Drug Shortages in the News
A number of drug shortages have been covered in the news over the past several weeks, including Pfizer’s sole source Sodium Bicarbonate and, most recently, a number of non-medically necessary items[i], many of which are on HealthPRO contract.
Following is a summary of the action that HealthPRO, in collaboration with members, continues to take to alleviate their impacts across the country, as well as a report on the status of these backorders.
Collective Action on Drug Shortages
- Introduced national contracting strategies to mitigate the effects of drug shortages
- Split Awards contracts: introduced in 2012 for hospital-specific drugs, HealthPRO awards contracts for hospital-specific drugs to more than one supplier, giving members quick access to an alternative in the event of a shortage. This strategy contributes to diversity of supply.
- Open Market: ensures that suppliers who bring an alternate version of a medically-necessary drug into Canada have access to a business opportunity through a competitive bid process with HealthPRO; today we no longer rely on one supplier for nine critical drugs.
Given a full third of all pharmaceuticals are produced by just ten (10) drug companies, these strategies and their benefits can only be realized when the suppliers are presented with a national business opportunity.
- Implemented mandatory 60-day notification by suppliers
Advance notification is the best way to mitigate the effects of a shortage. Under our terms and conditions, suppliers are contractually required to provide HealthPRO with regular inventory holdings and at least 60 days’ notice of an expected undersupply.
- Full-time drug shortage support
A dedicated HealthPRO pharmacist and support team provides members timely information on backorders, available alternatives and insight into potential future supply disruptions and resolutions. HealthPRO’s national member based Drug Shortage Subcommittee addresses ways to provide additional information to members to reduce the time associated with managing drug shortages.
In our role, we collect and facilitate the dissemination of complete and accurate information to healthcare professionals across the country regarding the shortage, its causes, and potential alternatives available in the market.
- Drug Shortage Subcommittee
The Drug Shortages subcommittee, comprised of pharmacy directors, pharmacists, buyers and pharmacy technicians from across the country, meets monthly to discuss how to manage existing drug shortages and how to mitigate those that are anticipated, with concentration on hospital-specific injectable and sole source molecules.
Often, members will share therapeutic alternatives and conservation strategies, along with drug shortage communications developed for multidisciplinary audiences.
Drug shortages with potential for significant patient impact are escalated from this subcommittee to the Provincial and Territorial Drug Shortage Task Team.
- Provincial/Territorial (P/T) Drug Shortage Task Team
HealthPRO is an active participant in bi-monthly teleconferences of the Provincial/Territorial (P/T) Drug Shortage Task Team, a pan-Canadian group developed to manage and mitigate drug shortage impact in Canada, to discuss the most critical issues and escalate to Health Canada where necessary
HealthPRO represents our members’ voices in many national forums to promote assurance of supply and mitigate the effects of drug shortages.
- Represented members in a national dialogue on drug shortages by working in partnership with the Multi-Stakeholder Steering Committee (MSSC) on Drug Shortages, co-chaired by Health Canada and Alberta Health and Wellness. Jointly, we created a Multi-Stakeholder Toolkit to improve communication and action plans around shortages
- HealthPRO was welcomed by Health Canada to lead a national working group under the MSSC that identified contracting strategies that can reduce the impact of drug shortages on hospitals and patients
- HealthPRO participated in a national working group under the MSSC to identify the root causes of drug shortages
- Helped influence Health Canada’s decision to make the reporting of drug shortages mandatory by participating in the Drug Shortage public consultation in the summer of 2014
- As an upcoming priority, we will work with regulatory bodies to establish a mechanism to gain quicker access to drugs extra-jurisdictionally in instances where critical drugs are impacted by shortages
[i] As defined by Health Canada; these drugs are critical to patient care, however, alternatives are available in the market.
Status of Recent Backorders
Pfizer – Recall of Sodium Bicarbonate
Due to a Health Canada recall, this drug commonly used in critical care settings is on backorder. The two most commonly used formats of injectable sodium bicarbonate drugs authorized in Canada, vials and prefilled syringes, are both supplied by Pfizer. This backorder only impacts the vials.
HealthPRO has worked with Pfizer to ensure they are placing supply of pre-filled syringes on allocation to meet the demand of all members until the recall is resolved (anticipated by October 2017). We are also collaborating with Health Canada to determine if product can be accessed extra-jurisdictionally.
As a longer term solution, we have connected with other manufacturers to determine if additional commercial solutions can be introduced to the market.
Pfizer – Importation ban on numerous non-medically necessary items
On June 19, 2017, Health Canada classisfied Pfizer’s McPherson, Kansas manufacturing site as non-compliant with Good Manufacturing Practice (GMP) and assigned terms and conditions to the importation of certain “non-medically necessary items” manufactured at the plant. These drugs are critical to patient care, but are deemed to be non-medically necessary as there are alternatives available in the market.
This importation ban applies to future production only, not to product already imported into Canada. Inventory of the latter has been placed on allocation to ensure hospitals have fair and equitable access to these products.
Members continue to have access to many of these products at a contracted price, as HealthPRO had selected a Split Award Strategy[i] for several of these drugs. We are also working with the Provincial/Territorial Task Force on Drug Shortages to ensure there are therapeutic alternatives for a number of additional drugs that are expected to be on backorder by September 2017. The duration of the importation ban is yet to be determined as Pfizer works to remediate its facilities to meet Health Canada’s criteria.
Drug shortages are a global, complex problem but, by working collectively, we are committed to finding a way forward. For more information, please contact:
Vice President, Pharmacy Services
HealthPRO Procurement Services Inc.
firstname.lastname@example.org or 905-568-3478 ext. 243