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Controlled Substance LogsControlled Substance Logs
What are controlled What are controlled substances?substances?• Substances of high abuse potentialSubstances of high abuse potential
• Are outlined in the Controlled Substance Are outlined in the Controlled Substance Act of 1970 which reduced drug abuse by Act of 1970 which reduced drug abuse by defined certain legal and illegal acts defined certain legal and illegal acts pertaining to these substances use pertaining to these substances use
• Established the Drug Enforcement Agency Established the Drug Enforcement Agency (DEA) to enforce the law(DEA) to enforce the law
• The law was designed to provide an The law was designed to provide an approved means for proper manufacture, approved means for proper manufacture, distribution, dispensing and use of distribution, dispensing and use of controlled substances through licensing of controlled substances through licensing of legitimate handlers of these drugs.legitimate handlers of these drugs.
• This is a “closed” system and has been This is a “closed” system and has been very effective in reducing the diversion of very effective in reducing the diversion of these drugs into the illicit market these drugs into the illicit market
5 Classes (Schedules) of 5 Classes (Schedules) of Controlled Substances Controlled Substances
• Schedules are based on their use or abuse Schedules are based on their use or abuse potentialpotential
Schedule I –high abuse potentialSchedule I –high abuse potential
research use onlyresearch use only
LSD, heroinLSD, heroin
DEA form C-222 requiredDEA form C-222 required
no acceptable medical useno acceptable medical use
5 Classes (Schedules) of 5 Classes (Schedules) of Controlled SubstancesControlled Substances
• Schedule II – High abuse potentialSchedule II – High abuse potential
Requires written Requires written prescriptionprescription
No refills on scriptNo refills on script
DEA form C-222 requiredDEA form C-222 required
Oxymorphone, Morphine,etcOxymorphone, Morphine,etc
Abuse may lead to severe Abuse may lead to severe addiction addiction
5 Classes (Schedules) of 5 Classes (Schedules) of Controlled SubstancesControlled Substances
• Schedule III – Less than I & II abuse Schedule III – Less than I & II abuse potential potential
oral or written script, up to 5 oral or written script, up to 5 refills in 6 monthsrefills in 6 months
DEA registration numberDEA registration number
Hycodan, anabolic steroids, etcHycodan, anabolic steroids, etc
abuse may lead to moderate abuse may lead to moderate dependencedependence
5 Classes (Schedules) of 5 Classes (Schedules) of Controlled SubstancesControlled Substances
• Schedule IV - low abuse potentialSchedule IV - low abuse potential oral or written scripts with 5 oral or written scripts with 5 refills in 6 monthsrefills in 6 months
DEA registration numberDEA registration number
Diazapam, phenobarbitalDiazapam, phenobarbital
Abuse may lead to limited Abuse may lead to limited dependencedependence
5 Classes (Schedules) of 5 Classes (Schedules) of Controlled SubstancesControlled Substances
• Schedule V - low abuse potentialSchedule V - low abuse potential
no DEA limits on no DEA limits on dispensingdispensing
DEA registration numberDEA registration number
Lomotil, Robitussin ACLomotil, Robitussin AC
lowest potential for lowest potential for abuse abuse
• All veterinarians who use these drugs must All veterinarians who use these drugs must have a DEA license number have a DEA license number
• Records must be maintained on the Records must be maintained on the acquisition and distribution of controlled acquisition and distribution of controlled substances substances
• All controlled substance records must be All controlled substance records must be “readily retrievable” if an inspector appears “readily retrievable” if an inspector appears at the hospitalat the hospital
Controlled Substance Controlled Substance ComplianceCompliance
A recording system must be set up to account A recording system must be set up to account for:for:
1.1. receipt of CSreceipt of CS
2.2. inventory of CSinventory of CS
3.3. legal distribution of CSlegal distribution of CS
4.4. signature sheet for anyone (staff) who can signature sheet for anyone (staff) who can handle CShandle CS
5.5. scripts to local pharmaciesscripts to local pharmacies
6.6. use of CS in hospitaluse of CS in hospital
Ordering Controlled Ordering Controlled SubstancesSubstances• Any supplier who you will buy CS from must Any supplier who you will buy CS from must
have a photocopy of the doctors current have a photocopy of the doctors current BNDD (Bureau of Narcotics and Dangerous BNDD (Bureau of Narcotics and Dangerous Drugs) registration number on file.Drugs) registration number on file.
