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-Preparation and Implementation-
Preparedness
An effective response to various emergencies requires prepared, well-trained local responders who can interact with state and federal agencies. Training for responders should cover the characteristics of biological and nonbiological agents that can be used in destruction. Pharmacists should be trained in their duties as responders, and they should be protected in the event of an attack so they can perform those duties. Security of the pharmacy may be a top concern because break-ins to obtain medications may occur.
Although the threat of terrorist attacks has grown in recent years, natural disasters such as floods, hurricanes, and tornadoes are a recurring cause of mass destruction. For these situations, too, pharmacists should be involved in local disaster planning.
Even small communities must be prepared to handle a mass casualty incident until state and federal assistance arrives. In such circumstances, healthcare providers must manage many patients who require urgent care, and pharmacists are likely to be pressed into action to deliver the medications needed to save lives; relieve pain; and limit potential damage from exposure to caustic, infectious, or other harmful agents. Pharmacists may be involved in treating not only patients suffering from exposure to nerve gas, biological weapons, or trauma, but also victims of a bombing.
Pharmacies' maintenance of just-in-time inventory works against an adequate response to disasters and terrorism. Competition for limited resources could challenge the ability to maintain civic order. Pharmacists involved in an emergency situation may find that providing information is relatively simple but providing pharmaceuticals is more difficult because pharmacies routinely stock commercially available products in limited quantities only. Many pharmacists can compound some preparations to help fill the need until commercial stocks are replenished. Compounding pharmacists can provide various dosage forms to all types of patients.
Pharmacists' Involvement During the Emergency
Pharmacists' involvement in disaster planning is the first step in preparing for a terrorist attack. A formulary should be developed to include primary and secondary treatments for the effects of chemical, biological, and nuclear weapons. Variables in the dosing of antibiotics, antitoxins, vaccines, and prophylactic treatments for adolescent and pediatric patients should not be overlooked. The use of chemotherapeutics (and their respective teratogenic effects) in pregnant patients should be noted in each treatment protocol. Because a chemical, biological, or nuclear attack will create drug shortages, pharmacists should have preplanned procedures for rationing and agreements for support from a network of pharmacies.
Pharmacists can also provide valuable information when the agent used in an attack may not be clear, such as in an unusual outbreak of infections. Because they often see hundreds of patients daily, pharmacists can help detect unusual occurrences that might be related to bioterrorism. For example, pharmacists might observe cases of a disease that is not endemic, unusual patterns of antibiotic resistance, atypical clinical presentations, case distribution in a certain geographic region, unusually high numbers of cases, and morbidity and mortality rates that deviate from the baseline.
After a terrorist incident occurs, pharmacists working with limited assets will be asked to provide medications in a very short time. In preparation for this situation, pharmacists should maintain current, accurate information on product procurement and manufacturing options. Self-reliant and adaptable, compounding pharmacists can provide drug treatment alternatives to lessen the damage from an attack. Formulations and procedures for extemporaneous compounding must be created, reviewed, and tested before an emergency occurs. Preestablished reference publications, bulk materials, source information, and pharmaceutical items (antibiotics, antidotes, antitoxins, other supportive-care agents) will facilitate hands-on training in the treatment of victims of biological, chemical, or nuclear attacks. In addition to providing pharmaceuticals, pharmacists can disseminate supplies such as gloves, gowns, masks, and respirators; provide information about dosages and vaccination schedules; and counsel patients.
Assistance is available from the federal government's Strategic National Stockpile, which has prepared "12-hour push packages" for immediate response. These caches of pharmaceuticals, antidotes, and medical supplies are designed to provide a broad range of items that may be needed in the early hours after an event. The packages are positioned in strategically located secure warehouses for deployment to designated sites within 12 hours of a federal decision to distribute these assets. The push packages contain bulk-packaged dosage forms such as tablets; there may be several hundred thousand in a drum, and they will need to be packaged into units for distribution to patients.
