Medicine shortages can turn a routine procurement requirement into a complex supply problem very quickly.

A product that was previously available through normal UK wholesale channels may become allocated, delayed or unavailable altogether. Pharmacy teams then need to establish what stock remains, whether alternative products are appropriate and whether another supply route can be identified.

The appropriate response varies by medicine, patient requirement and local governance. UK shortage management may involve remaining licensed stock, alternative presentations, clinically appropriate alternatives, mutual aid or, in some circumstances, an imported unlicensed medicine. DHSC and NHS England work with manufacturers, wholesalers and clinical partners to assess reported shortages and issue professional guidance through mechanisms including Medicine Supply Notifications and the NHS Medicines Supply Tool.

Below are answers to some of the most common procurement questions Alcatia Pharma encounters.

Currently struggling to source a medicine?

1. What counts as a medicine shortage?

A medicine shortage occurs when available supply cannot adequately meet demand within the healthcare system.

There can be several causes, including manufacturing disruption, unexpected demand, discontinuation, problems obtaining ingredients or packaging, regulatory issues and disruption elsewhere in the pharmaceutical supply chain.

Manufacturers are legally required to notify the Department of Health and Social Care of qualifying shortages and discontinuations. DHSC and NHS England then assess reported issues and determine what action may be required.

For an individual procurement team, however, the practical problem often appears much earlier:

the medicine you normally order is no longer available when you need it.

2. Where should pharmacy teams check for official shortage information?

For NHS professionals, national information may be communicated through:

• Medicine Supply Notifications;
• the NHS Medicines Supply Tool hosted by Specialist Pharmacy Service; and
• Serious Shortage Protocols where one has been issued.

A procurement problem does not necessarily have to appear on a national shortage notice before you begin investigating alternative supply.

Local wholesaler availability, allocations and emerging supply disruption can all create difficulties before a formal national response is required.

3. What should we do first when a medicine becomes unavailable?

Start by defining the exact requirement.

Before searching for alternatives, establish:

• medicine or active ingredient;
• strength;
• pharmaceutical form;
• manufacturer or brand, if essential;
• pack size;
• quantity required;
• minimum acceptable shelf life;
• storage requirements; and
• required delivery date.

This prevents procurement teams and suppliers from spending time investigating products that are technically similar but unsuitable for the actual clinical requirement.

The next step is to establish which available supply routes can realistically meet that specification.

4. Does our usual wholesaler being out of stock mean the medicine is unavailable nationally?

No.

Availability can vary between suppliers and different parts of the pharmaceutical supply chain.

A product may be:

• unavailable from one wholesaler;
• subject to allocation;
• available only in limited quantities;
• available through another authorised UK route; or
• unavailable as a licensed UK product while stock exists internationally.

A shortage investigation should therefore distinguish between “our normal supplier cannot fulfil the order” and “no viable supply route currently exists.”

5. What options should procurement teams consider during a shortage?

Depending on the medicine and clinical circumstances, potential routes can include:

1. Remaining licensed UK stock.
2. An alternative authorised UK supplier.
3. Another pack size, strength or presentation.
4. Another clinically appropriate licensed medicine.
5. Mutual aid between NHS organisations.
6. A UK-manufactured unlicensed medicine.
7. An imported unlicensed medicine.

The appropriate clinical option must be determined by the relevant pharmacy and prescribing professionals.

For unlicensed medicines specifically, NHS SPS states that they should only be used where the patient's special clinical need cannot be met by an available licensed medicine.

6. Can another hospital supply us with stock?

Potentially.

NHS hospital pharmacies can use mutual aid in exceptional circumstances when standard supply routes cannot deliver quickly enough. This may include national shortages, sudden increases in demand or urgent patient requirements.

SPS advises that mutual aid should not replace the normal pharmaceutical supply chain and should generally only be requested once other supply options have been explored.

It can nevertheless provide an important short-term route for urgent requirements.

7. Can we source the medicine from overseas?

Potentially, yes.

Medicines may be available internationally even when the usual UK product cannot be obtained.

However, overseas sourcing is regulated pharmaceutical procurement. The product's UK licensing status, country of origin and proposed import route determine what authorisation is required.

For an unlicensed medicine, the MHRA requires an appropriate importer licence and notification of the intended import before the medicine is brought into the UK.

The relevant question is therefore not simply:

“Does another country have stock?”

It is:

“Can an appropriate product and compliant supply route into the UK be established?”

8. What is an unlicensed medicine?

An unlicensed medicine is a medicine that does not hold the relevant UK marketing authorisation.

That does not necessarily mean that it is unlicensed everywhere.

An imported product may be commercially manufactured and licensed in another country but still be considered unlicensed when supplied in the UK.

MHRA guidance permits the supply of unlicensed medicines in defined circumstances where there is a special clinical need that cannot be met by an available licensed medicine.

