IPPE-1 LAW QUESTIONS

1. You were recently hired as the pharmacist-in-charge of a pharmacy. The owner is not a pharmacist and is not familiar with pharmacy regulations.

a. When must you complete a Self-Assessment Form?

b. When is the next time you must complete the Self-Assessment Form again?

c. What is the purpose of the Self-Assessment Form?

d. Who must sign off on the Self-Assessment Form?

e. For how long must the Self-Assessment Form be kept in the pharmacy?

f. What are the pre-requirements that must be completed for someone to be PIC?

a. Within 30 days of a change in Pharmacist-in-Charge (PIC).

• Annually thereafter.

b. Every year before July 1

c. Evaluate pharmacy compliance with state and federal law.

• Identify deficiencies and correct them.

d. Pharmacist-in-Charge (PIC).

• Pharmacy owner/representative if required.

e. Maintain for 3 years in the pharmacy.

f. Must:

• Hold active California pharmacist license.

• Be designated PIC with Board notification.

• Complete inventory of controlled substances upon assumption of PIC duties.

2. A patient requires consultation, but the patient does not speak English, and no one on your staff speaks the patient’s language.

a. By law, what must you and your pharmacy do to prepare for these types of situations to fulfill your duty to consult?

b. By law, what are the minimum consultation points that must be included in your consultation with the patient?

a. Must provide language assistance:

• Interpreter services.

• Telephone language line.

• Translation resources.

b. Discuss:

• Drug name and description.

• Route, dosage form, dosage.

• Directions and duration.

• Special directions/storage.

• Side effects/interactions.

• Self-monitoring techniques.

• Refill information.

• Action for missed doses.

3. Your pharmacy delivers medications to patients’ homes.

a. How must you fulfill your duty to consult for medications delivered to homes?

b. How many days per week must your pharmacy offer consultation?

a. Must provide:

• Written notice of right to consult.

• Toll-free or direct pharmacist access.

b. Consultation available at least 6 days per week.

4. You were recently hired as the pharmacist-in-charge of an independent pharmacy. You have a staff of two part-time pharmacists, one full-time technician, two part-time

technicians, and two clerks. The full-time technician has worked for the pharmacy for several years and is usually the first one at the pharmacy.

a. Who is allowed to possess a key to the pharmacy?

b. If you have a limited number of keys, how are you supposed to transfer keys from person to person.

a. Who may possess a key?

• No more than 1 simultaneously: Pharmacy owner, building owner or manager or family member of pharmacist owner

• Pharmacist: can have access to controlled drug cabinet

• EXTRA KEY: PIC sig must be on seal of container so pharmacist can determine whether or not the key has been removed

b. Transfer of keys

The key cannot be handed to a pharmacy technician, intern pharmacist, or clerk to be passed on to another pharmacist, therefore the transfer of pharmacy keys must be done between an outgoing pharmacist and incoming pharmacists.

5. A staff pharmacist (who is the only pharmacist working) wants to leave the pharmacy for his lunch.

a. Is the pharmacy allowed to continue to operate during his absence?

b. If so, what operations are allowed to continue during his absence?

c. At what point must he close the pharmacy and halt all operations?

a. Yes, if pharmacist absent ≤30 minutes.

b. What may continue?

• Clerical functions.

• Sales transactions.

• Prescription pickup of previously checked prescriptions.

c. When must operations stop?

If pharmacist unavailable beyond permitted absence.

No:

• New prescriptions.

• Consultations.

• Clinical judgment activities.

6. A staff pharmacist decides to head to the back room of the pharmacy for his lunch break. Right when the pharmacist leaves, the technician tells you (a pharmacy intern) that there is a patient waiting for a consultation on a new prescription and a physician is on the phone waiting to call in a new prescription.

a. What do you do?

b. What are you allowed to do if a patient asks for a consultation on an OTC

product?

