Special containers and products requiring reconstitution

Special containers and products requiring reconstitution

There are special requirements and reimbursement arrangements for dispensing those products which are recognised as being packaged in special containers or items requiring reconstitution.

What is a 'special container'?

A product is granted special container status in cases where it is not practical to split a pack, for example where the product is sterile or hygroscopic. A product can be classed as special container in its complete original pack size or in its sub-pack size (for example a tablet blister strip).

Where the quantity of a product ordered by the prescriber does not coincide with that of an original pack size and the product is considered a special container (as a  complete pack or sub-pack size), contractors are required to supply the special container or combination of containers nearest to the quantity ordered and endorse the prescription form with the number and size of these containers. Where the quantity ordered falls exactly between two containers, contractors should round down, and supply the nearest complete container.

Criteria of special containers and products requiring reconstitution

Part II Clause 10 B of the Drug Tariff outlines the following criteria which needs to be met for a product to be granted special container status. Where the quantity ordered by the prescriber does not coincide with the of an original pack and the drug or chemical reagent is:

  • Sterile
  • Effervescent or hygroscopic, or
    • a. Liquid preparations for addition to bath water
    • b. Coal Tar preparations
    • c. Viscous external preparations
  • Packed in a castor, collapsible tube, drop-bottle, pressurised aerosol, puffer pack, roll-on-bottle, sachet, shaker, spray, squeeze pack, container with an integral means of applications or any other container form which it is not practicable to dispense the exact quantity:

The contractor shall supply in the special container or containers the quantity nearest to that ordered and endorse the prescription form with the number and size of those containers. Where the quantity ordered falls exactly between two containers, contractors should round down, and supply the nearest complete container.

Payment for the nearest complete pack or number of packs also applies to antibacterial, antiviral or antifungal preparations listed in 5.1, 5.2 and 5.3 (except 5.3.1) of the British National Formulary (BNF), which are for oral administration and requires reconstitution from granules or powder. Part II Clause 13 of the Drug Tariff states that:

when the quantity reconstituted from an original pack or packs is unavoidably greater than the quantity ordered and it has not been possible for the contractor to use the remainder for or towards supplying against another prescription, payment will be calculated from the Basic Price of the preparation and will be based on the nearest pack or number of packs necessary to cover the quantity ordered”.

Please note that the phrase “necessary to cover” is interpreted as the amount dispensed must allow the patient to complete the full course of medication prescribed. Therefore, if a product matching the above description is required to be reconstituted, contractors will be paid based on number of packs required to cover the quantity prescribed.

Difference between Part II Clause 13 (RECONSTITUTION OF CERTAIN ORAL LIQUIDS) and special container rules

Where the quantity ordered falls exactly between two containers, the rounding down rules do not apply to eligible oral anti-infective products which require reconstitution. This is because where the quantity of a liquid antibiotic, for example, reconstituted from granules or powder, is unavoidably greater than the quantity ordered and it is not possible for the contractor to use the remainder of the reconstituted product to fill another prescription, the contractor should supply enough packs necessary to cover the quantity ordered and will be reimbursed based on the nearest pack or number of packs necessary to cover the quantity ordered.

Identifying products which have been marked as special containers

Products classed as special containers in Part VIII of the Drug Tariff are marked with a small black square (◼) next to the drug name, for example:

 

Eligible products for oral administration which require reconstitution from granules or powder are marked with a small black circle (•) next to the drug name in the Drug Tariff, for example:

 

Examples taken from June 2020 Drug Tariff

To confirm the status of a product not listed in the Drug Tariff, you can check the NHS Dictionary of Medicines and Devices browser (dm+d) browser which is updated weekly (every Thursday) by the NHSBSA. Alternatively, dispensing system supplier should automatically prompt users as to which products which are classed as special container and indicate the number of packs (or sub-packs) to dispense. Check with your system supplier on the frequency of dm+d system updates which should ideally be done weekly in line with NHSBSA’s scheduled weekly update. PSNC also maintains a special container database which is updated on a monthly basis and can be found at: psnc.org.uk/SCdatabase.

Dispensing the exact prescribed quantity if it is different to the special container pack size

Where the quantity ordered does not coincide with that of the special container pack size you are required to supply the nearest complete pack or sub-pack(s) nearest to the quantity ordered.

