Pharmacy Operations Flashcards
(105 cards)
1
Q
Board’s vision statement:
A
“Healthy Californians through quality pharmacist’s care”
2
Q
The Board is elects a…. and includes how many members?
A
President, vice president, and a treasurer. The board may appoint an executive officer, who may (or may not) be a board member. 13 members, each of whom serves 1 or 2 four-year terms.
3
Q
Pharmacists, interns, pharmacy technicians, and pharmacy technician trainees must wear:
A
Name tags when at work, in 18-point type, that contain their name and license status
4
Q
All licensees must also join…
A
the board’s email notification list within 60 days of becoming licensed
5
Q
Each pharmacy must have a pharmacist-in-charge (PIC) who is responsible for the daily operations of the pharmacy and has the authority to make sure the pharmacy is compliant with both federal and state law. The PIC can supervise…
A
up to 2 pharmacies, as long as they are within 50 driving miles of each other
6
Q
Any change of PIC must be reported by the pharmacy and the departing PIC to the board in writing within…
A
30 days
7
Q
The PIC must complete a biennial (ie, every other year) Self-Assessment form for their pharmacy…
A
before July 1st of each odd-numbered year (eg, by July 1, 2021, then again by July 1, 2023)
8
Q
An additional Self-Assessment form must be completed within 30 days if a new permit is issued, and when the pharmacy…
A
has a new PIC, or moves to a new location
9
Q
Each Self-Assessment form will be kept in the pharmacy for…
A
3 years
10
Q
The Self-Assessment form is not sent to anyone, but if the pharmacy is visited by an inspector…
A
they will need to produce the form and the inspector will compare the actual situation in the pharmacy to what is on the form
11
Q
To be a licensed pharmacist, a candidate must have:
A
- Reached the age of 18 years or older
- Graduated from an Accreditation Council for Pharmacy Education (ACPE)-accredited school of pharmacy or be a graduate of a foreign school of pharmacy and be certified by the NABP’s FPGEC
- Completed at least 150 hours of semester college credit, 90 of which must be from a pharmacy school. The candidate must also have earned at least a baccalaureate degree in a course of study devoted to pharmacy.
- Completed 1,500 hours of pharmacy practice experience.
- Candidates who graduated from an ACPE-accredited school of pharmacy after January 1, 2016 are deemed to have satisfied the pharmacy practice experience hours.
- Foreign graduates and those who graduated before January 1, 2016, must complete 1,500 intern hours within the U.S. A Pharmacy Intern Hours Affidavit is required and must document experience in both community and institutional settings.
- Passed the NAPLEX and CPJE. A person who has failed the CPJE 4 times will need to enroll in an ACPE-accredited school of pharmacy in order to complete 16-semester units of additional coursework in pharmacy.
- Passed a criminal background check.
12
Q
Under California law, all registered pharmacists (RPhs) can provide the following services after meeting certain training requirements:
A
- Administer drugs and biologics when ordered by a prescriber. Previously, pharmacists were allowed to give only oral and topical drugs. They can now give drugs by other routes, including by injection.
- Provide consultation, training, education about drug therapy, disease management, and disease prevention.
- Participate in multidisciplinary reviews of patient progress, which includes appropriate access to medical records.
- Furnish self-administered hormonal contraceptives, which include oral formulations (BC pills), transdermal (patch), and vaginal (ring) preparations and injections.
- Furnish travel medications recommended by the CDC and which do not require a diagnosis.
- Furnish Rx nicotine replacement products for smoking cessation, including the inhaler (such as Nicotrol) and the nasal spray (such as Nicotrol NS).
- Independently initiate and administer immunizations recommended by the CDC to patients 3 years of age and older. A physician protocol is still required to give immunizations to children younger than 3 years old.
- Order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies, in coordination with the patient’s PCP for the diagnosing prescriber.
