MPJE Made Easy NJ

Bulk Rx Container Labels (must contain what)

-name and address of manufacturer/packer/distributor -established name of drug product -ingredient info (including qty/proportion of each active) -if other than PO use: names of all inactives -qty in terms of weight or measure -net qty of container -statement of recommended or usual dosage, or reference to PI -legend: "caution, federal law prohibits dispensing without a rx" or "rx only" -route of admin if it is not PO -identifying lot or control # -statement for pharmacist specifying type of container to be used in dispensing -expiration date, unless exempted -labeling on or within package must have adequate info for use **NDC # not required but it is requested on all rx and otc drug labels **presence of NDC # does not mean the drug has received NDA approval - just assigned by FDA for convenience

NJPMP Pharmacy Reporting Requirements

-surname, first name, DOB of pt -street address and telephone # of pt -date the medication is dispensed -rx number and the NDC of drug dispensed -pharmacy permit # -prescribing practitioner's name and DEA# -name, strength, and quantity of drug dispensed and # of refills -whether the drug was dispensed as refill or new rx -date the rx was issued -source of payment for drug dispensed -identifying info for any individual, other than pt, who picks up rx, if pharmacist believes the person picking up may be seeking to get it for another reason ^^ ID info: -individual's first and last name -relationship to patient -if avail: type of, and ID # on, a state or Fed gov ID

Schedule III (phys: moderate, psych: high dependence)

Buprenorphine (Subutex) Fiorinal/Codeine Dronabinol (Marinol) Xyrem (gamma hydroxybutyrate, sodium oxybate) Codeine/ASA Buprenorphine/Naloxone (Suboxone) Paregoric Tylenol/codeine tabs ANABOLIC STEROIDS: Ethylestranol (Maxibolin) Nandrolone decanoate (Deca Durabolin) Stanozolol (Winstrol) Fluoxymesterone (Halotestin) Oxandrolone (Anavar) Testosterone patch (Androderm, Testoderm) Methandrostenolone (Dianabol) Oxymetholone (Anadrol)

DEA Number Legit?

2 letters + 7 numbers Type A registrant = practitioner -they use "B" for first letter but it has been exhausted - Now, "F" and "G" too Wholesalers begin with "P" or "R" Mid-level practitioners start with "M" Second letter = First letter of last name Add 2nd, 4th, 6th digits - Double that Then add 1st, 3rd, 5th digits to this total The last digit of this total should be the last digit of DEA# Ex - 1234563 2 + 4 + 6 = 12 x 2 = 24 24 + 1 + 3 + 5 = 33 The last digit of DEA should be 3 ^ this only determines that it's potentially correct ^only way to know for sure is via DEA database

Medication Guides

FDA requires them if: -drug is one for which pt labeling could help prevent serious AEs -drug is one that has serious risks (v benefits) of which pts should be made aware of because info regarding it could sway their decision to use it -drug is important to health and pt adherence and directions for use is crucial for effectiveness Manufacturers must: -obtain FDA approval of the Med Guide before distributing -ensure Med Guide provided in sufficient numbers, or provide means to produce Med Guides in sufficient numbers, to distributors/packers/dispensers so that the dispenser can give one with each rx ^must give it directly to patient

Beyond Use Dates

For non-sterile solid and liquid products repackaged into UNIT DOSE or single unit containers: -expiration date should not exceed 6 MONTHS -the 6 month period should not exceed 25% of the remaining time between date of repackaging and expiration date on unopened original manufacturer container. ^Ex: to repack on 1/1/16 w/ 6 month BUD - container exp must be 1/1/18 or later For MULTIPLE UNIT CONTAINERS (like typical rx vial): BUD no later than: -expiration date on manufacturer container -1 YEAR from date the drug is dispensed ^whichever is earlier

CS Distribution after Business Closes

If NOT transferring business activity: -must return certificate of registration with unused 222 Forms to DEA in Wash DC office (and DCU) ^return to DCU within 10 DAYS -complete DEA 41 Form and wait for response on how to dispose CS If transferring: -submit proposal to DEA and DCU 14 DAYS in advance and include: -name/address/DEA#/State CDS of person going away and same info for the one coming in -whether business activities will continue at current place or new one ^ on day of transfer, complete CS inventory taken (222 Form to transfer C-II) Also have to report the name/address of the person/firm who will maintain invoices and executed order forms of the discontinued business or period no less than 2 YEARS

NJPMP Corrections

If pt says the fill info is wrong, pharmacy permit holder must: -verify that the info is incorrect and, if so, correct the info in patient profile and PMP within 14 DAYS of pt notification then tell the pt is is fixed - if not justified, they need to tell pt within 14 DAYS and advise the pt of the process for requesting the BOP to review the disputed request for correction

Disposal of spilled CS

If they are recoverable: -destroy using accepted destruction method listed -fill out DEA Form 41 If they are NON-recoverable (like down sink): -record in CS records -2 witnesses needed -no DEA Form 41 needed!

Misbranding

Labels are required to state: -qty and/or proportion of any active ingredient ^specifically mention of presence of alcohol -inactive ingredient list in alphabetic order Specific req for OTC only: -adequate directions for use -adequate warnings against use by children and others for whom it might be hazardous Adequate directions for use: -statements of all conditions/purposes/uses for which drug is intended and commonly used for -normal dose for each intended use and doses for individuals of diff ages -frequency and duration of admin/application -admin/application in reference to time of meals, onset of sx, etc -route/method of admin/application -any required preparation for use

Emergency Dispensing

Limited to 72 hours' supply Immediately turn to written Prescriber must send rx within 7 days - "Authorization for emergency dispensing" If they don't, report it to DEA and DCU If you don't, can't take these orders anymore

Bosentan (Tracleer) REMS

Limits avail to specialty distributor pharmacies participating in TAP program Requires certification of prescribers and dispensers and enrollment of pts educational requirement too

How Physician can obtain Investigational Drug for Pt NOT involved in a Clinical Study

Make sure manufacturer is willing to provide it Physician submits IND to FDA - for individual pt use A # is assigned to application - treating physician to provide this # to drug supplier so they can ship it to them Treatment can occur 30 DAYS after FDA IND submission and has not otherwise put the app on hold - or upon earlier notification by FDA to physician Required content of IND for individual patient use: -statement that this is a request for individual pt IND treatment -brief clinical history of pt -proposed tx plan -get letter of authorization from manufacturer - chemistry, manufacturing, controls info on pharmacology and toxicology -informed consent statement stating informed consent and approval of use by appropriate IRB will be obtained before starting tx -Investigator Qualification Statement - specifies the training, experience, and licensure of treating physician -FDA Form 1571 completed with physician listed as sponsor -contact phone # and fax #

REMS - to insure benefits outweight risks of some drugs

Med guides Communication plans Elements to ensure safe use: -special training for prescribers/dispensers -restricting distribution -dispensing based on evidence or documentation of safe use conditions (signing informed consent form) -pt monitoring and follow up (like labs) -pt registries

