Download Pharmacy Law Final Exam Study Guide - Spring 2025 and more Exams Nursing in PDF only on Docsity!
What are the general rules of HIPPA? I.E. you can't display PHI (protected health information) other than for providing what? - correct answerCannot display PHI other than for providing health care treatment, obtaining payment, and for day-to-day health care operations What does HIPPA apply to? - correct answer-Health care providers (ie. pharmacies) -Health plans -Health care clearninghouses What are the requirements of HIPPA? - correct answerHIPPA Requirements: -Notifying patients of rights/uses (Notice of Privacy Practices) (NOPP) *Need to inform patients on their rights to PHI -ensuring pharmacy personnel compliance -appointing privacy officer -securing patient records (all personal must be trained in regards to privacy of HPI and maintain confidential patient records What content is to be included in the Notice of Privacy Practices (NOPP)? - correct answerNOPP content: -how pharmacy intends to use and disclose information -obligation to notify patient of a breach of unsecured PHI -Legal duties of the pharmacy to protect confidentiality of PHI -statement of uses and disclosures that require authorization in written document form -statement of patient rights and how to exercise those rights (ex: how to access amendment and accounting) -statement that patients may complain to the pharmacy or DHHS and how to file a complain -name of the individual to contact with privacy concerns, including telephone number What are NOPP obligations that have to be met by the pharmacy? - correct answerNOPP obligations for the pharmacy: *provide to patients *good faith effort to obtain signature (6 yr retention) *must be displayed in a clear and prominent location in the pharmacy *must make a copy of the NOPP on request to anyone who requests a copy, whether customer or not *If pharmacy has a website, must make a notice and acknowledgement available on that website If a patient refuses to sign a Notice of Privacy Practices, can you refuse treatment? what should you do in this instance? - correct answerNo, cannot refuse treatment if someone refuses to sign acknowledgement **If patient refuses to sign, DOCUMENT the refusal****
RPh job to make good faith effort to obtain signature, if someone doesn't want to sign, make careful note Pharmacy can use/disclose PHI without authorization as long as it is for ____________, __________________, or __________________ - correct answerPharmacy can use/disclose PHI without authorization as long as it is for TREATMENT, PAYMENT, or HEALTH CARE OPERATIONS Note: for any purposes other than these listed, would need patient authorization What are some examples of treatment where the pharmacy can use/disclose PHI? - correct answerTreatment: Dispensing medications, counseling, maintaining profiles, consulting with patient's other health care providers What are some examples of Payments where pharmacy can use/disclose PHI? - correct answerPayment= submitting claims for reimbursement, determining patient eligibility and extent of coverage, sending bills to patients What are some example operations that the pharmacy is enabled to use/disclose PHI? - correct answerOperations= Quality assessment, fraud detection, audits, certifications, business management What are the authorization required statements? - correct answer-right to revoke the authorization in writing -Inability to condition treatment on the basis of whether the patient signs authorization -potential for info that is released to be re-disclosed (i.e. might be to a non-covered entity that is not subject to HIPPA) What is authorization in regards to PHI and what should it include? - correct answerAuthorization: -separately signed and dated document -specific description of PHI at issue -Specific ID to whom PHI will be disclosed -Description of each purpose for which PHI will be used/disclosed -expiration date or event after which authorization no longer valid If financial remuneration received is reasonably related to the costs of making the communication, is it considered marketing? - correct answerNo, this is not considered marketing and would not require an authorization Any financial remuneration from a drug company beyond the cost of providing the reminder would require what? i.e. anytime pharmacy is receiving reimbursements and/or money is being exchanged, this action requires what? - correct answeran authorization
What are the 3 basic patient rights to their PHI information? How must the pharmacist comply with each right? - correct answerPatient Rights:
- Access-right to inspect and copy their PHI. Pharmacist must comply within 30 days
- Amendment- right to amend records containing PHI. Pharmacist must comply within 60 days