13
Q
In order to ensure that pharmacists are up-to-date with new drug changes and tx guidelines, 30 hours of CE must be completed during…
A
each 2-year license period
14
Q
For license renewals on or after July 1, 2019, at least 2 hours of…
A
pharmacy law and ethics must be included with each renewal
15
Q
The license expires on…
A
the last day of the pharmacist’s birth month
16
Q
The first 2-year license cycle is exempt from:
A
CE requirements since the pharmacist is considered up to date
17
Q
The certificate of completion of CEs must be kept for…
A
4 years
18
Q
Pharmacists must disclose (on the renewal form) if any government agency issued disciplinary action against any of their licenses that resulted in…
A
a restriction or penalty being placed on the license (such as revocation, suspension, probation, public reprimand or reproval). Pharmacists must disclose on the license renewal form if they have been convicted of any violation of law, except for traffic violations that do not involve alcohol or controlled substances. Electronic fingerprints must be on file with the board.
19
Q
It is common in smaller pharmacies for there to be… only one pharmacist on duty, and if the pharmacist leaves for a break, there will be no pharmacist present. In such a case. the pharmacist can…
A
- leave the pharmacy for breaks and meal periods for up to 30 minutes.
- The pharmacy can stay open and the pharmacist does not need to stay in the pharmacy area during the break.
- The ancillary staff can stay in the pharmacy if the pharmacist believes that the drugs and devices will be secure when he or she is gone.
- During this time, the staff can continue to perform “non-discretionary” duties such as those that do not include making decisions that require clinical judgment.
20
Q
Interns cannot counsel patients when there is no pharmacist to supervise them. Any duty performed by other staff members must be reviewed by the pharmacist upon his or her return to the pharmacy. When the pharmacist is away, staff may only…
A
refill medications that the pharmacist has already checked and do not require patient counseling.
21
Q
A law passed in 2018 prohibits a community pharmacy from requiring a pharmacist to work alone. It requires that…
A
another employee of either the pharmacy or the establishment is made available to assist the pharmacist at all times, with some exceptions.
22
Q
The maximum #s of staff that a pharmacist can supervise are as follows:
A
- Interns: 2 per pharmacist
- Technicians, Community Setting: the first pharmacist may supervise 1 technician; each additional pharmacist may supervise 2 technicians
- Technicians, Hospital Settings: 2 per pharmacist
- Technician Trainees: 1 per pharmacist for a 120-140 hour training period; if the trainee’s externship involves a rotation between community and hospital pharmacy, the externship can be up to 340 hours in total
- Clerks: no limit (a reasonable #, at each pharmacist’s discretion)
23
Q
The advanced practice pharmacist (APh) license enables pharmacists to provide clinical settings in various settings. The role of an APh is similar to that of clinical pharmacists in a hospital or ambulatory care setting. Historically, and in the absence of provider status, clinical services have been performed under a CPA or protocol. APhs can:
A
- Perform patient assessments
- Order and interpret drug therapy-related tests in coordination with the patient’s PCP or with the diagnosing prescriber
- Refer patients to other healthcare providers
- Participate in the evaluation and management of disease and health conditions in collaboration with other healthcare providers
- Initiate, adjust and discontinue drug therapy pursuant to an order by a patient’s treating prescriber and in accordance with established protocols.
- If the APh is starting or adjusting a controlled substance, the APh must be registered with the DEA
24
Q
In order to be recognized as an APh, a pharmacist must meet 2 of the 3 following requirements:
A
- Earn certification in a relevant area of practice such as ambulatory care, critical care, oncology pharmacy, or pharmacotherapy
- Complete a postgraduate residency program
- Have provided clinical services to patients for one year (and at least 1,500 years) under a CPA or protocol with a physician, and APh, a pharmacist practicing CDTM or within a health system.
25
In order to maintain the APh designation, the pharmacist must...
pay a renewal fee and provide proof of completion of 10 hours of CE per cycle. These hours are in addition to the 30 hours required for the pharmacist license. The APh is exempt from the CE requirement in the first renewal cycle.