Limitations on Opioid Prescribing/Dispensing

Special requirements when prescribing: -C-II CDS for pain any opioid drug; for the tx of chronic pain; and the prescribing of opioid drugs for tx of acute pain "Initial prescription" = rx issued to a pt who: -has never previously been issued a rx for the drug or its pharmaceutical equiv -was previously issued a rx for the drug or its pharmaceutical equiv and the date on which the current rx is being used is more than 1 YEAR after the date the pt last used or was admin the drug or its equiv "Practitioner" = currently licensed, registered or otherwise authorized to prescribe drugs in the course of professional practic: -physician -podiatrist -PA -CN midwife

Electronic Rx for Controls

The pharmacy application provider must have a third party audit or certification review determining that the app complies with DEA requirements App must be able to import, display and store Rx info accurately and consistently If get an oral/written Rx for one submitted electronically, check to see if electronic one was received/filled. If both received, void one of them. If electronic sent to another pharmacy, check to see if they filled it. If they received but didn't fill - they must void or cancel it. If they did fill it, you must void the paper rx you got. DEA requires TWO factor authentication for prescribers for controls -something you know (like password) -something you have (like hard token kept away from computer being accessed) -something you are (biometrics)

CS Storage

secure, substantially constructed locked cabinet or dispersed throughout the stock in such a way to obstruct theft or diversion ^it's not actually required by fed/state law to lock up the C-IIs

Dietary Supplements

supplement diet -vitamin -mineral -herb/botanical -amino acid -substance that increases dietary intake -concentrate/metabolite/constituent/extract or combo of above The FDA regulates them as a special type of FOOD not drug DSHEA allows dietary supp manufacturers to promote structure/function claims which would normally classify them as a drug BUT they cannot claim to diagnose/cure/treat/prevent disease These 4 statements are allowed by DSHEA: -product will benefit a classical nutrient deficiency disease as long as it also discloses prevalence of the disease in US -description of the role in affecting the structure/function of body -characterization of the documented mechanism by which it acts to maintain structure/function Statements: "not evaluated by FDA" "not intended to diagnose/treat/cure/prevent any disease

CS Theft/Loss

Notify the DEA (Field Division Office) in writing within ONE BUSINESS DAY of discovery of "significant loss"- do it by Fax ^up to profess judgment of pharmacist to determine what is a significant loss Must also file a report with the NJBOP including copy of DEA 106 Form The DCU also needs a DEA Form 106 copy 106 Form can be submitted electronically. info on it: -name and address of firm -DEA registration number -date of loss/theft -items taken/lost including their estimated value, any identifying symbols or cost codes on containers -type of theft/loss -if police were notified -list of missing items -name and title of person completing report If nothing was lost - don't need DEA Form 106 but you gotta tell the DEA! To determine if significant, here are factors to consider: -quantity of CS missing -specific drugs missing -whether the loss can be associated with access of them to specific ppl or to unique activities that take place involving the CS -pattern of losses over time - whether they are random and the results of efforts taken to resolve them -if known, whether specific CS are likely candidates for theft -local trends and other indicators of theft or diversion

CS Rx Transfer

OK on one time basis only But pharmacies sharing real-time, online database may transfer up to max refills allowed by law ^must communicate between 2 pharmacists Transferring pharmacist must write" -"VOID" on face of rx -name/address/DEA # of transferee pharm -name of transferee pharmacists -date of rx transfer -pharmacist that transferred it Transferee pharmacist must write: -"transfer" on face of rx -date of issuance of original rx -original # of authorized fills -original date of dispensing -# of valid refills left and dates and locations of past fills -pharmacy name/address/DEA #/Rx# from which rx info was transferred -name of pharmacist who transferred rx -pharmacy name/address/DEA #/Rx # from which rx info was originally filled

CIII-V Partial Filling

Only 5 refills allowed > 5 partial fills allowed (record in same manner as refill) Don't dispense if Rx > 6 months

CSOS - Controlled Substance Ordering System ^electronic

Optional - need digital certificate if you do it ^only registrant and power of attorney ^valid until DEA registration under which it is issued expires Registrant MUST appoint a CSOS coordinator - signs for registrant (digital sig from DEA) When received, record qty and date - must link to original order Keep records electronically x 2 YEARS If supplier refuses order, notify purchaser with statement - this should be linked to original order No one can change a defective order - fill new form Voiding by supplier - they're not required to retain record of items not filled (but purchaser is) but in the linked record they should indicate nothing was shipped for voided items If order lost - send a signed statement to supplier with unique tracking number and date of lost - state goods covered in first order were not received through loss ^If the supplier receives the first order, they should indicate that it is "not accepted" and send it back to purchaser who must link this to the order and the statement For each order filled, a supplier must forward order to DEA within 2 BUSINESS DAYS

Phases of Clinical Testing in Humans

PHASE I: -performed in small number of HEALTHY ppl (20-80) and is used to determine PHARMACOLOGY of drug and its TOXICOLOGY, NOTTT efficacy PHASE II: -performed on limited # of people who actually have the DISEASE (100-300) to determine EFFICACY PHASE III: -performed on larger scale of AFFECTED individuals (1,000-3,000) ^If results are favorable, company submits NDA to FDA for consideration Investigational drugs can be approved for pts in general population if: -pursuant to a tx protocol that has been submitted to FDA -drug is used to treat serious or immediately life threatening disease -there is no comparable or satisfactory alternative -approved for being used in a controlled clinical trial, or all clinical trials have been completed and sponsor is actively pursuing market approval

Poison Prevention Packaging Act

PPPA enforced by CPSC (consumer product safety commission) - NOT FDA Requires CRC: -80% under 5 kept OUT -90% of adults can OPEN ^fails if a child can access more than 8 doses or a toxic amount, whichever is less Physician or pt can request non-CRC (written or oral, but only pt can issue request for a blanket waiver, not physician) ^blanket waivers can also be made on behalf of all membrs of a family by head of household Exemptions: -Manufacturer that produces multiple pack sizes of OTC requiring CRC can produce one in non-CRC but must state "this package for households without young children" or "package not child resistant"

Central Filling for CS

Rx may be transmitted electronically from retail to central fill Transmitting pharm has to write "central fill" pharmacy on face of rx and record: -name -address -DEA# of central fill pharmacy + date of transmission Transmitting pharm has to keep record of receipt of the filled rx including: -date of reciept -method of delivery -name of employee accepting delivery Central fill pharm must keep copy of the rx if sent by fax or electronic record of info sent: -name -address -DEA # of transmitting pharm + date of receipt + name of pharmacist filling rx + date rx being filled ^ also keep record of date delivered to retail pharm + method of delivery

Kefauver Harris Amendment

Required more carefully controlled clinical studies Imposed additional requirement that drugs be EFFECTIVE in addition to safe Established GMPs and increased inspection authority of FDA

Pain Management Agreements

Required to enter into one when issuing THIRD Rx for C-II for pain or any opioid -document the understanding of both practitioner and the pt concerning the pt's pain management plan -establish pt's rights in association w/ treatment and the pt's obligations in relation to responsible use, d/c of use, storage and disposal of C-II and any opioid including restrictions on the refill of or the acceptance of such rx from other practitioners or prescribers -ID the specific meds and other modes of tx that are included in plan -specify measures the practitioner may employ to monitor the pt's compliance such as random specimen screens and pill counts -delineate the process for terminating the agreement, including the consequences if the practitioner has reason to believe that the pt is not complying w terms of agreement

