Term
| What is the one distinguishing characteristic of a Schedule 1 controlled substance? |
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Definition
No accepted medical use in the US.
The drug or substance has no currently accepted medical use in treatment in the United States
There is a lack of accepted safety for use of the drug or other substance under medical supervision
Examples of C-I substances include heroin, marijuana, mescaline, LSD, and GHB |
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Term
| Which of the schedules has products that are legal to sell (dispense) without a prescription? |
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Definition
Class V
• The most commonly sold OTC, are in combination with the expectorant guaifenesin.
• Some contain legend drugs like promethazine, which would make them Rx only because of the second ingredient |
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Term
| What are the 8 factors that DEA and/or the US Congress considers in placing a drug into the broad definition of controlled substances and therefore under control of DEA? |
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Definition
- Actual or relative potential for abuse
- Scientific evidence of pharmacological effect
- Current scientific knowledge of the substance
- History and current pattern of abuse
- Scope, duration, and significance of abuse
- Risk to public health
- Psychic or physiological dependence liability
- If substance is a prodrug for an already controlled substance (SudaFed) |
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Term
| According to the text should you look for the most recent schedules for drugs in the Code of Federal Regulations or the United States Code? |
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Definition
| Code of Federal Regulation |
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Term
| “Doors and fours” is street slang for how much Codeine”? |
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Definition
| “Doors and fours” is street slang for how much Codeine”? |
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Term
| Are drugs placed into Schedule I thought to have high dependence liability? |
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Definition
| Schedule-I drugs have a high abuse potential but the physical dependency and psychological dependency have not been defined since they have no medical use in the US |
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Term
| Speaking of codeine, how much is the upper limit of codeine in Schedule IV? |
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Definition
| There are no codeine products in Class IV. Codeine combinations are in Schedule-III or Schedule V |
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Term
| What two factors are considered when determining what type of registration a “person” will receive from DEA? |
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Definition
Schedules of drug handled
Activity in which they will engage - Registration for a certain activity- such as research, distribution, and dispensing- often is too restrictive for the activities of the registrant |
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Term
| Be able to place an activity into the appropriate registration type and know the “Coincident Activities” associated with (or not) the registration type: e.g. Manufacturer can distribute without being registered as a Distributor..etc. |
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Definition
Coincident activities – extra things you can do with a registration.
Manufacturer – can distribute to another registrant without being registered as a distributor
Dispenser – (pharmacy) can distribute without being registered as a distributor |
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Term
| Try to make sense out of the so-called 5% rule for pharmacies registered as dispensers who can distribute CS. |
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Definition
| Total doses distributed by a dispenser to a practitioner cannot exceed 5% of total dispensed and distributed in a calendar year. Ie. 1000 dose units of drug A in year, can only distribute 50 dose units. If it gets close-register as a distributor. |
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Term
| Distinguish between “dispensing” and “distributing”. |
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Definition
Dispensing – pharmacies, physicians, other.
Distributing – wholesalers, manufacturers, etc. sending or selling to another registrant |
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Term
| What general groups of individuals can prescribe or order in an institution - including prescriptions that are going out of the institution without being registered individually? Don’t forget the exclusion of so-called “Mid-level” practitioners. |
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Definition
| Residents, interns, foreign-trained physicians. Not permanently living in the state. CANNOT be a mid-level provider such as nurse practitioner, physician assistant or OD. Must be employed by the registrant. |
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Term
| . Physicians and other “practitioners” often want to write a prescription for a supply of controlled substances to supply the need for general office dispensing. Is that legal? Can it be made legal? What makes it illegal (besides the fact that the regulations say you can’t). |
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Definition
| No, it is not legal. No patient name. Can do it for maintenance and detox only if drug is class III, IV, or V and the FDA has approved it for this use. Subutex (buprenorphine) or Suboxone (buprenorphine and naloxone) are permitted for office-based detoxification and maintenance prescriptions. |
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Term
| What are the rules that attach to the use of the Institution’s DEA registration number. |
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Definition
- Done in the usual course of practice.
- Practitioner is authorized by jurisdiction to prescribe
- Within the exempt individual’s scope of employment – cannot prescribe outside of hospital.
