Care of the Critically ill and Injured During Pandemics and Disasters: Strategy 1
In critical care medicine, supply chain vulnerabilities have already resulted in many key medication shortages, including antimicrobials, sedatives, vasopressor medications, and anesthetics (Table 2, e-Table 1). These shortages are not due to disasters, and, hence, when disasters occur, they will exacerbate these preexisting vulnerabilities. cheap wellbutrin
When medication shortages occur, alternative agents are often used, but they are often associated with suboptimal results or adverse events. Reasons attributed to inferiority of these substitutes include a lack of familiarity with the substituted medications, inherent increased toxicity of the alternative agent, and others, such as increased antimicrobial resistance rates. Even when substitutions can be made without immediate clinical consequences, they may lead to increased costs or use of a branded medication and a substantial increased time and effort by providers, pharmacists, and hospital administrators to address shortages.
Large-scale assessments of medication and medical supply chain vulnerability and shortages have been undertaken to help inform US national policy as well as institutional preparedness. Although these assessments were undertaken in the United States, the results and conclusions can be generally applied to other nations and provide important perspectives for future preparedness (Table 3).
Although the long-term problem of medication and medical supply chain vulnerability is recognized and addressed by national governments, international cooperatives, nonprofit organizations, manufacturers, and others, individual health-care facilities and systems can use six strategies to prepare for and mitigate the impact of medication and medical supply shortages when they occur. These strategies form the foundation for supply chain vulnerability suggestions and are particularly important when considering the abrupt nature of mass critical care events; they are summarized here and in Table 4.
Strategy 1: Routine purchasing of key critical care supplies and medications from more than one supplier may minimize the impact of a drug shortage as well as having clinical familiarity with the other suppliers’ product. For most drug shortages there are alternative manufacturers or suppliers available.
Table 2 – Shortages of Critical Care Medications in the United States 2010 to 2013 by Medication Category
Medication Category | No. of Medications in Shortage | No. of Medication Shortages Resolved | Medications in Shortage for Which No Alternative Source/Formation Was Available | Medications in Shortage: Representative Examples |
Analgesic | 8 | 3 | 1 | Fentanyl injection |
Hydromorphone hydrochloride injection | ||||
Ketorolac tromethamine i njection | ||||
Oxycodone immediate release tablets and capsules | ||||
Antiinfective | 53 | 24 | 11 | Acyclovir capsules and tablets, and topical cream, ointment |
Ampicillin sulbactam | ||||
Azithromycin injection, and suspension | ||||
Aztreonam injection | ||||
Cefazolin injection | ||||
Cefotaxime injection | ||||
Ceftazidime injection | ||||
Ciprofloxacin injection and immediate-release tablets | ||||
Clindamycin injection | ||||
Doxycycline hyclate injection | ||||
Fluconazole injection | ||||
Levofloxacin injection | ||||
Meropenem injection | ||||
Metronidazole injection, tablets, and capsules | ||||
Nafcillin sodium injection | ||||
Oseltamivir phosphate oral suspension | ||||
Sulfamethoxazole/trimethopriminjection | ||||
Vancomycin hydrochloride injection | ||||
Antiinflammatory | 5 | 0 | 0 | Methylprednisolone acetate injection |
Prednisone tablets | ||||
Cardiovascular | 26 | 6 | 2 | Adenosine injection |
Amiodarone hydrochloride injection | ||||
Atropine sulfate injection | ||||
Digoxin injection | ||||
Diltiazem injection | ||||
Dobutamine injection | ||||
Enalaprilat injection | ||||
Epinephrine 0.1 mg/mL emergency syringes and injection | ||||
Esmolol injection | ||||
Hydralazine injection | ||||
Labetalol injection | ||||
Metoprolol injection | ||||
Nicardipine hydrochloride injection | ||||
Nitroglycerin injection | ||||
Norepinephrine injection | ||||
Phenylephrine hydrochloride injection | ||||
Vasopressin injection | ||||
Coagulation | 9 | 5 | 3 | Argatroban injection |
Enoxaparin injection | ||||
Heparin sodium injection | ||||
Phytonadione (vitamin K) injection | ||||
Protamine sulfate | ||||
Warfarin sodium tablets | ||||
Diuretic | 4 | 0 | 1 | Furosemide injection |
Torsemide injection | ||||
Gastrointestinal | 4 | 1 | 0 | Famotidine injection |
Octreotide injection | ||||
Pantoprazole injection | ||||
Neurologic | 6 | 2 | 1 | Fosphenytoin injection |
Levetiracetam injection | ||||
Phenytoin injection | ||||
Valproate sodium injection | ||||
Nutrition/electrolyte | 7 | 0 | 3 | Amino acid products with electrolytes in dextrose with calcium (Clinimix E) |
Calcium chloride and gluconate injections | ||||
Magnesium sulfate injection | ||||
Potassium chloride injection | ||||
