Can’t prescribe, can’t dispense: the challenge of medicine shortages

Medicine shortages are an ever increasing problem for the UK primary care system, with the Department of Health and Social Care (DHSC) logging an average of 137 shortage notifications per month from medication manufacturers in 2023, an increase of 67% from 2021.¹ With shortages becoming more common, community pharmacies are spending more time attempting to source alternatives and on the phone to GP practices, with practice staff subsequently burdened with prescribing alternatives on an ad hoc basis.² Patients may question the reason for or, more worryingly, be confused by changes, and medication regimens may be disrupted while waiting for a suitable alternative to be sourced. Supply shortages affect a wide range of therapies, including type 2 diabetes, hormone replacement therapy (HRT), epilepsy, and attention deficit hyperactivity disorder (ADHD) medications in recent years.³

Why does it happen?

The medicines supply network is a complex system, encompassing raw materials suppliers, manufacturers, wholesalers, prescribers, pharmacies, and, ultimately, patients. Different parts of this network are exposed to a variety of external factors beyond their immediate control, including market forces, regulatory policy, changes in guidelines or product licensing, and operational challenges. The system’s many moving parts and different vulnerabilities means there can be numerous reasons for shortages of a particular drug. Medicine shortages can be broadly grouped under three causes: demand surge, capacity reduction, and coordination failure.⁴

Demand surge

The first of these, ‘demand surge’, is when the capacity to manufacture or supply a medicine can’t keep up with an increase in prescribing. This can be caused by pandemics, disasters, changes in guidance, and behavioural reactions to supply disruption. It is thought that demand surge was one of the drivers behind HRT shortages in recent years — a combination of greater public awareness (or the ‘Davina Effect,’ following a Channel 4 documentary presented by Davina McCall)⁵ and updated National Institute for Health and Care Excellence (NICE) guidance to broaden the scope of HRT prescribing in the management of menopausal symptoms.^6,7

Capacity reduction

‘Capacity reduction’ sits at the other end of the spectrum, accounting for shortages where not enough of the required medication can be produced. Inability to increase manufacturing capacity, regulatory barriers, inventory management, manufacturing quality challenges, raw material availability, and product discontinuation, can all cause capacity reduction.⁴ An example of this would be the nifedipine brand shortages in 2019, which were partly caused by a shortage of bulk raw materials for production.

Coordination failure

Finally, ‘coordination failure’ describes a situation when there is enough of a particular drug to match demand, but for some reason the medication can’t find its way to the intended patients. Brexit could be considered an example of a geopolitical manifestation of this problem. New alignment of regulatory processes between the UK and the EU, the fall in the value of the pound, shortages of heavy goods vehicles, and new requirements for transport are all factors that affect both the flow of medicines in and out of the country, and affect the UK’s desirability as a place to manufacture medicines in the first place.⁸ Community pharmacies can often find themselves on the sharp end of this, at times dispensing medication at a financial loss or having to be dependent on the volatile and ever-increasing number of price concessions made by the DHSC.⁹ These concessions are temporary ad hoc interventions, acting as financial top-ups when pharmacies cannot source specific medicines at the NHS Drug Tariff price.

While this overarching classification does not consider all of the intricacies of the complex medicine supply system (other factors could include tendering processes, stock quotas, competing industry priorities, and so on),¹⁰ it provides useful, broad insights into the problem.

Current solutions

Serious Shortage Protocols can be issued by the DHSC in the event of a medicine’s shortage. These allow community pharmacies to make prescription substitutions for unavailable items without needing to contact the prescriber. However, they are time-limited and have narrow and prescriptive scopes, offering community pharmacy teams little flexibility to respond to current stock availability. The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), also has regulatory actions around quality assurance it can take to respond to high impact drug shortages, which includes easing restrictions on imports (as well as restricting exports where necessary) and fast-track approvals of batches of medication.³ In addition, the DHSC Medicines Supply team collate up-to-date information about current shortages and work as part of the Medicines Shortage Team to provide support for the management of significant supply problems.³ Current information on specific drug shortages, alternatives to use, and expected resolution dates are also available to clinicians through the Specialist Pharmacy Service’s medicines supply tool (accessible with a free-to-register account).¹¹

Future Solutions

National best practice recommendations encourage generic prescribing wherever suitable, with the British National Formulary stating that generic prescribing ‘will enable any suitable product to be dispensed, thereby saving delay to the patient and sometimes expense to the health service’.¹² However, local prescribing incentives often encourage prescribing of ‘branded generics’ (a drug marketed under a brand name, after the drug is generically available) to facilitate local health system saving, resulting in significant workload if that particular brand of medicine goes out of stock for both GP practices and community pharmacies. Perversely, such practice can actually cause significant cost to the wider NHS, by undermining national funding mechanisms and increasing the vulnerability of the medicines supply chain.¹³ We are aware of no robust evidence to suggest economic benefits from branded generic switching. Encouraging generic prescribing where possible (coupled with a responsive national drug tariff price and effective price concessions system), as opposed to prescribing a smorgasbord of branded generics, would allow community pharmacies to provide whichever product is available, without having to contact the patient’s GP practice for a prescription alteration.

Pharmacists also have a significant role to play in mitigating additional workload landing on GPs’ already too-full desks, with prescribing practice-pharmacists well placed to deal with medicine-based queries independently.¹⁴ Close working relationships and good communications with local community pharmacies can help prescribers across primary care understand which medicines are currently available and which ones are out of stock. It should be noted that different pharmacies may have different wholesale suppliers for their stock, which means that medication availability may vary from one pharmacy to another. Some pharmacy chains already have live stock-checkers for patients and clinicians to see which pharmacies have a medicine in stock (for example Boots pharmacy; https://www.boots.com/online/psc/). Having joined-up local communications can help identify which pharmacies are affected by medicine shortages on a given day (thus avoiding ‘ping-ponging’ patients around the local system).

Finally, with all newly-registered pharmacists from 2026 set to be independent prescribers, there is scope for a national system to be established to empower community pharmacists with limited prescribing rights. Schemes in Canada have allowed pharmacists ‘level 1’ prescribing rights to substitute brands for generic options and make minor alterations to prescriptions for drug formulations or quantities.¹⁵ A similar national scheme for community pharmacists to make minor amendments such as these to mitigate the effects of drug shortages would reduce workload on general practice significantly. Appropriate governance of any future schemes would be needed, to ensure that commercial interests would not adversely impact clinical appropriateness.

In conclusion, medicine shortages are a growing, multifactorial problem, which adversely impact patients, but also increase workload for front-line professionals. Although legislation and regulation exists to lessen the impact, additional solutions should be actively pursued, particularly around strengthening interprofessional collaboration, and avoiding potentially short-term ‘cost-cutting’ exercises for which evidence of benefit is lacking.

Provenance

Commissioned; externally peer reviewed.

Competing interests

Tomazo J Kallis was funded through Wellcome-NIHR School for Primary Care Research ‘PhD Programme for Primary Care Clinicians’ grant. Rupert A Payne has declared no competing interests.