- Hospital verifies authority to prescribe
- Hospital keeps accurate list of names and suffixes. |
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Term
| Know how to verify a DEA registration number by use lf the “super secret” method not in the law anywhere. |
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Definition
| (1st + 3rd + 5th) + 2(2nd + 4th + 6th) = checking number (the singles digit should match the last DEA #) |
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Term
| In the code (CFR) §1301.76) it says that no registrant can employ any individual who has a felony conviction related to controlled substances. Is that forever? |
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Definition
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Term
| What schemes are accepted by DEA for the in-store storage of controlled substances? |
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Definition
- Substantially constructed, locked, cabinet OR
- Dispersed with regular (non-controlled) drugs, in a manner which obstructs theft or diversion
- Can do BOTH |
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Term
| What is he general rule for the time required to retain and maintain controlled substances records? |
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Definition
| 2 years from the date of record |
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Term
| While many types of CS records can be shipped off to the "main headquarters" of a chain pharmacy, there are three identified records that must be kept (retained, maintained) in the registered location. What are those three records? |
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Definition
1. prescriptions
2. inventories
3. executed order forms - i.e. DEA form 222 |
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Term
| If required, where would the “Red C’ be placed, and how big does it have to be? |
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Definition
Bottom right hand side.
No less than 1 inch.
Used to help find CIII – V prescriptions |
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Term
| What record-keeping instrumentality can, relieve the pharmacist of the obligation to affix the “Red-C” to a prescription? |
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Definition
Need to be able to find prescription in the system by entering in the prescription # and retrieving:
1. Prescribers name
2. Patients name
3. Drug dispensed
4. Date filled |
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Term
| Electronic storage of information of prescription information if certain criteria are met. Among those criteria is the list of information that must be readily retrievable by merely entering the prescription number. What are included in that listing? |
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Definition
Need to be able to find prescription in the system by entering in the prescription # and retrieving:
1. Prescribers name
2. Patients name
3. Drug dispensed
4. Date filled |
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Term
| What prescription storage schemes are permitted in the CSA? (Paper prescriptions) |
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Definition
There are 3 schemes:
1. Using 3 files: C-II only, C-III-V only, non-controlled only
2. Using 2 files: C-II only, C-III-V (Red C on these unless waived) and non-controlled
3. Using 2 files: C-II + C-III-V (Red C on these unless waived) and non-controlled |
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Term
| The Biennial inventory is “taken” (counted, measured, estimated, and recorded) how often? If you “take” inventory every year does the newest inventory satisfy the requirements? |
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Definition
| The day the business opens for the first time AND no less than every 2 years thereafter. Must be recorded and kept at location for at least 2 years. |
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Term
| Describe the rules of inventory that apply to drugs kept in locations other than the pharmacy licensed area. |
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Definition
| In the event there are controlled substances belonging to the registrant but which are at a remote location-such as in the emergency kit of a long-term care facility or in a “crash cart” or some place like that, they must be recorded as if they were in the registered location. |
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Term
| Know the inventory rules that include rules on counting or estimating, and method (form)of entry onto a paper copy. |
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Definition
· C-II drugs must be counted accurately to the unit.
· Drugs scheduled in C-III, C-IV, and C-V may be estimated unless the original container held more than 1,000 units. It does not matter what the number of tablets or capsules is in the container at the time of inventory, but only how many it held when it was opened and when it was opened for the first time. This is one of the reasons that pharmacists seldom purchase bottles larger than 1,000.
TRICK QUESTION ALERT: It is not 1000 or more, it is more than 1,000!
The record must contain the number of commercial containers (full bottles that are opened) as a separate entry from the number of loose tablets.
Example:
4 x 100 methylphenidate 10 mg tablets
70 tablets methylphenidate 10 mg tablets
Note that the information recorded for each are:
· Number of Commercial Containers (meaning: unopened, full)
· Number of dose units in opened containers (called finished units)
· Name of the drug (trade or generic, or both)
· Strength of the drug (if applicable)
· Dose form of the drug (tablet, capsule, injection…)
Note the C-II drugs are recorded on a separate sheet from the rest of the controlled substances. Or if maintained in another manner, must be readily retrievable from the C-III, C-IV, and C-V drugs.
Note that the date recorded must be on the inventory. |
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Term
| Inventory at open or close? What’s that? |
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Definition
In the pharmacy, the number of dose units of all drugs must reflect either the number on hand at the time the pharmacy opens or at the time the pharmacy closes for the day (or some other time in case of a pharmacy open 24 hours a day.) Simply stated, to be able to accurately count how many drugs were stolen in a robbery.
