JP Exam II Study Guide.docx

Exam Date: July 27, 2023 Lectures 7 to 10 Total questions: 49 Check-list: Scope of Practice? Controlled substance schedule? What are the rules for this CS schedule? Date of issue/validity In state or out of state provider? Narcotic or non-narcotic? Are refills allowed? Quantity restriction...

Exam Date: July 27, 2023 Lectures 7 to 10 Total questions: 49 Check-list: Scope of Practice? Controlled substance schedule? What are the rules for this CS schedule? Date of issue/validity In state or out of state provider? Narcotic or non-narcotic? Are refills allowed? Quantity restrictions? Exceptions to quantity restrictions? Refill restrictions? Is the DEA valid? Detox and maintenance of substance use disorder? Indication or 3 day rule? Lecture 7: June 22, 2023 (17) Controlled Substance Scheduling (10) See Controlled Substance Flashcards Federal law: Comprehensive Drug Abuse Prevention and Control Act (CSA)- administered by the DEA Creates a closed system from start to finish including manufacturing, distributing, and dispensing federally controlled substances The Attorney general must: include recommendations regarding scientific and medical matters from the Secretary of Health and Human Services, can change scheduling without HHS approval to avoid an imminent hazard to public safety, make rules pursuant to rulemaking procedures (on the record, opportunity for hearing) Factors that determine the schedule of controlled substances It’s actual or relative potential for abuse Scientific evidence of pharmacological effect State of current scientific knowledge History and current pattern of abuse Scope, duration, and significance of abuse Risk to public health Psychic or psychological dependence liability Whether the substance is an immediate precursor to an existing controlled substance Schedule II: high abuse potential, acceptable medical use (may have severe limitations), abuse may lead to severe psychological dependence Includes: narcotics, amphetamines, and barbiturates (opium, morphine, fentanyl, methadone, meperidine, secobarbital, pentobarbital, amphetamine, hydrocodone, codeine sulfate tablets) Schedule III: potential of abuse is lower, currently acceptable medical treatment, may lead to moderate-low physical dependence or high psychological dependence Includes narcotic-analgesic combinations, narcotic cough medications, intermediate acting barbiturates, anabolic steroids (Fiorinal, Ketamne, dronabinol) 1.8 g codeine or dihydrocodeine per 100 mL (not more than 90 mg per dosage unit) 300 mg ethylmorphine per 100 mL (not more than 15 mg per dosage unit) 500 mg opium per 100 mL or 100 g (nor more than 25 mg per dosage unit) 50 mg morphine per 100 mL or 100 g Schedule IV: low potential of abuse, currently accepted medical treatment in the US, abuse may lead to limited physical dependence or high psychological dependence Includes: long-acting barbiturates, hypnotics, benzodiazepines (Ambien, clonazepam, triazolam, diazepam, alprazolam, chloral hydrate, phenobarbital) Schedule V: little potential for abuse, currently accepted medical use in the US, abuse may lead to limited physical dependence or high psychological dependence Includes cough syrups with codeine, antispasmodics, neurologics (Lomotil, Robitussin A-C, Lyrica) 200 mg of codeine per 100 mL or 100 g 100 mg of dihydrocodeine, ethylmorphine, or opium per 100 mL or 100 g 2.5 mg of diphenoxylate and not less than 25 mcg of atropine per dosage unit 0.5 mg difenoxin and not less than 25 mcg of atropine per dosage unit Massachusetts Schedule II-V are the same as the federal level Schedule VI: created for prescription drugs that are not currently II-V, includes all legend drugs that are not controlled substances Labeling: Commercial Container- all commercial containers of drugs in schedule I-V must bear a CS symbol of the schedule it has been assigned Labeling: Prescription Container: the label of a II, III, or IV drug must say that it is a crime to transfer the drug to any other person other than the patient Controlled Substance Registration Requirements (2) Manufacturers and Distributors: annual renewal of registration Dispensers: renewal every 3 years Exemptions to Registration: agent or employee of the registrant acting in the normal course of business or employment (pharmacist), common carrier acting in the normal course of business or employment (USPS), an ultimate user who possesses the CS for a lawful purpose (patient) Individual practitioner: physician, dentist, veterinarian or other individual licensed or registered to dispense controlled medication in their jurisdiction, does not include pharmacists, pharmacy, or institutional practitioner Individual practitioners who are agents or employees of another practitioner other than a mid-level practitioner (NP, nurse midwife, PA) who is registered to dispense controlled substances may when acting in the normal course of their employment, administer or dispense (but not prescribe) using the registration or their employer Institutional Practitioner: when acting in the normal course of business, they can administer, dispense, and prescribe controlled substances under the registration of the hospital or institution Conditions: Administering, dispensing, and prescribing is done in the normal course of practice The individual practitioner is authorized or permitted by the jurisdiction The hospital/institution by