Repackaging paracetamol during the coronavirus (COVID-19) pandemic

19 Mar 2020

While pharmacies continue to be able to procure Prescription Only Medicine (POM) packs of paracetamol (pack size of 100 tablets, or more), many pharmacies are reporting ongoing shortages of paracetamol tablets 500mg as Pharmacy (P) and General Sales List (GSL) packs.

We have sought advice from the Medicines and Healthcare products Regulatory Agency (MHRA), and our professional indemnity advisors, advice regarding repackaging the POM packs of paracetamol (pack size of 100 or more) to create smaller packs of containing maximum of 32 tablets for over-the-counter sale/supply to patients. A step by step guide has been produced to help pharmacy teams in undertaking this.

Under Regulation 4 of the Human Medicines Regulations 2012 (HMR), a pharmacist is able to break down a larger pack to prepare a single supply of a non-prescription item for retail sale. In these circumstances, the requirements within Part 13 of the HMR are disapplied.

·     The labelling requirements set out in Part 2 of Schedule 26 to the HMR will apply.

·     Additional specific labelling requirements for paracetamol will also apply as set out in Part 4 of Schedule 25 to the HMR.

·     The sale and supply provisions in the Regulation 236 of HMR do not apply if the quantity of paracetamol (or aspirin) sold or supplied to a person at any one time does not exceed 100 tablets.  This regulation does not exempt any other drug.

To enable you to repackage the larger packs of paracetamol tablets 500mg to meet patient need please ensure you comply with the following requirements:

·     Every pack supplied must comply with the labelling provisions as set out in the

o      HMR 2012 Part 2 of Schedule 26 , (Part 1 of Schedule 26 is not necessary for over the counter (OTC) supply) and in

o      Part 4 of Schedule 25 to the HMR

·     Patients must be supplied with the corresponding patient information leaflet (PIL) – this must be of the exact Product Licence (PL) used. This must be a printed or photocopied PIL; sending the patient an electronic link to access the PIL remotely is not acceptable.

·     Patients are expected to be provided with sufficient information to ensure that they can use the medicine safely in an informed manner. What specific information needs to be provided to the patient should be a matter of professional judgement for the pharmacist.

·     Keep an audit trail/record of broken bulk supplies with your Business Continuity Plan.

·     The total quantity sold to any patient must not exceed 100 tablets.

·     Different batches of medicine must NOT be mixed when repackaging into smaller packs.

However, please note the following important points:

·     The decision to take this step should be taken only be considered if your pharmacy/business has completely run out of the ready-made ‘P’ and ‘GSL’ packs of paracetamol, and repackaging larger packs will support patient care during this public health emergency.

·     Repackaged medicines should only be used within the same pharmacy business/legal entity.

·     We expect all members who take the decision to repackage medicines in this manner to supply ready-made packs whenever available, and definitely once the current emergency situation with coronavirus (COVID-19) pandemic has resolved and regular supply chains are reinstated.

·     Repackaging should not be carried out in the normal course of your business, or because of financial reasons only. OTC packs should be procured and supplied whenever available.

·     When making a decision to re-package POM packs for supply over the counter, please consider the impact on your ability to meet prescription demand.

Professional indemnity insurance

·     NPA professional indemnity insurance will indemnify members who are required to break bulk of the typical OTC painkillers and medicines, e.g. paracetamol, ibuprofen and aspirin, in circumstances where they are unable to obtain original packs of those medicines in ‘P’ and ‘GSL’ pack sizes.

·     Where pharmacies have bulk packs of paracetamol, ibuprofen, and aspirin, we will cover the breaking down of those bulk packs into the equivalent of ‘P’ packs; that is to say, each pack must contain no more than the maximum number of tablets permitted for the relevant ‘P’ pack size as applicable for each drug.

·     Each pack must be labelled in accordance with Part 2 of Schedule 26 and any other specific labelling requirements pertaining to the relevant drug.

·     Labelling requirements set out in Part 4 of Schedule 25 are applicable to paracetamol.

·     It is imperative labelling requirements are complied with and records of broken bulk supplies are retained so that the integrity of the stock can be maintained and, from an audit perspective, traced back to the original manufacturer if required.

·     In addition, a printed PIL (or a paper copy) must be supplied with each pack to patients.

·     Members should keep records of broken bulk supplies and details of batch numbers so that the integrity of the stock can be maintained and, from an audit perspective, traced back to the original manufacturer if required.

 

The HMRs 2012 are accessible via this link: http://www.legislation.gov.uk/uksi/2012/1916/contents/made

For further information please contact the NPA Pharmacy Services team on 01727 891800 or email at:  pharmacyservices@npa.co.uk.