MPJE Mississippi 2022 + Federal + USP
CII-CIV label warning
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
Under the FDCA, what must be included on the label by manufacturers of legend drugs?
"Rx Only" or "Caution: Federal law prohibits dispensing this drug without a prescription" Federal law requires the following on a dispensed script label: 1. name/address of dispenser 2. serial/script # 3. date of filling 4. prescriber's name 5. pt's name 6. directions for use 7. cautionary statements
Disposal of prescription medication by the ultimate user
"Take back" programs offered by DEA allows pts to dispose of prescription meds to certain facilities, like pharmacies but require a permit to accept these meds *Should not flush drugs down sink/toilet unless instructed by prescription label *If no instructions or available take-back programs, dispose of in trash after removing from original containers & mixing them w/coffee grounds or kitty litter; place mixture in a sealable bag, empty can, or other container before discarding in trash *Fentanyl patches should be flushed down toilet
High Risk Storage Controlled Room Temp Cold Temperature Solid Frozen State (-25 - -10) C
*24h* Controlled Room Temp *3 days* Cold Temperature *45 days* Solid Frozen State (-25 - -10) C
Medium Risk Storage Controlled Room Temp Cold Temperature Solid Frozen State (-25 - -10) C
*30h* Controlled Room Temp *9 days* Cold Temperature *45 days* Solid Frozen State (-25 - -10) C
Low Risk Storage Controlled Room Temp Cold Temperature Solid Frozen State (-25 - -10) C
*48h* Controlled Room Temp *14 days* Cold Temperature *45 days* Solid Frozen State (-25 - -10) C
Transferring C-II scripts
*Cannot be transferred from 1 pharmacy to another If a pharmacy doesn't have that C-II drug in stock & has received a written script, the pharmacy can return the script back to pt & instruct them to have it filled at a different store if they need the script filled on the same day. If electronic script, pt should contact prescriber to send e-script to another pharmacy. If pharmacy has enough drug in stock for a partial fill, they may do so but must have pt return for remaining amt w/in 72hrs OR the pharmacy can borrow/purchase C-II drug from a nearby pharmacy, which requires a Form 222.
Electronic prescriptions for CS
*For C II-V scripts Most healthcare settings use this documentation of medical care, which includes electronic medical records, computer-based prescribing systems, & networks to transmit/receive scripts. Safeguards must be in place to prevent unauthorized persons from hacking into the system & illegally transmitting CS scripts. Credentials that are permitted for DEA-sanctioned validation will include 2 of the following: 1. Something you know (password/response to a question) 2. Something you have (a hard token, which is a cryptographic key stored on hardware device kept separately from computer being accessed, like a PDA, cell phone, smart card or flash drive) 3. Something you are (biometric info, like iris or fingerprint scan) *Alt to using 2-factor authentication: digital certificate containing user's credentials & is issued by DEA *If prescriber sends a script from software pending DEA approval, pharmacy needs to print out script & contact prescriber for verification *If prescriber's software is pending DEA approval, it cannot be used to transmit scripts *Prescriber can sign multiple e-scripts for CS for 1 pt w/1 signature but cannot use that same signature for other pts' scripts *Store all e-scripts x2yrs *If e-script for C III-V drug fails, prescriber will need to send it to pharmacy by another method (written, fax, or phone) & replacement must specify that an initial e-script had been sent. If initial e-script was received & dispensed, then replacement is voided. If initial e-script was received but not dispensed, then initial e-script is voided & pharmacy uses replacement to dispense to pt
C-III dosing limits
*No more than: Codeine 1.8g/100mL Dihydrocodeine 1.8g/100mL Ethylmorphine 300mg/100mL Opium 500mg/100mL Morphine 50mg/100mL Marinol (dronabinol)
C-V dosing limits
*No more than: Codeine 200mg/100mL Dihydrocodeine 100mg/100mL Ethylmorphine 100mg/100mL Opium 100mg/100mL Diphenoxylate 2.5mg *No less than: Atropine sulfate 25mcg
C-IV dosing limits
*No more than: Difenoxin 1mg *No less than: Atropine sulfate 25mcg
Continuing Education hours
- 15 hours/year - Evidence submitted if audited w/i 5 days - Board may grant extensions or waivers for active military members.
License of Foreign Grad
- 1600 Hrs Extern/Intern - Obtain Foreign Grad Certification (Exam and at least 550 on TOEFL english test) - Application - Background check and others as norm license
MS Board of Pharmacy
- 7 members, 1 from each district. - Appointed by the governer from a list of 5 names. - At least 1 memebr with 5 years inst. experience and 1 member with at least 5 years retail experience. - Limit 2 (5 year) terms in any 15 year period -MEMBERS SHALL: Be citizens of MS x 5 years, license in good standing, Rph x 5 yrs, actively engaged in pracatice. - Meet at least 1 time per quarter - may meet more. - If miss 2 straight meeting may be grounds for removal by govrnr - President Elected by board - Majority = Quorum - Executive Director - Salaried, Rph x 5 yrs, Citizen x 5 yrs,
License Renewal
- ANNUAL, Dec31 - Submit application online
Rx transfers (called is "RX copies")
- CONTROLLED SUBSTANCES CANNOT BE TRANSFERRED. Non-controls can be transferred between 2 pharmacists provided: -write void on face of rx and date of transaction (If computer then cancell the rx) - write to whom copy has been issued, date of issuance and rph initials. The Transferee's pharmacist must record: -Name and add of pharmacy from which rx was transferred and the original rx# there. -Name of the transferor Rph -Pt name, original date, original disp, original refills, refills remaining.
Qualified Nuclear Pharmacist (ANP)
- Certified by MS St Dept of Health, Div Radiological - Completed Minimum of 200 hours of instruction in neuclear pharmacy - Attained a minimmum of 500 clinical hours in nuclear pharmacy under the supervision of a qualified pharmacist. (Nuclear techs must register with BOP)
Pharmacy Intern/Extern Registration
- Every person enrolled in pharmacy school pursuing Rph shall obtain Intern/Extern Registration prior to enrolling/participation in intern/externship. - Expires if: leave SOP, 6 mo port-grad, expiration date. - Notify board with Employment or address changes.
Practical Experience Requirement
- Extern/Intern total hours: 1600 Hrs - Must be valid extern with license and certified by SOP as student making normal progress toward licensure. - No more than 50 hours per week credited toward hours; when school not in session - All practical experience gained in MS under direct supervision of MS RPh - To get credit for HR must be registered with BOP and issued a registration to dispense CS. - Practical experience expires 2 yrs post-grad.
Emergency Medication Supplies
- Have seal that must be broken if opened -Label exterior w/ exp date Label interior - all drugs listed and labeled - Notify Rph if used restock/reseal.
Unit Dose single dose unit of issue packaging expirations (Inst/LTCF)
- If USP standard 671 Class A or B packaging - light resistant good for 12 months. - Exp 90 days for unstable or not USP 671.
Continuing Education
- Must be ACPE approved or MS BOP approved. - 15 hours per year. - 2 on Opioids - 2 Live - Pharmaceutical Care Pharmacist: 6 hours per disease on National updates
Dispensing of Sched 5 CS OTC
- Must be dispensed by RPh, Rph resp for record keeping. - No more than 4oz or 24 units in 48 hours (fed law is stricter with 48 hours bc state says 72) - No more than 2 sales in 7 days and 3 sales in 30 days. - Purchaser must present ID with name, Add, DOB - Must be at least 18 years or older. - Record book: Name, Address date name/qty of CS PATIENT SIG, RPh intials. maintain for 2 YEARS. note that the patient has to furnish info of a bonafide medical need ACCORDING TO STATE LAW
Prescription Validity
- Must have MD/PT relationship - obtained through medical history and physical/mental examination. - If rx written in code or inadequate info for the interpretation of the rx - invalid. -CII rx for anorectic for the treatment of obesity is not a valid RX.
License by transfer
- NABP transfer application - Grad from accredited SOP - At discretion of BOP apprea for presonal interview - Passed Exam - Background Check - Valid license in State - Fee
Examinations
- NAPLEX and MPJE must score at least 75 - May repeat exam but not take more than 4 times if pass exam must get License with in 2 YEARS also practical hours expire after 2 years
Permanent Closure of Business
- Notify BOP at least 14 days prior and what has been done with CS. - CS inventory - Send pharmacy permit, CS registration and a copy of CS inventory to Board. - If sending CS to another pharmacy complete DEA 222 form. - Return DEA registration and blank 222 forms to DEA and submit notice of where CS are going with in 14 days.
Responsibility of Pharmacist
- Only Rph (or intern/extern) shall give consultations to pts or other health care providers. - Only Rph/Intern/Extern can accept telephones prescriptions or give info about rx/rx drugs - Responsible for all activities of Tech and must be present supervising - Verify accuracy of information - RPH determines if a refill is appropriate (not tech) - Rph shall, where appropriate, counsel patients and review profiles.
Loss of Controlled Substances
- PIC must report loss/theft directly to board immediately - Complete inventory of CS with in 48 hours and send copy to BOP within 15 days with report.
Institutional Emergency Medication Kit Permits
- Permit required for Institutional facitlity (except hospitals) - LTCF, Hursing homes. Biennial renewal. Permit required for each provider pharmacy. (Tara) Provided that: - Contents (up to 42 approved items) are supplied No CII medications Copy of inv on file, Unit dosing (12 doses or less) pre-packaged medications w/ par value. -Withdrawl log - name room# name strength qty of drug DATE/TIME withdrawal/admin, name of preson withdrawing -Additions to BOP approved inventory must be approved by the BOP. USE: Only in emergency pursuant to medication order. (not when community or hospital pharmacy available SECURITY: Kept in securely locked room. Inst must have CS permit. Copy of rx order (CIII-V) must be delivered to pharmacist within 72 HOURS. records of individual ekits are kept by pharmacy... note that the institution has to has CS registration with board it does not say they have to have a DEA reg
Practicing in another state by MS expired by > 2yr
- Petition board for reinstatement, appear before BOP - Furnish valid license in another state. - Proof of 10 CE hours for current licensing period - Pay all renewal fees - MPJE
Renewal of License invalid x 2 years (not practicing elsewhere)
- Petition board for reinstatement, appear before BOP - Work as intern for 20 hours for each year w/o valid license. - Proof of 15 CE hours for current licensing period - Pay all fees in arrears - MPJE- GOTTA RETAKE IT
Drug Samples
- Pharm owned by charitable org, non-profit and has prior approval from BOP - In Institutions, MD can use samples for patients in-house and can not charge them for use.
Pharmacy Permits
- Renew Biennally, DEC 31 - Written application with fee - Inspection with in 60 days - Must have RPH licensed in MS (PIC)
Change of PIC
- Return pharmacy permit to BOP with written notice and date of change. - Must complete CS inventory and send copy with permit.
Patient counseling
- Rph OR agent of Rph must OFFER to duscuss matterrs which deemed significant. RPH must do the counseling if offer accepted. - If not available RPh shall make known that Pt counseling is available and how to reach RPh. - Alt forms of Pt information may be used to supplement verbal counseling. - Counseling shall NOT be required INPATIENT - Patient may refuse counseling MAIL ORDER Counseling: Provide printed material which supplies name, add, Ph# af pharmacy and all info required in counseling.
Absence of Rph in Institutional Setting
- Rph must provide on-call services at all times. Access: -Locked cabinets located outside pharmacy for auth ppl only. -Only prepackaged drugs (assigned a Par use value) -Withdrawl and addition documentation, audit monthly Access to Pharmacy: -Only Auth RNs with specialized training in any one shift has access.
Drug Product Selection (Dispensing of generic in lieu of brand ordered)
- Two line prescription provision: line on lower right "substitution premitted", line on lower left "Dispense as written" - If not using this pad write "Dispense as written" in own handwritting. - Does not apply for medicaid patients - must comply with current medicaid guidelines. - Must inform purchaser of product selection. - Must be AB rated Can Switch to generic if: - Purchaser requests selection - MD Doesn't disallow selection - Results in lower cost to purchaser.
License by examination
- Written application - Background check - Graduated from approved SOP - Passed Exams - Submit documentation of practical experience - Fee
Pharmaceutical Health Care/Modify Therapy Under Protocol
- Written protocols on file with BOP - W/I scope of MDs practice. (institutional - any patient, community - one SPECIFIC patient) QUALIFICATIONS: MS license, 16 HR CE on Pharm car, development and clinical, Pre-approved study course fo less than 16 hours per disesase state. - Every 2 years need 6 hours per diasease on National updates PROTOCOL expires in ONE year
Emergency Dispensing NONcontrolled
- may disp one time emergency dispensing of rx up to 72 HOUR supply. Provided that: - Not a CS - RPh Judgement - Notify MD of emergency dispensing w/i 7 days - Record dispensing on seperate non-refillable rx and filed with other rxs. Record circomstances - Only at Pharmacy with original Rx
Return of Medications from LCF to Provider Pharmacy
-Dispensing is considered when the medication leaves the dispensing pharmacy and is delivered to the LTCF. -If medication is discontinued prior to dispensing may be returned in 5 DAYS. - CS can NOT be returned (also if dispensed in bulk packages cant be returned) -Return records x 2 YEARS
Home Health/Hospice Permits
-Must obtain a permit from BOP (written application, Biennial Q 2 years) - Does not require Pharmacist -Only dispense drugs on approved list (unless drug was obtained persuant to valid rx. -Records of Acqusition and disposal x 6 years -Compliant with labeling requirements.
When to take inventory
1. 1st day pharmacy is open for business 2. Newly scheduled drugs or drugs moved from 1 schedule to another 3. Annually (Qyr) & maintained x2yrs *Must have exact count for C-II drugs *Estimate count for C III-V drugs unless container hold >1,000 tabs or caps Perpetual inventory required for: 1. C-II drugs in Class C pharmacies 2. All CS stored at a remote location 3. All CS in Class C Ambulatory Surgical Centers (ASCs) 4. All CS in Class F pharmacies *Inventories (other than initial & change of PIC) be signed by PIC & notarized w/in 3 days of the day inventory is completed, excluding Saturdays, Sundays, & federal holidays Records must be written, typewritten, or printed & must include: 1. date of inventory 2. if inventory was taken at beginning or close of business 3. name of CS 4. dosage forms & strengths 5. # of dosage units or volume in each container 6. # of commercial containers
Accepted methods of filing prescriptions
1. 3 files: 1 for C-II drugs, 1 for C III-V drugs, & 1 for non-CS. TX no longer requires Legend scripts to be kept in hardcopy if image is saved. 2. 2 files: 1 for C-II drugs & 1 for all the rest w/a red "C" on C III-V drugs
Prescriber's & pharmacist's corresponding responsibility
1. A drug can be scheduled due to risks of addiction, physical dependence, & accidental/intentional drug diversion 2. A practitioner can issue valid scripts for a legit medical purpose only. Condition being treated must be one that the prescriber would be expected to treat. 3. If pharmacist doesn't believe that the script is for a legit medical need, then the pharmacist has the right not to fill it. Any concern regarding the scrip should be investigated.
Labeling requirements for nonprescription drugs
1. A principle display panel, which refers to the part of an OTC drug label that's most likely to be displayed/examined in a retail setting. Should be large enough to accommodate all the mandatory label info. 2. A statement of identity, which refers to established name of drug, followed by an accurate statement of the general pharmacological category or principal intended action of drug (e.g. chlorpheniramine, antihistmaine). The statement of identity should be included on principal display panel. 3. A declaration of net quantity of contents, which is expressed in terms of weight, measure, numerical count, or a combo or numerical count & weight, measure, or size 4. Name & address of manufacturer, packer, or distributor 5. NDC # is requested, but isn't required to appear on all OTC drug labels 6. Adequate directions for use, which includes dosing, preparation, frequency, duration, time, & route of administration 7. "Drug Facts" panel, which is an FDA-approved label used to educate pts
Acceptable ways to store CS
1. All CS stored in a securely locked cabinet 2. CS dispersed throughout drug stock with non-CS on the shelves 3. Some of the CS stored in a securely locked cabinet and the rest dispersed throughout the pharmacy stock on the shelves
Pharmacy clerk permission
1. Answer the phone 2. Accept scripts from drop-off window 3. Ring up pts at point of sale (cash register) 4. Retrieve pts' filled prescription from will-call area 5. Verifying pt's insurance coverage 6. Type scripts into computer *No max # of clerks allowed in pharmacy at one time
Specialty pharmacists
1. Compounding 2. Consultant 3. Critical care 4. Drug info specialist 5. Hospice 6. Hospital staff 7. Hospital clinical 8. Industry-based 9. Long-term care 10. Managed care 11. Military 12. Nuclear 13. Nutrition support 14. Oncology 15. Operating room 16. Pediatric 17. Pharmacogenomics 18. Pharmacy benefit manager 19. Poison control 20. Primary care 21. Psychiatric 22. Public health service 23. Regulatory 24. Veterinarian 25. Advanced practice 26. Emergency department 27. Informatics 28. Transplant 29. Pain management 30. Pharmacist editor 31. Nephrology
Three categories of engineering controls-
1. Containment Primary Engineering Control (C-PEC) 2. Containment Secondary Engineering Control (C-SEC) 3. Supplemental engineering controls
Ways to provide ADE written statements to pts
1. Drug container, like a plastic container/bottle 2. Consumer Medication Info (CMI) - not approved by FDA (available for all scripts & is usually stapled to or placed in bag) 3. Pt Package Inserts (PPI) - approved by FDA 4. MedGuides - approved by FDA 5. Any paperwork required as part of a REMS
Significant loss considerations
1. Drugs subject to diversion 2. Specific substances lost or stolen 3. Quantity lost in relation to type of business 4. Individuals w/access to lost/stolen drug 5. Hx or pattern of losses or local diversion issues 6. Any unique circumstances surrounding loss/theft
References required in a typical retail pharmacy
1. FDA Orange Book 2. State pharmacy law book 3. General OTC drug reference (Handbook of Nonprescription Drugs) 4. General prescription drug reference (Lexicomp)
Drugs not safe to use in vacuum tubes
1. Hazardous compounds (chemotherapy) 2. Combustible products (some gels/sprays) 3. Protein products, which can become damaged from agitation (insulin & immunoglobulins)
NABP recommends that 3 items be displayed in pharmacy:
1. If pharmacy is involved w/radiopharmaceuticals, radiation caution signs should be posted throughout restricted area 2. Biohazard caution signs should be properly used & posted throughout appropriate area(s) 3. Appropriate notices to employees are posted
Errors or omissions on a CS script
1. In most states, a pharmacist can amend minor misspellings, fill-in pt's address, & add prescriber's DEA # to a script. 2. Pharmacist can amend dosage form, strength, quantity, & directions for use, after consultation w/prescriber (including making any quantity changes required for insurance coverage). 3. All significant changes need to be documented on script & pharmacist will write his/her name or initials to indicate who made call to prescriber. 4. For all scheduled CS, 3 items cannot be changed: a. pt name (unless minor spelling mistakes) b. drug itself (except generic substitution) c. prescriber's signature 5. If prescriber's signature is obviously misspelled, pharmacist should be wary of forgery 6. For errors/omissions on scripts for C III-V drugs, pharmacist can simply call prescriber, note any authorized modification, & document prescriber was contacted 7. C-II drugs are more susceptible to drug abuse/diversion, therefore laws regarding amendments on these scripts are generally more stringent. DEA defers decisions on permitted modifications to C-II scripts to the state boards & pharmacist's professional judgment.
