changed?

10 days

How many hours of CE must be live?

10 per biennium

How long is Medicaid/Medicare record keeping

10 years

Medicaid / Medicare recordkeeping

10 years

How long must all prescriptions be maintained? How may they be maintained?

10 years... paper need to be kept for at least 3 years

Controlled Substances must also include:

10. Date of initial fill if a refill 11. Cautionary statement required under Federal Law (Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed

Controlled Substances Prescriptions must also include

Technicians

1:1 ratio default but may be increased with written approval for BOP Max with BOP approval was 3:1 but now 3:1 for sterile compounding, 4:1 for dispensing, 6:1 if not involved with sterile compounding or dispensing Must be registered and at least 17 years of age, provide proof of Board approved training program 20 hrs CE biennially: 4 live and 2 med errors Must wear visible badge and ID self as tech in all communications

Pharmacist to Technician RATIO in FL?

1:3 or 1:unlimited ???

Drug Paraphernalia--FL Laws *Most charges for Drug Paraphernalia are classified as?

1st Degree Misdemeanor Possession or Advertisement or Retail Sale (*2nd violation--> 3rd Degree Felony)

How many detox episodes may be attempted per year?

What are the CE requirements for pharmacists?

2 CE in medication errors, 2 CE controlled substances every renewal. 1 CE HIV on first renewal. 10 hours through live seminar, video teleconference, or interactive computer-based application every renewal. Can attend BOP meeting for 5 credits, 5 credits for volunteering for the indigent, and 5 credits for each professional credit post graduation.

How many days worth of phenazopyridine can a pharmacist prescribe?

2 days worth.

How long must controlled substance records be maintained?

2 years

How long must documents outlining CQI plans be kept?

2 years

How long should RPhs maintain their proof of CEs?

2 years

Max Percentage Topical Hydrocortisone Cream?

2.5%

How long after an investigation of a pharmacist licensed in another state begins does the pharmacist have to notify the FL BOP?

20 days

What are the CE requirements of a pharmacy technician?

20 hours of CE every 2 years, with 4 live CE and 2 hours of medication errors.

How long is a patent term?

20 years for a new drug, or indication

How much of a compounded product may be a controlled substance without the pharmacy having to register as a manufacturer?

20%

What percentage can a pharmacy compound without having to register as a manufacturer?

20%

How many internship hours must an applicant have to gain an RPh license in FL?

2080

What length of time is referred to as a maintenance treatment period in an opioid treatment program?

21 days

How long does a pharmacist have to record a quality related event?

24 hours

How long does a pharmacy have to produce drug records when asked?

24 hours

How many extra CE hours must consultants get?

24 hours

How many extra CE hours must nuclear pharmacists get?

24 hours

Class II Institutional Pharmacy (aka Hospital) Day supply of drug that can be DISPENSED outpatient (only if pt is discharged from the ER)?

24-hour supply *Remember, Class II Institutional Pharmacies can typically only dispense INPATIENT

Maximum amount (mg) Fluoride that a pharmacist may ORDER AT ONE TIME?

264 mg

How many CE hours are required in order to be licensed to order and interpret lab tests?

3 initially, 1 after that

How long do records of distribution of samples have to be kept?

3 years

How long is the DEA registration for dispensers effective?

3 years

3 MAXIMUMS to remember regarding Sudafed in FL?

3-3.6-9 3--> 3 PACKAGES per individual SALE 3.6--> 3.6 grams per DAY 9--> 9 grams per MONTH

What are the quantity limits for purchasing pseudoephedrine from a pharmacy and through mail order?

3.6g per person per day; no more than 9g per person per month; no more than 7.5g per person per month through mail order pharmacies.

What are the CE requirements for all pharmacists

30 hours ACPE approved CE every 2 years First time renewal to include 1 hr HIV/AIDS, Each renewal 2 hours of Med errors 10-30 hours live seminar; if renewal is <12 months after licensure no CE required; between 12 and 24 month 15 hours

Continuing Education Requirements (all pharmacists

30 hours ACPE approved CE every two years (30 CE credits = 3 CEU) o First time renewal to include 1 hr HIV/AIDS (FL), Each renewal 2 hours Medication Errors

CE Hours Normal # of CE hours needed to renew license?

30 hours BIENNIALLY (q 2 yrs)

What is the max first dose of methadone in an OTP?

30mg, 40mg for the day

Maximum DAY supply that a Pharmacist can ORDER prescription drugs for patient?

34-day supply

How much CE credits required to order labs?

3hrs CE.

How many tiers are there in Medicare Part D?

4 Tiers and copay may change if a drug changes tiers Tier 1: Least Expensive 90.9% of hight severity meds on Beers Criteria Tier 2: Preferred Brand Tier 3: Non-Preferred Brand Tier 4: Rarer, high cost drugs

What is the quantity limit on dispensing a controlled non-prescription product other than opium?

4 oz in 48 hours

How long are controlled records kept

4 years

How long are the terms for the members of the FL BOP?

4 years

Recordkeeping How long do the following records need to be kept for? - Original Prescriptions (or Electronic) - Logbook signed by Pharmacists verifying correctness?

4 years! (increased from 2 years)

What are the weekly requirements for hours of operation for community pharmacies?

5 days, 40 hours

How many hours of CE can you get for attending a board meeting?

5 hours in risk management

What is the maximum acceptable medication error rate that may be found at a LTCF?

What percentage can a pharmacy distribute to other pharmacies without having to register as a distributer?

C-III Morphine Maximum concentration?

50 mg/100 mL/grams

Medical Center Pharmacy v. Mukasey 2008

5th Circuit court appeals rules...Statute (NDA) severable Compounded drugs not uniformly subject to or exempt from NDA requirement

Total # of drugs on FL's Negative Drug Formulary?

How many days worth of drug can Florida pharmacist prescribe a mild analgesic?

6 days worth.

What are the hours of operation for mail-order pharmacies?

6 days, 40 hours, toll-free number available

Any cancer drug with an EXPIRATION DATE within [] cannot be accepted by the program?

6 months

After what period of time does an unfilled DEA Form 222 become invalid if a distributer can't supply it?

60 days

Audit Rights

7 day advanced calendar notice Not allowed during first three days of the month without Pharmacist's consent o Limited to 24 months after claim is submitted o Audit that requires professional judgment must be conducted by a pharmacist o Audit may be reviewed, corrected by pharmacy

Audit Rights

7 day calendar notice; not allowed during the first 3 days of the month w/o pharmacist's consent

Florida's Prescription Drug Monitoring database How many days does pharmacy have to INPUT the dispensing of a controlled subtance?

7 days

What is the maximum amount of time a prescription can be written for administration to a patient for the relaxed labeling rules to apply?

7 days

Drugs that Pharmacists can WRITE for in Florida

Analgesics Nausea Antihistamines/Decongestants (> 6yo) Decongestants Antibacterial, fungal, viral Keratolytics Vitamins Shampoo Acne H2 ANADAKVSAH

Which practitioners are NEVER able to prescribe?

Anesthesiologist Assistants, Doctors of Oriental Medicine, Nurses, Respiratory Therapists, Psychologists

How frequently do manufacturers have to inventory the samples they've given out?

Annually

How often do manufacturers and distributers have to renew their controlled substance licenses?

Annually

How often must pharmacies be inspected?

Annually

How many drug tests per year are required at OTPs?

How many members are on the FL BOP?

The BOP is composed of

9 members appointed by the Governor and confirmed by the State 7 licensed pharmacists ( state res, practice for at least 4 yrs, at least 1 at least 60 y/o) 2 community pharmacy 2 Class II (hospital) 3 open requirement 2 community members

What percentage of adults should be able to open manufactured drug vials?

90%

Pharmacy Access Requirement

90% of urban patients must live within 2 miles of a participating pharmacy 90% suburban within 5 miles 70% rural within 15 miles helps bring pharmacy to rural areas

Fluoride and Pharmacists in FL Amount of Fluoride in H20 must be LESS THAN ___ in order for pharmacist to write for Fluoride drug?

<0.5 ppm fluoride

How long after dispensing an emergency supply of medication does a pharmacist have to notify the prescriber of this action?

A "reasonable time"

The process of determining if a drug is GRASE is left up to who?

A group of experts qualified by training and experience

How many clinical trials are required by the FDA to prove a new drug is safe?

A minimum of 2

DEA numbers for practitioners/dispensers always begin with:

A or B

What is a "B product" in the Orange Book?

A product that does not have a bioequivalent

What signs must be hung in pharmacies?

A sign regarding generic substitutions. For Medicaid providers must have 2 signs: 1 that informs patients of a toll-free number to call if their prescription is denied, and "Important Information About Your Florida Medicaid Prescription Drug Benefits Sign." Also 1 inch block lettering of pharmacy hours by door or pharmacy area, a sign designating a patient consultation area, and 2 inch block lettering that says "Prescription Department Closed" during off hours.

What is an ANDA?

Abbreviated New Drug Application... requires only that a manufacturer of a generic prove only bioequivalence

What do you call a prescription that is written for a control outside of the acceptable use of medical practice?

An order purporting to be a prescription

List 2 Chemicals - solvents used in the manufacture of a controlled substance

Acetone, HCl, K/NA-Permanganate

What is API?

Active Pharmaceutical Ingredients ... The raw chemical drug formulation used to make the medication. eg Methotrexate is the finished product but what bulk drug substances did you use to make it?

FL Medicaid

Administered by Agency for Health Care Administration Eligibility determined by DCF OR SSA

Who administers Medicaid?

Administered by each state but subject to federal approval and regulation under CMS

If a drug is not in tamper-proof packaging, what violation is this considered? What if it is manufactured without cGMP?

Adulteration for both.

1938 Federal Food Drug and Cosmetic Act

Adulteration- may be gross/filthy/no follow-cGMP (Think INSIDE the pill) Misbranded- improperly labeled, not FDA registered establishment, no follow REMS/PPPA, improper advertising (Think OUTSIDE the bottle)

21 CFR 202.1 Drug Advertising and Promotion

Advertising protected under the first amendment but as commercial speech therefore: No false or misleading statements Must be fair and balanced Must disclose material facts

DEA form 224b

Affidavit for Chain Renewal

How often must an out-of-state pharmacy sterile compounding be inspected to ship drugs into Florida?

After 6 months initially and then yearly.

Standards for the Prescription of Obesity Drugs

All Prescriptions for weight loss drugs must be in writing signed by the prescribing physician. Initial prescriptions may not be called into the pharmacy. Refills may be phoned in. Physician must meet personally with patient and may only prescribe FDA approved drugs.

Standards for the Prescription of Obesity Drugs

Where do copies of DEA Form 41 go?

All copies go to the DEA

Which drugs require a patient package insert to be provided with them?

All estrogens and oral contraceptives. PPI is given with each prescription if outpatient and with initial dose + every 30 days if inpatient. Other products may voluntarily seek approval to provide PPI to patients.

What drugs can dispensing practitioners dispense?

All except C2 and C3 drugs, unless methadone or a surgical procedure per the 3 day rule.

Describe Class I institutional pharmacies:

All meds are administered, no dispensing

Common databases are permitted in Fl

All pharmacies accessing must be properly licensed and under common ownership Must maintain record of all pharmacist activity When filling rx from one location in another using common database you are refilling not transferring

2000 Drug Additction Treatment Act (DATA 2000)

Allows authorized physicians to treat drug addiction with buprenorphine (Subutex/Subuxone) in office-based practice whereby pharmacist dispense drugs o 100 patient limit per physician year one (275 patients thereafter) • Authorized physician unique provider number staring with X • Treatment requires completion of a number of FDA Forms (patient consent, responsibility statement, application for approval of use)

1994 Dietary Supplement Health and Education Act

Allows dietary supplements to be categorized as food

1996 FDA Export Reform and Enhancement Act

Allows export of FDA approved drugs if labeled

What is the purpose of the IND Exemption?

Allows for interstate transport of investigational new drugs for purposes of studies

1951 Durham-Humphrey Labeling Amendments to FDCA

Allows refills of prescription Establishes Rx and OTC drug categories

Which practitioners are unable to prescribe?

Chiropractors, Pharmacists, Naturopaths (may still have some narrow allowances under the statute)

What is a unique non-requirement for licensure as a pharmacist?

Citizenship

List 1 Chemicals - drugs involved in the manufacture of a controlled substance

Ephedrine, Pseudoephedrine, Ergonovine, Iodine, Sasfrole, Piperidine

e SLCPS - Schedule listed Chemical products: used in manufacture of Meth

Ephedrine, pseudoephedrine, phenlypropanolamine

Only difference between a Class II and Class II Modified

Class II Modified Institutional pharmacies are located in short-term/primary care centers that do NOT satisfy Space/Equipment standards

Which class of medical device requires premarketing approval?

Class III

How can the central filling pharmacy be written on the label?

Code

C-V Codeine Maximum conc?

Codeine 200 mg/100 mL

Pharmacist must create a record and contact the physician as soon as possible

Essentially any drug other than a CII can be refilled as law is written.

Is it legal for retail pharmacies to have samples?

Essentially, NO

What are the duties of the Prescription Drug Manager?

CQI programs, record keeping, automation, closing, inspection, compliance with laws, and the number of locations.

Describe the rules associated with expiration dates on repackaged medications

Can be either 12 months from date of repackaging or the manufacturers expiration date, whichever is lesser

Define labeling:

Can be written, printed or graphic matter and can either be upon the immediate container of an article or accompanying an article

What are the conditions for a pharmacist ordering a fluoride drug for a patient?

Can order 1 year's worth of fluoride, not switching between brands, and only if fluoride is not in the water.

How long are prescriptions are valid in Florida?

Florida prescriptions expire in one year o CIII-CV expire in 6 months per Controlled Substance Law

Can midlevel practitioners prescribe in Florida?

Florida licensed midlevel practitioners can prescribe non-controlled substances, but cannot prescribe controls until Jan. 1 2017. An out of state DEA licensed midlevel practitioner can write for a controlled substance if "necessary for the continuation of treatment of a chronic or recurring illness."

COMPOUNDED prescriptions have specific recordkeeping requirements

Date of compounding, traceable control number, complete formula maintained in a readily accessible format, pharmacist / technician signature or initials, manufacturer of materials used, quantity in units of finished product, package size and number of units prepared and name of the patient who received the particular compounded product

Record Keeping for compounded prescriptions

Date of compounding, traceable control number, complete formula maintained in a readily accessible format, pharmacist/tech signature or initials, manufacturer of materials used, quantity in units of finished product, package size and number of units prepared and patient name

What is the main caveat applied to partial filling C-III through C-V?

