Medicines shortages and quota allocation

• Demand is forecast every night for each product, depot and customer group, with each forecast flagged when it isn't reliable.
• Signals from supplier deliveries, quota letters, Medicine Supply Notifications, Serious Shortage Protocols, price concessions and unusual orders are combined into a ranked watch list of products likely to run short in the next four to eight weeks, each with its reasons.
• When a product goes on quota, a proposed allocation is calculated from rules agreed in advance, based on each customer's normal need rather than their latest order, with a reserve for hospitals and urgent patient orders. A supply manager approves it.
• Pharmacies are offered other licensed packs of the same medicine where they exist. A different strength or formulation is never substituted, because that changes what the patient receives and is the pharmacist's or prescriber's decision.
• Customers see an honest expected date and their remaining allocation in the ordering portal, and customer services get a plain-English summary of every shortage.
• People stay in control: buyers, supply managers and the Responsible Person own the rules and the exceptions, and every allocation is logged with its reason.

• MHRAWholesale dealer's licence (WDA(H)) and the supply duty
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  The Human Medicines Regulations 2012 (regulation 43(2)) require the licence holder to ensure appropriate and continued supplies so patients' needs are met, and DHSC has said hoarding can breach this. Allocation rules share stock across all customers, keep a reserve for urgent need, and never hold stock back for margin.

• MHRAGood Distribution Practice and the Responsible Person
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  Every alternative offered must be a licensed product from a qualified supplier, delivered to a customer qualified to receive it. The Responsible Person signs off the substitution rules, and changes go through change control. Controlled drugs stay within the existing Home Office-licensed processes and records.

• DHSCBest practice guidance on supply and distribution (revised August 2026)
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  Wholesalers should manage quotas fairly with a clear review process, avoid regional gaps, share demand changes with manufacturers within competition rules, and report suspected hoarding. Each of these is a feature of the design, not an afterthought.

• DHSCHealth Service Products (Provision and Disclosure of Information) Regulations 2018
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  Wholesalers must answer DHSC requests for sales and volume data promptly. A clean data platform turns each request into a report, not a project.

• MHRAWindsor Framework (since 1 January 2025)
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  Medicines for Northern Ireland are now licensed UK-wide in 'UK Only' packs, so one stock pool can usually serve the whole UK. Older in-date packs licensed for Great Britain or Northern Ireland only are tagged, so an allocation never sends them to the wrong place.

• ICOUK GDPR and the Data Protection Act 2018
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  This is mostly business data, but customer records name pharmacists and some dispensing doctors trade as individuals. No patient data is needed. A short DPIA, UK regions, and a contract that stops providers training their models on your data.

On a phone, the table shows the platform you pick. Sovereign / on-prem means open, portable components you can run in your own data centre or with a UK or European provider; IONOS is shown as one example, and others exist. What sovereign cloud means →

• A written allocation policy that says what "fair" means, how reserves for hospitals and urgent orders work, and how new customers are treated, approved before anything is built.
• A weekly shortage review that works from the watch list, with a named buyer for every product on it.
• An urgent route for patient-specific requests, with a duty supply manager who can release reserve stock, including out of hours.
• Unusual ordering patterns flagged to a person, who decides whether it's hoarding and whether to report it to DHSC. Nothing is blocked automatically.
• A named owner for every model, prompt, rule and data feed, with change control through the quality system.
• Customer services trained on what an expected date means, and how sure it is, before it appears in the portal.

1. 3 weeks

   Discovery

   Map how shortages and quotas are handled today, measure stock-outs and availability calls, check product data and dm+d mapping, and draft the allocation policy.

2. Gate · must be true to passBaseline agreed, data access confirmed, allocation policy drafted with the Responsible Person and commercial, and legal's view on data sharing.

3. 8–10 weeks

   Pilot

   Forecasts and the watch list run in shadow mode across all lines, back-tested on last year's shortages. Allocation proposals run alongside today's spreadsheet for a handful of quota lines.

4. Gate · must be true to passThe watch list caught most past shortages early, proposals are at least as fair as today's, and buyers and the Responsible Person sign off.

5. 4–6 weeks

   Production

   Approved allocations go live for quota lines, and expected dates appear in the ordering portal, with monitoring, support and a rollback plan.

6. Gate · must be true to passMonitoring, support model, rollback plan and customer services training in place.

7. Ongoing

   Scale

   Add hospital contracts, share agreed forecasts with manufacturers, then reuse the pattern for short-dated and slow-moving stock.

8. Gate · must be true to passEach extension passes the same pilot gate.

R ResponsibleA AccountableC ConsultedI Informed· not involved

Where I'd fit

1. 1

   Goes wrong

   The model learns from orders, but a shortage changes the orders: pharmacies over-order, switch strengths and order from three wholesalers at once.

   How the design avoids it

   Forecast normal need from steady order history, treat SSPs and quota changes as known events, and never allocate on the latest order alone.

2. 2

   Goes wrong

   Allocation becomes a black box, and customers who lose out can't be told why.

   How the design avoids it

   Allocation is plain, tested rules, not a model. The AI supplies the inputs; the rules are written down, signed off and explainable to any customer.

3. 3

   Goes wrong

   The same medicine sits under five product codes, so alternatives and duplicates are missed.

   How the design avoids it

   Map every pack to dm+d during discovery, with a named owner, before trusting any forecast.

4. 4

   Goes wrong

   Expected dates shown to pharmacies turn out wrong, and trust goes.

   How the design avoids it

   Show a date only with how sure it is, say "not known" when it isn't, and measure how often the dates were right.

5. 5

   Goes wrong

   The watch list cries wolf, so buyers stop reading it.

   How the design avoids it

   Back-test on last year's shortages, keep the list to what buyers can act on, and track which warnings proved right.

1. Late 2026–2027
   DHSC's response on the shortage information regulations

   DHSC consulted from February to May 2026 on wider reporting of supply problems, requests for stock and future delivery data when demand may outstrip supply, penalties without a prior compliance notice, and giving hub-and-spoke dispensing hubs the same reporting duties as wholesalers. Keep stock, delivery and sales history in a form you could hand over within days.

2. Late 2026–2027
   Pharmacist dispensing flexibilities

   DHSC consulted on letting pharmacists supply a different strength or formulation in some cases. The consultation closed in December 2025, and in October 2026 DHSC said it would set out next steps within weeks. If it goes ahead, demand will move between strengths and forms faster than today. Group products by medicine, not only by pack, so the forecast can follow.

3. 2026–2027
   Project Revive

   NHS England, the MHRA and Medicines UK launched a 12-month pilot in February 2026 to bring dormant licences for 378 at-risk medicines back to market, with a longer-term programme planned for 2027. New suppliers for old products will appear. Make adding a supplier and its quota a configuration change, not a code change.

4. No date yet
   Shortage information at the point of prescribing

   DHSC and NHS England plan to show shortage information to prescribers, with an information standard in development. Keep your availability data structured, dated and easy to share, so you're ready if it's asked for.