Drugs that must be stored separately from the rest of the pharmacy drug stock
1. Investigational new drugs 2. Expired drugs 3. Recalled drugs
Current good manufacturing practices (CGMPs)
1. Manufacturers must register w/FDA & must be inspected Q2yrs 2. All drugs must come from a factory registered w/FDA or they're considered misbranded 3. If standards of strength, quality, or purity are lacking, drug is considered adulterated *Practiced by manufacturers & outsourcing facilities
Drug delivery
1. Need to provide a toll-free phone number w/stated hrs if pt has questions/concerns 2. There are no restrictions on use of common carriers 3. Acceptable to deliver CS in mail 4. Outside packaging shouldn't contain any identifiable marks that could indicate contents 5. Inner labeling must be in accordance w/federal & state labeling requirements 6. Can only be returned if it hasn't left control of pharmacy, meaning contents must remain in manufacturer's original, sealed, & tamper-evident bulk, unit-of-use, or unit-dose packaging or dispensing pharmacy's original packaging & returned same day *Doesn't need a signature when delivered to pt
Central pharmacy recordkeeping
1. Pharmacy wishing to maintain shipping/financial records a central location rather than registered location must notify nearest DEA Diversion Field Office 2. Unless pharmacy is notified by DEA that permission to keep central records is denied, pharmacy may begin maintaining central records 14 days after notifying DEA 3. Shall NOT include executed DEA order forms (Copy 3 of Form 222), prescriptions, or inventories. These MUST be kept at the pharmacy *MUST provide DEA w/central records w/in 48hrs upon request
New pregnancy/lactation labeling
1. Pregnancy 2. Lactation 3. Females & Males of reproductive potential
Pts cannot buy drugs in other countries & bring them into US except under these conditions:
1. Quantity is for a </=90 day supply, & is for the pt (cannot be resold) or 2. An effective tx isn't available in US, the condition is serious, & the imported drug has no unreasonable risk
Drugs that do NOT require child-resistant packaging
1. SL NTG 2. SL & chewable isosorbide dinitrate </=10mg 3. erythromycin ethylsuccinate granules for PO suspension & PO suspensions in packages containg </=8g of equivalent erythromycin 4. Cyclically administered PO contraceptives in manufacturers mnemonic (memory-aid) dispenser packages that rely solely upon activity of >/=1 progestogen or estrogen substances 5. Anhydrous cholestyramine in powder form 6. All unit-dose forms of K+ supplements, including individually-wrapped effervescent tabs, unit-dose vials of liquid K+, & powdered K+ in unit-dose packets, containing no more than 50mEq of K+ per unit-dose 7. Na+ fluoride drug preparations including liquid/tab forms, containing no more than 110mg of Na+ fluoride (equivalent of 50mg of elemental fluoride) per package or no more than a concentration of 0.5% element fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids & containing no other substances 8. betamethasone tabs packaged in manufacturers' dispenser packages, containing no more than 12.6mg betamethasone 9. pancrelipase preparations in tab, cap, or powder form & no other substances 10. prednisone in tab form, when dispensed in packages containing no more than 105mg of drug & no other substances 11. mebendazole in tab form in packages containing no more than 600mg of drug & no other substances 12. methylprednisolone in tab form in packages containing no more than 84mg of drug & no other substances 13. colestipol in powder form in packages containing no more than 5g of drug & no other substances 14. erythromycin ethylsuccinate tabs in packages containing no more than equivalent of 16g erythromycin 15. conjugated estrogen tabs, USP, when dispensed in mnemonic packages containing no more than 32mg of drug & no other substances 16. norethindrone acetate tabs, USP, when dispensed in mnemonic packages containing no more than 50mg of drug & no other substances 17. medroxyprogesterone acetate tabs 18. sacrosidase (sucrase) preparations in a soln of glycerol & water 19. hormone replacement therapy products that rely solely upon activity of 1 or more progestogen or estrogen substances 20. colesevelam HCl in powder form in packages containing no more than 3.75g of drug 21. sevelamer carbonate in powder form in packages containing no more than 2.4g of drug
Labeling requirements for all CS
1. date of initial fill 2. date of current fill for C III-V refills (C-II scripts have no refills, therefor initial fill date will be the only date on label) 3. pharmacy name & address 4. prescription serial # 5. pt name 6. prescriber name 7. directions for use 8. cautionary statements 9. refills (if any)
C-SEC requirements-
1. externally vented 2. physically separated 3. appropriate air exchange 4. negative pressure between 0.01 and 0.03 inches of water column relative to other areas
SOP should cover-
1. hazardous communication program 2. occupational safety program 3. designation of HD areas 4. receipt 5. storage 6. compounding 7. use of engineering control 8. hang hygiene 9. PPE 10. deactivation 11. decontamination 12. cleaning 13. disinfection 14. dispensing 15. transport 16. administering 17. environmental monitoring 18. disposal 19. spill control 20. medical surveillance
Prescribing info on approved drug
1. indications & usage 2. dosage & administration 3. dosage forms & strengths 4. boxed warnings, if present 5. CIs 6. warnings & precautions 7. ADEs 8. DDIs 9. use is specific populations (pregos, nursing, pediatrics & geriatrics) 10. description 11. clinical pharmacology 12. clinical studies 13. references 14. how supplied/storage & handling 15. pt counseling info
Healthcare providers authorized to prescribe
1. physicians (MD, DO) 2. dentists (DDS, DMD) 3. podiatrists (DPM) 4. veterinarians (DVM) 5. nurse practitioners (NP) 6. pharmacists (Pharm.D.) 7. optometrists (OD) 8. naturopathic doctors (ND) 9. other registered practitioner who is: -authorized to prescribe CS by jurisdiction/state in which the practitioner is licensed to practice -registered or exempt from DEA registration -an agent/employee of a hospital/institution acting in normal course of business under registration of hospital/institution *Exempt from DEA registration: US Public Health Services, Federal Bureau of Prisons, US Armed Forces (Army, Air Force, Navy, Marine Corps, & Coast Guard), & institutions/employees of Indian healthcare facilities *Preferred for physicians to prescribe w/in area of expertise *NDs are generally limited to "natural" compounds like vitamins, natural hormones, AAs *Mid-level practitioners (MLPs) prescribing authority varies by state & can include nurse practitioners (NPs), certified nurse midwives (CNMs), anesthetist nurses (ANs), physician assistants (PAs), & optometrists (ODs) *an employee/agent (nurse or office assistant), under direct supervision of prescriber, may communicate script info to pharmacist; agent can also prepare a script for prescriber to date & sign
Info required in pt profile
1. pt name, address, telephone number 2. DOB 3. gender 4. disease state info, drug allergies/intolerances, ADEs 5. comprehensive list of meds/devices previously dispensed (including OTCs, herbals, supplements) 6. any relevant pharmacist comments *If issue is present, pharmacist must manage it according to his/her professional judgment, involving either contacting prescriber for notification/clarification, &/or discussing concern & any management necessary w/pt or caregiver
These areas should be available for?
1. receipt and unpacking 2. storage 3. non-sterile compounding 4. sterile compounding
When gowns are required, they should-
1. resist permeability of HDs (prefer coated with laminate materials)-- cloth is not acceptable 2. be long-sleeved and cross in the back 3. be disposable
OTC products must be packaged in tamper resistant containers according to the Federal Anti-Tampering Act except
1. skin products 2. insulin 3. lozenges 4. tooth cleaning powder
if you substitute a brand for generic and the dr does not say you cant write the name on label what do you do
1. write brand name 2. generic name + MFR/repkgr
High Risk is prefiltered (not for sterilization but to remove particulate matter) via:
1.2 mcm filter
how long do mfr have to notify board of closure
10 days
Competencies of handling HDs must be assessed every __ months
12
what is the expiration date for multiple use container
12 months or mfr date which ever less
RPH: Tech ratio
1:3 (Retail and Institutional) Interns/Externs, Clerical personnel do not count toward this ratio.
how long are records of administration kept in hospital
2 YEARS
how long are records of controlleds disposal kept
2 years
The computer must have capability of printing hard copy printouts -how long do they have to go back and how long do you have to produce that audit trail (has to have the brans and or generic plus strength and dose for all CS
2 years and must produce in 24 hours - or yo butt in hot water!,
how long do pharmacists have to review orders
24 hours or asap
BUD for open/penetrated multidose container (with preservatives) is
28 days
Filing of Prescriptions
3 file system: CII, CIII-V, RX 2 file system: CII, All others Hard copies maintained w prescription number and organized numberically AND chronologically -Maintain hard copies x 6 YEARS from original dispensing -Maintain compounding records x 6 YEARS
how much CV can be sold under state law and what info has to be on label
4 oz in 48 hours (not 24 units bc we dont sell CV tabs as nonrx) no more than 2 sales in 7d and 3 in 30 days and you have to put the expiration date on it
C-PEC for sterile compounding must provide ISO Class __ or better
5
how long to submit proof of CE
5 working days
how long does the computer system have to go back for refills and refill hx
6 months
how long are rx originals kept
6 years
Tuberculosis (TB) tx
6mos-2yrs, depending on level of resistance, in a consistent manner (w/out food, QD, or 2-3x/wk) Can result in hepatic/ocular damage Rifampin is an inducer *Give pyridoxine (vitamin B6) to alleviate neuropathy from isoniazid
Compounded HDs must follow BUD for USP __
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what must a PBM obtain before doing business in MS
A LICENSE NOT A PERMIT ANNUALLY and have to five docs of fiscal year FINANCIAL statements the statements have to be turned in by march 1 or 60 days after fiscal year
Policy
A course of action for a specific activity
Drug donations to cancer or other repository programs
A handful of states have enacted programs specifically for accepting & distributing unused cancer-related prescription drugs
Institutional medication records
A medication or chart order is written by a prescriber for immediate administration to a pt in a hospital or other institutional setting. The prescriber enters medication order, the order is sent to pharmacy for dispensing, & nurse directly administers drug to pt. The drug is NEVER in possession of the pt. Medication orders are not considered prescriptions & do not need to meet al the CSA requirements of prescription packaging or labeling. Medication orders do not need to be readily retrievable (either by being kept physically separate from all other orders or electronically retrievable), & the facility needs to keep records of drug administration.
Pharmacy sells CS to another pharmacy
A pharmacy can sell CS to other pharmacies or prescribers (w/out being registered as a distributor) as long as total # of dosage units doesn't exceed 5% of total # of CS dosage units dispensed/calendar year. Both parties must be registered w/DEA to dispense CS.
How much tx can a a practitioner not registered w/DEA administer for narcotic addiction?
A practitioner who isn't specifically registered w/DEA to treat narcotic addiction may administer (but not prescribe) a day's worth of tx at one time to a pt while proper referral to an opioid tx program is being arranged. Can be done for up to 3 days
Drug formularies
A preferred drug list that the institution, healthcare plan, or pharmacy benefit manager (PBM) has chosen for their pts or members. Should include safest & effective drugs, be in accord w/current clinical guidelines, & take into consideration cost-effectiveness of drug. Usually includes prescribing guidelines & other clinical decision making tools to help prescribers select preferred drugs. Some systems incorporate lab values to assist w/drug selection. Pharmacy benefit manager (PBM): manages pharmacy "benefit" for a healthcare system or as a third-party payer for groups that contract w/PBM to manage all aspects of drug use (like "Express Scripts"). Includes selecting drugs to include on formulary, formulary maintenance, insurance billing, pharmacy central filling & prescription delivery (mail order), community pharmacy payment processing, & software systems that enable individual pts to manage their benefit online & for clients to manage their services & costs. Open formulary: usually used in hospitals, where any drug on formulary can be chosen w/out a variable cost structure Healthcare plans have formularies to outline which drugs will be covered in outpt or retail setting. Typical formulary for outpt use has 3, 4, or 5 tiers (lower the tier, lower the co-pay). *Specialty drugs (primarily biologics) can be included at a higher tier Co-pay: out-of-pocket expense that pt is responsible for in order to receive healthcare related services like prescriber visits & prescription drugs *Usually eliminate look-alike, sound-alike drugs & expensive similar risk-benefit drugs *Can make 2nd line options if 1st cheapest & most effective don't work for a pt
Dietary supplements
A product (other than tobacco) intended to supplement diet that bears or contains >/=1 of the following: vitamin, mineral, herb or other botanical, or amino acid & their concentrates & extracts. These can be in combination A dietary substance meant to supplement diet by increasing dietary intake & which isn't used as conventional food or as sole item of a meal or diet Labels: must include a descriptive name of product, wording "supplement" or "dietary supplement", the name/address of manufacturer, packer, or distributor, a complete list of ingredients & net contents (amt in container) *Supplemental facts is required on each supplement *Must include disclaimer that FDA hasn't evaluated claim & must have supporting research to back up any claims made in advertising or in package labeling *Difference between this & a drug: health claim of product (supplements cannot claim to cure, prevent, correct or treat disease/conditions *Is allowed to claim that supplement addresses a nutrient deficiency, supports health or is linked to body functions *Problems w/product: report to FDA's safety reporting portal (SRP) *Must follow CGMPs; manufacturer is responsible for quality control procedures, designing & constructing manufacturing plants, & testing ingredients & finished product
Pt Care & Affordable Care Act of 2010
A provision to expand elder abuse legislation from a state to a national level Pharmacists can report abuse to: 1. Social services 2. Law enforcement
Class I recall
A situation in which there's a reasonable probability that use/exposure will cause serious adverse health consequences or death Example: morphine tab manufactured w/10x the amt of API
Class III recalls
A situation in which use of or exposure isn't likely to cause adverse health consequences Example: coloring on tabs may have been applied inconsistently
Class II recall
A situation in which use/exposure can cause temporary/reversible adverse health consequences or where probability of harm is remote Example: ketorolac injections have been recalled in 2010 & 2015 due to possibility of particles in vials
Prescription drug monitoring programs (PDMP)
A statewide electronic database that collects designated data on drugs dispensed in the state. DEA isn't involved w/administration of any state PDMP. Good for pharmacists to discover "pharmacy hopping" or "doctor hopping." Primary purposes are to support access to legit medical use of CS & to identify/deter or prevent drug abuse/diversion.
BSC Class II B2
ALL contaminated air is under negative pressure of surrounded by negative pressure exhaust must be external 100% air exhausted NO contaminated air may be recirculated into the hood
BSC Class II B1
ALL contaminated air is under negative pressure of surrounded by negative pressure exhaust must be external 70% air exhausted and 30% air re-circulated some contaminated air may be re-circulated into the air
Inventory of CS
ANNUAL CS INVENTORY on or about May 1st - May 15th it is ANNUALLY according to state law and you can do it as of opening or as of closing but you have to indicate that on the inventory form and you have to sign and date it - inventory records must be maintained AT THAT SITE
Certificate of Analysis (COA)
APIs that are not USP or NF grade must be accompanied by what?