Each partial fill counts as a refill, max of 5

general permit

Each pharmacy is typically granted only a single permit

What about PDM OR Consultant of Record?

Each pharmacy must name a PDM or Consultant of Record and must notify the board of any change. If you leave a job or sell your business but do not notify the board you can be held liable even though you were not involved

Community pharmacy (Independent/Chain)

Each store must have its own permit Must have a prescription drug manager of record named

Different prescriptions required for different drug classes/scheduled.

Cannot prescribe drugs from different schedules on same prescription blank Controlled substance prescriptions require counterfeit-resistant, vendor-approved blanks o Veterinary drugs exempt from requirement to use counterfeit-resistant pads

refill if prescriber unavailable, including controlled substances

Florida permits a one-time 72 hr emergency

ABC Required: for usp 797

Anteroom (ISO 8 or better [lower]), Buffer Room (ISO 7 or better)/Compounding Room (ISO 5 or better involving uni-directional HEPA-filtered air). Lower the ISO, the more sterile the area. Facilities must be tested twice a year minimum for sterility and air particle count o Chemotherapy must be compounded in a dedicated hood

What ISO levels must the anteroom, buffer room, and compounding room be rated as?

Anteroom is ISO 8 or lower, Buffer room ISO 7 or lower, and compounding room ISO 5 or lower.

Recall: Drugs written by Pharmacists with AGE limit?

Antihistamines + Decongestants (6 years old)

At what dosage does the FDA expect reporting of a serious, unexpected adverse effect of a drug?

Any dose

not permitted to be included on FL's Negative Drug Formulary

Any drug that has all A-rated generics

Nonresident Pharmacy Permit (Mail Order)

Any out of state pharmacy that ships, mails, delivers, or advertises it fills prescription medications to patients in FL must register as a nonresident pharmacy o Must always maintain an active pharmacy license and DEA registration if dispensing controls

Nonresident Pharmacy Permit

Any out of state pharmacy that ships, mails, delivers, or advertises it fills prescription meds to patients in FL must register as a nonresident pharmacy Must be open at least six days a week and 40 hours a week and maintain a toll-free telephone number that is listed on the label of each prescription bottle filled

DEA form224c

Application for Modification of Registration for Online Pharmacies

FDA-2632 (form):

Application for approval of use of detox drugs in a treatment program

What is the official title of the "Orange Book"?

Approved Drug Products with Therapeutic Equivalence Evaluation

How often do pharmacies have to renews their controlled substance licenses?

At least every 3 years

How often must a backup pharmacy record keeping system be updated?

At least weekly.

(Antitrust) Tactics of Industry

Authorized generics; Brand in a Bottle--> undermines 180 d exclusivity. ex Pfizer and Greenstone Product hopping/switching; altered formulation not therapeutically equivalent Reverse Payments; payments to generic company not to market Sham litigation; baseless filings to delay entry Filing "inequitable" patent application

Preventing HIPAA violations

Avoid discussing patients in elevators, hallways and in the cafeteria Patients charts should not be left where others can read them Counsel patients in a private area

For medications that pharmacists can prescribe, in what situations can they not prescribe them?

Cannot prescribe injectables, or to pregnant or nursing mothers.

Evergreening Stragegies

Changing formulations, routes of admin, stereoselectivity and or indications, or switching to OTC.

2012 Generic Drug User Fee Act (GDUFA)

Charges Fees for Generic Rug manufacturers for ANDA and to market generally

Hatch-Waxman Act 1984 Drug Price Competition and Patent Term Restoration Act

Balanced patent protection for innovator drugs with increasing availability of generic drugs Went from only 19% generics in 84 to >80% today

Sale of Syringes

Based on city/county ordinances which vary from Rx to OTC Must never sell syringes to a minor w/o rx under FL Law

Prescriptions may be compounded in FL pharmacy

Based on routine, regularly observed prescribing patterns and med should not be commercially available

What time of day should inventories be done?

Before open or after close (not during business hours)

Define Waste

Behavior or conduct that results in the use of more resources than needed

Schedule 4

Benzodiazepines, Sonata, Lunesta, Soma, Tramadol

Expiration Date vs. Beyond Use Date

Beyond-Use Date is ALWAYS 1 year from date of dispensing UNLESS the Expiration Date (set by the manufacturer) is <1 year

Controlled Substance Inventory How often?

Biennial (+/- 6 months from last inventory)

1944 Public Health Service Act (PHSA)

Biologic drugs approved under a BLA (not an NDA)

64B16-27.831

Board of Pharmacy: Dispensing controlled substances in FL for Pain

Who enforces antitrust laws?

Both Federal and State

Which pharmacy must be printed on the Rx Label?

Both Pharmacies (Originating + Central)

Who is monitored?

Both Pharmacist and Prescribers

Repackaged drugs must be labeled with (R-E-P-A-C-K 6 Requirements)

Brand or generic name Strength Dosage form Name of the manufacturer Expiration Date Lot number

What types of competition are in the pharmaceutical industry?

Brand-Brand Brand-Generic Generic-Generic

Schedule 3

Buprenorphine, Anabolic Steroids - Oxandrin, Testosterone, ketamine, Didrex, Suboxone, Tylenol w/ Codeine, Fiorinal, (Fioricet is non-controlled, but scheduled III in Florida)

What does the DEA require of records for controlled drugs compared to non-controlled?

C-I and C-II should be separate, and C-III through C-V should either be separate or readily accessible

Which Control(s) limit dispensing to a 30-day supply if taken over-the-phone?

C-IIIs--> limited to 30-day supply dispensed

What are the inventory requirements for C1-C5 drugs in terms of quantity records?

C1-C2 must always have an exact count. C3-C5 can be estimated counts unless the bottles contain >1000 units, in which case an exact count is necessary. C2 inventory must be kept separate from C3-C5.

What are the storage requirements for C1-C4 medications?

C2-C4 can be locked in a safe, dispersed throughout the pharmacy, or a mixture of both. C1 must be stored in a cabinet anchored to the wall or floor.

Martin Shkreli

CEO of Turning Pharmaceuticals.. purchased marketing rights Daraprim for HIV from Impax ...no generic competition so raised price by 5455% Perfectly legal although may not be ethical

What is manufacturing?

Commercial preparation of a pharmaceutical for widespread use.

What do antitrust laws protect?

Competition, keeps market competitive

Impaired Practitioners (Drugs/Alcohol/Mental/Physical (DAMP) condition

Complaints involving DAMP impairment will not be subject to disciplinary action (ie loss of licensure) if the Probable Cause Panel/Board of Pharmacy (PCP/BOP) determines the pharmacist, working with a state-approved impairment consultant: o Acknowledges the impairment o Voluntarily enrolls in an approved-treatment program o Withdrawals or limits scope of practice as determined by consultant o Makes available pertinent medical records to consultant Upon fulfilling the requirements of the program, the pharmacist may return back to practice unrestricted as long as no other complaints have been filed. o No practice while in program Pharmacist pays own expenses If there is no complaint a pharmacist may still join the program without oversight by PCP or BOP. Must withdraw from practice If pharmacist does not comply with the program, such facts will be disclosed to the board for action (ie suspension, etc...)

What are the requirements to become a consultant pharmacist?

Completion of a consultant pharmacist course of 12 hours, a 40hr clerkship over 3 consecutive months within 1 year of the course, 60% of which must occur at the institution holding the pharmacy permit. Must obtain 24hrs CE every 2 years in addition to required 30hrs.

FL Board of Pharmacy

Composed of 9 members, appointed by the Governor, confirmed by the Senate o 7 licensed pharmacist members, state residents, representative of various practice settings, in practice for at least 4 years, at least 1 member must be at least 60 years of age 2 Community pharmacy representative 2 Class II institutional Pharmacy /Modified Class II 3 members open requirement o 2 community members, state residents, not pharmacists, no connection to the profession, drug wholesales or pharmaceutical manufactures

board of pharmacy-part I

Which medication is listed on the FL negative formulary without regard to dosage form?

Conjugated estrogen

FDA-2635 (form):

Consent to treatment with an approved narcotic drug

Class I vs. Class II vs. Modified Class II Institutional Pharmacies All Institutional Pharmacies must be under who's supervision?

Consultant Pharmacist

Pharmacist and labs

Consulting RPH or Pharm D may order labs Consultant must receive 3 hours of CE relating to lab and clinical testing as established by the board.

Who enforces the PPPA?

Consumer Products Safety Commission (CPSC)

When are controlled substances dispensed not reported to E-Forsce.

Controlled substances dispensed in hospitals, nursing homes, correctional facilities, ambulatory surgical centers, hospice, ICD-FFs, emergency rooms, one-time doses, 72-hour emergency fills, children <16yo, and drugs directly administered to patient by doctor.

What types of drugs can Florida pharmacies not advertise about?

Controlled substances, non-FDA approved indications, or drugs for mental alertness, energy, weight loss, stimulation, or appetite control.

What do OTC monographs do?

Covers classes of drugs and identifies ingredients that are allowed to be included in OTC products... much more efficient than an NDA which is the other way to bring an OTC to market

Which form is required for animal shelters to purchase euthanization drugs?

DEA Form 222

Which form is used to transfer controlled substances?

DEA Form 222

What form is used to order the form that is used to order controls?

DEA Form 222a

Which form is used for destruction of controls?

DEA Form 41

Destruction of Controlled Substances--depends on the type of facility Modified Class II Institutional Pharmacy vs. Institutional Class I Nursing Home (i.e. LTCF) Big difference between the two?

DEA Form 41 is NOT required for Nursing Homes

What form is required if controlled substances are destroyed?

DEA form 41. Witnessed and signed by PDM and Department inspector (no DEA prior approval required), or two licensed individuals. Form must be mailed to DEA at least 2 weeks before proposed date and approved by them. Also may use DEA reverse distributors for 222/41 respectively

What signs must you have?

Daily operating hours- in block letters at least 1 inch in unobstructed view either on the front door or by the pharmacy Sign that indicates "Patient Consultation Area" or something equivalent-- no size requirement Sign indicating pharmacy closed- Block letters and at least 2 inches. States exactly "Pharmacy Department Closed" Don't forgot the generic sub

What are technicians are allowed to do?

Data entry, labeling, counting, initiate communication to confirm pt info and med info and can initiate communication with prescriber to obtain clarification on missing or illegible dates, name, brand or generic preference, quantity, license number or DEA May receive refill auth

Biennial complete and accurate inventory

Date may vary by no more than 6 months from the biennial date that would otherwise apply

Physician Assistants (PA), Nurse Practitioners (ARNP)

Effective January 1st 2017 may prescribe controlled substances 7 day max CII narcotics

What must be on the label of a Customized Patient Medication Package (CPMP)?

Day and time each dose is taken, serial number of the CPMP itself and of each drug, the drug name, strength, physical description, total quantity of each drug, name of prescriber for each drug, directions for use, cautionary statements for each drug, date of preparation, expiration date (60 days unless drug expiring sooner), the dispensing pharmacy's name, address, and telephone number, and any other warnings.

Technicians: Pharmacist Ratio

Default 1:1 ratio • Up to 3:1 ratio allowed for sterile compounding • Up to 4:1 ratio allowed for dispensing • Up to 6:1 ratio allowed if not involving with sterile compounding or dispensing Must be registered

HIPAA Limits Marketing

Defines marketing and includes exceptions for certain treatment or health care operations activities. Requires individual authorization for all uses or disclosure of PHI for marketing purposes with limited exceptions

Who do you notify if you believe a prescriber is involved in diversion?

Dept of Health

What types of drugs do not require tamper resistant packaging?

Dermatologics, dentrifices, insulin, throat lozenges, prescriptions dispensed by pharmacists, hospital medications, and any product with the statement "this package for households without young children," or "package not child resistant for small packages."

What meds are on the negative formulary?

Digitoxin, Conjugated Estrogen, Dicumarol, Solid Oral Dosages of Chlorpromazine, Controlled Release Theophylline, Oral Pancrelipase Any drug that has all A-rated generics are not permitted to be included on FL's Negative Drug Formulary

C-V Dihydrocodeine Maximum conc?

Dihydrocodeine 100 mg/100 mL

Schedule 2

Dilaudid, Demerol, Oxycontin, Sublimaze, Dexedrine, Ritalin, Vicodin (hydrocodone with APA), Pentobarbital, MS Contin, Codeine straight, Amphetanine, Tylox, Codeine, Hydrocodone straight, Cocaine, PCP0

AntiHISTAMINES (gen 1) Pharmacists can write for?

Diphenhydramine (Benadryl/Sominex/Unisom) Brompheniramine (Dimetapp) Dexchlorpheniramine (Polaramine) Carbinoxamine (Clistin) Pyrilamine

Exceptions to Minimum Necessary Requirements

Disclosure to/for -requested by healthcare provider for treatment -subject individual or representative -pursuant to authorization -required by law

Florida Prescription Drug Monitoring Program of Controlled Substances

Dispensing CII-CIV drugs are reported to the States Prescription Drug Monitoring Program Pharmacist dispensing of controls monitored; as well as physician prescribing of controls o Attempts to minimize diversion of controlled substances

Describe Class II institutional pharmacies:

Dispensing and administration of drugs may occur

893.04 Law (criminal)

Dispensing of controlled meds

o Taking Transfer/Copy

Dispensing pharmacist must tell patient the prescription at other pharmacy is now cancelled, establish legitimate prescription with valid refill(s) (including pharmacy/pharmacist is licensed), record the prescription, the name of the copying pharmacy, the prescription number, the drug, the original amount dispensed, the date of original dispensing, and number of remaining refills

Taking Transfer/Copy

What information is reported to E-Forsce when a controlled substance is dispensed?

Doctor's name and DEA number, pharmacy's name address and DEA number, name address and DOB of patient, name strength and quantity of the drug, date prescription was written and date filled, method of payment, and drug's NDC.

DEA Form 41

Document disposal and destruction of scheduled drugs

Known whistleblowers

Doug Durrand TAP Vice President of Sales Jennifer Buth formerly Denk- PharMerica

FL Medicaid Pain meds limits

Effective June 2, 2010 Max on CII scripts -Oncology and sickle cell 6 per month Effective August 3, 2010 CIII-IV -Max 4 per 30 days

When can a drug be considered adulterated?

Either when actually found to be adulterated or when found to be POSSIBLY adulterated (poor storage conditions, etc.)