Simple Reasons outlined in packet:
The simple reason for this complex operation is that in the event of a robbery, or an inspection, assuming the pharmacist does not stop to count all the drugs being thrown into the bag either at the point of a gun or in the middle of the night, the police and the pharmacist who need to know how much was taken will use the most recent biennial inventory, add the drugs received by the pharmacy in the time between the inventory and the burglary or robbery, subtract the number of drugs dispensed or distributed and those numbers will give the number of drugs that should be on hand. Then a count is made to see what are the differences between the expected number and the actual number. This is what was taken. If the pharmacy is busy, there can be a number of any individual tablets dispensed either before that drug is counted or after it is counted making it impossible to tell what to do with the prescriptions filled on the day of the inventory and potentially making a very wrong number reported as theft. |
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Term
| Does #27 count for the “Opening Inventory”? (And that hash mark (#) means, in this context, “number”. |
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Definition
| The initial inventory date is the date of the start of the operations for the registrant. That is the first day of business for a pharmacy. If this is the most currently biennial inventory, I would assume that this could be used. If there is a more current biennial inventory that has to be used according to the guidelines. |
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Term
| What items are pre-printed on the DEA FORM 222 when you receive them? |
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Definition
Each order form is pre-printed with:
1. Name of registrant
2. Address of the registrant
3. Registration number of the registrant
4. The authorized activity for that registrant
5. The authorized schedules of drugs
6. The serial number of the form |
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Term
| How does the electronic DEA FORM 222 differ from the paper 222? |
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Definition
· Electronic form requires digital signature issued to purchaser by DEA
· Requires 9 character tracking number unique to order- last 2 digits of year, X, 6 characters selected by purchaser (i.e. 10 X EA3456)
· Electronic signature
· No endorsement allowed
· Can order CIII-CV and noncontrols as well- cannot order these on paper 222
· All other requirements are the same as paper |
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Term
| For what purpose (in pharmacy and in context of this course) is the “Power of Attorney”? Does this mean you get to skip law school? |
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Definition
| The power of an attorney is a written document (Power of Attorney form) in which one person appoints another person to act as an agent on his or her behalf, thus conferring authority on the agent to perform certain acts or functions on behalf of the principal. The most recent signer of the registration has the authority to sign. The person who gets the authority is called the “Attorney in Fact”. This person will sign the principal’s name and the agent’s name when signing a DEA 222 bill : Roberta Registrant by Freida Farmacist (Attorney in Fact). The POA form is kept in the pharmacy, so nobody knows unless inspected. So yes, this means you get to skip law school since the Attorney In Fact would be responsible for your legal actions in this matter and whatever else the signer has granted legal power to. |
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Term
| What designations are given to the two parties on a 222. |
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Definition
| “Purchaser” and “Supplier” |
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Term
| Can a pharmacy using the electronic form 222 use the same tracking number for all the orders from a single pharmacy? |
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Definition
No, the tracking number is unique to a specific order.
Ex) 13 X EA3456 – (13 – last 2 digist of the year, “X”, then 6 characters selected by the purchaser – alpha numeric, or all numbers, or all letters. |
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Term
| In general, what items can be ordered on an Electronic 222 that can not be ordered on a paper 222? |
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Definition
| CIII - CV and non-controls can be ordered on an electronic Form 222, but not on paper. |
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Term
| What is “endorsement” in the context of this course? Which order form can and which can’t? |
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Definition
| Endorsement is when a supplier who cannot fill the order signs it over to another supplier. The endorsement is all or nothing – cannot do “partial endorsements” (not just a line or two of the order). Endorsement is NOT permitted with electronic orders. |
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Term
| What can and what cannot the pharmacist do with an error on a form 222 made by the pharmacist? |
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Definition
| The form must be absolutely accurate – no changes, no erasure, no cross outs. The supplier has more flexibility – they can cross out items if the pharmacist requests and can make small changes. A completed form is only good for maximum of 60 days. Defective forms are returned to the purchaser by the supplier. |
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Term
| What must be done if executed form 222 are lost in the mail? Stolen? Drugs lost in transit? If lost or stolen forms or drugs are later recovered? |
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Definition
| Lost or reported forms must be reported to the DEA. If the form is lost before shipment (lost in the mail, lost by supplier) then the pharmacist should make out a duplicate exactly as the first, including the serial number of the first – in case the original shows up some time (the supplier won’t duplicate). If later found, then report the find to the DEA. All stolen forms need to be reported to the DEA with the numbers if you know them or the approximate date of receiving the forms. Stolen forms are completely useless but the DEA still seems to take them this seriously. Defective forms are returned by the supplier to the purchaser and kept there for 2 years. |
