Strategies To Prevent Manufacture and Distribution of Substandard Medications

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of these problems.

Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reaching 95 degrees Fahrenheit.  Recently, Allergan’s Taytulla birth control products were recalled due to the packaging of active tablets and inert tablets in the wrong order, potentially leading to patients likewise taking the tablets in the wrong order and not obtaining the desired result. Allergan stated, “As a result of this packaging error, oral contraceptive capsules that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.”

Harm to patients and damage to a company’s reputation are the two most obvious consequences of substandard product. Yet, many companies pay too little attention to these problems, preferring short-term gain over long-term reputation and profitability. Within companies, it is common to hear the argument that quality is a cost center and does not directly contribute to the company’s profits. While the quality function is obviously not the same as sales and marketing, prevention of losses due to quality issues (e.g., product recalls) or remediation (e.g., addressing lawsuits or FDA enforcement actions) affects the bottom line every bit as much as sales. In this webinar we provide you with best practices that have been proven effective, and equip you with the means to advocate for these ideas within your organization.

The problem

• Poisons
• Temperature excursions
• Risks to patients
• Risks to companies

Solutions

• Maintain a robust quality system
• Supplier quality
• Product testing
• Monitoring temperature    

Join industry and governmental efforts to improve product quality worldwide

• Current initiatives
• Benefits to Pharma companies

Explore new technologies to bolster product integrity

• Blockchain
• Portable testing devices

Make a hardheaded assessment of risk and reward when assessing cost reduction initiatives

• Identify most vulnerable areas
• Cost-benefit considerations

Review of learning objectives

If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. Examples of potential dangers that can occur include temperature excursions, inappropriate use, and unsafe ingredients inadvertently added to the product.

In terms of effect, substandard pharmaceutical product is a worldwide issue on a par with counterfeiting. The following examples illustrate how the origins of such cases can vary but lead to similar deadly results. In the case of tainted cough syrup that caused at least 400 deaths in Panama in 2006, an inactive ingredient was the culprit when diethylene glycol, a poisonous substance used in antifreeze, was sourced by a Chinese manufacturer. In another instance, heparin sourced from China and used in a product made by Baxter Laboratories led to 149 deaths in the U.S. in 2007 and 2008. While there was no deliberate malicious intent, there was a neglect of quality that led to the tragic result. These and other events have raised questions about the quality of active ingredients sourced from many countries and used in products manufactured and marketed in the U.S.

• Product Security
• Packaging
• Labelling
• Manufacturing
• Warehousing and Distribution

Michael Esposito has over 30 years’ experience in the pharmaceutical industry and 17 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for Johnson & Johnson Consumer Healthcare and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.