9. When can an unlicensed medicine be considered?

The key principle is special clinical need.

MHRA guidance states that the needs must be clinical in nature and determined by the prescriber responsible for the patient's care. Regulation 167 of the Human Medicines Regulations allows unlicensed medicines to be supplied when no available licensed medicine can meet that patient's needs.

A shortage can create exactly this type of situation if the licensed medicine that would ordinarily meet the requirement cannot be obtained and suitable licensed alternatives are not appropriate.

An unlicensed medicine should not simply be treated as another purchasing option because it is cheaper or easier to obtain.

10. Does an imported unlicensed medicine need MHRA approval?

The terminology matters here.

The importer must notify the MHRA before importing the medicine, but a “no objection” response is not the same as the medicine receiving a UK marketing authorisation.

The MHRA can:

• raise no objection;
• request further information;
• impose conditions; or
• object to the proposed import.

SPS also makes clear that imported Specials have not undergone the same MHRA assessment for quality, safety and efficacy as a licensed UK medicine, so additional purchaser assurance is required.

11. How long does an MHRA unlicensed import notification take?

For a standard notification, the MHRA has a 28-day assessment period following acknowledgement.

Where justified, the MHRA may expedite the process. Its current guidance states that, for life-threatening or immediately injurious clinical emergencies, it may be able to assess a notification within two working days.

That does not mean the medicine itself can necessarily be delivered within two days.

Supplier availability, product assessment, documentation, freight, customs and temperature-control requirements may all affect the overall lead time.

12. Can an unlicensed medicine be imported from any country?

Potentially, but different licensing requirements apply.

MHRA guidance currently states that an unlicensed medicine imported from an approved country for import requires an appropriately authorised WDA(H). A medicine imported from a country outside that framework requires a Manufacturer's “Specials” Licence covering the import activity.

This is why finding stock internationally does not automatically mean a wholesaler can import it directly.

The regulatory route has to be established alongside the sourcing route.

13. Who can import an unlicensed medicine?

The importer must hold the appropriate MHRA authorisation for the proposed activity.

For products coming from an approved country for import, this can be an appropriately scoped Wholesale Dealer's Authorisation, WDA(H). Other source countries require a Manufacturer's “Specials” Licence for the relevant import.

Procurement teams should therefore verify the authorisation of the organisation handling the import rather than assuming that every pharmaceutical wholesaler can perform the same activities.

14. What should we check before purchasing an imported unlicensed medicine?

SPS recommends additional assurance because an unlicensed medicine has not undergone the normal UK marketing-authorisation assessment.

The purchaser should establish that the medicine:

• is of appropriate pharmaceutical quality;
• meets the purchasing specification;
• is suitable for the intended patient; and
• is packaged and labelled in a way that minimises medication error.

Depending on the product, teams may also need information covering:

• manufacturer;
• country of authorisation;
• overseas marketing authorisation;
• excipients;
• concentration;
• pack configuration;
• storage;
• shelf life;
• labelling;
• product information; and
• supply-chain documentation.

Local pharmacy QA and governance procedures determine the assessment required for the individual organisation.

15. If the molecule and strength are the same, is the overseas medicine equivalent to the UK product?

Not necessarily.

Medicines containing the same active ingredient and nominal strength can still differ in characteristics including:

• excipients;
• concentration;
• vial or ampoule volume;
• administration device;
• release characteristics;
• preparation instructions;
• storage requirements;
• pack size;
• appearance; and
• labelling.

The proposed overseas product itself therefore needs to be assessed rather than relying only on the molecule name.

SPS specifically recommends confirming that an unlicensed medicine meets the purchasing specification and is suitable for the patient before purchase.

16. What if the packaging is not in English?

This is common with imported medicines and should form part of the local risk assessment.

Differences in language, packaging and presentation can increase the risk of medication error.

SPS guidance on unlicensed medicines recommends that governance and risk assessment consider packaging and labelling, including the possibility of misidentification or inappropriate use.

The appropriate mitigation will depend on the individual product and organisation.

17. Can procurement teams buy an unlicensed medicine before local approval is complete?

Local processes vary, but NHS SPS recommends that a quality assessment is completed before an unlicensed medicine is purchased for the first time.

Organisations should also have formal governance arrangements covering sourcing, purchasing, quality assessment, receipt, storage, record keeping and responsibilities for unlicensed medicines.

In practice, the sourcing investigation and local assessment will often progress alongside one another so that time is not lost unnecessarily during a shortage.

18. Can we ask a supplier to hold stock while we assess it?

Potentially, but this will depend on the supplier, product and market.

International shortage stock can move quickly, particularly where multiple countries are affected by the same supply problem.

It is therefore useful to tell the sourcing team early if:

• internal approval is required;
• QA documentation must be reviewed;
• a purchase order may take time;
• the requirement is still awaiting clinical confirmation; or
• there is a hard deadline by which the product must be secured.

