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What happens if you aren’t compliant with vaccine storage requirements?

There are both legal and ethical consequences to improper vaccine storage. This article breaks down why you need to comply with vaccine storage requirements.

Vaccines are one of the many medical revolutions that keep our populations safe and healthy from the nasty diseases lurking out in the world. As we’ve said before, a vaccine is only as effective as its cold chain! The buck stops with the clinic, practice or, for our feathered and furred friends, the veterinary practice where the cold vials are finally stored in a fridge after travelling the world at sub-zero temperatures.

Some vaccines, such as Ebola, need to be transported at -80°C. The World Health Organisation (WHO) calls this the “ultra-cold chain” and highlights that it’s a particularly challenging one to correctly enforce, with a 700L ULT freezer consuming as much as energy as a walk-in cold room. More typically though, vaccines need to be kept between 2°C and 8°C and any temperature fluctuations could damage the vulnerable contents within.

PharmaScout’s Smart Fridges play a critical role in South African vaccine cold chain.

“Vaccine requirements are developed for a reason,” says Prof Duncan Steele, the deputy director and strategic lead for enteric vaccines in the Enteric and Diarrheal Diseases team at the Bill and Melinda Gates Foundation. “Vaccines are produced to very high standards which are monitored by WHO to ensure that the vaccines are safe and effective – part of that is ensuring that the ingredients are stable and do not degrade so that the vaccine doesn’t work properly. Fortunately, most countries have strong ‘cold chain’ infrastructure (fridges, freezers, refrigerated trucks for transport and well trained staff to administer the vaccines under careful constraints). Sometimes these can be challenging to correctly implement – especially in less developed regions – but storing the vaccine at the right temperature, is important to make sure the vaccines are safe and effective when they reach the patients.” Prof Duncan coordinates teams across Vaccine Development and Vaccine Delivery and has been working with enteric vaccines for over three decades.

So what does happen if vaccine requirements aren’t correctly complied to? There are two broad consequences – some are legal, and some are ethical. 

THE LEGAL CONSEQUENCES

There is a trust system built into medication compliance, in which the manufacturer and distributor are relied on to self-control, destroying stock that’s been damaged. However, the government doesn’t just rely on good will to keep people, and animals, healthy. The South African Health Products Regulatory Authority (SAHPRA) regulates all health products and conducts inspections. However, the challenge is at the pharmacy, clinic and doctor level where historically they have tried to be a provider but with minimal outlay. 

In compliance with Good Pharmacy Practice, the Pharmacy Council will do inspections at the pharmacies, however individual inspectors have different ideas on what is compliant or not and how to implement it. It’s different for distributors as SAHPRA is more forceful, ensuring that the criteria is met.

THE ETHICAL CONSEQUENCES

Imagine waiting for hours for medical attention, like many people around the country do at clinics, and then the medication or vaccine you’re administered doesn’t work because it was improperly stored! As the impassioned paediatrician, Dr Tim de Maayer, wrote to Daily Maverick, health conditions are already challenging across South Africa. Correctly storing vaccines is a responsibility of healthcare providers to ensure patients are receiving top-tier care. 

“As healthcare workers, it is our ethical duty to make sure the pharmaceuticals we administer are safe and effective, and part of that is ensuring the correct storage protocol is observed,” says Cape Town based ENT, Dr Rachel Blokland, “Otherwise, much of what we do is in vain, and we risk losing the public’s trust. Additionally, we need to ensure minimal wastage in the resource-strained system we operate in.” 

The implications of non-compliance are huge: 

  • Vaccine wastage, as damaged vaccines need to be discarded. Says Pharmaceutical Online, “[Politicians] must face a chilling fact that globally nearly half of all vaccines are lost when exposure to unsafe temperature ranges cause the vaccines to lose their efficacy. A majority of these losses are due to failure within the cold chain distribution process. Most states do not even know how much of their budget is spent to cover the costs related to cold chain failure because it goes unmonitored, unreported and unmeasured.”
  • Lack of trust in vaccinations. In an age where anti-vaxxers run rife, and close to 20% of Americans refuse point blank to get the COVID-19 vaccine, applying vaccines that don’t work is hugely damaging to the public’s relationship with vaccinations. 
  • Ineffective vaccines, meaning people need revaccinations (as happened in the USA recently).

As you can see, correctly storing and maintaining vaccines is not only a legal requirement, it is a moral responsibility as well.

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    2022-08-03
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