Pharmacy Practice Flashcards
Refill transfers: the pharmacist at a registered pharmacy who transfers original Rx information shall:
(i) write void on the front of the original hard copy
(iii) Record:
• The fact that an authorized refill of the prescription has been transferred
• the name of the patient
• the name, address, phone # of the pharmacy to which it was transferred
• the name of the pharmacist receiving the Rx information
• the name of the pharmacist transferring the information
• the date of the transfer
Refill transfers: the pharmacist at a registered pharmacy who accepts the original transferred Rx information shall record:
(i) Produce a hard copy of such info and ensure that the term “refill transfer” appears on the face of the hard copy. Must also record the following:
(ii) the name of the patient; that an authorized refill of the Rx has been transferred; the name, address, and phone # of the pharmacy from which is was transferred; the name of the pharmacist receiving the Rx info.; the name of the pharmacist transferring the info.; the date of the original Rx and most recent transfer; and the original Rx #
CE Records: Must keep for 6 years after completion
Keep five items of info. on each course for 6 years from the date you completed it: (1) title of the course or program and any ID # assigned by the sponsor (2) # of hours completed (3) the sponsor’s name and any ID # (4) verification by the sponsor of your attendance (5) the date and location of the program or course.
For oral control prescriptions, what information must be reduced to writing?
(1) Prescriber’s name, address, and DEA #. (2) Patient’s name and address. (3) Date ordered. (4) Name and quantity of controlled substance ordered. (5) Directions for use. (6) Notation indicating it is a “telephone order”
Once you receive the official NY state Rx for an oral order (must be within 72 hours) (or electronic Rx), what do you have to write on it? Note: the words “authorization for emergency dispensing” must appear on the face of the Rx
On the front of Rx:: • The words “follow-up prescription to oral order” • Prescription # • Date the oral order was filled • Your signature
On the back of the Rx:
• Follow-up prescription to order # ___ (Rx#)
• Oral order filled on ___ (date)
• follow-up Rx received ___ (date)
When a pharmacist administers an anaphylaxis treatment agent, what information must be documented?
Note: record and maintain this information in the patient’s medication profile or on a separate form
- Recipient’s name
- Date and address of administration
- Administering pharmacist’s name
- Name of the treatment, manufacturer, and lot #
What must be done after administering the anaphylaxis treatment agent?
- Contact the local EMS system or ensure equivalent follow-up care is provided
- Inform the patient’s PCP (if applicable)
Can you dispense an out-of-state prescription for a Schedule II, III, IV, or V controlled substance?
Yes, but only within the 30 days of the date the Rx was signed
Facilities with an “institutional dispenser (limited)” license must maintain a daily running record of controlled substances received that logs what information?
- Date, name, and quantity of prescribed controlled substance
- Name of prescriber
- Name of patient
- Name of pharmacy
- Serial # (Rx #) of the prescription
When a follow-up Rx for oral CII or benzo is not received within 72 hours, the pharmacist should record on the back of the oral order that “written Rx not received” with the date and name/signature of the pharmacist AND…
Notify the NYS Bureau of Controlled Substances in writing within 7 days. The DEA must also be notified, but the method and time frame are not specified in federal law.
Each time a controlled substance refill (CIII-CV) is dispensed, the pharmacist must document on the back…
Sign the actual Rx form, date it, and indicate the quantity dispensed
Each time an official New York State prescription or an out-of-state written prescription for a schedule III, IV or V controlled substance is refilled, the dispensing pharmacist shall document that the refill information entered into the computer has been reviewed and is correct by manually signing:
(i) A hard-copy printout of each day’s controlled substance prescription refill data; each pharmacist must sign and date the printout to indicate it is correct and include the refills for that day. Printouts can be long and may come from a central “computer room.” This more common in pharmacist that fill a large # of Rxs. The printout must be provided to the pharmacy within 72 hours of the date when the refills were dispensed.
(ii) a bound logbook containing a statement that the refill information entered into the computer that day has been reviewed and is correct as show.
(iii) When a prescription is received electronically, the prescription and all required annotations shall be retained electronically.
Controlled substance inventory must be taken…
every 2 years on May 1st of ODD years. Must keep inventory record on-premises for 5 years. Keep CII records separate from all other controls.
