NY Controlled Substance MPJE Questions and Answers Already Passed

NY Controlled Substance MPJE Questions and Answers Already Passed Who has scheduling authority in NYS? Legislature What types of institutions need registration? Class 3 or class 3a For CS prescriptions, what is required? MDD, quantity (numeric and written), prescriber name imprinted, gender, age + other NYS rx requirements Max for buprenorphine for addiction? Physicians can ONLY prescribe; max 30 life of CS rx? 30 days how much of a c2 can be dispensed if it's an emergency telephone order? 5 days max How long must CS records be kept? 5 years Do prescribers, pharmacies, and hospitals fall into dispenser definition? Yes What is considered a dispenser of CS? Being able to deliver a controlled substance to an ultimate user by lawful order of a practitioner including prescribing and administering and the packaging, labeling, and compounding necessary for such delivery (includes prescribers, pharmacies, and hospitals) What is considered delivery of CS? Prescribing, administering, and dispensing to the ultimate user Schedule 1 CS High potential for abuse, NO currently accepted medical use in US Includes: heroin, marijuana, LSD, peyote, mescaline, MDMA, gamma-hydroxybutyric acid (GHB) Schedule 2 CS High abuse potential, may lead to psychological or physical dependence Has accepted medical use in US Includes: tincture of opium, morphine, codeine (alone), fentanyl, hydromorphone, methadone, meperidine, alfentanyl, levorphanol, cocaine and its salts/derivatives/etc., oxycodone, oxymorphone, sufentanyl, nabilone, hydrocodone, stimulants (amphetamine, d-amp, methylphenidate, phenmetrazine), depressants (amobarbital, pentobarbital, secobarbital) ANABOLIC STEROIDS ARE C2 NYS, C3 FEDERALLY Schedule 3 CS Less abuse than C1/C2; currently accepted medical use in US Includes: APAP/Codeine, Buprenorphine, buprenorphine/naloxone, butabarbital, butalbital+aspirin+caffeine(+/- codeine), dronabinol, gamme hydroxybutyrate, ketamine Anabolic steroids control act of 1990 Requires anabolic steroids to be placed in C3 due to increased use Schedule 4 CS low potential for abuse relative to C1-3, currently accepted medical use in US Includes: BDZ, meprobamate, phenobarbital, zaleplon (sonata), zolpidem, carisoprodol, modafinil, butorphanol, chlordiazepoxide, eszopiclone, diethylpropion, pentazocine, phentermine, eluxadoline Schedule 5 CS Low potential for abuse relative to C5, limited physical or psychological dependence, accepted medical use in US Includes: antitussives with codeine, antidiarrheals with opiate, pregabalin, ezogabine, lacosamide Special NYS rule about BDZs? BDZ classified as C4 but treated as C2 Special NYS rule about chorionic gonadotropin? C3 in NYS but federally not scheduled What are the CS licenses for manufacturers and distributors, specifically manufacturer? specifically manufacturer out of state? distributor? distributor out of state? Manufacturer - 1 Manufacturer out of state - 1a Distributor - 2 Distributor out of state - 2a What are the CS institutional dispenser licenses? 3 3a is for limited institutional dispenser What are the research CS licenses? Researcher 2-5, Researcher industrial 2-5? Instructional activities 2-5? Treatment programs, methadone? Research 2-5: 4 Researcher industrial 2-5: 4a Instructional activities 2-5: 5 Treatment programs, methadone: 6 What are the CS license for research and instructional institutions? Tx methadone and other substances? Hospital pharmacies detox, temporary tx? Research and instructional activities 1? Analytical laboratories? Tx methadone and other substances: 6a Hospital pharmacies detox, temporary treatment: 6b Research and instructional activities: 7 Analytical laboratories: 8 CS licenses for importers and exporters? Importer: 9 Exporter: 10 Exporter broker: 10a CS license for community pharmacy? Registered community pharmacy/automated dispensing system: 11 Does a pharmacy need to be dual registered with the DEA? No unless the pharmacy is distributing more than 5% of the total dosage units of a controlled substance in a 12 month period Then the pharmacy would have to register as a distributor What individuals can lawfully purchase, possess, or transfer CS in absence of DEA registration? Agent/employee acting in usual course of business like the individual pharmacist, nurses, practitioners Who may prescribe CS? A practitioner who is authorized to prescribe + licensed in his/her profession + registration number from DEA +/- registered under Federal Controlled Substance Act How to check if a DEA# is valid? 