Faxed scripts for CS
Acceptable for C III-V drugs if all required info is on script & prescriber has signed fax prior to sending it to pharmacy; prescriber can write the script for a C III-V drug on tamper resistant security form & fax it to pharmacy *C-II scripts can be faxed only until pt can bring written Tx C-II Form to pharmacy or: 1. if drug is being compounded for administration by parenteral, IV, IM, SQ, or intraspinal route 2. if for an LTCF pt; script must say "LTCF pt" 3. if pt is in a Medicare-certified or state-licensed hospice; script must say "hospice pt" *Pts may not fax script to pharmacy themselves
Pre-signing scripts for CS
According to CSA, a CS script must be signed & dated on date it's issued to pt Pre-signing for CS & non-CS drugs is NOT ALLOWED (illegal)
CS Record keeping
Acquisition Records - Keep x 2 years Disposition Records - Keep x 6 years (also hard copy rxs) Includes: inventory, receipt, disposition/dispensing. - Maintian at registered location. Records of reciept for CII seperate from III-V - Hard copy print out of all dispensing shall be produced daily or at regular intervals (<7 days), rph sign and date print out. File chronologically - Keep x 2 YEARS - Transmit records of CS dispensing (>48 day supply) to Prescription Drug Monitoring Program. - Disposal, Keep records x 2 YEARS
Repackaging
Act of taking a finished drug product from container in which it was distributed by original manufacturer & placing it into a different container w/out further manipulation of the drug
Display of licenses
All facilities must publicly display or have readily available all licenses of licensed personnel
Written material that's included as part of package labeling
All info provided by manufacturer for distribution w/drug, even if it's not physically affixed to product, is considered part of labeling, including: 1. drug container (plastic container or bottle) 2. Consumer Medication Info (CMI)-not approved by FDA 3. Pt package inserts (PPI)-approved by FDA 4. Medication guides (MedGuides)-approved by FDA 5. Any paperwork required as part of a REMS
Staff training requirements for compounding
All staff require on-going, periodic training for type of compounding conducted. The staff need to be evaluated at least annually. During training session, steps are demonstrated to staff that will be making preparations. Staff must be able to demonstrate steps back, w/out instruction. All training & evaluation results must be documented. Steps in training procedure should include: 1. knowledge of USP Chapter on Non-Sterile &/or Sterile Compounding & other relevant publications 2. all procedures used 3. hazardous compound training *Compounding pharmacist who has signed off on product is responsible for finished product
Partial fills of C III-V drugs
Allowed by DEA if recorded in same manner as a refill & if total quantity dispensed in all fills doesn't exceed total quantity prescribed *No dispensing >6mos past issue date
Partial fills of C-II drugs
Allowed if: 1. pharmacy doesn't have sufficient stock of drug 2. pharmacist needs additional time to verify legitimacy of script 3. pt requests a lesser quantity, which is commonly due to drug cost *Pharmacist must note on script it was a partial fill & must be fill remainder w/in 72hrs or the script becomes "void" & prescriber needs to be notified *LTCF/terminally ill: pharmacist can partially fill & has 60 days from written script date to fill remainder; for each partial fill pharmacist must indicate: 1. date of partial fill 2. amt dispensed 3. amt remaining 4. name of dispensing pharmacist *If electronic recordkeeping system is used, the following must be maintained & updated in real-time when a partil fill is dispensed: 1. original prescription # 2. issue date 3. prescriber's name 4. pt's name 5. address of LTCF, hospital or pt's home 6. drug name, dose, formulation, strength, & quantity 7. quantity authorized 8. list of partial fills dispensed
Self prescribing & prescribing to family members
American Medical Association (AMA) recommends against physicians treating oneself or immediate family members; there are limitations bc prescribers may not be able to objectively/adequately interview, examine, order diagnostic tests/drugs, or counsel themselves or their family members due to personal relationships & potential for drug diversion *Insurance companies may not provide coverage for tx of oneself or known relatives. *Federal law requires all prescription meds be prescribed only in context of valid prescriber-pt relationship that includes a written record of encounter
Gloves must meet what standard?
American Society for Testing and Materials Standard D6978
Emergency Dispensing of CII rxs
An Oral prescription for qty of emergency period not to exceed 48 HOURS, reduce to writting. within 7 days obtain an rx signed by MD for dispensed medicaiton and qty and attach this rx to the written copy from oral.
What are Safety Data Sheets (SDSs)?
An informational document that provides written or printed material concerning a hazardous chemical. The SDS is prepared in accordance with the HCS
Devices
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar that's recognized by USP An item intended to be used in diagnosis of disease or other conditions, or in the cure, mitigation, tx, or prevention of disease An item intended to affect structure or any body function, & which doesn't achieve its primary intended purposes through chemical action & which isn't dependent upon being metabolized
RX orders and refill authorizations
An oral RX must be communicated directly to a pharmacist (or intern/extern) or when recorded, Rph must be able to review the Rx.
Insulation for Low, Medium, and High Risk
Ante Area (ISO 8 or 7) Buffer area (ISO 7) PEC (ISO 5) DCA (Direct Compounding Area - First Air)
Drug paraphernalia
Any equipment that's used to produce, conceal, & consume illicit drugs
DEA Form 224
Application for DEA # for prescribers, hospitals, & pharmacies *DEA registration renewals are sent 60 days prior to expiration in order to provide ample time to complete and process
Supplemental NDA (sNDA)
Application for a new drug dosage
BSC Class III used for (sterile/non-sterile) compounding-
BOTH designed for highly infectious microbial agents and other hazardous operation
BSC Class II A2 used for (sterile/non-sterile) compounding-
BOTH sterile and non-sterile preferred for most sterile HD compounding
BSC Class II B2 used for (sterile/non-sterile) compounding-
BOTH sterile and non-sterile-- PREFERRED for sterile compounding volatile HDs and radionuclides
BSC Class II B1 used for (sterile/non-sterile) compounding-
BOTH sterile and non-sterile-- can be used with TRACE AMOUNTS of volatile toxic chemicals and radionuclides
6 months
BUD for non aqueous formulations
14 days refrigeration
BUD for water-containing oral formulation
30 days room temp
BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations
Tx of narcotic dependence
BZDs, barbiturates, opioids & partial-opioid agonists have 3 common concerns: addiction, physical or psychological dependence, & tolerance. Addiction: chronic, relapsing brain disease that's characterized by compulsive drug seeking & use, despite harmful consequences (a strong need to use a drug for a purpose other than intended use)
Wholesaler/MFG Permits
Biennial License renewal, Dec 31. CS Registration if handling - ANNUAL, Dec 31 records kept x 2 years
Compounding/repackaging CS
C II-V drugs for a prescriber's office use under these circumstances: 1. it's compounded as an aqueous, oleaginous, or solid dosage form 2. it doesn't contain >20% CS 3. it's only distributed to prescribers authorized to dispense CS
which controlled drugs do not require caution label
CV and blinded study (also no label requirements if in hospital <7ds CII <34 ds or 100u CIII-CV
Federal MAX limits on codeine & opium
Can be dispensed Q2 days to pts >/=18yo: 240mL (8oz) or 48 dosage units of any CS containing opium 120mL (4oz) or 24 dosage units of any other CS *May need ID to purchase if pharmacist is unfamiliar w/pt *Record pt name/address, drug name/quantity, date purchased & pharmacist's name/initials in logbook
Emergency contraception (EC)
Can prevent pregnancy when taken up to 5 days following unprotected sexual intercourse FDA-approved pills: 1. levonorgestrel (Rx & OTC) 2. ulipristal (Rx) *Available OTC, no gender or age requirements, & no prescription or ID is required *FDA has approved Plan B One-Step & similar products for up to 72hrs after unprotected sex, but pharmacists can recommend them up to 120hrs *ulipristal (Ella) is preferred if 72-120hrs since unprotected sex *More effective if taken ASAP *Female birth control pills at high doses can be EC but isn't recommended *Copper intrauterine device (IUD) is an effective EC if inserted up to 5 days after unprotected sex (MOST effective)
Additional label requirement for central fill pharmacies
Central pharmacy must include retail pharmacy's name & address on label & a unique identifier (like central fill pharmacy's DEA #) to indicate it was centrally filled
Renaming, relocating, or closing a pharmacy
Change of business name, closure, or relocation requires notification to state board w/in a short or "immediate" time limit (30 days)
Approved C-PEC for nonsterile HD compounding-
Class I BSC Containment Ventilated Exposure (CVE) Class II BSC CACI
syringes, infusion pumps thermometers diagnostic reagents heating pads are this device class
Class II
Approved C-PEC for sterile HD compounding-
Class II BSC Class III BSC CACI
contact lenses pacemakers heart valves are this device class
Class III (most regulated class) require premarket approval
Charitable programs
Commonly, states permit prescription drugs in single use or sealed packaging from state programs, nursing homes & medical facilities to be provided to low-income residents who cannot afford their drugs. This helps offset costs of providing healthcare to uninsured pts in emergency rooms & clinics. Laws include some restrictions to secure drug integrity: 1. drugs must be in original, unopened, sealed, & tamper-evident unit-dose packaging 2. drugs must not be expired 3. exp date must be visible & at least 6mos from donation date (in most states) 4. CS cannot be donated-these are excluded (in most states) 5. a state-licensed pharmacist or pharmacy is part of verification & distribution process 6. pt receiving donated drugs requires a valid script
Non-sterile compounding
Community pharmacies regularly perform this on a routine basis. Some states define mixing water w/powder for a suspension as compounding while others do not & call it "reconstitution."
Disposal of prescription medication by ultimate user
Community-based drug "take-back" programs are good options for pts to dispose of prescription medications. "Take-back" programs are offered by DEA. There are also new rules that allow authorized facilities, like pharmacies, to collect unused & unwanted prescription drugs, including CS. Previously, CS could only be returned to a location w/law enforcement present. A facility that's willing to collect unused drugs will need to apply for a permit. Pts should follow any specific disposal instructions on drug labeling or pt info that accompanies drug. Drugs shouldn't be flushed down sink/toilet unless instructed by script labeling. If no disposal instructions are given on drug labeling & no local take-back program is available, pts should dispose of drugs in household trash following these steps: 1. remove drugs from original containers & mix them w/an undesirable substance like kitty litter or used coffee grounds (making is less appealing to kids, pets, & unrecognizable people who go through the trash) 2. Place mixture in sealable bag, empty can, or other container, then discard in trash *Some drugs are especially harmful if taken by someone other than the person for whom it was prescribed, & some medications that have highest risk will include specific disposal instructions on labeling. (immediately flush unused meds/patches down toilet, like fentanyl) *It's not acceptable practice to flush drugs down toilet except where risk is high
NDA/BLA
Complete package of info on the drug & will include all collected animal/human data, PK/PD analysis, including drug interaction studies, & complete review of manufacturing process
Medium Risk Examples: 3
Compounding of TPN fluids (manual or automated) during which there are *multiple injections,* detachments, and attachments of nutrient source products... Filling of *reservoirs* of injection and infusion devices with *more than 3 sterile* drug products and eacuation of air from those reservoirs before the filled device is dispensed. Transfer of volumes from *multiple ampules* or vials into one or more final *sterile containers*.
Requirements for death w/dignity
Currently, Oregon, Washington, Vermont, & California have Death w/Dignity laws, which allow mentally competent, terminally ill adult state residents to voluntarily request for physician-assisted death & receive a script medication to end their life in a quick & painless manner. Terminally ill pts who wish to obtain a script under these states' law must be a resident & follows a series of steps in order to be permitted to take this course of actions: Death w/Dignity requirements: 1. >/=18yo 2. resident of a state permitting physician-assisted death 3. capable of making & communicating healthcare decisions for him/herself 4. diagnosed w/a terminal illness that will lead to death w/in 6mos 5. 2 physicians must determine whether the above criteria have been met Timeline it takes for a pt to receive medication: 1. pt makes 1st oral request to physician 2. after at least 15 days from initial request, pt makes a 2nd oral request to physician 3. pt makes a written request to physician 4. after at least 48hrs from written request, pt may pick up prescribed meds from pharmacy
How often are inventory audits performed where CS are stored outside pharmacy in other areas of the pharmacy
DAILY so you have monthly inspection and daily audit
what is required on a prescription LABEL
DATE OF FILLING RPh intials (expiration and phone is federal req) NEVER SAID THE DOSE FORM of course not dr or pt address
Emergency filling of C-II drugs
DEA permits emergency dispensing of orally authorized scripts for C-II drugs if immediate administration of the drug is necessary to avoid pt harm & there's no reasonable alternative. *In normal circumstances, prescribers cannot call in scripts for C-II drugs & must be authorized via a written/electronic script *Prescriber must provide an original script (written/electronic) by 7th day following fill date; if written it must include "Authorization for Emergency Dispensing" & date of oral prescription; if electronic, pharmacist must annotate record of e-script w/emergency authorization & date of oral order *Central fill pharmacies are prohibited from preparing emergency fills **If original script isn't received, pharmacist must report breach to local DEA office
Granting power of attorney
DEA registrant orders CS for pharmacy w/Form 222 or CSOS, where person may not be present all the time but can authorize others to order CS in their place thus a "power of attorney (POA)" Legal document that gives this person the registrant has chosen power to act in registrant's place (can be non-licensed individuals); can have >1 POAs & registrant can revoke the POA at any time *If new registrant completes renewal application, new POA forms need to be completed (there is no official form) *These documents aren't sent to DEA but must be filed w/completed Forms 222 & should be readily retrievable for inspection
CS storage
DEA requires CS to be kept in a securely locked cabinet of "substantial construction," meaning the cabinet shouldn't be easy to break apart *Alt option: dispersing CS throughout stock of non-CS
Processing C III-IV refills during "downtime"
DEA requires pharmacies to develop a back-up procedure to document dispensing of refills of C III-IV drugs; it's recommended that pharmacies develop a back-up procedure to document dispensing of all other scripts then eventually transferred to computer ASAP Federal laws also require pharmacies to keep a central recordkeeping location that can provide a printout of refill info to requesting pharmacy w/in 48hrs. *C-II drugs are not allowed refills & C-V drugs have less risk of diversion *May use tabletop label printer or hand write prescription labels
Pharmacy Permits Expire
December 31 Renew Biennially
Counseling limited-English proficient pt
Depending on local & regional demographics, pharmacies may interact w/pts w/limited grasp of English language. The largest # of limited-English proficient (LEP) pts who speak Spanish, Chinese, Korean, Vietnamese, or Tagalog are located in NY, California, Texas, & Florida. All pts in US need to know how to safely use their meds. In states w/large immigrant populations, the state board may have specific protocols & requirements for communicating w/LEP pts. May include use of a language translator to assist w/pt counseling.
Drug Quality and Security Act of 2013
Differentiated between traditional compounding pharmacies versus outsourcing facilities
High Risk Examples: 4
Dissolving *nonsterile* bulk ingredients to make solutions that will be sterilized Exposing sterile ingredients and components (even packaging) to *worse than ISO 5 for more than 1 hour* Measuring and mixing sterile ingredients in nonsterile devices *before* sterilization. *Assuming*, w/o appropriate evidence or direct determination, that packages of bulk ingredients contain *at least 95%* by weight of their active chemical moiety.
Adulteration
Drug itself is bad (drug quality isn't up to standard) *Can be strength different than official standards or different than what's listed on the label
Off-label promotion by manufacturers
Drug manufacturers cannot initiate convos w/other healthcare providers regarding off-label use for 1 of their drugs. Manufacturers & their reps may discuss off-label use if a healthcare practitioner has voluntarily, on their own initiative, requested the info.
Traditional compounding & Section 503A
Drug products prepared using traditional compounding methods were given 3 exemptions from requirements that apply to prescription drugs: 1. compliance w/CGMPs 2. labeling w/adequate directions for use 3. need to obtain FDA approval for new drug product Must be performed by licensed pharmacist (some cases, a physician), & be based on a script that's been written for an individual pt. This enables pharmacist to prepare a drug formulation to fit unique needs of an individual pt. Valid reasons why this type of compounding may be required: 1. if a drug exists onlt in tab/cap & pt has difficulty swallowing hard formulations 2. in shortages; like if a drug typically comes in suspension for children's use but only cap formulation is available, a pharmacist may compound cap contents into a suspension 3. to create a dose or concentration that's not commercially available 4. to add flavoring for palatability 5. to exclude inactive ingredients (excipients) that an individual pt has an allergy or sensitivity to, like wheat, lactose or certain preservative 503A also permits pharmacist to prepare small batches of a compounded preparation in advance if dispensing hx of store supports the need. This is convenient bc it takes time to set up ingredients/equipment, prepare product, document preparation, & clean area. If pharmacist in a medical building prepares 3-4 scripts of same strength of a progesterone cream each day, pharmacy can prepare a few days' worth of cream so it's ready when scripts are received. Federal law doesn't define an exact amt of compounded drug that can be prepared in advance, but some states define a set # of days (like 3 days). These preparations need to be labeled w/appropriate BUDs.
