If a hospital or healthcare facility is handling controlled substances, who must they be registered with?

NC Drug Control Unit

NOTE:

Community or retail pharmacies do not have to register with the NC Drug Control unit.

If a hospital or healthcare facility is handling controlled substances, how often must they renew their registration with the NC Drug Control Unit?

Annually

T/F

In a hospital or healthcare facility pharmacy, the pharmacy must be directed by a pharmacist manager who is fully aware of and responsible for all activities involved in the preparation and dispensing of medications.

TRUE

When discrepancies occur with controlled substance counts in a hospital or healthcare facility, Pharmacist Managers must report to which of following?

I. NC Board of Pharmacy

II. DEA

III. FDA

A. I only

B. I and II only

C. II and III only

D. I, II and III

B. I and II only

How soon shall discrepancies with controlled substance counts in a hospital or healthcare facility be reported to the Pharmacy Manager?

Within 24 hours

In a hospital or healthcare facility medications are dispensed only upon receipt of a medication order. Medication Orders in a Hospital or Heathcare Facility can be in written, oral, fax or electronic form.

NINE Elements of a Medication Order.

1. Date Written
2. Patient's Name and Location
3. Medication Name
4. Medication Strength
5. Medication Dosage Form
6. Route of Administration
7. Directions for Administration
8. Discernible Quantity (30-day supply)
9. Prescriber's Signature

NOTE:

There are no restrictions on the form of medication orders. Medication orders are not prescriptions.

In a hospital or healthcare facility medications are dispensed only upon receipt of a medication order. Medication Orders in a Hospital or Heathcare Facility can be in written, oral, fax or electronic form.

What do Medication Orders in a patient's profile contain?

1. Patient's Name and Location
2. Patient's age, sex, weight, height, allergies
3. Medication Name
4. Medication Strength
5. Medication Dosage Form
6. Route of Administration
7. Directions for Administration
8. Medication Start and Discontinuance Date
9. ID of Pharmacist or Verifying Tech Entry

T/F

In a hospital or healthcare facility medications orders can be given in oral form. Oral medication orders shall be recorded immediately and signed by the physician.

TRUE

In a hospital or healthcare facility which of the following are measures that can be taken to avoid indefinite open-ended medication orders?

I. Routine monitoring of patient's drug therapy by pharmacist

II. Automatic Stop Order Policy covering those medication orders that do not specify a number of doses or duration of therapy

III. Automatic Cancellation of all medication orders after a predetermined time interval.

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

How often must healthcare facilities who credential practitioners for prescribing privileges provide the pharmacy with credentialling information for each practitioner?

Annually OR immediately if privileges are revoked

NOTE:

This lets the pharmacy know what practitioners are approved by the healthcare facility to write medication orders and see patients at that facility.

In a hospital or healthcare facility all drugs dispensed must be labeled and identified to the point of administration.

Labeling Requirements for Medications in a Hospital or Healthcare Facility:

In a hospital or healthcare facility all drugs dispensed must be labeled and identified to the point of administration.

Additional Labeling Requirements for Parenteral Admixtures:

1. Name of Drug Added
2. Amount of Drug Added
3. Expiration Date
4. Expiration Time

In a hospital or healthcare facility all drugs dispensed must be labeled and identified to the point of administration.

Additional Labeling Requirements for Compounds:

1. ID of Person who prepared compound
2. ID of Pharmacist who verified compound
3. Expiration Date (BUD)
4. Storage Requirements
5. Appropriate Packaging and Labeling for Hazardous Materials

Auxiliary Medication Inventories contain drugs and devices only in amounts to meet immediate therapeutic needs of patients.

THREE Examples of Auxiliary Medication Inventories.

1. Patient Care Unit Medications
2. Ancillary Drug Cabinet
3. Emergency Kits

NOTE:

Pharmacist manager and health care facility staff shall develop a list of drugs and devices.

An auxiliary medication inventory shall ONLY contain drugs and devices only in amounts to meet immediate therapeutic needs of patients.

The pharmacist manager in consultation with the medical staff must develop a list of drugs and devices that may be stocked in Auxiliary Medication Inventories. These drugs shall be labeled.

What are the labeling requirements for drugs contained in Auxiliary Medication Inventories?

1. Drug Name
2. Drug Strength
3. Drug Lot#
4. Manufacturer
5. Expiration Date

When medications are taken out of the Auxiliary Medication Inventory. What must be recorded after withdrawal?

1. Date of Removal
2. Name, Strength, Dosage Form and Quantity
3. Name of Patient
4. Name or ID of Person who removed drug or device

Which of the following is designed to meet the immediate therapeutic needs of patients?