Medicare

Enacted by federal government in 1965 to reduce health care costs for individuals over 65 and for certain diabilities Part A- Hospital Part B- Out patient medical insurance Pard C-Managed Care-Medical advantage (A and B)

2007 FDA Amendments Act

Drug laws focused on drug safety

Breakage, damage, spillage of recoverable or destruction of controlled substances must be reported to DEA on a DEA Form 41 (Registrants Inventory of Drugs Surrendered).

Drug may also be disposed of through shipment to a reverse distributor o Any drug spilled/broken/damaged non-recoverable, pharmacist must document the circumstances of the breakage in their inventory records. Two individuals who witnessed the breakage must sign the inventory records, indicating what they witne

Medicare formulary

Drug must be for medically accepted indication Investigational not covered and off-label may not be covered 60 day notice required for formulary change Med with new BB Warning can be removed anytime

What must be included on a prescription for a controlled substance?

Drug name, address of patient, name of patient, prescriber name, address of prescriber, date written, strength of drug, form of drug, amount of drug, refills, sig, signature of prescriber, fill date, initials of pharmacist, prescription number, DEA number of prescriber.

What must be included on a non-controlled prescription?

Drug name, address of patient, name of patient, prescriber name, address of prescriber, date written, strength of drug, form of drug, amount of drug, refills, sig, signature of prescriber.

Pedigree Papers

Drug wholesaler must provide a pedigree paper Not for veterinary or drop ship

n emergency medication kit for residents

Drugs selection determined by Medical Director, Director of Nursing and Pharmacist. Must have written policies and procedures for use.

What are legend drugs?

Drugs that are unsafe to be used without medical supervision... prescription drugs

What is the control program called?

E-FORSCE- must repost within 7 days of dispensing Compounded Controls are reportable in the database

Pedigree Papers

Each drug wholesaler of prescription drugs must provide a pedigree paper to the person who receives the drug o Pharmacy and Wholesaler maintain copies Often wholesaler maintains pharmacy's copies as well - which is fine o No pedigree papers for veterinary drugs and drop shipments

Omnibus Budget Reconciliation Act of 1990 (OBRA 90)

Established expanded standard of pharmacy practice -Ex must offer to counsel patients States required to adopt to continue to receive funds under Medicaid Manufacturers required to provide best price to Medicaid through rebates Pharmacies required to maintain a DUR program and to conduct reviews on all Medicaid rxs dispensed Required investigation to determine whether the DUR requirements improve patient care and decrease costs

What must be in place in order for a Pharmacist to give the 4 vaccinations?

Established protocol under the supervision of a physician

What does HIPAA cover?

Established standards for electronic health care transaction and unique identifiers and security and privacy rules

2010 Biologics Price Competition and Innovation Act

Establishes a generic approval pathway for biologics (BLA);

1984 Hatch-Waxman Amendment to FDCA- aka Drug Price Competition and Patent-Term Restoration

Establishes an abbreviated drug approval process for generic drugs (ANDA) based on bioequivalence

C-V Ethylmorphine Maximum conc?

Ethymorphine 100 mg/100mL

How often are licenses renewed?

Every 2 years

How often are scheduled drugs revised and updated?

Every 2 years

How often does inventory of controlled substances need to be performed?

Every 2 years

How often must controlled substances be inventoried and how long should those records be kept?

Every 2 years and inventory record must be maintained for 2 years.

How often must pharmacy permits be renewed?

Every 2 years.

Checking for EXPIRED Medications q _ MONTHS must a pharmacy check for EXPIRED medications?

Every 4 months

How often do BUD checks need to occur?

Every 4 months

How often are sterile compounding rooms tested for sterility and particle count?

Every 6 months.

When do pharmacy permits expire?

Every odd year on February 28.

1991 FDA Modernization Act

Exempted compounded medications from NDA requirements of FDCA

How bioequivalent do generics have to be?

Extremely close, they may vary in rate and extent of absorption, but not by much. They must be bioequivalent for the most part and have the same dosage form as the brand

The Pediatric Rule (the carrot)

FDA allows manufacturer to submit a pediatric study of a brand drug in return for six month of add-on exclusivity

What is the Bad Ad Program

FDA sponsored outreach program launched May 2010. Educates health care providers... seeks providers to identify and report advertising violation

Who regulates the pharmaceutical industry?

FTC Bureau of Competition, Health Care Services and Products Division

What happens when mergers cause monopolization and price increases?

FTC investigates and may seek to disgorge company of profits or force divestment of a product

What are the penalties for HIPAA violations?

Failure to comply with any electronic data, security, or privacy standards can result in Civil monetary up to $25,000 per standard per year-- $100 for inappropriate disclosure Violation of privacy regulations for commercial or malicious purposes can result in criminal penalties of $50,000 - $250,000 in fines and 1 to 10 years imprisonment

T/F: If a pharmacist is a PDM of more than one pharmacy, the pharmacies must be under the same ownership

False

T/F: Pharmacy Interns can write prescriptions for patients

False

T/F: Central Fill Pharmacy MUST be under the same ownership as the original pharmacy?

False (As long as a written contract is created)

T/F: CS' can be prescribed via telemedicine

False (remember, need at least one in person visit)

T/F: All retail pharmacies selling sudafed MUST use an electronic system?

False, BUT the pharmacy must REQUEST EXEMPTION*

Emergency C-II Prescription Federal vs. Florida (stricter)

Federal= Supply as much as is needed for emergency FL= maximum 72-hour supply

180 D Generic Exclusivity

First company to file and approved ANDA receives 180 days marketing exclusivity

Pharmacist SUSPICION of diversion of CS for PAIN Who MUST the Pharmacist report to (per FL law)?

Florida Dept of HEALTH

Pharmacy may use reverse distributor to dispose controlled substances

For schedule II controlled substances, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the pharmacy. o For schedules III-V controlled substances pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred.

Pharmacy must maintain patient records and they must be immediately retrievable

Full name, address, and telephone number, age or date of birth, and gender, list of all new and refill prescriptions over preceding four years, pharmacist clinical comments Must make reasonable efforts to obtain allergies, chronic diseases, and current medications o Hard copy or a computerized record must be maintained for at least Four years

Product liability and drugs

General rule: Sellers of defective products responsible.. ex Walmart and beach chair Drugs considered unavoidably unsafe -- must have proper directions and warnings about known side effects -- manufacturers/vendors liable for failure to warn or misinformation -- pharmacists/manufacturers not liable for harm ex Vioxx liability for failure to warn of known effects

Rule of 3

Generally, the quantities are evenly divisible by 3 (not typically morphine and opium) Codeine 90 mg dose (or <1.8 g / 100 ml), Hydrocodone 15 mg dose (or < 300 mg/ 100 ml)

Rule of Five

Generally, the quantities are evenly divisible by 5 <200 mg codeine/ 100 ml, <100 mg opium/ 100 ml, <2.5 mg diphenoxylate

Rules to keep in mind

Generic name must be listed and should be 1/2 the font size or larger. Violations of advertising rules considered misbranding

Pediatric Equity Act (the stick)

Gives FDA the Authority to require pediatric studies of FDA approved drugs for labeled indications Applies only -- drug likely to be used in substantial number of pts Requires manufacturers to submit "Pediatric Assessment" with all NDAs

Acknowledgment of Notice

Good faith effort to obtain written acknowledgement of receipt Signed acknowledgement is not required each time a prescription is dispensed

Who appoints members of the FL BOP?

Governor

2009 Family Smoking Prevention and Tobacco Act

Grants limited authority to FDA involving tobacco (from ATF)

What does HIPAA protect?

HIPAA protects individually identifiable health information We can disclose Minimum necessary information

computerized record of controlled substance prescriptions dispensed

Hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by authorized law enforcement o Date / Patient name and address (+ species) / Drug name and Quantity

If a pharmacy employee became aware of diversion among other employees, who would he or she report this activity to?

Head of security of the pharmacy

HIPAA

Health Insurance Portability and Accountability Act Provides federal protections for individually identifiable health information held by covered entities and their business associated -NSU not a covered entity but the clinic is Enacted by congress in 1996

Who are covered entities?

Health plans, clearing house and health care providers

Categories of Direct to Consumer Advertising

Help-Seeker/Disease oriented --> See your MD if you have this disease Reminder --> Flash of drug and indication Product claim/indication -->goes in to much more depth, has drug effect and disclaimer

Cancer Drug Donation Program

Hospital must complete and submit a Notice of Participation form o May charge the recipient of the drug or supply a handling fee of no more than 300 percent of the Medicaid dispensing fee or no more than $15, whichever is less for each cancer drug or supply dispensed o Drugs must remain in their original sealed container or in a tamper-evident unitdose packaging. Never in actual possession of patient o May not be accepted or dispensed if there is less than six months remaining until the expiration date. o Controlled substances are not eligible for donation. o Eligible patients uninsured and do not qualify for third-party insurance coverage, Medicaid, or any other state or federal assistance programs

Cancer Drug Donation Program (499.029 for more information)

Hospital pharmacy may accept donated cancer drugs and supplies from eligible donors, inspects the donated cancer drugs and supplies for authenticity and dispenses the cancer drugs and supplies to eligible patients

What facilities are not reported in E-FORSCE

Hospitals, nursing homes, correctional facilities, ambulatory surgical centers, hospices, emergency rooms, patients under the age of 16 one time fill, 72 hour emergency refill and patient directly administered by a physician

What kind of coursework may the Board require?

Laws and Rules must be at least 12hrs/ Med Errors (QRE) must be at least 8 hours

Which insulin product requires an Rx?

Humalog

If prescriber not available to verify QUANTITY or date written, WHEN can a Pharmacist dispense a C-II to C-IV with missing information?

If a PREVIOUS prescription of the patient's is on file

What must the pharmacist write on a prescription upon filling it?

If a controlled substance, must put initials on the prescription and the date filled. For central pharmacies, local pharmacy must write date, pharmacist transmitting, "central fill," central pharmacy's name address and DEA number. Upon refilling a C3 or C4 prescription, the pharmacist must write the date of refill, the amount dispensed, and their initials on the back of the prescription.

Nonresident Pharmacy Permit (Mail Order) part 2

If also providing sterile products in FL, must ALSO register as nonresident Sterile Compounding Pharmacy Nonresident Sterile Compounding Permit required to ship, mail, deliver, or dispense any sterile products into the state o Also applies to FDA Licensed Outsourcing Facility;

Medication guide is considered part of the labeling

If it is not included but was required by the FDA then it is considered misbranding

What are the CE requirements for license by endorsement?

If licensed previous 2 years, must submit proof of 30 hours of CE over 2 years

When can Pharmacists NOT write for ORAL meds?

If pt= Pregnant/Nursing

Dispensing Controlled Substances in FL for Pain

If there are any concerns about the use/abuse/legitimacy of a controlled substance prescription, the pharmacist SHALL: o Verify Rx with prescriber. If not able to verify and believes Rx to be valid should dispense 72 hr supply o Require Picture ID and make copy or document ID. If no ID still must confirm identity o * note should always obtain ID when dispensing prescriptions for controlled substances in FL if patient is not known*

1982 Federal Anti- Tampering Act

Illegal to tamper with OTC drugs

What is DAMP?

Impaired practitioners (Drugs/Alcohol/Mental/Physical condition)-- program for pharmacy students and other licensed healthcare provider Complaints involving DAMP will NOT be subject to disciplinary action Pharmacist pays own expense

What is generally covered by Medicaid?

In and out patient hospitalization Labs and x-rays Care in skilled nursing home Physician, home health, dental, nursing care Outpatient prescription drug

When can a prescriber in a Class II institution dispense drugs?

In emergency room, 24 hour supply

Compounding Quality Act 2014

In response to New England Compounding Center deaths Registers Outsourcing Facilities

The FDA does not allow transport into the US of unapproved new drugs, even if they're approved in other countries. What is the exception to this?

In some cases the FDA will allow a 90 day supply of a drug to be brought into the US as long as it is medically necessary

How must prescriptions for weight loss be delivered?

In writing

Define Abuse

Inappropriately taking advantage on the program for personal benefit

Sterile Compounding Permitted USP 797

Incorporates USP 797 Guideline into law ABC Require Antiroom: ISO 8 or better --Facilities must be tested twice a year minimum for sterility and air particle count Expiration/Beyond Use dates

What kind of demand is there in the pharmaceutical industry?

Inelastic demand -- price does up but demand stays the same (High reservation prices)

Final check of prescriptions

Initial or sign the prescription face and write date filled Must conduct prospective drug use review (check suitability of prescription) for each prescription filled and take the necessary steps to ensure safe practice Must counsel patients on medication if requeste

Primary TYPE of drugs Pharmacists can NEVER write in FL?

Injectables!

Internet Pharmacy

Instate or out of state pharmacy which uses the internet to communicate with FL patients or fill prescriptions for FL patients --- must always maintain an active pharmacy and DEA registration if dispensing controls Required to register as an internet pharmacy in FL Must be open at least six days a week and 40 hours a week and maintain a toll-free telephone number that is listed on the label of each prescription bottle filled

Controlled Substances prescription transfers

Interns may give/take transfers

How does a patent help the inventor?

It gives an intentional monopoly to the holder but requires full disclosure to the public Have to say everything I know about my product and how it works...will inadvertently allow other people to use my information to further their own research

What is the 340B Drug Pricing Program about?

It is a discount program part of the Public Health Service Act-- manufacturers have to provide outpatient drugs to eligible entities at significantly reduced prices. Eligible Entities must register and be enrolled with the program and comply with all requirements

What type of industry is the pharmaceutical industry?

It is an oligopoly; market is dominated by a small number of manufacturers. Incentives for price fixing --> everybody keeps pricing at same range Conscious parallelism -->as one player moves the other player moves Tacit Collusion and collusive pricing tendencies (generally illegal) Heavy reliance on game theory

How strong is a package insert legally?

It represents SOME evidence of the standard of care

What if the registrants address is incorrect on a DEA Form 222?

It should be returned to the DEA for correction

FL Board of Pharmacy

Job is to protect the public (FL patients)

In what environment can a pharmacist order and interpret tests?

LTCF

What are some situations that would be considered misbranding?

Label is lacking: the "established name" of the drug, each active ingredient, quantity of container ingredients, adequate information for use (Rx drugs only), name or location of the manufacturer, packager, or distributor, or other words, statements or information as required by law. OTC labels that lack directions for use, adequate warnings, or address/phone number of manufacturer to report serious adverse effects. Drug made in nonregistered establishment. Failure to report contact information to report adverse drug effects. Prescription drug promoted in violation of advertising provisions. Drug is not in accordance with USP/NF specification. Drug is for sale under the name of another drug. Drug is misrepresented to be a recognized drug. Drug is packaged in violation of PPPA/FATA. Drug is not in compliance with REMS and is health endangering when used as prescribed. Drug is lacking precautionary statement for drugs subject to deterioration.