2 letters + 7 digits (1+3+5) + 2(2+4+6) = XY where Y is the 7th digit of the DEA # Second letter is the first letter of the last name What is the first level for the DEA# for practitioners? mid level? distributors? Practitioners: A, B, or F Mid level (NP, RPA, NM): M Distributor: P or R What are some illegitimate purposes for prescribing a CS? Office use, maintenance of addiction, amphetamine in weight control, methadone for dependence CS specific prescription requirements? Patient name + address + sex + age (not birthdate but can add) Doctor's printed name + address + DEA + phone + handwritten/electronic signature Specific directions for use (CANNOT just say PRN)) including dosage, frequency and MDD Date of issue Quantity (written and numeric) When do refills on CS expire? 6 months after the date it is written NOT filled Is MDD required? Yes it is a requirement on the prescription but can fill if it's not there. If MDD specified on RX then MUST put on label Refills on C2? NO Refills on C3-5? Yes; maximum 5 refills and must be specified in numeric and written form What are the 5 things you CANNOT add if missing on controlled substance Rx? Patient name Date Name of drug Quantity Dr signature What are 7 things you can add after authorization? Practitioner DEA/phone Directions for use Drug strength Maximum dose Code (if written for longer than 1 month) Patient address* Patient age/gender* Pharmacist must sign + date after receiving authorization *add after good faith effort What can a prescriber not change? Signature, date, drug name, patient name Can a prescriber's secretary call in CS? No the prescriber must do it C2 oral prescriptions? Up to a 5 day supply Pharmacist must receive NYSRx within 72 hours; need to mark follow up on rx and MUST MATCH EXACTLY Pharmacist endorse upon prescription date of delivery and signature MUST ALSO HAVE: "AUTHORIZATION FOR EMERGENCY DISPENSING" When to notify if oral emergency C2 doesn't have a follow up rx? 7 days; notify BNE + DEA if you do not get the follow up rx (fill out form) Oral prescription for C3? 5 day supply like C2 Within 72 hours pharmacist must receive NYSRX MUST MATCH EXACTLY Endorse upon face of rx that it is a follow up, date of filling rx, rx#, signature Oral prescriptions for C4? 30 day supply or 100 units Within 72 hours pharmacist must receive NYSRX MUST MATCH EXACTLY Endorse upon face of rx that it is a follow up, date of filling rx, rx#, signature Oral prescription for C5? 5 day supply like C2 Within 72 hours pharmacist must receive NYSRX MUST MATCH EXACTLY Endorse upon face of rx that it is a follow up, date of filling rx, rx#, signature Explicit language on back of rx for follow up oral cs emergency rx? Follow up prescription to oral order, pharmacy prescription number #, oral order filled #, follow up prescription received # Can prescriber issue a new CS rx within 30 days of date of any previous prescription? No unless patient has used all but a seven day supply provided by any previous issued rx What are the CS prescription codes for up to 3 months or up to 6 months of an anabolic steroid? (A-F) + can also name the condition on the face of the prescription A: pAnic B: ADD C: seizure, Convulsive, or spasm activity D: relief of pain E: narcolEpsy F: hormone deficiency states Can a pharmacist call the doctor to add a code on the CS rx? Yes How many refills can be on a C3-5 prescription? Max 5 refills that expire within 6 months of date issued Partial fill rules for C2? Can partial if do not have enough quantity in stock; must fill remaining within 72 hours OR if patient is resident in RHCF OR if patient is diagnosed as terminally ill Can a patient request a partial for a C2? NO If a patient is terminally ill or RHCF needs a partial for a C2 Must note terminally ill or RHCF on the patient + date, quantity dispensed, quantity remaining, signature Fill remainder within 30 days from date written fill within 60 days if original quantity > 30 day supply (like with code) Partial fills for C3-C5? Yes, patient can also request Total quantity dispensed does not exceed total quantity prescribed for 30 day period What label is required for CS? ORANGE LABEL! Auxiliary label must say marked/printed "Controlled Substance, Dangerous Unless Used as Directed" If a pet is for a CS what must be on the label? Species of animal What must be included on the legend on the rx label? CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed How long must a pharmacist hold CS records? 5 years from date of transaction Must also be filed electronically in real time with BNE Maintained on premises where licensed activity is conducted How should rx be filed? C2 one pile (add steroids to this file) C3-5 one pile (BDZ here even tho treated as C2) Non-controlled prescriptions last pile What is DEA Form 222 for? Legal distribution and transfer of C1 and C2 May be obtained only by persons who are registered with DEA Must be signed by same person who signed more recent DEA or by person with power of attorney Characteristics of the DEA form 222? Triple copy (Brown - Green - Blue) Only one item entered per line Total number of items should correspond to # of lines filled Must have name and address of supplier and be signed/dated by authorized person Copy 1 and 2 to supplier; 3 to purchaser (pharmacy) Pharmacy must record # of containers received and date on Copy 3 Copy 2 eventually gets sent to regional admin of DEA If the original amount is not delivered and DEA form 222 given/received then how long to give remaining balance? 