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DƯỢC LÍ Goodman & Gilman's The Pharmacological Basis of Therapeutics 12th, 2010

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may be telephoned to a pharmacy only in emergency

situations. To be an emergency:

• Immediate administration is necessary

• No appropriate alternative treatment is available

• It is not reasonably possible for the physician to provide

a written prescription prior to the dispensing.

For an emergency prescription, the quantity must

be limited to the amount adequate to treat the patient during

the emergency period, and the physician must have

a written prescription delivered to the pharmacy for that

emergency within 72 hours. If mailed, the prescription

must be postmarked within 72 hours. The pharmacist

must notify the DEA if this prescription is not received.

Refills

No prescription order for a schedule II drug may be

refilled under any circumstance. For schedule III and IV

drugs, refills may be issued either orally or in writing,

not to exceed five refills or 6 months after the issue date,

whichever comes first. Beyond this time, a new prescription

must be ordered. For schedule V drugs, there are no

restrictions on the number of refills allowed, but if no

refills are noted at the time of issuance, a new prescription

must be made for additional drug to be dispensed.

Preventing Diversion

Prescription blanks often are stolen and used to sustain

abuse of controlled substances and to divert legitimate

drug products to the illicit market. To prevent this type

of diversion, prescription pads should be protected in

the same manner as one would protect a personal

checkbook. A prescription blank should never be presigned

for a staff member to fill in at a later time. Also,

a minimum number of pads should be stocked, and they

should be kept in a locked, secure location except when

in use. If a pad or prescription is missing, it should be

reported immediately to local authorities and pharmacies;

some areas have systems in place to allow the

rapid dissemination of such information. Ideally, the

physician’s full DEA number should not be pre-printed

on the prescription pad, because most prescriptions will

not be for controlled substances and will not require the

registration number, and anyone in possession of a valid

DEA number may find it easier to commit prescription

fraud. Some physicians may intentionally omit part or

all of their DEA number on a prescription and instead

write “pharmacist call to verify” or “call for registration

number.” This practice works only when the pharmacist

may independently verify the authenticity of the prescription,

and patients must be advised to fill the prescription

during the prescriber’s office hours. Pharmacists can

ascertain the likely authenticity of a physician’s DEA

number using an algorithm.

Another method employed by the drug seeker is

to alter the face of a valid prescription to increase the

number of units or refills. By spelling out the number of

units and refills authorized instead of giving numerals,

the prescriber essentially removes this option for diversion.

Controlled substances should not be prescribed

excessively or for prolonged periods, as the continuance

of a patient’s addiction is not a legitimate medical

purpose.

DRUG STANDARDS

AND CLASSIFICATION

The U.S. Pharmacopeial Convention, Inc. is a nongovernmental

organization that promotes the public

health and benefits practitioners and patients by disseminating

authoritative standards and information on

medicines and other healthcare technologies. This

organization is home to the U.S. Pharmacopeia (USP),

which, together with the FDA, the pharmaceutical

industry, and health professions, establishes authoritative

drug standards. These standards are enforceable

by the FDA and the governments of other countries

and are recognized worldwide. Drug monographs are

published in the USP/National Formulary (USP-NF),

the official drug standards compendia that organize

drugs into categories based on pharmacological actions

and therapeutic uses. The USP also provides chemical

reference standards to carry out the tests specified in the

USP-NF. For example, a drug to be manufactured and

labeled in units must comply with the USP standard for

units of that compound. Such standards are essential for

agents possessing biological activity, such as insulin.

The USP also is home to the USP Dictionary of

U.S. Adopted Names (USAN) and International Drug

Names. This compendium is recognized throughout the

healthcare industry as the authoritative dictionary of

drugs. Entries include one or more of the following:

U.S. Adopted Names, official drug names for the

National Formulary (NF), previously used official

names, International Nonproprietary Names, British

Approved Names, Japanese Accepted Names, trade

names, and other synonyms. In addition to names, the

records in this file contain other substance information

such as Chemical Abstract Service (CAS), registry

number (RN), molecular formula, molecular weight,

pharmacological and/or therapeutic category, drug

sponsor, reference information, and structure diagram,

1885

APPENDIX I

PRINCIPLES OF PRESCRIPTION ORDER WRITING AND PATIENT COMPLIANCE

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