Pharmaceutical manufacturing is a complicated process requiring highly specialized skills in quality control, automated manufacturing, validation, and verification. Due to the high stakes of producing pharmaceuticals, it is paramount to ensure that the final product is as safe as possible to avoid causing harm to the consumer. This can be accomplished by adhering to safety and manufacturing protocols and regulations.
Find out everything you’ve always wanted to know about the Drug Supply Chain Security Act (DSCSA) by downloading our infographic.
What is a Drug Recall and How Does It Affect My Business?
A drug recall can prove disastrous for the company behind it. A drug recall occurs when a medication is found to be defective or harmful, and when a defect is discovered (either by the FDA or the company behind its manufacturing), all products in circulation are immediately recalled and removed from shelves or medical dispensaries.
The effects of a drug recall are widespread and severe, making it very important to prevent a drug recall from the very start. It’s no surprise that a recall primarily affects the business where it hurts most; the wallet. When a recall is required, the company must reimburse those who paid for the product. Depending on the quantity in circulation, this can be a devastating figure.
Not only does it affect the finances short-term, but there are also long-term financial implications of a drug recall. A recall often tarnishes the brand behind the product due to the lack of faith in the products they produce, causing sales to decrease. For smaller companies, this can stifle any chance of recovering from the mishap.
Possible Reasons for Recalls
Below you will find a list of the top 7 reasons for pharmaceutical recalls:
- Increases Risks of Harmful Diseases
Although clinical trials are often conducted, it is difficult to tell if there are long-term side effects of medicines from lab testing for short periods of time. Drugs can cause a higher chance of stroke, heart problems, and death in some patients, making them unsafe to use and requiring a recall.
- Interacts with Specific Drugs, Foods, or Drinks
In some cases, consumers of a specific pharmaceutical are on a unique regiment of drugs that are carefully calculated to be safe. When a drug is introduced to the market, it is possible that it has not been tested with their combination of drugs, leading it to interact and cause adverse effects. The same can happen with foods or drinks, with alcohol often presenting complications with medicines.
- Contains the Wrong Amount of an Ingredient
Due to a miscommunication or manufacturing error, it is possible that a drug may contain too much or too little of a specific ingredient. This can cause the medicine to either have too strong or too little of an effect on the user, which can cause additional health problems.
- Contamination of Drug During Manufacturing
If proper precautions are not taken during manufacturing, it is possible that there can be chemical contamination. Facilities that manufacture multiple drugs need to be particularly careful that their production is sterile and free of any drug or chemical residue that can find its way into the drug.
- Does Not Offer Proper Safety Warning
Medicines are required to contain safety warnings, alerting the user to any potential side effects, interactions, or dangers of the product.
- The Dosing Guidelines are Incorrect
Dosing is one of the most critical parts of administering and using drugs. If the wrong dosing information is provided, you risk accidental overdose which can lead to death or underdose which may offer no benefits.
- Faulty Packaging Leading to Contamination
Some drugs require a sterile environment to be safe and effective to use. If there are mistakes in the transport or packaging of the substance, contamination can occur and eliminate the benefits it provides.
How to Prevent Drug Recall
Clarke Solutions assures the Safety, Identity, Strength, Purity, and Quality (SISPQ) of every product, every time. Our team possesses deep domain knowledge and experience in Manufacturing and Packaging, Serialization and Traceability, Automation, and Verification and Validation. Our experts assess the needs of our clients’ lines from start to finish and design, implement, and test systems to automate tasks for maximal production and yield. Our years of experience and high standards are invaluable when it comes to preventing drug recalls. To find out more or request a free consultation, contact us today!