I. Emergency Kits

II. Patient Care Unit Medication Inventories

III. Ancillary Drug Cabinets Inventories

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

NOTE:

Auxiliary Medication Inventories

T/F
Auxiliary Medication Inventories must be used in a hospital or healthcare facility with a pharmacy permit.

TRUE

NOTE:

The ONLY exception is when being used as an emergency kit.

T/F

In a healthcare facility setting, controlled substances may be stocked and removed from auxiliary medication inventories.

TRUE

NOTE:

Hospital or healthcare facility must make sure there is a record of these controlled substances.

Which of the following is/are TRUE regarding auxiliary medication inventories?

I. Only drugs in unit dose packaging shall be removed from the auxiliary medication inventory or from the pharmacy and administered to a specific patient in amounts to meet the needs for immediate therapeutic requirements.

II. Controlled substances may be stocked and removed from auxiliary medication inventories.

III. Drugs in auxiliary medication inventories shall be pre-labeled by the pharmacist with the drug name, strength, lot # and expiration date.

A. I only

B. I and II only

C. II and III only

D. All

D. All

Which of the following describes a mechanical system that performs functions relating to the storage, packaging, counting, labeling and dispensing of medications and collects, controls, and maintains all transaction information?

Automated Dispensing or Drug Supply Device i.e., Pyxis machine

NOTE:

Can also be used as an auxiliary medication inventory or emergency kit.

Medication orders need to be prospectively verified by the pharmacist before the nurse removes the drug from a automated dispensing device (pyxis machine).

What are THREE exceptions to this rule?

1. Override Medications
   • Medications used in an emergency.
2. Physician Controlled Medications
   • Medications administered under the direct supervision of a physician.
3. Subsequent Doses
   • Nurse can pull subsequent doses of a medication that is already verified by a pharmacist.

T/F

Automated Dispensing Devices may only be stocked by a pharmacist.

FALSE

Automated Dispensing Devices can be stocked by non-pharmacist personnel.

Automated Dispensing Devices can be stocked by non-pharmacist personnel.

Name THREE procedures that can be used for verification of stocking an Automated Dispensing Device.

1. Pharmacist conducts a DAILY AUDIT of medications placed into Automated Dispensing Device.
2. Using Bar code or Electronic Verification
   • Requires an initial and quarterly quality assurance by pharmacist.
3. Tech Check Tech (hospital pharmacies ONLY)
   • Allows a validating technician to verify other registered technicians in filling floor stock without verification from pharmacist

THREE Qualifications of Validating Technicians.

1. Registered with NC BOP
2. Certified Technician
3. Associate's Degree in Pharmacy Technology

Which of the following activities may a Validating Technician perform?

I. Stock of patient care unit medications

II. Stocking of ancillary drug cabinet inventories.

III. Stocking of automated dispensing or drug supply devices.

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

Which of the following activities may a Validating Technician perform?

I. Stock of emergency kits

II. Validate the filling of floor stock and unit dose distribution systems.

III. Prepackaging of prescription drugs within the hospital pharmacy.

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

Which of the following activities may a Validating Technician perform?

A. Prepackage medications

B. Stock Automated Dispensing Systems

C. Verify a patient-specific medication order

D. A & B

E. All of the above

D. A & B

NOTE:

Verifying a patient-specific drug order can only be done by a pharmacist.

How long shall transaction records (non-controlled and controlled medications) distributed by an Automated Dispensing Devices be kept?

3 years

T/F

Medication reuse from an Automated Dispensing Device is permissible.

TRUE

NOTE:

As long as the drug's purity, packaging and labeling have been examined, and it has been approved.

T/F

Automated Dispensing Devices must be used in a facility with a pharmacy permit.

TRUE

NOTE:

If NOT, it can ONLY be used as an emergency kit.

In Summary Describe an Auxiliary Medication Inventory.

1. Immediate Therapeutic Needs of Patients (Emergency Situations)
2. Location outside of the Pharmacy
3. Nurse pulls medication WITHOUT a prescription order (MD must provide prescription order after emergency)
4. Examples: Floor stock, Drug cabinets, emergency kits

In Summary Describe an Automated Dispensing Device.

1. Can function as an Auxiliary Medication Inventory
2. Location outside of the Pharmacy
3. MD writes a prescription order, pharmacist verifies, and nurse pulls medication and subsequent doses.
4. Examples: Pyxis and MedStation

The emergency department staff is complaining about the long time it takes the pharmacy to deliver certain medications during a code situation. Which of the following ways could the pharmacy improve their turn around time?

A. Install an Auxiliary Medication Inventory such as a drug cabinet

B. Install an Automated Dispensing Device such as a Pyxis machine

C. Both of the above

D. Neither of the above

C. Both of the above

NOTE:

Auxiliary Medication Inventory is used to meet immediate therapeutic needs, however an Automated Dispensing Device can also be used as an Auxiliary Medication Inventory.