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Term
| What must be done with unused (unexecuted) order forms if the pharmacy goes out of business? Or if the pharmacy is purchased by someone else? |
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Definition
| If the registrant ceases business for whatever reason, all unused forms are returned to the DEA. They cannot be transferred to a new registrant. |
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Term
| What is the disposition of the various (3) copies of a paper 222? |
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Definition
| The three copies of a paper 222 are the original (Copy 1), the duplicate (Copy 2) and the triplicate (Copy 3). The purchaser sends copies 1&2 to the supplier with the carbon paper in place. The supplier records the items shipped (delivered) on orginal (1) and the duplicate (2). Supplier keeps the original and sends back the duplicate to the regional office of the DEA at the end of the month. The purchaser records items received and date received on the triplicate and keeps this for 2 years. |
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Term
| What is within the rules for suppliers who cannot supply the whole C-II order? |
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Definition
| The supplier can endorse the order to another supplier. They must endorse the ENTIRE order, no partial endorsements. |
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Term
| Three criteria are listed as essential to the issue of a prescription. What are those criteria? |
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Definition
• Legitimate medical purpose
• Individual practitioner
• Usual course of practice |
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Term
| What are the two currently-accepted drugs for the office-based treatment of addiction? |
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Definition
• Subutex (buprenorphine)
• Suboxone (buprenorphine and naloxone) |
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Term
| What types of maintenance and/or detoxification spelled out in the law? |
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Definition
• Maintenance: administering in relatively stable dosage levels not trying to get to drug-free state
• Detoxification: decreasing doses trying to reach drug free state
o Short term- up to an including 30 days
o Long term- 31-180 days
• Cannot normally issue a prescription for narcotic controlled substance for maintenance or detoxification. |
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Term
| What are the required components of a prescription which, if missing, will force the pharmacist to complete the Rx or be liable for filling an illegal (for reasons of incompleteness) prescription? |
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Definition
• Full name of patient
• Address of the patient
• Date of issue
• Drug name
• Strength (if applicable)
• Dosage form
• Quantity prescribed
• Directions for use
• Name of prescriber (signature if handwritten)
• Address of prescriber
• DEA number of prescriber |
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Term
| What is the meaning of the term “Post Dating”? |
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Definition
• Writing a future date
o Ex. Writing 4/1/10 when the date written is actually 3/1/10 |
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Term
| In addition to DATA 2000, physicians can dispense (but not prescribe) controlled substances to an individual patient who is waiting for admission to a treatment program. What are the rules for that kind of office dispensing? |
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Definition
• DATA 200 (Drug addiction treatment act of 2000)
• DATA 2000 permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act to treat opioid addiction with CIII-CV drugs approved for that purpose
• In addition to being licensed and having a DEA number the physician must meet one or more of the following conditions:
o Sub-specialty board certification in addiction psychiatry from American Board of Medical specialties
o Addiction certification from the American Society of Addiction Medicine
o Sub-specialty board certification in addiction medicine from the American Osteopathic Association
o Completed not less than 8 hours of training for management of opioid addiction
o Participated as an investigator in one or more clinical trials leading to approval of a narcotic drug for maintenance or detox treatment
o Other training or experience that demonstrates ability to treat opioid addicted patients
o Must attest that they have the capacity to refer addiction treatment patients for appropriate counseling and other non-pharmacological therapies
o Will not have more than 30 patients on such addiction treatment at any one time- applies to solo and group practice
• Physicians not registered through DATA 200 can administer or dispense but NOT prescribe a narcotic controlled substance for up to 3 days (not more than one day’s medication at a time) or until patient is admitted to treatment center to relieve withdrawal symptoms. Cannot renew or extend the 3 days. |
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Term
| DEA has designated two drugs as being acceptable for use in the DATA 2000 program. What are those two drugs? (Both trade and generic names). |
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Definition
• Subutex (buprenorphine)
• Suboxone (buprenorphine and naloxone |
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Term
| Is a pharmacist permitted to dispense the drugs specific to DATA 2000 (Q 47 above) for other legitimate reasons, such as pain therapy? |
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Definition
• Yes, once a drug is approved by the FDA, there are no federal restrictions that can control the use of the drug for other uses outside the approved indication.