Take Back Programs

Required to provide notice about drug take back programs upon dispensing to each pt a CDS Rx med Pharmacies are required to distribute (other than LTCF pharmacies) a notice prepared by Div of Consumer Affairs informing them of the location of 24x7 drop off locations

CS Mailing

Requirements for mailing: -place in plain outer mailing container or securely over wrapped in plain paper -inner container must also be labeled to show rx # and name and address of pharmacy, practitioner, or other person dispensing the rx -the outer mailing wrapper or container is free of markings that indicate nature of content

Anti-Tampering (federal act)

Requires tamper-evident packaging for: -all OTC human drug products -cosmetic liquids -oral hygiene products -vaginal products -contact lens solutions Tamper-evident if: -having one or more indicators or barriers to entry, which if breached or missing, can be reasonable expected to provide visible evidence that tampering occurred There should be a labeling statement to alert the consumer to tamper-resistant feature(s) used ^place so that it will be unaffected if a TRP feature if breached or missing Alternatively - the package can be "distinctive by design" ^aka it can't be duplicated with commonly available materials or processes Two piece hard gelatin caps need to be sealed using tamper evident technology Exceptions to TRP: -dermatologicals -dentifrices (dental) -insulin -lozenges ^ don't confuse this with poison prevention packaging (requires child resistant packaging for certain things) ^tamper evident is not necessarily child resistant **An OTC drug required to be packaged in tamper evident container but is NOT, is considered by the FDA to be adulterated or misbranded or both

Opioid Treatment Programs

Responsibility and oversight is with SAMHSA (substance abuse and mental health services admin) OTPs: MAT with comprehensive plan - combines meds with behavioral health services for individualized approach Must obtain approval and certification from SAMHSA andddd from the state methadone authority Must register with DEA as Narcotic Tx Program via DEA Form 363 Must be accredited by an independent, SAMHSA-approved accrediting organization Methadone and levo-alpha-acetyl-methadol (LAAM) are the only C-II drugs used in OTP Others (C-III): buprenorphine and buprenorphine-naloxone

OTC Labels

-identity of product (established name) -pharmacologic property -name and address of manufacturer/packer/distributor -net contents of package -cautions or warnings needed to protect consumer -adequate directions for use ^in a way a layman can use a drug safely for purposes which it's intended -drug facts panel

Sales Limits (cough/cold products)

(methamphetamine precursors = ephedrine, pseudoephedrine, phenylpropanolamine) **grams of BASE -cannot sell more than 3.6 GRAMS/DAY/purchaser (regardless of # of transactions) -cannot purchase more than 9 GRAMS/30 DAY period -mail order cannot sell more than 7.5 GRAMS/30 DAY period ^not subject to logbook, training, cert requirements but seller needs ID still All products should be placed behind counter or in locked display in floor Logbook - written or electronic: -purchaser must sign the book and enter name/address/date and time of sale -check their ID to make sure they match - enter product name and quantity sold ^logbook requirements don't apply to purchases of single sale packages with no more than 60 mg of pseudoephedrine -must contain a notice basically stating than any false info can lead to being fined max $250,000 if an individual or $500,000 if an organization, jail max 5 years or both -retain entries X 2 YEARS Need to present ID - in NJ need to be 18 Federal law does not have an age requirement tho employees have to be trained and send self certifications to Attorney General - update ANNUALLY ^retailer should keep record to confirm training Any loss or disappearance must be reported to DEA ORALLY ASAP and then followed up w/ written report within 15 DAYS -also report to local law enforcement of loss of 30 GRAMS or more

Plan B (LNG)

(other generics: Next Choice One Dose, May Way Take Action) No age requirement (anymore. it used to be 17) It is in regular aisle of pharmacy

OTC Drugs Subject to PPPA Requirement (CRC)

-Aspirin (any form) any dose -Iron containing drugs elem Fe 250 mg or more -Iron containing diet supps elem Fe 250 mg/package -APAP > 1 gram/package -Diphenhydramine > 1 gram/package -Ibuprofen (PO) > 1 gram/package -Loperamide (PO) > 0.045 mg/package -Lidocaine > 5 mg/package -Dibucaine > 0.5 mg/package -Mouthwashes 3 gram or more of ethanol/package -Naproxen 250 mg/package -Ketoprofen > 50 mg/package -Minodixil > 14 mg/package -Fluoride > 50 mg elem fluoride/package Exemptions: -Effervescent tabs/granules containing NMT 15% APAP or ASA -Unflavored APAP or ASA powders in unit dose containing NMT 13 grains APAP/dose or 15.4 grains ASA/dose

Drug Recalls

-Class I: when there is a possibility that the product will cause serious adverse health effects or death -Class II: when the product may cause temporary or medically reversible adverse health effects - probability of serious effect is remote -Class III when the product is NOT likely to cause adverse health effects *if pharmacist dispenses a recalled drug, they can be charged with violation of FDA and cosmetic act **The FDA cannot order drug recalls but can ask companies to initiate them in lieu of injunctive relief or a seizure which FDA can undertake if the company doesn't respond to their request

Rx Exceptions to PPPA (non-CRC)

-NTG (SL) -Isosorbide dinitrate (SL and chew) 10 mg or less -Sodium fluoride NMT 110 mg sf/package = 50 mg of elemental fluoride per package -Anhydrous cholestyramine (powder) -Methylprednisolone (tabs) NMT 84 mg/package -Mebendazole (tabs) NMT 600 mg/package -Bethamethasone (tabs) NMT 12.6 mg/package -Potassium supps in unit dose form (effer tabs/unit dose vial of liquid, powdered in unit dose pack) NMT 50 mEq/dose -Erythromycin ethyl succinate granules for PO suspension and PO suspensions NMT 8 gram of erythromycin/package -Colestipol (poweder) Up to 5 gram/packet -Erythromycin ethyl succinate (tabs) NMT 16 grams/package -Preparations in aerosol containers for inhalation therapy -Pancrelipase preparations -PO contraceptives (cyclically admin in manufacturer's memory-aid dispenser) -Conjugated estrogen (tabs in mnemonic dispenser packages) NMT 32 mg of drug -Medroxyprogesterone acetate (tabs) -Norethindrone acetate (tabs in mnemonic dispenser packages) -Sacrosidase (sucrase) (preps in a solution of glycerol and water) -Hormone Replacement Therapy products - rely solely upon activity of one oe more progestogen or estrogen substances

Drug Facts Panel (includes what)

-active ingredients (including dosage unit and qty/dosage unit) -purpose -uses/indications -warnings ^ regarding route/contraindications/DDIs/food intrxns/side effects and what to avoid/signs of tox/pregnant or breastfeeding warning/keep out of reach of children and accidental OD warning -directions -other info (as required by monograph/regulation/approved labeling -inactive ingredients -optional: questions? with phone number to call