Critical Logistic Needs
A terrorist event might result in curtailment of travel and shipping, impeding the availability of pharmaceuticals and possibly leading to rationing. Plans should be in place for security of the pharmacy, pharmacists, and other personnel such as trained technicians. During a disaster, armed guards may need to be posted at pharmacies.
Disaster planning might include the following steps:
- Determine the needs of your pharmacy and community (and your own family).
- Ensure that the pharmacy is involved in planning with the local government and healthcare system.
- Install a water purification system to provide an uninterrupted supply of water for the pharmacy.
- Establish and maintain close communication with authorities.
- Develop an emergency distribution system for pharmaceuticals within your service area.
- Work in advance with the state board of pharmacy; certain state laws may need to be relaxed during the emergency.
- Establish a reasonable stock of bulk drug substances and supplies for compounding. Bulk drug substances can be easily and rapidly formulated into various dosage forms for all age groups.
- Make plans for the security of the pharmacy.
- Install a generator to provide electricity to your entire facility in the event of lost power.
Compounded and Manufactured Treatments after a Disaster
Pharmaceuticals may be needed for decontamination, prophylaxis, or treatment, depending on the causative agents and the timing involved. Decontamination might involve a number of preparations (e.g., sodium hypochlorite solutions), depending on the agents used. Vaccines are available for anthrax, botulism, cholera, plague, Q fever, smallpox, tularemia, viral encephalitides, and the viral hemorrhagic fevers. Treatment is specific to the agent used. Treatment after attacks with chemical agents (poisons) might include (1) use of antagonists that compete with the poison for receptor sites, (2) use of compounds that inhibit the poison by reacting with it to form less active or inactive complexes or by interfering with its metabolism, (3) use of chelating agents, (4) use of agents that block essential receptors and thereby mediate the toxic effects, (5) use of compounds that reduce the rate of conversion of the poison to a more toxic compound, (6) induction of emesis, and (7) routine symptomatic treatment. Commonly used agents include BAL, dimercaptopropanesulfonate, dimercaptosuccinic acid, sodium nitrite, and sodium thiosulfate.
The ability to prepare a wide variety of dosage forms in response to an attack is important. All members of an affected community may need to be treated, and this will require various routes of administration and dosage forms, depending on the drugs involved.
Preparation of enemas, nasal preparations (local and systemic), oral liquids, oral solids (capsules, tablets, troches), ophthalmics, parenterals, solutions for inhalation, suppositories, and topicals will be important.
Dosage forms that may be required for various age groups include the following:
- Neonates: Enemas, injections, oral inhalations, oral liquids, suppositories
- Infants: Enemas, injections, oral inhalations, oral liquids, suppositories
- Young pediatric patients: Enemas, injections, oral inhalations, oral liquids, suppositories, topicals
- Older pediatric patients: Enemas, injections, oral inhalations, oral liquids, oral solids, suppositories, topical
- Adults: Enemas, injections, oral inhalations, oral liquids, oral solids, suppositories, topicals
- Geriatric patients: Enemas, injections, oral inhalations, oral liquids, oral solids, suppositories, topicals
Regulatory and Quality Control
An emergency situation may require the relaxation of certain restrictions on the practice of pharmacy, including pharmacy compounding. State boards of pharmacy may want to determine in advance which regulations can be eased immediately after an event to allow timely provision of pharmaceutical preparations and services.
Relatively simple standard quality control measures can still be performed during the crisis, including physical assessment (observations), weight, volume, pH, and specific gravity.
Stability Considerations
Stability must be considered even in an emergency situation when drug preparations are likely to be for immediate and short-term use.
Pharmacists should observe compounded drug preparations for signs of instability. Chemical, physical, microbiological, therapeutic, and toxicological stability should be addressed. The beyond-use date, or period during which a compounded preparation is usable after dispensing, should be based on available stability information and reasonable patient needs with respect to the intended drug therapy. Beyond-use dates are set according to the state board of pharmacy or local jurisdiction requirements with the state to which the compounded medication is to be dispensed. In an emergency, one must consider other factors and whether or not a slight loss in strength of a product is of any real consequence as compared to doing without the drug.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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