May 17, 2020

Study: Changes in Pill Shape, Color May Lead to Lapses

Dr. Aaron S. Kesselheim
Annals of Internal Medicine
Generi
Admin
3 min
A loss of confidence in safety or effectiveness of the pill they are taking results in patients steering away from their medication, according to a recently published study.
In the latest study published on Monday, July 14 by Annals of Internal Medicine, research suggests that changes in a given medications color or shape ma...

In the latest study published on Monday, July 14 by Annals of Internal Medicine, research suggests that changes in a given medication’s color or shape may prompt patients to discontinue much-needed medicine after a heart attack.

As generic drugs continue to see an increase in consumption compared to their high-priced original counterparts, their variation in appearance may be causing confusion amongst patients, ultimately leading some to discontinue their use.

“Patients need to be on guard about pill appearance changes, particularly since it’s hard as a patient to know what’s going on when the blue pill you’re used to taking every morning suddenly is now yellow,” said lead author of the study Dr. Aaron S. Kesselheim, from Brigham and Women’s Hospital in Boston.

The authors of the study urge the Food and Drug Administration (FDA) to rethink their hands-off policy when it comes to regulating the appearance of generic medications.

The FDA does not require a consistent appearance for generic drugs that are otherwise clinically interchangeable – however, it must have the same active ingredient as the original and be delivered the same way – leaving room for aesthetic freedom of choice by the manufacturer.

Drug manufacturers who make generic pills negotiate deals with pharmacies, mail-order pharmacy benefit managers and hospital formularies with one thought in mind: price. The best price determines which pill (from the corresponding manufacturer) the patient will receive when the monthly refill comes around. A mail-order pharmacy may distribute a manufacturer’s drug one month, but then change manufacturers the following month resulting in the distribution of the same drug with a different appearance.

A loss of confidence in safety or effectiveness of the pill they are taking results in patients steering away from their medication, the authors summarized.

According to the U.S. Centers for Disease Control and Prevention, 20 to 30 percent of prescriptions are never filled, while 50 percent are not continued as prescribed.

Researchers studied the pill-taking habits of over 10,000 patients from around the world who were discharged after hospitalization due to a heart attack between 2006 and 2011. In the first year after an event such as a heart attack, it is critical that patients take certain medications to avoid complications and stay on the road to recovery.

But the study found that when patients noted a change in the appearance of their generic pills when going for a refill (29 percent), the odds that they would stop taking the drug increased by 34 percent for a change in pill color and 66 percent for a change in pill shape.

Changing pill appearance is not the most important factor contributing to medication non-adherence, but it is a new one to consider, said Kesselheim.

In addition to public policy actions, the authors said doctors should proactively inform patients about potential changes in pill colors and shapes, and reassure them that the medicines should work identically despite differing appearances.

“The more physicians and pharmacists can do to prepare patients that this might happen, I think the easier the transition will be,” Kesselheim said. 

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Apr 30, 2021

The challenges to vaccine distribution affecting everyone

covid-19vaccine
vaccinesupply
Supplychain
Blockchain
Jonathan Colehower
5 min
The challenges to vaccine distribution affecting everyone
Jonathan Colehower, CEO at CargoChain, describes the COVID-19 vaccine distribution challenges impacting every country, organisation and individual...

While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined. 

Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.  

Production capacity 

Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short. 

Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification. 

The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.

It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.

Distribution requirements

It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.

For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.  

The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.

Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.

Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.

Disconnected information systems 

While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration. 

A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.

By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.

Political influence and social equality 

As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.

In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.  

However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.

Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution. 

The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.

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