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Nongovernmental regulations 
Pharmacies also face nongovernmental regulation and 
audits. 
No criminal penalties but civil and financial liability. 
Standard of practice---- 
Fill as written? 
Call prescriber? 
Pt best interest? 
What would typical practictioner, armed with typical 
knowledge of the profession, do in response to the 
situation?
Nongovernmental regulations 
• Typical practitioner?---- 
• 1-- grad from accredited college of pharm with 5 yr 
BS 
• 2—completed exam by state license 
• 3—completed cont ed 
• 4—current and complete knowledge of medications 
dispensed 
• 5---operate in compliance with laws of pharmacy
Nongovernmental regulations 
• If he were to dispense without current and complete 
knowledge of new drugs, he would be violating the 
standard of practice. 
• Could something be legal to do, but yet constitute a 
violation of the standard of practice? Yes!!!! 
• looking at the patient profile we note the patient is 
allergic to penicillin antibiotics. Since amoxicillin is a 
penicillin antibiotic, the patient would most likely suffer 
an allergic reaction. Would it be legal to fill this 
prescription? Yes, it would. Would it be wise to fill it? No, 
it most definitely would NOTi 
• contact the presenter for an alternative drug
Nongovernmental regulations
Nongovernmental regulations 
• hospitals nursing homes long term care facilities, ambulatory care 
providers, and medical laboratories. 
• Some third party payors and HMOs demand Commission certification 
before they will authorize treatment of their members 
• Institute for Safe Medication Practices (ISMP) 
• non-profit organization dedicated to educate the health care community 
and consumers about preventing medication errors 
• causes of medication errors--- 
• incomplete patient information when prescribing and administering drugs 
• miscommunication between doctors, pharmacist and other hearth care 
team members 
• confusion generated by look-alike or sound-alike drug names 
• confusing drug labeling 
• identical or similar packaging for different doses of a drug 
• misinterpreted abbreviations 
• FDA has formed an official partnership with the ISMP 
•
Nongovernmental regulations 
• Third Party Audits---verification from the auditor that the 
claims submitted and paid were correct and reasonable 
• Does the prescription hard copy exist? 
• Did the patient pick up the prescription? 
• Do we stock the merchandise we say we do? 
• ask for a reimbursement of the non-verified prescriptions 
or worse. 
• Employer Audits--normally will have a book that covers 
the manner in which the employer feels the business 
should be run 
• responsibilities and duties of each member of the 
pharmacy team, mission statement
Nongovernmental regulations 
• Third Party Audits---verification from the auditor that the 
claims submitted and paid were correct and reasonable 
• Does the prescription hard copy exist? 
• Did the patient pick up the prescription? 
• Do we stock the merchandise we say we do? 
• ask for a reimbursement of the non-verified prescriptions 
or worse. 
• Employer Audits--normally will have a book that covers 
the manner in which the employer feels the business 
should be run 
• responsibilities and duties of each member of the 
pharmacy team, mission statement

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Nongovaudit

  • 1. Nongovernmental regulations Pharmacies also face nongovernmental regulation and audits. No criminal penalties but civil and financial liability. Standard of practice---- Fill as written? Call prescriber? Pt best interest? What would typical practictioner, armed with typical knowledge of the profession, do in response to the situation?
  • 2. Nongovernmental regulations • Typical practitioner?---- • 1-- grad from accredited college of pharm with 5 yr BS • 2—completed exam by state license • 3—completed cont ed • 4—current and complete knowledge of medications dispensed • 5---operate in compliance with laws of pharmacy
  • 3. Nongovernmental regulations • If he were to dispense without current and complete knowledge of new drugs, he would be violating the standard of practice. • Could something be legal to do, but yet constitute a violation of the standard of practice? Yes!!!! • looking at the patient profile we note the patient is allergic to penicillin antibiotics. Since amoxicillin is a penicillin antibiotic, the patient would most likely suffer an allergic reaction. Would it be legal to fill this prescription? Yes, it would. Would it be wise to fill it? No, it most definitely would NOTi • contact the presenter for an alternative drug
  • 5. Nongovernmental regulations • hospitals nursing homes long term care facilities, ambulatory care providers, and medical laboratories. • Some third party payors and HMOs demand Commission certification before they will authorize treatment of their members • Institute for Safe Medication Practices (ISMP) • non-profit organization dedicated to educate the health care community and consumers about preventing medication errors • causes of medication errors--- • incomplete patient information when prescribing and administering drugs • miscommunication between doctors, pharmacist and other hearth care team members • confusion generated by look-alike or sound-alike drug names • confusing drug labeling • identical or similar packaging for different doses of a drug • misinterpreted abbreviations • FDA has formed an official partnership with the ISMP •
  • 6. Nongovernmental regulations • Third Party Audits---verification from the auditor that the claims submitted and paid were correct and reasonable • Does the prescription hard copy exist? • Did the patient pick up the prescription? • Do we stock the merchandise we say we do? • ask for a reimbursement of the non-verified prescriptions or worse. • Employer Audits--normally will have a book that covers the manner in which the employer feels the business should be run • responsibilities and duties of each member of the pharmacy team, mission statement
  • 7. Nongovernmental regulations • Third Party Audits---verification from the auditor that the claims submitted and paid were correct and reasonable • Does the prescription hard copy exist? • Did the patient pick up the prescription? • Do we stock the merchandise we say we do? • ask for a reimbursement of the non-verified prescriptions or worse. • Employer Audits--normally will have a book that covers the manner in which the employer feels the business should be run • responsibilities and duties of each member of the pharmacy team, mission statement