Must wait for the pharmacist to return from break if a consult is required

• No prescription medication may be provided unless it is a refill 

• Cannot perform discretionary duties

7. You are the only floater pharmacist for a busy community pharmacy.

a. You happen to have two (2) technicians working with you.

i. Can these two (2) technicians rotate between helping customers, picking up the phones, and filling prescriptions if they are not both pulling medications at the same time?

ii. What is the maximum number of technicians who can handle medications at any given time?

iii. What does the law say about technicians who are certified to perform expanded duties?

b. You happen to have three pharmacy interns (an APPE student, an IPPE student, and a paid pharmacy intern) working with you.

i. Can all three pharmacy interns, at the same time, help with filling prescriptions, counseling patients, and administering immunizations?

ii. What is the maximum number of interns who can be performing these duties at any given time?

c. What is the maximum number of clerks that can be working at any given time?

a. Two Technicians

i. Can rotate duties?

Yes.

ii. Maximum handling medications?

2 technicians per pharmacist.

iii. Expanded duty technicians?

May perform authorized expanded functions if certified.

b. Three Internsi. Can all work simultaneously?

No.

ii. Maximum?

2 interns per pharmacist.

c. Clerks

No statutory clerk ratio.

8. You are the pharmacist-in-charge (PIC) for a large regional chain pharmacy that dispenses an average of 700 prescriptions per day. You are working on the schedule for your staff. There are a few days when you have no other staff available so your staff pharmacist will be working alone.

a. What do you have to do to ensure you comply with the law?

b. Does the PIC have authority to schedule staff to assist the pharmacist?

c. Does the PIC/Pharmacist have to report unsafe pharmacy conditions to store Management?

d. What are the exceptions to the law?

a. Need To

• Ensure appropriate staffing

• PIC has authority to schedule staff to assist the pharmacist

• PIC must report unsafe pharmacy conditions

b. PIC authority?

Yes. PIC determines staffing needs.

c. Report unsafe conditions?

Yes.

d. Exceptions?

• If not supported, you have authority to operate at a reduce capacity

• If you feel patient safety will be compromised, you can enact your authority

9. A 12-year-old female drops off a prescription for Lutera birth control tablets. Later, her mother rushes to your pharmacy, demands to know what medication her daughter is getting, and wants to pick up the daughter’s prescription.

a. What should you do?

b. What if the prescription is for Zoloft (an antidepressant)?

a. Lutera (birth control)

Minor may consent to contraceptive services.

Do NOT disclose without authorization.

b. Zoloft

Is an exception to the rules so parents and guardians are PERMITTED to know information about psychotropic medications

• Can only be used with written directions from prescribing physician and strict authorization guidelines

10. A patient comes into your pharmacy with

a. A prescription for “Inderal 10 mg” tablets. You have different generic versions of Inderal by different manufacturers, along with the trade brand of Inderal 10 mg.The prescriber has indicated no restrictions such as a “Do Not Substitute” request. What is the most appropriate action for you to take?

b. A prescription for Triamcinolone 0.1% Cream #60 gm. You are out of the cream but have a 60-gram tube of Triamcinolone 0.1% Ointment. The ointment will cost the same as the cream. The prescriber has indicated no restrictions such as a “Do Not Substitute” request. What is the most appropriate thing to do?

a. Inderal

May substitute FDA-approved generic propranolol unless prescriber prohibits.

b. Cream vs Ointment

Cannot substitute dosage form.

Must contact prescriber.

11. A patient comes in with 4 new prescriptions. 2 prescriptions are out of stock, and 1 prescription is a duplicate therapy of the patient’s current medication, and 1 prescription is an emergency contraceptive.

a. Is the pharmacist obligated by law to fill every prescription the pharmacy receives?

b. What are the exceptions to this law?

c. How should the pharmacist handle a prescription that is out of stock?

a. Must pharmacist fill every prescription?

No.

• Professional judgement can determine that filling would be unlawful, unsafe, harmful / or conflicts with beliefs

• But they must ensure the patient has timely access to legally prescribed and cannot obstruct patient care

b. Exceptions

• If dispensing would be contrary to law

• Med would cause harmful drug interaction

• Would adversely affect patient medical condition

• Medication not in stock

• Pharmacist has ethical moral or religious objection

• Patient or third party doesn’t have standard payment

c. Out-of-stock prescription

• Notify patient.

• Order medication or transfer prescription when permitted.

12. A patient comes in with a prescription for Ella 30mg. The pharmacist is not comfortable filling this prescription due to personal and religious reasons. The pharmacist is the only pharmacist working this shift.

a. How should this situation be handled?

b. What should have been done so that this situation may have been prevented?

a. What should happen?

