Prescription Writing and the PDR

Objectives

The medical student will learn the basic concepts of prescription writing, including basic terms and abbreviations. The medical student will be able to apply these concepts in writing valid prescriptions. The medical student will learn the federal drug schedule laws and be able to apply the laws to his/her prescription writing. The medical student will become familiar with the organization of the Physician's Desk Reference (PDR). The medical student will be able to apply his/her knowledge of the PDR in selecting medications and in enhancing his/her understanding of the use of medications. Prescription Writing

The prescription is one of the most important therapeutic transactions between physician and patient. The art of prescription writing is an ancient inheritance. Its origin is lost in antiquity, but its importance through the centuries has made it one of the most significant written communications of the human race. The ancients started their prescription with an appeal to the gods for its success. The ancient symbol, Rx, signifying the appeal, was established centuries ago and has been carried down to the present time. Many ancient prescriptions were noted for their multiple ingredients and complexity of preparation. The importance of the prescription and the need for complete understanding and accuracy made it imperative that a universal and standard language be employed. Thus, Latin was adopted, and its use was continued until approximately a generation ago. Present-day prescription practices lead, for the most part, to prescriptions containing a single ingredient, written in English, with doses given in the metric system. The ancient "Rx" and the Latin "Signatura," abbreviated as "Sig.," are all that remain of the ancient art of the prescription. To avoid undesirable and/or serious effects on the patient, both physician and pharmacist must render the highest of professional services. Accurate diagnosis; proper selection of medication, dosage form and route of administration; proper size and timing of dose; precise dispensing; accurate labeling; and correct packaging all must be provided. Form of the Written Prescription A prescription, stripped to its barest form, consists of the superscription, the inscription, the subscription, the signa, and the name of the prescriber - written within the confines of a form. Superscription The date when the prescription order is written; the name, address and age of the patient; and the symbol Rx (an abbreviation for "recipe," the Latin for "take thou." Inscription The body of the prescription, containing the name and amount or strength of each ingredient. Subscription The directions to the pharmacist, usually consisting of a short sentence such as: "make a solution," "mix and place into 10 capsules," or "dispense 10 tablets." Signatura From the Latin "signa," meaning "write," "make," or "label," this sections contains the directions to the patient. These should always be written in English; however, physicians continue to insert Latin abbreviations, e.g. "1 cap t.i.d. pc," which the pharmacist translates into English, "take one capsule three times daily after meals." Since the pharmacist always writes the label in English, the use of such abbreviations or symbols should be discouraged. The instruction, "take as directed," is not satisfactory and should be avoided. The directions to the patient should include a reminder of the intended purpose of the medication by including such phrases as "for pain," "for relief of headache," or "to relieve itching" (Table 1). Labeling

When the physician wants his patient to know the name of the drug, the box on the prescription form marked "label" should be checked. Refills The physician should designate the number of refills he wishes the patient to have. Proprietary vs. Non-Proprietary ("Generic") Prescriptions In recent years, some hospitals and private physicians are indicating on the prescription their willingness or desire that the pharmacist dispense a non-proprietary or "generic-named" preparation instead of the trade name item written on the prescription. Some have a box on the prescription designated "N.P.P." In this way, the pharmacist can use a form of the drug which may be less expensive to the patient. The amount to be dispensed should be clearly stated and should be that needed by the patient. Excessive amounts should never be dispensed, as it is not only expensive to the patient, but may lead to accumulation of medicines in the home, which can later cause harm to the patient or members of his family. It is far better to have several refills of a prescription than to have an excessive amount prescribed at one time (Table 2).

LAWS AFFECTING PRESCRIPTION WRITING Types of Drugs

Legend Drugs: These drugs may not be dispensed by a pharmacist without a prescription from a physician, osteopath, dentist, etc. Federal and State drugs are "legend." Labels on these medications carries the legend: "Caution! Federal law prohibits dispensing without a prescription." Controlled Drugs: In addition to requiring a prescription, these drugs require additional safeguards for storage. Refills are also limited. Both State and Federal government agencies promulgate regulations regarding these drugs. The Federal agency is the Drug Enforcement Administration and the State agency is the Division of Narcotics and Dangerous Drugs of DHHR.