26
An intern pharmacist can perform almost all functions of a pharmacist at the discretion and under the supervision of a pharmacist. An intern pharmacist cannot...
have a key to the pharmacy. All prescriptions filled by an intern pharmacist must be checked by a pharmacist before dispensing.
27
In order to be registered as an intern pharmacist, the candidate must meet one of the following requirements:
* Be currently enrolled as a student in a pharmacy school that is ACPE-accredited or which is recognized by the board.
* Be a graduate of a school of pharmacy that is ACPE-accredited or which is recognized by the board and who also has an application pending to become licensed as a pharmacist in California.
* Be a graduate of a foreign pharmacy school who has obtained certification from NABP's FPGEC. This is obtained after passing an English competency test and the Foreign Pharmacy Graduate Equivalency Exam (FPGEE).
28
In hospital settings, pharmacy technicians who have received specialized training can participate in a....
tech-check-tech (TCT) program. After a tech has finished filling or replenishing the unit-dose distribution system, floor stock or ward stock, another tech can check the accuracy of the work (THEY CANNOT APPROVE MEDICATIONS ORDERS). The TCT program is permitted only in acute care hospitals that have an ongoing clinical pharmacy program, and which have the pharmacists locate in the patient care areas.
29
A pharmacist must check compounded and repackaged drugs before a tech uses them to fill unit-dose distribution systems and floor/ward stock. The pharmacy must have a description of the hospital's clinical program on file before starting a TCT program. The PIC will need to carefully monitor the program to...
ensure that the requirements outlined in the hospital's TCP P&Ps are in place. A pharmacy tech assigned to this activity must have received specialized training, which will be outlined in the TCT P&Ps.
30
An individual can become licensed as a pharmacy tech if he or she is a high school graduate or possesses a general educational development (GED) certificate equivalent, and meets any one of the following requirements:
* Obtained an associate's degree in pharmacy technology
* Completed a course of training specified by the board
* Graduated from a school of pharmacy recognized by the board
* Completed a board-approved certification program accredited by the National Commission for Certifying Agencies including the Pharmacy Technician Certification Board (PTCB) and the National Healthcareer Association (NHA) programs
31
A pharmacy technician trainee is a person who is required to complete an externship as part of their educational program to become a pharmacy technician. The purpose of the externship is to gain practical training experience. The externship can be up to a total of...
340 hours, with not more than 140 hours in any single rotation. The trainee will be able to perform non-discretionary tasks, which must be under the direct supervision of a pharmacist.
32
A non-licensed person (clerk/typist) can type a Rx label and enter Rx information into a computer, and request and receive refill authorizations. A clerk is not allowed to pull drugs from the shelf or refill Rx medications. However, clerks can...
put drugs on the shelf and give patients their Rxs at the point of transaction. There are no max limits on the number of clerks allowed to be in the pharmacy at one time. THere can be as many clerks as the pharmacist feels comfortable supervising.
33
The board contracts with Maximus, Inc. to provide a confidential assessment, referral, and monitoring services for the Pharmacists Recovery Program. The purpose of the program is to...
evaluate the drug abuse and/or mental illness, develop a tx plan, monitor progress, and provide support. The individual receives help to recover and, if possible, returns to practicing pharmacy.
34
The Pharmacy Recovery Program accepts referrals on a voluntary basis. ANy pharmacist or intern in California who is experiencing alcohol or drug abuse or mental illness can seek assistance by contacting a 24-hour toll-free number. All voluntary requests for information and assistance are confidential and are not subject to discovery or subpoena. Family, friends, employers, and colleagues are encouraged to contact the program for assistance. If a pharmacist suspects another pharmacist is impaired at work, they must report this to board within...
