pharmacy law

  1. What are elements of negligence
    • duty
    • breach of duty
    • causation
    • damages
    • ALL 4 elements must be proven
  2. what is duty
    • objective reasonable standar--to act with the degree of care that a reasonably prudent pharmacist would use under similar circumstances
    • decisions require professional judgment will be jusdged on basis of reasonableness
    • proof of the standard of care and hether it was breached usually established by expert witnesses
  3. what is breach of duty
    • misfilling a rx
    • if a pharmacist violates a statute or regulation the violation could establish negligence
    • person harmed must be within the class the statute or regulation seeks to protect the harm must be of the type it seeks to protect
  4. what is actual cause
    • plaintiff must prove defendants negligent conduct was a substantial factor in harm caused
    • BUT FOR the conduct
  5. what is proximate cause
    • determin of the extent to which the defendant should be held liable for the conduct
    • what was forseeable
    • unforseeable superceding cuases will sever the defendants responsibility
  6. What is actual damage
    • loss of income
    • medical expenses
    • pain and suffering--there exist ceilings
  7. what are punitive damages
    awarded for willful or reckless negligence
  8. what are defenses of negligence
    • contributroy --common law rule completely barrin recover
    • comparative--statuatory requiring court to base judgment award on relative negligence of each party
    • statute of limitations--has to see u within a specific time period
  9. vicarious liability--respondeat superior
    • employer responsible for the negligent act of employees
    • purpose of rule to cause employers to hire and train compentent employees
    • plaintiff has right to sue employer and or employee
  10. liability for failure to perform expanded responsibilities
    pharmacists have no duty to warm pts of adverse effects... back in the day
  11. traditional rule of law
    pharmacists duty is to dispense medication precisely as written
  12. rationale for traditional rule
    • relationships--pt relies on physciain not pharmD, interevere with phys-pt relationship, no independent pt-rph relationship
    • foreseeability--only physician has requisite pt info
    • social policy--unfair burden on pharmacists
  13. dutyto warn under leanred intermediary doctrine
    • assuming risk known--mfr owes duty to warn md
    • learned intermediary=md
    • rationale--with regard to rx drugs, it is prescribing md who knows best
  14. emerging judicial trends--duty o pharmd to provide expanded patient services based on what three factors
    • relationship
    • foreseeability
    • public policy
  15. what are special circumstances pharmd has duty to warn
    • special instructions by mfr to warn
    • contraindications
    • spedial knowledge by pharmacist of patients condition
  16. what is assumption of duty--baker decision
    • held liable when it voluntarily assumes a function that is under no legal oblication to assume and a pt relies on that function.
    • Setting up a patient profile, then pharmd responsible for it
  17. what is corporate negligence
    • corp is responsible and liable for its own acts apart from employees
    • company's syustem as a cause of errors rather than individual
    • punitive damages may be awarded to force companies to develop higher quality system
  18. what does teh quality assurance program establish
    • maintain policies and procedures related to error situations
    • implement an incident reportin system where errors are reported and documetned, investigated and acted upon
    • periodically evaluate employees
    • continually assess and improve qualitiy of their systme
  19. how is a pharmacist a risk manager
    • have a responsibilty to patient after an error is made
    • must understand the importance fo verbally comminuatcin with patietns when disucssing an error and importance of always adequately documenting everything
    • pahramcist snould be able to apply some general risk management rules to error situations
  20. whta is malpractice insurance importance
    • individual insurance in atddtion to coverage provided by employeer
    • exclude coverage for intential violations
    • make sure it covers vaccination and mtm
  21. what is obra 90 framework
    • requires manufactuerers to provide drug prodcuts to medicaid program at their best price
    • lowest price at which they sell the product to any customer
    • require mfr to rebate the state the difference between the avg mfr price and best price
  22. what are DUR programs
    • retrospective reviews
    • educational programs
    • prospective reviews
  23. retrospective DUR does what
    • each state has to establish DUR board composed of physicians and pharmd to oversee retro dur
    • DUR board reveiws medication use data and compares to target criteria
    • has authority to recommend and establish educational programs for providers who are not meetin target criteria
  24. whats a prospective DUR
    • provides opportunity to evaluate the prescribed drug therapy before the RX is dispensed
    • examine data generated from PRO dur to determin e if drug use progblesm are being resollved or continuing
  25. what are components of PRO DUR
    • SCREENIN--detect potential drug use problems before RX is dispensed, (7 general categories of potential problems which should be screened)
    • counseling--requires OFFER TO COUNSELING, allows pharmacist to use professional judgement.