• The PHYSICIANS that have a DATA 2000 DEA number are encouraged to place it on the prescriptions
o DEA number begins with X rather than A or B
• The indications are that if the pharmacist knows the Rx for either Suboxone or Subutex are for maintenance or detoxification, the pharmacist should obtain the number and place it on the Rx. |
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Term
| If a narcotic dependent patient with appendicitis enters a hospital, is the hospital permitted to continue with maintenance or detoxification already underway when admitted without being registered as a “Treatment Center”? |
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Definition
sec. 1306.07 subparagraph (c) it states "this section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drug to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts."
During the stay in the hospital for medical reasons other than addiction or withdrawal, the hospital personnel can give them support doses of narcotic drugs to prevent withdrawal during the stay. Again, this is without registration as a treatment center. There is no time limit on such treatment. (Pg. 136) |
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Term
| What is an “institutional practitioner”? |
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Definition
| • A hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy |
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Term
How is an “Emergency” defined in law - such that a telephone prescription for a C-II drug can be dispensed before receiving a legal (original) prescription? What are the pharmacist’s obligations in this situation? If a “covering prescription” is required by law, how long does the prescriber have to provide that prescription? If the prescriber does not deliver (or cause to be delivered) that Rx, what obligation is the
pharmacist under? |
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Definition
• Definition of “Emergency” as defined by law
o 1. Immediate administration of the prescribed drug is necessary for proper treatment of the patient.
• Means before the Rx could get there; Patient may be far from the doctor, Doctor may be out of town and phoning back; Does not mean “this instant”
o 2. No appropriate alternative exists, including a non‐C‐II or non‐controlled drug.
o 3. It is not reasonably possible for the prescribing practitioner to provide a written Rx prior to the dispensing.
• Obligations
o Quantity prescribed can only be for the “emergency period”
o If practitioner is unknown to pharmacist, must verify
• Look up in phone book, call back.
• Make a “reasonable effort”.
o Practitioner must deliver a “covering Rx” to the pharmacy in 7 days.
• Must be identical to the phone Rx, written by the pharmacist (except signed by practitioner)
• Must say “Authorization for emergency dispensing” on the face of the covering Rx.
• Two copies are attached together (the one the RPh wrote and the one the physician wrote),and kept for 2 years
• If postmarked within 7 days, that’s OK.
o If they do not provide an exact replica hard copy in 7 days, we are required to report it to the DEA |
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Term
| Facsimile prescriptions are a pain in the north end of a south bound yak. But (no that’s spelled right) for federal purposes, the interest is in what prescriptions for C-II drugs can be faxed to a pharmacy and retained by the pharmacy without receiving an original. Know the rules for this use of a faxed prescription, drugs permitted, patient location or status, and whatever else you can find in this rule. Note especially, hospice (terminally ill) patients, and LTCF (Long Term Care Facility) patients. |
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Definition
• The Law
o a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription
o A prescription for a Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription
o A Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for |
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Term
| Be able to describe completely the refills, partial refills, partial fills, inability to supply, and other relevant factors in the filling of controlled substances prescriptions. |
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Definition
• Rules for C2s (C3-C5 covered in #60)
• An initial partial fill can always be done – just may not be able to fill the rest of the partial
o RPh only has a few (inability to supply) – give partial fill, and complete the fill within 72 hours
o Pt only WANTS a few – fill a few, cancel rest of Rx, and notify practitioner
o Pt can only AFFORD a few – RPh has some choices
• Dispense what he can afford, complete fill within 72 hours (new from DEA)
• Dispense what he can afford, cancel the rest, notify prescriber
• Exceptions to the 72 hour completion rule
o Long Term Care Facility patients (nursing homes) OR Patient’s illness is terminal.
• Can’t see MD every day for new Rx, so better to partial fill and continue partial filling
• Often done in unit doses (ex: 1 week at a time)
• Terminally ill patients have varying requirements. (may have frequent dose changes)
• Often cannot predict when they are going to die.
• Do not want to dispense large quantities and have excess
• Rules for partial filling
• No more than the face amount.
• No dispensing past 60 days from the date of issue of the prescription.
