What’s New in the Patient Safety World

May 2012

Drug Shortages Taking a Toll

 

 

At our Patient Safety Committee or Medication Safety Committee or P&T Committee meetings we used to spend a fair amount of time discussing drugs recalled. Now we spend a much greater amount of time discussing drug shortages. The number of drug shortages has escalated dramatically over the past 5 years. Not only are the drug shortages causing problems in healthcare facility operations and budgets, but they are also now clearly impacting on patient safety.

 

Anesthesiology, an area especially hit hard by drug shortages, recently responded to a survey put out by the American Society of Anesthesiologists (ASA). Almost 98% of the respondents said they had been impacted by the shortage of at least one drug (Clark 2012, ASA 2012). This has resulted in use of less than preferred drugs, altered procedures, delays, canceled cases and, regrettably, some deaths. In addition, use of the alternative drugs has tended to lengthen postoperative stays and increase costs of care.

 

ISMP (Institute for Safe Medication Practices) did its own survey recently and identified frequent occurrences of patient harm as a result of drug shortages (ISMP 2012).

 

Lack of treatment or delayed treatment are the most well-known consequences of the drug shortage problem. In fact, it was largely the shortages of cancer chemotherapeutic agents that initially raised this issue to the public level. But there are many other consequences as well.

 

Problems with use of alternative medications or alternative preparations were the biggest issues identified in the ISMP survery. The alternative drug may simply be less adequate than the preferred drug (35% of the cases with harm in the ISMP survey). But errors made in the dose or form of the alternative medication are also problematic (27% of the cases with harm in the ISMP survey). Providers may be less knowledgeable about the use of those alternatives. The recent shortage of morphine in Canada (ISMP Canada 2012b) has probably led to more use of HYDROmorphone (Dilaudid) and we’ve previously discussed the fact that many physicians do not understand that Dilaudid is much more potent than morphine on a mg basis (see our September 21, 2010 Patient Safety Tip of the WeekDilaudid Dangers”). Similarly, in facilities accustomed to using IV lorazepam in status epilepticus, a shortage of IV lorazepam might lead to use of IV diazepam and providers may be less familiar with dosing, half-lifes, etc.

 

Alternative preparations may be problematic in other ways. In the recent ISMP newsletter a shortage of the multivitamin prep used with parenteral nutrition led to use of a different multivitamin in an oral form. The patient developed Wernicke’s encephalopathy and only then was it recognized that the alternative prep did not contain thiamine.

 

Shortages of local anesthetics have given rise to providers using unusual concentrations of those agents (or the concentrations of other agents mixed in with the anesthetic such as epinephrine), thereby increasing the likelihood of misuse in some circumstances.

 

The ISMP survey provides numerous specific examples of adverse effects caused by switching to alternative agents.

 

Both ISMP (ISMP 2012, ISMP 2010) and ISMP Canada (ISMP Canada 2012a) have provided useful guidance for facilities in dealing with and preparing for such drug shortages. The American Society of Hospital-System Pharmacists (Fox 2009) and a previous ISMP newsletter (ISMP 2010) made a number of recommendations on planning and contingencies for drug shortages.

 

First and foremost, you need to be aware of potential impending shortages. As before, such discussions should be a priority at your regular meetings of your P&T Committee (or your Patient Safety or Medication Safety Committees if applicable). Use your collaborative networks, formal or informal, to learn about impending shortages and potential solutions. Hopefully your group purchasing organization is out there doing some of this for you but use your hospital associations, your specialty societies, the Internet and social media networks as well.

 

While you may be unable to plan in advance for drug shortages of a specific drug, you can put in place the infrastructure and contingency plan to deal with shortages as they arise. One solid recommendation is doing a failure mode and effects analysis (FMEA) on drug shortages. This is a good way to get a handle on how you would develop and implement contingency plans in the event of a significant drug shortage. The 2010 ISMP newsletter (ISMP 2010) contains a sample FMEA from OhioHealth Pharmacy Systems that can serve as a good starting point for your own FMEA.

 

ASHP (Fox 2009) recommends an approach to planning for drug shortages in three phases: identification and assessment, preparation, contingency. In the assessment phase you would do things like identify the potential shortage, assess your current inventories, determine what potential outside sources and supplies might be available, and estimate the expected duration of the shortage if possible. You also would assess your supplies of any likely alternative agents. Remember also that a shortage of one drug may also lead to a shortage of the alternative drugs as well. A good “threat analysis” here would take into account patient care, patient safety, and cost issues as well.

 

The preparation stage is where you identify who will be impacted by the expected shortage (both patients and staff), what alternatives are available, how you will prioritize use of that drug and the alternatives, and how you will educate staff (and patients, if necessary) about options.

 

Prioritization can be complicated. Take parenteral lorazepam, one of the drugs for which there has been a recent shortage, as an example. You would first go through your pharmacy and purchasing/billing information to determine where and for what conditions this drug has been used historically. You might identify areas of use as the ICU’s, OR, procedure room, ER, behavioral health, and med/surg nursing units. You need to do a similar analysis for any agents you might be considering as alternatives. In your analysis you might note that ER use is infrequent but you might also identify that having it available for treatment of status epilepticus is a priority. So you might end up with a prioritization that says you’d like to restrict use to the ER and ICU, especially if the alternative agents are more readily usable in the other locations.

 

The ISMP Canada bulletin (ISMP Canada 2012a) also recommends you have plans in place to minimize wastage of the drug in potential shortage. However, they are careful to note this must be done in a safe manner. They have particularly good recommendations about precautions that must be taken any time that a product is divided up into multiple doses.