Misbranding

Label missing o "Established Name" of the drug o Each active drug ingredient listed o Quantity of container ingredients o Adequate information for use (Rx drugs only) o name or location of manufacturer (packer or distributor) o Words, statements, information as required by law conspicuously and prominently displayed

Expiration dates (Beyond Use Dating is the terminology now used that you can't begin infusing anything Beyond the Date of expiration)

Low risk compounding (48 hrs room temp, 14 days cold , 45 days frozen). Medium Risk (30 hrs room temp, 9 days cold, 45 days frozen) High risk compounding (24 hrs room temp, 3 days cold , 45 days frozen

What are the expiration dates for low risk, medium risk, and high risk compounded sterile products?

Low risk: 48hrs room temp, 14 days cold, 45 days frozen. Medium risk: 30hrs room temp, 9 days cold, 45 days frozen. High risk: 24hrs room temp, 3 days cold, 45 days frozen.

Schedule 5

Lyrica (requires Rx), Robitussin AC, Phenergan with Codeine

DEA numbers for midlevel practitioners begin with:

Pharmacy must record each prescription filled in a data processing unit

Maintain record for at least four years o Have capacity to produce a daily hard-copy printout within 72 hours

1997 FDA Modernization Act

Manufacturer friendly set of drug laws

1992 Prescription Drug User Fee Act

Manufactures must pay a user fee along with each drug is marketed and must be reauthorized every 5 years

Schedule 1

Marijuana, ecstasy, heroin, LSD, Peyote, Salvia, Peyote (allowed in Native American Church ceremony)

Pharmacists can order fluoride treatments if patients do not have fluoride supplement in their water

Maximum one year of therapy. Must not switch fluoride brands

Pharmacist may not change any "Essential Element" on Rx

May change address, quantity, strength, directions with authorization, always use proper judgment Note the DEA has issued conflicting guidance as to what constitutes "Essential Element"

Dispensing Epi/Naloxone injectors

May enter into Collaborative Practice Agreements with a prescriber

Rules and requirements for Consultant Pharmacists

May hire other consultant but consultant on record responsible Consultant must notify Board within 10 days of relinquishing responsibility Requires completion of a consultant pharmacist course of at least 12 hours Must undergo 40 hrs clerkship under supervision of a consultant pharmacist preceptor within 1 year of completing the course Must obtain 24CE every 2 years approved for consultant in addition to the 30 required for all pharmacists (54)

Consultant pharmacists

May hire other consultant to do work, although ultimate responsibility remains with consultant of record Consultant of record must notify Board within 10 days of relinquishing responsibility Requires successful completion of a Consultant Pharmacist course of at least 12 hours sponsored by an accredited college of pharmacy located within the State of Florida, and approved by the Florida Board of Pharmacy Must undergo a 40 hr clerkship under the supervision of a consultant pharmacist preceptor within one year of completion of the course, must be completed over three (3) consecutive months, 60%of which shall occur on-site at an institution that holds a pharmacy permit. Consultant preceptor must be licensed consultant pharmacists for at least one year can precept no more than two pharmacist applicants at a time Must obtain 24 CE credits every two years approved for consultant in addition to the 30 required of all pharmacusts (54 credits total)

immunizations

May immunize for influenza, shingles pneumococcal and all vaccinations listed by the CDC schedule including international travel vaccines with proper credentialing including Meningococcal B o Under protocol with physician only (conditions, categories, terms, scope, etc) o Interns can also also immunize 1:1 supervision of a pharmacist o Complete board approved/certified 20 hrs minimum education including CPR training, epinephrine, reimbursement procedures, reporting to VAERS Pharmacist may administer epinephrine if necessary per protocol 3 hr CE course biannually o Maintain $200,000 of professional liability insurance o Maintain record for 5 years

Pharmacist and Immunization

May immunize for influenza, shingles, pneumococcal and all other listed by the CDC schedule -Protocol with physician, board approved/certified 20 hrs min education -Maintain record for 5 years -Registered intern may also vaccinate, 1:1 supervision

Dos and Don'ts in Pharmacy

May not use or disclose information except for treatment, payment or regular health care operations Must adopt and implement privacy procedures Family and friends may pick up prescriptions for a patient Pharmacist may use intercom to call patients to pharmacy Pharmacists may counsel patients on OTC conditions May leave message on answering machines or with family members Semi private counseling areas are acceptable

What are restrictions on the inspector?

May not view pts script records or other confidential data without warrant May not take any physical materials w/o consent or a subpoena

What about compounded prescriptions and office use

May order for office use in amounts limited to anticipated use. Must be labeled for Office Use Not For Resale

What is the name of the voluntary program used to alert manufacturers of harmful side effects?

MedWatch

What is another name for Medicare Modernization Act?

Medicare Part D

Describe modified Class II institutional pharmacies:

Meet all requirements of Class II pharmacies except for space requirements

Who doesn't have to renew?

Members of FL pharmacy for 50+ years receive lifetime licenses

board of pharmacy -part 2

Members serve 4 year terms May discipline pharmacists who deviate from law/rule o Sanctions may include fine, suspension, revocation o Defaulting on student loans subjects the graduate to suspension of pharmacist license o Failing any drug test subjects the pharmacist to suspension or restriction of the license to practice Probable Cause panel investigates rule violations or complaints to determine if there is sufficient cause to bring before the full board. Meets as often as necessary o Composed of two members of the Board of Pharmacy, one of which must be a pharmacist (usually chair) o Double affirmative (positive) vote required to find probable cause exists that a violation has occurred

FL Board of Pharmacy-Part 2

What are 2 examples of a class 2a institutional pharmacy?

Methadone clinic, dialysis center.

What kind of violation is dispensing of a legend drug without a prescription?

Misbranding violation

Modified Class II -- meets class II requirements except space and equipment

Modified Class II A -- Methadone clinic, dialysis center *formulary limited to 15 drugs or less Modified Class II B -- Surgical Center *no formulary limitations-- drugs stored in bulk or unit dose Modified Class II C -- no drugs stored in bulk, non currently in FL

What document is included for OTC drugs that covers dosage, ingredients, and a variety of other information?

Monograph

What are some issues?

Monopolization, Agreements not to compete, Agreements on price or price related terms, Predatory pricing, Horizontal mergers between competitors, Vertical mergers -- PBMs, Potential competition mergers, Illegal tying and other arrangements

Internet Pharmacy Permit

Must always maintain an active pharmacy and DEA registration if dispensing control

Who can get a permit?

Must be 18 year to get one Pharmacist/Non-Pharmacist may own/permit a pharmacy

permit requirements

Must be 18 years of age Pharmacist / Non-Pharmacist may own/permit a pharmacy o No Medicaid or other healthcare fraud or criminal activity Fingerprint, application, and background check

Pharmacy must maintain a back-up recordkeeping system

Must be backed-up on a regular basis, at least weekly o Must report to the Board in writing any significant loss of data within 10 days of discovery

Only Pharmacy may sell poisons

Must be labeled with pharmacy name and address and the word "Poison" Must make seller aware of poisonous characteristics and ensure legitimate use if unusual quantity

Pharmacist Responsibilities

Must be licensed o 18 years of age, pass NAPLEX and MPJE, meet internship requirements o License renewal every two years

What are the Pharmacist Responsibilities

Must be licensed: 18 years of age, pass NAPLEX and MPJE, meet internship requirements. License renew every 2 years Fit and competent to practice Report any fraudulent script to law enforcement Final check of prescriptions Conduct prospective drug use review Must conduct prospective drug use review Present and on duty while working Make drug pricing readily available upon request May take a 30 min meal break while keeping pharmacy open Direct and immediate responsibility over all interns and technicians and accept full responsibility Dispense a one-time 72 hr emergency refill if prescriber unavailable, including controlled...State of emergency 30 day fill Responsible for compounding meds

What are the required hours?

Must be open 40 hours/ 5 days per week PDM may petition for less than 40 but must be >20 and must post hours available and make rph available for 40 hours

Pharmacy

Must be open to inspection (Medicaid/Board of Pharmacy/State Health Department/Insurance companies) o May not view patient's prescription records or other confidential data without a warrant o May not take any physical materials (evidence) without consent or a subpoena

What is the time period requirement of inventory after the initial control inventory in a pharmacy?

Must be performed at any point within two years of the initial inventory

FDA 2253 for advertising

Must be submitted in advance by manufacturers pre-clearance unnecessary

tech requirements- Part 2

Must complete 20 hours of CE required biennially o 4 hours live, 2 hours med errors Pharmacy must have written job descriptions for technicians as well as policies and procedures in pharmacy, signed by the technicians. o Ensure each technician is knowledgeable and work requests do not exceed the written job description/policy/procedure. o includes information on 12 items defined in rule (this manual must be maintained at the pharmacy) o Prescription Department Manager must maintain documentation of appropriate training, such as certification, attendance logs, and quiz scores

What are the requirements for a pharmacist to give immunizations?

Must complete a minimum of 20 hours of CE related to immunizing and have $200,000 of professional liability insurance.

1970 Poison Prevention Packaging Act

Must dispense drugs using child -resistent containers EXCEPT: PANS-E/Pains-E "don't be a Pans-E, use child proof containers" except: • Provera, Prednisone / Amorphous cholestyramine/ isosorbide diNitrate/sublingual nitroglycerine, sexy birth controls/ Erythromycin, Effervescent aspirin, Effervescent acetaminophen

What signs are required?

Must hang sign regarding generic substitution (all pharmacies) Medicaid provide most post 2 signs: -Important Notice to Medicaid Recipients -Aviso Importante a Recipientes de Medicaid

DEA form 224

New Application for Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner

DEA Form 224:

New registration

Nuclear Pharmacy part 2

Must have a secured radioactive storage and decay area o The Hot lab, storage area, and compounding and dispensing area shall be a minimum of 150 square feet (surprisingly tested) Must have full spectrum of supplies (syringes, gloves, protective labcoat) and equipment (hood, shield, scintillation counter, etc) Registered technicians employed only in a nuclear pharmacy may write new prescriptions from a prescriber's oral prescription

What is the required size and counter space for a pharmacy?

Must have at least 150sqft of floor space and 10sqft of counter space, with at least 4sqft extra for every pharmacist on duty >1.

requirements of pharmacy to operate

Must have working sink, running water, sufficient shelving to maintain a clean/organized practice, refrigeration for drugs, sanitation, a print or electronic drug information, a print or electronic copy of FL drug laws, quarantine area for defective drugs, and anything else typically relied upon for your particular practice. Must be clean and orderly Must have a patient consultation area directly next to pharmacy o Must have a sign that indicates "Patient Consultation Area" o

What classes must be covered?

Must include all therapeutic categories Protected drug classes: antineoplastic anticonvulsants antiretrovirus antipsychotics antidepressants immunosuppressants

Who is eligible for Medicaid?

Must meet income guideline and also required for patients who are blind, disabled, aged and member of these families with dependent children

Procedure for closing a pharmacy

Must notify board prior to closing, return permit, and advise where prescriptions will be transferred Must physically deliver prescriptions to location and must be within reasonable proximity

What are the requirements for counseling patients?

Must offer to counsel verbally and in writing; anyone may offer but only pharmacist or pharmacist-supervised intern can counsel. Counseling not required for inpatients or any other institutions that administer. Must offer to counsel anyone who picks up medications for a patient.

Hospital interns and residents

Must provide Hospital DEA number and individual physician's internal hospital code o Prescriptions may be filled by outside community pharmacy using Hospital's DEA number

Record keeping requirements

Must record each filled in a data processing unit Maintain for 4 years Have capacity to produce a daily hard-copy within 72 hours Each individual Rph shall verify that the data indicated on the daily hard-copy print out is correct by dating and signing within 7 days from dispensing Each pharmacy must maintain a log book in which each individual pharmacist shall sign a statement each day (stored for 4 years)

Nuclear Pharmacist

Must renew license every 2 years Must receive 24 hours approved CE for nuclear pharmacy every 2 years: Cannot be applied towards the required 30 for all pharmacists

Nuclear Pharmacist

Must renew their license every two years Must receive at least 24 hrs approved continuing education credit for nuclear pharmacy every two years o Cannot be applied towards the required 30 general hours required of all pharmacists o Must complete 200 hour approved didactic coursework o Must complete 500 hours on the job training

What are the rules about substitution?

Must substitute generic unless 1.) patient requests otherwise 2.) prescriber mandates "Medically Necessary" 3.) Drug is on the negative formulary 4.) No generic available Must pass full savings on to the patient

If any concerns about the use/abuse/legitimacy of a controlled substance the pharmacist shall

Must verify rx with prescriber. If not available and pharmacist believes ok to dispense then only a 72 hour supply

2016 Comprehensive Addition and Recovery Act (CARA)

NP and PA administer, prescribe, and dispense narcotics in office-based opioid treatment programs 30 to 100 (first yr) and 275 thereafter

What is required on the label of a compounded medication?

Name address and phone number of the compounding pharmacy, name and strength of the preparation of a list of active ingredients and strengths, pharmacy's lot number, beyond use date, quantity, appropriate ancillary instructions (storage, hazards, cautions, etc), and either "for institutional or office use only - not for resale" or "compounded drug" if to a veterinarian.

What are the label requirements for a compound?

Name address and phone of compounding pharmacy. Name and strength of the preparation of a list of active ingredients Pharmacy's lot number and beyond use date Quantity in container Ancillary instructions (storage etc)

What must be recorded when selling pseudoephedrine, ephedrine, or phenylpropanolamine?

Name, address, and DOB of the buyer; the product and quantity dispensed; description of the ID used to make the purchase; date and time of sale.

Only OPTHALMIC that a Pharmacist can write for?

Naphazoline (Naphcon-a) 0.1%

DEA form 510

New Application for Domestic Chemical

DEA form 225

New Application for Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter

dea form 363

New Application for Narcotic Treatment Programs

Other economic considerations

No Price regulation in the US, --- Direct regulation in Canada, France and Italy --- Indirect-- Japan control on insurance reimbursements and UK regulated profits Pricing is extremely complex in the US -- Different costs to different purchasers Role of insurance and managed care Economies of scale

Modified Class II C

No drugs can be stored in bulk None currently registered in FL

FL Pharmacist can order/dispense from limited formulary without a prescription (Pharmacist only class of drugs

No injectables, pregnant patients or nursing mothers, recommended dose and duration only (34 d max), must create a prescription, maintain patient profile and store for at least FOUR years including chief complaint (in patients own words).

