1. 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?

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!!!!
Pt has rx for amoxicillin. 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 NOT
contact the prescriber for an alternative drug

4. Malpractice—negligence by professional
Penalty may be –
Restrictions, suspension, fines, revocation, jail
The Joint Commission=Formerly JCAHO.
conducts voluntary certification inspections on nearly 20,000 health care organizations and programs

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
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

6. ISMP 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

7. ISMP says…. About 100,000 American die from medical errors
44,000 hospital drug error deaths
FDA and ISMP work together to analyze dangerous errors
39% errors during dr ordering(bad abbrev, handwriting, bad info)
28% nurse administration
Rest is transcription and dispensing
Right drug
Right dose
Right pt
Right time
Right route
Right technique
Right documentation

8. Medication errors Fatigue, noise, lighting, management,stress
Pt monitoring
Drug knowledge
Lack of pt info(allergies,surgeries,ect)
Rule violations
Herbal meds
Otc meds
Internet meds
Street drugs
Medwatch.gov=voluntary reporting
Also USP medication error reporting program