14 days
35
Board inspectors assess if pharmacists are compliant with federal and state laws and regulations. The pharmacy can face disciplinary actions if legal requirements are not met, including completion of the Self-Assessment form. An action plan must be noted to correct any non-compliance. The form is not sent anywhere but is kept on file in the pharmacy in case an inspector wants to see it. There is a Self-Assessment form for different practice settings:
community pharmacy/hospital outpatient, compounding, and hospital inpatients
36
The board has requirements for the pharmacy practice site, which include:
* An unobstructed area of adequate size for the safer practice of pharmacy
* A sink with hot and cold running water
* A readily accessible restroom
* A suitable area for confidential patient consulation
* Safeguards in place to prevent the theft of drugs and devices
* The pharmacy premises, fixtutres, and equipment must be kept in a clean and orderly condition, properly lighted and free from rodents and insects
* The original board-issued pharmacy license and the current renewal must be posted where they can be clearly read by the public
37
If a pharmacy compounds sterile drugs, additional requirements state that:
* The pharmacy maintains written documentation regarding the facilities and equipment necessary for safe and accurate compounding, including records of certification of facilities or equipment, if applicable
* All equipment used to compound drug products is stored, used, and maintained in accordance with the manufacturer's specifications
* All equipment used to compound drug products is calibrated before use to ensure accuracy
* Documentation of each calibration is recorded in writing and kept in the pharmacy
38
Only a pharmacist can have a key to the pharmacy. Other pharmacy staff, including interns, are not...
permitted to possess a key. One extra key may be kept by the pharmacy owner, or building owner, or managed in a tamper-evident container for the purpose of delivering the key of a pharmacist or providing access in case of an emergency.
39
Security systems should include protection against outside and inside theft, including theft of electronic information and patient records. Pharmacies should install an...
alarm system, security cameras, "panic' buttons, and adequate exterior lighting (and leave lights on after closing). There should be at least 2 employees on the premises during opening and closing. Staff members should be alert to suspicious activity and pay attention to anyone who appears to be loitering, both inside and outside of the store.
40
Each pharmacy should have a Policy and Procedures (P&P) manual. A policy is a course of action for a specific activity, and the procedure (written into the policy) includes the steps that must be carried out by the staff. For example, the pharmacy's Quality Assurance P&Ps would outline the steps involved in conducting a quality assessment in order to reduce medication errors. The manual can protect the pharmacy in case of litigation and may be required for state or insurance reimbursement.
41
Records for drug acquisition (eg, invoices) and disposition records (eg, Rx records, chart orders) are kept for...
3 years
42
All schedule II drug records and inventories are kept separate from all others. Pharmacists are responsible for maintaining records and reporting to the board in compliance with legal requirements, as listed in the table (pg. 16).
43
Hospital pharmacy chart orders for controlled substances must be maintained for:
7 years
44
Patient acknowledgment of HIPAA forms and transaction info./history/and statement for most Rx drugs as required under the Drug Supply Chain Security Act must be maintained for:
6 years
45
Completion of continuing education certifications must be maintained for at least...
4 years
46
Forms that must be stored for 3 years include:
* Community or clinic pharmacy Rxs
* Hospital pharmacy chart orders for non-controlled drugs
* Quarterly schedule II controlled substances inventory (state requirement)
* DEA Forms 222, CSOS records, power of attorney forms
* Purchase invoices for all Rx drugs
* Self-Assessment forms
* Documentation of transfers or sales to other pharmacies, licensees, and prescribers
* Theft and loss reports of controlled substances (DEA Forms 106)
47
Per federal law, biennial controlled substances inventory forms and pseudoephedrine, ephedrine, phenylpropanolamine, norpseudoephedrine sales logs must be stored for...
2 years
48
Patient medication profiles and medication error/quality assurance reports must be stored for...
1 year from the time the drug was last dispensed
49
Within 30 days, reporting is required in the event of:
* Change of pharmacist address or name
* Change of pharmacist-in-charge (PIC)
* Changes in the pharmacy permit
50
Within 14 days, reporting is required in the event of:
• theft by or impairment of a licensee
51
In the event of theft of controlled substances, report to the DEA...
immediately (within one business day) and report to the California Board of Pharmacy within 30 days
52
In the event of bankruptcy, insolvency, and receivership, report to the board...
immediately
53
A self-assessment form must be completed...
