Drugs and Prescriptions

Introduction

When using and prescribing drugs and different medications, there are many elements to understand before giving advice to a patient. A career in the healthcare field requires you to be able to read, interpret, and document drug orders. For over-the-counter medications, you can use the Physicians' Desk Reference, drug monographs, and package inserts as sources of information to pass on to patients to ensure proper use of drugs and medications.

 

Physicians' Desk Reference (PDR)

The Physicians' Desk Reference (PDR) is a compilation of information on FDA-approved prescription (Rx) and over-the-counter drugs. The PDR, which is updated annually, was initially designed to provide physicians with information relevant to writing prescriptions. It's now widely available and frequently used by other medical and healthcare providers and even by consumers.

You'll see physicians and other healthcare providers accessing this information as apps on their mobile devices. The information that the physicians and nurses need is at their fingertips.

 

There are many different publishers of PDRs. For the purpose of this course, we're using the PDR Nurse's Drug Handbook. PDRs generally refer to a drug's generic name. Within the PDR Nurse's Drug Handbook is the generic name of the drug in bold, along with the phonetic pronunciation. In the header are the classification (the type of drug or class under which the drug is listed), the FDA's pregnancy category, trade names (names under which the drug is marketed), and whether the drug is prescription or over-the-counter. After the header is additional information, such as uses, contraindications (symptoms or conditions that make a particular treatment or procedure inadvisable), side effects, laboratory test considerations, drug interactions, dosages, and more. 

 

Drug Monographs and Packaging

A drug monograph is a concise collection of information about a given drug that's required by the FDA to describe the characteristics of the drug. It's usually a printed document containing detailed information that has been reviewed and approved by the FDA for accuracy and detail, and it describes all aspects of the use of the drug for medical purposes. The information in the drug monograph has been derived from the multitude of data submitted in the New Drug Application (NDA) to the FDA and has been transformed into an organized, concise, and official description of the actions of the drug.

The monograph is filed with the FDA as the official information that must, by law, accompany the drug, possibly in edited form, in all advertising, promotion, and descriptions of the drug. It is, in a sense, a legally binding document that can be used to describe the actions of the drug if questions concerning these actions arise. A copy of the drug monograph can be obtained by anyone upon request to the FDA.

 

The drug monograph or its edited version can be found in many sources of drug information, including the insert that accompanies a drug package as distributed to the pharmacy, the Physicians' Desk Reference, and other official and unofficial compendia of drug information. Drug monographs that accompany the promotional literature of a drug present a great deal of information in a very concise manner. 

 

A package insert is a copy of a drug monograph that accompanies the drug in its package when distributed for sale and use. Each new drug package opened for dispensing in the pharmacy contains the package insert for that drug. If the medicine is packaged in a box or plastic container, the package insert is folded and placed inside the box. If the medicine is available as pills or liquid in a bottle, the insert is affixed with some type of adhesive to the outside of the bottle.

Drug monographs accompany drugs when they're shipped throughout the country to pharmacies and other dispensaries. Once the monograph is folded and placed into the drug package, it then becomes known as the package insert. Because the package insert is the drug monograph, it's concise, contains a great deal of information, and takes up a very small space. The package insert is affixed to the outside of the medication bottle in its original configuration.

The original packet takes up a space of 1 1/2 inches by 2 1/2 inches. If the insert is unfolded, it opens to a final size of 12 inches by 18 inches. Since both sides of the 12-by-18-inch paper are filled with type, the entire package insert holds about 32,400 words—a lot of information!

These inserts change shape and size frequently, but an online version of this information is almost always available.

Package inserts come in various sizes, depending on how they accompany the medicine and the size of the medicine bottle or box. Imagine a small ointment tube in a box into which an insert must be placed. In this case, the insert is probably folded many times and printed in very small type. A large box of medicine, however, probably contains a larger printed insert.

 

Key Points

• The Physicians' Desk Reference (PDR) is a compilation of information on FDA-approved prescription and over-the-counter drugs.
• The PDR is updated annually and provides physicians with information relevant to writing prescriptions.
• A drug monograph is a concise collection of information about a specific drug that is required by the FDA to describe the drug's characteristics.
• A package insert is a copy of the drug monograph that is packaged with the drug when distributed for sale and use.
• One of the roles of a healthcare provider is to read, interpret, and document medication orders.
• A prescription is a written order for dispensing or administering medications.
• Prescriptions are usually written by physicians, dentists, and other licensed healthcare professionals as allowed by law.
• A medication order is a written or verbal order issued by a licensed healthcare professional for administration of a medication in a healthcare setting.
• Latin abbreviations are used frequently in prescription writing; this allows the prescriber to write long sentences quickly.
• A pharmacist must rewrite Latin abbreviations into a complete English sentence and place it on the label for the patient to understand.