- Accounting-right to have accounting of disclosures. Pharmacist must comply within 60 days What office enforces HIPPA? - correct answerHIPPA is enforced by the Office of Civil Rights (OCR) Before submitting any records on the basis of a subpoena, what must the pharmacist be sure to do first? - correct answerBefore submitting a subpoena (writ ordering a person to attend court) the pharmacist MUST be sure that there is evidence that the person whose records are being sought has given the ok. Otherwise, pharmacist could be liable Is it ok to submit PHI based on a court order? what about a subpoena without patient consent? - correct answerCourt order--> yes, ok to submit only based on a court order Subpoena--> must be sure there is evidence that the person whose records are being sought has given the ok What recent updates have been added to HIPPA? - correct answer(1)BREACH NOTIFICATION: -formerly only had to be reported if posed a risk of financial, reputational, or other harm New. ***Now all cases of impermissible acquisition, access, use or disclosure of PHI need to be reported unless the pharmacy or BA can demonstrate low probability that PHI was compromised (2) Expanded Patient Access to records -pts. can now request copy of their health information ELECTRONICALLY (3) Can now restrict disclosures to health plan if paid out-of-pocket Retail pharmacies are routinely inspected by ________________ - correct answerRetail pharmacies---> inspected by the State Board of Pharmacy Hospital Pharmacies are routinely inspected by _______________ - correct answerHospital Pharmacies--> inspected by the Dept. of Health ___________________ can report its findings to the _______________ which can then follow up with its own inspection - correct answerDepartment of Health can report its findings to the Board of Pharmacy which can then follow up with its own inspection
What is the regulation for when and how you have to notify the board for any name and address changes of the pharmacy? - correct answer-Notify the Board of any name/address changes within 10 days of the change *Board uses address to mail all important updates and documents -supply official documentation for name change The Pharmacy permit should include 3 names and 1 address. What are the 3 names? - correct answer-name and address of the pharmacy -Name of current owner -Name of the current pharmacist manager ***Cannot display any name other than the name in which the pharmacy is registered Ex: Mushneo's Pharmacy cannot be advertised as Jerry's Pharmacy What are the regulations around Pharmacist Break? - correct answer-sole pharmacist can take a 30 minute break -pharmacist must remain within the immediate building -pharmacist must still be available for counseling and emergencies -pharmacy can remain open during break to: receive new prescriptions prepare Rxs for final verification deliver rxs that have already been verified If a pharmacy is located in a mall, can the pharmacist go to other stores within the mall during their break? - correct answerNo. cannot meander around to other stores in the mall The pharmacy can remain open during a pharmacist break to: - correct answer-receive new prescriptions -Prepare Rx's for final verification -Deliver Rx's already verified When is a new permit required? How soon must it be filed? - correct answerNew permit required for change in: -name -ownership -controlling interest (of pharmacy) *File within 30 days of the change What are the proper protocols for pharmacy closing? When must you notify the board? - correct answerPharmacy Closing: *Notify Board of Disposition of files/drugs **Need permission of the Board if over 30 days since the closing before disposal, sale, or transfer
-RPh reviews Rx or order prior to dispensing -verifies final product -immediate available on the premises to direct the work and respond to questions or problems that arise What is a recent regulation change for interns? - correct answerRecent regulation changes now allow pharmacy interns to accept and transcribe oral order or telephone prescriptions Comment on technician protocols and how they are unique - correct answerTechnician protocols: -pharmacist manager shall create and maintain a written protocol for each tech -Protocols specifies duties each tech may perform -Pharmacist manager and tech shall date and sign the protocol and each amendment *this is a unique and important consideration What value of non-proprietary drugs and devices at cost is a pharmacy required to have? - correct answerInventory of $5000 of non-proprietary drugs and devices at cost How long must original prescriptions or images be retained for from the date of most recent filling? - correct answerOriginal prescriptions or images must be retained for 2 YEARS from the date of the most recent filling What is the pharmacist manager responsible for in regards to the inventory? - correct answerpharmacist manager responsible for:
- removing expired, unfit, adulterated or misbranded drugs
- Keeping records of controlled substances disposed of What has been the "shift" over the past several years regarding the supplies a pharmacy is required to have? - correct answerFormerly, there used to be a long laundry list of supplies the pharmacy was expected to be supplied with, down to the number of spatula's and number of mortar and pestals NOW. equipment should be consistent with the scope of practice you are in -Refrigerator in the Rx area must have a temperature monitor What reference materials must be maintained in the pharmacy? - correct answer- current copies of the pharmacy Act -Current copies of Title 49, Chapter 27 (remember these are the primary set of regulations for pharmacy in PA) -Federal and PA statutes and regulations related to the practice of pharmacy -adequate reference library Note Online access is permitted and is acceptable if you can demonstrate being able to access these documents online
What are the procedure for a new pharmacy or change of location? - correct answer- plans may be submitted to the Board for prior approval -The board will notify the applicant of approval or disapproval within 90days!!!! Remember to notify the board when you are ready for inspection How does a pharmacy have to proceed with the board for projected alterations? - correct answer-plans for the alterations and precautions for health and safety must be submitted to the board at least 30 days before any alterations take place *if no objection is received (no news is good news) and you can proceed -pharmacy practice and continue if these stipulations above have been met Building standards: the prescription area must be _________ sg. ft - correct answerPrescription area shall be at least 250 sq. ft. What are the regulations for the length of the prescription counter? If three pharmacists are on duty at the same time, how does this alter the requirement? - correct answerPrescription counter of at least 10 ft. in length by 2 ft width **if 3 RPh's (MORE THAN 2) pharmacists on duty simultaneously, increase length by 5 ft. for each additional pharmacist (3 RPh's = 15 ft.) Note: 2 pharmacists = 10 ft in length *this does not account for interns that may be working If a generic medication is used, what must specifically be stated on the label? - correct answerIf generic used, must include the manufacturer's name or abbreviation on the label Can you dispense a CV cough preparation without a prescription in this jurisdiction? - correct answerNo! In PA, a CS based cough syrup cannot be sold without a prescription **Cannot dispense a CV cough preparation containing Dilaudid, Codeine, or cough prep with any other narcotic without Rx (certain states do not require a Rx for these, but PA does ) Can you refill a fill a script when the doc is deceased or no longer in practice? - correct answerCannot KNOWINGLY fill or refill a script where prescriber is deceased or no longer in practice..."Doc is dead, so is the script" -So if you saw the doc was no longer in practice for whatever reason in the newspaper, if a pt. with a script for Xanax came in that day, you could not fill the script *If unknowingly you were to fill the script, say you hadn't seen the paper, there would be no penalty for this act because it was unknowingly
What should the pharmacist record in writing when delivering a prescription copy? - correct answerPharmacist shall record, in writing: -date copy was given -to whom the copy was given (ID if the patient is not known to you) -By whom the copy was given What are regulations regarding sales of syringes and needles? Is a prescription required? - correct answer-Syringes and needles sales may be made without a prescription under the direct, immediate, personal supervision of the pharmacist Needles and syringes must be: -kept in the prescription area -no age limit -no quantity limit -no record keeping requirement (new) Do you have to keep a record of needle and syringe purchases? - correct answerNo! this is new! What should Parenteral, enteral, or TPN labels include? - correct answerLabels for Parenteral, enteral, or TPN should include: -pt. name -ingredients (including: name, strength, quantity of each, diluent, and expiration date) -initials of the pharmacist Compare and contrast the labeling requirements for Unit-dose drugs and Non-unit dose drugs - correct answerUnit-dose: DO NOT REQUIRE to conform to normal labeling requirements Non-Unit dose drugs: shall include: -pt. name -drug name -drug strength -dosing instructions -lot number Not enumerated in PA, but what does the FDA require in labeling Unit-dose drugs? - correct answerFDA requires: -drug name -drug strength -lot number -exp. date -name of mfgr, packer, or distributor What is PDR and when is it required? - correct answerPDR= Prospective Drug Review