Therapeutic equivalence/therapeutic interchange
Drug products w/different chemical structures that are of same pharmacological class, & usually can be expected to have similar outcomes & adverse rxn profiles when administered in therapeutically equivalent doses. In a community setting, pharmacist is looking for a generic substitution for a branded drug. In hospital, pharmacist is looking for a different drug in same pharmacological class, in an equivalent dose. Therapeutic interchange protocol: collaboration between pharmacists & physicians in an institution (hospitals, nursing facilities, or transitional care settings); has become much more important recently bc of increase in # of similar drugs in same class. P&T committee will determine what drugs are in institution's protocol. (antacids, FQs, K+ supplements, cephalosporins, statins, insulins, & laxatives) *Converting to PO instead of IV can reduce cost, pharmacy preparation time, nursing time to hang IV bag, & infection risk by maintaining an intact skin barrier
Single dose (unit-dose) script labels
Drugs packaged as unit-doses are convenient for hospitals & skilled nursing facilities bc it reduces drug diversion, drug waste, & medication errors. It's a non-reusable container designed to hold a quantity of drug intended for direct, PO administration as a single dose. Unit-dose packaging can be performed by drug company or prepared from multiple-dose containers in pharmacy. A benefit is that if drug is not used & container is intact, drug can be returned to pharmacy stock & re-dispensed. Before administering drug, nurse scans barcode on pt's wristband & unit-dose package. If that drug wasn't entered into pt's medication list by a pharmacist, an alert will sound, preventing nurse from administering wrong drug to pt. Unit doses are likely stored in an automated dispensing cabinet (ADC) rather than a specific pt cassette-thus, label won't require info like pt name, prescriber's name, dispensing date, or script #. Since size of unit-dose packaging is too small to accommodate all mandatory info on a typical label, only the following is required: 1. drug name 2. quantity of active ingredient 3. BUD 4. lot # 5. name of manufacturer, packager, or distributor 6. any required cautionary statements *According to USP/NF standards, BUD for these containers is no later than either of the following: 1. 1yr from date drug is repackaged or 2. exp date on manufacturer's container, whichever is earlier
Narrow Therapeutic Index drug substitution
Drugs where small differences in doses or blood concentration could cause tx failure or toxicity. They have very small differences between subtherapeutic dose, therapeutic dose, & toxic dose. Small differences in bioavailability between generic drugs can cause a significant difference in serum drug concentration & requires close monitoring. Negative formulary: when a state doesn't allow substitution of NTI drugs; in these states, NTI drug must be dispensed w/same formulation from same manufacturer as was previously filled to provide therapeutic consistency for pt, unless prescriber &/or pt have been notified & consents to change. Examples: lithium, digoxin, & warfarin
Written, oral, electronic, & faxed scripts
Durham-Humphrey Amendment of 1951 authorized dispensing of meds pursuant to a valid written script, or an oral script, which is immediately reduced to writing A script should minimally contain the following: 1. pt's full name, DOB, & street address 2. prescriber's name, license designation, address 3. name, strength, dosage form, & quantity of drug prescribed 4. directions for use 5. refills authorized, if any 6. date of issuance 7. prescriber's signature
Calcium threshold amt/daily dose
Each (insert appropriate dosage unit) contains: (insert ingredient names in alphabetical order & quantity of each) >/=20mg Ask a doctor before use if you have kidney stones or calcium-restricted diet >3.2mg
Potassium threshold amt/daily dose
Each (insert appropriate dosage unit) contains: (insert ingredient names in alphabetical order & quantity of each) >/=5mg Ask a doctor before use if you have kidney stones or potassium-restricted diet >975mg
Magnesium threshold amt/daily dose
Each (insert appropriate dosage unit) contains: (insert ingredient names in alphabetical order & quantity of each) >/=8mg Ask a doctor before use if you have kidney stones or magnesium-restricted diet >600mg
State boards of pharmacy
Each state & jurisdiction has a board of pharmacy (or a similar body) whose primary purpose is to protect public health. Is responsible for granting & revoking professional licenses for pharmacists & other licensed personnel in state who practice in a pharmacy. Sets requirements for intern hrs required to sit for licensure, & continuing pharmacy education (CPE) hrs & requirements that must be maintained by licensed pharmacists. Will meet on a scheduled basis to review rules & regulations set by state & amend there, or add new requirements, when necessary. Board will consist of some variation of public & professional members who serve at designated terms of length, & will be under directorship of an executive who's assisted by various staff members. Will oversee pharmacy inspectors who inspect individual pharmacies to ensure compliance w/federal & state laws & regulations. TEXAS: 11 members (7 pharmacists from Class A & C pharmacies, 1 tech, 3 public members) *Term of service: staggered 6yr terms, no more than 2 consecutive terms
CS ordering system (CSOS)
Electronic equivalent to DEA Form 222 but can be used to order all CS & non-CS; has no limits on quantity of items to be ordered; can use digital signature & must report transaction to DEA w/in 2 business days of filling order *Reduces ordering errors, requires less paperwork, & reduces administrative costs; less stockpiling & less waiting time to fill up a paper order form *Delivery is faster; can receive items w/in 2 business day (improves inventory control) *Order CANNOT be endorsed to another supplier Steps: 1. Pharmacy/purchaser enrolls w/DEA 2. Pharmacy/purchaser digitally signs order that's sent to wholesaler/supplier 3. Wholesaler/supplier verifies certificate & fills order 4. Wholesaler/supplier supplies pharmacy/purchaser w/CS 5. Wholesaler/supplier reports transaction to DEA *Utilizes Public Key Infrastructure (PKI) technology to securely exchange data (purchaser/pharmacy enrolls w/DEA to receive CSOS digital certificate & public-private key pairs *digital certificate: authorized digital identity that contains info about registrant name, email, location name/address, DEA #, schedules that registrant can order, & exp date of certificate *public key: used to encrypt data *private key: used to decrypt data, which enables purchaser & supplier to securely exchange data Invalid orders: 1. if any required data field is missing 2. if it's not signed w/DEA-sanctioned digital certificate 3. if digital certificate is exp 4. if purchaser's public key will not validate digital signature *Cannot be corrected & a new order must be submitted *Supplier isn't required to keep record of orders that weren't filled, but purchaser must keep electronic copy of voided order *If supplier partially voids an order, supplier must indicate in linked record that nothing was shipped
Automated dispensing systems (ADS) & automated dispensing cabinet (ADC)
Electronically records/dispenses single doses of medication; pharmacist must enter prescription info into system before a medication is dispensed from ADS, w/exception of emergency overrides (which should be strictly limited); considered pharmacy stock before dispensed *Must have a separate DEA registration
Compounding
Entities and personnel involved in compounding HDs must be compliant with the appropriate USP standards for compounding including <795> and <797> • When compounding HD preparations in a C-PEC, a plastic-backed preparation mat should be placed on the work surface of the C-PEC. • The mat should be changed immediately if a spill occurs and regularly during use, and should be discarded at the end of the daily compounding activity. • Disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with HDs. • Bulk containers of liquid and API HD must be handled carefully to avoid spills. If used, APIs or other powdered HDs must be handled in a C-PEC to protect against occupational exposure, especially during particle generating activities (such as crushing tablets, opening capsules, and weighing powder).
Controlled Substance (CS) Registration with BOP
Every Rph (annually), Intern/Extern (valid for 4 years or 6 mo post-grad), Pharmacy must obtain CS registration
Recordkeeping of CS
Every pharmacy must maintain current, complete, & accurate records of each CS purchased, received, stored, distributed, dispensed, or disposed. DEA requires all records of CS be kept x2yrs. Records must include: 1. Completes & blank DEA Form 222 or CSOS equivalents 2. Power of attorney forms 3. Receipts &/or invoices for C III-V drugs 4. Initial/biennial inventory records for CS 5. Records of transfers of CS between pharmacies 6. Records of CS distributed (like sales to other registrants, returns to vendors, distributions to reverse distributors) 7. Records of CS dispensed (scripts, C-V logbook) 8. Reports of theft or significant loss (DEA Form 106) 9. Inventory of drugs surrendered for disposal (DEA Form 41) 10. DEA registration certificate 11. Self-certification certificate & paper/electronic logbook for pseudoephedrine sales
Scripts from foreign countries
Except for a few states, a pharmacist may not fill scripts from other countries. Whenever a script is filled, it must meet state's requirements (like TSBP C-II forms)
Expiration dates vs BUDs
Exp: identifies time during which the drug will still meet requirements of USP monograph, as long as it's kept in its appropriate storage conditions in original container BUDs: date that pt should no longer use medication; it's never >exp date on manufacturer's container or 1yr from date drug is dispensed, whichever is earlier *If no exp date is listed, then it's considered misbranded
TF can compund and mfr at the same location
F
TF liquid meds can be donated to charity
F and all meds for donation must be packaged in original container that is sealed
TF pharmacists can offer compounded meds to drs for resale
F but dr can get compounded meds to ADMINISTER to pts but cant solicit SPECIFIC products
TF written rx can have stamp signature
F have to have written sig
TF a retail pharmacist who compounds sterile meds can compound them in same area as other compounds
F separate area
TF a dr that dispenses meds to a pt has to have CS reg with board
FALSE
TF perpetual inventory must be maintained in institution for CII-V
FALSE ONLY FOR CII
TF you can partial fill an rx faxed for a compund med for infusion
FALSE can only use fax as original
TF you can partial fill an rx faxed for a hospice patient
FALSE can only use fax as original.
TF invoices for controlled substances have to be signed and dated
FALSE invoices must be signed and INITIALED by preson receving the CS
TF have to also counsel in patients in hospital
FALSE only outpt
TF legend drug are permitted to be stored in patient care areas
FALSE unless director approved
Consumer medication info
FDA mandates that useful written pt info be provided to pts w/each new script. CMI handouts are paper leaflets of drug info that are put inside bag, or stapled to outside. *Info should be simplified for pts to understand & should reflect FDA-approved package insert *They should explain how to use drug & what to expect *These aren't reviewed or approved by FDA
Returning or disposing prescription medication to supplier
FDA permits pharmacies to return prescription drugs to wholesalers & manufacturers as long as there's proper recordkeeping. Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be physically separated from other prescription drugs until they're destroyed or returned to supplier. Open prescription drug containers must be identified as opened (this is often done in pharmacy by marking an "X" on container), & kept physically separated from unopened containers if they're sent to be destroyed or are returned to supplier. If storage conditions under which a prescription drug has been returned cast any doubt on drug's safety, identity, strength, quality, or purity, then drug should be returned to wholesaler or manufacturer, or sent to disposal, unless contents can be tested & quality has been confirmed.
Risk evaluation & mitigation strategy (REMS)
FDA was given authority to improve drug safety via use of these drugs that have risks that may outweigh benefits. Risk/benefits should always be established between healthcare provider & pt. If a REMS exists for a drug/drug class, risks are considered serious & FDA uses REMS requirements to make sure risks are known & managed adequately. 4 parts to REMS program: 1. Communication plans 2. Elements to assure safe use 3. Implementation systems 4. MedGuides Key points: 1. REMS may be required for new drug or when safety issues arise w/existing drug 2. REMS can be applied to an individual drug or to a drug class, like REMS required w/long-acting opioids 3. Manufacturer (which FDA refers to as drug's sponsor) has to develop REMS, & FDA reviews it & approves it, when it's acceptable 4. Since safety issues are different, REMS are different, & components will depend on risks associated w/drug or drug class 5. Requirements include some combo of prescribing, shipping, & dispensing safety requirements Examples: 1. Severe infection: pt is educated on warning sx of infection prior to prescribing 2. Severe allergic rxn: healthcare professional requires certification to administer drug 3. Liver damage: liver function monitoring is required during use 4. Severe birth defects: negative pregnancy test required prior to dispensing each script
MedGuides
FDA-approved pt handouts that come w/many prescription medicines that may have a serious/significant health concern Drugs that require MedGuide: 1. antidepressants 2. antipsychotics 3. anticonvulsants 4. most antiarrythmics 5. NSAIDs *Must be given when: 1. Drug is dispensed in outpt setting, & drug will be used by pt w/out supervision of healthcare provider, w/each new fill & refills 2. First time drug is being dispensed to healthcare provider for administration to pt in an outpt setting 3. When pt or their caregiver asks for it 4. If MedGuide has been revised 5. If drug is subject to REMS program
Scripts from retired/deceased prescribers
Federal law doesn't specify whether a script remains valid after it's discovered that the prescriber has become retired/deceased. If no guidance from state, then it's the pharmacist's discretion when deciding to fill/refill a script. Pharmacist should also encourage pt to look for a new doctor before current script runs out.
National drug code (NDC) #
First is labeler code, assigned by FDA, & is 4-5 digits Second is product code & identifies strength, dosage, & formulation & is 3-4 digits Third is package code & identifies package size & type & is 1-2 digits *2nd & 3rd segments are assigned by labeler
Kefauver-Harris Amendment
First law that requires that any new drug to be proven effective if used as directed before being marketed
Food, Drug, & Cosmetic Act
First law that requires that any new drug to be proven safe if used as directed before being marketed
DEA-required warning statement on label
For all C II-IV drugs: "CAUTION: Federal law prohibits transfer of this drug to any person other than person for whom it was prescribed" *C-V drugs are not required to have this statement
Root cause analysis
Formal name for the process to determine what led to an error
Master formulation record
Formula or "recipe" book that pharmacy uses to prepare compounded products. This is the "how-to" instructions for compounded products made at that pharmacy. Some formulas may be based on store's past experience & others will come from professional compounding compendia. Must be complete enough to enable any competent staff member to follow instructions & replicate product. Should include: 1. official/assigned name, strength, & dosage form of preparation 2. calculations needed to determine & verify quantities of components & doses of active pharmaceutical ingredients (APIs) 3. description of all ingredients & their quantities 4. compatibility, stability & storage info, including references when available 5. equipment needed to prepare preparation Appropriate mixing instructions should include: 1. order of mixing 2. mixing temps or other environmental controls 3. duration of mixing
Abbreviated New Drug Application (ANDA)
Generic drug approval which requires product's chemistry, manufacturing controls, & labeling. *Doesn't require pre-clinical or clinical trials
MedWatch
Healthcare professionals that "watch" medication use in public & find ADEs not found in clinical trials; pts can also report data
DRUGS CAN NOT BE RETURNED AFTER LEAVE PREMISES
I KNOW
Codeine scheduling
II: as a single agent III: if combo product V: if combo cough syrup
Buffer room requirements-
ISO 7 minimum of 30 air changes per hour NEG pressure of 0.01-0.03 inches of water column relative to adjacent areas
Ante-room or non-HD buffer room requirements-
ISO 8 minimum of 30 air changes per hour POS pressure of at least 0.02 in of water column relative to adjacent areas
Microbial contamination per cubic meter (1000 L) requiring action: ISO Class 5 ISO Class 7 ISO Class 8
ISO Class 5 >1 ISO Class 7 >10 ISO Class 8 >100
Sterile HD Compounding C-SEC where C-PEC is housed, preferred ?
ISO Class 7 ante-room with ISO Class 7 buffer room
Returns from pharmacy will call (pick up) area
If a pt hasn't picked up filled medication (which hasn't left pharmacy premise), unclaimed medication can be returned to stock, provided that there's an exp date on label. Returned medication can be combined w/a stock bottle only if they have same lot #. Many states or companies have implemented their own policies on unclaimed medications, like requiring courtesy calls if medication is unclaimed & a time duration before medication can be returned to stock.
Scripts from other states/territories
In most cases, a script written by an out-of-state prescriber in a different US state/territory is valid if a true prescriber/pt relationship exists.
Tamper resistant security
In order for outpt drugs to be paid for under federal Medicaid program, all written scripts must be on tamper resistant security forms that contain at least 3 tamper resistant security features (This doesn't apply to electronic, oral, or faxed scripts) 1. batch/lot #s 2. opaque writing 3. 6 quantity check boxes 4. refills 5. "Do Not Substitute" 6. statement about single drug script 7. description of security features 8. microprint signature line 9. thermochromic ink *CMS requires security features that include the following: 1. Prevents duplication (the word "void" appears due to thermochromic ink, which appears if photocopied) 2. Prevents erasure or modification of written info (quantity check boxes, refill indicators, or chemically reactive paper) 3. Prevents use of counterfeit forms (pre-printed serial #s or watermarks)
Valid prescriber/pt relationship
In order to fill a script, a prescriber/pt relationship should exist. NABP requires each of the following to be met for the script to be "valid": 1. a pt has a medical complaint 2. medical hx has been taken 3. face-to-face physical exam adequate to establish medical complaint has been performed by prescribing practitioner or through a telemedicine practice approved by appropriate practitioner board 4. logical connection exists between medical complaint, medical hx, physical exam, & drug prescribed
Prescription medication loss or theft
In the event of a robbery, pharmacy staff shouldn't resist, either verbally or physically. Staff should never try to apprehend/restrain robber. Robbers are often armed. Staff should take notice of appearance of robber in order to provide a description to law enforcement later. Staff should sound alarm & call police when it's safe. Doors should be locked immediately to prevent re-entry. Theft/loss of CS must be documented on DEA Form 106. DEA recommends the following measures to be aware of & reduce risk of theft: 1. maintain an inventory of CS 2. monitor staff for changes in behavior or mood 3. contact law enforcement if theft is suspected 4. perform clinical background checks for all pharmacy staff 5. give alarm codes for all personnel 6. limit issuance of pharmacy keys 7. change locks, alarm codes, & safe combinations periodically 8. ensure lighting is adequate in pharmacy area at all times 9. place opioids out of sight 10. have obvious surveillance or cameras in plain sight 11. install duress alarms 12. have adequate, physical barriers to prevent unsolicited entrance behind pharmacy counter 13. install steel window curtains & doors
Personal health information (PHI)
Includes information that can be used to identify a specific person, such as medical record number, account number (used for billing), email address, photos or images, device identification numbers, fingerprints, phone numbers, social security numbers, vehicle identification numbers, and relative information. Includes: 1. pt's past, present, or future physical or mental health or condition (medical record) 2. healthcare provided to pt (lab tests, surgery) 3. past, present, or future payment for providing healthcare to pt, which can identify pt (hospital bills) Does NOT include: names, residential addresses, or phone #s listed in a public directory like a phone book bc there's no health data associated w/it Healthcare providers must be mindful of the following: 1. avoid discussing pt care in elevators 2. shred all documents prior to disposal 3. cover pt identifiers on prescription bottles/bags prior & during dispensing 4. close pt records on computer screens when not in use & logout of system Can be shared w/: 1. pt 2. other healthcare providers providing care to pt 3. persons requiring info for tx, payment, or operational purposes 4. others, when authorized by pt 5. limited data set can be provided for research, public health or institutional operations 6. law enforcement, DEA, FDA, medical board inspectors, pharmacy board inspectors (for a public health purpose or drug abuse concern) *Important for pharmacy: PHI includes the medication labels; these contain patient identifying information. Labels must be shredded. Root cause analyses are done for medication errors.