Exceptions to the rules around quantity to supply for special containers

In a small number of cases, where there is an over-riding clinical requirement to dispense the exact quantity ordered rather than the nearest complete pack or sub-pack size (for example, if the drug is required to be packaged into a weekly compliance aid of if there is a risk that the patient may misuse the drug), pharmacists would need to assess the clinical appropriateness of splitting the pack to dispense the exact quantity bearing in mind the impact on the stability of the drug once removed from its original
packaging. There may be patient safety issues to consider if a pharmacist decides to dispense the exact quantity ordered (if not a multiple of the sub-pack size). For example, if a hygroscopic drug is not stored and used correctly, exposure to moisture could affect the integrity of the drug by potentially decreasing its stability and/or efficacy.

Special container endorsements

For products classed as special containers, pharmacy teams are required to endorse the prescription form with the number and size of the containers used to dispense from.

Products requiring reconstitution endorsements

With regards to items requiring reconstitution, NHSBSA will automatically flag any eligible items as special containers and therefore reimbursement will be calculated automatically based on the nearest number of packs required to cover the quantity ordered. This will occur even if resulting liquid is not of limited stability as the stability of the liquid does not affect the quantity to be reimbursed.

Pharmacy teams are advised to endorse the amount of packs supplied to enable the patient to complete the full course of medication prescribed.

In cases where there is a clinical requirement to dispense the exact quantity of a product ordered rather than the nearest pack size, to protect against any suggestion of  fraud, the contractor should dispense the prescribed quantity and endorse the prescription form clearly with the quantity supplied and the pack size used.

Pricing

In calculating reimbursement, the special container rules are automatically applied and contractors will be reimbursed for the nearest pack or combination of packs. With regards to items requiring reconstitution, payment will be based on the nearest pack or number of packs necessary to cover the quantity ordered.

Sorting and submission

There are no specific requirements for sorting these prescriptions separately (unless the prescription meets one of the criteria for inclusion in the red separator).


Worked Examples

Q. What quantity would I be reimbursed for supplying against a prescription ordering Prograf 5mg capsules x 40 capsules?
Prograf 5mg capsules are available in a pack size of 50 which is recognised as having special container status. In cases where the prescriber orders a quantity which does not coincide with an original pack and the product has been classed as a special container, the pharmacist should supply a special container or combination of special containers nearest to the quantity ordered. If a prescription calls for 40 Prograf 5mg capsules, you would be reimbursed for dispensing 50 capsules.

Q. I have received a prescription for Ibuprofen 10% gel x 30g but only the 100g pack size is listed in Part VIIIA of the Drug Tariff. What quantity should I dispense and what will I be reimbursed for?
Part VIIIA of the Drug Tariff contains the monthly indicative NHS reimbursement prices for products prescribed generically. Where an item is in Part VIIIA, contractors are reimbursed the price listed against the corresponding pack size (unless a price concession is granted). In this example, only one pack size of Ibuprofen 10% gel is listed in the Tariff (100g pack), even though a variety of other pack sizes exist (30g, 40g and 50g). All available pack sizes are classed as special containers.

For reimbursement purposes, you would be reimbursed for 100g even though a prescription requests 30g. From a legal perspective, you should “supply the special container or containers nearest to that ordered”. Therefore, in this example, even though you will be reimbursed for dispensing the 100g pack size, you should supply the 30g size as ordered. To prevent any allegation of fraud, PSNC recommends that the prescription is clearly endorsed with the pack size used.

Q. I have received a prescription for “Amorolfine 5% medicated nail lacquer x 3ml”, what should I dispense and what will I be reimbursed for?
Amorolfine 5% medicated nail lacquer is available in three different pack sizes (2.5ml, 3ml and 5ml) and all pack sizes are classed as special containers. However, Part VIII of the Drug Tariff only lists the 5ml pack size of Amorolfine 5% medicated nail lacquer and therefore for reimbursement purposes, you would be reimbursed the price listed for 5ml pack size even though a prescription requests 3ml. From a legal perspective, you should “supply the special container or containers nearest to that ordered”. Therefore, in this example, even though you are reimbursed for dispensing the 5ml pack size, you should supply 3ml pack size, as ordered. To prevent any allegation of fraud, PSNC recommends that the prescription is clearly endorsed with the pack size used.