-helps to assure no adverse medical events b/c of therapeutic duplication, D-D interaction, incorrect dosage, etc. *Required prior to filling new prescriptions or drug orders (except when physician is directly dispensing drug to patient) PDR required for: -prescriptions dispensed at retail pharmacy locations -orders dispensed to hospital outpatients or inpatients -prescriptions dispensed to personal care home residents Be careful not to confuse PDR with what? - correct answerDon't confuse PDR with the offer to counsel!!! --> offer to counsel is only required for NEW retail and outpatient prescriptions, NOT INPATIENTS PDR is for EVERYBODY Comment on the regulations for the offer to counsel and when it is required - correct answerOffer to counsel shall be made to each patient or caregiver for each NEW retail or outpatient prescription *if pt. or caregiver comes into pharmacy, offer shall be made ORALLY, but can be written if oral would be less effective (i.e. hearing impaired, non-English speaking) *If pt or caregiver doesn't come in, offer can be made via telephone; delivery person, or written offer (must include toll-free phone number to contact the pharmacist How long must a patient profile be maintained after the last entry? - correct answerPatient profile maintained for 2 years after the last entry For how long is a pharmacy internship certificate valid for? - correct answerIntern license valid for 6 years from the date of issue, but invalid if enrollment in pharmacy school ceases How many hours must an intern serve? How many of those hours should be in a pharmacy? A pharmacy intern can work NMT how many hours a week? - correct answerIntern shall serve total: 1500 hours 500 hours in pharmacy, 1000 hours through college of pharmacy internship NMT 50 hours/week can be earned What are the requirements for the board to consider a non-traditional internship? - correct answerBoard will consider non-traditional internship if:
-Experience in the practice of pharmacy -demonstrate knowledge of American pharmacy practice -proficient ability to communicate in english -must have FPGEC (Foreign Pharmacy Graduate Exam Initiation Committee) from NABP before reg. as pharmacy intern -->Board may approve special internship of less than 1500 hours, but no less than 500 -->after internship, applicant may sit for the NAPLEX and MPJE For how long must the pharmacy retain hard copy or readily retrievable image of transmitted prescription information? - correct answer2 years from the date of most recent filling What are the elements of a malpractice claim (negligence)? - correct answerDBCD D-duty B-breach C-Causation D-damages *need all 4 elements for malpractice claim What components are encompassed within "duty" - correct answerDuty ORPP- Ordinary Reasonable Prudent Pharmacist Statutory (ex: OBRA PDR) Traditional definition of duty ("By properly filling legal prescriptions that contained no apparent discrepancies on their face, the pharmacy fulfilled its duty to patient" Post-OBRA duty-->courts are increasingly holding pharmacist to take responsibility for knowledge and duty -->Ex. if pharmacist called Dr. on discrepancy, still dispensed drug although identified a risk, patient dies, RPh can still end up in court because they did not fulfill their duty to patient What is Breach? - correct answerBreach is the second element needed in a malpractice claim Breach usually occurs in a dispensing error: -wrong drug -right drug but wrong directions -right drug but wrong strength A dispensing error (aka Breach ) creates a presumption of _________ and what two prongs have been satisfied? - correct answerBreach creates a presumption of negligence and the 1st 2 prongs have been satisfied:
- RPh had a duty 2.Breached that duty
The third element needed for a malpractice claim, Causation, is usually the most difficult to prove. What are a few examples? - correct answer-co-morbid conditions -Disease process itself (patient already has one foot on a banana peel) The 4th element to malpractice claim, Damages, must be.... - correct answer-actual harm to the patient -a dispensing error alone is not enough (if medication has not been taken by the patient, you can't be sued What are some examples of compensatory damages? - correct answerTypical compensatory damage awards: -lost wages -actual medical bills -pain and suffering *compensatory damages are designed to return the injured party to where he/she would have been without the harm Are punitive damages the same as compensatory damages? - correct answerNo, completely different. Punitive damages can include: -exemplary damages (court wants to make and ex out of you to teach a valuable lesson) -need actual harm to pt -wanton and reckless conduct **the sky is the limit to the consequences What are the 2 standards of proof, and what is each defined by? - correct answerStandards of Proof:
- Criminal--> the standard of proof is beyond a reasonable doubt
- Civil--> standard of proof is by a preponderance of the EVIDENCE OBRA 90 was the 1st federal law to...... - correct answerregulate pharmacy practice standards---> congress required states to expand practice to receive federal funds for Medicaid What is the main goal of OBRA 90? How do most state choose to implement the regulations into the pharmacy act? - correct answerGoal of OBRA 90: Save money -most states (including PA) chose to promulgate the regulations, through pharmacy act) and apply OBRA provisions to all patients (not just Medicaid patents) States cannot afford Medicaid w/out the federal funding What does OBRA 90 Drug Use Review (DUR) - correct answerDUR includes:
- Drug-disease contraindications
- Adverse Drug-Drug interactions
- Drug-allergy interactions
- Incorrect Drug Dosages
- Incorrect Duration of Drug Treatment
- Clinical abuse or misuse When are pharmacists expected to screen (a component of DUR)? What happens if a pharmacists fails to screen? - correct answer-Pharmacists are required to screen each prescription PRIOR to dispensing, and to use the patient profile to obtain the relevant information **Pharmacists are expected to detect potential problems which may be clinically significant by reviewing pt. profile, checking compendia standards, and monitoring professional literature Failing to screen: If RPh fails to screen for potential problems--> pharmacist can be held liable for NEGLIGENCE PER SE (1st two prongs, 1) duty and 2) breach have been met To determine whether a pharmacist acted properly when screening, the pharmacists actions will be compared to what? - correct answerORPP= Ordinary, reasonable, prudent, pharmacist under OBRA and prospective DUR (Drug Use Review), what are the parameters regarding a pharmacist offering to counsel? - correct answer-offer to counsel is required to pt. or caregive. Offer can be made by ancillary personnel, either in person or through a toll-free telephone number....OBRA 90 allows the pharmacist to determine the content of the counseling based upon professional judgement of what is significant -Patient has the right to decline counseling, just ensure that the rejection is documented!!! What side effects should a pharmacist focus on while they are counseling? - correct answerFocus on side effects that are COMMON and SEVERE -those very likely to occur, but that are self-limiting (HA) abd of minor significance when they do occur -those that are very likely to occur, and are significant when they do -those that are not likely to occur, but are SEVERE when they do How are pharmacists required to document relevant info regarding drug therapy? - correct answerComments required to document relevant to drug therapy: -when screening uncovers a problem -how that problem was resolved -when a patient requires unique counseling -when a pharmacist notices something out of the ordinary about a patient's behavior or drug therapy
At a minimum level, this is an important process because it documents that OBRA 90 requirements are being met and it serves as a reminder to jog the pharmacist or the relief pharmacist that the problem has occurred before Provide an overview of OBRA and the purpose of Documentation - correct answerUnder OBRA, documentation goes beyond risk management where pharmacists can protect themselves from liability Overall, intent is to promote good patient outcomes rather than protect pharmacists ***** what is the most prevalent liability under OBRA 90 that resulted for pharmacists? How may this be corrected (what did one study show?) - correct answer52% were the result of dispensing the wrong drug COUNSEL. a study showed that 83% of dispensing errors are discovered during counseling and corrected before the patient leaves the pharmacy. What are the steps you should take if faced with claim for malpractice? - correct answer-IMMEDIATELY contact management and/or the insurance carrier about the claim -write down any information relevant to the claim -Do NOT DELAY in reporting the claim ****DO NOT TAMPER WITH ANY RECORDS OR DOCUMENTATION associated with patient or claim -do not add additional documentation to the patient's records A pharmacy may use an automated Medication system (AMS) to fill prescriptions or medication orders if: - correct answerAMS (automated medication system) can be implemented if: -Pharmacist manager or pharmacist under contract with LTCF responsible for supervising operation -must validate the system of accuracy prior to implementation of the system (testing results available) -make system available to the Board for validation -system must electronically record the activity of each pharmacist, technician, or other authorized personnel (time, date, initials or other identifier) What are some responsibilities of operating and maintaining an Automated Medication System (AMS)? - correct answer-Review and approve all P&P (operation, safety, security, accuracy, access, patient confidentiality) -Ensuring that AMS meds are inspected MONTHLY (expiration dates, misbranding, and physical integrity, security and accountability) -assigning, discontinuing, or changing personnel access -ensuring that AMS is stocked accurately and accountability record is maintained How often do AMS medications need to be inspected? - correct answerMONTHLY