Orphan Drug Act (1983)
Includes products that will treat diseases that affect <200,000 people in US or for products w/no reasonable expectation that the cost of research & development will be recovered by sales revenue
Surrendered
Individual agrees to voluntarily gives up licensure, often w/compulsion in order to avoid penalties &/or criminal charges
"Wholesaler"
Intermediary company in drug distribution chain who receives drugs from manufacturer, & distributes them to individual pharmacies
Pharmacist-in-charge (PIC)
Is responsible for daily operations of pharmacy above all other staff pharmacists; if something goes wrong w/the pharmacy like missing a substantial amt of CS over a period of time, if records weren't being stored properly, or if CS inventories are not performed when required, it's on the PIC Additional regulations: 1. limiting # of pharmacies for which the PIC is responsible for supervising 2. setting a MAX physical distance permissible between pharmacies if PIC is responsible for >1 location 3. requiring a minimum # of hrs that a PiC must be present at the pharmacy 4. requiring a pharmacist to complete a minimum # of yrs of experience as a staff pharmacist in order to be eligible to become a PIC
Drugs
Items recognized as drugs by USP, NF, & official Homoeopathic Pharmacopoeia, & their supplements Items used to diagnosis, cure, mitigate, treat or prevent disease Items (other than food) intended to affect structure or any body function
Cosmetics
Items that are intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to human body for cleansing, beautifying, promoting attractiveness, or altering appearance, & components of cosmetics, except soap (which isn't a cosmetic)
Food
Items used for food & drink, components in food or drink, & chewing gum
who can get a partial CII
LTCF, terminally ill, long term home health patient
Misbranding
Label is inaccurate (except incorrect drug strength - that's adulteration)
Compounded product labels
Label on container must include: 1. generic name 2. quantity or concentration of each active ingredient (for caps include mcg or mg/cap) 3. BUDs 4. storage conditions 5. script or control #, whichever is applicable 6. container used in dispensing 7. any required auxiliary labels (like "Shake Well" for emulsions & suspensions, "Keep Refrigerated", "External Use Only") 8. label should include statement or similar "This is a compounded preparation" 9. packaging & storage requirements
Exemptions to labeling requirements
Labeling requirements aren't required w/an inpt medication (ordered w/a "medication order") & if drug will be administered by a healthcare professional; use must be short-term (C-II drugs can be MAX 7 days; C III-V drugs MAX of no more than 34 day supply or 100 dosage units, whichever is less)
Withdrawal time (WDT) - indicates the length of time that animal tissue of food-producing animals cannot be used for human food supply
Labels of CNSPs for food-producing animals must included what provided by the veterinarian?
Durham-Humphrey Amendment
Law established difference between Rx and OTC drugs Label requirements: 1. label must not be false/misleading 2. drug dispensed must not be an imitation drug 3. drug must not be sold under name of another drug 4. packaging & labeling must conform to official compendia standards 5. if drug is susceptible to deterioration, it must be packaged/labeled appropriately
Internet pharmacies & Ryan Haight amendments
Legit mail order pharmacies: dispense meds only w/a script from a prescriber who has performed a good faith medical exam (even CS) Rogues internet pharmacies: do not require a script Requirements for CS to be sold online: 1. DEA registration as a pharmacy & completion of "Application for Modification for Online Pharmacies" 2. Notifying DEA & state boards of pharmacy in each state in which it intends to conduct business 30 days before dispensing 3. Displaying on homepage a declaration stating: "In accordance w/the CSA & DEA regulations, this online pharmacy has made the notifications to DEA Administrator required by 21 U.S.C. 831 & 21 C.F.R. & 1304.40" 4. The site has to list physical location of pharmacy, contact info (email/phone) & healthcare professionals employed by the site, including all contracted practitioners, w/degrees & license #s. The name & license # of PIC must be included. 5. Statement must be listed on site & followed: "This online pharmacy is obligated to comply fully w/the CSA & DEA regulations. As part of this obligation, this online pharmacy has obtained a modified DEA registration authorizing it to operate as an online pharmacy. In addition, this online pharmacy will only dispense a CS to a person who has a valid prescription issued for a legit medical purpose based upon a medical relationship w/a prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance w/section 309 of the CSA (U.S.C. & 829), or a medical evaluation via telemedicine in accordance w/section 102 (54) of the CSA (21 U.S.C. & 802(54))" 6. DEA requires a monthly report of total quantity of each CS dispensed if >100 prescriptions have been filled or if 5,000 or more dosage units have been filled of all CS
Suspended
License is inactive; may be reinstated after conditions are met (i.e. completion of pharmacist recovery program, probation)
Revoked
License is taken away by licensing agency
Reinstated
License that was taken away is given back, in active status
Healthcare providers authorized to prescribe meds
Licensed healthcare practitioners by law to prescribe meds & can include physicians (MD, DO), dentists, podiatrists, veterinarians, nurse practitioners, pharmacists, optometrists, & naturopathic doctors
what differences are required by the CV nonrx logbook vs the meth act logbook
METH book has to have the TIME CV has to have the RPh INITIALS (remember that meth act pharmacy doesnt have to dispense so they would not need rph initials - makes sense
A. Official name, strength, and dosage form B. Calculations needed C. Description of all ingredients and their amounts D. References for compatibility and stability E. Equipment needed F. Mixing instructions G. Labeling information H. Container to use for dispensing I. Packaging and storage requirements J. Description of the final cnsp K. Quality control procedures and expected results
MFR must include:
when drugs are stored outside institutional pharmacy how long until have to inspect them
MONTHLY and be inaccessible to unauthorized personnel
Pharmacy Technicians
MUST BE: at least 18 years old, Have HS degree or GED, Background check, fees, written application, photo RENEWAL: Annually. Must pass or maintain pharm tech certification via exam, provide proof of current approved certification. RATIO: Tech:Rph 3:1 CAN: Obtain provider authorization for refills provided that nothing about the prescription has changed. Bulk compounding/parenteral with review from Rph. Reconstitution EVERY tech shall have a name tag that readily identifies them as a technician and shall communicate immediately on the phone that they are a tech.
Biologics & biosimilars
Manufactured from living organisms by programming cell lines to produce desired therapeutic substances. Complex, large molecules Common biologics: human growth hormone & injectable tx for arthritis & psoriasis *True generics are not possible
Direct-to-consumer advertising (DTC)
Manufacturers advertise directly to pt via commercials & magazine ads *Not federally legislated & FDA pre-approval isn't required
Compounding vs Manufacturing
Manufacturing involves development & production of licensed drugs, which are produced in bulk for groups of pts rather than for an individual pt. Outsourcing facility pharmacies can bulk-compound, which is an explicit exception provided under 503B. 1. Manufacturing is regulated by FDA; compounding is regulated by state boards except for requirements of outsourcing facilities 2. Manufacturing requires CGMPs; compounding doesn't, unless it's an outsourcing facility 3. Manufacturing doesn't require a script; individual compounding is done by script for a specific pt 4. Manufactured drugs have NDC #s; compounded drugs don't 5. Outsourcing facilities require a separate license, must register w/FDA, but aren't registered as drug manufacturers, & agency doesn't approve their scripts before marketing, nor automatically receive ADE reports
Resale of discounted prescription drugs
Many hospitals & health maintenance organizations are able to purchase drugs at a discounted rate due to competitive bidding & nonprofit status. Resale of prescription drugs was prohibited by Prescription Drug Marketing Act (PDMA), w/these exceptions: 1. sales/purchases to other facilities w/in same organization 2. sales to nonprofit affliates 3. for emergency reasons
Counseling when pt isn't present
Many states still require an "offer" of counseling when scripts are delivered to home or work, or sent through mail or by delivery service. An acceptable method is to provide pharmacy business hrs & a toll-free phone # on printed drug info or container label. Some states require mail-order pharmacies to be open for a minimum # of hrs & days per week to receive pt calls.
Exemptions for pt counseling
Many states won't require pharmacists to counsel on pts receiving institutional care, like in a hospital. It's presumed that the healthcare provider or related staff taking care of pt will provide any necessary drug info. Some hospitals will send pharmacists to floor to review drugs being given or to provide counseling when pt is ready to be discharged (discharge counseling). Or when pt or caregiver has been offered counseling & the offer was refused. *Texas: must counsel or "offer" counseling, documentation of "offer to counsel", documentation of pt's refusal for counseling, process for counseling when pt isn't in pharmacy, discuss w/pt prior to generic substitution, & requires distribution of written materials
Pseudoephedrine
Max amt sold/day = 3.6g Max amt sold/30 days = 9g Max amt for mail order = 7.5g/30 days *60mg or less does not need to be documented *DEA requires logbook to be kept x2yrs
Hazardous Communication Program
Method of dealing with hazardous material. Consists of five parts: • Written program describing implementation • Container labeling (all must be labeled, tagged or marked with the identity of the material and appropriate hazards) • Safety Data Sheets for each HD used; and that SDSs are readily accessible to personnel during each work shift • Employee training for those who may be exposed to HD when working • Personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs
Sterile compounding
Most common type is preparing IV medications in a hospital setting. If medication isn't prepared in an aseptic manner & becomes contaminated, the pathogen (which will be injected directly into pt's blood stream) could cause infection. Is required for injections, inhalations, wound/cavity irrigation baths, eye drops & ointments. Water used must be "sterile water for injection" or "bacteriostatic water for injection." Requires personnel trained & evaluated at least annually for competency in aseptic techniques, environmental control, quality assurance testing & end-product evaluation & sterility testing. If product is an injectable, compounding environment must be ISO 5 laminar air flow hood w/in an ISO 7 clean room (w/positive air pressure differential relative to adjacent areas) or and ISO 5 clean room w/positive air pressure differential relative to adjacent areas or a barrier isolator that provides ISO 5 environment. Clean room garbs (low-shedding coverall, head cover, face mask, & shoe covers) is required & should be put on/taken off outside designated area. Hand, finger, & wrist jewelry isn't allowed. Head & facial hair have to be out of the way (tied up) & covered. Cytotoxic agents require specialized gowns, gloves, masks, & product labeling.
Pt Package Inserts (PPI)
Must be given with all estrogen containing products (lets pt know benefits/risk like clotting risk) *Given w/each dispensed drug (new & refills) in outpt setting *Considered misbranding if not given *In hospital/LTCF setting, must be provided to pt prior to administration of 1st dose & Q30days thereafter *Require FDA approval *Currently, FDA requires MedGuide to relay risks to pt, or, w/more severe risk, a REMS program
Written prescriptions for CS
Must be written in ink, indelible pencil, or typewritten; must be signed/dated by prescriber Prescription must include: 1. pt's full name & address 2. prescriber's full name, business address, & DEA # 3. drug name, strength, dosage form, quantity prescribed, & directions for use 4. # of refills authorized *Medication orders: orders written for direct administration to pts in facilities like clinics & hospitals aren't considered prescriptions & don't need to meet prescription requirements
Package insert for a legend drug
Must include safety info, is intended for healthcare provider, & must be approved by FDA
Delivering CS to pts
Must meet the following requirements: 1. Prescription label contains name & address of pharmacy (or practitioner) dispensing the script 2. Inner container is marked & sealed as required by CSA, & is placed in a plain outer container or securely wrapped in plain paper 3. Outside wrapper/container is free of markings that could indicate its contents
Consulting Pharmacists to Inst/LTCF
Must: Have MS license, Have attended w/i 2 years 8 hours or more of training on inst pharm services. Copy of consultant reviews kept x 2 years. Dispose of patient's medication after 90 days. paper trail of disposal 2 years IF loss of CS must notify consultant pharmacist w/i 24 hours and he notifies board immediately
BSC Class 1-
NEGATIVE pressure ventilated cabinet to protect personnel and environment from contaminated air air entering cabinet working environment is NOT sterile clean air is filtered outside
A patient comes to your pharmacy and is out of refills for her lyrica. she is hurting and would like a emergency fill. can you do this
NO its for noncontrolled subs for 72 hours supply (one time) and has to record as a SEPARATE NON REFILLABLE PRESCRIPTION - WHO KNEW - it should also have its own rx number and the original rx number and the circumstances for the fill
__ maintains a list of antineoplastic and other HDs often used in healthcare
National Institution for Occupational Safety and Health (NIOSH)
Emergency filling of C III-V drugs
Needing prescriber authority for these refills depends upon state, but it's the pharmacist's job to determine if the refill is necessary w/out prescriber authority bc not filling it may interrupt pt's ongoing care & have significant ADEs Refills must be properly documented & an original prescription for the emergency filling must be obtained in a timely manner *Emergency day supply: 72hrs *C-II emergency fills are not allowed w/out prescriber's authorization; an oral authorization is the bare minimum **If original script isn't received, pharmacist must report breach to local DEA office
Transmission of Prescriptions
New Scripts may be taken by RPh only Oral - Reduced to writing and filed with paper copy rx's Electronic- Transmitted only to pharmacy of pt choise and be trasmitted by authorized MD or MD agent. Must write down the name of transmitter Fax - Must have all items on rx PLUS patient AGE, TIME and date of transmission, DR PHONE #, full name of person sending and PHARMACY intended to recieve fax. AND THE FAX SERVES AS ORIGINAL Written - Must have MD signature. Facsmile or stamped signatures are not acceptible. CS - Electronic transmission of CS must follow DEA rules
Pt identification prior to dispensing CS
No federal law that requires an ID for a CS but it is recommended if the pt is not known to the pharmacy staff *Commonly asked: name, DOB & sometimes address to confirm pt's identity *Some states require the DL # & enter it into a state system to prevent possible drug diversion & "red flag" circumstances
Refills of CS
No refill restrictions on C-V drugs. C III-IV drugs may be refilled up to 5x w/in 6mos (original fill is not a refill). C-II drugs can never be refilled.
CS eligible for refills
No refills allowed on C-II drugs. C III-IV scripts may be refilled up to 5x w/in 6mos of date written. After 5 refills or 6mos, whichever comes first, a new script will be required. *Original fill isn't counted as a refill
Pharmacy clerk
Non-licensed personnel w/no specific training required; person accepting scripts at "drop off" window, verifying pt's insurance coverage, & completing transaction of sale or "pick up" window *Permitted to type scripts into computer & pharmacist will verify that it matches to actual script *Prohibited from stocking/pulling medications from shelves or package scripts *Not allowed to handle prescription meds other than at point of sale *No MAX limit of clerks that can work in a pharmacy
Change of Address/Employment/Legal Name
Notify Board within 10 days. must notify with change in employment listing old employer and new employer. Change of name must include a copy of document that created name chage (marriage certificate)+ wallet card
Drug utilization reviews (DUR)
OBRA requires each state to have DUR program in order to be reimbursed for Medicaid services. Prospective: evaluation of pt's drug therapy prior to dispensing by the dispensing pharmacist *Looks for following errors: 1. therapeutic duplication 2. incorrect dosing 3. incorrect tx duration 4. CI to drug 5. interaction between drug, a disease state, or pt allergy 6. abuse/misuse Retrospective: review of drug therapy after medication dispensing by state *It's still pharmacist's job to check pt profiles for DDIs or repeated drug therapy due to less expensive OTC products, promotional discount coupons, getting drugs at the VA, getting drugs under pt assistance plan directly from manufacturer, or getting free drug samples from prescriber
when do you have to give a PPI example
OC accutane statins
BSC Class 1 used for (sterile/non-sterile) compounding-
ONLY non-sterile
CVE used for (sterile/non-sterile) HD compounding-
ONLY non-sterile
Behind the counter drugs (BTC)
OTC drugs stored behind the counter bc sale may need to be recorded, which requires identity of purchaser (driver's license, identification card, or passport) & has quantity restrictions (pseudoephedrine) *Some C-V drugs, like codeine in cough syrups are sold OTC in some states but needs to be dispensed by a pharmacist. Quantity/age restrictions &/or recordkeeping rules may also apply.
Child-resistant packaging
OTC, Rx, & dangerous household chemical containers designed so that 80% of kids <5yo cannot open them while at least 90% of adults can Drugs that require C-R packaging: 1. All PO prescription drugs (except inhalers & topical mouth drugs) 2. Liquid anesthetics (lidocaine, dibucaine, & OTC NSAIDs) 3. OTC iron supplements, multivitamin/minerals w/iron, & natural products w/iron 4. loperamide (Imodium) 5. minoxidil (Rogaine) 6. Rx drugs that were converted to OTC 7. mouthwash (fluoride) 8. PO & non-PO investigational drugs *Requested by either pt or prescriber *Pt can provide a blanket waiver for all dispensed drugs *C-R packaging is exempt if drug is administered directly by healthcare provider to pt *If elderly/handicapped pts need non-CR packaging, label must say "Easy open" or "This package is for household w/out young children" or "Package not child-resistant"
Correcting errors & omissions on scripts
Omission: type of error in which required info on a script has been left out, such as the # of tablets required Errors on a script for non-controlled drugs can be revised by pharmacist if error is minor (misspelling drug name). If it's not a minor error, pharmacist should consult w/prescriber, & document discussion, including agreed to change(s). After verification w/prescriber, script can be re-written as an oral script. Sometimes, original script will be voided & prescriber will resend another script via fax/e-script
Pts returning previously dispensed medications to the pharmacy
On occasion, pts come back to pharmacy asking to return prescription medications. This can be due to a variety of reasons: dose may have changed, course of tx has been completed, or pt simply has too much of drug. FDA compliance policy guide recommends that a pharmacist shouldn't accept returned drugs from pts & return it to pharmacy shelves (or pharmacy stock) after it has left pharmacy premises. This is bc pharmacist no longer has any assurance of strength, quality, purity, or identity of drugs. Many state boards of pharmacy have regulations prohibiting this practice. Pharmacist dispensing a drug is legally responsible for adulteration that may be present if returned drugs are combined w/pharmacy stock & subsequently re-dispensed to other pts.
Minimum cleaning/disinfection frequency _ISO Class 5 PEC _Counters/easily cleanable work surfaces _Floors _Walls _Ceilings _Storage shelving
PEC: beginning of each shift, before each batch, not longer than 30 minutes following previous disinfection for ongoing compounding activities Counters/easily cleanable work surfaces: Daily Floors: Daily Walls: Monthly Ceilings: Monthly Storage Shelving: Monthly
Initiation or modification of drug therapy By Rph (Institutional)
Per written & MD signed protocol Rph can initiate or modify drug therapy. Must be on file at BOP. Valid for 1 year.