Rx for Naloxone

-ask if rx for the person whose name is on it -document on rx that the question was asked along w/ the answer -if rx is for the end user, fill as any usual rx, including offer of counseling -if rx is for person who is gonna give it in emergency, set up separate, readily retrievable profile - don't process thru insurance note that required info given with dispensing Must document that the OD prevention info was given with dispensing (except first responders, etc). The info should include: -info on opioid OD prevention and recognition -instructions on how to perform breathing and resuscitation -info on opioid antidote dosage and instructions on opioid antidote admin -info describing importance of calling 911 emergency telephone service for assistance w/ an opioid OD -instructions for appropriate care of an OD victim after admin of the opioid antidote -instructions on CIs, precautions, and ADRs ^Pharmacy must document the dissemination of OD prevention info and the contact info of the person getting the info to the extent known, in pt's medical record, or another record log if unavail/inaccessible or it's for a professional acting in their capacity

CS Destruction

-on-site method of destruction (only if they have modified DEA registrations that allow them to be collectors) ^notify the DCU within 5 DAYS if become a collector or any subsequent change of that status -promptly deliver the CS to reverse distributor's registered location by carrier pick up or reverse distributor pick up at registrant's location -for return/recall - deliver promptly by carrier pick up or pick up by other registrants at the registered location TO: --the registered person from whom it was obtained --the registered manufacturer of the substance --another registrant authorized by manufacturer to accept them on their behalf Request assistance from Special Agent in Charge of the Administration in the are in which the practitioner is located ^ do by submitting DEA Form 41 to Special Agent in Charge in practioner's area (list all the CS on the form) How to dispose: -transfer to registrant authorized to transport/destroy the substance -deliver to an agent of the Administration or to nearest office of Admin -destruction in presence of an agent of the Admin or another authorized person For on-site destruction: -2 employees of the registrant handle or watch the handling CS handling until those drugs are rendered non-retrievable -2 employees personally witness the destruction of the CS until it is non-retrievable -maintain record of the destruction in DEA Form 41 -record should include name and signatures of those 2 employees If spilled and recoverable - 2 people destroy and send DEA 41 If spilled and not recoverable - 2 witnesses for a record of it but no DEA 41 needed **If regular destruction is required, the Special Agent in Charge can authorize it without a new DEA approval each time but only if: -registrant keeps records of such disposals and file periodic reports with Special Agent summarizing the disposals - conditions on method/freq/details

Switching Rx to OTC

3 ways it can happen: 1) manufacturer requests switch by submitting Supplemental application to its original NDA 2) manufacturer may petition FDA 3) FDA may add or amend existing OTC monograph

Schedule V (phys and psych dependence: low)

Actifed/Codeine Lomotil Novahistine expectorant Novahistine DH Promethazine/Codeine Promethazine VC/Codeine Guaifenesin/Codeine APAP/Codeine liquid Pregabalin (Lyrica)

Schedule IV (phys and psych dependence: low)

Alprazolam (Xanax) Butorphanol (Stadol) Chloral hydrate (Nortec) Chlordiazepoxide (Librium) Clonazepam (Klonopin) Clorazepate (Tranxene) Diazepam (Valium) Ethchlorvynol (Placidyl) Flurazepam (Dalmane) Lorazepam (Ativan) Oxazepam (Serax) Pentazocine (Talwin) Tramadol (Ultram) Temazepam (Restoril) Zolpidem (Ambien) Halazepam (Paxipam) Midazolam (Versed) Mazindol (Sanorex) Phenobarbital Triazolam (Halcion) Carisoprodol (Soma) Modafinil (Provigil) Zaleplon (Sonata) Eszopiclone (Lunesta)

Ryan Haight Online Pharmacy Consumer Protection Act

Amends CSA to prevent illegal distribution of CS through the internet Pharmacies must have modification of existing DEA registration to allow for operation of an online pharmacy (+reporting and disclosure requirements) Must report MONTHLY to DEA of the qty of each CS dispensed, if during the month have dispensed: -1,000 prescriptions -5,000 dosage units ^Report by NDC Online pharmacies, within 30 DAYS prior to engaging must: - register with DEA -contact the respective Board for all states they wish to do business in Online pharmacy requirements for homepage: -statement that pharmacy complying with Act -name/address/phone# of pharmacy -name/professional degree/states of licensure for PIC and their phone # for contact -list of states in which pharmacy is licensed -certification that pharmacy is registered with DEA as online pharmacy -name/address/phone#/professional degree/states of licensure of practitioner with contractual relationship with pharmacy -this statement: "this online pharmacy is obligated to comply fully with the CSA and 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 controlled substance to a person who has a valid rx for a legit medical purpose based upon a medical relationship with a prescribing practitioner. this includes at least one prior in person med eval in accordance with section 309 of CSA act (21 USC 829) or med eval via telemed with section 102 (54) of the CSA (21 USC 802 (54)) Exemptions from definition of "online pharmacy": -refilling (via internet) is solely for schedule III-V -filling new rx for schedule III-V where pharmacy previously filled non-internet rx for same pt and at pt's request contacts the prescriber for new rx ^so most pharmacies that maintain a website are not considered online pharmacies and not subject to the disclosure and reporting requirements Online pharmacies can also get a VIPPS accreditation from the NABP - to distinguish that they are legit not rogue (will have VIPPS seal on site and ".pharmacy" domain)

Schedule II drugs (phys and psych dependence: severe) in SUPPOSITORY form - become Schedule III

Amobarbital Amphetamines (Dexedrine, Adderall) Cocaine Diphenoxylate Fentanyl (Duragesic, Actiq, Fentora, Lazanda) Hydromorphone (Dilaudid) Meperidine (Demerol) Methadone (Dolophine) Methamphetamine (Desoxyn) Methylphenidate (Ritalin, Concerta) Morphine MS Contin Oxycodone (Tylox, Percocet, Percodan) Oxycontin Pentobarbital (Nembutal) Secobarbital (Seconal) Oxymorphone (Opana) Tapentadol (Nucynta) Nabilone (Cesamet) Codeine Hydrocodone/APAP (Vicodin, Lorcet) Hydocan Hydrocodone/Clorpheniramine (Tussionex) Hydrocodone/Ibuprofen (Vicoprofen)

Bar Coding Requirements

Applies to manufacturers/repackers/relabelers/private label distributors These products are subject to the requirement: -prescription drugs -biologics -OTC that are dispensed pursuant to an order and are packaged or labeled for hospital use/marketed/promoted/sold to hospitals Must have a bar code that (at minimum) contains the NDC in a linear bar code which must be included on drug label

Who schedules

Attorney General but they need a science/medical eval form from Secretary of Department of HHS If a drug is imminent hazard to public safety, Attorney General can put it in schedule 1 without consulting HHS

OTC Approval Process

Can be marketed under NDA or ANDA or OTC monograph Under monograph process, FDA reviews the active ingredients and labeling of many drug classes (not individual drugs) - for each category, an OTC monograph is made and published in Federal Register ^Kinda like a recipe - the manufacturer has to adhere to acceptable ingredients, doses, formulations and labeling Monograph defines safety and efficacy and labeling of all active ingredients ^In this process, FDA pre-approval is not needed (interesting)

