This policy establishes procedures for the purchase, storage, distribution, and safe use of controlled substances and experimental or prescription drugs used by ALASKA SCIENCE CENTER - BIOLOGICAL SCIENCE OFFICE (ASC-BSO) personnel for the capture and manipulation of wildlife species. Nothing in this policy supersedes any federal regulation or law. Because the controlled substances laws and regulations were developed with clinical practice in mind, some interpretations are required to adapt the required procedures to wildlife research and management. Many wildlife species cannot be restrained and handled without the use of controlled substances, the use of which is a revocable privilege. Therefore, it is in the best interests of ASC-BSO researchers and administrators to have procedures in place that permit use of these substances in full compliance with the law.

DEFINITIONS:

Controlled Substances: Narcotics and other dangerous drugs that fall under the jurisdiction of the Controlled Substances Act. These drugs are classified into one of five groups based on their potential for abuse and ability to cause psychic or physical dependence. Schedule I drugs have the highest abuse potential and have no accepted medical use. Schedule V have the least abuse potential. Descriptions of the drug schedules and examples are given in Table 1.

Controlled Substance Act: The Controlled Substance Act of 1970 was enacted by Congress and became effective on 1 May 1971. It was designed to improve the administration and regulation of manufacturing, distribution, and dispensing of controlled substances by providing for a "closed" system for legitimate handlers of the drugs.

Drug Enforcement Administration: The federal agency under the Department of Justice charged with the responsibility to control narcotic and dangerous drug abuse through enforcement and prevention. Any licensed practitioner who distributes, prescribes, or dispenses any controlled substances must be registered with the Drug Enforcement Administration (DEA).

Experimental Drugs: See Investigational New Animal Drugs.

Investigational New Animal Drugs: Unlicensed drugs not yet approved for manufacture and sale in interstate commerce. Investigational New Animal Drugs (INAD) are only available on a limited basis to clinical investigators through an application administered by the Food and Drug Administration’s Bureau of Veterinary Medicine, Division of New Animal Drugs. Their use requires the collection and reporting of data back to the manufacturer for its use in licensing the drug for general use, usually as a prescription drug.

Prescription Drugs: Those pharmaceuticals regulated by the Food and Drug Administration and, because of toxicity or other potential for harmful effects, restricted to use by or on the order of a licensed practitioner (physician, dentist, veterinarian, etc.). All veterinary prescription drugs are labeled: "Caution -- Federal law restricts this drug to use by or on order of a licensed veterinarian." The law requires a valid client-patient-veterinarian relationship before dispensing prescription drugs.

Extra-Label Use of Drugs: Extra-label use refers to the administration or application of an approved drug in a manner not according to the directions on its label. Most drug use in wildlife species is extra-label use. In 1994, Congress extended the legality of extra-label use of drugs by licensed practitioners, with the new regulations taking effect in January 1997. Additional usage protocols and additional record-keeping are required.

Veterinary Medical Officer: Also known as the wildlife veterinarian, this is an individual within the ASC-BSO, having a Doctor of Veterinary Medicine degree. Federal veterinarians are not required to hold state licenses to practice veterinary medicine, but often do as a matter of courtesy. This individual maintains the proper registration to purchase, store, and dispense controlled substances, experimental (INAD) drugs, and prescription drugs required for wildlife projects administered by ASC-BSO.

Valid Client-Patient Relationship: Federal law prohibits medical personnel from dispensing or prescribing prescription drugs or controlled substances without a valid client-patient relationship. In order to supply biologists with involving prescription drugs or controlled substances, there is a legal requirement for the wildlife veterinarian to be significantly involved in the planning, execution, and review of projects, in order to establish the validity of the relationship. In a natural resource agency, the "client" is the wildlife or fisheries biologist requesting the drugs, and the "patient" is the wildlife involved.

DEA PERMITS

One DEA permit for the purchase, storage, and use of controlled substances will serve all ASC-BSO researchers. An exception may be made by the Center Director. The wildlife veterinarian will be the accountable official with responsibility for storage, accounting, and control of controlled substances. Only individuals delegated by the Center Director via power of attorney may order controlled substances.