whom he is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs They are acting within their scope The institution recognizes the intern, resident, or foreign trained physician to dispense or prescribe under the hospital registration and gives than a special internal code as a suffix to add to the end of the DEA The current list of internal codes are kept by the institution Activities that require registration: manufacturing, distributing, reverse distributing, dispensing or instructing (practitioner, hospital, clinic, retail pharmacy, central fill pharmacy, teaching institution), research, narcotic treatment programs, importing, exporting, chemical analysis DEA Form 224: Registration application for Dispenser (Pharmacy) DEA Form 225: Registration application for Distributors, Manufacturers, and Narcotic Treatment programs Security Requirements (2) Registrants must provide effective controls and procedures to guard against theft and diversion of controlled substances Factors involved in determining efficacy: Type of activity conducted, type and form of controlled substances handled, quantity of controlled substances handled, location of the premises, type of building, type of closures on vaults and safes, adequacy of lock control systems, adequacy of alarms Massachusetts specific (247 CMR 6): all controlled substances (CII-V) must be stored in pharmacy area, CVI may be stored in pharmacy area or adjacent to pharmacy area (clean room), CII-V shall be locked in a substantially constructed cabinet or dispersed throughout the CVI stock in a manner designed to reduce diversion Power of Attorney (1) A registrant may authorize one or more individuals (whether they are located at the registered location or not) to issue orders for Schedule I and II controlled substances of their behalf by executing power of attorney for such individual DEA Forms (222, 41, 106), record of Theft or Loss and MA Requirements (2) DEA 224: used to apply for CS registration by dispensers DEA 225: used to apply for CS registration by manufacturers, distributors, and NTPs DEA 223: CS registration is the application is approved by the DEA DEA 222: form used to order CI and CII medications CSOS: electronic version of DEA form 222 May not be used if any of the following occur: The required data field have not been completed The order is not signed using a digital certificate issued by the DEA The digital certificate has expired or been revoked prior to signature The purchaser’s public key will not validate the digital certificate The validation of the order shows that is in invalid for any reason Required for each distribution, purchase, or transfer of a schedule II substance If the DEA 222 is lost in transit, notify the DEA in writing DEA 106: form is issued to report loss or theft DEA 41: registrant record of controlled substances that have been destroyed A pharmacy may transfer controlled substances to the DEA registered reverse distributor who will destroy them (this will require a DEA form 222 because is is a transfer, not destruction) Pharmacy must maintain record of distribution to the reverse distributor including name, dosage form, strength, quantity, and date transferred The authorized reverse distributor will complete DEA form 41 Loss or Theft- notify the field division office of the Administration in the area in writing of the theft or significant loss of any controlled substances within 1 business day of discovery Complete and submit to the field division office Form 106 Any theft or suspected theft MUST be reported to the DEA Significant loss? Consider: the quantity of controlled substances lost in relation to the type of business, the specific controlled substances lost, whether the loss of controlled substances can be associated with access to controlled substances by specific individuals or unique activities, a pattern of losses over time, random losses, results of efforts to resolve the losses, whether the controlled substances are candidates likely for diversion, local trends and other indicators of diversion potential for missing controlled substance Massachusetts Requirements for Theft and Loss: registrants are required to report the loss of any controlled substances upon discovery to the Drug Control Program within 24 hours of discovery Drug Control Program requires a Drug Incident Report (and DEA 106 per federal law) Board of Registration in Pharmacy will require Policy 16-02 Must let the state police know and fill out Massachusetts DCP form + attach copy of DEA 106 CSA or DEA does not address breakage or spillage, but witnessed breakage or spillage does not constitute a loss of controlled substances because the registrant can account for this Consider options for disposal, and document everything Lecture 8: June 29, 2023 (11) Opioid Treatment Programs, Methadone, and Treatment Outside OTPs (1) Prescribers may not in the usual course of professional practice prescribe narcotic controlled substances to a narcotic addict in order to maintain or detoxify the addict They may administer or dispense directly if they are registered as a narcotic treatment program Three day rule: The physician (not a registered narcotic treatment plan) can administer narcotic drugs to a dependent person to relieve acute withdrawal symptoms when necessary arrangements are being made for referral (not more than 1 day at a time and may not be carried on for more than 3 days) No