exam 2 review questions Flashcards
What are criteria used when determining an appropriate schedule for a substance?
Actual or relative potential for abuse
Scientific evidence of its pharmacologic effect, if known
State of scientific knowledge regarding the substance
History, scope, patterns of abuse; scope and significance of abuse
Risk to public health
Psychic or physiologic dependence liability
Whether the drug or substance is an immediate precursor of an existing controlled substance
What office has the authority to place a substance in a schedule?
U.S. Attorney General
Schedule I
- high potential for abuse
- no currently accepted medical use in treatment in the United States
- lack of accepted safety for use of the drug or other substance under medical supervision
- these substances may NOT be prescribed
- examples: LSD, PCP, marijuana, mescaline, heroin
Schedule II
- high potential for abuse
- drug or substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions
- abuse of the drug or other substance may lead to severe psychologic or physical dependence
- examples: cocaine, morphine, Dilaudid, fentanyl, amphetamine, secobarbital, pentobarbital, methylphenidate, Ritalin®, Tylox®, Demerol®, Mepergan Fortis®, (as of 2014) hydrocodone
Schedule III
- drug or substance has a potential for abuse less than those in schedules I and II
- drug or substance has a currently accepted medical use in treatment in the United States
- abuse may lead to moderate or low physical dependence or high psychologic dependence
- examples: Tylenol® with codeine #3, anabolic steroids, growth hormone
Schedule IV
- drug or substance has a low potential for abuse relative to the drugs and substances in schedule III
- the drug or substance has a currently accepted medical use in treatment in the United States
- abuse may lead to limited physical dependence or psychologic dependence relative to those substances in schedule III
- examples: Valium®, Ativan®, Ambien® **Now Tramadol (Ultram®)!
Schedule V
- drug or substance has a low potential for abuse relative to those in schedule IV
- drug or substance has a currently accepted medical use in treatment in the United States
- abuse may lead to limited physical or psychologic dependence relative to those in schedule IV
- examples: Novahistine DH®, Robitussin AC®, Lomotil®
What federal agency regulates controlled substances in the US?
DEA
Who must obtain a registration to handle controlled substances?
Every person or firm who manufactures, distributes, or dispenses any controlled substances or who proposes to engage in the same must register with the DEA (and, also in Texas, the Department of Public Safety [DPS])
In addition to the Texas State Board of Pharmacy (TSBP), what Texas agency regulates controlled substances? Who must register with this agency?
DPS- every person or firm who manufactures, distributes, dispenses, distributes, analyzes, or conducts research with any controlled substances or who proposes to engage in the same
Do pharmacists obtain individual controlled substances registrations? Why or Why not?
No, we do not obtain out own registration, we work within a registered entity.
DEA 222
Schedule II drugs require a DEA form 222 which is a triplicate form when ordering.
Which agency registration includes a waiver granting the agency the right to inspect records and the controlled premises?
DPS
DEA 224
New Application for Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner
DEA 225
New Application for Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter
DEA 363
New Application for Narcotic Treatment Programs
DEA 106
used when there is a theft or loss of controlled substances
What is the “code” for determining is a DEA registration number is valid?
Consist of nine characters – 2 letters and 7 numbers
· First letter will be either A, B, or F for a dispense, M for midlevel practitioner, P for a distributed
· Second letter is the first letter of the registrants last name
· Add 1st, 3rd, 5th digits
· Add to the above sum the sum of the 2nd, 4th, and 6th digits multiplied by 2
· The right most digit of the result should correspond with the ninth character
The DEA and DPS can inspect the pharmacy with regard to controlled substances; they can obtain samples; records not allowed to be inspected without the consent of the registrant include:
1) financial data, 2) sales data, 3) pricing data
DEA 222 form has three copies. These copies whether paper or electronic provide what three parties information regarding a transfer of Schedule substances?
Copy One: retained by supplier/distributor/wholesaler
Copy Two: sent by supplier/distributor/wholesaler to regional administrator of the DEA
Copy Three: retained by the purchaser
When an order for Schedule substances has been placed, the supplier has how long to complete the order?
A supplier must complete the shipment pursuant to an order form within 60 days; order form is void 60 days after purchaser executes form
How many NDC numbers may be ordered on a DEA 222 form?
10
Who may sign a DEA 222 form?
PIC or someone who has power of attorney
What is power of attorney and how is it used with respect to ordering Schedule II substances?
The person who signed the application for registration is the person authorized to sign the order forms OR a person with power of attorney to sign for that person. A copy of the power of attorney must be kept by the purchaser at the registered site WITH executed order forms.