Which of the following would be appropriate for a hospital pharmacy to install in order to quickly dispense patients' maintenance medications (i.e Metformin)?

A. Auxiliary Medication Inventory such as a drug cabinet

B. Automated Dispensing Device such as a Pyxis machine

C. Both of the above

D. Neither of the above

B. Automated Dispensing Device such as a Pyxis machine

NOTE:

This is not for the immediate therapeutic need of a patient; therefore, Auxiliary Medication Inventory would not be appropriate.

Repackaging in a Hospital or Healthcare Facility Pharmacy

T/F
Hospital or healthcare facilities must register as a "Repackager" to repacking medications.

FALSE

Hospital or healthcare facilities DO NOT NEED TO register as a "Repackager" to repacking medications.

Labeling Requirements for Repackaged Medications.

1. Generic or Trade Name
2. Drug Quantity
3. Drug Strength
4. ID of Manufacturer
5. Lot or Control #
6. Expiration Date
7. Cautionary Notations
8. Batch # (instead of manufacturer and lot #)

NOTE:

Repackaging should be performed by or under the supervision of a pharmacist.

Absence of a Pharmacist at a Hospital or Healthcare Facility

In a healthcare facility a pharmacy is not open 24 hours a day, 7 days a week, arrangements need to be made for the provision of drugs and pharmaceutical care.

What are the TWO options that the pharmacist-manager has to assure access to drugs in the absence of a pharmacist?

1. Remote Order Entry: Contract with another health care facility, pharmacy, or pharmacy
2. Authorize and train a nurse to remove the drugs from the pharmacy during the absence

In absence of a pharmacist in a hospital or health care facility a nurse may be authorized to remove drugs from the pharmacy if... SATA

A. Drug needed is not in auxiliary medication inventory'

B. "On call" pharmacist is accessible

C. Pharmacist maintains a list of authorized persons and documents the initial orientation, continuing education and quality control process.

D. Pharmacist maintains a list of restricted medications that may not be removed from the pharmacy.

A. Drug needed is not in auxiliary medication inventory'

B. "On call" pharmacist is accessible

C. Pharmacist maintains a list of authorized persons and documents the initial orientation, continuing education and quality control process.

D. Pharmacist maintains a list of restricted medications that may not be removed from the pharmacy.

Which of the following are requirements for a nurse to remove medications from the pharmacy during the times a hospital pharmacy is not open? SATA

A. Nurse must contact "on call" pharmacist for all medications removed

B. Nurse must receive adequate training for removing medications from the pharmacy.

C. All medications can be removed by a nurse from the pharmacy.

D. Medication must be pre-labeled by a pharmacist.

A. Nurse must contact "on call" pharmacist for all medications removed

B. Nurse must receive adequate training for removing medications from the pharmacy.

D. Medication must be pre-labeled by a pharmacist.

NOTE:

Drugs must be pre-labeled by the pharmacist with the drug name, strength, lot # and expiration date.

If a nurse removes a medication from a hospital pharmacy which is NOT OPEN 24 hours a day, during the absence of a pharmacist, within how many hours must a pharmacist obtain and verify a medication order?

A. 24 hours

B. 48 hours

C. 72 hours

D. 96 hours

A. 24 hours

How long shall a record of medications removed from auxiliary medication inventories or from pharmacy inventory be kept?

3 years

How often shall the pharmacist-manager verify the accuracy of the records of medications removed?

Quarterly

T/F

Supportive personnel may work in the pharmacy during the absence of a pharmacist.

TRUE

NOTE:

To perform clerical, repackaging and distributive functions. Drugs may leave the pharmacy ONLY if checked by a pharmacist.

T/F
Controlled substances cannot be stocked and removed from auxiliary medication inventories. Controlled substances cannot be removed from the pharmacy in the absence of a pharmacist.

FALSE

Controlled substances MAY be stocked and removed from auxiliary medication inventories. Controlled substances CANNOT be removed from the pharmacy in the absence of a pharmacist.

In a hospital or healthcare facility pharmacy the responsible pharmacists and pharmacy technicians for medication compounding and dispensing must be recorded and identified.

How long must these records be kept?

30 days

In a hospital or healthcare facility a Pharmacist-Manager shall document medication errors resulting from the administration of an incorrect medication or dose.

How long shall these records be kept

3 years

In a hospital or healthcare facility a Pharmacist-Manager shall retain all documents, labels, vials, supplies, substances, and internal investigation reports relating to an event where a prescription drug has caused or contributed to death of a patient.

How long shall these records be kept?

3 years

NOTE:

When a patient dies as a result of a medication error it must be reported to the NC Board of Pharmacy within 14 days

In a hospital or healthcare facility a Pharmacist-Manager shall maintain records of ordering, receiving, dispensing, or transfer of controlled substances.

