PHAR 621 - Exam 1
How long do you have to convince the inspector after receiving a notice of violation?
14 days
What is an intern pharmacist allowed to do?
Anything that the supervising pharmacist allows you to do
What to do if a PIC quits?
30 days to find a replacement Previous PIC and the owner of the pharmacy must write to the BOP within 30 days and the pharmacy needs to show they were trying if can't find one in time
If there is only 1 pharmacist, and they believe that the security of the dangerous drugs and devices will be maintained in their absence, how long is the pharmacy allowed to remain open without a pharmacist?
30 minutes
What is considered impairment to be reported to the Board of Pharmacy?
Admission of, video or document showing, or termination (don't make assumptions) based on inability to perform their respective responsibilities in the pharmacy due to chemical, mental, or physical impairment
One of the examples of unprofessional conduct includes the commission of any act involving moral turpitude, dishonesty, fraud, deceit, or corruption, whether the act is committed in the course of relations as a licensee or otherwise, and whether the act is a felony or misdemeanor or not. What is moral turpitude?
Anything that is basically immoral: theft, drinking and driving (DUI), neglecting financial obligations (alimony, taxes, child support)
Definition of a medication error
Anything the patient gets that is different from what the prescriber intended
Where can you mail/deliver prescriptions to the patient? What is the exception?
Anywhere that the patient expressly designates: residence, workplace, place in which patient receives health care services (doctor's office), anywhere else that the pharmacy can show good cause to deliver it and the BOP allows it DEA says controlled substances can only be delivered directly to the ultimate user; cannot be delivered to doctor's office
What happens if you get busted by another state's board of pharmacy?
California BOP will bust you too
Is it okay for a pharmacist to smoke marijuana in California?
Cannabis is legal in California, but is a schedule I medication according to federal law. The CA Board of Pharmacy will always enforce the more strict law. It should not be in your system while performing the duties of a pharmacist.
What is an intern pharmacist not allowed to do?
Cannot perform the final check of a prescription Anything that requires supervision without supervision Hold the keys to the pharmacy
What does it take to be a PIC?
Just needs to be a pharmacist on payroll (don't have to work), proposed by a pharmacy, and approved by the BOP
What is the minimum for a quality assurance review record?
Date, location, and participants in the quality assurance review: when, where, who Pertinent data and other info relating to the error(s): what Documentation of any patient contact Findings and determinations generated by the quality assurance review Recommended changes to P&Ps, systems, or processes, if any
When must a pharmacist be available to give a consultation for delivered/mailed drugs?
During regular hours of operation within an average of 10 minutes or less or get back to them within 1 business hour For no less than 6 days per week (pharmacy does not have to be open, but a pharmacist must be available) For a minimum of 40 hours per week
Other than the reporting requirements of impairment and theft, what else is required, especially when an inspector comes?
Every pharmacy must have written policies and procedures for taking action to protect the public in the event of impairment and theft
Who cannot own a pharmacy?
Felons Prescribers Spouses of prescribers
If a prescription is not in stock, what are you required to do?
Immediately notify the patient and arrange for the drug or device to be delivered to the site or directly to the patient in a timely manner OR Promptly transfer the prescription to another pharmacy known to stock the prescription drug or device that is near enough OR Return the prescription to the patient and refer the patient to a pharmacy that stocks the prescription drug or device that is near enough
When you determine a medication error has occurred, what should be done as soon as possible?
If the drug was administered to/by the patient or resulted in a clinically significant delay: Tell patient or agent that a medication error has occurred and tell them what to do to avoid injury then tell the prescriber No harm, no foul but still have to fill out a medication error report either way
It is a medication error as soon as the patient takes the bag, but when can the drug be reused instead of quarantined?
If the patient did not open the vial or step outside the pharmacy (controlled air conditioning and humidity environment); 4 walls as determined by the wall license
Which action from the Board of Pharmacy is reserved for those so bad that the normal time to process a disciplinary action is too long and they want you out immediately?
Immediate action that leads to disciplinary action: Interim Suspension Order (Cease & Desist)
Any pharmacy owner who commits any act that would subvert or tend to subvert the efforts of the PIC to comply with the laws governing the operation of the pharmacy is guilty of what?
Misdemeanor
What are the requirements of name badges?
Must be at least 18-point font Indicating name and license status
What constitutes direct supervision and control and what does not?
Must be physically in the building to supervise with real-time audio and visual, but can give supervision via cameras Does not need to be paying attention (talking on phone and busy typing); only could pay attention if wanted to
Which action from the Board of Pharmacy is like a speeding ticket?