What is the quantity limit on C3-C4 prescriptions?

No limit unless it is a verbal order for a C3 drug. Verbal orders for C3s are limited to a 30 day supply.

How many DAYS must a Community Pharmacy licensed in the state of FL be open for PER WEEK?

No specificed # of days--> >/40 hours per week

Can physician self prescribe controls

No they cannot but can write for family friend within the scope of practice. Must document in chart. No pre-signed blanks

Can Central Filling Pharmacies DELIVER any CS (C-II to C-V) to ultimate user?

No!

Can a person have a control w/o a valid prescription?

No, It is illegal

Can 2 prescription from different classes be written on same hard copy?

No, different classes cannot not on the same blank

Can returned medications be put back in stock?

No, except unit dose meds

Is a prescription a legal document?

No, it's an order

Can dispensed prescriptions be returned to stock?

No, never but we can still give refunds Unclaimed prescriptions may be stored and reused but subject to a 1 year beyond use date

Do destruction of controls require permission from the DEA?

No, not if DEA Form 41 is immediately mailed to DEA (unless using an officer of the law as a witness, in which case yes)

Are medication guides required for all drugs?

No, only certain drugs that the FDA deems appropriate

Are PAs and Nurse Practitioners allowed to prescribe controls

No, the may prescribe med under the supervision of a licensed physician but NO CONTROLS

Are we responsible for Standard for the prescription of Obesity drugs

No, this falls under 64B8 which is the Board of Medicine. Initial prescriptions may not be called in but refills may be

Are Pharmacy INTERNS allowed to administer vaccines under the supervision of a pharmacist?

No--certified pharmacists only

What is required before pharmacies can ship drugs into Florida?

Non-resident permit.

What are excluded from coverage?

Non-rx vitamins Weight loss or gain drugs Fertility ED Outpatient drugs requiring monitoring As of January 1st 2013 Barbs and Benzos covered

What records is a prescriber required to keep regarding the prescription of controlled drugs?

None

Prescription Drug Managers (aka PICs in CA)--PDMs Is there a MINIMUM # of practicing years a pharmacist must have in order to be a PDM?

Nope--straight out

What is 503B- Outsourcing Facilities

Not a compounding pharmacy...the triad does not exist. "gain requlatory oversight over 'non-traditional compounding pharmacies' that compound sterile products" Voluntary registration with the FDA Under direct supervision of a licensed pharmacists Must report compounded products, source materials (API) Allows bulk compounding of drugs on FDA shortages list w/o Rx

Are samples allowed in pharmacy?

Not allowed in community but allowed in Class II institutional pharmacy upon written request of prescriber

1982 Federal False Claims Act

Not allowed to falsely bill Medicare/Medicaid

Can PA or NP prescribe controls?

Not if FL

What are the quantity limits of codeine, opium, dihydrocodeine, dihydrocodeinone, and ethylmorphine to still be considered C3 drugs?

Not more than 1.8g/100mL of codeine or dihydrocodeine or 90mg per dosage unit. Not more than 300mg/100mL of dihydrocodeinone or ethylmorphine or 15mg per dosage unit. Not more than 500mg/100mL or 100g of opium or 25mg per dosage unit.

What are the quantity limits of codeine, dihydrocodeine, ethylmorphine, opium, and diphenoxylate to still be considered C5 drugs?

Not more than 200mg codeine per 100mL or 100g. Not more than 240cc or 48 solid doses of substances containing opium, or 120cc or 24 solid doses of substances containing any other C5, with purchaser not obtaining more than 120oz or 24 solid doses of any other C5 in prior 48 hours. Not more than 100mg/100mL dihydrocodeine, ethylmorphine, or opium. Not more than 2.5mg diphenoxylate with not less than 25mcg of atropine per tab.

Special-Closed System Pharmacy

Not open to the public Prescriptions are individually prepared for dispensing utilizing closed delivery systems to facilities where prescriptions are individually prepared for the ultimate consumer -- nursing homes, jails, ALFs etc

Do pharmacists have to contact patients who have received a drug that was later recalled?

Not required by law.

Are permits transferable?

Not transferrable but renewable every two years

Theft or significant loss

Notify DEA and local police o Complete DEA Form 106

Federal labeling requirements on select products or else considered misbranded

OTC sore throat lozenges/troches o If severe or persistent call physician, may be severe Ipecac o Call for professional advice before using Nonoxynol 9 o Does not protect against HIV Phenindione o Causes agranulocytosis and hepatitis "Contains FD&C Yellow No. 5 (tartrazine) as a color additive" o Further warning statement required in precautions section of package insert "Contains FD&C Yellow No. 6 as a color additive" "Phenylketonurics: Contains Phenlalanine ___mg o Aspartame containing drugs "Contains sulfite..." Systemic antibiotics, "to reduce the development of resistance Isoproterenol Glandular preparations

Which law provides the framework for DURs?

Obra 90

Optometrist-can only prescribe

OcularTopical and Systemic drugs per formular (see Formulary 463.0055) - some analgesics, antibiotics, antivirals, and antiglaucomas o Only control allowed is Tylenol 3 with Codeine). Must have complete additional training to prescribe oral medications (ie 20 hour course

In what setting may buprenorphine be prescribed?

Office based community setting

What is 503A- Permissible Compounding 503a-1

Ok to make extra if there is regular use "... compounded for ... an identified individual patient ... unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner ... very limited quantity based on expected and customary business" Boards of Pharmacy to submit actions taken against compounding pharmacies

How many patients can a doctor treat for addiction at any one time?

Once the doctor gets a waiver from CSAT, he can treat up to 30 patients the first year and up to 100 patients in subsequent years.

How long after discovery of loss or theft does a registrant have to report it to the DEA?

One day

Poisons

Only a pharmacy may sell poisons Must be labeled with pharmacy name, address and the word "Poison"

Under what circumstances can marijuana be dispensed to patients?

Only cannabis with THC >10% CBD and <0.8% THC under Charlotte's Web Law to a Florida resident. Cannot be grown, sold, or dispensed by a pharmacist.

When is a Pharmacist allowed to dispense a C-II to C-IV to a patient if the Rx only has the numerical notation (missing the written number)?

Only if the patient has a previously filled prescription with same #

Where are drugs allowed to be stored?

Only in the pharmacy area. Hospitals may store in areas deemed necessary to treat (Surgical Units/ER)- Must be in policies and procedure manual Nursing homes may store secure, available only to appropriate licensed staff

If Pharmacist write a Rx, who can fill it?

Only the PHARMACIST that wrote the order (so not even other pharmacists...therefore not Interns or Technicians)

Pharmacy must be

Open to inspection: Reasonable appropriate hours

C-V Opioid Maximum conc?

Opioid 100 mg/100 mL

Maximum CONC. of drug dispensed without an Rx?

Opium- 100 mg per 100 mL (or 100 grams) Codeine- *200 mg per 100 mL Dihydrocodeine- 100 mg per 100 mL Diphenoxylate- 2.5 mg per >25 mcg Atropine Sulfate Ethylmorphine- 100 mg per 100 mL

AMOUNT vs. CONCENTRATION Maxilmums Maximum AMOUNT of drug dispensed without a Rx?

Opium- 240 mg Codeine- 120 mg Dihydrocodeine- 60 mg Ethylmorphine- 30 mg

DEA form 222

Order CI and CII

Which pharmacy's NAME/ADDRESS must be on label?

Originating Pharmacy

OUTSOURCING PHARMACY- OUT OF STATE Nonresident Sterile Compounding Permits

Out of state pharmacies (Outsourcing Facilities) may register with the Florida Board of Pharmacy as a non-resident SCP

1890 Sherman Antitrust Act

Outlaws agreements that restrain trade

DEA numbers for distributers begin with:

P or R

entitled to prescribe controlled substances

PA and ARNP) o Optometrists can prescribe Tylenol with Codeine #3 only o Require DEA and state registration o Cannot delegate authority to another, although an agent can phone in prescription at request of registrant (ie receptionist) including emergency prescriptions of CII

First vs. Second vs. Third Degree Felonies

PPT #82

What is a notable exclusion to the reference standards listed in the Obra 90?

Package Insert

What drugs are exempt from child-proof packaging requirements?

Packaged with <105mg prednisone, amorphous cholestyramine, isosorbide dinitrate, sublingual nitroglycerine, birth control pills, erythromycin, and OTC products that expressly say that they do not have child-resistant packaging.

What is the 505(b)(2)?

Paper NDA... permits approval of drugs without completing lengthy studies to prove safety and efficacy if these are already existing elsewhere. This is good for different dosage forms such as salts/esters.

What does US Constitution Article I Section 8 cover?

Patents, Copyrights and Trademarks

Central Fill Pharmacies are permitted in FL

Patient drops off prescription at local pharmacy who then transmits to Central Fill Pharmacy (fax/electronic transmission). This central fill pharmacy then fills the prescription and mails to local pharmacy who then dispenses to patient. ofill prescriptions for controlled substances on behalf of retail pharmacies with which they have a contractual agreement (no emergency CII) o All records must be maintained by both pharmacies for 2 year period

What might be a factor in differentiating between a disease of pain and a disease of addiction?

Patient functioning

What must be included on a drug label for both controlled and non-controlled?

Patient name, prescriber name, pharmacy name, prescription number, drug, date of dispensing, directions for use, address of pharmacy, expiration date. For controlled, must add date of initial fill if a refill and "federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed" (C2-C4 only).

Who may blanket-request that all medications not be in child-resistant containers?

Patients (NOT prescribers)

Is compounding by a pharmacist okay?

Perfectly legal if MD writes a prescription and the pharmacists compounds it.

What practices need to be in place once permitted?

Permits and licenses must be conspicuously displayed Individuals must be readily identifiable by license through name badges *** Check expiration dated every four months (three times a year) and remove expired drugs immediately *** Maintain continuously quality improvement program to deal with errors -- requires a written policy and procedure manual -- there must be a record/database of errors *** Each incident must be documented/summarized by the pharmacists that first becomes aware of the matter *** Records maintained as a component of a pharmacy Continuous Quality Improvement Program are confidential under HIPAA and are exempt from discovery

2013 Drug Quality and Securtity Act/ 2014 Compounding Quality Act (503B)

Permits registration of large-scale compounding pharmacies ( Outsourcing Facility) -Products must be labeled "compounded drug" and "not for sale"

Who must sign the power of attorney to allow for other individuals to complete the DEA Form 222?

Person who signed the most recent DEA application for the pharmacy

Prescription Drug Data Mining

Pharmaceutical companies purchase doctor's prescribing records from pharmacies. Shows how much is being prescribed and sold. PT ID removed IMS Health, Verispan

Fraud, Waste and Abuse

Pharmacies filling Medicaid and Part D required to provide FWA training to staff -detection correction and prevention -cannot develop own materials -employees must undergo annual training Must ensure all employers, vendors and contractors are not in the OIG Exclusion list which lists people charged with fraud

1996 Health Insurance Portability and Accountability Act (HIPAA)

Pharmacies that bill electronically must limit disclosure of patient health information (PHI) to amount "minimally necessary" • Pharmacy employees may not use or disclose health information except for treatment, payment, regular health care operations o May provide to patients upon request (verbal okay

Modified Class II Institutional Pharmacy

Pharmacies that meet all the requirements for a Class II permit, except space and equipment requirements (typically primary alcoholism treatment centers, free-standing emergency rooms, rapid in/out surgical centers, certain county health programs, and correctional institutions) Must have consultant pharmacist of record named o Consultant must provide written, on-site consultation (drug regimen review) at least once a month All drugs dispensed must be for on-site use only Consultant pharmacist must provide written protocols and a policy and procedure manua

Who is allowed to RE-STOCK Automated Dispensing Systems (ADS) under the ownership of a separate pharmacy housed in a LTCF?

Pharmacist OR "other licensed professional")

Both pharmacies must have WHAT AVAILABLE to pt?

Pharmacist available for >/ 40 hours per week (either in person or via phone) for patient counseling

Valid FLORIDA Controlled Substance Prescriptions Note: follows all the laws we know of in CA, except 1?

Pharmacist filling the CS must INITIAL/Date the FRONT of the Rx

o Giving Transfer/Copying

Pharmacist must determine valid request, provide the prescription, the name of the pharmacy, the prescription number, the drug, the original amount dispensed, the date of original dispensing, and number of remaining refills. Pharmacist must record the transferring pharmacy name, pharmacist, and date of request and cancel the electronic prescription (or void written prescription)

Giving Transfer/Copying

Who can take oral Rxs?

Pharmacist or intern

Stocking & Restocking Automated FILLING Systems Which 2 types of employees CAN stock/restock, but require DIRECT SUPERVISION?

Pharmacy Interns Pharmacy Technicians

Mailing C-II,III,IVs & Patient Identification When is a pharmacy EXEMPT from obtaining suitable identification before mailing a C-II through C-IV?

Pharmacy can verify patient through PBM (or insurance plan)

Beneficiary Inducement Statute

Pharmacy cannot give anything of value to a Medicare Beneficiary to induce use of its services -includes waivers of copay or deductibles -no coupon co-pay program Can't say come to my pharmacy and I will give you a gift card

Regulation of Daily Operating Hours

Pharmacy must be open a minimum 20 hrs a week Required to have a sign in block letters at least one inch must state hours of operation in unobstructed view

Executing 222 [Copy 1 is brown (supplier), Copy 2 is Green (DEA) and Copy 3 is Blue (Pharmacy)]

Pharmacy places the order and retains Copy 3 o Copy 1 and 2 mailed to supplier Supplier fills the order and retains Copy 1 o Completes Copy 1 and 2 o Copy 2 mailed to DEA Pharmacy completes Copy 3 upon receipt of order o Containers and date received

Special-Limited Community

Pharmacy services provided to employees and dependents for personal use, patients of a hospital (Institutional Class II permit) under a continuation of a course of therapy, Patients in the emergency room

*Urinary analgesic Pharmacists can write for in FL? a) Max day supply?

Phenazopyridine (Pyridium a) 2 days!

Decongestants Pharmacists can write for?

Phenylephrine Azatadine

FDA-2633 (form):

Physician request for authorization to prescribe detoxification medication

Which practitioner has the greatest prescribing allowances?

Physicians MD/DO because they have the greatest scope of practice

Telemedicine 2 licensed practitioners can engage in telemedicine?