• Keep accurate records of all dispensing |
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Term
| Know the rules regarding a practitioner who issues identical C-II Prescriptions at the same time to the same patient. |
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Definition
• 1306.12 (b) (1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to 90 day supply of a schedule II controlled substance provided the following conditions are met:
o (i) each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice:
o (ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately ) indicating the earliest date on which a pharmacy may fill each prescription:
o (iii) the individual practitioner concludes that providing the patient with multiple prescription in this manner does not create an undue risk of diversion or abuse:
o (iv) the issuance of multiple prescriptions as described in this section is permissible under the applicable state laws and
o (v) the individual practitioner complies fully with all other applicable requirement under the act and these regulations as well as any additional requirements under state law. (2) Nothing in this paragraph
• (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing schedule II controlled substances. Rather, individual practitioners must determine on their own based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so |
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Term
| What labeling is required for controlled substances? |
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Definition
• For CII-CV
• Name of dispenser
• Address of dispenser
• Name of practitioner
• Serial number of Rx
• Name of patient
• Date filled
• Directions, if any
• Cautions, if any
• Note: drug name and strength, quantity prescribed, refills, Rph initials, NDC number, phone number of dispenser are not required |
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Term
| What labeling is permitted for dose units too small to hold all the information asked for under Q 56 above? Those are unit dose, or unit of use. |
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Definition
• Must be able to identify:
o Supplier
o The product
o The patient
o “set forth” directions and cautionary statements
• Unit dose are individually labeled with drug information (name, strength, exp date, etc.)
• Pharmacist uses another method for other information. |
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Term
| There are other rules associated with the labeling of unit dose drugs concerning the day’s supply (C-II is shorter than C-3,4,5, and the drugs so labeled cannot be in the possession of the patient until administering. Look into those. |
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Definition
• For CII
o Not in possession of patient prior to administration
o Institution keeps records
o Pharmacist system complies
o Maximum of 7 days supply
• Same rules apply to unit doses of CIII-CV EXCEPT that maximum quantity supplied is 34 days supply or 100 dose units, whichever is less
• These exceptions do not apply to “bedside medications” that the patient controls |
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Term
§1306.13(c) is about computerized records for partially filling, and continuing to partially fill, C-II drugs for long term care. Nothing surprising here, if something were missing you likely would know what it was.
§1306.13(c) is about computerized records for partially filling, and continuing to partially fill, C-II drugs for long term care. Nothing surprising here, if something were missing you likely would know what it was |
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Definition
(c) Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:
(1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of the medication authorized (to include dosage, form, strength and quantity), listing of the partial fillings that have been dispensed under each prescription and the information required in Sec. 1306.13(b).
(2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.
(3) Retrieval of partially filled Schedule II prescription information is the same as required by Sec. 1306.22(b) (4) and (5) for Schedule III and IV prescription refill information. |
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Term
| On the depiction of a pharmacy label is the “No Transfer” warning. Every dispensed container of a CS has to have that EXCEPT when the label is going on a unit dose that is going to a LTCF. It makes sense, think about it for a couple of minutes. |
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Definition
| • “Caution: Federal Law Prohibits the Transfer of this Drug to Any Person other than the patient for whom it was prescribed.” |
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Term
| C3 and C4 can be refillable if authorized. Know the rules of refills, including partial filling and partial refilling. |
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Definition
• Maximum refills permitted to be authorized is FIVE (5). Partial refills add up to the total allowed.
Ex: Dispensing 15 on an Rx for 30 is NOT a refill, it is a partial refill.
• The doc cannot change the law with her pen!
• The time limit on ANY kind of filling for C3 and C4 i.e. initial, refill, partial fill, is SIX (6) months.
• The Rx can be transferred to another pharmacy (different ownership) only once and up to the number of refills authorized or 6 months, whichever comes first of remaining refills are transferred with the Rx.
➢ PARTIAL REFILLS
• They add up. An Rx for Ambien 10mg #30 with 4 refills is good for 150 tablets however the patient wants to get them. Can be dispensed all at once or 10 tablets initial fill plus 14 partial refills of 10 tablets each to give 150 total. (Pg. 147)
• Must specify the quantity if it is different than the original “face amount” written on the Rx. If not specified, it is deemed by “operation of law” to be the “face amount”
Ex: Rx written for Ambien 10mg #30. During a partial fill, must specify that 15 were dispensed, otherwise it is assumed that the full original quantity was dispensed.