 

During this phase you should also be firming up your relationships with collaborative partners. For example, planning with neighboring hospitals about the ability to borrow medication for emergency cases (or transfer patients to a facility that has the necessary agent).

 

ASHP also cautions against hoarding, stockpiling, and speculative purchasing because these practices may inadvertently exacerbate the shortages.

 

The education and communication components of the preparation phase are crucial. You should have a formal process by which therapeutic alternatives are identified. This should include not only pharmacists but also nurses and physicians (and other providers as necessary). You might do this through your formal medical staff committee structure. However, given the typical delays in wending through the medical staff bureaucratic and committee layers, a better plan might include delegation by the medical staff to an ad hoc group having appropriate medical staff representation. You will have to educate physicians and nursing staff about the alternative agents (different doses, half-lifes, side effect profiles, monitoring parameters, look-alike/sound-alike issues, product segregation, alerts, warnings, independent double checks, etc.). You may also have to make changes to your pharmacy IT systems, EMR/CPOE, order sets, standing protocols, clinical decision support systems, barcoding, automated dispensing machines, and maybe even your smart pump drug libraries. You have to figure out what are the best ways to communicate to your various staff and how often. Communication in this setting is not a one-time deal. It must be sustained.

 

The contingency phase includes decisions about whether drug products might be purchased from “gray market” sources or from compounding pharmacies, knowing that there may be risks to both these sources. These decisions should be based on a philosophy adopted by the organization well before the pressures and emotions generated by the acute shortage occur. Budgetary concerns must also be addressed and additional funds may need to be requested not only for higher drug costs but for additional staffing and overtime needs for all the other things involved in dealing with these issues. And Risk Management should be involved, particularly if you will be prioritizing which patients will get the drug in shortage and which will not. You should also have a strong communication plan, not only for your providers and staff but also for the patients likely to be affected by the shortage.

 

After implementation it is critical that you monitor carefully for both adverse consequences of the shortage and adverse consequences of the alternative therapies implemented. And, once the shortage has been resolved, close the loop and go back and garner all the lessons learned in dealing with that particular shortage. You’ll need to know what worked and what didn’t because you’ll need to know these when, not if, the next drug shortage arises.

 

 

Reasons for the shortages are myriad. A GAO report (GAO 2011) noted that the cause of shortages of 12 of 15 drug shortages were primarily due to manufacturing problems. The 2009 ASHP report (Fox 2009) provides a good compilation of the multiple factors contributing to drug shortages. But it is not only manufacturing problems that have led to shortages. Problems that make marketing of some generic drugs non-competitive and especially problems with our current reimbursement system (Gatesman 2011) are also root causes. Whatever the root causes, this problem has clearly escalated to the point that it is now a significant patient safety hazard. With pressure coming from state and national healthcare associations, medical societies, ISMP, ASHP (American Society of Health-System Pharmacists) patient advocacy groups and others, Congress is looking at a number of potential bills aimed at alleviating the problems of drug shortages.

 

In the interim, you have to be ready to deal with drug shortages. Make awareness of drug shortages a priority for your system and make sure that you have contingency plans to deal with them even before they occur.

 

 

 

References:

 

 

Clark C. Nearly All Anesthesiologists Report Drug Shortages. HealthLeaders Media 2012; April 19, 2012

http://www.healthleadersmedia.com/content/PHY-279127/Drug-Shortages-Taking-Tremendous-Toll

 

 

ASA (American Society of Anesthesiologists). Drug Shortage Survey. 2012

http://www.asahq.org/For-Members/Advocacy/Federal-Legislative-and-Regulatory-Activities/Drug-Shortages.aspx#Drug%20Shortages%20Survey

 

 

ISMP (Institute for Safe Medication Practices). A shortage of everything except errors: Harm associated with drug shortages. ISMP Medication Safety Alert. Acute Care Edition 2012; April 19, 2012

http://www.ismp.org/Newsletters/acutecare/showarticle.asp?id=20

 

 

ISMP Canada. Drug Shortages and Medication Safety Concerns. ISMP Canada Safety Bulletin 2012; 12(3): 1-4 March 20, 2012

http://www.ismp-canada.org/download/safetyBulletins/2012/ISMPCSB2012-03_Drug_Shortages.pdf

 

 

ISMP Canada. Recall of Morphine 2 mg/mL (1 mL Ampoules) and Medication Safety Strategies in a Drug Shortage Situation. ISMP Canada Safety Bulletin 2012; 12(4): 1-2 March 26, 2012

http://www.ismp-canada.org/download/safetyBulletins/2012/ISMPCSB2012-04_MorphineRecall_and_MedSafetyStrategies.pdf

 

 

ISMP (Institute for Safe Medication Practices). Weathering the storm: Managing the drug shortage crisis. ISMP Medication Safety Alert. Acute Care Edition 2010; October 7, 2010

http://www.ismp.org/Newsletters/acutecare/articles/20101007.asp

 

 

Fox RE, Birt A, Janes KB, Kokko H, et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66: 1399-1406.

www.ashp.org/DocLibrary/BestPractices/ProcureGdlShortages.aspx

 

 

US Government Accountability Office (GAO). Drug Shortages. FDA's Ability to Respond Should Be Strengthened. GAO-12-315T, Dec 15, 2011

http://www.gao.gov/products/GAO-12-315T

 

 

Gatesman ML, Smith TJ. The Shortage of Essential Chemotherapy Drugs in the United States. N Engl J Med 2011; 365: 1653-1655

http://www.nejm.org/doi/full/10.1056/nejmp1109772

 

 

 

 

 

 

 

 


 

 


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