Ensure patient receives medication without obstruction.

Arrange alternative pharmacist or referral.

• MUST PROVIDE PRIOR WRITTEN NOTICE - CANNOT INVOKE IN THE MOMENT / RIGHT TO REFUSE IS CONDITIONAL, NOT ABSOLUTE

• Must receive without material delay or material burden of the patient (not the pharmacist)

b. Prevention

Employer should have policies addressing foreseeable refusals.

13. A patient presents a written prescription for Norco™, a schedule II-controlled substance.

a. What security features must you look for on the prescription to determine the prescription is not a counterfeit?

b. What must be in the prescriber’s own handwriting (in ink) on this prescription, and are there any exceptions to this law?

c. What must you do if the prescription is missing the prescriber’s signature in the prescriber’s own handwriting?

d. What must you do if the only thing that is missing is the unique serial number?

e. What if the prescription has all the required features (including the handwritten signature and date), but is missing the quantity?

a. Security features

California compliant security form:

• Latent “VOID” pattern appearing when copied

• “California Security Prescription” watermark

• Chemical void protection

• Thermochromic ink

• Opaque background preventing erasure

• Description of security features printed on form

• Quantity check-off boxes

• Statement that prescription is void if number of drugs prescribed is not noted

• Preprinted prescriber information

• Refill check boxes

• Date of origin

• DAW checkbox

• Security printer identification number

• Prescriber identifier checkbox (if multiple prescribers listed)

• Unique serialized number/barcode

• Serialized number.

• Security features preventing copying/alteration.

b. Handwritten requirements

Prescriber signature and date.

EXCEPTION FOR ORAL CII ORDER 11167 → can do emergency fill of a CII (taken as a verbal, document that it’s an authorization for an emergency)

c. Missing signature

Cannot dispense.

d. Missing serial number

Cannot dispense until corrected.

e. Missing quantity

Prescriber may authorize correction.

PRESCRIPTION REQUIREMENT

• Drug name, Quantity, Strength, Directions for use, 

• Patient information, Prescriber address and telephone number

14. You have a patient with a prescription for atorvastatin 20mg once daily #30 with 6 refills remaining. The patient wants to reduce the number of trips to the pharmacy and wants to know if you can change the quantity to #90.

a. What may you do?

b. Do you need physician authorization to make this change?

c. What if the medication was for sertraline instead of atorvastatin?

d. What if it was carisoprodol (Schedule IV controlled substance)?

a. Atorvastatin

For atorvastatin 20 mg once daily #30 with refills remaining, you may increase the quantity to a 90-day supply if:

• The patient has completed an initial 30-day supply.

• The medication is prescribed for a chronic condition.

• The total quantity dispensed does not exceed the total amount authorized by the prescriber.

• The prescription is not for an excluded drug category.

So you may dispense #90 tablets instead of #30.

b. Need authorization?

No.

Under California's 90-day conversion law, you may furnish up to a 90-day supply without obtaining prior authorization from the prescriber, provided the requirements of the statute are met.

You must notify the prescriber of the change.

c. Sertraline?

No, you may not automatically convert it to a 90-day supply under §4064.5.

The law excludes psychotropic medications.

Since sertraline (an SSRI antidepressant) is considered a psychotropic medication, you would need prescriber authorization to change the quantity to #90.

Exam answer: Cannot automatically convert; prescriber authorization required.

d. Carisoprodol?

No.

Controlled substances are excluded from California's 90-day conversion law.

Carisoprodol is a Schedule IV controlled substance, so you cannot independently increase the quantity from #30 to #90.

You would need a new prescription or prescriber authorization consistent with controlled substance requirements.