* every odd-numbered year before July 1st
| * within 30 days, when there is a new pharmacy permit, or change in PIC, or a change in pharmacy location
54
Pharmacist continuing education (30 hours) must be completed...
every 2 years (except for the first cycle)
55
Per the state requirement, schedule II controlled substances inventory must be completed...
every 3 years (quarterly)
56
A medication error investigation must be completed...
• within 2 days of the error
57
Within 1 business day of dispensing any schedule II-V drug, dispensing data must be submitted to...
CURES
58
Pharmacies have 2 options for filing paper Rx records:
• Option 1: 3 separate files (one file for schedule IIs, one file for schedule III-Vs, and a file for all non-controlled drugs)
• Option 2: 2 files (one file for schedule IIs, and one for all other drugs dispensed
If option 2 is used, a red "C" must be stamped at least one inch high so the scripts are readily retrievalbe. The red "C" requirement is waived if the pharmacy has an electronic Rx recordkeeping system, which can identify controlled drugs by Rx number.
59
Before opening a new pharmacy, there must be a complete inventory of all controlled substances. If there is no stock of controlled substances on hand, the record should show a zero inventory.
60
The federal requirements to conduct an inventory al all controlled substances (schedules II-V) on a biennial basis (every 2 years). In addition, the California requirement is to conduct a schedule II inventory at least...
every 3 months (quarterly). In addition to the quarterly inventory, a new PIC must complete an inventory within 30 days of their appointment. It is recommended that the outgoing PIC also conduct an inventory.
61
The DEA Controlled Substances inventory includes:
• A physical count, not an estimate, of all schedule II controlled substances. The biennial federal inventory can count as one of the state inventories for the year in which it was taken.
• A review of all acquisitions and dispositions. This means that all schedule II drugs that came into the pharmacy (eg,
from wholesaler deliveries) and all that went out (eg, Rxs, sales to other pharmacies/clinics) should be compared to see if the current inventory count corresponds correctly. If not, the cause of any discrepancies should be identified.
62
Pharmacies must maintain inventory records at each location. Hospital pharmacies must conduct an inventory both...
within the pharmacy and complete a separate report for each satellite location
63
The inventory records of schedule II drugs must be kept separate from all other controlled substances. However, there is no requirement to...
submit a copy of the inventory to the DEA
64
If a pharmacist suspects a loss of Controlled Substance inventory, the inventory must be taken...
ASAP to confirm the loss. Losses and known causes must be reported to the board within 30 days of discovery (when the loss was found) or within 14 days if theft, use, self-use, or diversion by a board licensee is the cause. If the cause is unknown, the pharmacy must further investigate to identify if and take corrective action to prevent additional losses.
65
Inventory is counted at either the beginning or close of business. Inventory is not performed during business hours because it will change as medications are dispensed. The records must be in a written, typewritten, or printed format. Inventory taken with a recording device must be reduced to writing promptly. The final form must be on a paper and must contain:
* Date of the inventory and when it was taken (i.e. at the beginning or close of business)
* Names of controlled substances, dosage forms, and strengths
* Number of dosage units or volume in each container (see comment below for how to count)
* Number of commercial containers (the type of container the drug came in from the supplier)
66
If a drug becomes scheduled or changes schedules, pharmacies must inventory newly scheduled drugs on the date...
the scheduling became effective.
67
When conducting an inventory of controlled substances, counting should be performed as follows:
* For sealed, unopened containers, an exact count is not needed. use the count listed on the drug container.
* For opened containers of controlled substances:
* All schedule I and II containers require an exact count
* Schedule III-V containers that hold <1,000 dosage units or less can be estimated
* Schedule III-V containers that > 1,000 dosage units require an exact count
* The inventory records must be kept for 3 years.