Non-disciplinary enforcement: Citation (with or without fine)
Which action from the Board of Pharmacy still shows up on your permanent record as an aggravating factor?
Non-disciplinary enforcement: Citation (with or without fine)
Which action from the Board of Pharmacy is a formal letter of finger wagging that is not as severe as public reproval?
Non-disciplinary enforcement: Letter of admonishment
What are the 4 types of actions that the Board of Pharmacy can do to people they license?
Non-enforcement action Non-disciplinary enforcement Immediate action that leads to disciplinary action Disciplinary action
Which action from the Board of Pharmacy is an order of abatement that is basically a ticket for you to fix?
Non-enforcement action: Corrective Action Order
Which action from the Board of Pharmacy almost always lead to enforcement?
Non-enforcement action: Notice of violation
Which action from the Board of Pharmacy is a heads up of the things you have violated?
Non-enforcement action: Notice of violation
Although the PIC is responsible for everything that happens in a pharmacy, what are they not liable for?
Not responsible for the criminal acts of the people in the pharmacy that the pharmacist had no knowledge, or did not knowingly participate in Still regulatorily liable and maybe civilly though (government attack your license and someone sue you for money)
What are the things that will show up when you search up someone with a license from the Board of Pharmacy?
Only disciplinary actions (public reproval, probation, suspension, revocation) and their accusation documents
What is the only way a pharmacy can buy test strips?
Only from the BOP's list of wholesalers as reliable suppliers to prevent stolen, resold, and defective test strips
Are pharmacies allowed to take back drugs?
Only if it is a medication error
Who are allowed to be in the pharmacy?
Only pharmacists, interns, authorized officer of the law, or a person authorized to prescribe Other people are only allowed in the presence of a pharmacist
Who does the Board of Pharmacy give licenses to and can have direct control over?
Pharmacists, interns Technicians, tech-in-training Pharmacies Wholesalers (not drug manufacturers)
What is the Board of Pharmacy's mandate?
Protect Californians (not help pharmacists or pharmacies)
What intern activities require direct supervision?
Providing consultations, including for OTC products (functions that require professional judgment) Taking new verbals over the phone (refills do not require supervision and can even done by clerks) Engaging in clinical communication with other healthcare providers
What are clerks/cashiers allowed to do?
Receive refills Type Rx in computer Place drugs in ready/pick up area Hand sold drugs to the patient
What are some not-so-obvious examples of wholesalers that require licenses from the Board of Pharmacy?
Reverse distributor (take away expired drugs) Logistics coordinator (3rd party logistics who don't touch drugs but match up the drug source with the drug need) Non-resident wholesaler
What is the purpose of the quality assurance program?
To prevent the recurrence of a medication error
Why is the medication error report important and people are encouraged to admit to their bad deeds?
The medication error report describes who, what, when, and all the things that caused the medication to occur and why it will not happen again They will be considered peer review documents used as a tool internally for people to learn from it and cannot be used in court
Other than any number of pharmacists, who else is allowed to hold the pharmacy key and under what condition?
The non-pharmacist pharmacy owner OR the building owner OR the building manager OR the family member of a pharmacist owner (technician that is not one of those is not legally allowed) The key must be kept in a tamper evident container to be delivered to a pharmacist or for access in an emergency (fire, flood or earthquake) and the signature of the PIC or staff pharmacist must be present on the container to readily determine whether the key has been removed from the container
Who are required to wear name badges?
Those with licenses from BOP: Pharmacists, Interns, Pharmacy technicians, Pharmacy technician trainees
When may a pharmacist refuse to dispense?
Unlawful prescription or dispensing is unlawful Prescription is harmful to the patient Not in stock Ethical/moral objection but only if have the specific drugs in writing to employer, employer can accommodate without creating undue hardship to the patient, and employer has written protocols in place that the patient can still get the drugs in the event of ethical/moral objection
Can you be the PIC for multiple pharmacies?
Up to 2 pharmacies at a time that cannot be farther than 50 driving miles apart
When does the law require a consultation for a patient?
Whenever the (pharmacy's) patient asks for it; need medication profile to be able to give consultation When the medication is new to the patient (not the pharmacy) Whenever the pharmacist deems in their professional judgment that a consultation is needed (DUR on a regular refill with a sticker from the RPh that indicates a consult is required)
When must theft and impairment be reported to the Board of Pharmacy?
Within 14 days of discovery of the theft/self-use of dangerous drugs or chemical/mental/physical impairment by a licensed pharmacy member
