Understanding Michigan Pharmacy Law: Prescriptions, Communication, and E-Signatures, Slides of Management Fundamentals

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Michigan Pharmacy Law

Chapter 4

Dispensing and Prescribing

Part A

The Prescription

What is a Prescription?

An order

for drugs (both Rx-only and OTC) or devices writtenand signed or transmitted by other means ofcommunication, including oral telephone orders andthose received electronically for drugs or devices written and signed or transmittedby other means of communication, including oraltelephone orders and those received electronically

Third Class of Drugs

Behind the Counter (BTC)

Emergency Contraceptives

Plan B for women over 17 y/o

Pseudoephedrine OTC Schedule V

Cough Syrups

Anti-diarrheals

Communication of an Order

traditional handwritten or typed piece of paper

telephone

fax (facsimile)

“electronic prescribing”

e-prescribing e-script

Distinguish Communication and

Prescribing

Prescribing is act of ordering

Communication of a prescription is notprescribing

Uniform

Requirements

 name of the patient,  name of the drug being ordered,  dosage of the drug,  date the prescription is being originated (also called the date theprescription was “issued”) and  directions for use of the drug, number of times a day the drug is to be administered to or by the patientover a 24-hour day.  The name, address and phone number of the prescriber must appear onthe vast majority of prescriptions; this is not always required for prescriptions that originate in aninstitutional setting, such as a hospital, if there have been arrangementsfor recording the prescriber’s name differently.  Don’t confuse this information with “labeling”

Electronic Signatures in Global and National Commerce Act of 2000

ESIG

PL 106-229 enacted June 30, 1999, (SB 761) and(HB 1714 IH); 15 USC 7001 and effective October 1,^2000

See Vivian, JC, “E Signatures in Pharmacy Practice,”^ U.S. Pharmacist

, Vol. 26: 02, February 2001

E-SIG

A signature cannot be denied legal effect solely because it isin electronic form  DEA has been developing standards for electronictransmission of prescriptions using digital security technology. Not yet for C-IIs  Centers for Medicare and Medicaid Services (CMS) hasadopted standards for electronically transmitted prescriptionsthat are subject to Medicare Part D benefits