CS Registration Suspension/Revocation

Can happen if applicant: -materially falsified the app -been convicted of felony related to CS -had state license or registration suspended, revoked, denied Before they take it away, the DEA has to first issue an Order to Show Cause upon the registrant - this means they have an opportunity to defend themselves and explain they it shouldn't be taken away If they taking it away: -deliver certificate of registration to DEA -deliver all 222 Forms to DEA -deliver all CS to DEA or keep them under seal

Vet Prescribing

Can prescribe/admin/dispense only: -in good faith in the course of professional practice -not for use by humans A doc can't write for an animal A vet can't write for a human For controls, the rx would not list the animal's name but rather their species and name/address of the owner

Central Recordkeeping

Chain pharmacies can keep control records at central location but must notify DEA and DCU 14 DAYS in advance (registered/certified mail and request return receipt) -which records? -exact location? - address -name -DEA # -type of registration -computerized/manual? -access codes? ^ upon written request from DEA, provide records to central location WITHIN 2 BUSINESS DAYS ^ DEA can show up at any time without warrant to check records and if not compliant, can lose ability to do central record-keeping Can't record these centrally: -prescriptions -inventory records -completed 222 forms (uncompleted is ok)

Schedule III Limitations (Max doses)

Codeine and dihydrocodeine: 1.8 gm/100 mL 90 mg/dosage unit Ethylmorphine: 300 mg/100 mL 15 mg/dosage unit Morphine: 50 mg/100 mL Opium: 500 mg/100 mL 25 mg/dosage unit

Schedule V Limitations (Max doses)

Codeine: 200 mg/100 mL Dihydrocodeine: 100 mg/100 mL Ethylmorphine: 100 mg/100 mL Opium: 100 mg/100 mL Diphenoxylate: 2.5 mg Atropine: 25 ug per dose Difenoxin & NLT: 0.5 mg Atropine: 25 ug per dose

Durham Humphrey Amendment

Created distinction between OTC and RX drugs. Manufacturers used to decide if OTC or Rx now those that are only safe w/ direction of physician require Rx -authorized regills on rx -authorized oral rx (telephone) -deemed rx label as meeting adequate directions for use requirement

Office Based Addiction Tx

DATA (Drug Addiction Treatment Act) expanded tx of opioid addicts beyond clinic - allows use of buprenorphine (Subutex) and buprenorphine-naloxone (Suboxone) to be dispensed in retail pharm for addiction tx Subutex - initial tx Suboxone - maintenance tx ^both C-III Prescribers are given an additional DEA # (ex: if AB 9787079 then it would be XB 9787079) ^they must be registered to prescribe it, must have certification in Addiction Medicine OR completed 8 hours of CE Limited initially to 30 active patients - but can request to treat up to 100 after 1 YEAR - must have capacity to refer pts to ancillary services (like psychosocial therapy) ^if they have treated 100 patients for at least 1 year, they can apply to increase patient limit to 275 They also need to request a waiver from CSAT which notifies DEA of all waiver requests - "DATA waived practitioner" Pharmacists can verify if the physician can write for it by calling a number, emailing SAMHSA or checking their site CARA (comprehensive addiction recovery act) expanded the prescribing privilege to NPs and PAs ^thanks obama

Agents of Prescriber

DEA - prescriber can authorize a non-employee agent to transmit a rx for a CS to a pharmacist via a written agreement for them to become considered agents of the prescriber The authorized agent can: -prepare a CS rx for signature signature of the prescriber -orally communicate a prescribers'c C-III to C-V prescription to a pharmacist or via practitioner signed fax -transmit by fax a prescriber's written C-II rx to a pharmacist for a patient in hospice or LTCF The agent can NOT do emergency oral communication of a C-II DEA says the original signed agency agreement should be kept by practitioner during term of relationship and for reasonable period after termination/revocation Signed copy should also be provided to: -he agent -their employer (if diff) -any pharmacies that regularly receive communications from agent

DEA Final Rule on Disposal of CS

DEA registrants can voluntarily establish disposal programs to collect CS from patients - need a modified DEA registration to do this Can be manufacturer/distributor/reverse distributor/narcotic tx program/hospital or clinic with onsite pharmacy/retail pharmacy Programs can have mail-back, collection receptacles and collection events ^collection events only auth for law enforcement ^person or pharm can partner with them tho LTCF -can have collection receptacles from auth hosp/clinic/pharmacy -someone can dispose for the patient ^need to destroy the CS but no specific method but they should still be non-retrievable, unavailable, unusable and not capable of being transformed to a CS -specific process/records for destruction of collected CS - v specific

CS Rx Info

Date and signed on date of issuance -full name and address of patient -drug name/strength/dosage form/quantity/directions -name/address/DEA # of prescriber -manual signature of physician (no stamps)

Detoxification

Detox treatment = dispensing of an opioid agonist tx med in decreasing doses to someone to alleviate adverse physiological or psych effects of withdrawal from continued use with intention to bring person to drug-free state SHORT term = no more than 30 DAYS LONG term = more than 30 days but no more than 180 DAYS Maintenance tx = dispensing opioid agonist tx med at stable dosage levels for more than 21 DAYS for opioid addiction

Methadone (Dolophine)

Dispensed in retail for analgesia ONLY For addiction, it is allowed in clinic with exceptions: -dispensing by a physician over a 3-day period while in process of enrolling patient in aclinic (like in a physician office - rx not issued) -admin to hospitalized pt for condition unrelated to the addiction -for intractable pain (ex: terminal cancer pt) Only physician/RN/LPN/RPh or any other healthcare person authorized by Federal and State law to admin or dispense opioid drugs operating under direction of physician can admin Methadone @ a clinic

CS Commercial Package Labeling

Each commercial container should have a printed symbol on the label with the schedule of the CS The symbol should be prominent on the label and large enough for easy ID upon inspection without removal from the dispenser's shelf The symbol should be located in the upper right hand corner at least 2x as large as the largest type printed on the label OR overprinted on the label, half the height of the label On each container, there should be a seal affixed securely to the: stopper/cap/lid/covering/wrapper to disclose upon inspection any tampering/opening of the container NJ law limits seal requirement - they say "bottle/vial" too....federal law prevails ^not sure what this means

Alosetron (Lotronex) REMS

Each pt prescribed it must have a signed Patient Acknowledgement Form for documentation of safe-use conditions (via Prescribing Program for Lotronex - PPL) pharmacist only dispenses rx for it in presence of PPL STICKER -sticker provides verificaton that the rx is written by certified prescriber enrolled -NO telephone,fax, computerized rx for it

REMS for ER/LA Opioids

Education program for prescribers (CE) Patient counseling document to give to pts Pts will get a Medication Guide (updated one page) - on safe use and disposal. there are instructions to consult professional before changing dose, signs of potential OD and emergency contact instructions - advice on safe storage to prevent accidental exposure to others