68
The board can grant waivers to allow for off-site storage of records. All records stored off-site must be kept in a secure area to prevent unauthorized access (eg, at a records maintenance facility or a commercial storage center). The waiver must be kept in the pharmacy. If the waiver for off-site storage of records is approved...
a signed copy of the form will be returned to the pharmacy within 30 days. Off-site storage of records is not allowed until the board approves the waiver. A new waiver is needed if the records are moved to a different location
69
The pharmacy must be able to produce off-site storage records within 2 business days upon the request of the board or...
another authorized officer of the law.
70
Prescription records are kept for 3 years total. Prescriptions for non-controlled substances must be kept at the pharmacy for at least one year. After that,
the pharmacy can choose to store the prescriptions off-site for another 2 years (to save space)
71
Prescriptions for controlled substances must be kept at the pharmacy for at least 2 years. After that, the pharmacy can...
choose to store the prescriptions off-site for another year
72
Durable Medical Equipment (DME) is provided under Medicare Part B if the equipment was prescribed for use in the home. Initially, the DME supplier, such as a pharmacy, receives a verbal or written dispensing order for the product the patient needs. Verbal or written dispensing orders can be used to provide the DME, but cannot be used to bill Medicare. Billing requires a...
• Detailed Written Order (DWO)
73
For DME, the Detailed Written Order must include:
* the prescriber's signature and date
* detailed description of the item (such as the brand name and model number)
* Only supplies that are clearly related to the order can be added to the DWO by the supplier
* Medicare does not accept PRN refills; refills must be detailed with the rest of the order:
```
The DWO must include:
• The item/s
• Dosage or concentration, if applicable
• Route of administration
• Frequency of use for test strips and lancets
• Duration of infusion, if applicable
• Quantity
• Number of refills
```
74
The Drug Supply Chain Security Act (DSCSA) was passed in 2013. The DSCA outlines steps to build a system to...
track and trace drugs (only for human-use) as they are distributed throughout the U.S.
75
Manufacturers, wholesale distributors, pharmacies, and repackagers are required to provide the subsequent purchases with product tracing information when engaging in transactions involving certain Rx drugs. Pharmacies must be able to capture and maintain transaction information (TI), transaction history (TH), and a transaction statement (TS), in paper or electronic form, for each drug product received for...
6 years from the date of the transaction. There are some situations that are exempt from this requirement, including dispensing drugs to a patient, providing drugs to a practitioner for office use, and distributing samples.
76
Drugs/devices that are only delivered to the licensed premises and signed for and received by a pharmacist. Deliveries to a hospital pharmacy can be made to a central receiving location within the hospital. However, the drugs or devices must be delivered to the licensed pharmacy premises within...
one working day following the delivery and the pharmacist on duty at that time must immediately inventory the drugs or devices
77
A pharmacy can take delivery of drugs/devices with the pharmacy is closed, and no pharmacist is on duty, if all of the following requirements are met:
* The drugs/devices are placed in a secure storage facility in the same building as the pharmacy
* Only the PIC or a pharmacist designated by the PIC can access the secure storage facility after the drugs/devices have been delivered
* The secure storage facility has a means of indicating whether it has been entered after the drugs/devices have been delivered
* The pharmacy keeps written P&Ps for the delivery of drugs/devices to a secure storage facility
* The agent delivering drugs/devices leaves documents indicating the name and amount of each drug/device delivered
* The pharmacy is responsible for the drugs/devices and keeping records relating to the delivery of the drugs/devices
78
A transaction history statement includes:
the transaction information for each prior transaction going back to the manufacturer of the product
79
A transaction statement is a statement that the entity transferring ownership in a transaction:
* Is authorized
* Received the product from a person that is authorized
* Received transaction information and a transaction statement from the prior owner of the product
* Did not knowingly ship a suspect or illegitimate product
* Had systems and processes in place to comply with verification requirements
* Did not knowingly provide false transaction information
* Did not knowingly alter the transaction history
80
Transaction information includes:
* Proprietary or established name of names of the product
* Strength and dosage form of the product
* National Drug Code (NDC) # of the product
* Container size
* Number of containers
* Lot numbers of the product
* Date of the transaction
* Date of the shipment, if > 24 hours after the date of the transaction
* Business name and address of the person from whom ownership is being transferred
* Business name and address of the person to whom ownership is being transferred
81
The hospital drug supply must be inspected by a pharmacist, intern, or technician at least every 30 days. This includes automated dispensing systems, refrigerators, freezers, and emergency supply stock. The inspection should include...
