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Factors Involved in U.S. Generic Drug Shortages

The lack of general medicine has weighed on an already strained health system. Unfortunately, drug shortages can ultimately lead to adverse patient outcomes and extreme increases in treatment costs. Health professionals, especially pharmacists, have a consistent role in dealing with this public health crisis.

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In order to adequately address the problem, researchers have tried to investigate the causes of the generic deficiency. Studies show that drug shortages are ultimately caused by a variety of factors. However, the most likely causes of generic deficiencies are economic and regulatory factors.

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To counter the harmful effects of a drug shortage, public health officials, health professionals and economists try to pinpoint the root cause. It is now believed that a drug shortage is the result of a combination of factors, including poor gain.

Quality control challenges, corporate mergers, complex generic supply chains, natural disasters, and regulatory barriers. Laws that have been tried such as the FDA Safety and Innovation Act (FDASIA) and its amendments, including the General Drug Cost Amendments (GDUFA) I and II, and Title X. to fight drug shortages; Despite significant improvements, the crisis continues. 3,7-9=

The shortage of generic drugs affects many areas of the health spectrum. Pharmacists often bear the burden of overcoming drug shortages, eg. This includes coordinating drug supplies, developing alternative drug protocols, and dealing with patient and other health care dissatisfaction.

Approved Drug Products with Therapeutic Equivalence Evaluations

The Orange Book identifies drugs approved on the basis of safety and efficacy by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetics Act. The publication does not contain any drug on the market that is approved only for safety reasons.

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The main criterion for submitting a product is that it is subject to application with an effective authorization that has not been withdrawn for safety or efficacy reasons. Inclusion of a product on the list does not depend on current official action at the administrative or judicial level against medicinal products.

Additionally, the Orange Book includes a therapeutic equivalence rating (2 symbolic rating codes) for approved multi-source (generic) prescription drugs.

These ratings serve as public information and advice to public health authorities, prescribing authorities and pharmacists to help educate the public about drug choices and reduce health care costs.

The therapeutic equivalence ratings in this publication are not official FDA actions affecting the legal status of products under the law.

Lastly, the Orange Book lists the patents that have been developed to protect drugs. Patent lists and usage codes are provided by the owner of the drug application and the FDA must register them.

The Orange Book does not list organic products such as vaccines. They are included in the list of licensed organic products which are subsequently adopted with reference ratings of exclusivity and biosimilarity or interchangeability known as Purple Books.