Outsourcing facilities & Section 503B
Permits pharmacies to register w/FDA as "outsourcing facilities" under 503B, in order to bulk compound & distribute drugs across state lines if the following are met: 1. drugs must be compounded in compliance w/CGMPs 2. facility pays a fee to FDA, & is subject to FDA inspection 3. preparations must be made by or under supervision of licensed pharmacist 4. facility must meet recordkeeping requirements, including source of ingredients, sterility data, & ADE hx GOAL: to prevent a repeat of lack of aseptic technique while still providing a way to obtain some drugs in short supply *facility must be involved in preparing sterile compounds for humans, not animals.
Oral (phone) scripts for CS
Pharmacist can receive C III-V scripts over the phone *C-II scripts aren't valid via phone except in emergency situations *Federal law permits prescribers to designate someone else (office staff or nurse) to communicate new/refill info to pharmacists via phone or fax (this person doesn't need to be licensed nor special training); communication must be under supervision of prescriber & prescriber is responsible for their actions & any medication errors they make
Recognizing red flags to prevent drug diversion
Pharmacist has the right to tell pt: "I do not feel comfortable filling this script" or "I will not fill this script;" it's a felony offense for a pharmacist to knowingly fill an invalid/fraudulent script. The law doesn't require a pharmacist to dispense a script of suspicious origin. Possible red flags: 1. irregularities on face of script itself 2. nervous pt demeanor 3. age or presentation of pt (youthful pts seeking chronic pain medication) 4. multiple pts all w/same residential address 5. multiple prescribers for same pt for duplicate therapy 6. cash payments 7. frequent requests for early refills 8. suspicious scripts brought in at busiest time while pt decides to wait for it to be filled 9. scripts written for an unusually large quantity 10. scripts written for duplicative drug therapy 11. initial scripts written for strong opioids 12. long distances traveled from pt's home to prescriber's office or to pharmacy 13. irregularities in prescriber's qualifications in relation to type of medications prescribed 14. scripts for medications w/no logical connection to an illness/condition 15. pts coming to pharmacy in groups (especially if most of the pts live far away from pharmacy or prescriber & each pt has similar scripts issued by same prescriber) 16. same diagnosis for many pts 17. same combos of drugs prescribed for multiple pts
Electronic recordkeeping requirements for refills of C III-IV drugs
Pharmacist must verify & document that refill data entered into system is correct. All computer generated script & refill documentation must be stored in a separate file at the pharmacy & must be maintained x2yrs from dispensing date. Any of the following methods is acceptable: 1. daily, hard copy printout of refills for CS w/signature & date of all pharmacists involved w/dispensing that day. Must be provided w/in 72hrs of date when refill was dispensed. 2. Bound logbook or separate file documenting each day's refills. Each dispensing pharmacist during the day signs a statement saying that what they dispensed is correctly listed in logbook/file. Electronic system must provide online retrieval of original script info for those scripts currently authorized for refill. Must include: 1. original script # 2. date of issuance 3. pt's full name & address 4. prescriber's name, address, & DEA # 5. name, strength, dosage form & quantity of CS prescribed (& quantity dispensed if different from quantity prescribed) 6. total # of refills authorized by prescriber Electronic recordkeeping system must be able to print out refill info. Must include: 1. original script # 2. date of each refill 3. pt's name & address 4. prescriber's name 5. name/identification code of dispensing pharmacist 6. quantity dispensed
Face-to-face counseling
Pharmacist provides counseling in an area suitable for confidential pt consultation to protect pt's privacy, including protected health info (PHI). Depending on state, pt consultation may be initiated by pharmacist or other pharmacy personnel. In all states, pharmacist must provide actual counseling. It's up to pharmacist to decide which info should be discussed. Due to time limitations, pharmacists may discuss select info, such as: 1. name/description of drug 2. route of administration 3. dosage form 4. dose 5. duration of therapy 6. how to prepare drug for administration 7. techniques for self-monitoring 8. common &/or severe ADEs or DDIs 9. what to do if a dose is missed 10. prescription refill info 11. importance of compliance 12. storage
Vaccine administration
Pharmacist's authority to give vaccines is determined by each state's laws & regulations governing pharmacy practice. All 50 states permit some type of vaccine administration by pharmacists as part of their scope of pharmacy practice. May occur pursuant to individual script orders or through standing orders/protocols. CDC Advisory Committee on Immunization Practices (ACIP) encourages pharmacists & other healthcare providers to establish standing order programs in LTCFs, home healthcare agencies, hospitals, clinics, workplaces, & managed care organizations. Centers for Medicare/Medicaid Services (CMS) no longer requires a physician order for influenza or pneumococcal immunizations administered in participating hospitals, LTCFs, or home healthcare agencies. State-specific protocols or standing-order programs can be developed w/state pharmacy associations, boards of pharmacy, & health departments. In order to provide immunizations, pharmacist must have taken a comprehensive training program which includes: 1. epidemiology of & pt populations at risk for vaccine-preventable diseases 2. public health goals for immunizations (local, regional, state, & federal goals) 3. vaccine safety (risk-benefit analysis) 4. screening for CIs & precautions of vaccination 5. vaccine stability, transportation & storage requirements 6. immunologic drug interactions 7. vaccine dosing, including interpreting recommended immunization schedules & pt immunization records, & determining proper dosing intervals & feasibility of simultaneous administration of multiple vaccines 8. proper dose preparation & injection techniques 9. s/sx of ADEs to vaccines, ADE reporting, & emergency procedures, like basic & advanced cardiac life support (BCLS & ACLS) 10. documentation 11. reporting to PCP or local health department & vaccine registry 12. billing
Retail pharmacy when RPh not present
Pharmacy must be physically secured from other services with Rph is not present. - Physical barrier - PIC responsible for adequate security - Report and theft of loss to BOP IMMEDIATELY and do CS inventory in 48h and send report in 15days --- also report to DEA immediately and fill out 106 2 copies
Clinical trial phases
Phase I: Healthy subjects, ~20-80 subjects (safety, ADEs, PK & PD properties) Phase II: Pts w/disease, ~35-100 subjects (safety, efficacy, dosing range studied) Phase III: Pts, ~300-3,000 subjects (efficacy for treating condition compared to placebo or gold-standard tx) *If completed successfully, manufacturer files new drug application (NDA) or biologics license application (BLA) Phase IV: Pts (post-market surveillance) "MedWatch"
OTC monograph approval process
Phase I: active ingredients are reviewed to determine safety & efficacy; results are published in "Federal Register" in the form of an advanced notice of proposed rulemaking (ANPR) for interested parties to submit comments/data Phase II: agency's review of active ingredients in each drug class, public comments, & any new data that's available; results are published in "Federal Register" in a tentative final monograph (TFM) for interested parties to submit comments/data Phase III: drug monograph that establishes drug is safe & effective; if drug can't comply w/monograph requirements, an IND & NDA review process is required for drug to be approved & released to marked
"Fair balance"
Positive info about drug must be balanced w/negative info
Simple compounding
Preparation of CNSPs according to USP monographs, use of manufacturer's information to reconstitute a commercial product, or following the complete directions in a peer-reviewed journal
Moderate compounding
Preparations requiring special calculations or procedures or mixing a CNSP for which the stability data is unknown
Complex compounding
Preparing CNSPs that require special producers or equipment
Multiple scripts for C-II drugs
Prescriber can write for multiple (usually 2-3) scripts for a C-II drug, which are filled sequentially & cannot exceed a 90-day supply in total from 1 office visit; each drug can only be dispensed for 30 days at a time *Script cannot be post-dated *Prescriber must include when script was written & earliest acceptable fill date *1st prescription can be filled on day it was written
Advertising
Prescription drugs (FDA) *Requirements: at least 1 approved use, generic name, & a brief summary/major statement or "adequate provision" of drug's risks OTC drugs (Consumer Product Safety Commission, under Federal Trade Commission [FTC])
CIII-V Expiration Dating
Prescriptions for CIII-V may not be filled after 6 MONTHS or 5 times for the full amount prescribed. Yes, this includes CV (which is not included federally)
HIPPA
Protects privacy of PHI, outlines how it can shared, & provides pt right to access their own info. Also involves insurance portability, which allows individuals to keep their insurance if transitioning from 1 job to another. Is a federal privacy law. It is permissible to share protected health information with insurers for reimbursement information without the signed consent of the patient. The signed HIPAA form is for the pharmacy to prove compliance; a signature is not required. The signature cannot be the same one used to decline consultation. Violations of HIPAA are serious, and generally involve charges and fines. In addition to protecting health information, HIPAA also involves "portability" -- which gives certain rights to keep insurance for a period of time after leaving employment. *Pharmacy can disclose PHI to: 1. provide tx & coordinate healthcare 2. counseling of pts 3. determining pt eligibility for insurance claims Privacy abuse examples: 1. labels w/identifiers sent to shredding (recycling) company 2. pharmacy employees snooping around in celebrity pt records 3. pictures or info about pts posted on social media sites *Pharmacy must keep pt acknowledgement of HIPPA for 6yrs
Emergency kits for LTCFs
Pts can check into a LTCF outside of regular business hrs or need medication for an acute purpose that's not on their regular medication plan, therefore DEA permits CS to be in these kits *DEA requires CS comes w/DEA registrant & that security safeguards are in place to restrict access. *Prescriber should write a script for use & pharmacist will enter it into system to document use, even if given to pt before script is written
Pts disposing CS
Pts can take unused/unwanted/expired CS to: 1. Local government drug collection programs 2. Authorized collection sites (pharmacies, hospitals, & clinics) 3. Authorized collectors w/mail back packages 4. DEA-sponsored Take Back Days
Pt counseling
Pursuant to OBRA 90, pharmacists must offer oral consultation before dispensing scripts to Medicaid pts. Majority of states have made the offer to counsel a mandatory requirement for all pts. Some state laws only mandate offer to counsel for new scripts, while other states mandate offer to counsel for refills as well. Although offer to counsel must be made, pt or pt's caregiver may refuse counseling.
home health and hospice records kept for _ yrs
RECORDS OF ACQUISITION AND DISPOSITION ARE KEPT FOR 6 YEARS
DEA Form 41
Record of CS destroyed
Refill Authorization
Record refill auth on original rx, date qty, initials. - CS auth refills in excess of 5 rf/6mo - treat as new prescription. Techs can take refills
Paper recordkeeping requirements for refills of C III-IV drugs
Refills must be documented; pharmacist must notate on back of script: his/her initials, date dispensed, & amt dispensed. If amt dispensed isn't notated for each refill, it's assumed that the pharmacist dispensed a refill for the remaining amt
Script refills
Refills of scripts are allowed as long as refills were authorized orally or in writing by prescriber, however the amendment didn't specify time limits. Majority of states allow scripts to be refilled up to 1 year from original issue date. Refills for C III-V have shorter time limits (6mos) in which refills are permitted relative to non-controlled drugs, & some states have limits on # of total day supply refills can provide. *C-II drug refills are prohibited
DEA Form 225
Registration for manufacturers, distributors, researchers, analytical labs, importers, exporters
Disposal of CS wastage in an institutional setting
Remainder of CS that cannot be used any further is not reported w/DEA 41, but it MUST be properly recorded in a log book
When a pharmacy should register as a manufacturer with the FDA
Repackaging products to distribute to other pharmacies
DEA Form 106
Reporting theft or significant loss of CS w/in 1 business day upon discovery *Should also report to local law enforcement if theft is suspected *If loss occurs from central to retail: central reports loss *If loss occurs from retail to central: retail reports loss
DEA Form 363
Required for Narcotic Tx programs
DEA Form 222
Required for each distribution, purchase, or transfer of C I-II drugs; pharmacist uses it to order C-II drugs, sell/lend C-II drugs to another pharmacy/prescriber, borrow C-II drugs from another pharmacy, or return CS to wholesaler/reverse distributor supplier can send partial shipment but MUST supply balance w/in 60 days from date on 222 Form *Pharmacist should also use invoices (esp for C III-V drugs, which must contain: drug name, dosage form, strength, quantity, date transferred, & recipient's name/address/DEA registration #) *Not required when transferring a C-II from a central fill to its retail pharmacy or when a C-II is dispensed to a pt *May only use black/blue pen ink, typewritten, or indelible pencil *Only 1 supplier/form *Purchaser must record total # of different items ordered on last line (10 items MAX) *MUST complete 3 columns: # of packages, size of package, name/dosage of drug *MUST be signed/dated by person who signed 224 Form or who has been granted power of attorney *If a mistake is made, write "VOID" on form and dispose *DEA requires purchasers to keep Form 222 Copy 3 for at least 2yrs *Supplier cannot fulfill order if order form is illegible, incomplete, or altered so supplier sends Copies 1 & 2 back to purchaser w/rationale for not filling & purchaser keeps all 3 Copies; supplier MUST draw line through cancelled items on Copies 1 & 2 & write "VOID" on space for "# of items shipped" *Purchaser can cancel all or part of an order by notifying supplier in writing; also needs to draw a line through canceled items & write "cancelled" on space for "# of items shipped" *Lost/stolen forms: if sent to supplier, purchaser must re-order w/new form & prepare a statement that the order wasn't received, including serial # of lost/stolen form, & date of loss; MUST attach statement to new order form & send to supplier & filed together; if supplier subsequently receives original order form, it's marked as "not accepted" & returned to purchaser who then will keep all 3 Copies
Poison Prevention Packaging Act applies to:
Residents of senior citizen apartment complexes; consider where children are likely to be present and do not include settings where drugs are administered by healthcare professionals *Was enacted in order to protect young children (primarily) from accidental drug overdose
Pharmacy & therapeutics committee
Responsible for managing formulary & all aspects of drug use in a healthcare system, which could be a small hospital or a large PBM. Includes physicians, pharmacists, nurse(s), administrator(s), quality improvement manager(s), & medication safety officer. Primary responsibilities: create & update formulary (a continual process as drugs change), conduct medication (or drug) use evaluation (MUE/DUE), have responsibility for ADE monitoring & reporting, & conduct medication error safety initiatives (which will involve medication safety officer) & develop clinical care plans/protocols, including development of protocols to guide use of high-alert drugs, which have a high risk of causing pt harm when used incorrectly. Hospital pharmacists rely on guidance from ASHP, the Joint Commission, ISMP, & select professional organizations for best practices in hospitals, like high-alert drug protocol development, management of blood products, quality assurance for sterile compounding, therapeutic interchange, & many other areas related to practice of hospital pharmacy
Requirements for CS prescriptions
Same as Federal DOES NOT REQUIRE DOB does require pt address and DEA number AND DATE AND DOSE FORE DRUG AND STRENGTH
Partial Filling of CII
Same as federal - must supply remainder within 72 hours and notate qty on FACE of rx. regs say LTCF or terminally ill home health patient can partial fill the prescription up to the written qty or 50 DAYS FROM THE DATE OF ISSUANCE.
Manufacturer drug samples given to prescribers to provide to pts
Samples can only be given to prescribers or to a hospital pharmacy or other healthcare entity at written request of prescriber. "Healthcare entity" excludes retail pharmacies. *Must be stored separately form other drug inventory. Many states require prescriber's office to maintain receipts of samples received. Samples are different than "starter packs" & from drugs that are provided free of charge, or at a reduced price, pursuant to an indigent pt program
Insulation for Low Risk only
Segregated Compounding Area PEC (ISO 5) DCA (Direct Compounding Area - First Air)
Dispensing of CII rxs
Send Ahead: CII may be faxed provieded the original signed rx is presented to pharmacy prior to dispensing. CMPD/IV/HOSPICE/LTCF: Fax of CII rx counts as legal rx Can have laddered Rxs up to 90 day supply with "do not dispense before" -CII PRESCRIPTIONS ARE VOID 6 MONTHS FROM ISSUANCE
Controlled Substance Act (CSA)
Sets the regulations for CS; pharmacists can use DEA's Pharmacists Manual as a guide to interpret CSA & how it applies to pharmacy practice
Drug recall documentation
Should be kept >/=2yrs *Recalls may be initiated by FDA request, by an FDA order under statutory authority or at the manufacturer's own initiative
Continuous quality improvement program (CQI)
Should include: 1. Designated individuals responsible for program, including implementation, maintenance & monitoring 2. A set time frame under which CQI is initiated after QRE (Quality-related event) has occurred. NABP recommends that investigation be initiated w/in 3 days & individual state boards may have a more stringent requirement of 1 or 2 days. 3. Formulation of a plan to amend pharmacy system & workflow to avoid a repeat of the same or similar type of QRE, based on data provided by the CQI 4. Any required changes in pharmacy systems & workflow processes 5. Education to staff, performed on a continual basis, on safe practices. Lessons learned from CQI must be passed on to rest of pharmacy team *NABP recommends each pharmacy conduct a self-audit at least quarterly to determine if QREs have decreased & a survey of customers (or a sampling of customers) at least annually to help determine pt perception of pharmacy's quality
Low Risk Examples: 2
Single-volume transfers of sterile dosage forms from ampules, bottles, bags, and vials using sterile syringes with sterile needles, other administration devices, and other sterile containers. The solution *content of ampules* should be passed through a *sterile filter* to remove any particles. Simple aseptic measuring and transferring with *not more than 3 packages* of manufactured sterile products, including an infusion or diluent solution to compound drug admixtures and nutritional solutions.
Sodium threshold amt/daily dose
Sodium free </=5mg Very low sodium </=35mg Low sodium </=140mg Ask a doctor before use if you have a sodium restricted diet >140mg
Emergency refills w/out prescriber's authorization
Some states allow emergency refills w/out prescriber's authorization if prescriber is unavailable to authorize refill &, if in pharmacist's professional judgment, failure to refill script might interrupt pt's ongoing care & have a significant adverse effect on pt's well-being.