-drug therapy management decisions by pharmacist to make within the scope of the physician's practice Notes regarding this: -pharmacist may not provide incentives -if pharmacist employed by doc under a collaborative agreement, may not exchange in any retail dispensing in context of employment -voluntary agreement How long is a collaborative agreement effective for? - correct answerEffective for a period not to exceed 2 years Under a collaborative agreement, what are the responsibilities of the pharmacist? - correct answer-shall utilize an area for in person, telephonic or other approved electronic consultations that ensures the confidentiality of the patient information being discussed -initiate management of drug therapy upon written referral from the physician, which includes the frequency of management of drug therapy in person -confirm physician has active and unrestricted license and agreement is within scope of practice -pharmacist shall have access to records of the patient who is the recipient of the management of drug therapy -physician shall have access to pharmacy records What are the qualifications for authority to administer injectable medications, biologicals, and immunizations? - correct answer-active license to practice pharmacy in PA -certification of having completed a course of education and training (10 hours) -CPR certificate -separate application to the board is required **Liability insurance (1 million per occurrence of calims made is required) (just like for drug therapy management What are two instances for which 1 million dollar liability insurance is needed per occurrence or claims made? - correct answer1) Drug therapy Management
- As a qualification to administer injectable meds, immunizations, or biologicals What is the renewal application requirements regarding the pharmacists rights to immunization and administering injectables? - correct answer-in conjunction with pharmacist license renewal -certification of 2 hour CE completion and maintain CPR certificate What did governor Wolf sign into legislation in June 2015? - correct answerRevision for pharmacists to administer flu vaccines to children age 9 and older. The amendment went into effect immediately and did not require further regulation to make it happen. -this requires parental consent under 18
-regs are being developed to allow interns to immunize under direct supervision of pharmacist (this will require additional regulations through the Board of Pharmacy) For notification requirements what is the new requirement that is in place for pharmacists after administering an immunization under an order or protocol? - correct answernot only notify the ordering prescriber or participation provider within 72 hours but NEW requirement is to notify the PCP (if known) within 48 hours of the administration What is the Cancer Drug Repository Program? Can you just start participating in this program? - correct answerMust apply to Board to participate, can't just start reusing the cancer medications Cancer drug repository program includes donated drugs accompanies by cancer drug repository donor form that have to meet the following parameters: -original unopened, sealed, and tamper-evident unit dose packaging (or single unit- dose) -At least 6 months excisting expiration date -cannot be a controlled substance -not restricted distribution -not refrigerated or compounded What are requirements to receiving donated drugs and how must donated stock then be maintained under the Cancer Drug repository program? - correct answer-should have designated area to receive donations and provide written ackowledgement -visually inspect for adulteration and misbranding -maintain record of disposal for drugs not accepted *Store donated drugs separately!! Don't want to mix them with current stock!! -Inform patients that drug was donated and PATIENT MUST SIGN INFORMED CONSENT FOR THEIR ACKNOWLEDGEMENT What are the 4 D's of Cancer Drug Repository Program Recordkeeping? - correct answerDonation Dispensing Distribution Destruction To be in the Cancer Drug Repository Program, what is the patient eligibility? - correct answer-Cancer diagnosis -No or limited Rx coverage -no MA (Medical Assistance) eligible -not exceeding 350% of Federal Poverty Level (FPL)