Q. I have received an FP10 prescription for ‘Erythromycin 40mg/ml / Zinc acetate 12mg/ml lotion x 90ml’. This product is available in packs of 30ml and 90ml; both sizes are listed in the Drug Tariff and are classed as special containers. I have dispensed three packs of 30ml. Is it okay to simply endorse “90ml” on the prescription?
An unqualified number in the endorsement column could be misinterpreted by the NHSBSA, for example if “90ml” is endorsed, the NHSBSA may interpret this as the pack size used and reimbursement could be based on the price of one pack of 90ml rather than 3 packs of 30ml resulting in financial loss to the pharmacy contractor. The recommended endorsement format in this scenario is “amount dispensed/pack size used” (e.g. “90ml/30ml”).

Q. What quantity should I dispense against a prescription ordering Amoxicillin 125mg/5ml oral suspension x 140ml?
The pharmacy would be reimbursed for supplying  2 x 100ml.

As this product falls under Part II Clause 13 of the Drug Tariff – Reconstitution of certain oral liquids, the contractor can round up to dispense the nearest complete container as it is important for patients on antibiotics to cover the complete course of treatment prescribed. Reimbursement for dispensing two packs will be automatic under these rules, but, as is usual with Part VIIIA products, it is good practice to endorse the prescription and declare the total amount dispensed over the pack size used.

Q. What quantity would I be reimbursed for supplying against a prescription ordering ‘Epilim 100mg crushable tablets x 28’?
Epilim 100mg crushable tablets have been re-classified as a special container in sub-packs of 10. If a prescription calls for 28 tablets, you would dispense and be reimbursed for 30 tablets (3 x 10 sub-packs).

Q. What quantity would I be reimbursed for supplying against a prescription ordering 15 x Epilim 100mg crushable tablets?
Epilim 100mg crushable tablets are widely available in packs of 30 and are classed as a special container in sub-packs of 10. Where the quantity ordered falls exactly between two special container pack sizes, the contractor should round down the quantity dispensed to the nearest complete special container pack size. In this case, if a prescription calls for 15 tablets, a contractor would round down to dispense and be reimbursed for 10 tablets (1 x 10 sub-pack).

Q. What quantity would I be reimbursed for supplying against a prescription ordering 112 x Epilim 200mg gastro-resistant tablets?
Epilim 200mg gastro-resistant tablets have been re-classified as a special container in sub-packs of 10. If a prescription calls for 112 tablets, you would dispense and be reimbursed for 110 tablets (11 x 10 sub-packs).

Q. What quantity would I be reimbursed for supplying against a prescription ordering 4 x Epilim Chrono 200 tablets?
Epilim Chrono 200 tablets have been re-classified as a special container in sub-packs of 10. If a prescription calls for 4 tablets, you would dispense and be reimbursed for 10 tablets (1 x 10 sub-packs).

You may want to dispense the exact quantity bearing in mind the impact on the stability of the drug once removed from its original packaging. There may be patient safety issues to consider if a pharmacist decides to dispense the exact quantity ordered (if not a multiple of the sub-pack size). For example, if a hygroscopic drug is not stored and used correctly, exposure to moisture could affect the integrity of the drug by potentially decreasing its stability and/or efficacy.

Q. What quantity should I dispense against a prescription ordering Heminevrin 250mg/5ml syrup x 100ml?
Clomethiazole 31.5 mg/ml oral solution sugar-free (Heminevrin 250mg/5ml syrup) has been re-classified as a special container as it is not practicable to dispense the exact prescribed quantity where this is different from the original pack size (300ml) or its multiple. The reason for this is that the SPC for Heminevrin 250mg/5ml syrup states the following: ‘Store in the original container. Do not transfer the syrup to another container since it may not be compatible with the container material’.  Therefore, for a prescription ordering 100ml of Heminevrin 250mg/5ml syrup, you would dispense and be reimbursed for supplying the complete pack size of 300ml. The patient should be advised to only take the drug for prescribed duration of treatment and return any residual balance to the pharmacy for safe disposal.