How long shall these records be kept?

3 years

T/F
An automated system may be used to keep the records regarding controlled substances dispensed to patient if the original medication order and dispensing history can be immediately retrieved.

TRUE

How soon must records from a hospital or healthcare facility be available to the NC Board of Pharmacy?

Within 48 hours

T/F

All hospital records must be kept for 3 years.

FALSE

Day to day records that identify the responsible pharmacist and pharmacy technician for medication compounding and dispensing must be kept for 30 days.

Health Care Facility Emergency Departments are permissible to dispense medications to patients of emergency departments and for patients to take home.

Labeling Requirements for Medications Dispensed from ED

1. Healthcare Facility Name
2. Healthcare Facility Address
3. Healthcare Facility Phone #
4. Patient Name
5. Physician Name
6. Dispensing Date
7. Product Name
8. Directions for use
9. Precautionary Statements

Which of the following are TRUE regarding medications being dispensed from a healthcare facility emergency department?

I. A prescription needs to be issued from a practitioner.

II. Patient is required to be counseled.

III. If a 24-hour outpatient pharmacy is not available a prescription may be dispensed and is limited to not more than a 48-hour supply or the smallest commercially available quantity.

A. I only

B. I and II only

C. II and III only

D. I, II and III

B. I and II only

NOTE:

If a 24-hour outpatient pharmacy is not available a prescription may be dispensed and is limited to not more than a 24-hour supply or the smallest commercially available quantity.

An emergency department of health care facilities having 24-hour outpatient pharmacy service shall consist of drugs that meet the immediate needs of emergency department patients.

Quantities in each container shall me limited to not more than:

A. 24-hour supply

B. 48-hour supply

C. 72-hour supply

D. a weekly supply

A. 24-hour supply

How long should a Perpetual Record of all dispensed drugs be maintained with pharmacy records?

3 years

In a Hospital and Healthcare Facility Pharmacy the Perpetual Record should contain.

1. Date Dispensed
2. Patient's Name
3. Physician's Name
4. Drug Name
5. Drug Strength
6. Drug Dosage Form
7. Drug Quantity
8. Drug Dose

How often shall a Pharmacist-Manager of a hospital or healthcare facility pharmacy verify the accuracy of a Perpetual Record?

Monthly

Medication orders in health care facilities, without a quantity indicated on the order, should be limited to which of the following day supply?

A. 7 days

B. 15 days

C. 30 days

D. 60 days

C. 30 days

Long Term Care Facilities

T/F

An automated dispensing device can be installed in a LTCF by a retail pharmacy registered with the DEA.

LTCFs are allowed to have controlled substances in an automated dispensing device.

TRUE

NOTE:

ONLY if registered with the DEA. If not registered with the DEA LTCFs may not order or maintain stocks of controlled substances.

T/F

The retail pharmacy that installs the Automated Dispensing Device must maintain a separate DEA registration at the LTCF location.

TRUE

NOTE:

Retail Pharmacy may keep records of the Automated Dispensing Device at their pharmacy.

T/F
A pharmacy permit is required from the NC Board of Pharmacy in order to have an Automated Dispensing Device at the LTCF.

TRUE

NOTE:

Can apply for a Limited-Service Permit.

T/F

A pharmacy can place an emergency kit with controlled substances in a non-DEA registered LTCF.

TRUE

NOTE:

The pharmacy is responsible for the emergency kit and must be registered with the DEA. Therefore, it is considered an extension of the pharmacy and is covered under the pharmacy's DEA registration. A separate DEA registration is not needed. unlike when a pharmacy placed an Automated Dispensing Device in a LTCF that contains controlled substances.

How many controlled substances can be contained in an Emergency Kit within a LTCF?

7 Controlled Drug Entities (C-II through C-V)

• No more than 5 doses of each drug entity for each 50 licensed beds

What must be established for a LTCF nurse or employee to be an agent of the patient's prescriber?

Written agreement

LTCF Agents of a Prescriber (LTCF nurse or employee) may perform which of the following tasks?

I. Call in an emergency oral C-II prescription to the pharmacy

II. Transmit a fax prescription for all controlled (including C-II) and non-controlled substances from the prescriber.

III. Prepare a written prescription for the signature of the practitioner.

A. I only

B. I and II only

C. II and III only

D. I, II and III

C. II and III only

NOTE:

Agents of a prescriber at a LTCF can ONLY call in a prescription for non-controlled substances and CIII, CIV and CV to the pharmacy.

Nuclear Pharmacy (Not Completed)

How many hours of TRAINING must a NUCLEAR Pharmacist receive?