Physicians OR PA's

Dispensing Practitioners

Physicians and other prescribers are able to register as dispensing practitioners May not dispense CII or CIII Must comply with pharmacy rules and be open to inspection Use of samples does on require registration as dispensing practitioner

Federal labeling requirements

Phytondione (Vitamin K) oral and injectable are prescription-only. Epinephrine injection requires prescription/ Inhaler OTC (being phased out CFC) Isotretinoin - iPledge program utilized, required registration for wholesalers, prescribers, pharmacies dispensing and all male and female patients, 30 day supply only, females must use two methods of birth control, one month prior to one month after therapy, two negative pregnancy tests prior to initiation of therapy Thalidomide -

What act initiated the need for child-resistant packaging?

Poison Prevention Packaging Act (PPPA)

Central fill of controlled substance prescriptions is permitted

Prescription information may be transmitted by fax or electronically to central fill pharmacy o Local pharmacy must write date, pharmacist transmitting, and "Central Fill" on face of prescription along with the central pharmacy's name, address and DEA number. o Central fill pharmacy fills the prescription and ships drug to local pharmacy for dispensing and counseling o Both pharmacies must be registered with DEA and store records for FOUR years from date of last fill. o May NOT fill prescriptions Schedule II in EMERGENCY SITUATIONS; use local pharmacy only [

How long should prescription be held for

Prescription records must be stored for at least four years

LTCF partial fills permitted for CII

Prescription valid for only 60 days from date written. Each partial fill, the pharmacist must document date of fill, quantity dispensed and remaining quantity and sign

Prescription rules

Prescriptions expire in one year. CIII-CV expire in 6 months but CII do not have an expiration date..default to 1 year

Pharmacy and Recordkeeping

Prescriptions must be stored for at least four years

Antikick Back Laws

Prevents any remuneration in return for generating Medicare, Medicaid, or other health care program business ex. physician has practice but also has another imaging business...send pt to get xrays to own practice

False Claims Act 31 USC 3729

Probibits false or fraudulent claims to be filled with the US Gov't Liable for treble damages (3 times the damage) -Private individuals allowed to file whistleblower suites and share in the recovery. Qui Tam Lawsuits. Generally 15 to 25% of recovery ex. filling 90 days when pt only needs 30

What is a Class III recall?

Product is not likely to cause serious damage

What is a Class II recall?

Product may cause temporary or medically reversible damage

What provisions are in Medicare Part D?

Program must accept participation from any pharmacy agreeing to drug plan conditions 90 day drug supplies for long term therapy MTM program services Vaccine Coverage

Sherman Antitrust Act Section 1

Prohibits all contracts and agreements in restraint of trade ex. CVS and Walgreens can't work on pricing

Clayton Act Section 3 Exclusive Dealings

Prohibits exclusive dealing contracts If I have all the API for a drug I can't say that I am only selling it to Company X

2008 Ryan Haight Online Pharmacy Consumer Protection Act

Prohibits internet prescriptions for controlled substances without in-person medical evaluation

Clayton Act Section 7 including Hart-Scott Rodino

Prohibits mergers and acquisitions which substantially lesson competition Requires pre-merger notification, approval, and waiting period by FTC for certain mergers

Sherman Antitrust Act Section 2

Prohibits monopolizations and attempts to monopolize

Clayton Act Section 2 Robinson Patman Act

Prohibits price discrimination Can't sell same product to different people at different prices... bulk pricing is still okay

1987 Prescription Drug Marketing Act

Prohibits sale/trade/purchase of drug samples

May transfer drug to another pharmacy transfer drug to other pharmacy

Provide Board date of transfer, name, address, DEA# of two pharmacies, complete inventory of controlled substances o Close-out inventory, including controlled-substances o Permit NOT transferable

1982 Orphan Drug Act

Provide incentives for companies to develop for rare diseases

Special Sterile Compounding Permit

Required before any permitted pharmacy may engage in the preparation of compounding sterile products

2003 Medicare Prescription Drug Improvement and Modernization Act (Medicare Part D)

Provides prescription drug coverage to Medicare patients (>65 yo, disabled, ESRD) with copays and donut hole o Excludes weight loss, fertility, cosmetic, hair growth, bzd/barbiturates, OTC, cold and cough relief

What is not required on the prescription label?

Pt address, date written, address of prescriber, quantity, dosage form, number of refills remaining, formulation

What is the term used to refer to inappropriate dispensing of a medication?

Quality Related Error

What is a Class I recall?

Reasonable certainty that the drug will cause serious harm or death

What are technicians not allowed to do?

Receive new non-written prescription or receive any change in the medication, strength or directions of an existing script Interpret for therapeutic acceptability Final verification Prospective new drug review Monitor prescription usage Transfer Rx Patient counseling

What responsibilities can technicians not partake in?

Receive verbal prescription or alter the medication, strength, or directions of an existing prescription; interpret prescriptions for appropriateness; conduct final verification of dosage and directions; engage in prospective DUR; monitor prescription usage; override clinical alerts without notifying the pharmacist; transfer prescriptions; prepare a copy of a prescription; counsel patients; or engage in any other act that requires a pharmacist's professional judgement.

Permits are not transferrable

Renewable every two years

DEA form 224a

Renewal Application for Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner.

DEA Form 224a, 225a, 363a:

Renewal of registration

Dispensing CII-CIV

Reported to the State Prescription Drug Monitoring Program

What is the E-Prescribing Incentive Program?

Reporting program that uses a combo of incentive payments and payment adjustments to encourage electronic prescribing Must use a qualified ePrescribing system Intended to help with medication errors

1986 National Childhood Vaccine Injury Act

Reports involving vaccines must be reported via VAERS form

Nuclear Pharmacy

Require the practice of a FL licensed nuclear pharmacists to be named prescription department manager (PDM) Registered tech, only in this type, may write new prescriptions from a prescriber's oral prescription

o Patient Package Insert (PPI) is considered part of the drug labeling

Required for all estrogens and oral contraceptives - Outpatient: Required with each prescription - Inpatient: Provided before first dose and every 30 days thereafter Other products may Voluntarily seek approval to provide these to patients. Approved by the FDA

Internet Pharmacy Permit- part 2

Required to register as an Internet Pharmacy in FL Pharmacy must be open, ie accessible at least six days a week and 40 hours a week, with a tollfree telephone number that is listed on the label of each prescription bottle filled (doesn't need to be 24/7/365) Must designate a licensed prescription drug manager o PDM does not need be licensed in FL o PDM must notify state within 30 days of relinquishing responsibilit

Continuous Quality Improvement Program to deal with errors

Requires a written policy and procedure manual. Must take proactive steps towards improvement. o Must conduct reviews at least every three months (quarterly) and consider how staffing levels, workflow, and technology contributed to the error. o There must be a record/database of errors.

2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act

Requires manufacturers to report serious ADRs to FDA for OTC and dietary supplements

Nuclear Pharmacy

Requires the practice of a FL licensed nuclear pharmacist to be named Prescription Department Manager (PDM) o M

2005 Combat Methamphetamine Act (+2008 Methamphetamine Production Prevention Act)

Restricts pharmacy sales of pseudoephedrine (PSE) o 3.6 grams per person per day (#146, pseudoephdrine HCl 30 mg) o 9 grams of PSE per person per 30 day period (#366, pseudoephdrine HCl 30 mg) o Mail order 7.5 grams of PSE per person 30 day period (#305, pseudoephdrine HCl 30 mg) o See http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/appendix/appdx_g.htm for quantity limits • All solid dosage forms of PSE must be sold in blister packs with no more than 2 doses/blister • All PSE is placed behind the counter, or secured in pharmacy • All purchasers must furnish picture ID (see exception immediately below)

ROI

Return on Investment

Central fill pharmacies are permitted in FL

Rx dropped off at local pharmacy who transmits to central fill Central fill , fills and the sends back to local for pt p/u May fill controlled substances if contractual agreement

Dispense Pharmacist-only Narcotics

Schedule V only, Adult patient only (18 years of age minimum), proof of identification required (even if patient known), bound volume must be maintained as a record Dose not to exceed 120 milligrams of codeine [60 milligrams dihydrocodeine, 30 milligrams of ethyl morphine,] or 240 milligrams of opium within 48 hrs Pharmacist may withhold sale at discretion if believe purpose is abuse

What kind of Pharmacists-only narcotics are allowed?

Schedule V only, adult pt 18 y/o minimum. Proof of ID required, even if pt known, and bound volume must be maintained as record Dose not to exceed 120mg codeine or 240mg opium within 48 hours

DEA Registered Pharmacy may keep an Emergency Kit, containing controlled substances in a LTCF that is not registered with the DEA

Security safeguards must be in place o Must maintain inventory and records

SLCPS - Schedule listed Chemical products: used in manufacture of Meth

Sellers must self-certify to DEA through the computer that 1) Employees have been trained 2) Records of the training are being maintained 3) sales limits are being enforced4) Products are being stored behind the counter or in a locked cabinet AND 5) A written or electronic logbook is being maintained.

What are Antitrust laws?

Series of laws created to prevent anti competitive practices (monopolies) amongst a business industry and promote free competition when companies merge price goes up and quality goes down (tries to balance this effect)

Privacy rule permits use and disclosure of PHI w/o pt permissions:

Serious threats to health or safety Public health activities Victims of abuse Judicial and administrative proceedings Law enforcement purposes

What are the API requirements

Should be of FDA approved in order to be used in compounding Must meet compendial requirements. i.e. have a certificate of analysis for compounding Properly labeled by manufacturer -- caution: for manufacturing, processing or repacking or for prescription compounding -- Rx only (when required) Source to be inspected with NDA -- product must be listed and facility must be registered

Medicare Prescription Drug Improvement and Modernization Act of 2003

Signed in December 3 2003 Established new Medicare Part D drug benefit effective 2006 Created provision for MTM and pharmacist reimbusement

Social Security Act

Skilled nursing facilities must provide "pharmaceutical services" including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals to meet the needs of each resident o must be provided in a timely manner that avoids discomfort or endangers the patients health and safety Facilities must employ or obtain the services of a licensed pharmacist who - Provides consultation on all aspects of the provision of pharmacy services in the facility Must have policies on drug related issues A licensed pharmacist must review each resident's medication regimen at least once a month

What are some barriers to entry?

Slow speed of entry Governmental regulated industry Intellectual property rights Globalization Supplier agreements Cost advantages independent of scale Sunk costs Susceptible to predatory prices

"Outsourcing Facilities

Special Sterile Compounding Permit (SSCP) are available for these facilities

What is required before a pharmacy can prepare sterile products?

Special Sterile Compounding Permit.

What is compounding?

Specially preparing a particular med to meet the specific need of an individual patient base on the specific request of a physician. Triad of care >> Physician to patient to pharmacist

Meaning full uses is explained by core objectives

Stage1 Core= CPOE, eRx, Drug-drug and Drug-allergy interactions, maintain active med and allergy lists, record and chart changes in vital signs Stage 1 Hospital = Record demographics, record smoking status for patients 13 years or older Stage 2 and Clinical Quality Measures

How often are inspections done?

State =twice during the first year of operation Minimum of 1 per year thereafter If passed for 3 years w/o discipline inspected every 2 yrs

1990 The Omnibus Budget Reconciliation Act (OBRA 90)

States required to mandate pharmacists to conduct prospective drug reviews and counsels all Medicaid pts for reimbursements

*Stipulation for requesting exemption?

Store must sell < 72 grams of Sudafed per month

Executing 222

Supplier can endorse form to another, if unable to complete order Each form must be signed and dated by a person authorized to sign or granted power of attorney from registrant (wide leeway in who/how many are granted power of attorneys)

2002 Thompson v. Western States

Supreme courts ruled advertising restriction unconstitutional under 1st Amendment Did not rule on NDA requirement

What is an example of a class 2b institutional pharmacy?

Surgical center.

T/F: All Institutional Pharmacies are allowed to store medicinal drugs

tech requirement-Part 3

Technicians must wear a visible identification badge with name and title (Registered Pharmacy Technician) and identity themselves in all communications as technicians Pharmacists may delegate certain tasks to technicians (Registered Technicians including Technicians In Training). Pharmacist must have Direct Supervision meaning can provide personal assistance. This includes the use of Technology

Who regulates prescription drugs?

The FDA

What can the FDA do if damaging information about a drugs initial trial comes to light after the drugs approval?

The FDA can pull the approval

Who regulates nonprescription drugs and supplements?

The FTC

Which publication is considered an official compendium under the FDCA?

The Homeopathic Pharmacopeia

Who regulates compounding and who regulates manufacturing?

The State/Boards of Pharmacy regulate compounding but manufacturers are regulated by the FDA.

Which DEA Form 222 would you use to return inventory to a distributor?

The distributors form

Calculating DEA Number- e.g. BS1212125

The first letter is a code identifying the type of registrant (currently in use: A/B/F/G/M) o M for midlevel practitioner only The second letter is the first letter of the registrant's last name. Step 1: add the first, third, and fifth digits of the DEA number (1+1+1) Step 2: add the second, fourth, and sixth digits of the DEA number (2+2+2) Step 3: multiply the result of Step 2 by two (6 x 2) Step 4: add the result of Step 1 to the result of Step 3 (3+12) Then, the last digit of this sum must be the same as the last digit of the DEA number.

The second digit in a DEA number is usually:

The first letter of a registrants last name

Recordkeeping requirements (4 years) for Compounded meds in FL

The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the order; o The name, strength, and quantity of the compounded drug provided, including the number of containers and quantity in each; o The date the drug was compounded; o The date the compounded drug was provided to the practitioner; o The lot number and beyond use date.

Dispensed prescriptions may not be returned to stock and must never be redispensed.

The pharmacist may wish to give credit or a refund but cannot comingle any drug because the quality cannot be assured. o Unused unit-dose medications dispensed to inpatients and properly labeled may be returned to the pharmacy for redispensing. o Pharmacist must maintain appropriate records for any unused or returned medicinal drugs.

If a PA or NP prescribes something, who's name goes on the label?

The prescriber (not the overseeing physician)

Who does the Florida BOP protect?

The public

What is required before a vendor pharmacy (class 1 or modified 2b pharmacy) can submit a starter dose prescription to a starter dose pharmacy?

The vendor pharmacy must have written authorization from the facility to utilize a starter dose pharmacy, a written contract with the starter dose pharmacy, written authorization from a prescribing practitioner to act as the practitioner's agent for the purpose of transmitting a starter dose prescription, possess a valid prescription from the prescribing practitioner, maintain a record of each starter dose prescription, and maintains a P&P manual that references starter dose prescriptions.