removing outdated, unusable (adulterated), recalled, and mislabeled (misbranded) drugs.
82
Records of inspections must be kept for at least 3 years. Irregularities must be reported within...
24 hours to the PIC and the director or chief executive officer of the healthcare facility.
83
Information regarding drug and vaccine shortages are available at the following websites:
• Drugs and vaccines:
American Society of Health-system Pharmacists (ASHP): www.ashp.org/durgshortages
Food and Drug Administration (FDA): www.fda.gov/drugs/drugssafety/drugshortages
* Vaccines only
* Centers for Disease Control and Prevention: www.cdc.gov/vaccines/vac-gen/shortages
84
All drug stock needs to be kept in a secure manner and in proper storage conditions with the right...
temperature, humidity, and light to keep it from becoming adulterated.
85
Controlled drugs should be stored in a locked cabinet or be...
dispensed throughout the other drug stock (on the shelves)
86
Drugs that must be separated from other drug stock include:
* Investigational new drugs
* Repackaged or resold drugs (must be assigned a Beyond-Use Date)
* Recalled Drugs
* Expired Drugs
* Drug samples (not allowed in retail pharmacies)
87
Supplies of drugs for use in medical emergencies must be immediately available at each nursing unit or service area within an inpatient facility. The emergency drug supply must be stored in a clearly marked portable container (eg, a crash cart) which is...
sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container must be listed on the outside cover and must include the earliest expiration date of any drugs within.
88
A drug recall occurs when a drug is removed from the market bc it is defective or potentially harmful. If the recall involves specific batches or lot #s, the pharmacist will need to check the stock and remove the recalled drug. If there are multiple areas where a drug is stored within a facility...
it is imperative that the drug is removed from all storage areas (including patient care areas and automated dispensing cabinets)
89
The FDA does not mandate that the pharmacy contact the patient. In a Class I recall, the pharmacist is responsible for...
determining which patients received the drug and notifying each patient's prescriber. The FDA does not mandate that the pharmacy contact the patient (the prescriber must decide whether to inform the patient).
90
The manufacturer of the recalled drug is responsible for notifying its customers; this includes distributors and patients. When a recalled drug is returned to the pharmacy, it is quarantined (separated) from other drugs...
before being returned or destroyed. Drugs that are quarantined for any reason (recalls, adulteration, expiration) must be labeled appropriately and placed in separate containers.
91
Drug recalls are classified based on the level of severity (class I-III):
Class I: There is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death. Ex. two lots of fentanyl transdermal 12 mcg/hr patches were recalled bc some packages contained fentanyl 50 mcg/hr patches.
Class II: Use of or exposure to the drug can cause temporary or reversible adverse health consequences, or the probability of harm is remote. Ex. several lots each of metformin ER, ranitidine, and losartan were recalled due to containing unacceptable levels of a probable carcinogen, NDMA.
Class III: Use of or exposure to the drug is not likely to cause health consequences. Ex. one lot of paliperidone ER 3 mg tablets was recalled due to failing dissolution tests.
92
A pharmacy or outsourcing family must contact the recipient pharmacy, prescriber or patient, and the board of pharmacy regarding a compounded drug product that is being recalled if both of the following apply:
* Use of or exposure to the recalled compounded preparation can cause serious adverse effects or death.