1. 200 hours of didactic training
2. 500 hours of training under a licensed nuclear pharmacist

Label Affixed to the Immediate INNER Container of Radiopharmaceutical,

1. Radiation Symbol
2. "Caution Radioactive Material"
3. Radionuclide and chemical form
4. Amount of radioactivity
5. Expiration date and time
6. Name of Procedure
7. Prescription Number
8. Pharmacy Name

Label Affixed to the Immediate OUTER Container of Radiopharmaceutical,

1. Radiation Symbol
2. "Caution Radioactive Material"
3. Radionuclide and chemical form
4. Name of Procedure
5. Prescription/LOT #
6. Pharmacy Name and Address
7. Prescriber Name
8. Date of Dispensing
9. Amount of Radioactivity
10. Expiration Date
11. Expiration Time
12. If liquid - Volume
13. If a gas - ampules, vials, or syringes
14. If a solid - weight
15. USP limits
16. Physician Use Only

What protects individually identifiable health information held or transmitted by a covered entity or its business associate?

HIPAA

HIPAA is also known as

Protected Health Information (PHI)

HIPAA...

I. Relates to the individuals past, present or future physical or mental health or condition

II. Identifies the individual name, address, phone number or vehicle information.

III. Includes electronic, paper or oral form

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

A covered entity must comply with HIPAA and includes health care plans, health care providers such as prescribers, pharmacies and pharmacists, and personnel that conduct transactions electronically.

What are TWO exemptions for when a covered entity may disclose Protected Health Information (PHI)?

1. Privacy Rule Permits
2. Individual or Indvidual's' Representative authorizes in WRITING

NOTE:

Personal representative is a person legally authorized to make health care decisions on individual's behalf such as a parent of a minor or a person who has power of attorney.

What are THREE exemptions for when a pharmacy can disclose Protected Health Information (PHI)?

1. Treatment: Filling prescriptions, counseling, contacting prescribers
2. Payment: Billing insurance companies
3. Operations: Quality assessment, audits, business management

NOTE:

"TPO"

HIPAA does not require that every risk of an incidental use or disclosure of PHI be eliminated.

What must pharmacies implement to prevent the disclosure of information?

Reasonable Safeguards

NOTE:

Designated areas for counseling, stand behind this line signs, using indoor voices.

When protecting patient's health information, the use of only the minimum amount of information is necessary to accomplish the intended purpose of the use, disclosure or request. Pharmacies should use the "Minimum Necessary" when possible.

What are FOUR exceptions to the "Minimum Necessary" requirement?

1. Health Care Provider for Treatment
2. Patient or Patient's Representative
3. Disclosure made pursuant to authorization by the patient
4. Disclosure that is required by law
   1. Reporting controlled substances to the prescription drug monitoring program (CSRS)

Each covered entity (including a pharmacy) must provide a notice of its privacy practices.

Which of the following are TRUE regarding Privacy Practice Notice?

I. Notice must contain several elements, concerning how the covered entity will use the patient's PHI, safeguards and grievance process.

II. Notice must be posted in a clear and prominent place.

III. Notice must be delivered to patients not later than the second service encounter.

A. I only

B. I and II only

C. II and III only

D. I, II and III only

B. I and II only

NOTE:

Notice must be delivered to patients not later than the FIRST service encounter.

T/F

A covered entity must supply Privacy Practice Notice to anyone on request and make electronically available on web site.

TRUE

T/F

Pharmacies must make a good faith effort to obtain a written, electronic or mail acknowledgement by all patients that they received the Privacy Practice Notice.

TRUE

T/F

If a patient refuses to sign the acknowledgement of Privacy Practice Notice Receipt, treatment can be refused.

FALSE

If a patient refuses to sign the acknowledgement of Privacy Practice Notice Receipt, treatment CANNOT be refused.

NOTE:

Only can be signed by the patient or the patient's personnel representative (Parent of minor or Power of Attorney)

Only required ONCE for each patient even if you update your Privacy Practice Notice.

Which of the following is TRUE regarding acknowledgement of Privacy Practice Notice when received by the patient?

I. Treatment can be refused if the patient refuses to sign the Privacy Practice Notice.

II. The reason for failing to obtain the patient's written acknowledgement must be documented.

III. Written acknowledgement is only required once for each patient.

A. I only

B. I and II only

C. II and III only

D. I, II, and III

C. II and III only

If a patient refuses to sign the acknowledgement of Privacy Practice Notice Receipt, treatment CANNOT be refused.

The acknowledgement of Privacy Practice Notice can only be signed by the patient or the patient's personnel representative (parent of minor or Power of Attorney).

If a prescription is filled for a patient and their spouse picks up the prescription and the spouse does not have Power of Attorney. How will the Privacy Practice Notice be signed?

The Privacy Practice Notice may be sent to the patient by mail to be acknowledged and signed by the patient.

A breach of PHI is defined as an impermissible use or disclosure under the privacy rule that compromises the security of the protected health information.

