MPJE (Federal Law)

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

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

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

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 (TEXAS USES THIS!!!) 2. 2 files: 1 for C-II drugs & 1 for all the rest w/a red "C" on C III-V drugs

Tech requirements

1. >/=18yo 2. Have high school diploma or GED 3. Lack a criminal hx *Need to complete CE hrs in order to retain certification

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

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)

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

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

Pharmacist intern hour requirements

1500 practice hrs Expiration: 6mos post-graduation; intern hrs expire 2yrs after completion

Tx pharmacist CPE requirements

30hrs/2yrs: 1hr Tx pharmacy law

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

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 selling CS

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.

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)

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

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

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

Pharmacist technician

Are permitted (w/some state exceptions) to perform the following while under direct supervision of a pharmacist: 1. enter scripts into computer 2. package scripts (removing drugs from stock, counting drugs, placing drugs into containers, labeling container) 3. call prescribers for refill authorizations 4. compound medications

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)

Tx pharmacist license renewal

Biennial; last day of birth month

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

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)

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

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

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

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

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

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

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

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

Codeine scheduling

II: as a single agent III: if combo product V: if combo cough syrup

Barbiturate scheduling

II: single agent formulations of amobarbital, pentobarbital, & secobarbital III: if above drugs are formulated as a suppository or as a combo product w/non-CS butabarbital: III butalbital: III (only available in combo w/non-CS) phenobarbital: IV

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

Pharmacist intern

In training to become a pharmacist & can perform all functions of a pharmacist at discretion of & under supervision of a pharmacist *ONLY pharmacist & intern can take new scripts over the phone

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

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

Misbranding

Label is inaccurate

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)

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

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

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

Tech certification

Must pass Pharmacy Technician Certification Examination! Certification allows them to: 1. Enter scripts into computer 2. Assist w/drug storage, insurance claim processing & cashiering

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

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

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

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.

Transferring C III-V scripts

Only allowed 1 transfer via direct communication between 2 licensed pharmacists *Only exception is if the pharmacies share a real-time, online database of prescription database (same chain stores) then script can be transferred up to max # of refills on script Transferring pharmacy- hard copy of script is pulled & "VOID" is written on front & receiving pharmacy info is written on back of voided scripts: 1. pharmacy's name 2. business address 3. DEA # 4. name of transferring pharmacist 5. name of receiving pharmacist 6. date of transfer Receiving pharmacy- script is reduced to writing by pharmacist & "transfer" is written on face of transferred script & the following is recorded: 1. date of original prescription was issued 2. original # of refills 3. date it was first dispensed 4. pharmacy's name, business address, DEA registration #, & script # from which the script info was transferred 5. name of pharmacist who transferred script 6. pharmacy's name, business address, DEA registration #, & script # from which the script was originally filled *The above info may be documented electronically & kept x2yrs

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

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

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])

"Tech check tech" (TCT)

Program where 1 tech checks work of another tech, such as in prescription preparation

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.

DEA Form 41

Record of CS destroyed

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 Copy 1: brown; supplier keeps (pharmacy keeps this copy when returning drugs to wholesaler or reverse distributor) Copy 2: green (ALWAYS goes to DEA) Copy 3: blue; purchaser keeps *purchaser keeps copy 3 & sends attached copies 1 & 2 to supplier/wholesaler; supplier records # of containers furnished per item along w/date of shipment; 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 on Copies 1 & 2 & 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

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

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

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.

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.

"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

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.

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

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

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

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

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

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

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)