If the prescriber or employee of prescriber calls in an oral authorization to refill an RX on file, the pharmacist must write on the back of the original Rx:
The date, time, name of the prescriber authorizing refills, initials/signature as receiver of authorization. Controls may only be called in by the prescriber (not an employee).
What information must be documented in the inventory record? Note: a separate entity is required for each type of substance and package size.
- Date of the inventory
- If the inventory was taken at the beginning or close of business
- Name, strength, quantity, or volume in each container, and dosage form of each controlled substance
- Package size and # of packages
- Total content of all packages of that size on the date of the inventory
Inventory: For sealed, unopened containers of all controlled substances, an exact count is needed (just copy from package). For opened containers of controlled substances:
- All schedule I and II containers require an exact count
- Schedule III, IV, V containers holding ≤1,000 dosage units can be estimated
- Schedule III, IV, and V containers holding >1,000 dosage units require an exact count
Scheduled III-V drugs can obtained from a supplier/wholesaler by using a purchase order or through CSOS. Invoices or packing slips must contain:
- Name of each controlled substance in order
- Drug formulation (e.g. oral solution)
- # of dosage units in each container
- # of packaged ordered and delivered
A pharmacy can transfer controlled substances to another pharmacy, the original supplier or the manufacturer. A DEA form 222 or CSOS must be used to transfer schedule I and II drugs. An invoice or CSOS is used to transfer schedule III-V drugs and must contain the following information:
- Drug name, dosage form, strength, and quantity
- Date of controlled substance transfer
- Recipient’s name, address, address and DEA number
The breakage, damage or spillage of controlled substances is not considered a “loss” of controlled substances. If the breakage or spillage is not recoverable, then…
the registrant must document the incident in the inventory records, and 2 witnesses to the breakage or spillage must sign the record
Original Rxs, executed copies of Form 222, and inventory records must be kept…
on-site
Shipping and financial records can be stored…
at a central location after submitting written notification to the local DEA field office. States may also required pharmacies to request permission to store records off-site
Unless the DEA denies the request to keep records off-site, the registrant can begin storing the records at a central location…
14 days after the DEA receives this request
Upon request, the pharmacy must provide the DEA with the central records within…
48 hours
All schedule II drug records must be kept…
separate from all other records.
For in-transit losses, the pharmacy is only responsible for making the report if the registrant has already signed for the delivery and…
subsequently notices that some or all of the controlled substances are missing
Before dispensing a new Rx, or if there are changes made to an existing Rx, a pharmacist or intern providing prescription services shall be required to personally counsel on:
- the name and description of the medication and • known indications
- dosage form, dosage, route of administration, duration of drug therapy
- special directions and precautions for preparation, administration, and use by the patient
- common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur
- techniques for self-monitoring drug therapy
- proper storage
- prescription refill information
- the action to be taken in the event of a missed dose
If a patient requests access to their Rx records, how many days does the pharmacist have to comply with HIPAA?
If asked to provide a copy of an individual’s prescription records, the pharmacy must provide access to the PHI no later than 30 calendar days from receiving the request. This is an outer limit; pharmacies should respond to requests for prescription records ASAP
The pharmacy may impose a reasonable cost-based fee to provide the Rx records to the patient. The fee may only include the cost of:
- labor for copying the protected health information requested by the individual, whether in paper or electronic form
- supplies for creating the paper copy or electronic media if the individual requests that the electronic copy be provided on portable media
- postage when the individual has requested the copy, summary, or explanation be mailed
- preparing an explanation or summary of the protected health information, if agreed to by the individual
Can a pharmacy provide HIPAA information for marketing?
No, only if the patient signs an authorization form first.
How many days does the pharmacy have to comply with amending a patient’s pharmacy records if the patient asks?
60 days
When can a pharmacist release an individual’s Rx records for court cases?
- If they have received a signed court order from a judge
- if they received a subpoena issued, often from an attorney’s office. However, only if certain conditions are met. Before responding to the subpoena, the pharmacy should receive evidence that there were reasonable efforts to notify the person whose records are being sought so the person has a chance to object to the disclosure or seek a qualified protective order for the information from the court. A qualified protective order would be a stipulation by both parties that the records being sought would be used for the sole purpose of the litigation, and then either be destroyed or returned at the end of the proceedings.
What conditions must be met before responding to a subpoena requesting access to an individual’s Rx records?
