This Beef Cattle Drug Is Known to Be Fatal to Humans Upon Accidental Injection Exposure

A 38-yr-old cattleman died as a result of an accidental injection of an animal antibody known every bit Micotil which has no known antitoxin. On March 8, 2003, the victim was preparing to vaccinate a heifer inside a barn. He was carrying a 12cc plastic disposable syringe in his right manus when a moo-cow that was in an next pen charged him, hitting the fence betwixt the two. The victim was knocked to the footing. Either when struck or from the fall, he was injected with an unknown amount of the antibiotic. He immediately began to feel dizzy and nauseous. He was able to return to the "vet room" within the befouled and call his wife who was nearby in the firm. An ambulance was called and the victim was rushed to a nearby hospital where he died less than an hour subsequently.

The Nebraska Workforce Evolution, Department of Labor's Investigator concluded that to help prevent futurity similar occurrences:

• Veterinarians and fauna wellness distributors, prior to releasing Micotil, should require the purchaser to sign a product information fact sheet that indicates Micotil tin can be fatal in humans, and that in that location is no antitoxin for this medication every time they purchase the product.
• Users of syringe-loaded medications should practice safe handling procedures during all phases of creature treatment.
• Veterinarians/Cattlemen, when practical, should consider using another less-chancy antibiotic.
• All companies/agencies responsible for the manufacture and/or approval of veterinary medicines and supplies should proceed to devise new products that will reduce unintentional man exposure to accidental needlesticks/injections.
  

The goal of the Fatality Cess and Control Evaluation (FACE) workplace investigation is to prevent future work-related deaths or injuries, by a study of the working environment, the worker, the chore the worker was performing, the tools the worker was using, and the role of management in controlling how these factors collaborate.

This written report is generated and distributed solely for the purpose of providing current, relevant pedagogy to employers, their employees and the community on methods to prevent occupational fatalities and injuries.

On March 8, 2003 at approximately 7 p.thou. a 38-year-old cattleman died within an hour equally a result of an accidental injection of the bovine antibiotic Micotil 300®. The Nebraska Section of Labor was notified of the incident on March 9, 2003 through the local news media. The Nebraska Face investigator met with the victim's family on June x^thursday & 12^th. Site visits were conducted both days. The local emergency response personnel that responded to the incident site were interviewed on June 12^th. A telephone conference was held with the drugs' manufacturer, ELANCO on June 16^th . and with the Federal Drug Administrations' (FDA) Middle for Veterinary Medicine on June 19^thursday.

The victim was a self-employed cattleman/farmer. He was born and raised on a subcontract and had been raising cattle virtually his unabridged life. At the time of the incident the farm did non employ whatsoever other personnel. The victim was in adept concrete shape.

On the twenty-four hour period of the incident the victim was working alone inside the barn. He had brought a young heifer (young cow that has not previously calved) into the barn and placed her in a squeeze chute (come across photo #2). His intent was to inject her with the antibiotic Micotil 300®. He went to the "vet room", located within the barn where supplies and medicine were kept (come across photo #1). He probably withdrew between 10-12 ccs of the antibiotic (normal dosage requirement for this sized animal) from a 100 ml bottle, into a plastic disposable syringe and left the room with the syringe believed to exist carried in his right hand. As he walked down an alleyway towards the clasp chute (see photo #3), he had to laissez passer by a metallic swing gate that was post-fastened via hinges, enclosing a fenced-in pen that ran parallel along the east side (right side of victim) of the barn. This pen contained a "horned cow" that was set up to calve at any time. As the victim started to open up the gate and walk through to the squeeze chute, the horned cow charged, striking the fence console and/or the victim with plenty force to knock him to the ground (encounter photo #4). As he tried to regain his balance, he began feeling lightheaded. He was able to make it approximately 25 feet back down the alleyway to the "vet room" and use a phone located within the door to call his wife in the nearby house. She constitute him extremely giddy and becoming nauseous. 911 was called along with a neighbor. The local emergency rescue team (EMTs) responded from a nearby town within a few minutes and immediately transported the victim to a nearby hospital. En route they were met by an ambulance containing paramedics that could provide more care if needed.

Photo #1. Looking south down walkway towards vet room door on right side. Phone was located directly inside door on right side mounted to the wall.

Photo #2. Clasp chute where heifer was being held.

Photo #3. This is the walkway between the "vet room" on the left and cattle holding pens on the right. The squeeze chute that held the heifer is to the left through the opening just beyond the metal gate.

Photograph #four. Metal gate on the left is hinged on the left side and swung against the pen to let the heifer, one time inoculated, to leave the squeeze chute and exit the barn going through the opening on the left, down the walkway and out a door on the side. The victim was passing betwixt it and the metallic pipe console on the right side when the horned cow charged, knocking him to the ground. The pipe is 1¼ inch diameter and there is 8 inches in between pipes.