15. You are the pharmacist-in-charge when a Board inspector shows up at your pharmacy and says that:

a. Your prescription labels are out of compliance because it is missing information that should be on there for generic drugs. What information must be on this prescription label to comply with the law/regulation?

b. Your labels are out of compliance because it is missing information that should be on there when dispensing opioid medications. What information must be on this prescription label to comply with the law/regulation?

a. Generic drug labels

Must include:

• Name of drug / generic

• Name of manufacturer if generic

• Name of patient

• Direction, strength, dose, qty, expiration date indication

• Date of issue

• Name & address of the pharmacy

• RX number

• Description: color shape, clear liquid if it applies

b. Opioids

Include:

• Required opioid warning statement. “Caution: Opioid. Risk of overdose and addiction”

16. You are the pharmacist-in-charge and are tasked with figuring out what extra information needs to be dispensed with certain medications.

a. Which medications require special auxiliary labels?

b. Which medications require medication guides?

c. What type of medications require package inserts to be included when dispensing to patients?

a. Auxiliary labels

• Alerting patients of special handling warnings or instructions

• Meds that may cause drowsiness or impair driving

• Medications that need special storage (protect from light, refrigerate)

• Meds with specific admin (take with food or on empty stomach)

• Opioid meds

• Controlled with abuse potential

• Hormonal contraceptives

b. Medication Guides

• Drug has serious risks relative to benefits

• Patient adherence to instructions is crucial for drug effectiveness

• Patient has known or suspected serious condition

EXAMPLE: antidepressants (black box warning), NSAID, anticoagulants, REMS program drugs, clozapine, opioid analgesics, isotretinoin (iPLEDGE)

c. Package Inserts

Required for oral contraceptives, Isotretinoin (iPLEDGE REMS), Estrogen Containing Product (HRT, vaginal cream), IUDs

17. Late Friday evening, a patient calls your pharmacy to order a refill for Atenolol 50 mg, 1 tablet by mouth daily #30. You check the patient’s profile and see no refills remaining and the patient’s physician is on extended leave for 2 weeks.

a. What are you legally allowed to do to help the patient?

b. Does your decision change if the drug is Lorazepam 2 mg, 1 tablet by mouth daily prn anxiety # 30? If so, please elaborate.

a. Atenolol

May furnish emergency supply when interruption threatens health.

b. Lorazepam

Limited emergency dispensing allowed consistent with controlled substance rules.

when ok to refill

A prescription for a dangerous drug may be refilled without the prescriber’s authorization if they are unavailable to authorize if and if, the pharmacist's professional judgment, failure to refill the medication might interrupt the patient’s ongoing care and have a significant adverse effect on their well-being. 

• Pharmacist must notify the prescriber within a reasonable period regarding any refills dispensed under this section

can’t fill

prescription for any dangerous drug that is a controlled substance CANNOT be designated as refillable as needed

18. You are the pharmacist-in-charge of an independent pharmacy. A burglary occurs where the pharmacy is broken into, and all types of medications are stolen.

a. To whom must you report this information?

b. What must be reported?

c. How much time do you have to report?

d. What forms and/or methods must you use to report this information?

e. A week later, you suspect one of your technicians stole the controlled Substances.

i. To whom must you report this information?

ii. Within what timeframe must you do so?

iii. How must you report this information?

a. Report to:

• DEA.

• California Board of Pharmacy.

  • Report the significant medication loss and/or theft (within 30 days)

  •  14 days if theft, diversion, self-use by licensed person with the pharmacy*

b. Report:

• Report significant losses

• Controlled substance losses.

c. Timeframe (General Theft)

BOP: 30 days

DEA: 1 day (24 hours)

d. Forms

• 45 days for DEA form 106

• Board reporting procedures.

e. Employee theft

i. Report to:

• Board of Pharmacy.

• DEA

ii. Timeframe:

BOP: Within 14 days.

DEA: 1 BUSINESS day within discover of theft

iii. Method:

Written report.

General Theft

BOP: 30 days

DEA: 1 day (24 hours)

Employee of pharmacy

BOP: 14 days

DEA: 1 day (24 hours)

19. You are the pharmacist-in-charge, and you suspect one of your pharmacists drank alcohol. The pharmacist smells like alcohol when you get close to them, and the pharmacist looks very disheveled.

a. What must you do to address this with your pharmacist?

b. Must you send this pharmacist home?

c. Must you report this pharmacist?

d. If so, to whom and within what timeframe?

e. What does the law require you to have in place at your pharmacy, to deal with these types of situations?

a. What must PIC do?

Investigate and remove from duties if impaired.

b. Send home?

Yes.

c. Report?

Yes.

d. To whom?