TWO Exceptions of a Protected Health Information (PHI) Breach.

1. Unintentional acquisition of PHI at a covered entity location OR disclosure between two individuals at the same covered entity.
2. Unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.

The pharmacy must determine if a breach occurred and document if the breach met an exclusion.

How long must documentation of a potential breach be retained?

6 years

On a federal level, following the discovery of a breach, who must be notified?

I. Individuals Affected by the Breach

II. The Secretary of DHHS

III. The Secretary of DEA

A. I only

B. I and II only

C. II and III only

D. I, II, and III

B. I and II only

On a federal level, how soon must covered entities notify affected individuals following the discovery of a breach?

Without unreasonable delay and no later than 60 days after discovery by mail or electronically

On a federal level, how soon must covered entities notify the Secretary of DHHS following the discovery of a breach?

No later than 60 days after the end of the calendar year in which the breach was discovered

On a federal level, if MORE THAN 500 individuals are affected by a breach, who must the pharmacy notify?

I. The affected individuals

II. The Secretary of DHHS

III. The media

A. I only

B. I and II only

C. II and III only

D. I, II, and III

D. I, II, and III

NOTE:

On a federal level, if MORE THAN 500 individuals are affected by a breach, how soon must the pharmacy notify individuals affected, the secretary of DHHS, and the media?

Without unreasonable delay and no later than 60 days after discovery of breach

In North Carolina a breach of personal health information requires notification without unreasonable delay to which of the following:

I. Secretary of DHHS

II. Individuals Affected by the Breach

III. North Carolina Attorney General's Consumer Protection Division

A. I only

B. I and II only

C. II and III only

D. I, II, and III

C. II and III only

In North Carolina, if a breach includes more than _________ individuals, all reporting agencies must be notified.

In North Carolina, if a breach includes more than 1,000 individuals, all reporting agencies must be notified.

Marketing is communication by telephone mail and/or email about a product or service that encourages the recipient to purchase or use the product or service.

What are FOUR exceptions to the definition of marketing?

1. Face to face communication with a patient
   • Allowed to hand patient printed information
2. Describing health related products/ service offered by the covered entity (Covered entity does not receive financial incentives/payments)
3. Contacting individuals with information about treatment alternatives, case management, or care coordination (Covered entity does not receive financial incentives/payments)
   • Physician refers patient to another physician or specialist.
   • Physician shares medical records when consulting another physician.
4. Refill Reminder Programs

Which of the following is considered marketing?

I. Communication by telephone

II. Communication by mail or email

III. Communication face to face

A. I only

B. I and II only

C. II and III only

D. I, II and III

B. I and II only

Which of the following is considered marketing?

I. A covered entity selling personal health information (PHI) to another business for that business' own purposes.

II. Describing health related products or services offered by the covered entity.

III. Handing patients printed drug information.

A. I only

B. I and II only

C. II and III only

D. I, II and III

A. I only

A covered entity may sell personal health information to another business for that business' own purposes however, a covered entity must obtain patient authorization for any use or disclosure of personal health information for marketing purposes.

What must this authorization include?

1. Description of Disclosures
2. Patient Signature
3. Date
4. Expiration Date

T/F

Covered entities must document that each employee has completed HIPAA training.

TRUE

T/F

Covered entities must develop policies and procedures and identify a privacy officer to oversee the entity's compliance with HIPAA.

TRUE

Miscellaneous Federal Pharmacy Laws

Adulterated OR Misbranded

Contains in whole/part any filthy, putrid or decomposed substance

Adulterated

Adulterated OR Misbranded

Generic or established name is not on the label.

Misbranded

Adulterated OR Misbranded

Has been prepared, packaged or held under unsanitary conditions

Adulterated

Adulterated OR Misbranded

The labeling is false or misleading in any manner.

Misbranded

Adulterated OR Misbranded

Has been manufactured under conditions that do not meet GMP standards.

Adulterated

Adulterated OR Misbranded

Quantity of container contents are not present.

Misbranded

NOTE:

Word, statement or other information not prominently placed on label as required by law.

Adulterated OR Misbranded

Medications stored in room with extreme temperatures.

Adulterated

Adulterated OR Misbranded

Manufacture, packer or distributor name and place of business not on label.

Misbranded

Adulterated OR Misbranded

Manufacture is not registered with the FDA

Misbranded

Adulterated OR Misbranded

Dispensing a prescription without a prescription or refills.

Misbranded

Adulterated OR Misbranded

Strength, quality or purity differs from compendia standards (USP).

Adulterated

Adulterated OR Misbranded

Dispensing the incorrect strength of a prescription drug.

Misbranded

Adulterated OR Misbranded

Not following regulations of the Poision Prevention Packaging Act.

Misbranded

Adulterated OR Misbranded

Failure to manufacture OTC products in tamper evident packaging.