limitations on physician or authorized hospital staff to maintain or detoxify a patient in adjunct to medical or surgical treatment of an ailment other than addiction or for pain in which on relief or cure is possible A practitioner may administer, dispense, and prescribe any Schedule III-V narcotic for use in maintenance or detoxification of a narcotic-addicted patient Opioid Treatment Programs (OTPs): the only organizations that can treat for narcotic maintenance or detoxification Detoxification: dispensing for a period of time in decreasing doses to an individual to alleviate adverse physiological or psychological effects due to withdrawal as a method to bring the patient to a narcotic free state Short term: not more than 30 days Long term: more than 30 days but not over 180 days Maintenance: the dispensing for a period over over 21 days of a narcotic in the treatment of an individual for dependence on heroin or a morphine-like drug Methadone: CII analgesic used for the treatment of severe pain or detoxification and maintenance of narcotic addicts in an opioid treatment program 40 mg = OTPs only, not approved for management of pain Methadone may not be prescribed or dispensed for maintenance or detoxification of addicts in the regular course of medical practice, pharmacy dispensing is limited for the analgesic indication only! Must say “As needed for pain” Removal of the DATA-2000 Waiver: registration is no longer required for the treatment of opioid use disorder with buprenorphine, no longer an limitations on the number of patients a prescriber may treat in this way CMEA: Restrictions, Requirements, Record Keeping (2) OTC sale of products containing ephedrine, pseudoephedrine, PPA are now classified as schedule list chemical products, so they have limits on purchase Retail purchase: No more than 3.6 g/day or 9 g/month Import limit: No more than 7.5 g (of the 9 g/month limit) may be imported by mail Requirements: these products must be behind the counter or in a locked cabinet where consumers do not have access Record keeping: Sales over 60 mg PSE must be recorded Must record: product name, quantity sold, name and address of purchaser, date and time of sale, and purchaser's signature Massachusetts follows federal law Corresponding Responsibility, Red Flags, Prescription Drug Monitoring Program (2) The responsibility for the proper prescribing and dispensing for controlled substances is upon the prescribing practitioner, but corresponding responsibility rests with the pharmacist who dispenses the prescription Prescriptions must be issued for legitimate medical purposes by the practitioner acting within the usual course of professional practice (provider-patient relationship within scope of practice) Corresponding responsibility is at the federal and state level (Massachusetts) Legitimate medical purpose: determined by professional judgment Ex. ADHD medications, 60 days can only be for ADHD Consider: methadone for maintenance and detoxification, fictitious patients, controlled substance for general office use, without a medical exam, without a medical reason for controlled substance, high doses of a narcotic analgesic Red Flags: cocktailed medications, requests for early fills, large portion of controlled substances by one particular provider, doctors located 100 miles away from the pharmacy, other pharmacists refusal to fill, patients traveling in groups, requests to pay cash, patients presenting multiple prescriptions for controlled substances from multiple different doctors Prescription Drug Monitoring Program: electronic monitoring of controlled substances (CII-CV), many states participate in NABP PMP Interconnect Massachusetts: MA Prescription Awareness Tool (MassPAT) (105 CMR 700.012 and CMR 247 5.04) Massachusetts also requires Gabapentin to be reported CS Recordkeeping (1) Ordering CIII-V: the packing slip must contain the name of each controlled substance, the finished form, the number of dosage unit of the finished form in each commercial container, the number of commercial containers ordered and received The registrant must keep record on the receipt of the rate received and the accuracy of the order and this must be readily retrievable Federal inspections: fourth amendment protects individuals from unreasonable search and seizure, DEA needs a warrant or permission State Inspections: Board of Pharmacy has the authority to inspect pharmacies without a warrant or notice CS Inventories (3) CSA requires every registrant to maintain inventory (a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant) CSA requires that inventory record be maintained at the registered location and readily retrievable for at least 2 years Inventory of CIIs must be kept separate from all other controlled substances Inventory must include: Date When the inventory was taken (open or close of business) Name of each controlled substance inventoried Finished form of the substances Number of dosage units of each finished form in the commercial container Number of commercial containers in the finished form A count of the substance CII inventory must be an actual physical count CIII-V inventory may be an estimated count or measure of the contents unless the container holds more than 1,000 tablets or capsules, in which case an exact count is required Types of Inventories: Initial Taken when issued a DEA registration, an actual physical count of all