Board of Pharmacy within 14 day time frame.

e. Required policy?

Employee substance abuse/impaired-worker procedures.

Pharmacy must have P&P to address chemical/mental/physical impairment as well as theft/diversion or self use of dangerous drugs among licensed individuals employed by or with the pharmacy

• REVIEW any work they did that day for mistakes

20. You, a pharmacist, are tasked with supervising the ordering and receiving of medications for a pharmacy. What are the requirements for ordering and receiving medications:

a. Can anyone in the pharmacy order and receive noncontrolled and controlled substances (does this differ between the different schedules of controlled

substances)?

b. Who may sign for receipt of controlled substances, and does this differ between the different schedules of controlled substances?

c. Who may sign for receipt of noncontrolled substances?

d. Who may restock controlled substances on the shelf?

e. Who is allowed to restock noncontrolled substances on the shelf?

a. Who may order?

• Non-Controlled: anyone can check in order or place order

• Schedule iii-v: ONLY LICENSED pharmacist can receive order

• Schedule Ii: ONLY licensed pharmacist can receive and check in

• Licensed pharmacist can sign for schedule ii-v

The only exception to this rule is within Section 4059.5(g), where a registered Pharmacy Technician who meet the qualifications of Section 4132 shall be able to sign off Schedule III-V drugs at a remote site. But the batch shall be set aside for a licensed Pharmacist to review and countersign off.

b. Who signs for controlled substances?

• Only licensed pharmacist can sign for receipt

• Pharm techs can NOT sign for receipt

c. Non-controlled?

Authorized employees.

d. Restocking controlled substances?

Pharmacy technicians, interns, and pharmacists can restock controlled substances on the shelf, as long as they are CIII-CV.

• For CII medications: only pharmacists are allowed to restock them, as they are usually held within a safe/cabinet that only the pharmacist has access to.

e. Non-controlled?

Can be restocked by pharmacist, intern pharmacist, pharm tech, and pharm clerk

21. A patient from another state comes into your pharmacy with a prescription. The patient is staying with their grandparents for the next two weeks but wants to fill their prescription at your pharmacy.

a. What may you do if the prescription is for Atenolol 50 mg (non-controlled), 1

tablet by mouth daily # 30?

b. What if the medication is for Lorazepam 1 mg (Schedule IV), 1 tablet by mouth

daily prn anxiety # 30?

c. What if the medication is for Adderall XR 20mg (Schedule II) 1 tablet by mouth

daily # 30?

a. Atenolol

May fill if valid.

b. Lorazepam

May fill if valid and complies with controlled substance laws.

c. Adderall XR

May fill if valid Schedule II prescription.

22. You are asked by a Board of Pharmacy inspector about dispensing verbal C-II Controlled

Substances or C-II Controlled Substances on non-compliant forms.

a. If the patient is considered terminally ill, what steps must you take before filling

the prescription and what is the definition of terminally ill?

b. How does this differ if a physician is calling in a prescription for a C-II due to an

emergency situation? What is considered an emergency situation and what

requirements must be met when dispensing this medication?

c. How does this differ if the physician is calling in a C-II due to a

government-declared state of emergency?

d. If the patient is in a licensed Skill Nursing Facility (SNF) and a physician calls in a

verbal order for a prescription for a C-II controlled substance, what steps must you take before filling this prescription and what other types of patients are

covered by this same regulation?

e. How does this differ from a prescription phoned in for a terminally ill patient or a

patient in an emergency situation?

a. Terminally Ill Patients

Must note terminal illness status.

Terminally ill: expected death within one year.

b. Emergency Situation

Emergency exists when:

• Immediate administration necessary.

• No alternative available.

• Written prescription not practical.

Follow-up written prescription required.

c. State of Emergency

Additional exceptions may apply.

d. Skilled Nursing Facility

Verbal C-II allowed.

Also applies to hospice patients.

e. Difference

Special recordkeeping and follow-up requirements.

23. You are the intern pharmacist and received an electronic prescription for carisoprodol (Schedule IV).

a. Can a prescription for C-II, C-III, IV, and/or V controlled substances be

transferred between two licensed California pharmacies?

b. How many times can you transfer a controlled substance prescription between

Pharmacies?

c. Can you transfer a prescription for a controlled substance if the medication has

not yet been dispensed at your pharmacy?

a. Can CII–CV transfer?

