It is essential that pharmacists have conversations with patients about adherence, storage issues that lead to antimicrobial resistance

Pharmacy hours interviewed Amy Cadwallader, PhD, director of regulatory and public policy development at the US Pharmacopeia (USP), about the impact of antimicrobial resistance (AMR) on drug quality and the drug supply chain.

Alan Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy hours. With me is Amy Cadwallader, PhD, director of regulatory development and public policy at the US Pharmacopeia, or USP, who is here to discuss the impact of antimicrobial resistance, or AMR, on the quality of drugs and the drug supply chain.

So, Amy, can you tell us a bit more about your role at USP?

Amy Cadwallader: Of course, Alana, and thank you for inviting me. I am an analytical pharmacologist and toxicologist by training and relatively new to the USP team, having joined the team earlier this year. Previously, I led the pharmaceutical and science policy activities at the American Medical Association. In my role here at USP, I really lead the development of evidence-based policy positions and related content. I also maintain relationships with key stakeholders such as pharmacists.

Alan Hippensteele: The statistics on the impact of RAM are therefore staggering. Can you talk a bit about that?

Amy Cadwallader: So definitely. Antimicrobial resistance, or AMR, occurs, as the public knows, when microbes such as bacteria or viruses evolve and change, and this change makes the drugs we use to kill their infections less effective. [effective] or ineffective. In the United States, more than 2.8 million AMR infections are reported to occur each year, resulting in more than 35,000 deaths.

The World Health Organization has listed AMR as one of the top 10 public health threats facing humanity today, and in an alarming recent publication it was estimated that in 2019, more than one million people died worldwide from AMR infections, and an additional 5 million died from their complications. The paper also notes that if we don’t take immediate action by 2050, there could be over 10 million deaths from AMR each year. And I should also note that the main cause of AMR is the excessive and inappropriate use of some of these antimicrobial drugs.

Alan Hippensteele: How does drug quality affect AMR?

Amy Cadwallader: Of course, drug quality can contribute to AMR in 3 main ways. The first is the amount of active pharmaceutical ingredient, or API, in drugs. It may be lower and cause patients to take a subtherapeutic dose.

The second is poor quality excipients or inactive ingredients. If these are present in drugs, they can alter the pharmacokinetics of the drug and the drug may act inappropriately or ineffectively in the human body. The third comes from impurities or breakdown products that appear in some drugs, this can also result in a subtherapeutic dose.

I should also note that these 3 quality issues lead to a process called selective pressure, where exposing microbes to a moderate dose kills the weaker microbes, but the stronger ones grow and spread at a faster rate. raised.

Alan Hippensteele: It’s fascinating. So what is the role of pharmacists in the fight against AMR?

Amy Cadwallader: Of course, 2 main things come to mind. The first is to encourage stewardship, which means talking to patients about going through their medications and finishing everything.

The second is really ensuring quality, making sure there’s proper storage at the pharmacy and also having those conversations with patients about proper storage of medications at home. They can also talk with patients about not storing leftover drugs and disposing of them properly, because expired drugs, especially antimicrobials, have lower potency and this subtherapeutic dose can spread resistance.

Alan Hippensteele: So what is the role of USP in the fight against RAM?

Amy Cadwallader: So, thanks for asking. USP takes a multifaceted approach to combating antimicrobial resistance. The first is really to better understand the problem and how quality affects it. USP has a quality institute that sponsors independent research that answers evidence-based policy questions and really informs our policy-making, and the USP Quality Institute has sponsored research on the impact of drug quality on antimicrobial resistance.

Second, we have many public quality standards related to the manufacture of antimicrobials. Third, we look at supply chain vulnerabilities and how to address them to strengthen the supply chain to ensure adequate supply of these drugs. And finally, we engage in many dialogues on stewardship issues and also on innovation to continue the pipeline of new and innovative antimicrobials.

Alan Hippensteele: Right. How does the drug supply chain affect AMR?

Amy Cadwallader: Of course, thank you. That’s a very good question. The USP recently highlighted some data from an analysis tool, we have the drug supply map, and this data indicates that antimicrobial drugs are 42% more likely to be in short supply than others. medications. When medicines are in short supply, there is usually a proliferation of falsified and substandard medicines in the supply chain, and although these implications primarily affect low and middle income countries, the implications are truly global and in the spread of antimicrobial resistance. We therefore encourage a wider geographical distribution of API manufacturers and more sources of manufacture of these active pharmaceutical ingredients. We also encourage proper storage throughout the supply chain.

Alan Hippensteele: Right. What are some things we should be doing to fight AMR, and how can USP and pharmacists work together to achieve this?

Amy Cadwallader: Of course, pharmacists are very important points of contact for patients, and patients really listen to the advice they receive from their pharmacists. So I just want to point out that it’s really important for pharmacists to have these conversations with their patients about compliance and about storage issues. USP and pharmacists have worked so closely together for over 200 years since our inception and hearing the observations and challenges that pharmacists face on the front lines really helps inform our work and can help us better help all parties. stakeholders, including pharmacists.

Alan Hippensteele: Right, absolutely. Anything else to share?

Amy Cadwallader: No, I really think the big take-home message here is that we all need to be better stewards of antimicrobial drugs to ensure that the supply we currently have remains effective as we continue to innovate. I also think it’s important to understand why and how quality really matters for this problem. So if people want to know more, they can check out usp.org or any of the links we have provided.

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