    • right to wave counseling, sign name
    • obtain, record and maintian a record of specified information
  26. What is requried of drug use review for patients
    new, rx order, refil must exame the patients profile record and conduct a prospective drug review to id 7 possible issues
  27. What are seven possible issues need to review
    • overutiliziation or underutilization
    • therapue=tic duplication
    • drug disease contraindications
    • drug drug interactions
    • incorrect drug dosage or duration of drug treatment
    • drug allergy interactions
    • clinical abuse or misuse
  28. what is computerized med profile review requirements
    • previous six months
    • maintain patient profile records for not less than two years from date of lassst entry in profile record
  29. whats exception to counseling rule
    hospitals serving only inpt do not have to prepare a patient profile for pt being dc or receving dc orders
  30. what is a requid patient consultation procedure
    must develop and maintain a written pt consultation procedure providin for direct oral communication bt pt and pharmacist
  31. what are elements of counseling
    • name and description of drug
    • dosage form, dose, route of admin, duration of drug therapy
    • intended use of the drug and expected action
    • special directsions and precautions for preparations, admin and use by pate
    • common severe se, ae, interactions
    • techniques for self moniring drug therapy
    • proper storage
    • refill info
    • action to be taken in the even of a missed dose
    • pharmacist comments relevat to drug therapy
  32. consultation thigns
    • may charge
    • vary or omit hased on individual circumstances
  33. do mail orders or institutions have to offer counseling
    • still requid for mail order new rx or refill--but can be written info and available pharmacist to answer questions
    • must provide a toll free number for long distance numbers
    • NOT REQURIED--hospital inpatient, licensed nursing home or LTCF
  34. LTCF
    • self administer--periodic reevaluation
    • free from unnecessary drugs (antiopsychotics)
    • med errors (<5%)
    • pharmacy services (requied in LTCF) acquire, receive, dispense, admin. timely manner
    • pharmacist serive consultation--establish recordkeeping system and maintain and checkin the records
    • drug regimen review--consultation pharmacist must review each residents drug regimen atleast once a month
    • label requirements--name of resident and phsyician not requied on label of package but must be identifitied with the package to ensure correct admin
    • storages---key access determined by law, CII locked separeely unless usin unit dose
  35. Minnesota nursin home rules... when do things need to be reviewed
    reviewed monthly
  36. what is an unnecessary drug
    • in excessive dose, including duplicate drug therapy
    • excessive duration
    • without adequate indications for its use
    • presence of adverse consequences withch indicate the dose should be drecused or dc
    • pharmacist must report any irregularities to primary care physician
  37. what is the purpose of hipaa
    • impvoe efficiency and effectiveness of health care system
    • regulate privacy and secruity of health information
    • enforeced by dept of health and human services
  38. what are security requirements of HIPAA
    requres covered entities to develop pysical technical and organizational procedure safeguards in order to proptected health information from being impoerply acccessed altered, deleted or transmitted
  39. what information is covered in PHI
    relates to past, present or furture physical or mental health, provision of care, or patmetn of care and could id the patient
  40. whats a notice provisoin
    • pharmacy must provide a notice of privacy practices containin certain requid info
    • notice must be posted in prominent and visible location and made avialable upon requrest to any person
    • if have website, must also be posted there
  41. whats acknoledgement of notice
    • pharmacy must MAKE GOOD FAITH EFFORT TO
    • distrubte notice to patietns and obtain a written signed acknolwedgement of receipt
    • only requied once
    • pharmacist cannot refiues tx if pateint refuses to sign (document)
    • may be extended in several ways
    • acknloedgement may be signed by pt personal representative
  42. who can use and disclose PHI
    • provided for the purpose of treatmnet payment and operations
    • must be provided to the patient if patient
    • may be provided to patients personal representative
    • may be provided to patient agent using professional judgment
  43. what is minimum necessary requirement
    • pharmacy may onlly disclose the minimin anmount of PHI necessary to accomplish the objective
    • several important exceptions exist
    • minimum necessary is limited dddatea set, meaning the exclusion of direct patietn id
  44. what if incidental disclosure
    pharmacy is not responsbile as long as they apply reasonable safeguards to protect PHI
  45. what happens when there is a breach of PHI
    • all affected indiviualds must be notified
    • breach means--acquisition, access, use or disclosure of PHI in unpermitted manner which comproimses the security r privacy of the PHI
  46. excpetions to a breach (when a breach is not a breach
    • acquisition, access, use or disclosure is unintentional and in good faith and dose n oresult in further use or disclosure
    • when unauthroized person to who the PHI has been disclosed would not reasonbly have been able to retain it
    • disclosure is inadvertent between two authorized individuals at same facility if info is not futher used or disclosed
  47. breach decision steps
    • whether a breach occured.
    • if it did then must determine whether the breach poses a significant risk of financial reputational or other harm to individual
    • if no then no need to act
    • if yes then pharmacy must notify the affect person
  48. penalties for hipaa breach
    100$ per violation for unintentional violations and up to 50,000$ per violation for willful neglect violations. intentional acts involving fraud may result in prison
  49. what is covered by health information technology for economic and clinical health 2009 (HITECH)
    • amedni several parts of hipaa, appropriate 20$ bill to develop a nationwide HIT infrasturcture
    • protect privacy of PHI reduce med errors, reduce costs by improving admin efficiency improve coordination among providers and improve public helah and emergency response system
  50. who is covered by medicaid
    • indigent popu.lations, blind, disabled, aged, and famiilies wiht dependent children
    • jointly funded by state and feds
    • covers several services includin outpatietn drugs
  51. Who does medicare cover
    • Health insurace for ppl 65 years and older and certain disabled
    • A--hospitalization
    • B physician services
    • C alternative to B
    • D drugs
  52. what must medicare require for drugs
    • plans must ensure that beneficiaires have convenient access to a network of pharmacies, mail order, but not to replace retail, receive same quantity of drugs at either mail or retail
    • any willing provider requirement
  53. MTM
    • reimburses for MTM
    • minimum level of MTM servies
  54. who should get MTM
    four or more prescriptiosn to treat or prevent two or more chornic medical conditions
  55. what is medicares defined MTM
    • performing a comprehensive medication review to ID, Resolve, and prevent med related problems including adverse drug events
    • communicate essential info to pts other primaryu care
    • provide verbal education and training designed to enhance -pt understandin and appropriate use
Card Set
pharmacy law
pharmacy law exam pharmacist liability and malpractice