Over-the-Counter (OTC) Drugs: These drugs do not require a prescription. Controlled Substances Act of 1970

Schedules of Controlled Drugs: The drugs that come under the jurisdiction of the Controlled Substances Act are divided into five schedules. Drugs can be scheduled, unscheduled, or moved from one schedule to another as the need arises. Schedules are as follows: Schedule I Drugs in this schedule have no accepted medical use in the United States and have a high abuse potential. Examples are heroin, marijuana, LSD, peyote, etc. Schedule II Drugs in this schedule have a high abuse potential with severe psychic or physical dependence liability. Included are certain narcotic analgesics, stimulants, and depressant drugs. Examples are opium, morphine, codeine, hydromorphone, methadone, meperidine, oxycodone, anileridine, cocaine, amphetamine, methamphetamine, phenmetrazine, methylphenidate, amobarbital, pentobarbital, secobarbital, methaqualone, and phencyclidine. Schedule III Drugs in this schedule have an abuse potential less than those in Schedules I and II and include compounds containing limited quantities of certain narcotic analgesic drugs, and other drugs such as barbiturates, glutethimide, methyprylon, and chlorphentemine. Any suppository dosage form containing amobarbital, secobarbital, or pentobarbital is in this schedule. Schedule IV Drugs in this schedule have an abuse potential less than those listed in Schedule III and include such drugs as barbital, phenobarbital, chloral hydrate, ethchlorvynol, meprobabmate, chlordizepoxide, diazepam, oxazepam, chloroazepate, flurazepam, etc. Schedule V

Drugs in this schedule have an abuse potential less than those listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic analgesic drugs used for antitussive and antidiarrheal purposes. Registration

Physicians

Every physician who administers, prescribes, or dispenses any of the drugs listed in the five schedules must be registered with the State of Louisiana and the Federal Drug Enforcement Administration. "administer" to instill a drug into the body of the patient "prescribe" to issue a prescription order for the patient "dispense" to deliver controlled substances in a container to the patient The registration must be renewed annually, and the certificate must be maintained at the registered location. If more than one office is maintained where controlled substances are kept, then each office must have a separate registration. Address for Louisiana: Louisiana Department of Health and Human Resources Office of Licensing and Regulation Division of Narcotics and Dangerous Drugs P. O. Box 60630 New Orleans LA 70160 (person in charge: Raymond J. Fagot, R.Ph.) Federal Procedure: Obtain Form DEA-224 United States Department of Justice Drug Enforcement Administration P. O. Box 28083 Central Station Washington DC 20006 (Form DEA-224 may also be obtained from local or regional DEA offices.)

Interns, Residents, and Foreign Physicians

Interns, residents, or foreign physicians may dispense, administer, and prescribe controlled drugs under the registration of a hospital or other institution by whom they are employed, provided that:

the institution is registered; the physicians are authorized or permitted to do so by the jurisdiction in which they are practicing; the dispensing, administering, or prescribing is in the usual course of their professional practice; the institution has verified that the physicians are permitted to dispense, administer, or prescribe drugs within the jurisdiction; the physicians act only within the scope of their employment in the institution; the institution authorizes the intern, resident, or foreign physician to dispense or prescribe under its registration and assigns a specific code number for each physician so authorized, as shown in the following example:

DEA Hospital Registration # Code # AB123467 021 and;

a current list of internal codes and the corresponding individual prac-titioner's code is kept by the institu-tion and is made available at all times to other registrants and to en-forcement agencies upon request, for the purpose of verifying the authority of the prescribing physician.

Records Physicians DO NOT have to keep additional records if they:

prescribe controlled drugs; or administer controlled drugs.

Physicians DO have to keep additional records if they:

dispense controlled substances as a regular part of their professional practice, for which the patients are charged, either separately or together with other professional services. The records must indicate all drugs received or dispensed. The records must be kept for a period of two years. In addition to keeping records, every two years the physician must take an inventory of existing drugs stocked.