Misbranded or Adulterated

A new OTC medication claims that it will reverse coronary atherosclerosis if taken. Upon further investigation of the FDA, the manufacturer does not have clinical data to prove this statement.

Which of the following violations have occurred?

A. Adulteration

B. Misbranding

B. Misbranding

A pharmacy dispenses nitroglycerin to a patient in a plastic vial. Nitroglycerin adheres to plastic causing a loss of potency.

Which of the following violations have occurred?

A. Adulteration

B. Misbranding

A. Adulteration

If a pharmacy dispenses Atorvastatin to a patient and the patient does not have any valid refills remaining, which of the following violations occurred?

A. Adulteration

B. Misbranding

B. Misbranding

If a marketed drug product exhibits problems, the manufacture is encouraged to issue a drug recall notice.

Class 1 Drug Recall (Most Severe)

• Drug product may cause serious adverse health consequences including DEATH.
• Recall includes stocks in pharmacies and notifying patients.

If a marketed drug product exhibits problems, the manufacture is encouraged to issue a drug recall notice.

Class 2 Drug Recall

• Drug product may cause temporary or reverse effects.
• Probability of serious adverse events is remote

If a marketed drug product exhibits problems, the manufacture is encouraged to issue a drug recall notice.

Class 3 Drug Recall (Least Severe)

• Drug product is unlikely to cause adverse health consequences.

What insulin(s) are over the counter and do not require a prescription?

1. Regular Insulin
   • Humulin R and Novolin R and Insulin NPH (Humulin N and Novolin N)

NOTE:

Prescription ONLY insulins include Regular U-500, Humalog, Novolog, Lantus and Levemir

Which Regular Insulin is prescription ONLY?

Regular Insulin U-500

All healthcare facilities are prohibited from discharging hazardous waste pharmaceuticals to a sewer system such as down a sink or flushing down a toilet. Hazardous waste includes any drug that is identified as ignitability, corrosivity, reactivity or toxicity.

Which of the following classes of drugs are prohibited from being discharged into a sewer system?

I. Prescription Drugs

II. Compounded Drugs

III. OTC and Dietary Supplements

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

What is a unit of drug not intended for sale and intended to promote the sale of the drug product?

Drug Sample

T/F

Pharmacies may receive drug samples, but are prohibited from dispensing drug samples.

FALSE

Pharmacies are prohibited from receiving and dispensing drug samples.

T/F

Prescribers do not need a pharmacy permit if they are only dispensing drug samples. Prescribers must follow all packaging, labeling and record keeping requirement laws for prescription drugs when dispensing drug samples.

TRUE

T/F
Manufactures can distribute a controlled substance drug sample to a pharmacy only after the pharmacy makes a written request.

FALSE

Manufactures can distribute a controlled substance drug sample to a PRESCRIBER only after the PRESCRIBER makes a written request.

Manufactures can distribute a controlled substance drug sample to a PRESCRIBER only after the PRESCRIBER makes a written request.

What is included in the written request for a controlled substance drug sample?

1. Name and Address of Manufacture
2. Name and Address of Practitioner
3. Name and Quantity of Controlled Substance

Manufactures can distribute a controlled substance drug sample to a PRESCRIBER only after the PRESCRIBER makes a written request.

How long must the manufacture keep the written request?

3 years

T/F
Pharmacies must provide MedWatch number to all patients on all dispensed prescriptions.

TRUE

FDA requires a pharmacy to dispense a manufacturer-provided patient package insert (PPI) to the patient.

What medications require a patient package insert?

1. Estrogen or Progestin containing products
2. Oral Contraceptives

NOTE:

Regulated by the FDA.

In a community pharmacy when is the Patient Package Insert (PPI) given to the patient?

In a hospital/institutional pharmacy when is a Patient Package Insert (PPI) given to the patient?

Community: Given with each package dispensed

Institutional Hospital: Before administration of first oral contraception and 30 days thereafter

T/F

Drug leaflets are regulated by the FDA and are required to be provided to all patients when dispensing medications.

FALSE

Drug leaflets are not regulated by the FDA and it is left up to individual pharmacies to provide for all medications dispensed.

What is given and applies to certain drugs and biological products that the FDA determines to pose a serious and significant public health concern?

MedGuides

Give FOUR examples of medications that require a MedGuide.

1. Accutane
2. OxyContin
3. Abilify
4. Ritalin

Manufactures provide the MedGuides to the pharmacy. MedGuides are required if:

I. Could help prevent serious adverse effects

II. There is a serious risk that a patient should be aware of.

III. Patient adherence to directions is crucial.

A. I only

B. I and II only

C. II and III only

D. I, II and III

D. I, II and III

What is required and ensures that the benefits of certain prescription drugs outweigh their risk?