• DEA receives copies of all your CS order DEA receives copies of all your CS order forms and invoices. Orders for excessive forms and invoices. Orders for excessive amounts or unusual items may trigger an amounts or unusual items may trigger an auditaudit
Ordering schedule II drugsOrdering schedule II drugs
• Form 222, a triplicate form must be Form 222, a triplicate form must be filled out and mailed to the supplier.filled out and mailed to the supplier.
• The supplier keeps a copyThe supplier keeps a copy
• A copy is sent to DEAA copy is sent to DEA
• The 3The 3rdrd copy is returned to you with copy is returned to you with the orderthe order
Receiving schedule II drugsReceiving schedule II drugs
• When a schedule II drug is received, When a schedule II drug is received, the appropriate boxes on your copy the appropriate boxes on your copy of the form 222 need to be filled out of the form 222 need to be filled out with the number received and date with the number received and date of receipt.of receipt.
• Attach this form to your CS log copy Attach this form to your CS log copy of the invoice. of the invoice.
• The audit trail of all CS must be The audit trail of all CS must be clear, concise and readily retrievable.clear, concise and readily retrievable.
• You must keep good records of You must keep good records of receipt, inventory and eventual legal receipt, inventory and eventual legal distribution of all CS distribution of all CS
• When received, all controlled When received, all controlled substances must be recorded and substances must be recorded and numbered in the unopened container numbered in the unopened container log.log.
• A separate log must be maintained for A separate log must be maintained for each drug and form of that drug. (ie.)each drug and form of that drug. (ie.)– Phenobarbitol injectablePhenobarbitol injectable– Phenobarbitol 60 mg tabletsPhenobarbitol 60 mg tablets
• Copies of all invoices for CS must be kept Copies of all invoices for CS must be kept and readily available. and readily available.
• Schedule III, IV, and V must be labeled Schedule III, IV, and V must be labeled with a with a 1inch high red C1inch high red C in the lower right in the lower right hand corner.hand corner.
• Schedule II must readily identifiable from Schedule II must readily identifiable from III, IV and VIII, IV and V
• Can be kept in separate folders or mixed Can be kept in separate folders or mixed in the same onein the same one
• All CS must be kept in a double locked All CS must be kept in a double locked box.box.
• It is advisable to keep stock items in a safe It is advisable to keep stock items in a safe and only open in use containers in the and only open in use containers in the double lock boxdouble lock box
• If any need refrigeration, they must be in a If any need refrigeration, they must be in a special double lock box that affixes in the special double lock box that affixes in the refrigerator or the refrigerator needs to be refrigerator or the refrigerator needs to be padlocked.padlocked.
• 2 locked building doors DO NOT 2 locked building doors DO NOT sufficesuffice
• The safe or cabinet has to be bolted The safe or cabinet has to be bolted to the floor or wallto the floor or wall
• When taken out of stock, CS has to be When taken out of stock, CS has to be logged in an open container log while at logged in an open container log while at the same time being logged out of the the same time being logged out of the unopened stock logunopened stock log
• A signature and initial sheet for anyone A signature and initial sheet for anyone who has access to and use of the drug logs who has access to and use of the drug logs needs to be kept in the front of one of your needs to be kept in the front of one of your logs (usually the unopened stock log) logs (usually the unopened stock log)
• Any scripts given to clients to take to local Any scripts given to clients to take to local pharmacies need to be copied and kept in pharmacies need to be copied and kept in a file so that they can be tracked. a file so that they can be tracked.