60 days to give remaining balance if they do not deliver right amount What happens if DEA Form 22 is lost? Must execute new form, note serial # of lost form, date loss, and the fact the substance were not received Notify Special Agent in Charge of DEA in Division Office and provide serial # of each form missing Must approximate date loss/issuing Must notify if forms are found Are federal, state, tribal, and local law enforcement authorized to collect controlled substances from ultimate users for destruction? Yes When do controlled substances need to be inventoried? Biennially as of May 1, 1975 Must be done every 2 years or within 2 years of previous inventory C2 must be physically counted where C3-5 can be estimated (actual count must be made if container holds more than 1000 units + opened) If a drug becomes a controlled substance does it need to be inventoried? Yes What happens if there is theft or loss of CS? Notify nearest DEA office, BNE, and local police Complete DEA form 106 Complete DOH form 2094 What are the components of ISTOP? A-E A: prescription monitoring program + internet tracking system B: requiring e-prescribing C: updating state's controlled substance schedules D: CE for practitioners and pharmacists E: establish safe disposal programs For the ISTOP Prescription monitoring program how long are records/info on patient specific information kept? no less than 6 months and no more than 5 years Is the name of animal applicable in the ISTOP Prescription monitoring program? Species code? Yes, yes What does the duty to consult mean for prescribers? Practitioner must consult PMP prior to prescribing CS listed in C2-5 for purpose of reviewing a patient's controlled substance history (can designate someone) Is pharmacist consultation of PMP required? NO Can pharmacists designate someone else to consult PMP? Yes like interns, must be EMPLOYED by same pharmacy Do practitioners, pharmacists or designees have immunity with the PMP? Yes if they act in good faith Can a person ask other individuals or their legal guardians access to person controlled substance records history? Yes if given permission Can the DOH check the PMP? Yes, check for any violation of law or breach of professional standards Reporting controlled substances to PMP? Must be done in real time; can be done 24 hours after delivery, 72 hours for mail order Exceptions: economic hardship, tech limits, etc. What license does a hospital, veterinary hospital, mental hospital, or similar facilities have for CS? Class 3 license What can a hospital, vet hospital, mental hospital or similar facility do with a class 3 license? Purchase and store CS can distribute CS within institution to wards, floors, OR and ER and MUST be accompanied by an administration sheet When can an institution give a CS? When there is a written order OR emergency Emergency situations must have written rx and signed by MD within 48 hours with note of emergency and what condition is that happened How long do PRN orders last in a class 3 institution? Must be rewritten every 72 hours if continued How long do standing orders for CS last in a class 3 institution? Must be rewritten every 7 days if continued EXCEPTION: pt with convulsive disorders or ADD in institutional setting or RHCF or prisons (these last 30 days and those facilities must have class 3 license too) What is considered a class 3a facility? Nursing home, convalescent home, health related facilities, dispensaries or clinics that don't have institutional dispensers (pharmacy) within Can a 3a facility have stock of CS? Yes if it is a part of a class 3 facility When can a class 3a give a CS? Only when there is a prescription and filled by outside pharmacy 3a facility administer the CS to the patient If an emergency kit with CS was tampered with, when should pharmacy be notified? Within 24 hours How many CS can be in an emergency kit? injectables? up to 10 CS for only 24 hour supply max 3 can be injectable form What is in the acquisition records of class 3 and 3a facilities with substock? Running inventory of type, strength, quantity of each drug received and distribution Date of receipt and distribution Name and address of vendors Duplicate copies of forms for C2 What is in the distribution records of class 3 and 3a facilities with substock? Shows requisition record for the substock to be distributed Signed receipt for substock when delivered Administration sheet for each substock of C2 indicating name of CS, strength, dosage