Risk Evaluation and Mitigation Strategy (REMS)

NOTE:

Healthcare professionals and distributors may need to follow specific safety procedures prior to prescribing, shipping or dispensing the drug.

FOUR Elements of the REMS Program

1. Medication Guide (MedGuide) and Patient Package Insert
2. Communication Plan
3. Elements to Assure Safe Use (ETASU)
4. Implementation System

THREE Examples of REMS Medications.

1. Isotretenoin
2. Clozapine
3. Tranmucosal Immediate Release Fentanyl (TIRF) Products

Prescriptions must be designated to prevent unauthorized copying, erasure or modification and use of counterfeit prescriptions.

T/F

Written outpatient Medicaid prescriptions must be written on tamper-resistant prescription pads.

TRUE

What are 340B Drugs?

Medications that are provided to a contract pharmacy at a reduced cost and are dispensed to underserved and uninsured populations.

T/F

Pharmacies may only dispense 340B drugs to patients in the 340B program.

TRUE

Repackaging drugs must be in accordance with USP 795 and USP 797 and are only dispensed after receiving a prescription or medication order.

What is the Beyond-Use-Date (BUD) for repackaging a:

Non-Sterile Drug Product with an "In-Use" Time

"In-Use" Time or Expiration Date (whichever is shorter)

Repackaging drugs must be in accordance with USP 795 and USP 797 and are only dispensed after receiving a prescription or medication order.

What is the Beyond-Use-Date (BUD) for repackaging a:

Non-Sterile Drug Product NONAQUEOUS formulation (tablet or capsule):

6 months OR Expiration Date (whichever is shorter)

Repackaging drugs must be in accordance with USP 795 and USP 797 and are only dispensed after receiving a prescription or medication order.

What is the Beyond-Use-Date (BUD) for repackaging a:

Non-Sterile Drug Product Water Containing Oral Formulation (Solution or Suspensions):

14 days OR Expiration Date (whichever is shorter)

Repackaging drugs must be in accordance with USP 795 and USP 797 and are only dispensed after receiving a prescription or medication order.

What is the Beyond-Use-Date (BUD) for repackaging a:

Non-Sterile Drug Product Water Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations.

30 days OR Expiration Date (whichever is shorter)

Repackaging drugs must be in accordance with USP 795 and USP 797 and are only dispensed after receiving a prescription or medication order.

What is the Beyond-Use-Date (BUD) for repackaging a:

Sterile Drug Products with an "In-Use" Time

"In-Use" Time OR Expiration Date (whichever is shorter)

Repackaging drugs must be in accordance with USP 795 and USP 797 and are only dispensed after receiving a prescription or medication order.

What is the Beyond-Use-Date (BUD) for repackaging a:

Sterile Drug Products without In-Use Time

According to USP 797 OR Expiration Date (whichever is shorter)

EIGHT Labeling Factors of Over-the-Counter Drug Products.

1. Name of Drug Product
2. Pharmacological Category
3. Name of Manufacturer/Packer/Distributor
4. Address of Manufacturer/Packer/Distributor
5. Net Quantity
6. Expiration Date
7. Tamper Evident Labeling
8. Drug Facts Label
   • Active Ingredient
   • Inactive Ingredients
   • Purpose
   • Use
   • Warnings
   • Directions

National Drug Code (NDC) Number

How many digits are contained in an NDC Number?

11 Digits (3 Segements)

There are 11 digits and 3 segments in an NDC number. What does each segment represent?

1. First Segment: Labeler Code (Identifies Manufacturer or Distributor)
2. Second Segment: Product Code (Identifies strength, dosage form and formulation of drug)
3. Third Segment: Package Code (Identifies package size and type)

What is the Federal Anti-Tampering Act?

This act requires manufacturers to package OTC drugs in tamper-evident packaging.

Medical Devices:

Which class of medical devices requires "specific controls" to be met and includes blood pressure cuffs, syringes and percutaneous catheters?

Class II

Medical Devices:

Which class of medical devices requires manufactures to provide "general controls" during the production of the device and includes stethoscopes, bandages and crutches.

Class I

Medical Devices:

Which class of medical devices require premarket approval because the device is life-sustaining, important in preventing impairment of human health and includes pacemakers, replacement heart valves, coronary stents?

Class III

TWO USPS Mailing Requirements for Controlled Substances.

1. Must be registered with the DEA
2. Outside wrapper or packaging must be free of markings indicating a controlled substance is inside

USP 800

Describes practice and quality standards for the receipt, storage, compounding, dispensing, administration and disposal of sterile and nonsterile Hazardous Drugs (HDs).

Hazardous drugs are identified by:

National Institute for Occupational Safety and Health (NIOSH)

How often must entities review their list of hazardous drugs?

Every 12 months or when a new agent or dosage form is introduced