The pharmacy should first receive evidence that there were reasonable efforts to notify the person whose records are being sought so the person has a chance to object to the disclosure or seek a qualified protective order for the information from the court. A qualified protective order would be a stipulation by both parties that the records being sought would be used for the sole purpose of the litigation, and then either be destroyed or returned at the end of the proceedings.
Which prescriptions require pharmacists to use child-resistant packaging?
In general, it is not required for hospital patients or patients of long-term care facilities; in these settings, the medication is not in the possession of the patient. Where the medication is to be taken in a home setting, including a personal care home, then the normal child-resistant requirements apply.
Which insulins require a Rx?
Analog insulins. Rapid-acting analog insulins include Humalog (Lispro), Novolog (Aspart), and Apidra (Glulisine). Long-acting analog insulins include Lantus (Glargine), Tresiba (Degludec), Ryzodeg (Degludec/Aspart), and Levemir (Detemir).
Which insulins are available OTC, “behind the counter”? (less costly than Rx)
Human insulin including regular and NPH insulin. Ex. Novolin R, Humulin R, Novolin N, Humulin N, Humulin 70/30, Novolin 70/30
In New York, a pharmacist should not dispense any non-controlled drug or device if the prescription is presented:
More than 1 year (365 days) after the date of issuance.
Unless an earlier refilling is authorized by the prescriber, no prescription for controlled substances shall be refilled earlier than:
7 days prior to the date the previously dispensed supply would be exhausted if used in conformity with the directions for use.
A registered pharmacist who is certified by the New York State Education Department (SED) to administer immunizations is authorized to administer immunizing agents to prevent seasonal influenza to patients:
2 years of age or older
A pharmacist shall complete a training course in the administration of immunizations within…
the 3 years immediately preceding application for a certificate of administration
What topics must be covered in a program that trains pharmacists to administer immunizations?
a. techniques for screening patients and for obtaining informed consents
b. techniques in the administration of immunizing agents
c. indications, precautions and contraindications in the use of immunizing agents
d. handling of emergencies, including the use of medications required for emergency treatment of anaphylaxis
e. cardio-pulmonary resuscitation techniques
f. recordkeeping and reporting of immunizations and information
A patient comes to a pharmacy with a prescription for Oxycontin. After processing the claim, the pharmacist finds out that he does not have enough quantity to dispense the full supply. Under this circumstance, the pharmacist may:
Reverse the claim and return the prescription back to the patient; The other option would be to supply partial quantities of the written prescription. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner.
A confidential record is privileged and a pharmacist may release a confidential record only to:
(1) . The patient or the patient’s authorized representative;
(2) . A practitioner or another pharmacist if, in the pharmacist’s professional judgment, the release is necessary to protect the patient’s health and well-being;
(3) . The board or to a person or another state or federal agency authorized by law to receive the confidential record;
(4) . A law enforcement agency engaged in investigation of a suspected violation;
(5) . A person employed by a state agency that licenses a practitioner, if the person is performing the person’s official duties; or
(6) . An insurance carrier or other third party payer authorized by the patient to receive the information
The prescription information for controlled substances shall be filed electronically with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the Department, not later than:
24 hours after the substance was delivered.
What information from controlled substance prescriptions must be electronically transmitted to the NYDOH/BNE, (Prescription Monitoring Program)?
(i) . pharmacy Rx #;
(ii) . pharmacy’s NPI #;
(iii) . patient name;
(iv) . patient address, including street, city, state, zip code;
(v) . patient date of birth;
(vi) . patient’s sex;
(vii) . date prescription filled;
(viii) . metric quantity;
(ix) . national drug code number of the drug;
(x) . number of days’ supply;
(xi) . prescriber’s Drug Enforcement Administration (DEA) number;
(xii) . date prescription written;
(xiii) . serial # of official prescription form or an identifier designated by the department; and
(xiv) . payment method
What are the prerequisites to obtaining a Certificate of Administration?
- Possess current NY pharmacist license
- Complete an approved immunization training program with the past 3 years (APhA or ACPE certified immunization course)
- Possess current CPR or BLS certification
In the event that such licensed pharmacist shall no longer have personal supervision of the pharmacy, the owner shall notify the department of such fact:
and of the name of the licensed pharmacist replacing the pharmacist named on the license and shall apply for an amended registration showing the change. The amended registration must be attached to the original registration and displayed in the same manner.
Within how many days shall the New York State Pharmacy Board be notified of any change in the identity of the SP of a registered establishment?