Describe the process by which Schedule substances are returned to the supplier.
Pharmacist contacts distributor and request that the distributor/wholesaler issue an order form, the pharmacist “fills” the order form with the mdse. he/she is returning. The pharmacy (acting as a distributor) would retain one copy and forward one to the DEA.
Describe the process by which Schedule III, IV and V substances are ordered.
These substances are exempt from federal order form procedures (DEA 222) due to a lower potential for abuse and dependence
CII ordering steps
- An individual enrolls with DEA and, once approved, is issued a personal CSOS Certificate.
- The purchaser creates an electronic 222 order using an approved ordering software. The order is digitally signed using the purchaser’s personal CSOS Certificate and then transmitted to the suppliers. The paper 222 is not required for electronic ordering.
- The supplier receives the purchase order and verifies that the purchaser’s certificate is valid with DEA. Additionally, the supplier validates the electronic order information just like it would a paper order.
- The supplier completes the order and ships to the purchaser. Any communications regarding the order are sent electronically.
- The order is reported by the supplier to DEA within two business days
Describe the record of purchase of Schedule III, IV and V substances purchased.
-Acquisition records of these substances consist of invoices or packing slips from the wholesaler/distributor/supplier
What are lawful methods of storage of Schedule II substances in a community pharmacy?
CII’s must be stored in a secure, locked cabinet that is locked; CII’s may also be dispersed throughout the non-controlled stock in order to deter theft
Describe the action taken in the event of a loss or theft of controlled substances. What form is used? What agencies must be notified?
In the event of theft or significant loss of controlled substances: (1) notify the appropriate divisional office of DEA, the DPS and TSBP upon discovery of theft/loss, (2) Complete DEA Form 106 and provide copies to: DEA, DPS, TSBP, one for pharmacy’s records.
Form 106 is triplicate: pharmacy keeps the original copy for its records and forwards the remaining 2 copies to the appropriate DEA regional office; need to copy form and send to local state board of pharmacy (and if in Texas or other states where applicable, the state [Texas] Department of Public Safety) to notify these agencies of your actions.
Contains: (1) name and address of firm, (2) DEA #, (3) date of theft, (4) fact that local police was notified, (5) type of theft (break-in, robbery etc.), (6) list of the symbols or cost code used by the pharmacy in marking containers (if any), (7) list of the controlled substances missing through the loss of theft
Commercials containers must be labeled to clearly indicate the schedule of the substance. Describe the symbol required and the placement of the symbol on that container.
Commercial Containers must contain symbol indicating the schedule of the substance within the container (C-II, C-III, C-IV, C-V)
The symbol must be located in the upper right corner of the label in type size at least twice as large as the largest type otherwise printed on the label OR may be overprinted (similar to a watermark) in a contrasting color and in type size at least one-half the height of the label
When a legend drug product that is already on the market becomes a scheduled substance, the manufacturer has how long to update the label?
Substances added to the schedules or rescheduled must be labeled 180 days following the effective date of the scheduling.
What is the federal transfer label and what products are required to have this label?
Schedule II, III, and IV controlled substances must carry the transfer warning
Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
Which controlled substances records may not be kept at a central location?
Permission does NOT extend to: 1) executed order forms (222), 2) prescriptions, 3) inventories; these records must be maintained on the registered site at all times
What are a pharmacy’s records of purchase for Schedule II substances? Where must the records be kept and for how long?
· DEA 222
· CII records must be maintained separately including prescription files, invoices, and receipts, inventories
· Inventories and records are to be kept for 2 years from the date such inventory and records are made under federal & Texas regulations
What are a pharmacy’s records of purchase for Schedule III, IV and V substances? Where must the records be kept and for how long?
Packaging lists or invoices
CIII, CIV, & C5 records must be must be maintained separately including prescription files, invoices, and receipts, inventories
Inventories and records are to be kept for 2 years from the date such inventory and records are made under federal & Texas regulations
What are a pharmacy’s records of controlled substance dispersal? Where must the records be kept and for how long?
Prescriptions. The primary records of dispersal by a pharmacy are prescriptions; controlled substance prescriptions must be kept segregated from the other prescriptions to make then quickly and easily identifiable
How must prescriptions be filed according to federal law? What is the only lawful method of prescription filing in Texas?
· Three files: CII, CIII, CIV, CV
· Two files: CII – CV provided that CII, CIV, CV have the letter “C” no less than one inch high stamped in red ink on the lower right corner
· Two files: CII only, all others using the “Red C”
- 3 file method
Federal law requires a controlled substances inventory how often? When is the inventory taken? What is counted and by whom?
