Regulatory amendments to permit original pack dispensing from the start of 2025 have been signed by pharmacy minister Stephen Kinnock this week (September 2).

From January 1, pharmacists in England can supply patients with a drug in its “original outer packaging” even if the quantity dispensed is different to that specified on a prescription, according to the new regulations.

The quantity of the drug dispensed in its original packaging must be within 10% either way of the quantity on the prescription, they said.

Read more: Pharmacists to supply sodium valproate in whole original pack, DH confirms

The pharmacist must also judge that providing a different quantity to that prescribed is “reasonable and appropriate” and will not cause a patient to fail to follow “the medication regimen as intended by the prescriber”, they added.

But the amendments make exceptions for controlled drugs in schedules two to four of the Misuse of Drugs Regulations of 2001 and for special medicinal products as specified in the Human Medicines Regulations of 2012.

 

“Significant support”

 

In March last year, C+D reported that the government had published the outcome to its consultation on original pack dispensing (OPD) and on whole pack dispensing of medicines containing epilepsy and bipolar disorder treatment sodium valproate.

It said at the time that “in light of the overall positive response, the government intends to progress the proposals for OPD and the whole-pack supply of medicines containing sodium valproate”.

The consultation – which ran for six weeks from November 1 to December 13 2021 – garnered more than 80 responses, it added.

Read more: Pharmacy technicians allowed to supply drugs under PGDs from this month

There was “significant support” for OPD flexibilities and “overwhelming” support for the introduction of mandatory whole-pack dispensing of medicines containing sodium valproate, the update said.

The reform aimed to “support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer’s packaging about the safe and effective use of a product”, it added.

It also aims to “support efficiencies for pharmacies” by freeing up pharmacy teams “for other tasks such as providing clinical services to patients” instead of spending time splitting boxes, snipping blisters and repackaging medicines, the government said.

 

“Adverse financial effect”

 

But responses to the consultation raised concerns that:

• OPD will cause an “adverse financial effect for contractors with up to five pharmacies who have no legal or financially viable access to automated dispensing”

• An increased use of OPD could lead to a “decrease in income” for individual community pharmacies due to issues around reimbursement, such as around container allowances

• “Discrepancies” in records between prescriptions and exact quantities dispensed could lead to patient confusion, “re-ordering issues later” and more emergency supplies needing to be provided by community pharmacies

Read more: Pharmacist-run private clinics to be regulated in Scotland from June 19

• “Excess stock” in the hands of patients when they are dispensed more than prescribed would increase the risk of “medicine abuse or overdose”

• The need for more storage space could put “pressure” on pharmacies and they could be forced to create more medicines wastage

• Pharmacies will need to spend more time “explaining the process to patients and dealing with complaints”

The government stressed at the time that pharmacists can use their clinical judgement as to whether to use the OPD flexibility – which is “enabling and not mandatory” – or supply the exact quantity prescribed.

 

Savings “limited and variable”

 

The government also last year admitted that overall time and cost savings for pharmacies “are likely to be limited and variable”.

It said that it “noted” comments on reimbursement, with concerns that pharmacy contractors should be reimbursed according to actual supply a “key theme throughout the responses”.

However, reimbursement arrangements were “yet to be determined” through negotiations, it added.

Read more: ‘Level playing field’: Hub and spoke possible for all pharmacies from January

“The government also understands that pharmacies and GP practices may have to spend additional time with patients but has considered that this will level out over time,” it said.

According to a blog published yesterday by pharmacy law experts PLEA, October 2023 amendments to the Human Medicines Regulations 2012 (HMR) laid the ground for permitting original pack dispensing in England and Wales, but the “new provision” would only take effect in England once NHS terms of service had been amended.

However, the amendments on the whole-pack dispensing of medicines containing sodium valproate came into force immediately in October last year.

 

Legislation latest

 

In June, C+D reported that legislative amendments permitting pharmacy technicians to supply and administer prescription drugs under patient group directions (PGDs) would come into force that month, after being pushed through in a pre-election wash-up.

In the same month, the Scottish government introduced “particularly urgent” legislative amendments to regulate private clinics run by pharmacists or pharmacy technicians.

And in May, the government announced that it would make legislative changes to allow all pharmacies to use the hub-and-spoke dispensing model from January, including those that are different legal entities.