Controlled Substance Registration Protection Act

Enacted to protect DEA registrants and mandates a federal investigation result if any of this happens: -replacement cost of CS taken is $500 or more -registrant or other person is killed or suffers significant injury -interstate or foreign commerce is involved in planning/execution of the crime ^example: robbery planned in NJ and carried out in PA or robbery was carried out in PA and they fled to NJ Penalties if convicted.... Burglary/robbery: -max $25,000 fine and/or 20 years in jail Dangerous weapon used to carry out the crime: -max $35,000 and/or 25 years in jail Death resulted from the crime: -$50,000 fine and/or life in jail

CS Fax Rx

Faxing of all controls is ok - C-II a little different but for III-V and noncontrols, fax rx serves as original rx But for C-II, you need to get the original signed Rx except in these cases: -compounded for direct admin to patient by parenteral/IV/IM/SQ/or intraspinal infusion -for hospice pt - must be noted on rx that they're hospice -for any patient in LTCF ^ all 3 exceptions have to be for pain management

Trickett Wendler Right to Try Act

Federal law providing another path for pts not in a clinical study to get investigational drugs Reserved for terminally ill pts only The drug should have gone through at least Phase I There is no FDA oversight of the requests ---controversial

Clozapine (Clozaril) REMS

High risk of agranulocytosis "no blood, no drug" physician, pharmacist, patient registration/database program pharmacist wishing to dispense - pharmacy must be registered with Clozaril National Registry - prescriber must supply pharmacist with current bloodwork result (drawn within 7 DAYS irrespective of monitoring frequency and including a CBC and ANC count) before dispensing

Filing for controls

II always needs separate filing III-V can be either be with II or with non-controls (mark rx with red C in both cases - no red C needed if separated from everything else) **if pharmacy has computer system with rx ID numbers that can retrieve all original rx info - don't need to mark with red C 3-2-2 filing method: II / III-V / non-controls II /III-V and non-controls II and III-IV / non-controls

Lost/Stolen Order Forms

IN TRANSIT: Unfilled DEA 222 lost: -execute another order form in addition to statement containing this info about original order: -serial # -date of lost form -statement stating goods covered by first order form not received through loss of that order form Attach copy of the statement to copies 1 and 2 of second order form sent to supplier and retain copy 3 If supplier than gets the first order form, they should mark it "not accepted" and return copies 1 and 2 and the purchaser will attach them to copy 3 and the statement (copy 3 of second order shall be retained with copy 3 of first) ^same/similar process for single sheet NOT IN TRANSIT (used or unused): Must report to Special Agent in Charge of DEA in the Divisional Office responsible for area where registrant is ^report the serial # of form If supplier cannot state serial #s for original forms lost when being sent to purchaser, they have to report the approx date of reciept and names and addresses of purchasers If entire book lost/stolen and purchaser cannot state serial #s - approx date of issuance If anything is found later, immediately notify the Special Agent ** DCU should also be notified of these immediately! ^

IND/NDA Approval Process

IND approval subject to FDA receiving: -info on name of drug -its composition -methods of manufacturing -quality control -info from pre-clinical (animal) testing) -pharmacologic/kinetic and tox studies -outline of proposed clinical studies -^experience of clinical investigators If FDA does not reject the app in 30 DAYS of submitting - start clinical testing on humans **Sponsor cannot normally charge a pt for drug used in investigational study w/o special FDA approval **need informed consent

CS Registration Exemptions

Individual practitioners need to be registered w/ DEA to write for CS but if they're an employee of a hospital/institution, they can do it under that place's registration IF: -it is done in usual course of professional practive -they are authorized to do so in their state -the place has verified that they are permitted to in that state -the practitioner only acts within scope of his employment in that place -the place authorizes the intern, resident, or foreign trained physician to dispense or prescribe under the hospital registration and designates a specific internal code number for each person authorized. ^the code should be numbers, letters, and should be a suffix to the place's registration #, preceded by a hyphen (AP 0123456-12) -the list of codes and respective practitioners is made available to other registrants and law enforcement agencies Also exempted from individual registration = officials of: -Armed Services -Public Health Service -Bureau of Prisons ^in usual course of duties Also law enforcement ppl don't need one to possess CS as part of their official duties

CS Refills

Initial and date back of rx for each refill C-III and C-IV can be refilled max of 5 TIMES orrrrr over a period of 6 MONTHS - whichever comes first C-V can be refilled for up to 1 YEAR but the refills must be expressly authorized by prescriber on the rx 5-YEAR retention requirement on refill data verification whether it is on computer or log book Computer system for refill info is ok if it can provide: -online retrieval of order info -documentation that any refill info entered is correct ^pharmacist should print out each day's CS rx refill data - verify, date, and sign it - it should be printed within 72 hours of the time that the refill was dispensed. if can't print, sign logbook or separate file each day to verify the accuracy of the refill info -capability of printing out refill info ^if using central record keeping to store the info - must be able to provide the printout within 48 HOURS -auxiliary procedure to document refills in the event of system down ^must insure refills are authorized by orig rx order/max # of refills is not exceeded/all appropriate data is retained for online data entry as soon as system back up No additional refills are allowed for controls - the prescriber has to send a new and separate rx

CSA Inspection

Inspector is required to: -state purpose of inspection -present credentials -provide written Notice of Inspection ^if NOI is all they provide, pharmacist can refuse or withdraw consent at any time If there's a Search Warrant - cannot be refused ^can only do this is if law enforcement convinces a judge that crime has or will happen(ed) and there's evidence at the site Administrative Inspection Warrant - cannot be refused ^similar to SW but the judge issues AIW given probable cause of serving "a valid public interest" ^valid public interest could simply be that it's been too long since the last inspection or the pharmacy is ordering more CS than a similar pharmacy. ^way easier to obtain an AIW than a SW

Adulteration

Involves drugs/devices with impurities/poisons/decomposed ingredients The drug itself may be pure but considered adulterated if: -prepared/packed/held under unsanitary conditions where it may have been contaminated with filth or rendered injurious to health -it is manufactured in a way that does not conform to GMP standards established by FDA -container composed of poisonous/deleterious substance that can leech into contents -contains unsafe color additive -say it is or actually is a drug that's recognized in an official compendium and its strength/wuality/purity varies from official compendial standards (unless its variations are plainly stated on label) -not listed in an official compendium, yet the strength/quality/purity differs from that which it says it has -if it's a drug and anything else has been added to it to reduce its quality/strength or any substance has been substituted partly or fully There are situations where the strength/quality/purity of drug is affected and considered both ADULTERATION ANDDD MISBRANDING

Schedule I drugs (phys and psych dependence: severe) No medical benefit

Methaquolone Heroin Mescaline GHB LSD Marijuana Peyote THC

CS Modification/Termination/Transfer of Registration

Modifications (change in address, etc) -must notify DEA in writing -if approved, u get a new certificate which you have to keep with the old one -for change of address, must notify DCU in writing with date of change - ok as long as no change in ownership Termination (if someone dies or place gets shut down) -must notify DEA Transfer -must write request to DEA for approval -not the same as a transfer of business activity to another registrant when a pharmacy goes out of business (also notify DCU) For a corp or partnership, the DCU will consider the change in President or CEO or a change in ownership of 10% of the outstanding shares ^ if so, need a new application

