Download Nongovernmental regulations

Nongovernmental regulations
Pharmacies must comply with federal government laws but
also face nongovernmental regulation and audits.
No criminal penalties unless you did intentional damage ---but there is 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
• the civil charge of negligence would be born from the
breech of the standard of practice.
• When they are looking for clarification on the standard of
practice, courts of law will quite often turn to the state
pharmacy association.
• technician certification program technicians are in the
process of defining their own standard of practice
• The Joint Commission
• Formerly JCAHO.
• conducts voluntary certification inspections on nearly
20,000 health care organizations and programs
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 health 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?
• Ins might 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