That allows the supplier to explain what can realistically be held and for how long.

19. Can we source only part of the quantity we need?

Yes, and during a shortage that may sometimes be the only immediately available option.

For example, a procurement team may identify:

• limited UK stock for the immediate requirement;
• mutual aid for a specific patient;
• overseas stock for subsequent supply; or
• several batches becoming available at different times.

This can result in a staged sourcing strategy rather than a single order solving the entire shortage.

For unlicensed medicines specifically, SPS notes that there are restrictions on quantities purchased at one time and that importers may therefore hold limited stocks.

20. How much shelf life should we expect?

There is no universal answer.

Available shelf life depends on the product and stock found.

Procurement teams should therefore state their minimum acceptable shelf life at the beginning of the enquiry rather than after a product has been identified.

If a shorter shelf life could be acceptable for an urgent requirement, it is useful to make that clear as well.

A product that is unsuitable for routine inventory may still potentially fulfil an immediate patient requirement, subject to local approval.

21. How quickly can Alcatia source a shortage medicine?

It depends entirely on the requirement.

Some enquiries can be resolved through existing authorised supply channels relatively quickly.

Others require:

• an international search;
• supplier qualification;
• product documentation;
• local QA assessment;
• an MHRA import notification;
• specialised transport; or
• additional regulatory work.

The biggest factors are usually availability, quantity, source market and required delivery date.

This is why specifying when the medicine is actually needed is critical.

22. What information does Alcatia need from us?

At minimum:

Medicine or molecule
The exact product or active ingredient.

Strength
For example, 500 mg or 10 mg/ml.

Form
Tablet, capsule, oral solution, vial, ampoule, injection or another presentation.

Quantity
The number of packs, units, vials or doses required.

Required-by date
The date by which the medicine needs to reach you.

It is also useful to include:

• normal UK manufacturer or product;
• preferred manufacturer;
• pack size;
• minimum shelf life;
• storage conditions;
• known shortage reference;
• whether alternative presentations can be considered; and
• any essential formulation requirements.

23. Do we need to know whether we need licensed or unlicensed supply?

No.

If you already know that only licensed stock can be considered, tell us.

If your organisation has approved consideration of an unlicensed import, tell us that too.

But if you simply know:

“We cannot source this medicine through our normal route”

that is enough to begin an enquiry.

Alcatia can investigate what supply options exist and provide information for your team to assess.

24. Does submitting a sourcing enquiry guarantee supply?

No.

Availability can change quickly, particularly during national or international shortages.

A sourcing request allows the team to investigate:

• available stock;
• manufacturers;
• source markets;
• quantities;
• lead times;
• licensing status; and
• potential regulatory routes.

The resulting product still needs to meet the customer's procurement, clinical and governance requirements.

A sourcing enquiry should therefore be considered an investigation of viable options, not confirmation that the medicine can definitely be supplied.

25. Can Alcatia supply licensed and unlicensed medicines?

Alcatia Pharma Limited currently holds MHRA Wholesale Distribution Authorisation UK WDA(H) 59772.

The authorisation covers medicines with UK authorisation as well as medicines without UK authorisation intended for the UK market. Its authorised wholesale operations include procurement, supply, export and products imported from countries on the applicable approved list.

That allows Alcatia to investigate both conventional UK sourcing routes and appropriate specialist international supply options, depending on the product and circumstances.

26. When should we contact Alcatia?

Ideally, as soon as you believe normal supply may not meet the requirement.

You do not need to wait until the final pack has been used or every normal purchasing route has completely failed before asking whether alternatives exist.

Earlier enquiries provide more time to:

• search different suppliers;
• investigate international availability;
• obtain documentation;
• assess proposed products;
• complete internal governance; and
• arrange importation and logistics where required.

If the medicine is already urgently required, make the deadline clear when submitting the request.

The four pieces of information that matter most

When time is limited, start with four things:

What medicine?

Give us the molecule or product.

What exact presentation?

Give us the strength and pharmaceutical form.

How much?

Give us the quantity required.

By when?

Give us the required delivery date.

Those four pieces of information are enough for the sourcing team to begin establishing what may be possible.

Having difficulty sourcing a medicine?

Medicine shortage procurement is rarely about finding one universal solution.

The objective is to establish which supply routes remain available and which of those routes are appropriate for your organisation to consider.

Alcatia Pharma can investigate UK and international supply options for difficult-to-source medicines and provide the product information needed for your pharmacy team to assess the proposed route.

Tell us what you need

Medicine
Strength
Form
Quantity
Required-by date

This article provides general information for healthcare procurement and medicines-supply professionals. It does not constitute clinical, prescribing, legal or regulatory advice. Decisions concerning medicine shortages and the procurement and use of licensed or unlicensed medicines should be made by appropriately authorised professionals in accordance with current MHRA requirements, NHS guidance and applicable local governance procedures.