• CII: No transfer of refills.

• CIII–CV: Yes.

b. How many transfers?

One-time transfer unless shared real-time database permits more.

c. Unfilled prescription?

May transfer if legally eligible.

24. While on rotation, your preceptor quizzes you about medication errors.

a. What is legally considered a medication error?

b. What happens if you catch the mistake before you hand the patient the

Medication?

c. What about after you hand it to the patient but before the patient leaves the

Pharmacy?

d. What about after the patient leaves the pharmacy?

e. What must you do when you do find a medication error?

f. What are the requirements regarding Quality Assurance for the pharmacy?

g. What elements must be included in the record of the quality assurance review?

a. Definition

Any preventable event causing inappropriate medication use.

b. Caught before dispensing?

Not a medication error requiring QA review.

c. After handed but before leaving?

Medication error.

d.  After patient leaves?

Medication error.

e. Required action

Document and review.

f. QA Requirements

Continuous Quality Assurance Program.

g. QA Record Must Include

• Date.

• Description.

• Findings.

• Corrective action.

25. A.K. comes to your pharmacy to drop off a prescription for a C-II controlled substance. The prescriber wants you to dispense 60 tablets. But A.K.’s insurance only pays for 30 Tablets.

a. Is it unlawful if you decide to bill A.K.’ s insurance for 30 tablets and require cash

for the remaining tablets since you cannot refill C-II controlled substance?

b. Despite what you did in the prior scenario, A.K. comes back to your pharmacy a

few months later with a new prescription for the same medication and quantity,

but you do not have the full quantity in stock. What must you do?

c. And then a few months after that, A.K. returns to fill a prescription for the same

medication and quantity, and you have the full quantity in stock, but the patient

only wants to do a partial fill. How much time do you have to fill the remaining

portion of their prescription?

a. Insurance pays only 30 of 60

Permissible.

b.  Pharmacy lacks full stock

Remaining quantity must generally be supplied within 72 hours.

c. Patient requests partial fill

Remaining portion may be filled within 30 days of prescription issue date under federal law.

26. During a Board of Pharmacy inspection, the inspector is interviewing you regarding general record keeping requirements.

a. How many years must a pharmacy maintain records of acquisition and

disposition of dangerous drugs?

b. A medication profile must be kept as a pharmacy record for what period of time

from when the last medication was filled?

c. What are the requirements for filing controlled substances inventories and

Records?

d. What are the requirements for documenting the refills of controlled substances?

e. What record-keeping requirements apply to refills of controlled substances?

f. Should these controlled substance documents be kept separate from other

records?

a. Acquisition/disposition records

3 years

b. Patient profiles

1 year from last fill

c. Controlled substance records

Maintain readily retrievable.

d. Refill documentation

Document:

• Date.

• Quantity.

• Pharmacist initials.

e. Record requirements

Complete audit trail.

f. Separate records?

Schedule II separate; III-V readily retrievable.

27. You are asked to perform a Controlled Substance Inventory Reconciliation for the

Pharmacy.

a. How often is a complete controlled substance inventory reconciliation required

to be performed?

b. Does the schedule of the controlled substance matter?

c. Do you need to perform inventory reconciliation on non-controlled substances?

How often is a complete controlled substance inventory required to be

performed?

a. Frequency

At least every 3 months in California.

b. Does schedule matter?

No.

c. Non-controlled inventory?

Not required quarterly.

Complete controlled substance inventory:

• Biennially federally.

• Quarterly reconciliation California.

28. You are working at a California independent community pharmacy that wants to offer an automatic refill program to their patients. Since this independent community pharmacy has never offered such a program before, you must figure out how to create this automatic refill program from scratch.

a. What is required to establish an automatic refill program in any California

community pharmacy?

b. Are patients allowed to withdraw from the program if they opt in for automatic

Refills?

c. Are there any recordkeeping requirements?

a. Requirements

Patient consent required.

b. May withdraw?

Yes, anytime.

c. Recordkeeping?

Maintain documentation of consent and withdrawals.