• Suggestion, make 2 copies, 1 for the Suggestion, make 2 copies, 1 for the patient record and 1 for the DEA filepatient record and 1 for the DEA file
• In NYS, we have to use specific state In NYS, we have to use specific state prescription pads that void themselves if prescription pads that void themselves if tampered with or photocopiedtampered with or photocopied
• In the open use CS log, all use has to be In the open use CS log, all use has to be documented with:documented with:– DateDate– Patient/client namePatient/client name– Patient/client ID numberPatient/client ID number– Amount usedAmount used– New balance left in the containerNew balance left in the container– Initials of staff member who drew up or Initials of staff member who drew up or
counted out the drugcounted out the drug
• Frequent audits of your CS should be Frequent audits of your CS should be done. Depending on the size of the done. Depending on the size of the facility.facility.– DailyDaily– Every shiftEvery shift– EtcEtc
• A biennial drug inventory is mandatory by A biennial drug inventory is mandatory by DEA regulations.DEA regulations.
• Keep all CS records 5 years + since the Keep all CS records 5 years + since the statute of limitations is 5 years.statute of limitations is 5 years.
• A separate inventory of Ketamine on hand A separate inventory of Ketamine on hand must be recorded and stored with the must be recorded and stored with the biennial drug inventory records. This is biennial drug inventory records. This is due to severe Ketamine drug abuse issuesdue to severe Ketamine drug abuse issues
• Go to CS log transparenciesGo to CS log transparencies– Signature sheetSignature sheet– Unopened logUnopened log– Opened logOpened log– Biennial inventoryBiennial inventory
• Tramadol - (a pain medication) not Tramadol - (a pain medication) not currently controlled, may soon be currently controlled, may soon be changed to controlled because of the changed to controlled because of the increasing abuse of the drugincreasing abuse of the drug
• Any and all employees that have Any and all employees that have access to CS must be screened. This access to CS must be screened. This includes Drs, techs, assistants, includes Drs, techs, assistants, receptionists, kennel staff and receptionists, kennel staff and possibly groomers.possibly groomers.
• Anyone convicted of a felony can not Anyone convicted of a felony can not have access to or handle CShave access to or handle CS
Outdated Controlled Outdated Controlled SubstancesSubstances• It is illegal to use outdated CS since it is It is illegal to use outdated CS since it is
considered adulterated.considered adulterated.
• It It CAN NOT BE THROW AWAYCAN NOT BE THROW AWAY
• It should, with the appropriate documentation be:It should, with the appropriate documentation be:– Returned to the supplierReturned to the supplier– Given to a reverse distributorGiven to a reverse distributor– Given to a disposal agencyGiven to a disposal agency– Obtain DEA on site destruction permissionObtain DEA on site destruction permission
• Best is to return to supplier if Best is to return to supplier if possible. The supplier fills out all the possible. The supplier fills out all the necessary DEA paperwork and gets necessary DEA paperwork and gets the authorization. You then send it the authorization. You then send it back with the paperwork keeping back with the paperwork keeping your copy of the paperworkyour copy of the paperwork
• No cost to the veterinarianNo cost to the veterinarian
• Contracting with a reverse distributor Contracting with a reverse distributor who also fills out all the paperwork who also fills out all the paperwork with DEA and then picks up the CS with DEA and then picks up the CS from you to destroy. from you to destroy.
• No cost to the veterinarianNo cost to the veterinarian
• Hard to find themHard to find them
• Disposal agency also fills out all the Disposal agency also fills out all the DEA paperwork and picks up from DEA paperwork and picks up from youyou
• Fee for the serviceFee for the service
• If none of those are an option, you can fill out the If none of those are an option, you can fill out the appropriate paperwork DEA forms DOH-2340 and appropriate paperwork DEA forms DOH-2340 and DOH-166 or if schedule II a Form 222 also and DOH-166 or if schedule II a Form 222 also and submit to your regional DEA office for authorization submit to your regional DEA office for authorization to do an on sight ( at the practice) disposal.to do an on sight ( at the practice) disposal.