Pt identification prior to dispensing or administering prescription drugs
Some states require pharmacy staff to verify pt's identity in order to prevent drug diversion & reduce medication errors. There is no federal law requiring pts to provide identification prior to receiving scripts. In community setting, most common identifiers are pt name & DOB. If pt has a common name, home address can be requested. Some states require pt identification for all scripts in community setting while other states require identification only for CS. In order to reduce errors, institutional settings certified by The Joint Commission require healthcare providers to verify 2 pt identifiers prior to administering a drug or performing a procedure. Identifiers must be pt-specific, therefore identifiers that can be used for many pts aren't acceptable (prescriber's name, or pt's city or zip code). In an institution setting like a hospital, the medical record # (usually located on pt's wrist band) & pt's name or DOB are commonly used.
Pharmacy Intern
Somone who is: -Currently licensed by MS to engage in practice of pharmacy while under the supervision of Rph - Graduate of approved SOP who is licensed by the BOP for purpose of practical expericence as Req. for licensure. - Qualified applicant awaiting exam licensure.
Telepharmacy
States that have pts in remote, rural areas have enacted regulations for telemedicine & telepharmacy to help improve healthcare delivery to underserved communities. These regulations allow practice of virtual pharmacy using remote order verification, automated dispensing systems (ADS), video-conferencing, telephones, & Internet. Provides pharrmacists w/a means to verify scripts, perform DURs, & counsel pts remotely. State laws usually require remote telepharmacy sites to have a pharmacy license in order to receive 3rd party reimbursement. Pts bring scripts to remote sites, which are staffed by pharmacy techs or nurses. Central pharmacist supervises workflow over a teleconferencing system (in real-time) & verifies scripts transmitted from rural site. The script label & prepackaged medication are then dispensed from ADS at remote site. Tech scans barcode, attaches label, & dispenses medication to pt. Finally, pharmacist at central location counsels pt through a real-time video.
Sterilization (High Risk) by filtration *nominal pore size*: by steam temp: __; pressure: __; time: __; can also use dry heat, not specific Depyrogenation by dry heat: temp: __; time: __
Sterilization (High Risk) by filtration *nominal pore size*: *0.2 or 0.22 mcm* by steam temp: *121 C*; pressure: *1 atm* (15 psi); time: usually 20-60 min; can also use dry heat, not specific Depyrogenation by dry heat: temp: *250 C*; time: *60 min*
Pharmacy Extern
Student in professional program of SOP who is making normal progress toward completion of degree.
Patient Records
System maintains: Name, Add, Ph#, Age/DOB, Gender, profile orders recieved in last 2 years. -Make reasonable efforts to obtain all/rxns/OTC/Herb
TF LTCF does not include hospital
T
TF a consultant pharmacist can not serve a nursing home that does not have a CS reg
T
TF board will take action against license if you terminate an employee for theft without first contacting the board and failing to submitt info to PMP
T
TF med pak incdicates the time and date the med is to be taken
T
TF no program will be approved if it was already presented, attendence in mandatory for employment, not made availbel to all pharmacists who wish to attend
T
TF the pharmacist also has to make a record of the med pak that was dispensed
T
TF must have the NDC number for the drug for the PMP
T also the method of payment and the recipients id number
TF under fed law if you purchese CS to repackage u have to register as mfr
T and CS can only be 20% if you compound an rx
TF donated items must accompany a medication donation form
T and cant be returned to the donating facility - meds that are disposed keep records 2 years
TF you can partial fill CIII-V for anyone
T as long as it is within 6 months- probs have a scenario where you have to tell if its refillable or not.
False, it should be included
T or F; T phrase, "this is a compounded preparation" must be included on the label for CNSP
TF penicillins cant be repackaged in same room as other drugs
T or using same handling equipment
TF in institution all emergency supplies must be sealed with mechanism that must be broken - what are exterior interior req
T the exterior - has to clearly indicate it is emergency supply and have expiration and interior supplies must be listed and labeled
when you do CS inventory for loss of CS what has to be included on it
THE DATE AND SIG OF THE PHARMACIST IN CHARGE
who reports loss to BOP
THE PIC AND THE DISCOVERING PHARMACIST ARE RESPONSIBLE
TF PPIs must be given in the hospital and dr offices and pharmacies with dispensing
TRUE failure to do so is misbranding --- hospital at first admin and 30 days after
TF you can partial fill an rx faxed for a LTCF patient
TRUE you can use fax as original and you can partial fill it!!!.
"Terminally ill"
Term used in hospice setting to indicate pt is expected to have <6mos to live
Pre-clinical testing
Testing a new drug/product on an animal before clinical trials on humans. If tested safe, manufacturer will file an investigational new drug (IND) application w/FDA to start clinical trials.
Medication provisions during declaration of disaster or emergency
The Emergency Prescription Assistance Program (EPAP) is a federal program managed by Dept of Health & Human Services, which provides a way for pharmacies to process claims for prescription meds & limited durable medical equipment (DME) provided to uninsured individuals from a disaster area declared by US President. Claims for individuals w/private insurance (individual health insurance coverage or employer-sponsored coverage), public insurance (Medicare, Medicaid), or other 3rd party coverage, aren't eligible for payment under EPAP. Claims will be processed for a specific period of time to be determined under EPAP activation. Eligible individuals may be provided essential pharmaceutical & DME written prescription assistance limited to a one time, 30-day supply for a medication to treat an acute condition, to replace maintenance prescription drugs or medical equipment lost as a direct result of a disaster event or as a secondary result of loss or damage caused while in transit from emergency site to designated shelter facility, at no cost to pt. Enrolled pharmacies must check for other forms of health insurance coverage at point of sale to determine eligibility. In order to receive prescription meds &/or DME, eligible individuals must have 1 of the following: 1. new script from a licensed healthcare practitioner 2. current prescription bottle 3. script called in by a licensed healthcare practitioner 4. proof of an existing script *Enrolled pharmacies must dispense generic form of med unless otherwise indicated as Brand Medically Necessary (BMN) or Dispense as Written (DAW) by licensed healthcare provider
A. Official or assigned name, strength, and dosage B. Mar reference C. Names and quantities of all components E. Names of personnel who compounded, performed quality control, and approved the cnsp F. Date of preparation G. Assigned bud H. Copy of label I. Description of final cnsp J. Results of quality control procedures K. Documentation of any quality control excursions or other problems reported by patient or caregiver
The compounding record must include:
Conscience or moral clauses
The pharmacist's right to refuse dispensing certain meds (emergency contraceptives, PO contraceptives, abortion pills, ED drugs, meds sed for physician-assisted suicide) based on pharmacist's religious or moral beliefs has been a controversial issue, Some states have issued refusal or conscience clauses allowing pharmacists to refuse dispensing scripts based on personal values. In some states there are broad refusal clauses in state legislation that apply to all healthcare providers in general. In some states, a pharmacist must dispense a script despite moral objection, unless employer approves refusal & an alt pharmacist can provide medication in a timely manner. In other states, refusal is prohibited on moral, religious or ethical grounds, in all circumstances
Extemporaneous compounding
The preparation, mixing, assembling, packaging and labelling of a medicinal product based on a prescription order from a licensed practitioner for the individual patient
Script transfers
There are no federal limitations on transfer of non-CS &, unless limited by state law, a pharmacist can transfer scripts as long as there are refills remaining. The transfer must be directly communicated between 2 pharmacists (or 1 pharmacist & 1 intern). The pharmacist who transfers the script to another pharmacy must write/stamp "VOID" on face of script. Name/address of pharmacy which script is transferred to, name of pharmacist receiving the script, & transfer date is written on back of script. Pharmacist that receives script reduces it to writing & writes "transfer" on face of script, along w/info that's required for a script.
MD/PT Relationship
There must be a MD/PT relationship obtained through Med history, Physical exam, and/or mental evaluation prior to prescribing. If not rx is not valid. - Rx is still valid for 30 days after termination of MD/pt relationship, Pt must get new MD in that time.
Maintaining pedigrees to ensure quality of drugs
There's an increasing prevalence of counterfeit, misbranded, adulterated, & diverted prescription drugs showing up in US. To prevent these drugs from entering legit drug supply, Drug Supply Chain Security Act was passed, which outlines critical steps to build an electronic, interoperable "track & trace" system by November 2023 to identify & trace certain prescription drugs as they are distributed w/in US. Manufacturers, wholesale distributors, pharmacies & repackagers (collectively referred to as "trading partners") are required to provide subsequent purchase w/product tracing info when engaging in transactions involving certain prescription drugs. This mean that anytime drug is moved from one place to another, paperwork must follow. Pharmacies must be able to capture & maintain transaction info (TI), transaction hx (TH), & a transaction statement (TS), in paper or electronic form, for each drug product received x6yrs from date of transaction.
Generic drug substitution
To provide pt w/a lower cost drug, while still providing same therapeutic benefit. Laws vary by state. Can use FDA Orange Book to find substitutions. Most states allow for this unless pt/prescriber has requested otherwise. Permissive drug selection law: when a pharmacist decides whether or not to make a generic substitution Mandatory drug product selection law: when a state makes it mandatory to make a generic substitution unless pt or prescriber has noted otherwise *It's considered misbranding if pharmacist labels a generic drug as a brand drug or vice versa
which books used to compound sterile products
Trissels, Kinds AHFS amcn hospital formulary service, ASHP procedures for handling cytotoxic drugs
Class II BSC acceptable types-
Type A2 Type B2- volatile components
Potable water
Type of water used for performing hand hygiene and equipment washing
Formatting standards for multiple until (multiple dose) script labels
USP 17 on Prescription Container Labeling is the official standard for script format, appearance, content & language instructions. Goal of standardizing the labels is to promote pt understanding of medication usage, increase adherence, & reduce medication errors. These standards don't apply to inpt medication since those are pursuant to medication orders, & are labeled for a healthcare professional to administer. The following critical items should be prominently displayed in a large font (12-pt Times Roman or 11-pt Arial): 1. pt name 2. drug name (brand/generic) & drug strength 3. explicit, clear directions for use, in simple language *Use digits rather than spelling out #s *Avoid hourly intervals requiring the pt to count *Avoid specifying exact times to take a med
Handling hazardous drugs
USP 800 provides guidance on ways to protect staff from hazardous drug exposure
Nonsterile HD compounding must follow __ guidelines
USP <795> as well as <800>
Sterile HD compounding must follow __ guidelines
USP <797> and <800>
USP standard for Nuclear Pharmacy
USP Standard 825
BUDs & exp dates for compounded products
USP emphasizes that BUDs should be applied applied conservatively. If an exp date of any APIs is sooner than the BUD, the earlier exp date is used.If drug-specific stability data is available, is should be used to make BUD determination. Products kept in a refrigerator will usually be stable for longer periods than products left at room temp since heat speeds up chemical rxns that can degrade the substance. Containers can be chosen to block out light & moisture. Light & humidity exposure contributes to degradation. Preservatives may be required to block microbial contamination. Preservatives are required in sterile formualtions that contain >1 dose. Formulations & theirs BUDs: 1. nonaqueous formulations (lotions, creams, ointments): BUD is no later than time remaining until earliest exp date of any API or 6mos, whichever is earlier 2. water-containing PO formulations: BUD is not later than 14 days when stored at controlled cold temps 3. water-containing topical/dermal & mucosal liquid & semisolid formulations: BUD is not later than 30 days
Customized pt packaging for adherence
USP has published guidance on customized pt medication packages ("med paks"), which is found in USP 61. Instead of dispensing >/=2 prescribed drugs in separate containers, a pharmacist can prepare a customized med pak, w/consent of pt, pt's caregiver, or prescriber. Med pak has a series of containers, or compartments, & each compartment holds multiple doses of solid, PO drugs. Med paks make it easier to provide meds for pts on multiple doses, & are useful for increasing adherence in pts on a complicated medication regimen. Med pak label must contain: 1. pt name 2. serial/script # for med pak itself, & a separate serial/script # for each drug in med pak 3. name, strength, physical description, & total quantity of each drug 4. direction for use & required cautionary statements for each drug 5. required storage instructions 6. name of prescriber for each drug 7. date of preparation of med pak & BUD assigned to med pak, which shall be no later than 60 days from date med pak was prepared 8. name, address, & telephone # of pharmacy, & pharmacy's DEA registration #, if CS are included in med pak 9. any other info, statements, or warnings required for any of the drugs 10. if pt med pak allows for removal or separation of intact containers, each individual container shall bear a label identifying each of the drugs inside *If drug has a PPI, it should be sent w/med pak. Alternatively, all required info can be combined into a single educational insert & sent w/med pak *Each med pak should comply w/moisture permeation requirements for a Class B single-unit or unit-dose container (each container should be designed to show if it's been opened or not) A record of each pt med pak should be made, filed, & contain the following: 1. name/address of pt 2. serial # of script order for each drug 3. name of manufacturer/labeler & lot # for each drug 4. info identifying or describing design, characteristics, or specifications of pt med pak sufficient to allow subsequent preparation of an identical med pak 5. date of preparation of pt med pak & BUD that was assigned 6. any special labeling instructions 7. name/initials of pharamcist who prepared med pak
Compounding record or log book
Used to document individual products prepared & should include: 1. official/assigned name 2. strength/dosage of preparation 3. master formulation record reference for preparation 4. names/quantities of all components 5. sources, lot #s, & exp dates of all components 6. total quantity compounded 7. name of person who prepared preparation 8. name of person who performed quality control procedures 9. name of compounding pharmacist who approved preparation 10. date of preparation 11. assigned control/script # 12. assigned BUD 13. duplicate container label that's placed in log book 14. description of final preparation 15. results of quality control procedures (weight range of filled caps, pH of aqueous liquids) 16. documentation of any quality control issues & any ADEs or preparation problems reported by pt or caregiver
Using the Orange Book
Used when consulting bioequivalence between drugs; in vitro & in vivo studies that did not identify bioequivalence issues between the two products is used to establish bioequivalence for generic substitution; if a drug is listed as a generic equivalent, it has demonstrated pharmaceutical equivalence & bioequivalence. A rating: therapeutically equivalent to brand name drug or "reference listed drug (RLD)" B rating: is NOT therapeutically equivalent *2nd letter tells you what kind of formulation the drug is *If # is added to end of 2 letters, then it means >1 RLD of same strength has been designated under same heading
No longer than 3 years from the date of receipt
What expiration must be assigned if no expiration date is provided for ingredients>
Purified water
What type of water is used when water is included in a CNSP
diversion
When a drug has been legally prescribed for a medically-necessary use & is used instead by a different person for a use that's illegal & typically isn't medically necessary
Off-label prescribing
When drug will be used for a purpose which drug is not indicated for. Indicated uses are FDA-approved & will be listed in package insert. Off-label use also includes using drug for indicated condition but in a different pt population. If drug has been FDA approved for at least 1 indication, prescribers are legally allowed to prescribe it for any other reason they feel is both safe & effective for pt's health condition. Off-labeling prescribing is common & is often beneficial. There may be medical literature to support off-label use, & use may even be included in clinical guidelines. Occasionally, off-label use is inappropriate & unsafe. Pharmacists are legally permitted to fill scripts for off-label indications. Pharmacist must use his/her professional judgment when filling off-label scripts. Prior to filling, pharmacist should attempt to find out if drug has been studied for that purpose, if it's likely to be efficacious & if it appears safe for pt.
Directly observed tx (DOT)
When pts come to pharmacy 2-3x/wk to take their medicine in front of pharmacist *Pt may be given a small incentive to keep coming (small amt of money)
Affordable Care Act (ACA or Obamacare)
Will cover women's preventable health services at no cost sharing w/a valid script, which includes birth control & emergency contraception *Requires prescription
Procedure
Written into the policy, includes steps involved that must be carried out by staff
WHEN DOES A PERSON/ENTITY RENEW cs REGISTRATION WITH THE BOP
YEARLY FOR EVERYONE except intern/extern
Can sterile and non-sterile HDs be stored together?