controlled substances in registrant’s possession May not leave blank if the registrant does not have any controlled substances, write “0” No requirement to submit a copy to the DEA but it must be kept on file Types of Inventories: Perpetual (Massachusetts) A pharmacist shall keep a perpetual inventory of each controlled substance in schedule II which the pharmacist has received, dispensed, or disposed on in accordance with the law , must be done every 10 days (at the minimum) Types of Inventories: Biennial (Massachusetts and DEA) The registrant is required to take full controlled substance inventory every 2 years, same information required for the initial inventory May be taken on any date within 2 years of the previous date No requirement to submit to the DEA, but must be kept on file Registration: DEA #’s (2) A valid DEA number consists of 2 letters followed by 7 digits The first letter is a code that identifies the type of registrant A/B/F/G: hospital, clinic, practitioner, teaching institution, pharmacy M: mid-level practitioner (NP, PA, etc.) R/R: manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic treatment program The second letter is usually the first letter of the registrant or business The final 7 digits are computer generated Validity Check: Add the first, third, and fifth digits Add the second, fourth, and sixth digits and multiply by 2 Add the result of the first and second steps- the last digit of the result must be that same as the last digit of the DEA number Lecture 9: July 6, 2023 (21) Issuance of a Prescription, Rules per CS schedule, Prescriptions (required elements, validity, refills, maximum quantities, exceptions) (5) A prescription for a controlled substance may be issued only by an individual practitioner who is authorized to prescribe controlled substances by the jurisdiction in which he is licensed to prescribe and either registered with the DEA (or exempt) Issuance of a Prescription: Massachusetts May fill prescriptions for narcotic CII medications from out-of-state practitioners from contiguous states + maine (NH, VT, RI, CT, NY + maine) Only valid for 5 days Narcotic CII prescriptions from out of state prescribers (Mail Order) Prescription will be received by the patient via mail, commercial carrier, or other electronic means (mail order) The pharmacy is licensed in the state where the prescription originates The prescription must be filled by a pharmacist licensed in the state where the prescription originates The dispensed medication must be delivered to the state from which the prescription originates May fill non-narcotic prescriptions from out of state practitioners Only valid for 5 days 60 day supply ONLY for ADHD, not for other indications Federal Support Act: prescription of controlled substances must be transmitted via electronic prescribing software Massachusetts Care Act: every prescription must be an electronic prescription and include an electronic signature unless it is a prescription issued in accordance with the exceptions Failed e-script can only be dispensed if it is schedule VI (except gabapentin) Exceptions: prescriptions by veterinarians, electronic prescribing is not available due to temporary technological or electrical failure, practitioners who have received a waiver, emergency situations, prescriptions issued outside the jurisdiction of MA, expedited partner therapy (chlamydia treatment), compounded drug preparations, prescriptions issued for schedule VI medications, durable medical equipment Emergency Prescribing CII Medications: a pharmacist may dispense a CII medication upon receiving an oral authorization from the prescribing practitioner Limited to the amount needed to treat the patient during the emergency Within 7 days, the practitioner shall send a written or electronic prescription to the pharmacist for the emergency quantity that says “authorization for emergency dispensing” Required elements of a prescription: signed, dated, full name and address of the patient, drug name/strength/form, quantity, directions for use, and name/address/and registration number of the practitioner (only required for CII-V) All prescriptions in MA: Interchange is mandated unless the practitioner indicates ‘no substitution’ in accordance with the law CII Prescriptions in MA: The patient may fill, upon request, the prescription in amount not to exceed the recommended full quantity indicated Veterinarian prescriptions or expedited partner therapy prescriptions do not need to have a name on the prescription A prescription for a CII medication is not allowed to have refills- a new prescription must be issued Also a MA law Refills for CIII-V: refills on these medications are allowed, but the prescription may not be refilled more than 5 times in a 6 month period (the prescription expires after 6 months) Also MA law Refills for CVI: refills on these medications are allowed but the prescriptions expire after 1 year. If the patient has run out of refills/medication and the prescriber cannot be reached, the pharmacist may dispense a supply not to exceed 30 day supply or the smallest package size Dispensing rules per CS schedule- CII medications (5) Federal law does not indicate and expiration for CII prescriptions Federal law does not limit amount prescribed for CII prescriptions A prescription for a CII medication is only valid for 30 days from the date of issuance (applicable to MA providers