• All refills must be recorded either on the back of the original paper rx or on some other uniformly maintained readily retrievable record system. (Pg. 145) |
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Term
| Can C3 and C4 prescriptions be faxed to a pharmacy? Can the fax copy be retained as the original? |
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Definition
• Prescription can be called or faxed to the pharmacy – no original needed in those cases.
• C3-C5 ; for any drug for any patient – fax serves as the original rx. (Pg 139)
• Prescription requirements are the same as CII.
• Written (including typed, laser printed, computer generated, etc.) must still be signed by the prescriber.
Note: these are not legitimate “e-prescriptions” |
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Term
| Can additional refills be added to an existing C3, C4 Rx that has already been filled but which has run out? Even though nobody ever does this, it is possible to write a question about that. |
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Definition
| Not if the rx has run out. The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five refill, six-month limitation. (Pg 145) |
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Term
| The computer rules are found among the refill rules. That is because records of refills are about as important as records get. Look over the computer rules but don’t memorize them. It’s the refills themselves that are important here. Know those. |
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Definition
1. No refills on C2
2. C3 and C4 can be refilled no more than five (5) times – and then only as authorized by the prescribing practitioner.
3. All refills must be recorded; either on the back of the original paper rx or on some other uniformly maintained readily retrievable record system.
4. Given the rx number, the following refill information must be retrievable:
- Name and dose form
- Date of fill or refill
- Quantity dispensed
- Initials of RPh for each refill
- Total number of refills for that rx.
5. If only the date and RPh initials appear, it is deemed to be a record indicating that the entire face amount (prescribed quantity) of the rx has been dispensed. Any other quantity must be recorded as such.
6. Additional refills may be authorized on an EXISTING rx in the files of the pharmacist by oral communication to the pharmacist if all the conditions listed on page 146 are met. |
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Term
| Perhaps the most frequent question received in my office regard the partial filling of C3-C5 prescriptions. Apparently, one of the software packages at one of the chain stores says partial refills are counted as full refills. That is clearly wrong. Know the rule that says they add up and they expire. And what you have to do. |
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Definition
| Partial refills are authorized and they add up. An Rx for Ambien 10mg #30 with 4 refills is good for 150 tablets however the patient wants to get them. Federally legal to be dispensed all at once or 10 tablets initial fill plus 14 partial refills of 10 tablets each to give 150 total.. Most common error made by pharmacists is thinking that each partial refill counts as a full refill. That is not the case. The amount available on the example is 150, however the patient receives them. The mistake is calling each of those as “refills” rather than the correct “partial refills”(Pg. 147). |
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Term
| What is the one difference between the rx vial label for a C2 and the other CS? |
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Definition
| “Date filled” on C2 vs.”Date of initial filling” on C3-C5. |
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Term
| The transfer of prescription information for purposes of refilling a prescription in a different pharmacy than the original or refill is a long list of things. Know the elements that make a transfer of information complete. |
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Definition
• One time only unless within a real-time, on-line database shared by the pharmacies- then multiple transfers are permitted up to the number of refills authorized or 6 months, whichever comes first
• Needs to be between two licensed pharmacists
• Write “transfer prescription” on the face
• Need pharmacy name, address, DEA (both original fill and last fill)
• Date of Rx issue, date first filled, original number of refills, refills remaining, date of last dispensing, prescription number
• Name, address, DEA number of prescriber
• Transferring pharmacist’s full name
• All other requirements to fill a controlled Rx |
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Term
| The circumstances of transfer are spelled out in the text. How many times can the information be transferred: |
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Definition
• Between unrelated pharmacies.
One-time transfer only from Pharmacy A→ Pharmacy B (including refills); cannot be transferred back to pharmacy A OR any other pharmacy.