• Download forms from: Download forms from: www.nyhealth.gov/professionals/narcotic/www.nyhealth.gov/professionals/narcotic/ and and mail to appropriate area office of the Bureau of mail to appropriate area office of the Bureau of Narcotic EnforcementNarcotic Enforcement
• Not available in all areas of the countryNot available in all areas of the country
• Go to Bureau of narcotics destruction Go to Bureau of narcotics destruction formsforms
• If outdated CS is returned or destroyed, it If outdated CS is returned or destroyed, it must be logged out of stockmust be logged out of stock
• Justification for the use of all CS must be Justification for the use of all CS must be clearly demonstrated in the patient’s clearly demonstrated in the patient’s medical record.medical record.
• There has to be a valid Client/patient/doctor There has to be a valid Client/patient/doctor relationshiprelationship
• Any loss or theft of CS must be Any loss or theft of CS must be reported to DEAreported to DEA
• If a DEA inspector shows up at the If a DEA inspector shows up at the practice and shows proper ID and practice and shows proper ID and has a warrant or subpoena, you must has a warrant or subpoena, you must immediately show them all the CS immediately show them all the CS records except for financial recordsrecords except for financial records
• Penalties, up to and including Penalties, up to and including revocation of the veterinarian’s revocation of the veterinarian’s BNDD number can be assessed.BNDD number can be assessed.
• Without the ability to purchase Without the ability to purchase controlled substances practice is controlled substances practice is very limitedvery limited
Additional New York State Additional New York State RegulationsRegulations
In order to control CS abuse NYS requires In order to control CS abuse NYS requires all pharmacies, human and veterinary, to all pharmacies, human and veterinary, to upload by the 15 of the following month a upload by the 15 of the following month a record of all the CS that has been record of all the CS that has been dispensed from the practice in the past dispensed from the practice in the past month.month.
The Health Dept’s supercomputer checks to The Health Dept’s supercomputer checks to see if people are getting multiple scripts for see if people are getting multiple scripts for CS from different doctors or if doctors are CS from different doctors or if doctors are writing abnormally large amounts of CS writing abnormally large amounts of CS scripts. Which will trigger an investigation scripts. Which will trigger an investigation
• Article 33 of the Public Health Law and Part Article 33 of the Public Health Law and Part 80 of Title 10 regulations require 80 of Title 10 regulations require pharmacies to electronically submit pharmacies to electronically submit information to the New York State information to the New York State Department of Health (NYSDOH) from all Department of Health (NYSDOH) from all prescriptions dispensed for controlled prescriptions dispensed for controlled substances. Such information must be substances. Such information must be submitted not later than the 15th of the submitted not later than the 15th of the month following the month in which the month following the month in which the controlled substance was dispensed. controlled substance was dispensed.
• Go to upload word documentGo to upload word document
FYIFYI
• You can not fill prescriptions for any You can not fill prescriptions for any medications for other practitioners medications for other practitioners unless you are a licensed pharmacist unless you are a licensed pharmacist employed in a registered pharmacyemployed in a registered pharmacy
• Compounding of substances without Compounding of substances without a special license as a compounding a special license as a compounding pharmacy is illegalpharmacy is illegal
FYIFYI
• You can not order compounded You can not order compounded substances from a compounding substances from a compounding pharmacy and re-dispense them to your pharmacy and re-dispense them to your patients. This is distributing. You can only patients. This is distributing. You can only order them for in hospital use.order them for in hospital use.
• You must script out compounded You must script out compounded substances for a specific patient and have substances for a specific patient and have them filled through a compounding them filled through a compounding pharmacy. Marking up the price is illegal.pharmacy. Marking up the price is illegal.