SAFETY

The doses of immobilization and tranquilization drugs required to achieve an adequate response in large wild animals are all potentially lethal if accidentally injected into a human. The use of other substances exposes humans to contact, ingestion or inhalation of potentially damaging chemicals. Therefore, drug safety procedures must be carefully followed at all times. Before using a particular chemical, immobilizing drug or tranquilizer, it is each project leader’s responsibility to see that all personnel are familiar with the human safety aspects of the drug. These instructions shall include knowledge of symptoms following accidental injection; emergency treatment procedures; and name, location, and dosage of an antidote (if any). Material Safety Data Sheets should be requested at the time controlled substances and prescription drugs are ordered and a copy given to the wildlife veterinarian for filing at the storage site.

Personnel accidentally exposed to controlled substances or prescription drugs should seek medical assistance immediately. Incidents of accidental human exposure to controlled substances or prescription drugs should reported in full to the Center Director and to the wildlife veterinarian.

LIABILITY

Two areas are of concern when using chemicals to capture or treat wildlife. The first is the problem of establishing adequate withdrawal times to assure no harmful residues remain in meat that may be used for human consumption. Most uses of drugs in wildlife are extra-label simply because it is too costly to obtain the needed data to establish accurate withdrawal times in each species. Extra-label drug use should not be used in a game or subsistence animal within 45 days of a hunting season, if a season is established. If human consumption of an animal could possibly occur within 45 days of extra-label drug use, the animals must be marked and the hunting public made aware not to use these animals for food.

The second area of concern is the possible exposure of human beings to potentially dangerous drugs. No researcher should use controlled substances unless they are experienced with the drug or unless they have obtained training in the safe use of the drugs. Of special concern is the potential exposure of untrained or volunteer personnel to potentially dangerous drugs. Project leaders must avoid permitting personnel in these categories from participating in work that might expose them to such drugs.

ANIMAL WELFARE

Before capturing and handling a wildlife species, staff personnel will determine what is the best method to minimize injury and loss in conjunction with cost effectiveness. Alternative methods to chemical immobilization, time of year, status of animals (stage of pregnancy, body condition, sex, and age), ambient temperature, and snow conditions must be considered. The Animal Welfare Act and the Interagency Research Animal Committee Principles require approval of the institutional Animal Care and Use Committee (ACUC) for all work with animals. As part of that submission, the researcher must document the consideration of alternatives.

If chemical immobilization is used, ensure the proper drug(s) and dosage(s) are used to provide the necessary analgesia and anesthesia to accomplish processing and other procedures in a humane way. Animals should be positioned to prevent injury during handling and recovery. Ruminants must be placed in sternal recumbancy.

Animals should be treated appropriately if injury occurs in the capture or handling process. If injured beyond likely recovery, animals will be humanely euthanized. Researchers will comply with permit requirements of reporting losses of animals during capture and handling. All animals chemically immobilized shall be marked (ear tagged, tattooed, collared, leg banded, freeze branded or other appropriate method) for future identification, unless requirements dictate otherwise. The Animal Welfare Act requires an annual report detailing the numbers of mammals utilized in research. See the Animal Welfare Act Compliance Policy for more details.

QUALIFICATIONS AND TRAINING

Untrained or inexperienced personnel who want to capture wildlife must receive training on the techniques and drugs used in the target species. Such training must include safety concerns. In the short term, apprenticeships with personnel experienced in the use of specific drugs for the capture of specific species will suffice. Supplemental information on the characteristics and safety issues unique to the given drug and animal combination may be provided by the wildlife veterinarian. In the future, a formal training class given by the wildlife veterinarian or other qualified professional is anticipated. Instructions in recommended drugs and dosages by species, drug safety, proper handling procedures, emergency treatment, animal welfare, and record keeping will be provided. In addition, all field personnel directly involved or assisting in wildlife capture using drugs will be trained in first aid and cardiopulmonary resuscitation (CPR). Because the individual directly handling the capture drug is the most likely one to suffer accidental exposure, the provision of first aid and CPR training to at least one assistant present during capture is highly desired.

REGULATIONS, RECORDS, AND HANDLING

Regulations: Use of controlled substances, experimental, and prescription drugs must comply with all applicable federal and state regulations. Primary among these regulations is the licensing and registration requirement to purchase, store, and dispense controlled substance drugs. Table 2 lists regulated pharmaceuticals used by ASC-BSO staff on wildlife species. The wildlife veterinarian is responsible for maintaining DEA registration and a current list of regulated pharmaceuticals used by ASC-BSO staff.

Records: Accurate records of purchases, distribution, and use of controlled substances and experimental drugs will be maintained. A separate Drug Inventory Record (Form A) for each controlled substance and experimental drug will be kept at the storage location of these drugs.

All shipments or delivery of controlled substances within ASC-BSO will be verified by a Pharmaceutical Receipt Verification Card (Form B).

All use of controlled substances of any Schedule and all use of experimental drugs must be documented on a Controlled Substance/Experimental Drug Use Report (Form C) immediately following a field project. The original will be forwarded for filing with the Drug Inventory Record. Records will be kept of each use of a controlled substance, experimental or prescription drug. A separate form is highly desirable. In the case of controlled substance or experimental drugs, a copy of these records must be maintained at the registered storage site from which the drug was dispensed. No pre-designed form is required, but the form used must have adequate space to record the following: date, location, species, sex, actual or estimated age and weight, health status/condition, drug(s) used, dosage(s), route of administration, and responses. Copies of the original capture sheets should be provided to the wildlife veterinarian as soon as possible after returning from the field. If drugs were used on more than a few animals, a summary sheet of drug usage, containing the data listed above, should be supplied to the wildlife veterinarian.

All records pertaining to controlled substances must be available for inspection and copying by duly authorized officials of DEA. Failure to comply with established record keeping procedures may result in withdrawal from the researcher of the privilege of using controlled substances.

Borrowing and loaning of controlled substances. There is only very limited provision in the law for borrowing or loaning of controlled substances, even between licensed users. Transfers of Class II controlled substances are especially regulated and require special paperwork. Loaning or exchanging controlled substances make it impossible to maintain accurate records and cannot be substituted for adequate planning for drug needs and usage. For these reasons, no controlled substances purchased by personnel of the ASC-BSO can be transferred to any person not directly affiliated with the ASC-BSO. Transfer of controlled substances from personnel not employed by the ASC-BSO to ASC-BSO employees will not be permitted. No controlled substances purchased outside the ASC-BSO will be stored in the safe at the ASC-BSO. This policy does not interfere with appropriate and true cooperative research efforts between ASC-BSO personnel and personnel from other agencies or entities so long as such activities are conducted as a part of the Annual Work Plan and so long as inventories of controlled substances are not transferred between agencies or individuals.

Inventory: By law, an inventory of all controlled substances must be done every two years. The wildlife veterinarian will conduct the inventory. Any unexplained losses, thefts, or unaccountable shortages must be reported to the DEA. While the legal requirement is that all records must be maintained for a minimum of two years, it will be the policy at ASC-BSO that all drug records are part of the research record, and will be maintained indefinitely.

HANDLING:

Purchase: The DEA permit held by ASC-BSO is a "research" permit, which enables the Director, ASC-BSO to purchase controlled substances. The Director, ASC-BSO can delegate this authority to one or more individuals by means of a power of attorney. Individuals making purchases must comply with the limits of the registration and meet all applicable requirements stated in this document. Costs of all drugs will be borne by the individual research projects. It is the responsibility of the researcher to anticipate drug needs to permit them to be ordered and received before they are needed.

Authority to Purchase and Dispense: As required by law, the Director, ASC-BSO may delegate via written and witnessed power of attorney, the authority to purchase and dispense controlled substances. The persons authorized may change by decision of the Director, ASC-BSO, and the delegated persons are not a constant factor of the ASC-BSO Controlled Substances Policy. Changes in delegated authority will be announced. At present, authorized persons are (in the order they should be contacted): Daniel M. Mulcahy, Wildlife Veterinarian, William K. Seitz, Director, ASC-BSO; Dirk Derksen, Branch Chief; and Leslie Holland-Bartels, Branch Chief.

Storage: Controlled substances listed in Schedules II, III, IV and V shall be stored in a securely locked, substantially constructed cabinet or safe. Special category Schedule II drugs (etorphine, diprenorphine, and carfentanil) shall be stored in a bank safety deposit box or a safe that is equivalent to a U.S. Government Class V security container. Safes rated with Underwriter’s Laboratories as TL-15 or stronger will meet this requirement. Controlled substances storage sites must be registered with DEA. Only the wildlife veterinarian or another individual designated by the Director, ASC-BSO can place and remove controlled substances from the repository safe. A safe for short-term storage of dispensed controlled substances will be provided, allowing the researcher to store drugs while waiting to depart for the field or immediately upon return from the field, until access to the repository safe can be arranged with the wildlife veterinarian. The short-term storage safe will not be used to store drugs for more than ten working days. Special circumstances should be brought to the attention of the wildlife veterinarian for resolution. Controlled substances found in the short-term safe for an extended period will be returned to the repository safe by the wildlife veterinarian. It is highly recommended that drugs held in the short-term safe be kept in a locked box provided by the researcher. The name of the researcher must appear on the outside of the locked box. The date drugs were placed into the short-term storage safe must be attached to the stored drugs. No lock boxes will be permitted in the temporary storage safe unless a key or combination is provided to the wildlife veterinarian.

When authorized to do so by the Director, ASC-BSO, field stations may keep small amounts of Class III, IV, or V controlled substances for use in emergency, unplanned immobilizations of animals. No Schedule II controlled substances may be kept. The conditions that must be satisfied are: 1) Amounts of drugs are truly "small" (For Telazol, this amount is limited to sufficient drug to immobilize two brown bears); 2) This permission is not used as a loophole to maintain seasonal requirements of drugs; 3) The drugs are to be keep in a substantial locked cabinet or safe; 4) Rapid notification of usage of these drugs is made to the wildlife veterinarian; 4) The necessary forms are sent to the wildlife veterinarian as soon as possible following use of the drugs; 5) All areas of the ASC-BSO Controlled Substances Policy are complied with; 6) A inventory and accounting is made in January of each year which is sent to and reconciled with the wildlife veterinarian.

Storage in the field: Biologists receiving controlled substance dispensed for a specific project are not required to meet the above storage requirements while in the field. However, it is the project leader’s responsibility to see that all drugs are protected and secured by the best means available to prevent damage, accidental exposure, or theft.

Shipping and transportation: All drugs will be hand carried or sent by certified mail or other secure method. Drugs being hand carried must be in a locked container The individual shipping the drug(s) will fill out and enclose a preprinted Pharmaceutical Receipt Verification Card. The receiving individual will note any discrepancies, sign, date, and return it to the sender. Drugs being returned following a field project will also be handled securely. A receipt card will again be issued following the return of the drugs to an authorized storage area.

Destruction: All outdated or contaminated controlled substance drugs will be turned into the wildlife veterinarian for accounting and proper submission to DEA. Destruction of outdated or contaminated controlled substance drugs must be done by DEA according to procedures outlined in Title 21 of the Code of Federal Regulations.

INVESTIGATIONAL NEW ANIMAL DRUGS (INAD)

Occasionally drug companies or distributors will make available an experimental drug (INAD) that has potential applicability in wildlife species for immobilization, tranquilization, or treatment of specific conditions. The purpose of issuing INAD permits is to gather data on their use that will assist registration of the drug for a given species. Records of the use of INADs need to be submitted to the manufacturer. Use of INADs will be coordinated by the wildlife veterinarian to ensure all Food and Drug Administration reporting requirements are met. All new INAD applications should be made by the wildlife veterinarian.

The wildlife veterinarian has the authority to dispense INADs, and they will be handled in the same way as controlled substance drugs. If granted use of such a product for evaluation, the researcher must assure proper dosage, administration, and data collection. All animals given an INAD must be properly identified as discussed previously to permit future identification. Accurate individual animal records must be maintained and contain all information previously listed for individual animal forms with emphasis on: identifying markings, dosages of drug, route of administration, responses, and any adverse side effects.

STEPS FOR OBTAINING CONTROLLED SUBSTANCES AND INAD’s:

1. Consult with the wildlife veterinarian to assure proper drug selection, dose, dosage, and route of administration. Discuss alternatives.
1. If the use of a new drug is desired, an INAD permit may have to be applied for. The wildlife veterinarian will submit the needed paperwork to obtain this permit.
2. Prepare, submit, and gain approval of research plans for the Annual Work Plan and by the ACUC.
3. Identify the volume, stock concentration, and preferred source of drugs. Prepare a purchase order, including a billing code, and give it to the wildlife veterinarian or other delegated person for preparation of the order. Allow sufficient time to permit placement and receipt of the order. Persons presently having delegated authority to purchase or dispense controlled substances are: Daniel M. Mulcahy, Wildlife Veterinarian, William K. Seitz, Director, ASC-BSO; Dirk Derksen, Branch Chief; and Leslie Holland-Bartels, Branch Chief.
4. The wildlife veterinarian or other delegated person will place the order, receive the drugs, add them to the inventory, and store them. Another individual, designated by the Director, ASC-BSO, may also order, receive, store, and issue controlled substances.
5. When preparing to take to the field, notify the wildlife veterinarian or other delegated person of the volume of drugs required for immediate usage. The wildlife veterinarian or other designated individual will remove the drugs from storage, noting the withdrawal on the inventory.
6. When receiving drugs from the delegated person, the researcher will sign for them, assuring a closed circle of possession. Controlled substances should be placed in the short-term storage safe until the researcher leaves for the field.
7. While in the field, the researcher bears the responsibility for safe storage and usage on drugs, bearing in mind that loss or theft of controlled substances requires a formal report to the Drug Enforcement Agency.
8. Maintain records on the use of controlled substances while in the field. Account for all usage by maintaining a record of drug use on each animal, noting the time, date, location, species, gender, animal number, actual or estimated age and weight, health status/condition, drug(s) used, dosage(s), and responsible individual. Schedule II drugs require a separate record for all uses, which must be turned over to the wildlife veterinarian immediately upon return from the field. To simplify accounting, an individual animal capture/drugging sheet should be maintained when any controlled substance is used. This can be part of the researcher’s record sheets, and a copy submitted to the wildlife veterinarian. Note that controlled substances are accounted for by weight (usually mg), not by the number of vials or containers.
9. Upon return from the field, unused drugs are signed over to the wildlife veterinarian or other designated person as quickly as possible for return to inventory and storage and for completion of the closed circle of possession. The drugs may be placed in the short term storage safe until they can be handed over to the wildlife veterinarian or other designated individual. The researcher must account for all losses and uses of the drugs. Complete Form C to summarize total usage (by mg) of controlled substances. A copy of the original capture/drugging sheets, showing the information listed above, should be given to the wildlife veterinarian as soon as possible (within one week) upon return of unused controlled substances. If many animals have been captured, a list of animals by date and animal number, giving the total amounts of drugs used should be made and given to the wildlife veterinarian in addition to the individual capture sheets.

STEPS FOR OBTAINING PRESCRIPTION DRUGS:

1. Consult with the wildlife veterinarian to assure proper selection, dose, dosage, and route of administration of prescription drugs, and to establish a valid client-patient-veterinarian relationship as required by law.
1. Prepare, submit, and gain approval of research plans by the ACUC.
2. Identify the volume, stock concentration, preferred source of drugs. Prepare a purchase order, including a billing number, and give it to the wildlife veterinarian for placement of the order. In some instances, suppliers have required submission of a formal prescription form and a copy of the wildlife veterinarian’s license.
3. The wildlife veterinarian or his designate will place the order, receive the drugs and transfer them to the researcher.
4. Transfer of these drugs to another individual or project violates the principle of the client-patient-veterinarian relationship that is required by law for the use of prescription drugs. Discuss the uses of leftover drugs with the wildlife veterinarian.
5. Storage of prescription drugs other than controlled substances should be done in a secure manner to prevent casual access.

Table 1. Categories of controlled substances as regulated by Drug Enforcement Agency.

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Schedule IV Drugs: Less dangerous drugs, with some danger for potential abuse. Example: diazepam, phenobarbital.

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