Physicians who order controlled substances for dispensing or admin-istering must use special order forms (DEA 222C) to order the drugs. Requirements for Prescriptions Written for Controlled Substances

Required Information on the Prescription

Must be dated and signed on the day it is issued. Must have the full name and address of the patient. Must have the name, address, and DEA registration number of the physician. May be prepared by the secretary, but must be typed or written in indelible ink and signed by the physician. The physician is respon-sible for having all the pertinent in-formation on the prescription. Telephone Orders Telephone orders may be placed for drugs in Schedules III, IV, and V. A written prescription is required for ordering drugs in Schedule II. In an emergency, a prescription for Schedule II drugs may be telephoned to a pharmacy. If the pharmacy is willing to accept the telephone order, only enough drug to cover the emergency may be prescribed. The physician is then required to supply a written prescription to the pharmacy within 72 hours. The pharmacist is required to call the "Feds" if he doesn't receive the prescription within 72 hours. "Emergency" means that the immediate administration of the drug is necessary to proper treatment, that no alternative treatment is available, and that it is not possible for the physician to provide a written prescription order for the drug at that time. Refilling Prescriptions for Controlled Substances Refills for Schedule II drugs are not permitted. Refills for Schedule III, IV, and V drugs are permitted if the number of refills is indicated on the prescription. However, the prescription order may be renewed only up to five times within six months after the date of issue. After five renewals or after six months a new prescription order is required.

Physicians' Desk Reference

The Physician's Desk Reference (PDR) is published annually by Medical Economics Company, Inc. with the cooperation of the drug manufacturers whose products are listed within and is intended primarily as a reference for physicians. Its purpose is to make available the essential information on most major pharmaceutical products prescribed by physicians. Products described in the PDR that have official package circulars must be in full compliance with Food and Drug Administration regulations pertaining to labeling for prescription drugs. Contents of the PDR include: Manufacturers' Index - Section 1 (white). A list of manufacturers who have provided prescribing information in this edition of the PDR, their addresses, and emergency telephone numbers; and a partial list of available products. Brand and Generic Name Index - This index includes all entries in the Product Information and Diagnostic Product Information sections. Products are listed alphabetically by both brand and generic name.

An underline denotes a generic name. Bold page numbers indicate full prescribing information. Italic page numbers signify partial information. The symbol marks drugs shown in the Product Identifica-tion Guide. The symbol means product information is located in PDR For Nonprescription Drugs.

If two page numbers appear, the first refers to the product's photograph, the second to its prescribing information. For more on this index, see "How to Use the Brand and Generic Name Index." Product Category Index - Section 3 (blue). Products are listed according to the appropriate category, as determined by the publisher in cooperation with each manufacturer. Product Identification Section - Section 4. Under company headings, capsules and tablets are shown in color and actual size as an aid to identification. An index of participating manufacturers appears on page 302. Product Information Section - Section 5 (white). An alphabetical arrangement by manufacturer of over 2,500 pharmaceuticals, fully described as to composition, action and uses, administration and dosage, contraindications, precautions, side effects, the form in which supplied, and other information concerning use, including common names, generic compositions, or chemical names. The symbol Rx opposite the name indicates the product requires a prescription. The symbol C indicates its control class and that the prescription requires a DEA number. "How Supplied" under this section should not be taken to mean the quantity to dispense, unless in a tube or individual dispenser. Diagnostic Product Information - Section 6 (green). Diagnostic product description, listed alphabetically by manufacturer, to aid the physician in their use. Poison Control Center - A list of centers and emergency telephone numbers. Discontinued Products Section - List of products withdrawn from the market by the manufacturer. FDA - US Food & Drug Administration - List of professional and consumer information numbers, such as vaccine adverse event reporting and breast implant inquiries. Key to Controlled Substance Categories. Key to FDA Use in Pregnancy Guidelines.

How to Use the Brand and Generic Name Index - This index lists every product alphabetically by both brand and generic name. Generic names are underlined; brand names are not. Under each generic name, you will find a list of the brands that contain it. This enables you to find a particular product by either of its names. For example, "Ativan Injection" is listed once alphabetically and again under its generic name, lorazepam. Each time a brand name appears, it is followed by the manufacturer's name and the page to consult for further information. Under a generic heading, all fully described brands are listed first, followed by those with only partial information. In each case, the brands are listed alphabetically.

T. Davis, MD updated 8/30/05