Q. I have received a prescription for Lyrica 20mg/ml oral solution x 300ml, what quantity do I dispense?
Lyrica 20mg/ml oral solution comes in a pack size of 473ml which is classed as a special container. As pregabalin is a Schedule 3 Controlled Drug the prescribed quantity of 300ml should be dispensed and the remainder should be safely disposed of. As this product is annotated as a special container, the pharmacy contractor will be reimbursed for the complete pack of 473ml. Due to the nature of the product packaging and the method of its administration, it may be advisable for prescribers to review the prescribing of these products away from split packs, where clinically appropriate.


FAQs

Q. How do I report a drug which should have special container status but does not have the marker in the Drug Tariff or dm+d?
If you identify any particular product(s) which are not currently classed as special containers but you believe satisfy the criteria (as set out in Part II CLAUSE 10 B of the Drug Tariff), please notify PSNC’s Dispensing and Supply Team (0203 1220 810 or info@psnc.org.uk) who will investigate and assess if it meets the relevant criteria. Where appropriate, PSNC will make application to the NHSBSA and DHSC seeking for the special container status of the product(s) to be re-determined.

Q. Can products that are unlicensed specials be classed as special containers?
Yes, if the relevant criteria are met, unlicensed specials can be classed as special containers. If a pharmacy receives a prescription for an unlicensed special which has been classed as a special container, the usual special container rules for reimbursement would apply.

Q. Do drugs with a limited stability once opened, automatically qualify as special containers?
Having a limited stability after first opening does not automatically qualify a drug for special container status unless it meets existing special container criteria or is an eligible oral anti-infective drug that requires reconstitution.,  Due to the nature of products with limited stability, it may be advisable for prescribers to review the prescribing of these products away from split packs, where clinically appropriate.

Q. Do I receive additional fees for dispensing items that have a limited stability following reconstitution?
No additional fees are paid for items that have a limited stability following reconstitution even if multiple containers are supplied to the patient against one prescription in more than one dispensing episode. As only one set of fees can be claimed, it may be appropriate for a contractor to discuss with the prescriber the possibility of providing a separate prescriptions to recognise the requirement to use more than one pack owing to the product’s limited stability.

Q. Why have all tablet formulations of Epilim been reclassified as special containers?
Drugs that are hygroscopic are granted special container status as part of the criteria listed in Part II Clause 10 of the Drug Tariff. All tablet formulations (gastro-resistant, modified-release and crushable) of Epilim have been re-classified as special containers as the SPC’s of these products clearly state that ‘Epilim is hygroscopic. The tablets should not be removed from their foil until immediately before they are taken. Where possible, blister strips should not be cut.’

Q. Can Epilim tablets be dispensed in a Monitored Dosage System (MDS)?
Pharmacists dispensing small but frequent quantities (e.g. weekly) of Epilim tablets will need to assess the clinical appropriateness of cutting the blister to dispense the exact quantity bearing in mind the impact on the stability of the drug once removed from its original packaging. As Epilim tablets are hygroscopic and therefore sensitive to the effects of moisture, any water ingress may result in the chemical and/or physical stability of the drug being compromised. Given the nature of these products and the special precautions for storage as outlined in the SPC, it may be advisable for prescribers to review the prescribing of these products away from split packs, where clinically appropriate.

For further guidance on stability of drugs in Monitored Dosage Systems (MDS) please refer to the Specialist Pharmacy Service guidance on Usage of Medicines in Compliance Aids.

Q. Can I dispense the exact prescribed quantity if this is different to the special container pack size?
Where the quantity ordered does not coincide with that of the special container pack size you are required to supply the nearest complete pack or sub-pack(s) nearest to the quantity ordered. However, in a small number of cases, where there is an over-riding clinical requirement to dispense the exact quantity ordered rather than the nearest complete pack or sub-pack size (for example, if the drug is required to be packaged into a weekly compliance aid), pharmacists would need to assess the clinical appropriateness of splitting the pack to dispense the

Q. Will my payment be based on endorsement if I dispense the exact quantity ordered of a drug (which is not a multiple of a special container pack size)?
Using their professional discretion, if a pharmacist dispensed the exact prescribed quantity of a product classed as a special container, contractors will be reimbursed according to special container rules, regardless of any endorsement. The payment rules for special containers may mean that in some cases contractors are reimbursed more than the prescribed quantity and, in other cases, it may be less.


Related resources

Special Container Database

Quantity

NHSBSA dm+d browser



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