Also, cannot transfer to multiple pharmacies (ex: cannot transfer from Pharmacy A to Pharmacies B, C, and D)
• Between pharmacies that share a common data base (usually the same chain, e.g. CVS, Walgreen, and others)
Multiple transfers are permitted up to the number of refills authorized or 6 months, whichever comes first. |
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Term
| Can a single refill be transferred to an unrelated pharmacy with the original remaining active but with a refill less? |
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Definition
| No, any remaining refills are transferred WITH the Rx |
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Term
| What controlled substances can be sold without a prescription if the pharmacist approves? |
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Definition
• A controlled substance listed in schedules 2-5 which is not a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, may be dispensed by a pharmacist w/o Rx to a purchaser at retail, provided that:
• Max 120 ml (4oz) codeine containing drug for individual purchaser (not patient) in 48 hours
• Max 240 ml (8 oz) opium containing drug to single purchaser in 48 hours
• No more than 48 dosage units of any such controlled substance containing opium
• One purchaser cannot buy more than the allotted amount for more than one patient but may sell to two different purchasers at the same time
• It doesn’t matter that the drug is for different patients…it is sold to a purchaser
NOTE: all OTC are C5, but not all C5 are OTC |
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Term
| What information must be recorded for each such sale as in #68 above? |
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Definition
Must see an ID; Patient must be 18 or older.
Must record:
1. Date of dispensing
2. Name of purchaser
3. Address of purchaser
4. Drug dispensed
5. Quantity dispensed
6. Name or initials of the pharmacist |
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Term
| What are the rules for quantity sold and time between sales? |
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Definition
| Refer to number 68 (max 120ml per 48 hours for individual purchaser; max 240ml opium containing drug per 48 hours for individual purchaser, no more than 48 dosage units containing opium) |
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Term
| Central Fill Pharmacies is easier than it looks. Pick the requirements out of the regulation printed on page 152 of the course manual. |
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Definition
• Prescriptions for C-III, C-IV, and C-Vs can be transmitted electronically from retail to central filling pharmacy (including via fax); CENTRAL FILL must be written on the face of the original prescription; name, address, and DEA number of central fill pharmacy and name of pharmacist transmitting plus the date of transmittal must also be recorded on the original prescription
o Number of refills already dispensed and number remaining must be transmitted
o Original must be maintained in retail pharmacy for 2 years from the date of filling
o Records indicating the receipt of the filled prescription, method of delivery, and name of employee accepting delivery must be kept
• The central fill pharmacy must also keep a facsimile copy or electronic record of all information transmitted by retail pharmacy, the date of receipt of the prescription, the name of the pharmacist filling, the date of filling or refilling, and the date of delivery to the retail pharmacy |
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Term
| Disposal of drugs - Form 41 (inventory of drugs surrendered for destruction) is in the book. Know the process but don’t spend much time on it. Remember, if the drugs are C-II, it is a Form 222 distribution. Remember also, the form says send the drugs to DEA - but they quit taking them years ago. Reverse Distributors do it now. |
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Definition
• Form 41 is used if the person seeking disposal is a registrant.
• If the person is not a registrant they must write a letter detailing how they got the drugs, information about the source of the drugs (who they belonged to, which pharmacy), the name and quantity of the controlled substance, and the person’s name and address.
• Drugs intended for destruction be transferred to another registrant for destruction or can be destroyed in the presence of an Indiana Board of Pharmacy Inspector (would be considered an “authorized person” by the DEA). Finally, they can be sent to a facility that only destroys controlled substances. |
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Term
| NOTE the difference between “Significant Loss” or “Any Theft”. |
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Definition
-Both need to be reported using DEA Form 106 in quadruplicate (4 copies).
-Significant loss is 10 or more tablets.
-Any theft would include burglary (theft while closed), or robbery (theft while open).
-Theft typically includes some type of threat.
-Can use the Biennial inventory to track how much was stolen.
-To find the amount stolen:
Take (Last biennial inventory number) – (Drugs dispensed on prescriptions) + (Drugs received on invoice) = should be number on hand.
Take calculated ‘number on hand’ value – actual ‘number on hand’ value for the number stolen. |
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Term
| What form is needed for reporting this? |
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Definition
| DEA Form 106 is used to report theft or significant loss. |
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Term
| Anabolic Steroids are placed in which schedule? Don’t learn the names of the drugs. |
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Definition
| Almost all anabolic steroids are in the CIII schedule. |
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Term
| Not all anabolic steroids are controlled substances. Don’t get caught with a question that says “All” are controlled, many of the animal steroids are Rx only, but not controlled. |
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Definition
Anabolic steroids are typically CIII medications. CIII medications have moderate or low physical dependency or high psychological dependency. CIII medications do have an accepted medical use in the US. Many anabolic steroids are CIII because there is the potential for abuse by athletes, and body builders.
WATCH OUT FOR THE WORD ‘ALL’ THOUGH. NOT ALL ANABOLIC STEROIDS ARE CONTROLLED SUBSTANCES. |
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