CS Rx Label

Must contain: -pharmacy name and address -pharmacy telephone # -brand name, or if generic - "-----generic for ------" -strength of med -quantity dispensed -date upon which rx med is dispensed -CDS cautionary label -patient name -practitioner name -Rx # -directions for use -"use by" followed by product's use by date ^if dispensed in any packaging other than manufacturer's original - earlier of one year from date of dispensing OR expiration date on manufacturer bottle ^the patient name/brand or generic name/directions for use should all be in large/diff color/bolded type in comparison to other info on label For opioids: -auxillary label describing risks -BOP: "Opioid Risk of Addiction and Overdose" -in RED or YELLOW -in black text 10-12 font -on same side as rx label (front) Central Fill: -retail pharmacy name and address -unique identifier (central fill pharm DEA# indicating that the rx was filled at the central fill pharm) Normal labeling req are waived for institutional patients IF C-II is dispensed in no more than 7 DAY supply or C-III to V dispensed in 34 DAY supply or 100 unit doses (whichever is less) and the drug is not in possession of the ultimate user prior to admin and there are other appropriate safeguards

CII Partial Filling

Must fill remaining in 72 hours Exceptions: terminally ill or LTCF (write on rx) CARA: If not ^ If pt or prescriber requests partial fill, fill within 30 days Record: date of partial fill qty dispensed qty remaining pharmacist ID

CS Registration Requirements

Pharmacies register w/ Attorney General ANNUALLY -they must provide the DCU with the DEA number within 60 DAYS of registration -individual pharmacists not required to register but separate registration needed for each pharmacy owned ^except hospitals don't need separate registrations for decentralized pharmacies if all part of same physical structure ^hospitals do need one for any retail pharmacy they operate tho Manufacturers & Distributors register ANNUALLY ^separate registration required for each activity - manufacturing -distributing -reverse distributing -research -importing -exporting -narcotic tx plan -chemical analysis ^don't need to register for coincidental activities ^also don't need to if a pharmacy "distributes" CS to another pharmacy or physician as long as those sales are < 5% of CS dispensed/year Manufacturers, Wholesalers, Pharmacies all must register ANNUALLY with DCU as well! Retail pharmacies with ADS at LTCFs must have a separate registration at the location of each facility where the ADS are located

CS Rx Changes (Schedules III-V)

Pharmacist may: -add/change pt's address upon verification -add/change dosage form/drug strength/drug quantity/directions for use/issue date only after consultation and agreement from prescriber ^if you do consult them, note it on the Rx and in the medical record Can never change the pt's name or the CS prescribed (except generic sub if ok) or prescriber's signature

Emergency Kits

Pharmacy can place a kit with controls in a non-DEA registered LTCF if the appropriate state agency or regulatory authority specifically approved the placement and has procedures: -the source from which the LTCF may obtain CS for the kits must be DEA registered hospital/clinic, pharmacy, or practitioner -security safeguards for each kit are stored at the LTCF including who may access them and the specific limitation of type/quantity of CS permitted in kit -responsibility for proper control accountability of the kit within the LTCF, including the requirement that the LTCF and the supplying registrant maintain complete and accurate records of the CS placed in kit, disposition of the CS/the requirement to take and maintain periodic physical inventories -emergency medical conditions under which CS can be given - including requirement that CS admin by auth personnel only as expressly auth by individual practitioner and in compliance w provisions -prohibited activities that if violated could result in state revocation/denial/suspension of privilege to supply or possess kits containing the CS

CS Reverse Distributers

Pharmacy can send CS for destruction to a reverse distributor who will return them to the manufacturer to dispose of them Pharmacy records -drug name -dosage form -strengthterm-26 -quantity -date of transfer for any CIII-V Reverse distributor fills out 222 Form for any schedule II that are being destroyed They also fill out DEA Form 41 once drugs are destroyed DEA Form 41 not needed to record the transfer of CS between the pharmacy and the reverse distributor

Multiple Rx for C-II

Practitioner can issue multiple rx for patient to receive up to 90 DAY supply of C-II if: -each rx is issued for legit purpose in usual course of practice -they provide written instruction on each one indicating the earliest date on which a pharmacy can fill each one -concludes that providing pt with multiple rx in this manner does not create risk of diversion/abuse -if it is permissible under statw law -practitioner complies fully with all other applicable requirements under Act and these regulations as well as any additional state requirements ONLY for physicians ^ not PAs, etc Limited to 30 DAY supply per rx Need to be filled within 30 days of when they are allowed to be Max 3 Rx

Transmucosal Immediate Release Fentanyl (TIRF) REMS

Prescribers must be specially certified Can only be dispensed by pharmacies that are specially certified Only dispensed for outpatient use with evidence or other documentation of safe use conditions pts required to sign a Patient Prescriber Agreement Form -Abstral - SL tabs -Actiq - lozenge -Fentora - buccal tab -Lazanda - nasal spray -Onsolis - buccal film -Subsys - SL spray

CS Rx Restrictions

Rx cannot be written for any schedule II amphetamine or sympathomimetic amine for weight management or fatigue Al Rx for CS must be presented to pharmacist within 30 DAYS after issued date Prescribers don't write an Rx for controls to be dispensed by them - invoice for III-V and 222 form for II Rx may not be dispensed for methadone for detox or maintenance - but it can be dispensed in retail for analgesic purpose For CII - quantity should not exceed 30 DAY SUPPLY which shall be at lowest effective dose

C-V Retail Sales

Some C-V can be sold OTC if not a Rx by fed law and permitted by state law if: -sale is done by pharmacist or pharmacy intern under supervision of pharmacist -purchaser is at least 18 and have an ID -no more than 8 OUNCES or 48 DOSAGE UNITS of any substance with opium in any 48 HOUR PERIOD -no more than 4 OUNCES or 24 DOSAG UNITS of any other controlled substance provided in any 48 HOUR PERIOD -name and address buyer/name and qty of item/date/signature or initials of pharmacist recorded in bound record book Record book kept x 5 YEARS (federal law: 2 years)

Isotretinoin iPLEDGE REMS

Prevent fetal exposure to isotretinoin thru FDA approved program - no female should be pregnant on this -2 forms of contraception 1 MONTH before, during, and after tx -2 negative pregnancy (blood) tests before 1st rx given -pt must have negative result from CLIA certified lab prior to getting each rx -each month, prescriber must enter the pregnancy test results and 2 forms of BC she's been using into iPLEDGE -pharmacist must obtain authorization from iPLEDGE via website or phone before dispensing each rx

Opioid Prescribing

Prior to issuing 1st Rx for C-II for pain or any opioid drug AND Again prior to issuing the 3rd rx ^practitioner must discuss with pt the reasons why the med is being presriber, possible alternative tx, and risks associated with med -discussion must also include: - risks of addition or dependence - OD risk associated -danger of taking with benzos, alcohol, and other CNS depressants ^practitioner required to include note in patient record tht this discussion happened If < 18 and not emancipated minor - discussion and written acknowledgement is from parent/guardian W/ minors - give discuss prior to issuing each rx and include note in pt record stating it happened