29. While working as a pharmacist, you notice a young adult, YB, at the consultation window. YB nervously asks you if your pharmacy has any 28-gauge hypodermic needles and 3-ml syringes for sale. You check YB’s ID since YB has never been to your pharmacy. YB is 19 years old and will use these needles and syringes for self-injection.

a. Are you required by law to sell these hypodermic needles and syringes to YB?

b. If you do sell these hypodermic needles and syringes to YB, then what else must you do to comply with the law?

a. Required to sell?

No.

May sell to adults ≥18 years.

b. Additional requirements

Provide information regarding:

• Safe disposal.

• HIV/HCV prevention.

• Treatment resources.

30. A patient presents with

a. A prescription for lorazepam (Schedule IV) with the directions to “take one tablet

TID prn anxiety,” for a quantity of #90 tablets plus 6 additional refills.

i. When does this prescription expire?

ii. What is the maximum number of refills the prescriber may write for?

iii. What is the maximum number of refills the pharmacy may dispense?

b. A prescription for pregabalin (Schedule V) with the directions to “take one tablet

TID,” quantity #90 tablets with 6 additional refills.

i. When does this prescription expire?

ii. What is the maximum number of refills the prescriber may write for?

iii. What is the maximum number of refills the pharmacy may dispense?

c. A prescription for lisinopril (Non-control) with the directions to “take one tablet

daily,” quantity #90 tablets with 6 additional refills.

i. When does this prescription expire?

ii. What is the maximum number of refills the prescriber may write for?

iii. What is the maximum number of refills the pharmacy may dispense?

a. Lorazepam (Schedule IV)

• Expires: 6 months

• Prescriber may authorize: 5 refills

• Pharmacy may dispense: 5 refills

b. Pregabalin (Schedule V)

• Expires: 6 months

• Prescriber may authorize: 5 refills

• Pharmacy may dispense: 5 refills

c. Lisinopril (Non-Control)

• Expires: 1 year

• Prescriber may authorize: Unlimited as permitted

• Pharmacy may dispense: As authorized

31. After receiving and dispensing a controlled substance prescription, you remember that you still have to report this controlled substance prescription to the CURES database.

a. Which class of drug(s) must be reported to the CURES database?

b. How soon must this reporting be done?

c. What information is contained within a CURES patient activity report?

d. Does the law require you to print the CURES report and attach it to the

prescription?

a. Which drugs?

Schedules II–V.

b. Reporting deadline

Within 1 business day of dispensing.

c. Report includes

• Patient.

• Prescriber.

• Pharmacy.

• Drug.

• Quantity.

• Dates.

d. Must print report?

No.

32. A 28-year-old patient is picking up a Rx for Norco 5/325 #30. He’s from a neighboring city and has never been to your pharmacy before. You call the prescriber and the prescriber confirms that the prescription is appropriate for this patient’s back pain. The CURES report shows that this patient has picked up this same medication from 2 different pharmacies in the last month from the same prescriber. The report shows that the patient has not refilled the medication early.

a. Would you dispense this medication or not? As a pharmacist, may you avoid

dispensing a controlled substance prescription if you believe the prescription was

not issued for a legitimate medical purpose? If yes, what is the law that speaks to

this subject?

b. What is the pharmacist’s “corresponding responsibility” regarding the dispensing

of controlled substances?

c. What steps must you take to fulfill your corresponding responsibility as a

pharmacist when verifying prescriptions for controlled substances?

d. What are the “red flags” identified by the Board of Pharmacy to help you tell

whether a prescription is suspicious?

a. May pharmacist refuse?

Yes.

Authority:

• Federal Controlled Substances Act.

• 21 CFR §1306.04.

b. Corresponding Responsibility

Pharmacist shares responsibility with prescriber to ensure legitimate medical purpose.

c. Required verification steps

• Review prescription.

• Evaluate patient history.

• Review CURES.

• Contact prescriber when necessary.

• Resolve red flags.

d. Common Red Flags

• Early refills.

• Cash payments.

• Long travel distance.

• Multiple pharmacies.

• Multiple prescribers.

• High-dose opioids.

• Cocktail combinations (opioid + benzodiazepine + muscle relaxant).

• Forged or altered prescriptions.

• Suspicious behavior.

• Pattern inconsistent with diagnosis.