form, number of doses (think blue sheet at work) What is included in administration records of a class 3 and 3a with substocks? Date and hour of administration Name of patient Name of prescriber Quantity administered Balance on hand after administration Signature of administering nurse How are C1 and C2's stored in a class 3 facility? GSA class 5 steel cabinet or safe weighed < 750 lb; bolted or cemented to floor Vault must have at least 8" reinforced concrete How are C3-5 stored in a class 3 facility? Stationary, securely locked cabinet Can CS be in storage/locked medication carts? Only less than a 72 hour supply of C3-C5 can be in the medication carts NO C2's stocked in carts How do you dispose single use or partial dose CS in class 3/3a facility? Nurse or pharmacist can destroy Must be notated on administration sheet Destruction must be witnessed by a 2nd pharmacist, nurse or other person designated by admins What if multiple CS need to be destroyed/damaged? Must request permission from the BNE at least 3 weeks prior to proposed destruction date (DEA form 41) Must fill DOH form 2340 and includes: methods of destruction, 2 people witnessing, names of those people + DOH form 166 which lists what is being destroyed (drug) What happens if a patient needs to be transferred to another facility and needs CS? Physician can dispense a single dose of CS to medical attendant who is transferring if travel time > 3 hours In an emergency situation, can a practitioner dispense CS? Only if full time pharmacy/services are not available What is logged when you purchase pseudoephedrine, ephedrine, and phenylpropanolamine? The item purchased, item quantity, name + address of purchaser, date + time of sale (not required if single sales pack sold contains < 60 mg pseudoephedrine) Do you need ID to buy pseudoephedrine, ephedrine, and phenylpropanolamine? Yes How old do you need to be to buy pseudoephedrine, ephedrine, and phenylpropanolamine? 16 How much can you buy of an ephedrine base? 9 grams within 30 day period but also NO MORE than 3.6 g in a single day regardless of # of transactions No more than 7.5g out of 9g can be purchased in a 30 day period for MAIL ORDER PHARMACY (postal service) How long do you have to maintain records of purchases for pseudoephedrine, ephedrine, etc. ? 2 years after date of entry What do you need to do to sell pseudoephedrine, ephedrine, etc? Must provide documentation and certify training of all employees which will be sent to the DEA What does ESAP allow? Allows pharmacies to register with the NYS DOH to sell or furnish up to 10 hypodermic needles or syringes to persons 18 age+ What is the goal of ESAP To promote safe disposal and use of hypodermic needles or syringes How much can you buy with ESAP? Only quantities of 10 or less Can you advertise that hypodermic needles/syringes are available? No Is there a limit on the number of transactions a person can have when buying syringes through ESAP? No What is required to accompany a purchase of syringes through ESAP? Safety insert must be provided Who establishes the price of needles through ESAP? The provider Can you get reimbursed through insurance for purchasing needles? No Does ESAP require you to check ID before selling needles? No, even though age should be 18+ What does the safety insert include when you sell needles through ESAP? Information on proper use, risk of blood-borne disease, methods for preventing transmission or contraction of blood-borne disease, proper disposal, dangers of injection drug use, toll free number for info on HIV, statement that is legal for persons to possess syringes How many days can be prescribed for new onset acute pain (C2-C5)? max 7 days supply What needs to accompany a prescription for an opioid to a patient? Patient education material that notes risk of addiction, local treatment services, can be given hard copy or electronic What does the Opioid Overdose Prevention Law do? Increases the availability of naloxone for individuals at risk of overdose, and those who may witness an overdose How to comply with the Opioid Overdose Prevention Law? If you are a pharmacy with 20 or + locations, pursue or maintain a non-patient specific prescription with a HCP to dispense naloxone upon request OR register with department as an opioid overdose prevention program What practitioners can register to prescribe medical use marijuana? Physicians, NPs, PAs When can you dispense medical use marijuana? Must have registry ID card Must check PMP registry Can only give 30 day supply Must give safety insert Receipt to patient and a copy of receipt to DOH in real time What is the role of pharmacists in a dispensary? Supervise Must complete 4 hour course pursuant to section 1004.1 Can dispense no more than 30 day supply and not until patient has exhausted all by 7 days of their previous dispensed supply