Expedited Approval of FDA Drugs

Process involves for drugs that treat serious life threatening illnesses and provide meaningful therapeutic advantage over existing treatments Approval conditioned upon completing Phase IV post marketing studies

"Drug" definition

Recognized in -USP -Homeopathic Pharmacoepia of US -NF intended for use in diagnosis, cure, mitigation, treatment, prevention of disease anything affecting the structure or function of the body

Prescription Drug Marketing Act

Requests for samples must be initiated by physician and can be requested by physician for storage in hospital pharmacy but NOT retail pharmacy ^request must be written and with receipt Prohibits sale/purchase/trade of Rx drugs that have been purchased by hospital/healthcare entity/charity Exceptions: -sales to non-profit affiliates -sales to/from other members of hospitals of a group buying org -emergency sales or transfers to community pharmacy experiencing temporary shortage of Rx drug -sales pursuant to outpatient Rx in hospital

Pt Package Inserts

Required for: -PO Contraceptives -Estrogens Has to contain drug name, summary of efficacy, contraindications, risks, benefits, etc Considered misbranding if not given FDA Med Guide is preferred to PI now

Initial Rx for Opioids

SHould NOT exeed > 5 DAY supply for acute pain -lowest effective dose of an IR drug - NO ER or LA No less than 4 DAYS later - the prescriber can give a new rx for opioids to continue the acute pain treatment ^have to consult with patient first though -after, they can determine than additional days supply of drug is necessary and appropriate to tx needs and does not present risk of abuse, diversion, addiction ^ have to document their rationale for this Subsequest Rx for additional days supply of the prescribed drug have to be tailored to pt's expected need at the stage of recovery and in no case may the qty exceed 30 DAY supply -except for implantable infusion pump or multiple CII prescriptions issued at same time These requirements do not apply to a rx for a patient who: -is in active tx for cancer -receiving hospice care from licensed hospice -receiving palliative care -resident of a LTCF -being prescribed for use in tx of substance abuse or opioid dependence

DEA 222 Form ^ for ordering controls

Sent to registration unit of DEA in washington DC Purchaser sends copy 1 and 2 to supplier (keeps copy 3 - record date and # of containers received) Supplier sends copy 2 to DEA ^ if they can't fill it completely, they have 60 DAYS (from order form completion) to supply full balance ^they can endorse the other side of the form to send to another supplier if they don't have it ^if purchaser cancels any items, supplier lines through it and writes "cancelled" on copies 1 and 2 If mistake on form - mark all 3 copies VOID (don't erase/cross out etc) and DO NOT THROW THEM AWAY Can be filled/signed by registrant or power of attorney ^any pharmacist or pharmacy manager is NOT eligible - must have power of attorney to allow to do so These drugs need their own order form: -Carfentanil -Etorphine HCl -Diprenorphine Supplier can void part or whole orders (notify purchaser via writing) - line through items and write "VOID" in space where quantity of items shipped on copies 1 and 2 ^purchaser should keep this form and explanation Single sheet: implemented in Sept 2019 - 2 year transition period Use all triplicate forms on hand ^if run out before 2-yr - use single sheet if still have triplicates at 2-yr - use single sheet Process generally the same otherwise - make copy of the sheet instead of retaining copy 3 8 1/2 x 11 paper with space to order 20 items

GMPs

Set of regulations for manufacturers, not pharmacies Requirements for methods/facilities/controls used in manufacture/processing/packaging/holding of drug GMP applies to pharmacies if: -large scale compounding -hospital A repackages drug products for its own use and for hospital B and C -pharmacy chain repackages and re-labels quantities of drug products from manufacturer original container for shipment to individual franchises of chain -similar repackaging and re-labeling are conducted by individual pharmacies as members of an informal buying group

Naloxone Dispensing

Standing order - for person @ high risk of OD or person not at risk but who will give it to someone who is Pharmacist in good standing can request one from Department of Health 3 methods for RPh to get naloxone: -standing order from Department of Health -standing order from practitioner -via traditional rx Standing Order from DoH: -ask if naloxone for the person requesting it or to aide someone at risk -if for the person making the request, then fill as any usual rx, including the offer of counseling -if drug for person who may administer drug in emergency, set up separate profile, so that it is readily retrievable - do not go thru insurance ^be sure to note that required info was given w dispensing Under standing order from DoH: CANNOT dispense naloxone to professionals who may need to use them in their professional capacity!! -for professionals/first responders - need to obtain standing order rx from healthcare practitioner (see below) Standing Order from HealthCare Professional: -^same as above (ask if for them, etc) If drug is for professional/professional entity/emergency medical responder, etc: -set up separate profile reflecting "professional" or "emergency medical responder" so that the file is readily retrievable. Don't go through insurance. ^don't need additional training or info when dispensing

Prescription Monitoring Program NJ = PMP

Statewide database that collects Rx info on -CDS - controlled dangerous substances -Gabapentin -Human Growth Hormone (HGH) dispensed by pharmacies in NJ and by out of state pharmacies dispensing into NJ Pharmacists required to report CS rx info DAILY or no more than ONE BUSINESS DAY after a CS was dispensed Don't dispense C-II thru IV to pts who are suspected to use it for diversion, etc - first check PMP If you use it for anything other than providing healthcare (break HIPAA) - then you are subject to civil penalties of up to $10,000 for each offense and disciplinary action by the licensing Board

Controls Inventory

Take inventory: -at start (even if zero) and close of business -every 2 years -as soon as a drug becomes scheduled - same day -when there's change in ownership or PIC (old and new PIC must take inventory. if old not available, use alternate but report to Board) I and II - count exactly - records separate III-V - estimated - records "readily retrievable" ^UNLESS orig. bottle > 1,000 pills (then exact) keep records x 2 years can take inventory: -date of year which orig. inventory taken -regular general physical inventory day which is closest to and does not exceed 6 months from date that would otherwise apply -any fixed date using same 6 mo rule ^ for 6 mo rule, notify DEA and DCU of the date inventory will be taken similarly, inventory can be taken within 4 days of biennial date as long as DCU is notified of date

Thalidomide REMS

Terotogen -pregnancy tests are needed (STEPS program is very intense) STEPS program - has registration of all prescribers, pharmacies that dispense it, extensive pt info about the risks and all pts getting it STEPS approach: 1) controlling access to drug 2) educating prescribers, pharmacists, and patients 3) monitoring compliance

In Transit Losses

Whoever has custody of the CS (supplier/purchaser) is responsible for reporting the loss to the DEA and DCU If discovered loss after signing, purchaser must submit DEA Form 106. If they don't take custody of it and just return it back to the supplier, the supplier has to report it. Central/retail pharmacy - whoever has the contract with Fed Ex etc is responsible ^if the retail pharm is receiving from central fill via contracted carrier, they also have to fill out DEA Form 106