Bringing Seasonal Relief: A Total Quality Strategy Can Benefit Small-Molecule Allergy Drugs

quality strategy
Many people suffer from seasonal allergies but choose to take OTC medication rather than see a doctor for a prescription. A total quality strategy is necessary to maintain product quality in this necessary market.
Image source: Flickr CC user William Brawley

While much of the United States may still be experiencing the harsh temperatures of winter, spring is only a few weeks away. Unfortunately, warmer days also mark the coming of something else: seasonal allergies. Many people suffer from this condition—something that drug companies are well aware of, if the number of allergy relief products lining drugstore shelves is any indication.

Recent events, however, may alter what medications will be available over the counter in the near future. Earlier this year, a major pharmaceutical company had to recall its OTC versions of two popular allergy medications. One of the drugs was found to potentially contain an impurity while the other may have incorrect dosing markings. The recalled medications aren’t actually suspected of any harmful contamination, but no one wants to risk administering a potential overdose.

A Complete Quality Strategy Is Required for Over-the-Counter Allergy Medication

While the company is no doubt striving to address the problems that contributed to the recalls, these types of incidents need to be avoided at all costs. Firms don’t need to deal with the fall out, in terms of both reputation and economics. With the variety of OTC medications available on the market, allergy sufferers are likely to turn toward other brands for relief. And depending on the cause of the recall and the amount of time needed to tackle the issue, the incident can become attached to their name. People often say that any publicity is better than no publicity, but surely that popular adage doesn’t apply to pharmaceuticals. Without a doubt, firms specializing in OTC allergy drugs need to ensure that their quality strategy procedures support the development and manufacturing of high quality products.

Even though the recall may make consumers leery of the affected brands, it’s highly doubtful that they’ll give up OTC medications any time soon. In fact, the number of seasonal allergy sufferers is notoriously inaccurate because on the whole, allergies tend to be underdiagnosed and undertreated. An estimated 62% of allergy sufferers use OTC medication while only 14% of adults see a specialist for treatment. What makes these figures even more interesting is that they don’t correspond to patient satisfaction. Fifty-one percent of people who use prescription allergy medication are pleased with the results, but only a dismal 33% are with OTC versions.1 In addition, children are more likely to see a specialist for treatment or receive an allergy shot2, suggesting that something changes when an allergy sufferer reaches adulthood.

The root cause of those changes might be unsurprising to those familiar with present-day medical insurance plans. Like with other types of medication, cost has an influence. In some cases, medical insurance may not even cover prescription allergy medication until patients have tried OTC versions first. As a result, adults are more likely to self-treat allergy symptoms by selecting a product they saw in an advertisement or that was recommended by a friend. The problem with this tactic is that it’s a decision made without the input of a trained medical professional. Allergy sufferers who take OTC medication may, in fact, be taking the incorrect drug to address their symptoms. Under those conditions, we shouldn’t be surprised to discover that perceived efficacy is lower than expected, leading to user dissatisfaction. Due to these factors, allergy drug manufacturers must remain conscious of customer perception and how it may affect public opinion of product quality.

Hopefully, we won’t be seeing other allergy drug recalls in the near future. To prevent the possibility, pharmaceutical companies must confirm that their organizational culture supports a total quality strategy. Not only because it can minimize the chances of a product recall, but also because it can lead to better overall efficiency and productivity. The tendency of allergy sufferers to self-medicate means firms need to be able to respond to shifting market pressures while maintaining high quality standards. Quality management processes are often the cause of bottlenecks during the research, design and manufacturing stages, which can slow down the release cycle in a highly competitive market. On the other hand, these management processes cannot be overlooked. Otherwise, companies risk the chance of product recalls and regulatory action for noncompliance. Despite not being prescription medication, OTC allergy drugs still require the same level of attention and care due to the number of people who use them.

BIOVIA Total Quality is a complete suite of tools packaged to help companies with their quality management processes. In today’s competitive small-molecule drug market, poor quality can have a detrimental effect on a company’s reputation and market advantage, such as is sometimes the case with product recalls. Through proper implementation, a total quality strategy will ensure not only regulatory compliance but also product and process quality. With the support of the Total Quality solution, procedural bottlenecks are minimized through streamlining workflows, thereby increasing productivity. Above all, the BIOVIA solution allows you to maintain or increase perceived quality levels while lowering compliance costs, thus allowing your organization to maintain and increase profit margins. If your firm is interested in a solution that will complement your organization’s quality strategy, then please contact us today to learn more.

  1. “Most Allergy Sufferers Not Getting Relief from Over-the-Counter Meds,” November 6, 2015,
  2. “Why Are Seasonal Allergy Sufferers Using Over-the-Counter Medication if They Want Prescription Meds?” November 5, 2015,

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