YES, but sterile HDs should be stored in an area to minimize traffic into sterile compounding area
DEA validity
[2 letters then 7 numbers] 1st letter identifies type of practitioner/institution A/B/F/G: hospital/clinic/practitioner/teaching institution/pharmacy M: mid-level practitioner (nurse practitioner, PA, optometrist) P/R: manufacturer/distributor/researcher/analytical lab/importer/exporter/reverse distributor/narcotic tx programs X: if practitioner is authorized to prescribe narcotics (buprenorphine w/or w/out naloxone, Buprenex, Subutex, & Suboxone) 2nd letter is 1st letter of prescriber's last name Steps: 1. Add 1st, 3rd, & 5th digits 2. Add 2nd, 4th, & 6th digits 3. Multiply Step 2 result by 2 4. Add results of Step 1 & Step 3 (last digit of sum should match last digit of DEA #) *Prescribers in hospital or other institution, including medical interns, residents, & visiting physicians, can prescribe medication under hospital/institution DEA registration
which med can not be sold as an anoretic or stimulant as a valid rx
a CII
What should be worn to protect against airborne particles?
a NIOSH-certified N95 protective respirator
what institution is exempt from an emergency kit permit
a hospital and it is renewed BIENNIALLY
a dispenser does not include
a hospital for inpatient licensed nurse to admin drugs, wholesaler/distributor
USP <800> must be incorporated into an entity's overall occupational safety plan, this must include:
a list of HDs facility and engineering controls competent personnel Safe Work Practices Proper use of appropriate Personal Protective Equipment (PPE) Policies for HD waste segregation and disposal
when is CE waived
active military ONLY
what record of CII-V does not have to be maintained in connesux computer for dr
address
Supplemental engineering controls-
adjunct controls to offer additional layers of protection (i.e. closed system transfer device)
How does CVE work?
air is pulled in from the room toward HEPA filters in the back of the device, contaminated air is pulled back into the HEPA filters for filtration, clean air is recirculated back into the room
which drugs in institutional are required to be stored separately
alcohol and drugs for external use and disinfectants
USP <800> applies to-
all entities that store, prepare, transport or administer HDs all healthcare personnel who handles HDs
Where should all HDs be unpacked?
an area that is normal or NEGATIVE pressure from surrounding areas
NIOSH list of HD: Group 1-
antineoplastic drugs ex. cisplastin, methotrexate, topotecan, trametinib
what are approved CE credits
approved by board or american counsel on pharmaceutical education
How often should decontamination occur?
at least daily and after any spill
all meds supplied to hospital must have
barcode but the hospital doesnt HAVE to use them
When should decontamination occur?
between compounding different types of HDs
which has FDA approval PPI or medguide
both - if not given then you are misbranding the consumer med info is not FDA mandated and so is not misbranding is dont give - this prints for all drugs
what is the minimum label requirements for institutional labels
brand generic strength and route if other than oral and parenterals have additive label with name and amount of drug and expiration time and name of person responsible for compounding
How should effectiveness of decontamination be assessed?
by performing surface wipe sampling
What are pharmacy isolators?
cabinet with ventilated controlled environment access through fixed glove ports and a pass through air lock for supply entry
electronic CIII-IV in MS
can do all except CII and before can do it have to have a third party audit or certification review... under fed law prescribers must get 2 factor authentication credentialing or digital certificates DEA premits 2 of the following something you know something you have something you are and the dr uses that to sign the rx and that is the legal signature - the prescriber can make copies of the electronic rx AFTER it is signed and has to write copy only not valid for dispensing - the dr can not submit 2 diff pts with one signature but can do multiple rx for one pt - its doesnt have to be transmitted at same time of signing - pharmacy app service providers MUST back up files daily - retain records for 2 years
Customized Medication Packages - Med-Pak
can provide w/ consent of pt/caregiver/MD provided: - Bear label with all needed info. - ID # unique to med-pak, date of preparation - Exp date (not to exceed 90 DAYS)... NO 60 DAYS BC THATS FED LAW
who that dispenses med equip does not have to have med equip permit
community hospital and LTCF
class 100 environment mean
contains less than 0.5 microns per cubic foot
LAst TIME what goes on CII-V rx label
date of filling name address pharmacy rx number pat name dr name directions caution statement for CII-CIV NOTQTY NUMBER DISPENSED NOT DRUG NAME NOT STRENGTH THIS IS ALL FEDERAL THE STATE DOES NOT GIVE SPECIFICS ON IT AND THE REGULAR LABEL HAS THIS SAMJE STUFF FOR STATE EXCEPT RPH INITIALS REQUIRED
HD unintentional exposure can occur from?
dermal and mucosal absorption, inhalation, injection ,and ingestion (most common route is dermal)
Notice of Privacy Practices
describes how medical information about the pts may be used & disclosed & how the pt can access this info Offered when: 1. pt is offered service for the 1st time 2. privacy practice is updated 3. pt requests it *Not a federal requirement *Must also be placed in a prominent location w/in pharmacy & on pharmacy's website
Where should HDs be handled?
designated area with restricted access indicated by signs to promote worker safety and reduce risk of exposure
Compounding Aseptic Isolator (CAI)-
designed to maintain a HEPA air filtered aseptic compounding environment NOT for HD compounding
Compounding Aseptic Containment Isolator (CACI)-
designed to meet the requirements of both an aseptic isolator and a containment isolator used for sterile HD compounding
A designed person must be responsible for-
developing and implementing appropriate policies and procedures USP <800> compliance personnel competence environmental control of storage and compounding areas reporting potentially hazardous events coordinating testing/sampling in facilities implementing resolution plans based on events and testing results
what rule said hospital cant see drugs to retail
dingle bill and ER pts get 48h supply and inpt to outpt gets 30d and you can not authorize refills
what about the dr is not required to be on the hard copy printout but what must it have at the end
dr address and DEA and the patient address; must have rph date and signature of the person who printed it out
is medicated mouthwash a cosmetic or drug
drug
NIOSH list of HD: Group 3-
drugs that primarily pose reproductive risk to men and women who are actively trying to conceive or women who are breastfeeding ex. clonazepam, fluconazole, pamidronate, ribavirin, topiramate, voriconazole, warfarin
When unpacking HDs, __ must be worn until packaging integrity is confirmed
elastomeric half-mas with multi-gas cartridge and P100-filter
how long do PBM have to pay a claim
electronic is 15 days paper is 35 days if board finds that PBM has not paid 95% of clean claims by due date will be subject to fine
The PIC responsible for
ensure all are licensed registered with board, cant be PIC at more than 1 community or institutional I hospital or more than one facility that is open to the general public, that all staff should have opportunity to take periodic breaks as to reduce fatigue and mental/physical stress, if old PIC is void then new PIC submit for new permit in 10 days, if step down must return permit with written noticeand do CS inventory
An SOP for the safe handling of HDs for all situations must be maintained and reviewed how often?
every 12 months
How often to change gowns?
every 2-3 hours if no manufacturer information is available
Gloves must exchanged how often?
every 30 min
Environmental wipe sampling for HD surface residue should be perfomed how often?
every 6 months
NIOSH definition of HD-
exhibit at least one of the following in humans/animals: -carcinogenicity -teratogenicity/other developmental toxicity -reproductive toxicity -organ toxicity at a low dose -genotoxicity
tf brand name is required on mfr label ifit is the brand
false
BSC Class III
gas-tight enclosure accessed via glove ports HD and supplies enter via pass-through box provides maximum protection for environment and operator
When compounding HDs, the following PPE are required-
gloves (2 pairs) gowns head/hair covers shoe covers
BSC Class II A1
has POSITIVE pressure, contaminated air that is not surrounded by negative pressure and could re-enter the room
BSC Class II A2
has a NEGATIVE pressure space that prevents contaminated air from re-entering the room
when can an institution pharmacy destroy CS
if it is the remaining of a patient packsge or part of a single or unit use package
The PIC responsible for cont
if you have pharmacy that has other services - like walmart - the PIC is responsible for making sure there is physical barrier to detect entry + others RPh on duty
Where should HDs be stored?
in externally ventilated, negative pressure room with at least 12 air changes per hour refrigerated HDs must be stored in dedicated refrigerator in this room
Unpacking must NOT occur where?
in sterile compounding areas or positive pressure areas
What is decontamination?
inactivating, neutralizing or physically removing HD residue from non-disposable surfaces and transferring it to absorbent, disposable materials
What is disinfecting?
inhibiting and destroying of microorganisms must be done for areas intended to be sterile
Environmental wipe sampling includes-
interior of the C-PEC and equipment in it pass through chambers surfaces in stages or work areas near C-PEC floors near the C-PEC areas immediately outside of the buffer room or C-SCA patient administration areas
electronic have to submit transmitter name what about fax
it has to have date time phone number pharmacy info transmitter complete name and address of prescriber name and address and AGE of patient yes AGE
__ or __ may NOT be used for sterile compounding
laminar airflow workbench or CAI
what are the record retention numbers for mfr
maintain records 3 years readily retreivable but if held at another location have 2 days to retrieve and have 5 DAYS to produce the CUSTOMER ROSTER
BSC Class II A1 used for (sterile/non-sterile) compounding-
may be used for non-sterile HD compounding
TF a device requires a prescription
medical device
how do you classify a unit dose product withour an expiration date
misbranded
what happens if a pharmacist labels a generic drug with a brand name
misbranding
what expiration date for donated rx to charoty pharmacy
must be 60 days or more
what should be on the label of a unit dose or single dose pkg for inst/LTCF
name of drug strength dose form LOT EXP DATE
medication orders in institutional must have
name room number drug strength dose directions and SIGNATURE
TF a written protocol must be on file at the instititution for pharmacists to modify drug therapy and is good for 2 years
no says 2 yrs pp88 but another place says on file bop renew yearly
Which type of HDs can be stored with non-HD inventory if permitted by policy?
non-antineoplastic HDs (reproductive risk) and HDs not requiring manipulation
NIOSH list of HD: Group 2-
non-antineoplastic drugs that meet one or more NIOSH criteria for HD. some may pose reproductive risk ex. abacavir, cyclosporine, estrogen, phenytoin, spironolactone, zioduvine
what do you have to include when you close the pharmacy? what about the DEA
notify 14d before send permit and CS registration and CS inventory and tell them where the CS are going DEA they want your registration 222 forms tell them where the CS are going AND THE EFFECTIVE DATE and if the location is being moved
Pharmacy Name/Location Change
notify the board 10 days before if you close pharmacy you notify board 14 days before Apply for new permit w/in 30 days, get it w/in 60
refills for CS can put info on back of rx but cant get refills more than the 5 in 6 months
ok yeah and if the refills exceed the original then must write a new rx
where on the CII rx do you have to note a partial fill
on the face
when the pharmacist is absent and the pharmacy is locked - what has to take place
oncall pharmacist at all times, access to drugs is by LOCKED cabinets located outside pharmacy and must be prepackaged and assigned par value where when removed must be properly documented and audits of locked cabinets are done monthly, and only specifically authorized personnel can have access. when drugs are not in there that are needed - only designated nurses (with proper training) in any one shift can have access to the pharmacy and they can only remove A SINGLE DOSE. THIS MUST BE RECORDED with pt name room name of drug and strength, date time and signature of nurse
What should be done if a damaged container must be opened?
open in C-PEC on plastic-backed mat, remove and wipe down undamaged items, and dispose of damaged items as hazardous waste
Medical surveillance elements include-
organized approach to identify workers who may be exposed to HDs institution's employee health service should perform medical surveillance initial baseline assessment (med history, physical exam, lab testing) maintain medical records based on OSHA regulations prospective monitoring or workers through periodic surveillance using elements of data collected at baseline follow-up plans for workers who show a health change exit examination
institutional facility is aka
organized health care setting and includes correctional facility and drug abuse center
Personnel training should be done BEFORE and include-
overview of HDs review of SOP proper use of PPE equipment and devices response to known or potential exposure spill management disposal of HDs and trace-contaminated material
Medical surveillance-
part of a comprehensive exposure control program
what registrations is a hospital required to have according to regs
permit, CS registration, DEA registration
prescription label does not require
pharmacy phone number lot number ,mfr (unless writing generic per state)
who can the mfr distribute drugs to
physician podiatrist osteopath (DO) vet optometrist pharmacies dentist wholesalers
Entities must establish policies and procedures to ensure worker safety during all aspects of HD handling that includes-
plan on how to implement the standard all containers must be labeled with identity of material and appropriate hazard warnings Safety and Data Sheet (SDS) for each HD that are readily accessible to personnel during work information and training provided to personnel who may be exposed prior to initial work assignment personnel or reproductive capacity must confirm in writing that they understand the risks
Occurrence of exposure should prompt immediate evaluation of primary preventive measures. When exposure occurs, the entity should-
post exposure physical contamination of employee involved compare performance of controls with recommended standards conduct environmental sampling verify that controls are in proper operating condition and worker complied with exist policies develop plan and action to prevent additional exposure ensure confidential two way communication between the work and the employee health units follow up medical survey to demonstrate that the plan is implemented is effective ensure employee is notified of any adverse health effect detected
Spill control-
proper training for all personnel required isolate area and clean up immediately spill kits must be available must document spill and investigate as part of SOP
OBRA requires
prospective and retrospetive DUR and counseling
Engineering controls for compounding purpose-
protect from cross-contamination and microbial contamination (sterile HDs only)
USP Chapter <800> provides info on what?
provides practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environment project
what info for the presciption (NOT LABEL)
pt name dr name address date of issue name strength dose form qty directions for use refills signature NOT DOB
What is cleaning?
removal of contaminants from surfaces using water, detergents, surfactants, solvents
What is deactivation?
renders the compound inert
Drugs on the NIOSH list may be excluded from USP <800> containment guidelines if they do not __?
require additional manipulation other than counting and repackaging
TF home health and hospice does not require pharmacist
right and they keep acquisition and disposition records for 6 years
C-SEC: Containment Secondary Engineering Control
room in which the C-PEC is placed
generic equivalnet is
same active ingredient same strengh same dose form that has same therapeutic effect
IV HD preps admin-
should be spiked and have tubing primed with non-HD solution (diluent) within C-PEC
all employees with access to confdential info should read, ___ and comply with policy procedures
sign
each pharmacy facility issued a permit must have
sink cold/hot water, sufficient size, curent reference material, permits CS reg, DEA regs conspicuously POSTED, updated copy of BOP regs
WHAT has to be in child resistant
solid and liquid dose forms
what are state requirements for mfr label
stay in original pkg and name strength and LOT and EXPIRATION ----fed says also mfr name address qty wt active ingredient RX ONLY, route if not oral, and storage - SO MUST HAVE ALL THIS
leaflets pictograms labels videos are to ___ counseling and not meant to substitute
supplement
What does medical surveillance document?
symptom complaints, physical findings, and laboratory values to determine if there is a deviation from expected norm
what is on a unit of issue package inst/LTCF
these are for specific patients so - name room bed# dr name strength of drug, name of dr, directions for use and PHARMACY NAME AND ADDRESS --- it did not state expiration or lot#--- weird
Why must HDs be stored separate from non-HDs?
to prevent contamination and personnel exposure
specifics for med pak
unique ID date prepared beyond use of 60 per fed regs + normal label req like rph initials etc rx number
C-PEC: Containment Primary Engineering Control
ventilated device designed to minimize worker and environmental exposure when directly handling HDs
all cytotoxic meds should be compounded in what
vertical class II biological safety cabinet
When can cleaning not occur?
when compounding activities are occurring
personal confidential info can be released to pt prescriber practitioner , other pharmacists, board or authorized by law. anyone else needs
written release by the patient
how often does a med equip supplier have to get a permit and when does it expire
yearly June 30 if you close you have to tell board 10 days before BUT A MEDICAL GAS COMPANY IS EVERY 2 YEARS
How often should hood be inspected for under sterile regs
yearly room needs to be at least class 100
what do you provide to pt if you mail to pt a drug
you at minimum provide name address and phone number of DISPENSING PHARMACIST
LTCF and termially ill as home health patient you have this exception
you can PARTIAL fill a rx - fill in 50 days
compunding infusion pt, LTCF pt and hospice have this exception
you can use the fax are original
what wold u do if presented with an rx for methadone for maintenance teatment for a pt
you do not fill it bc invalid u cant dispense maintenance treatment meds if they are CII
Opioid tx programs
~1 million US people are addicted to heroin & other opioids like oxycodone, hydromorphone, & hydrocodone. Pts w/this addiction are more likely to be co-infected w/HIV, hepatitis, & STIs as well as mental health problems. Criminal hx often stem from this Methadone blocks euphoric effects of opioids & helps relieve craving for drug of abuse. Also used to treat pain & opioid addiction. Comes in 5, 10, & 40mg tabs. *40mg dose is only indicated for opioid addiction; the lower doses are for pain/opioid addiction *Roadblock: access to methadone tx clinic DATA 2000: legislation passed so practitioners can prescribe/dispense C III-V drugs to treat opioid addiction outside of a methadone tx clinic *ONLY buprenorphine w/or w/out naloxone are approved for this (Suboxone & Subutex) *Requires practitioner training then practitioner receives a unique identification # (UIN); same as their dEA # except 1st letter is "X" (Both #s should be on script) *Each practitioner can treat up to 30 pts at any 1 time for 1st year, then they can request to increase to 100 pts at any 1 time **A practitioner who isn't specifically registered w/ DEA to treat narcotic addiction may administer (but not prescribe) a day's worth of tx at 1 time to a pt while proper referral to an opioid tx program is being arranged. (Can be done for up to 3 days)
Administering
• HDs must be administered safely using protective medical devices and techniques. • Examples of protective medical devices include needleless and closed systems. • Examples of protective techniques include spiking or priming of IV tubing with a nonHD solution in a C-PEC and crushing tablets in a plastic pouch. • Appropriate PPE must be worn when administering HDs. After use, PPE must be removed and disposed of in a waste container approved for trace-contaminated HD waste at the site of drug administration. • Equipment (such as tubing and needles) and packaging materials must be disposed of properly, such as in HD waste containers, after administration. • CSTDs must be used for administration of antineoplastic HDs when the dosage form allows. • Techniques and ancillary devices that minimize the risk posed by open systems must be used when administering HDs through certain routes. • Administration into certain organs or body cavities (e.g., the bladder, eye, peritoneal cavity, or chest cavity) often requires equipment for which locking connections may not be readily available or possible. • Healthcare personnel should avoid manipulating HDs such as crushing tablets or opening capsules if possible. • Liquid formulations are preferred if solid oral dosage forms are not appropriate for the patient. • If HD dosage forms do require manipulation such as crushing tablet(s) or opening capsule(s) for a single dose, personnel must don appropriate PPE and use a plastic pouch to contain any dust or particles generated.
Transport of HDs
• HDs must be transported in containers that minimize the risk of breakage or leakage. • Pneumatic tubes must not be used to transport any liquid HDs or any antineoplastic HDs because of the potential for breakage and contamination • When shipping HDs to locations outside the entity, the entity must consult the Transport Information on the SDS. • The entity must ensure that labels and accessory labeling for the HDs include storage instructions, disposal instructions, and HD category information in a format that is consistent with the carrier's policies
Dispensing
• HDs that do not require any further manipulation, other than counting or repackaging of final dosage forms, may be prepared for dispensing without any further requirements for containment unless required by the manufacturer or if visual indicators of HD exposure hazards are present (e.g., HD dust or leakage). • Counting or repackaging of HDs must be done carefully. • Clean equipment should be dedicated for use with HDs and should be decontaminated after every use. • Tablet and capsule forms of antineoplastic HDs must not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants.