More data needed to tackle costs of cold chain breaches

A pilot study investigating loss of medicines due to cold chain breaches (CCB) in community pharmacies in the Australian Capital Territory (ACT), Australia, has found a lack of knowledge on the correct procedures to follow in the case of CCB, as well as additional stability data on medicines which could save money in the future.

In an article published in the Journal of Clinical Pharmacy and Therapeutics, Australian researchers determined that the ‘actual cost of vaccine and pharmaceutical loss due to a break in the cold chain is poorly studied and requires further research.’¹

‘It is difficult for pharmacists to ascertain the stability of medicines following a CCB, due to the unpredictable nature of power outages and variability in drug degradation on exposure to increased temperatures,’ the researchers wrote.

‘There are some protocols and recommended procedures provided by manufacturers to determine the stability of drugs when a CCB has occurred. However, stability research is generally limited, so many public health guidelines state that refrigerated pharmaceuticals should be discarded unless maintenance of the cold chain can be assured.’²

The researchers conducted a small pilot study of community pharmacies in the ACT, surveying the frequency of power outages and the contingency plans present for when CCB occur, as well as the amount and cost of medicines discarded due to these occurrences.

Of the survey’s 18 respondents, 50% of community pharmacies had not experienced any power outages, 39% had experienced one to two incidents, and 11% had experienced two to four incidents during the past 12 months.

Almost 90% of the outages were less than 4 hours in duration.

‘Of concern, 22% of respondents reported not knowing of any specific backup procedure, which may lead to the disposal of many medicines if a power loss occurred,’ the researchers wrote.

The survey results indicated that the cost of replacing medicines due to a CCB varied between pharmacies, but the average cost was an estimated $13,168. The researchers estimated that if just one in 10 community pharmacies in Australia experienced one significant power outage a year, the potential cost recovery of medicines would be approximately $7.6 million AUD per year.

‘There is a need for expanded national and international studies to further clarify the extent of this issue and indicate where significant investments could be made to better protect against medicine loss in the future, not only for economic reasons, but also to safeguard communities against medicine or vaccine shortages,’ the researchers wrote.

The cost of vaccines lost to CCB in Australia has been estimated to be $16 million AUD annually,³ but the value of losses of other medicines such as insulin, thyroxine and biologicals that also require cold storage has not been quantified.

As well as the financial cost, the loss of medicines due to CCB also poses the risk of medicine shortages. The researchers said the loss of medicines due to CCB is likely to cause a significant financial burden globally, but there is a lack of research into the actual costs.

`Data from a small local study indicate millions of dollars worth of medicines could be saved each year if additional data regarding the stability of medicines were available to the relevant parties,’ they wrote.

‘Furthermore, whereas recommendations for dealing with power outages are provided by several sources, data from the study also revealed a lack of knowledge on the correct procedures to follow in such circumstances. Further research to examine the extent of this issue would aid in identifying the principal difficulties associated with CCB due to power outages and the accompanying costs; this would encourage investment in stability testing of specific products after CCB, along with the development and dissemination of more comprehensive and useful guidelines for health professionals.’

Read the full article here.

PSA supports pharmacists’ practice needs and information on cold chain management can be found in the latest edition of the Australian Pharmaceutical Formulary and Handbook (APF24).  Visit https://www.psa.org.au/apf24

References

1. Kosari S, Walker EJ, Anderson C, et al. Power outages and refrigerated medicines: The need for better guidelines, awareness and planning. J Clin Pharm Ther. 2018;00:1–3. https://doi.org/10.1111/jcpt.12716
2. Drug and Quality Use of Medicines Committee. Medicine: management of refrigerated storage of medicines and vaccinations in clinical areas. [Procedural document for NSW Health]. 2014. At: http://www.seslhd.health.nsw.gov.au/Policies_Procedures_Guidelines/Clinical/Medicine/documents/MedicineManagementofRefrigeratedStorageofMedicinesandVaccinationsinClinicalAreasSESLHDPR300.pdf.
3. D’Onise K, Almond S, MacDonald B, Watson M, Scrimgeour S. Have purpose-built vaccine refrigerators reduced the cost of vaccine losses in South Australia? Aust NZ J Public Health. 2012;36:572-576.