Pharmacy Operations Flashcards
Board’s vision statement:
“Healthy Californians through quality pharmacist’s care”
The Board is elects a…. and includes how many members?
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.
Pharmacists, interns, pharmacy technicians, and pharmacy technician trainees must wear:
Name tags when at work, in 18-point type, that contain their name and license status
All licensees must also join…
the board’s email notification list within 60 days of becoming licensed
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…
up to 2 pharmacies, as long as they are within 50 driving miles of each other
Any change of PIC must be reported by the pharmacy and the departing PIC to the board in writing within…
30 days
The PIC must complete a biennial (ie, every other year) Self-Assessment form for their pharmacy…
before July 1st of each odd-numbered year (eg, by July 1, 2021, then again by July 1, 2023)
An additional Self-Assessment form must be completed within 30 days if a new permit is issued, and when the pharmacy…
has a new PIC, or moves to a new location
Each Self-Assessment form will be kept in the pharmacy for…
3 years
The Self-Assessment form is not sent to anyone, but if the pharmacy is visited by an inspector…
they will need to produce the form and the inspector will compare the actual situation in the pharmacy to what is on the form
To be a licensed pharmacist, a candidate must have:
- 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.
Under California law, all registered pharmacists (RPhs) can provide the following services after meeting certain training requirements:
- 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.
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…
each 2-year license period
For license renewals on or after July 1, 2019, at least 2 hours of…
pharmacy law and ethics must be included with each renewal
The license expires on…
the last day of the pharmacist’s birth month
The first 2-year license cycle is exempt from:
CE requirements since the pharmacist is considered up to date
The certificate of completion of CEs must be kept for…
4 years
Pharmacists must disclose (on the renewal form) if any government agency issued disciplinary action against any of their licenses that resulted in…
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.
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…
- 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.
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…
refill medications that the pharmacist has already checked and do not require patient counseling.
A law passed in 2018 prohibits a community pharmacy from requiring a pharmacist to work alone. It requires that…
another employee of either the pharmacy or the establishment is made available to assist the pharmacist at all times, with some exceptions.
The maximum #s of staff that a pharmacist can supervise are as follows:
- 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)
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:
- 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
In order to be recognized as an APh, a pharmacist must meet 2 of the 3 following requirements:
- 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.
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.
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.
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).
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.
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.
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
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.
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.
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.
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
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
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
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
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.
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.
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.
Records for drug acquisition (eg, invoices) and disposition records (eg, Rx records, chart orders) are kept for…
3 years
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).
