Co-beneldopa (including Madopar®) preparations re-classified as special containers

Update (30/01/2023) – Following representations from PSNC, the Department of Health of Social Care (DHSC) has re-determined the special container status of all Co-beneldopa capsules and tablets. In December 2022, PSNC advised that the special container rules apply to all branded or generically written prescriptions for Madopar® dispensed from December 2022 onwards (except for generically prescribed Co-beneldopa 12.5mg/50mg capsules). However, from February 2023, special container status will also apply to generically prescribed Co-beneldopa 12.5mg/50mg capsules too and this will be reflected in the February 2023 Drug Tariff – see updated table below


Following representations from PSNC and Roche Products Ltd, the Department of Health of Social Care (DHSC) has re-determined that all six Madopar® (Co-beneldopa) preparations meet the special container criteria as outlined in Part II Clause 10 of the Drug Tariff.

The NHS dictionary of medicines and devices (dm+d) has now been updated with special container status applied to the complete pack sizes of all Madopar® preparations. The special container rules apply immediately to all branded or generically written prescriptions for Madopar® dispensed from December 2022 onwards (except for generically prescribed Co-beneldopa 12.5mg/50mg capsules – see FAQ below).

The changes will reflected in the January 2023 Drug Tariff against respective product listings in Part VIIIA where Madopar® has been indicated as the reference product. The following products will be treated as special containers for prescriptions dispensed from December 2022 onwards:

Brand and/or Manufacturer
Generic drug name (dm+d descriptor) Pack size Special container
Teva UK Ltd Co-beneldopa 12.5mg/50mg capsules 100 Complete pack
Madopar® 50mg/12.5mg capsules (Roche Products Ltd) Co-beneldopa 12.5mg/50mg capsules 100 Complete pack
Madopar® 50mg/12.5mg dispersible tablets (Roche Products Ltd) Co-beneldopa 12.5mg/50mg dispersible tablets sugar free 100 Complete pack
Madopar® 100mg/25mg capsules (Roche Products Ltd) Co-beneldopa 25mg/100mg capsules 100 Complete pack
Madopar® 100mg/25mg dispersible tablets (Roche Products Ltd) Co-beneldopa 25mg/100mg dispersible tablets sugar free 100 Complete pack
Madopar® CR capsules (Roche Products Ltd) Co-beneldopa 25mg/100mg modified-release capsules 100 Complete pack
Madopar® 200mg/50mg capsules (Roche Products Ltd) Co-beneldopa 50mg/200mg capsules 100 Complete pack

With all Madopar® preparations now reclassified as special containers, Roche has issued the following statement: “Over the last few years pharmacists had been raising the challenges they were facing when dispensing Madopar according to its Summary of Product Characteristics (SmPC). Consequently, we proactively approached the Pharmaceutical Services Negotiating Committee (PSNC) to collaborate on a solution that would rectify the situation. We are delighted for Pharmacies and the patients they serve that the NHS Business Services Authority has awarded Madopar special container status.”

FAQs

Q. What quantity of Madopar® will I be reimbursed for on a prescription requesting 56 Madopar® capsules (any strength)?
A. Pharmacy contractors will be reimbursed the nearest complete pack size which is 100 capsules.

Q. Why have all Madopar® preparations been reclassified as special containers?
A.
  All strengths and formulations of Madopar® satisfy two of the special container criteria listed in Part II Clause 10 of the Drug Tariff – ‘hygroscopic‘ and ‘packed in…any other container from which it is not practicable to dispense the exact quantity‘. The Summary of Product Characteristics (SPC) for Madopar® states that the product should be stored in its original packaging and the bottle should be kept tightly closed. As per the SPC Roche cannot recommend the storage of Madopar® outside of its original packaging. This is because benserazide hydrochloride, one of the two active pharmaceutical ingredients in Madopar®, is hygroscopic. The packaging also contains a desiccant which makes it impractical to dispense the exact quantity if less than the original pack size is ordered.

Q. Can I dispense the exact prescribed quantity if this is different to the special container pack size?
A.
Where the quantity ordered does not coincide with that of the special container pack size you are required to supply the nearest complete pack size 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, 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. For example, if a hygroscopic drug is stored and used incorrectly, exposure to moisture could affect the integrity of the drug and potentially decrease its stability and/or efficacy.

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)?
A.
For products classed as a special container, pharmacy contractors are reimbursed according to special container rules. 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. Any endorsement of a quantity that does not correspond to the special container pack size (or multiple of) will be disregarded by the NHSBSA.

Q. Can Madopar® capsules be dispensed into a Monitored Dosage System (MDS)?
A.
Pharmacists will need to assess the clinical appropriateness of dispensing the exact quantity of Madopar® into weekly trays by considering the stability of the drug once it is removed from its original packaging. As Madopar® preparations are hygroscopic, and therefore sensitive to the effects of moisture, any water ingress may compromise the chemical and/or physical stability of the drug. As per the SPC Roche cannot recommend the storage of Madopar® outside of its original packaging. This would ultimately be a clinical decision.  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.


PSNC’s Dispensing & Supply team has reviewed over 4,000 products against Drug Tariff special container criteria. The total number of products granted special container status over the past 2 years to 158 following checks made by PSNC. The three main criteria under which PSNC has focused its attention are drugs that are considered to be hygroscopic in nature, viscous external preparations and those packaged in containers from which it is not practical to dispense the exact quantity. Of those checked, PSNC has identified and submitted applications for nearly 900 products that appear to meet one or more of the special container criteria. PSNC is still awaiting a decision from the Department on several outstanding requests.

Where a product meets the special container criteria as set out in the Drug Tariff, a special container indicator for the relevant pack size (complete pack or sub-pack) is applied to the respective product entries in the dm+d and in the Drug Tariff, where listed.

For a list of all the monthly changes to the special container status of products please see the following page Notice of changes to special container status of products.


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 comms.team@cpe.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.

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