· Every 2 years following the initial inventory
· Must be taken on the anniversary of the initial inventory
· Inventory requirements
o CI or CII: exact or measure à must be counted by the pharmacist
o CIII-V: estimated count is sufficient unless the container holds greater that 1000 dosage units in which case and exact count is necessary
· Inventories must be kept at the registered location for two years
Texas law requires a controlled substances inventory how often? When is the inventory taken? What is counted and by whom? What extra measure is required for the Texas inventory that is not required for the Federal inventory?
· Every year
· Initial inventory is required to be signed by the PIC and notarized within 72 hours or 3 working days
· Annual inventory à required for all controlled substances plus all dosage forms of nalbuphine (Nubain)
o Required to be signed by the PIC and notarized within 72 hours or 3 working days
Texas law requires a controlled substances inventory at the time of a change in pharmacist in charge (PIC). Describe this process.
· On the day of change of PIC of a class A and class C pharmacy, an inventory of the following shall be taken
o Must include
§ All controlled substances
§ All dosage forms containing nalbuphine and Soma (carisoprodol) and all dosage forms containing tramadol
o This inventory shall constitute, for the purpose of this section, the closing inventory of the departing PIC and the beginning inventory of the incoming PIC
o The incoming PIC must
§ Delete name of the departing PIC on the pharmacy license
§ Enter name of the incoming PIC on the pharmacy license
§ Notify the board in writing within10 days that a change of PIC has occurred
§ If the inventory was not taken by both pharmacist, the statement must give an explanation
Inventory records must be filed and kept in the pharmacy for how long?
· 2 years
What time frame must a Pharmacist notify the TSBP when there is a change in PIC
10 days
What time frame must a Pharmacist notify the TSBP when there is a change of address of pharmacy
10 days
What time frame must a Pharmacist notify the TSBP when there is a change of address of the pharmacist
10 days
What time frame must a Pharmacist notify the TSBP when there is a change of employment of pharmacist or technician
10 days
What determines who may prescribe scheduled substances in individual states?
· The medical practice act in each individual state defines who may prescribe drugs including schedule II substances in that state. Federal Law honors these states acts
A prescription for a substance in Schedule III, IV and V must include:
- Name, address, birthdate of patient
- Address of patient
- Quantity of drug written in both numbers and text
- Signature of prescriber (unless verbal order or electronic prescription)
- Tamper-resistant paper
Prescriptions for a Schedule III, IV and V substance:
- The prescriber may allow up to 5 refills
- The prescription is only valid for 6 months from date of issuance
- The prescription may be transferred only once to another pharmacy (unless the Walgreen’s rule. Explain transfer policy between pharmacies that share a real-time computer system)
Pharmacists may dispense a ____ of a RX drugs including _____ without authorization from the practitioner?
72 hour supply
CIII, CIV. CV
Prescriptions for Schedule II Drugs (federal law)
o Must be written or electronic
o No refills on C-II substances
What constitutes an emergency situation?
o Immediate administration is necessary for patient’s care; no proper alternative treatment is available; not reasonably possible for the prescriber to present a written prescription prior to dispensing
* all 3 must be met
How many days does the prescriber have to supply hard copy of prescription after emergency fill?
7 days
How to find rules on internet
- Texas State Board of Pharmacy: http://www.tsbp.state.tx.us/
- Select: Texas Pharmacy Rules and Laws
- Select: Texas Pharmacy Laws
- Select: Texas Controlled Substances Rules
- Select: Subchapter D: Official Prescriptions
What are safety features of the Texas Official Prescription?
- Control number - Located in the uppermost portion of the form, in the bottom left position
- Pantograph - Scanning and copying produce a VOID on the face of the prescription
- Thermochromatic ink - Applying heat or vigorously rubbing the thumbprint will reveal the word SAFE
- The DPS seal
Practitioner (prescriber) responsibilities
Complete the prescription according to federal and state requirements:
• Patient’s complete name, address (including city, state, and zip code), and age or date of birth
• Controlled substance prescribed
• Quantity of controlled substance prescribed, written numerically and as a word
• Intended use or diagnosis, if not deemed detrimental to the patient’s well-being
• Dated as of the day the prescription is written (cannot be post-dated)
• Preference for brand, if necessary
What does the pharmacist do when filling a C-II prescription using the Texas Official Prescription form?
