FDA Issues Prescription Label Requirements to Ensure Clear, Concise Understanding on Medication Uses and Risks

New guidelines from the FDA will ensure that prescription labels are easier to understand and include messaging about the dangers of abuse.

On July 1, 2019, the Food and Drug Administrationissued newprescription label requirements.

Medication that will be included under these new rules include those that are categorized under the Controlled Substances Act.Controlled substancesare highly potent and potentially addictive medications, includingopioids.

The new FDA prescription label requirements will include:

• Clearer, commonly understood terms
• Abuse-deterrent information
• Better patient instructions, including visual elements

The FDA has a history of tracking abuse and providing new standards or guidelines when widespread abuse is evident. This move represents their continued commitment to providing medical caregivers with checks and balances when they prescribe and distribute addictive drugs.

In their statement detailing this new measure, they state that its intended purpose is to limitaddiction, abuse, dependence andtolerance. Providing as much clarity as possible, they allege, will empower pharmacists and other medical professionals with better and more efficient information as they distribute medication.

Drug Abuse and Dependence Section of Labeling

Drug abuse can stem from a variety of factors related to inadequate labeling practices. A study by Friends of Cancer Research found that 56% of the 450 drugs reviewed had uses that extended beyond the FDA label. Supreme Court cases that have addressed labeling have largely relied on evidence of whether manufacturers are at fault for “failure to warn.” 

The elderly and non-English speakers are specifically at risk for unintentionally abusingprescription drugs. Not having clear, straightforward descriptions on medication labels can have fatal consequences.

The Role of Government

The FDA is the branch of the government that sets dispensing guidelines, inspects drugs and conducts research for new drugs. Their approval determines if a drug can be available to consumers, and their recommendations extend to most of the medications people take.

The Drug Enforcement Administration is the governmental branch that enforces rules and guidelines forthe way that prescription drugs are handledin the United States. This includes standards for how drugs are monitored, inventoried, moved as well as prescription guidelines and other dispensing issues.

The DEA and FDA work in conjunction to create and enact legislation related to drug handling and, in this case, packaging and information. Aprescription drug labelmust include certain information.FDAprescription labeling requirementsmust be clearly printed with:

• Pharmacy information
• Doctor information
• Instructions
• Physical description of the drug
• Federal caution statement
• Dates
• Pharmacy prescription number
• Number of pills
• Number of times the drug can be reordered

The federal caution is a statement required by the DEA and used to immediately determine if a drug is being used by the person it was prescribed for.Prescription drug warning labelsare meant to deter abuse. It is illegal to remove a warning label from a package of prescription drugs.

These new requirements are meant to provide patients with important information, including:

• Useful and Informative Product Labeling: Product labeling guidelines are in place to help pharmacists and patients immediately understand what the drug is, what it should look like, how much of it to take and other vital information.A human prescription drug labelmust include all of the legal information set forth by the FDA.
• Details on Abuse-Deterrent: The information that must be clearly printed on containers of prescription drugs is meant to immediately identify the origin and recipient of the drug, including where and by whom it was prescribed and consumption guidelines. The goal of this measure is to deter abuse and create at least an initial barrier from illicit sharing or selling of prescription drugs.
• Presentation of Applicable Drug Products: Understanding at a glance what drug is in a package and what it should look like is a helpful way for people who receive prescription drugs to detect mistakes immediately. Drug products are subject to specific labeling. This new measure should serve to make messaging even more clear.

Prescription Label Requirements for Opioid Analgesics

Prescription label requirementsare most vital for controlled substances, which arehighly addictiveand can be abused. One major area of need is opioid reduction protocols.

When medical providers prescribe opioids for acute pain relief and the prescription runs out, those who have become addicted may to turn to street drugs or take even more extreme measures, such as usingheroin, or even committing suicide.

As of April 1, 2019, the FDA is institutingopioid tapering protocolto help people gradually stop relying on these pain medications.Labeling requirements for prescription drugsthat include guidelines for tapering:

• Help people decrease their opioid use safely.Opioid addiction and dependencecan find safe recovery through thegradual discontinuation of opioids.Undergoing anopioid taper program, subject toopioid tapering guidelines, is often the best long-term solution for people who struggle with addiction issues.
• Reduce the danger of rapid discontinuation. The abrupt discontinuation of opioids can send someone using prescription drugs into a state of shock andacute withdrawal. Desperation and drug-seeking behaviors can follow this extreme experience.Opioid tapering protocolis a proven method to better serve people who have been reliant on opioids.

Moving Forward

Prescription drug label requirementshave the potential to greatly assist people in taking medications safely and correctly.Label requirementsthat are as universally understandable as possible will help both medical care providers and patients taking prescription drugs. The inclusion of clearer instructions, abuse and diversion deterrent messaging and enhanced visual elements will make understanding and taking opioid medications an easier and safer experience for everyone.