Nongovernmental regulations

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 healthcare organizations and programs

5. Nongovernmental regulations • hospitals nursing homes long term care facilities, ambulatory care providers, and medical laboratories. • Some third party payers 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