DEA Form 106:

Theft of controlled substance

Specific form of Theophylline on FL's Negative Form?

Theophylline CONTROLLED Release

What are biosimilars or biogenerics?

Therapeutic equivalent versions of currently marketed recombinant DNA-Derived protein products 12 year exclusivity Zarxio approved March 2015

What is the limit of pseudoephedrine sales by distributors?

There is no limit

How long are controlled (CIII through CIV) scripts valid? How many times can they be refilled?

They are valid for 6 months, can be refilled 5 times

What is the purpose of Antitrust laws?

They help maintain balance through competition and public policy.

Nursing homes whereby controlled substances have been dispensed and not used must not be returned to the pharmacy

They must locked and stored by the nursing home until destroyed (64B16-28.303 Destruction of Controlled Substances) - Permittee to complete DEA Form 41witnessed and signed by the consultant pharmacist/PDM along with DEA Agent or Inspector - May also be destroyed by at least two persons who are either a licensed pharmacist, physician, nurse, or sworn law enforcement officer → Requires DEA Form 41 and letter describing destruction to DEA at least two weeks prior. DEA must grant approval prior to destruction

What are nursing homes to do with dispensed unused narcotics?

They must not be returned to the pharmacy. The meds must be locked and stored until destroyed. May also be destroyed by at least two persons who are either a licensed pharmacist, physician, nurse, or a sworn law enforcement officer--> requires DEA Form 41 and letter describing at least 2 weeks prior. DEA must grant approval prior to destruction.

How to the laws of Medicare Part D affect electronic prescribing for Medicare patients?

They restrict it

What statement MUST appear at the bottom of a medication guide?

This Medication Guide has been approved by the U.S. Food and Drug Administration

What does the FDCA specify?

Three illegal acts: 1. Adulteration 2. Misbranding 3. Placing into interstate commerce of an unapproved drug

Prescriptions may be filed in one of three methods

Three separate files i. CII ii. CIII-CV iii. Non-Controls 2) Two separate files (CIII-CV Stamp) i. CII ii. CIII-CV + non-Controls 3) Two separate files (CIII-CV stamp) i. CII-CV ii. Non-Controls

May dispense generic even if brand was originally filled

Unless prohibited by negative formulary or "Medically Necessary"

Pharmacist:Pharmacy Intern Ratio?

Unlimited

What was the purpose of the Prescription Drug Marketing Act of 1987?

To close the loopholes in drug distribution and ensure the integrity of pharmaceuticals by preventing diversion from normal distribution

What was the purpose of the FDA Modernization Act of 1997?

To differentiate between compounding and manufacturing... this act was however found unconstitutional and currently the law is supplemented as allowing the state to regulate compounding (mostly)

What is the general purpose of the misbranding provisions in the FDCA?

To ensure that accurate and complete information accompany all drug products... this applies to advertisements as well

Acuvail add campaign

Totality of this presentation misleadingly suggests that Acuvail confers more therapeutic benefits and has been enhances in comparison....FDA not aware of any evidence

What is an example of monopolization?

Treatment of premature infants: PDA = congenital heart defect affecting more than 30,000 babies born prematurely each year in the US -Indocin IV DOC is manufactured by Ovation -Ovation received approval for Neoprofen (ibu iv) for PDA in 2006--- purchased Indocin rights from Merck in 2005 So here Ovation has bought out the competition..

Who approves CE providers?

Tripartite Continuing Education Committee

Cancer Drug Donor Program of FL T/F: Cancer drugs donated by a patient through this program CANNOT specify a specific patient for which his/her drugs should go to

True

Central Filling Pharmacy responsibilities T/F: Delivery of non-controlled drugs to ultimate user is NOT considered dispensing

True

T/F: It is LEGAL to electronically transfer prescriptions from originating pharmacy to central fill pharmacy

True

T/F: No prescriptions are required for any of the vaccinations that pharmacists administer

True

T/F: Pharmacists can write for Otic/Opthalmics?

True

T/F: If a pharmacy is closing it CAN legally SELL its controlled substances to a manufacturer/wholesaler/other pharmacy

True (DEA Form 222) - Buyer must initiate the 222

What is required in direct to consumer?

True statement of fact in brief summary. Major statement, adequate provision requirement for Broadcast. -- balance

How often does Florida inspect pharmacies?

Twice during the first year, then yearly, then every 2 years if no issues during the first 3 years.

How many permits can each pharmacy have?

Typically only allowed to have one, hospitals may have permit for onsite community pharmacy and in rare exceptions a community pharmacy may also have a special parenteral/enteral permit

Sterile Compounding permitted USP 797

USP 71 (sterility tests), USP 85 (Bacterial Endotoxins Test) and USP 731 (Loss on Drying) are now FL Law.

Who issues Patents in the US

USPTO

DEA Form 222

Used to order C-I or C-II, also to log in the receipt of C-I or C-II or transfer C-I or C-II to another registrant

DEA Form 106

Used to report theft or loss of controlled substances

Dicumarol Replacement for?

Warfarin

Is it ever legal for a Pharmacist to be a PDM of MORE THAN one community pharmacy

Yes--> but pharmacist/pharmacy must filed for exemption

When would a company not have to imprint a drug?

When it would be impractical or unnecessary

Patent v. Exclusivity

With exclusivity you don't have to give full disclosure. Patent give 20 years from filing but exclusivity gives 7 years for Orphan Drugs, 5 years for a new chemical (found new drug), 3 years for other or change and pediatric has a 6 month add on. So if you find a new drug good to use exclusivity first then file for patent later on to max time .. if patent running out and you discover a new use you can also use exclusivity then to extend period Patent Issued by USPTO and Exclusivity afforded by FDA

How long after notifying the DEA of intent to maintain in house electronic records may a registrant begin to do so?

Within 14 days

Program called E-FORCSE

Within 7 days of dispensing using ASAP Standards, pharmacy must report Doctors Name, DEA#, Date Rx written, Pharmacy's name, address, DEA#, Date Rx filled and method of payment, Full name, address and DOB of patient, name, national drug code, quantity, and strength of controlled substance.

What must all pharmacist have?

Working sink, running water, sufficient shelving to maintain a clean/organized practice, refrigeration for drugs, sanitation, a print or electronic drug information, print or electronic FL drug laws, quarantine area for defective drugs Must be clean and orderly

Applications must also include regarding controls

Written policies and procedures for preventing controlled substance dispensing based on fraudulent representations or invalid practitioner-patient relationships

Define label:

Written, printed, or graphic matter upon the immediate container of any article

Can you get CE hours for volunteer work?

Yes, 1 hour for every 2 hours worked...up to 5 hours total

Can you get CE hours for testifying for the Dept of Health?

Yes, 5 hours per case up to 10 hours

Can pharmacists and prescribers have a mutual relationship?

Yes, as long as there are no "kickbacks"

Can we compound a med that is not approved in the US but used widely around the world?

Yes, but must meet USP requirement and cGMP Ex. Domperidone indicated for N/V used off label to increase lactation

Can pharmacies advertise drugs?

Yes, but not controls

Can optometrists prescribe controls

Yes, but only Tylenol 3 and must have completed additional training program (20 hour course)

Can FL pharmacist order or dispense from limited formulary?

Yes, but practically non-existent; outdated No injectables for pregnant or nursing mothers recommended dose and duration only (34 day max) Must create a script and maintain pt profile and store for at least four years including chief complaint

Is it permissible to maintain controlled substance records offsite at a central facility?

Yes, but the DEA must be notified first

Can a C-II be faxed?

Yes, but the written script must be presented when picking up

Can pharmacies order C-I and C-II from suppliers electronically?

Yes, due to CSOS

Are pharmacies allowed to advertise drug prices?

Yes, it allows for competition but not allowed to advertise prices on controls.

Can medications be prescribed and dispensed for off-label uses

Yes, it is legally permitted but should be based on sound scientific evidence, expert medical judgement or published literature. Pharmacist should also use good professional judgement... Extent of duty to warn undetermined Off label marketing is widely prohibited

Is direct to consumer advertising allowed?

Yes, only in the US and New Zealand 1997 FDA Draft Guidance

Can you call doctors to inform them that a patient is getting narcotics from both of them?

Yes, that is your job! We have a moral responsibility

Does a permit require inspections of pharmacy?

Yes. Inspection must occur before a permit is issued. -- must provide written policies and procedures Must have sufficient drug information resources necessary to operate Once permitted inspection happens every two years but if you pass 3 in row you are inspected less often

Can a pharmacist dispense a controlled substance if the quantity is not written out?

Yes. Should try to verify the amount with the prescriber, but if unable to contact the prescriber it is ok. Pharmacist may ask for a photo ID if patient is unknown.

Class I

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Clas III

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Class II

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Define Fraud

acting in a dishonest manner with the intent to obtain a benefit for a service you are not entitled to

Registrations are married to __________

addresses

reporting

any fraudulent prescriptions to law enforcement. Must also report any significant loss of controlled substances to local law enforcement within 24 hrs

Prescriptions may be COMPOUNDED in FL pharmacy

differentiate from manufacturers who need manufacturing license in State and FDA approval to market products

Sale of syringes in FL

based on city/county ordinances which vary from requiring Rx to OTC. However, must never sell syringes to a minor without a prescription under FL law.

Each individual pharmacist who dispenses or refills drugs shall verify that the data indicated on the daily hard-copy printout is correct,

by dating and signing such document within seven days from the date of dispensing o Each pharmacy must maintain a log book in which each individual pharmacist shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered, stored for at least four years Must date and sign in the same manner as signing a check or legal documen

Florida permits a one-time 72 hr emergency refill if prescriber unavailable

cluding controlled substances Essentially any drug other than a CII can be refilled as law is written. Pharmacist must create a record and contact the physician as soon as possible

Low risk- aseptic manipulations entirely within ISO 5 or better hood0

combining 3 or less sterile products into a single bag/vial. Technically, you have 3 entries into the vial or bag - not 3 separate products. So if you need to enter the IV bag twice to place the entire dose of reconstituted drug, then you only have one more entry before you move to medium risk

Medium risk

combining more than three (3) commercial sterile drug products and those requiring complex manipulations and/or preparation methods. Must use ISO 5 or less - same technicality - it really is 3 entries into the IV container, not 3 separate drug products 0

all tablets dispensed must have a unique imprint/identifier that in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer - Exemptions include

compounded medications, radiopharmaceuticals, investigational drugs, and any product whose size or physical characteristics make imprinting unfeasible or impossible

2013 Drug Supply Chain Security Act

confirm that trading partners (manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers) are authorized under federal law o maintain lot-level product tracing information—namely, transaction information, history, and statements—for 6 years o establish systems for verification and handling of suspect or illegitimate products

Medication Guide

considered part of the Drug labeling Required for certain drugs the FDA determines has risks that need to be provided to patients • Currently about 200 drugs have a Medication Guide required If required and do not provide, drug is misbranded

Patient Package Insert (PPI)

considered part of the drug labeling Required for all estrogens and oral contraceptives - Outpatient: Required with each prescription - Inpatient: Provided before first dose and every 30 days thereafter Other products may Voluntarily seek approval to provide these to patients. Approved by the FDA

Non-Sterile Compounding 'Good Manufacturing Practices'

defined by USP 795

Recordkeeping requirements (4 years) of compounded meds

he name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the order; o The name, strength, and quantity of the compounded drug provided, including the number of containers and quantity in each; o The date the drug was compounded; o The date the compounded drug was provided to the practitioner; o The lot number and beyond use date.

Dispensed prescriptions may not be returned to stock and must never be redispensed.

he pharmacist may wish to give credit or a refund but cannot comingle any drug because the quality cannot be assured. o Unused unit-dose medications dispensed to inpatients and properly labeled may be returned to the pharmacy for redispensing. o Pharmacist must maintain appropriate records for any unused or returned medicinal drugs.

If prescription is not dispensed within a reasonable time

he transferring pharmacy should contact the copying pharmacy and the prescription should be revalidated through the same process, as described above.

Not reported:E-FORCSE

hospitals, nursing homes, correctional facilities, ambulatory surgical centers, hospices, intermediate care facilities for the developmentally disabled, correctional facilities, emergency rooms, patients under the age of 16, one-time doses, 72-hour emergency refills, and patients directly administered controlled substances by a physician

Disclosure that each applicant seeking permit must give

if 5% or greater financial interest must submit a signed affidavit disclosing 5% of greater interest in any permitted pharmacy in the past 5 years

Misbranded

improperly labeled, not FDA registered establishment, no follow REMS/PPPA, improper advertising (Think OUTSIDE the bottle)

give/take transfers for Controlled Substances

interns can under State and Federal law

Probable Cause panel

investigates rule violations or complaints to determine if there is sufficient cause to bring before the full board. Meets as often as necessary o Composed of two members of the Board of Pharmacy, one of which must be a pharmacist (usually chair) o Double affirmative (positive) vote required to find probable cause exists that a violation has occurred

Drug Recalls

involve a firm's voluntary removal or correction of a marketed product in violation of a law

If licensed in FL for 50 years or more,

lifetime license issued, no fee required

o Orders require Form 222 / CSOS

lso used to move CII from pharmacy to pharmacy or pharmacy to wholesaler Remember closed-loop system. Form 222 can also be used by pharmacy to ship drug to Reverse Distributor (pharmacy acting as supplier, maintains Copy 1) who disposes of drug using Form 4

Adulteration

may be gross/filthy/no follow-cGMP (Think INSIDE the pill)

tech/pharmacist ratio

may be increased with written approval from board of Pharmacy

Central fill pharmacy

may compound for another pharmacy with agreement

Central fill pharmacy

may compound for another pharmacy with agreement o May compound limited amounts for doctor's "Office Use" (see 64B16-27.70

Pharmacists and Interns

may give copies and transfers to another pharmacy

Patient Medication Information Sources

medication guide, patient package insert (PPI), and rochures/Pamphlets/Leaflets/ Consumer medication information (CMI)

Patient Medication Information Sources (3 types)

medication guide; patient package insert; Brochures/Pamphlets/Leaflets/ Consumer medication information (CMI)

How many years are pharmacies required to maintain books, records and documents related to MedPartD?

minimum of 10 years

Each applicant with a 5% or greater financial interest in the pharmacy seeking a permit

must submit a signed affidavit disclosing any 5% or greater interest in any permitted pharmacy in the past 5 years that has closed voluntarily or involuntarily, has voluntarily relinquished its permit, has had its permit suspended or revoked, or has had an injunction issued against it by a regulatory agency. Applications must include written policies and procedures for preventing controlled substance dispensing based on fraudulent representations or invalid practitioner-patient relationships.