only) A prescription for a CII medication from an out of state prescriber is only valid for 5 days from the date of issuance Controlled substances schedule II prescriptions cannot be filled for more than a 30 day supply upon any single filling Exceptions: Dextroamphetamine sulfate and methylphenidate hydrochloride may be filled for up to a 60 day supply if for the treatment of minimal brain dysfunction (ADHD) or narcolepsy Implantable infusion pumps consisting of CII medications can be filled for a maximum of 90 days (must follow USP 797 BUD dating) Further restrictions: opiates must have less than a 30 days supply, with the exception of palliative care Adults, first outpatient use: 7 day supply limitation Minors: 7 day supply limitation ALWAYS Exception for palliative care or cancer diagnosis (can give more than a 7 days supply for a minor or opiate naive patient) Emergency dispensing CII, Faxing CII, Partial fill CII, Multiple CII prescriptions for the same drug/patient (4) A practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially No more than a 90 day supply, in total All prescriptions must be dated with the date of issuance Subsequent prescriptions must have a do not fill before date- this cannot be changed and the prescription cannot be filled before this date Massachusetts Board of Pharmacy: must apply the 5 or 30 day rule to the prescription calculated on DNF date Partial fill (CII) is permitted if: The pharmacist is unable to fill the full amount for the prescription so long as the pharmacist can fill the remainder within 72 hours (the prescription will expire after 72 hours) Terminally ill (hospice) Long term care facility (partial fills up to 60 days from issuance) Patient request (up to 30 days from date of issuance) Massachusetts also allows partial CII fills up to 30 days after the issuance date for in state prescribers The remainder of the prescription must be filled at the original pharmacy The pharmacist must make a note in the patient’s file regarding the partial fill and the amount dispensed Out of state CII prescriptions: the initial partial fill must be within 5 days of issuance of the prescription and the subsequent partial fills must occur within 30 days of the issuance date Must include the partial fill disclaimer on the prescription per MA law Dispensing rules per CS schedule (CIII-CVI) (5) Federal law = Massachusetts Law Prescriptions for CIII-V medications expire 6 months after the date of issuance and is not authorized to be refilled more than 5 times A prescription for a CVI medication may not be filled or refilled after 1 year from the date of issuance Prescriptions for CIII medications shall not be filled for more than a 30 day supply on any single filling Exceptions: Implantable infusion pumps with CIII medications can be filled up to 90 days supply (Must follow USP 797 BUD dating) Partial fill from CIII-CV is permitted under federal and state law provided that: Each partial filling is dispensed and recorded in the same manner as refilling (date, amount dispensed, initials of RPh, etc.) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed No dispensing occurs after 6 months past the date of issue (and 5 times refilled?) Transfer of CIII-V Prescriptions: authorized refills may be transferred from one pharmacy to another pharmacy once within that 6 month period, unless there is a shared computer system or the prescription has not yet been filled Unfilled prescriptions (electronic, paper, fax, or oral prescriptions) for Schedule II-VI may be transferred Massachusetts follows federal law Correcting Controlled Substance Prescriptions (3) May Never/Change or Add (CII-VI): Patient’s name Controlled substance prescribed (except generic substitution) Prescriber’s name Prescriber’s signature Earliest date to be filled (Schedule II only) May Change/Add with the consultation of the provider: Schedule II Date of issue (may be added if omitted) Prescriber’s address Patients address May be added if omitted without consultation Practitioner must be consulted if the incorrect address is listed Prescribers DEA (do not need to consult the prescriber) Directions for use Dosage form Drug strength Quantity prescribed Supervising physician of mid-level practitioner “No substitution” and “Partial fill” language may be added if omitted without consultation but the prescriber’s office should be notified afterwards Schedule III-VI Date of issue (may only be added if omitted) Prescriber’s address Patient’s address May be added if omitted without consultation May be changed after consultation if the address was incorrect Prescriber’s DEA may be added if omitted without consultation Directions for use Dosage form Drug strength Quantity prescribed Refill information Supervising physician of mid-level practitioner “No substitution” language can be added without consultation if omitted but the prescriber’s office should be notified after May Change/Add without the consultation of the provider: If deemed appropriate, the day’s supply dispensed (30 versus 90 day supply) may be changed without consultation of the provider for schedule VI prescriptions only (excluding gabapentin). Information on the change must be documented on the prescription. With each change the following should be documented: date, item changed or added, name of the authorizing prescriber if applicable, and name of the pharmacist accepting or making the change