* The recalled compounded preparation was dispensed or is intended for use in California.
Notice must be provided to the recipient pharmacy, prescriber. or patient within 12 hours of issuing the recall. The pharmacy or outsounding facility must notify the board of pharmacy within 24 hours.
93
There are a variety of safe and responsible ways to dispose of drugs through:
take-back events, collection bin/receptacles, mail-back packages
94
Most drugs should not be flushed down the toilet, except for drugs on the FDA's Flush List such as:
* Buprenorphine
* Diazepam rectal gel
* Fentanyl-containing products
* Other CIIs
* Tapentadol
95
Pharmacies can voluntarily register with the DEA to take back unwanted drugs from patients by installing a collection bin. The bin must have a strong waterproof, removable liner. The pharmacy staff should not know what has been placed into the bin. Drugs that have been placed in the bin cannot be removed by anyone in the pharmacy. Only the...
reverse distributor staff is able to remove the liner that contains the drugs. Two pharmacy staff must watch the removal and sign that they witnessed the disposal.
96
Controlled substances can be comingled (mixed together) in the collection bin with non-controlled drugs. However...
sharps, needles, and illicit drugs cannot be placed in the bin
97
Within 30 days, the board must be notified of the establishment and the...
discontinuation of a drug take-back service
98
Within 14 days, the board must be notified of any tampering with the collection bin, theft of deposited drugs...
and any tampering, damage, or theft of a removed liner
99
Annually, at the time of facility license renewal, the board must be notified of the...
disclosure of service and location of each receptacle
100
Pharmacies can also provide pre-paid, pre-addressed mailing envelopes for patients to return drugs to an authorized destruction location. The patient puts the medications into the envelope and...
drops off the package at the post office. The package has a plain wrapper, without any markings or information that indicates what is inside. The package is waterproof, spill-proof, tamper-evident, tear-resistant, and sealable. The package has a unique identification number that enables it to be tracked.
101
The California Board of Pharmacy has a campaign to avoid water pollution and reduce risk called Don't Rush to Flush. Patients should be instructed to safely dispose of Rx, OTC, and veterinary meds by depositing them into designated drug disposal bins.
* At home, remove pills and other solid medications from their containers and consolidate in a clear plastic zipper bag. Keep liquid and cream medications tightly sealed in their original containers.
* Remove, mark out, or otherwise obscure personal information from solid and liquid/cream medication containers to protect your personal information. Recycle containers for solid medications in your household recycling (after obscuring personal info).
* Bring zipper bag and any liquids/creams to a Don't Rush to Flush location and place in the bin!
102
Each person licensed by the board (pharmacists, interns, and techs) is a "mandated reporter" of...
child abuse, elder abuse, and neglect. The mandated reporters must phone law enforcement or protective services as soon as they can, and prepare and send a written report within 2 working days or 36 hours of receiving the information concerning the incident. Failure to do so is a misdemeanor, punishable by up to 6 months in county jail and/or a fine of $1,000.
103
Physicians have independent prescribing authority and can prescribe both...
non-controlled and schedule II-V drugs
104
Providers with independent prescribing authority who can prescribe both non-controlled and schedule II-V drugs, but have a limited scope of practice include:
* Dentists
* Podiatrists (DPM)
* Veterinarians (DVM)
105
Optometrists (ODs) have independent prescribing authority and limited scope to practice. They can prescribe non-controlled and schedule II-IV (but not V) drugs. Also:
* They must be certified with the Board of Optometry to prescribe drugs and have a letter T at the end of their license number.
* For codeine-containing or hydrocodone-containing products, they can prescribe a max 3-day supply.
* Can prescribe other drugs relevant to their practice: oral analgesics and antibiotics, OTC drugs, topical antibiotics/antivirals/anesthetics/lubricants/anti-inflammatories/antihistamines, diagnostic drops (eg, atropine, other mydriatics to dilate the pupils), and glaucoma eye drops.