Common databases are permitted in FL

must be properly licensed and under common ownership Database owner must have written policy and procedure manual o Must maintain records of all pharmacist activity Each pharmacist must maintain right to exercise professional judgment No pharmacist is responsible for errors of another pharmacist not under direct, personal supervision.

Closing of a pharmacy must follow procedures

must notify Board of Pharmacy of closing, return permit, and advise to where prescriptions will be transferred must physically deliver the prescription files to a pharmacy operating within reasonable proximity and provide a means by which to advise the public of the new location of their prescription files, receiving pharmacy must keep files separate and not commingle

Chemotherapy compounding requires

vertical laminar hood with negative pressure and adequate protections including splash free devices

All prescriptions must be based upon a valid practitioner-patient relationship

ncludes a documented patient evaluation, including history and a physical examination adequate to establish the diagnosis for which any drug is prescribed and any other requirement. This is interpreted as physician must be in active practice, accessible conventional communications. Important note, Florida law has no rules defining valid prescription.

Interns

no ratio limits May give copies and transfers including controls Must register with the state and must be enrolled in an accredited pharmacy school

High risk

non-sterile ingredients, lack effective antimicrobial preservatives, sterile surfaces. Must use ISO 5 or less

Requirements for a patent

novelty, non-obviousness, utility

Alcohol and OTC internal analgesics/antipyretics

o Advises consumers with a history of heavy alcohol use to consult a physician o 3 or more drinks per day o APA - Liver damage o NSAIDs - Internal bleeding o Combination - Liver damage and Stomach bleedin

In FL, the following are never able to prescribe

o Anesthesiologist Assistants, Doctors of Oriental Medicine, Nurses, Respiratory Therapists, Psychologists

o In FL, the following (may prescribe under statute but very narrowly construed and thus practically should be viewed as) unable to prescribe:

o Chiropractors o Pharmacist o Naturopaths

technician requirements

o Complete application, pay fee, must be at least 17 years of age, provide proof of Board approved training program (proposed 160 hours within 6 months) • Disciplined pharmacist ineligible to be registered

Consultant pharmacist or PharmD with required coursework may order lab tests

o Consultant must receive 3 hours of continuing education relating to laboratory and clinical testing as established by the Board

Things Pharm tech can do - part 1

o Data entry; o Labeling of preparations and prescriptions; o Retrieval of prescription files, patient files and profiles, and other similar records pertaining to the practice of pharmacy; o The counting, weighing, measuring, and pouring of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system; o The initiation of communication to confirm the patient's name, medication, strength, quantity, directions, number of refills, and date of last refill; o The initiation of communication with a prescribing practitioner or their agents to obtain clarification on missing or illegible dates, prescriber name, brand or generic preference, quantity, license numbers or DEA registration numbers; o The acceptance of authorization to dispense medications pursuant to a prescribing practitioner's authorization to fill an existing prescription that has no refills remaining (refill authorization

more CE requirements

o 10 of 30 hours live seminar, video teleconference, or through an interactive computer-based application If first renewal is <12 months after licensure no CE is required Between 12 and 24 months 15 hours required o May acquire 5 credits (in Risk Management) attending all day Board meeting, 5 credits volunteer services to indigent, 5 credits / post graduate professional semester credit o Retain documents for 2 years after license renewed

n FL, the following may prescribe, limited to scope of practice

o Dentists (DDS, DMD) o Physicians (MD / DO) o Podiatrists (DPM) o Veterinarians (DVM)

techs can not do- part 2

o Engage in prospective drug review; o Monitor prescription usage; o Override clinical alerts without first notifying the pharmacist; o Transfer a prescription; o Prepare a copy of a prescription or read a prescription to any person for purposes of providing reference concerning treatment of the person or animal for whom the prescription was written; o Engage in patient counseling; o Receive therapy or blood product procedures in a permitted nuclear pharmacy; or Engage in any other act that requires the exercise of a pharmacist's professional judgment.

Dispense a one-time 72 hr emergency refill if prescriber unavailable, including controlled substances

o Essentially any drug other than a CII can be refilled. Pharmacist must create a record and contact the physician "within a reasonable time" o One vial of insulin okay, in lieu of 30d supply o Pharmacy interns or technicians cannot be delegated authority to prescribe o State of Emergency by Executive Order of Florida Governor (ie Hurricane) pharmacist may dispense 30 day emergency prescription refill supply

CIII-CIV

o Five refills in six months from date written o 1 transfer permitted If sharing a common (chain) database may transfer as many times as needed o In FL, Pharmacist and Interns can transfer controlled substance prescriptions o Prescriptions may be written, verbal, or electronic o Partial fills permitted. Any amount may be filled as long as total quantity or six month duration is not violated. Note: Partial Fills are not considered Refills! o Pharmacist may make any changes with consultation from prescriber o No special order form, although orders must be kept readily retrievable

o High potential for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision. o May not be prescribed, administered, or dispensed for medical use. May order/use for research and investigational use o Order using DEA 222 / CSOS

drug is misbranded in regards to medication guide

o Medication Guide is considered part of the Drug labeling Required for certain drugs the FDA determines has risks that need to be provided to patients • Currently about 200 drugs have a Medication Guide required If required and do not provide,

Compounded meds in Florida

o Must be in anticipation of prescriptions based on routine, regularly observed prescribing patterns, preparation pursuant to a prescription of drugs which is not commercially available, preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis and the patient has been made aware of the compounding

Unique FL law

o Must write prescription legibly

office use of controlled substances

o No "Office Use" of Controlled substances allowed to be prescribed or dispensed o May order "Office Use" of compounded prescriptions in amounts limited to anticipated use (see 64B16-27.000 Definition of Compounding). Must be labeled For Office Use - Not For Resale

o No limit on refills (Florida 6 month expiration) o 1 transfer permitted

CII

o No refills o No transfers o Sequential filling of multiple Rx's acceptable as long as each rx is written on a different blank, actual date of prescribing is written (no post-date), must contain information on earliest date to fill, and 90 day limit max in total.

case law

o Note FL has no law that requires pharmacists to dispense contraception or any other drug against their religious/moral opposition.

CII

o Oral Rx not permitted Exceptions 1) emergency (immediate administration of the drug is necessary for proper treatment of patient, no alternative treatment is available, and it's not possible for the prescriber to provide a written Rx, amount limited to emergency, pharmacist writes Rx ("authorization for emergency dispensing) and attaches the original when it arrives, must get written Rx (or postmark) within 7 days) Central fill not permitted for emergency situations o Facsimile Rx not permitted Exceptions 1) Home infusion/IV if narcotic compounded for pain 2) Residents of LTCF 3) State licensed Hospice Facility o Partial fill allowed within 72 hours. Must mark on prescription face amount dispensed. If no complete order within 72 hrs must contact prescriber and void remaining amount

techs can not do- part 1

o Receive new non written prescriptions or receive any change in the medication, strength, or directions of an existing prescription; o Interpret a prescription or medication order for therapeutic acceptability and appropriateness; o Conduct final verification of dosage and directions;

Label requirements of compounded meds

o The name, address, and phone number of the compounding pharmacy; o The name and strength of the preparation of a list of active ingredients and strengths; o The pharmacy's lot number and beyond-use-date; o The quantity or amount in the container; (note non-compounded drugs are exempt from labeling quantity) o The appropriate ancillary instructions such as storage instructions, cautionary statements, or hazardous drug warning labels were appropriate; and o The statement "For Institutional or Office Use Only - Not for Resale," or if the drug is provided to a veterinarian the statement "Compounded Drug."

Prescriptions may be COMPOUNDED in FL pharmacy -Label requirements

filing controlled prescriptions

valid doctor patient relationship and a legitimate medical purpose o Fill prescriptions for pain (narcotics) only if valid If the pharmacist has any questions about said validity the pharmacist must 1) verify with doctor and 2) if patient is unknown, photocopy identification or document on back of prescription o May reject the filling of a controlled substance prescription only after pharmacist: First tries and communicate and rectify the concern with the patient and the prescriber's office OR Checks the PDMP Database (e-Forsce) o Must report to Department of Health if suspect physician is involved with illegal diversion

Things Pharm tech can do - part 2

o The receiving, in a permitted nuclear pharmacy, of diagnostic orders only; o Assisting in preparing parenteral and bulk solutions or assisting in any act involving sterile compounding o Organizing of or participating in continuous quality improvement related events, meetings, or presentations; o Participation in a monitoring program to remove deteriorated pharmaceuticals to a quarantine area; and o While under the direct supervision of the pharmacist, performance of any other mechanical, technical or administrative tasks which do not themselves constitute practice of the profession of pharmacy. o A registered pharmacy technician, under the supervision of a pharmacist, may initiate or receive communications with a practitioner or his or her agent, on behalf of a patient, regarding refill authorization request

Program called E-FORCSE

o Within 7 days of dispensing using ASAP Standards, pharmacy must report Doctors Name, DEA#, Date Rx written, Pharmacy's name, address, DEA#, Date Rx filled and method of payment, Full name, address and DOB of patient, name, national drug code, quantity, and strength of controlled substance.

CV-Lyrica (pregabalin)

o requires prescription

CV cough preparations

o with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin o Dispensing non-prescription drug must be done by PHARMACIST 8 oz max opium containing product / 4 oz codeine per 48 hours

if pharmacist is "not present and on duty,"

pharmacy considered closed! away from the pharmacy doing any non-job related activity Pharmacist may leave to counsel patients, take a meal break and attend to personal hygiene, and do other job responsibilities

Dispensing Practitioners

physicians and other prescribers may register as dispensing practitioners, allowing them to dispense drugs on premises similar to a veterinarian. May not dispense CII or CIII drugs (may dispense CIV's and CV's) o May dispense associated with surgical procedure, 'approved' clinical trial, methadone per 3 day rule Must comply with same pharmacy rules, including open to inspection Must allow patients options to fill elsewhere Use of drug samples is not included in this section and does NOT require registration as dispensing practitioner

FTC Act Section 5

prohibits unfair or deceptive act or practices in the marketplace (products or false benefits)

Special- Parenteral and Enteral

provide parenteral (IV), enteral and cytotoxic pharmacy services to outpatients

Controlled Substance Recordkeeping

records maintained for 4 years

Special Sterile Compounding Permit (SSCP)-Part 2

requires Special Pharmacies to be under the professional supervision of the PDM or Consultant Pharmacist of Record licensed in the State of Florida. A Florida licensed pharmacist shall perform compounding and dispensing of medicinal drugs Compounding must be in strict compliance with the State Standards (64B16-27.700 and 27.797) of Good Manufacturing Practices If also compound, dispense patient-specific prescriptions, must register as a Hospital (Institutional Class II) or Community Pharmacy as well

Prescription Department Manager

responsible for Number of locations - limits, CQI Programs, Recordkeeping, Automation (QA/Security/Recordkeeping), Closing, Inspection, Compliance with the full law. Named on permit application, and fingerprinted. Notify board within 10 days if changed. o Rule: can only be PDM for one location only,

Special Sterile Compounding Permit (SSCP)-Part 1

special permit, which is required before any permitted pharmacy may engage in the preparation of compounding sterile products. not required for 1) Stand-alone Special Parenteral/Enteral pharmacies; 2) Special Parenteral/Enteral Extended Scope pharmacies; 3) pharmacies that only perform non-sterile compounding; and 4) non-resident pharmacies

Unclaimed prescriptions may be stored in pharmacy and reused,

subject to 1 year beyond-use date from date originally filled or manufacturer's expiration date

Brochures/Pamphlets/Leaflets/ Consumer medication information (CMI)

the pharmacy drug information provided by pharmacies with dispensed drugs Required under law to be provided for every prescription dispensed Are not FDA reviewed/approved and not part of the drugs labeling • If no provide, no liable for misbranding

What does a (Utility) Patent grant and inventor for an invention?

the right to exclude others from making, using, offering for sale, selling or importing given property

If prescription is not dispensed within a reasonable time,

the transferring pharmacy should contact the copying pharmacy and the prescription should be revalidated through the same process, as described above.

Patient Counseling

there must be an offer to counsel verbally and in writing. (Note that anyone can make the offer, but only the pharmacist or intern under the direct and immediate personal supervision can counsel).

State Pharmacy Inspections

twice during the first year of operation Minimum of 1 inspection per year thereafter Passed inspection for three years without discipline inspected every two years If fail inspection or disciplined during previous 2 years inspected annually until passed inspections for most current three years

o May dispense generic even if brand was originally filled

unless prohibited by negative formulary or "Medically Necessary"

Samples only in Class II institutional pharmacy

upon written request of prescriber

FL Medical Marijuana - Low THC Cannabis

veterinary drugs and drop shipments FL Medical Marijuana - Low THC Cannabis permitted for Compassionate Use - not tested AKA Charlottes Web law. Named after young girl with Refractory Seizures >10% CBD, <0.8% THC permitted for patients in state registry Physician orders (not prescribes); must maintain treatment plan. Patient must be State Resident. Pharmacists NOT involved in dispensing/selling/growing

FL allows compassionate use/ investigational use of a non-approved drug for a patient

who has given informed consent and has documentation from the prescribing physician has a terminal illness, that is expected death within 1 year/

The DEA registered reverse distributor

who will destroy the controlled substances is responsible for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances have been destroyed. A DEA Form 41 should not be used to record the transfer of controlled substances between the pharmacies

Destruction of controlled substances require execution of DEA Form 41

witnessed and signed by the prescription department manager and Department inspector (no DEA prior approval required) OR two licensed individuals (MD/DO, RN, RPh, Law Enforcement) Form must be mailed to DEA at least two weeks before proposed date and approved by them o Also may use DEA registered reverse distributors using form 222/41 respectively

Inspection must occur before a permit is issued

written policies and procedures for preventing controlled substance dispensing based on fraudulent representations or invalid practitioner-patient relationships must be provided o Permit must be issued before DEA will register

more tech requirements

• Interns can work as technicians without registering • Do not have to register while in technician school

2005 Combat Methamphetamine Act (+2008 Methamphetamine Production Prevention Act)

• Retailers must maintain logbook of transactions at least two years o Products packaged for individual sale that contain less than 60 mg of pseudoephedrine are exempt from the logbook and ID requirements - ie Travel Size • All pharmacy personnel selling PSE must have training and self-certification • In FL, Must be at least 18 years of age to buy PSE, must show ID, and sign log • In FL, Must be 18 years of age to purchase Dextromethorphan -

MPJE Florida #1

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