Sterile Water for Injection—Shortage Continues

By Julie Rubin, PharmD, BCPS Since December 2017, hospitals across the country have been struggling to obtain sterile water (SW) for injections – a critical ingredient in preparing many drug products for intravenous use. An FAQ from ASHP on this topic – issued in January – reported the product would be unavailable until March 2018, and while this...

By Julie Rubin, PharmD, BCPS

Since December 2017, hospitals across the country have been struggling to obtain sterile water (SW) for injections – a critical ingredient in preparing many drug products for intravenous use.

An FAQ from ASHP on this topic – issued in January – reported the product would be unavailable until March 2018, and while this deadline came and went, the shortage continued.

How did this shortage come about? It is in large part due to Hurricane Maria’s devastation of Puerto Rico which resulted in a shortage of the saline mini bags that are produced there. To combat this, many hospitals switched their practice of administrating medications via intravenous push, or IV push – the mixing of agents with sterile water. While this provided a workable stop-gap fix, manufacturers ultimately couldn’t keep up with the increase in demand for SW for injections, resulting in another shortage for hospitals to manage.

Since December, many hospitals have been implementing conservation strategies, such as batching the preparation of medications that require reconstitution to minimize waste of SW for injection.

For the latest timeframe on the shortage, health care professionals are encouraged to visit the ASHP website. Over the last month, some hospitals might have started seeing some relief with a selection of SW for injection vials returning to stock, but that, unfortunately, does not equate to the end of the shortage.

As many healthcare professionals are undoubtedly finding, obtaining two or three SW vials for injections might be possible, but that isn’t enough to make a targeted change to clinical practices.

Healthcare executives, physicians, pharmacists and other healthcare providers would do well to continue the conservation strategies for a little while longer until a more permanent supply is available, which could be another six months.

Many pharmacists and healthcare executives have implemented alternatives to infusion or intravenous therapies where appropriate, so hospitals aren’t reliant on only one method. Another option that many pharmacists have been implementing is to switch to oral medications to help manage SW stock and conserve available supplies.

The options for healthcare practitioners remain quite limited, and so these alternative practices might need to continue for a little longer.

As different clinical practices and strategies are implemented and trialed to address the shortage; changes to normal hospital workflows will eventuate, which could result in increased medication errors if not monitored properly. Executives and healthcare professionals will need to be mindful of changes to workflows and report any increased instances of errors to ensure appropriate solutions can be employed.

While hospitals can only respond reactively to manage drug shortages, this latest example reveals more can be done when it comes to the broader communication issues between drug manufacturers and the healthcare industry.

  • Shortages communicated earlier – Manufacturers should be required to communicate to healthcare facilities, and agencies such as the FDA, when a shortage is expected sooner than is current practice. The more information hospitals and healthcare facilities are provided, the better they can plan and change practices in order to mitigate shortages, thus decreasing any adverse outcomes for patients.
  • Predicting length of shortage – While it can be difficult to calculate, knowing how long a shortage might last is critical information to ensure the strategies being implemented to mitigate the lack of a drug or agent will last. While the shortage of SW, in particular, can be attributed to a natural disaster, and accordingly difficult to predict, there are plenty of other examples when a storm, flood or hurricane isn’t the contributing factor, for example, most recently the FDA issued communication predicting an EpiPen shortage is on the horizon. While reports indicate it is expected to be short-term, further clarity around timeframes can assist health care providers to better plan.
  • Incentivize manufacturers – Manufacturers should be encouraged to have a backup plan in place that is activated in the event one of their medical products is experiencing a back-log, whether via legislation, financial or otherwise. This could include increasing supply in the event that demand surges or when partnering with overseas suppliers.

By working as an industry – from manufacturers, government health care agencies, clinicians, and hospitals – we can be better prepared when a drug shortage strikes, and ultimately minimize the effects on patient care.

Julie Rubin, PharmD, BCPS, is the director of clinical services for CompleteRx, a leading pharmacy management company. She has 20 years of clinical pharmacy experience, advising hospital and health executives across the country on critical issues including strategies to handle the shortage of sterile water for injection, and is board certified in pharmacotherapy.

Source: www.completerx.com