Paralytic | 5 | 0 | 1 | Atracurium injection |
Pancuronium injection | ||||
Rocuronium injection | ||||
Succinylcholine chloride injection | ||||
Vecuronium bromide injection | ||||
Sedative | 7 | 0 | 1 | Diazepam injection |
Etomidate injection | ||||
Lorazepam injectable presentations | ||||
Midazolam injections | ||||
Propofol injection | ||||
Other | 6 | 4 | 1 | Naloxone injection |
Ondansetron injection | ||||
Total | 140 | 45 | 25 |
Table 3 – Summary, FDA Review of Medication Shortages From 2001 to 2011, With the Number of Medication Shortages Steadily Increasing From 61 in 2005 to 178 in 2010, and the Bureau of Industry and Security Office of Technology Evaluation at the US Department of Commerce Report Released in December 2011 Evaluating the Reliance on Foreign Sourcing for Medications and Medical Supplies
Key Shortage, Supply Disruption, Product Area, or Strategy | Implications |
Injectable medications, breakdown of shortages by drug class. Evaluation of shortages between January 2010 and August 2011 found that sterile injectable medications composed the vast majority (80%) of drug shortages. Tablet and capsule medications composed 10%, and other routes of administration (eg, transdermal, inhalation, suspension/solution) composed the remaining 10%. | 28% were chemotherapeutic agents. |
13% were antimicrobials. | |
11% were electrolyte/nutrition medications. | |
9% were neuromodulators. | |
6% were hormonal medications. | |
33% were of drug classes with five or fewer shortages. | |
Injectable medication shortages, market implications | In 2010, the top three manufacturers held 71% of the generic injectable medication market, and the top five manufacturers held 80% of the market. |
There were 342 injectable molecules for which a single manufacturer held > 90% of the market share and 451 injectable molecules for which only two manufacturers held > 90% of the market share. | |
Factors contributing to sterile injectable drug shortages i nclude a paucity of manufacturers, the need for specialized facilities for dedicated production lines, and a change on the part of medical facilities toward the use of just-in-time inventories. | |
Primary reasons for disruption in medication production and supply. This includes the factors identified at right, with the FDA’s concluding that the “problem of medical product shortages is complex and stems from economic, legal, regulatory, policy, and clinical decisions that are deeply connected.” | 43% were related to problems at the manufacturing facility. |
15% were due to delays in manufacturing or shipping. | |
10% were due to API shortage. | |
8% were due to business decisions to discontinue production. | |
5% were due to loss of manufacturing site. | |
4% were due to non-API component shortage. | |
4% were due to increase in demand. | |
2% were due to improper labeling. | |
9% were due to other/unknown causes. | |
Top medication product areas for which critical components, materials, or products were from non-US suppliers: includes many medications used commonly in critical care medicine, including insulin, imipenem, clindamycin, lidocaine, hydrocortisone, hydrochlorothiazide, ibuprofen, and acetaminophen. | 33% had no alternative source available. |
33% had a different non-US alternative source available. | |
4% had a US source available. | |
13% had both a US source and a non-US source available. | |
Key Shortage, Supply Disruption, Product Area, or Strategy | Implications |
Top medical supply product areas, for which critical components, materials, or products were from non-US suppliers: includes those used in critical care such as infusion/IV pumps, defibrillators, pacemakers, medical needles, syringes, sterilizers, oxygen analyzers, and IV catheters. | 44% had no alternative US source. |
17% had a different non-US alternative source available. | |
10% had a US source available. | |
23% had both a US source and a non-US source available. | |
Implications of “just-in-time inventory” strategies now routinely used by hospitals | 10% of health-care facilities maintain < 1 mo of inventory of medications and medical supplies. |
76% of health-care facilities maintain 1-3 mo of inventory of medications and medical supplies. |
Table 4 – Summary of Six Key Strategies Hospitals Can Use to Prepare for and Mitigate the Effects of Supply Chain Vulnerability
Strategy | Task Force Suggestion, Summary |
1 | The purchase of key medications and supplies should ideally be from > 1 supplier |
2 | Substituted medications and supplies should ideally be similar to those already used by an institution’s providers |
3 | Inventories should be tracked electronically to monitor medication and supply levels |
4 | Consider maintaining higher inventories of medications and supplies known or projected to be in short supply |
5 | Institute alternate use protocols as soon as a known or potential medication or supply shortage is identified |
6 | Support government and nongovernmental organizations in efforts to address supply chain vulnerability |