On the transmitted or mailed (very rare circumstances) prescription, indicate:
• Name, Address (including zip code), age of patient
• Official RX Control Number
• Date filled
• Pharmacy prescription number
• NDC code of the controlled substance dispensed
• Quantity dispensed, if less than the quantity prescribed (reporting prescribed quantity not required if quantity is changed)
• Pharmacy’s DPS registration number
On the pharmacy copy, indicate:
• Name of the dispensing pharmacist, with a signature
• rx number
• date (pharmacy software may provide a little sticker with date and rx number that can be placed directly on the form—-pharmacist must manually sign the prescription; no sticker or stamp can be used)
A Texas Official Prescription can be filled up to ____ from the date of issuance.
21 days
When a Texas Official Prescription is incomplete, what information is the pharmacist prohibited from supplying or changing?
- Name of the patient
- Name of the drug
- Name of the prescribing physician
- Date of the prescription
what can a pharmacist change on a CII?
Any other item, such as the strength of the drug, quantity of the drug, and directions for use providing the prescriber was notified & authorized the change
E-Prescribing
an Official Prescription form is not required when a practitioner e-prescribes a Schedule II controlled substance in accordance with Federal law. Comment: First, do not confuse e-script with submission of prescription data to Department of Public Safety. E-prescriptions are actual prescriptions that are transmitted electronically directly to the pharmacy. In the event a Schedule II substance is prescribed via e-script, a paper copy of the form is not needed. The pharmacy prints the prescription for the permanent file and has a computer record of the prescription in the computer.
Review: When Dispensing an Official Prescription, the pharmacist records on the form:
1. Dispensing pharmacist signs his/her name
2. Pharmacist dates the prescription
3. Fills in the prescription number
Electronic submission of C-II prescription in Texas
(this step is when the pharmacy communicates via computer with the Department of Public Safety to record the filling of the Scheduled prescription) Controlled substance prescription information to DPS within 7 days – Effective September 1, 2011, Senate bills 594 and 1273 state a pharmacy must transmit to the Department’s Texas Prescription Program controlled substance prescription information within 7 days after the prescription is completely filled.
DPS responsibilities
Department Responsibilities (Department of Public Safety)
· Provide prescriptions at cost to practitioners
· Securely maintain prescription records
· Respond to requests for information
Administered C-II drugs
If a doctor administers or dispenses in his office, he checks the appropriate boxes (administered or dispensed) pharmacists should not see the official prescription form in this case!
Practitioner should always sign the “dispense as written” line when administered or dispensed in his office
Practitioner sends both copies 1 and 2 to DPS (Texas Department of Public Safety): Practitioner retains copy 3 for his/her records
Procedure for when more than one drug is written on an Official Prescription
No more than one prescription can be written on one form
If the doctor has written for 2 C-II drugs on 1 form, the prescription is invalid & patient has to get 2 separate prescriptions
If the physician writes for a C-II and another controlled substance (III, IV, V) or dangerous drug, a pharmacist can “X” out the non scheduled drug and transfer it to a pharmacy prescription pad; The prescription can be filled , filed in C-II file with the appropriate copy mailed to DPS; prescription for dangerous or III, IV, V drug can be filed in appropriate file
If a physician writes for a non-schedule II drug on an official prescription form: fill the prescription, on copies 1 and 2, indicate that the drug is NOT a C-II, if a scheduled drug, indicate the schedule, if not scheduled, indicate that drug is a dangerous drug;
CII partial fills
- Pharmacist must note the fact of a partial fill on the face of the prescription giving the date and quantity dispensed
- The entire prescription must be filled within 72 hours; if the pharmacist is unable to supply the entire quantity within 72 hours, he/she must notify the prescriber and secure a new prescription
- In “Long Term Care” facilities, C-II prescriptions can be partially filled up to 60 days
What to do when prescriber is not from Texas
A pharmacy in this state may fill a prescription for a controlled substance listed in Schedule II issued by a practitioner in another state if:
(1) a share of the pharmacy’s business involves the dispensing and delivery or mailing of controlled substances;
(2) the prescription is issued by a prescribing practitioner in the other state in the ordinary course of practice; and
(3) the prescription is filled in compliance with a written plan providing the manner in which the pharmacy may fill a Schedule II prescription issued by a practitioner in another state that:
(A) is submitted by the pharmacy to the director; and
(B) is approved by the director in consultation with the Texas State Board of Pharmacy.
Can an out-of-state prescriber use the Texas Official Form?
No, Must be licensed in texas to use the TX official form