7 days
An oral prescription or an oral authorization for the refill of a prescription for the drug, other than a controlled substance, may be communicated by an employee of the prescribing practitioner.
True. The pharmacist receiving such oral authorization for the refill of a prescription shall write on the reverse side of the original prescription the date, time, and name of the practitioner authorizing the refill of the prescription.
An oral prescription or an oral authorization for the refill of a prescription for the drug, other than a controlled substance, may be communicated by an employee of the prescribing practitioner; provided however the pharmacist shall:
i. contemporaneously reduce such prescription to writing;
ii. dispense the substance in conformity with the labeling requirements applicable to a written prescription; and
iii. make a good faith effort to verify the employee’s identity if the employee is unknown to the pharmacist.
A pharmacist receives a new prescription for Tylenol No.3. The prescription reads: 1 tablet PO QD. Qty:60
Refill: 5
According to New York State Pharmacy Law, what will be the maximum quantity of the drug may a pharmacist dispense to a patient during the life of the prescription?
When the initial prescription is written for a quantity of substance in excess of a 30-day supply, the prescription may only be refilled once.
The Rx is written for a quantity 60 (more than 30 day supply based on direction 1 tab po qd). Since the Rx may only be refilled once; the maximum dispense quantity during the life of the prescription shall be 120 tablets.
When there is a class I recall of a Rx drug, pharmacies shall make a reasonable attempt to notify all patients that have been prescribed and who are currently taking such recalled drug dispensed from such pharmacy by…
phone or mail within 72 hours of the pharmacy being notified by the FDA, manufacturer, a wholesaler, or by other notice of such recall.
If upon presentation of the prescription, the pharmacist or pharmacy intern determines that the prescription is a prescriber-approved alternative drug, the pharmacist or pharmacy intern shall meet include with each Rx…
a written notification that clearly advises the patient that a prescriber-approved alternative drug has been dispensed, the directions for the use of such drug, and the availability of counseling on the drug.
The pharmacist or pharmacy intern shall make a reasonable effort to contact the patient or person authorized to act on behalf of the patient by telephone in order to personally offer counseling to that person about the prescriber-approved alternative drug. A reasonable effort shall mean…
at least 2 attempts to reach the patient or person authorized to act on behalf of the patient through telephone calls placed to such person by 48 hours after mailing or delivering the prescription. Must document such efforts, or if the patient doesn’t have a phone, or does not wish to be contacted by phone.
A pharmacist may fill a generic drug for a prescribed brand name unless the prescriber has…
written by hand or electronically, “DAW” in the box provided on a prescription. *No stamp or impression or preprint letter DAW is allowed.
Pharmacists or pharmacy interns shall conduct a prospective drug review before each Rx…
is dispensed or delivered to a patient or person authorized to act on behalf of the patient. Such review shall include screening for potential drug therapy problems due to therapeutic duplication, drug-drug interactions, including serious interactions with over-the-counter drugs, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.
A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver…
refuses such consultation and such refusal is documented in the records of the pharmacy.
For a prescription that is delivered to a patient by a mail or carrier, which of the following is/are true?
I. Must include a written offer to counsel the patient with each Rx.
II. The written offer to counsel shall provide a telephone # at which a licensed pharmacist or pharmacy intern may be readily reached.
III. For pharmacies engaged primarily in the mail order delivery of prescriptions, that telephone number shall be toll-free for long-distance calls.
In NY, patient-specific medication labels must contain the following information:
(i) the pharmacy name and address
(ii) the date prepared
(iii) the Rx serial number
(iv) the name of the prescriber
(v) the name and address of the patient
(vi) the drug name, manufacturer, and strength
(vii) the directions for use
Who may orally prescribe or authorize a refill for one or more hypodermic syringes or hypodermic needles?
a practitioner, a health care professional in an RHCF, or an employee of the prescribing practitioner.
The pharmacist shall make a good faith effort to verify the identity of such a person.
In an emergency, a practitioner may orally prescribe and a pharmacist may dispense, to an ultimate user, syringes and hypodermic needles, provided, however, the pharmacist shall…
(i). contemporaneously reduce such oral prescription to a written memorandum indicating the name, address and phone number of the prescriber, name and address of the ultimate user, date on which the hypodermic needles and/or syringe was ordered, quantity prescribed, directions for use, and the fact that it is a telephone order;