The ‘human’ side of drug shortages: Securing the supply chain

Paul Smaltz, vice president, pharmaceuticals, at Roquette, explores how taking a more ‘human’ look at the issue of drug shortages and supply chain resilience could help the industry find the fresh ideas it needs to tackle this increasingly pressing problem.

Key insights:

• The rarer the medical condition, the lower the chance of finding a suitable alternative when specialised medications are in short supply.
• Drug manufacturers are exploring more oral dosage forms as alternatives to cold storgae drug products to address supply chain issues.
• Extended-release forms of APIs using specially formulated excipients can eliminate the need to take multiple tablets a day and ultimately improve patient experience.

Shortages are shaping up to be a serious problem for the pharmaceutical industry. The past year has seen patients across Europe struggling to find previously common drugs, such as amoxicillin and even paracetamol, as well as specialised medicines for diabetes, ADHD and certain psychiatric conditions. Recent world events help explain some of these supply challenges, but pharma industry commentators contend that the issue is more structural – indeed nearly half of all respondents to a McKinsey survey cited single supplier sourcing as a critical vulnerability.

In terms of barriers to optimal healthcare outcomes, drug shortages are only rivalled by one issue: medical non-compliance. In the US alone, it is estimated that medication non-adherence accounts for as much as 50% of treatment failures, resulting in 125,000 deaths each year. Strategies for tackling patient compliance – including administration routes, taste masking or dispersion times – aren’t normally factored into discussions of supply chain issues – but should they?

Dual hits to patients’ health

Amid all the talk around logistics, it’s important to remember that at the end of every disrupted supply chain is a patient in need. When generic drugs are in short supply, doctors and pharmacists are forced to prescribe alternatives, which aren’t always as effective as the first-choice solution, due to different mechanisms of action, dosages, delivery methods, etc. In France, a study of medication replacements found that alternative prescriptions resulted in errors in at least 11% of cases – and these patients could be considered the lucky ones. The rarer the medical condition, the lower the chance of finding a suitable alternative when specialised medications are in short supply. It is unsurprising therefore that more than half of UK pharmacists feel the current supply chain issues are “putting patients' health at risk”.

Supply chain concerns share many similarities with the effects of medical non-compliance that healthcare professionals have been flagging for years. With an ageing population across Europe and global instances of chronic disease on the rise, there’s a pressing need for effective drug delivery formats. Yet many patient groups, particularly children, the elderly and people who experience issues swallowing, are often forced to use medications that are inconvenient, difficult or even dangerous to take. This in turn, leaves them susceptible to pill fatigue and other forms of non-adherence. Whether lack of access to appropriate medications is due to supply chain disruption or unsuitable delivery methods, the impact on patients is the same – less effective treatments, worse outcomes and lower quality of life. Fortunately, just as supply issues and medical compliance share many challenges, their solutions are equally interlinked.

Assessing potential answers

In the face of unprecedented events like war or a pandemic, some level of shortage is inevitable as drug manufactures pivot supply strategies. One way producers can simplify this process, however, is by exploring alternative delivery formats that are easier to store, transport and – crucially – take. A great example is the potential of oral and other non-parenteral dosage forms for vaccines.

Maintaining a meticulous cold chain during the transport and storage of liquid biologics is one of the toughest challenges involved with rolling out traditional vaccination programs.

For this reason, drug manufacturers are exploring oral dosage forms, such as orally dispersible tablets (ODTs), pulmonary inhalers and nasal sprays as alternative delivery methods for biologic medications. This area of research is still relatively new, but a number of studies have already shown that these delivery forms are easier to store and transport – making them less susceptible to supply chain disruption – and more attractive to patients, as they remove the need for off-putting needles.

Another solution which could address supply pressure and patient experience is extended-release dosage forms. These delivery methods use specially formulated excipients to control the release of the active pharmaceutical ingredient (API), maintaining a more consistent dosage level without the need for multiple pills throughout the day. The benefit in terms of supply is simple: fewer tablets/capsules needed means less susceptibility to shortages. For patients too, controlled release dosage formats simplify their medication routines, reducing pill fatigue for better prescription compliance.

Expert support at every step

The unexpected link between drug shortages and patient compliance is now hopefully coming into focus, but there is one final element to include. To successfully tackle these dual challenges, it is essential that drug manufacturers partner with excipient and API suppliers who are equally committed to delivering better outcomes for patients. With the right, high-quality excipients and an expert partner well-versed in the intricacies of the global pharma supply chain, manufacturers can unlock healthier futures for all.