Fast Track Approval Process for Shorted Drugs

May 2012 - Vol.9 No. 5 - Page #44

Q&A with Patricia Kienle, 


Pharmacy Purchasing & Products: In what ways do medication shortages put pharmacy at risk?
Patricia Kienle: Shortages can affect hospital pharmacy practice in a number of ways, but the response that introduces the most risk is use of the gray market. Many practitioners look at utilization of this market as a financial means to an end, but in reality, the potential patient safety risk introduced by such activity far outweighs any financial benefits. Furthermore, the patient safety issues that practitioners think they are addressing via the gray market are not necessarily being met in any case. The influx of counterfeit drugs and other non-regulated medications are pervasive in the gray market. By design, it is generally impossible to determine the provenance of products sourced in this manner, but the increased number of shortages is certainly exacerbating this troubling practice.  

Another scenario that generates significant concern is when the pharmacy is unable to acquire certain drugs and select practitioners, who may have a stock of these drugs in their office, home, or in storage, simply bring those products into the hospital setting for patient use. Such actions invariably circumvent the pharmacy in terms of medication safety mechanisms, which leads to the same situation as above: there is no way to determine how these drugs were stored, when were they were attained, whether they are in date, or if they were part of a recall, among other red flags. Effectively, there are drugs entering the hospital that the pharmacy director does not know about nor which have safety mechanisms controlling them, and that is extremely risky. 

PP&P: Is there a way to set up a fast-track approval process for responsibly accommodating new medications brought into the hospital?
Kienle: Yes, there is and that is exactly what needs to be done. However, the pharmacy manager or director needs to make sure that any such processes are not circumventing existing requirements from the facility’s P&T committee for medication management. This includes working with and educating medication buyers to not automatically accept medications from non-bona fide sources simply because that product may be in short supply at the facility. A standard vetting process needs to be implemented that defines the requirements for substituting certain medications with others based on shortages or other disruptions to supply. Such a process should include input from all relevant parties affected by the substitution to ensure accountability.

Regardless of the process details, the governing structure should prevent breaching existing policies regarding medication management simply because an emergent situation presents itself. Many health care practitioners will go to extreme lengths to acquire products considered necessary for patient care, but such measures need to be carried out with the complete understanding of the pharmacy and with oversight from the P&T committee. Such a system also needs to be developed in advance of shortage events, not during a high-pressure situation.

PP&P: What factors should the hospital take into account when developing a process for drug substitution due to shortage or other supply disruptions? 
Kienle: What is alarming is that the sheer volume of recalls and shortages affecting so many products has almost desensitized pharmacy practitioners to the real impact on medication management and patient safety. While not all shortage scenarios are dire—and developing substitution plans for oncology agents, anesthetic agents, and medications for pediatrics are among the most critical—this issue has pervaded almost every class of drug. Unfortunately, many shortages affect medications for which there are few if any alternative products. 

As mentioned, due to the pervasive nature of drug recalls and shortages, it is wise to establish a process for handling critical substitution issues in advance. In doing so, consider the following when reviewing possible courses of action in response to a specific drug or drug type shortage or recall:

  • Can other established formulary agents or other dosage forms be used?
  • Are there other approved drugs or dosage forms on the market that need to be considered for temporary or permanent formulary status?
  • Are there USP compounding monographs or peer reviewed compounding recipes that are appropriate for use?

In all cases, it is essential to inform all affected prescribers and other clinicians about what the hospital’s approach will be for handling supply disruptions of specific drugs.

During product shortages, a natural reaction is to consider purchasing medications from alternate vendors. Since many organizations use group purchasing organizations (GPOs) to determine if a pharmaceutical distributor is acceptable for general drug purchasing, many sites do not have a process to determine on their own whether an alternate pharmaceutical distributor is safe and appropriate. Therefore, I suggest that every hospital establish such a process and policy to enable an independent evaluation of an alternate distributor. Items to assess when determining if a vendor is acceptable include ensuring the vendor has the appropriate FDA permits, can provide the appropriate chain of custody for the medication in question, labels products appropriately, and offers other details, such as standard package sizes, to meet your needs. It is also worth determining whether there has been any pattern of recalls for the product using the FDA web site. Likewise, consult with your GPO for their suggestions. Mainly, be sure that your pharmacy purchaser is aware of the appropriate steps to take when purchasing from a source other than your primary distributor.

PP&P: Are there specific actions that should be expressly forbidden during the fast track process?
Kienle: Purchasing medications without concrete knowledge of the supplier and the pedigree of the product is a primary risk. There needs to be an understanding among pharmacy practitioners, prescribers, and hospital leaders that this situation needs to be controlled in the safest manner possible. Many pharmacy directors may be pressured to do whatever it takes to acquire a drug deemed necessary, but pharmacy is in a unique position to remind fellow staff of the dangers of buying medications from unfamiliar or unknown sources.

PP&P: Should considerations be different if the product on shortage is chemotherapy or another potentially life-saving medication?
Kienle: Having to make decisions about drug therapies that are considered life saving or have the potential to deter significant patient harm are some of the most difficult situations pharmacists can find themselves in. Historically, hospital pharmacies have been able to lend critically needed medications to other sites. However, given the dramatic increase in the breadth and length of drug shortages over the last few years, such practices are often no longer allowed or sanctioned, as many organizations have to protect the drug supply for their own patients; most facilities are not willing to risk putting their own patients in harm’s way to aid another facility. 

Options do remain though, and sometimes, manufacturers of drugs on shortage can assist with specific patient issues. Likewise, if your hospital is part of a multi-hospital system, moving medications among those sites may be less difficult than attempting to acquire medications from unaffiliated hospitals. Regardless, hospital pharmacists and pharmacy technicians are spending an incredible amount of time assuring that all patients have the medications they need, so pharmacy and health care leadership should support these efforts in any ways they can. 

Patricia C. Kienle, RPh, MPA, FASHP, an employee of Cardinal Health since 1999, currently serves as the director of accreditation and medication safety. She is the recipient of an MPA in health service administration from Marywood College in Scranton, Pennsylvania, a BSc in pharmacy from Philadelphia College of Pharmacy and Science, and has completed an executive fellowship in patient safety from Virginia Commonwealth University. Patti is also an adjunct associate professor at Wilkes University in Wilkes-Barre, Pennsylvania.


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