Information apropos medications and procedures administered at the incident site and during ambulance send were not revealed to the investigator due to doctor/patient confidentiality guidelines of both agencies involved.

The syringe and needle that the victim had been carrying was located at the incident site and was slightly aptitude, indicating that the victim had probably been injected with some of the antibiotic. This information was relayed to the emergency responders and hospital personnel and they contacted a poisonous substance control centre. When the ambulance arrived at the hospital, the victim was told by the treating md that there was no known antitoxin that could help him. The victim knew his family had arrived at the hospital and wanted to talk with them, just collapsed and died while getting off the emergency room table.

Later that evening the victim'due south father returned to the barn to check on the status of the heifer in the squeeze chute. As he passed betwixt the swing gate and pen argue where the incident occurred, the horned cow again charged the fence panel. After releasing the heifer from the squeeze chute he again passed in the opposite direction betwixt the swing gate and pen, causing the cow to charge him a second time. It tin be concluded with reasonable certainty that this charging moo-cow was responsible for knocking the victim downwards.

A request was fabricated by the immediate family to donate organs and/or torso tissue. That asking was denied due to the possibility that Micotil was nowadays in the victim.

Cattle: The heifer in the squeeze chute was a purebred cherry angus, weighing approximately 800 to 840 lbs. The horned cow in the adjoining pen was a longhorn crossbreed weighing between 800-1000 lbs. The horns were approximately 12 inches in length and stuck straight out, unlike the side-to-side horns of most longhorn cattle. Information technology could not exist determined if only the strength of impact knocked the victim down, or if a portion of the cow's head and/or horns struck him and/or the syringe. Family unit members stated that there appeared to exist impact marks of some type on the victim'south coveralls near the possible injection site.

Syringe/needle: The syringe in use that twenty-four hours was a 6 inch long, 12 cc Monoject 200™ with an 18 gauge, i ½" long needle (identical to that seen in photograph #v). It could not be determined whether the protective cap was on when the victim left the "vet room" and/or when he was struck. Although intended for single utilise, it is mutual practice amongst cattlemen to utilise this type of needle for several injections. The investigator was non able to determine if the incident syringe/needle was new or had been used before. The victim was correct handed and was believed to be conveying the syringe/needle in that mitt, which was the side of his trunk that was impacted. Information technology is believed, based on the weight of the heifer and the Micotil 300® dosing instructions that the syringe would have contained between ten-12 ccs. Afterwards the incident the syringe contained approximately one.5 cc'south. It was non medically determined how much was injected into the victim. The needle, either during the bear on from the moo-cow or when the victim fell to the ground, stuck the victim in the right side groin surface area. Examination of the insulated coveralls by hospital personnel showed an expanse where information technology is believed the needle penetrated through the exterior layer, which would indicate it was being carried in his hand. Family unit members stated that examination of the incident needle and the luer-tip of the syringe showed that both bad been drastically aptitude, presumably from the bear upon and accidental injection.

Photo #5. The syringe in use that day was a 6 inch long (with protective cap installed) 12cc Monoject 200™ with an 18 gauge 1½ inch long needle. With the cap on the needle tip is approximately ¼ inch from the terminate.

Note: The investigator did not take admission to either the incident clothing or syringe.

Antibiotic: ²Micotil, which contains Tilmicosin phosphate, is used to control respiratory affliction in cattle (bovine respiratory disease), more commonly called Dairy Calf Pneumonia (DCP), a very expensive and difficult-to-treat problem. Information technology was designed to provide a unmarried-injection therapy intended to reduce stress on the fauna, thus requiring less labor since it is a low-volume dose used at a single injection site. It reaches effective concentration levels in lung tissue in 2 hours and maintains effective concentration levels throughout the respiratory tract for three to four days. Information technology works with the animal'due south own immune system to destroy pathogenic leaner.

Micotil is an antibiotic that originally offered a lower cost per treatment than many other antibiotics for this indication available at the time. It was outset introduced in Canada in 1990, and so in the United States in 1992 and immediately gained wide acceptance. It is currently being marketed in several countries throughout the world.

A dosage of 1.five mL per 100 lbs. of animal weight is recommended. It is to be injected subcutaneously (below the skin) in cattle. It can not exist administered intravenously in cattle, every bit that proves fatal. The manufacturer states on all product literature that information technology is not to be used with automatically powered syringes, presumably due to its hazards to humans or possibly inefficiency to administer subcutaneous injections via this method. Most cattlemen use some form of disposable plastic syringe for injection.

Elanco is the only producer of Micotil. It is sold, through a distributor, only to licensed veterinarians. The victim had used Micotil® for several years. Information technology could not be determined where or when he purchased the antibiotic in employ during the incident.

According to the death certificate, the cause of death was: Respiratory failure as a outcome of cardiac arrest as a consequence of lethal injection.

Recommendation #one: Veterinarians and fauna wellness distributors, prior to releasing Micotil, should require the purchaser to sign an information fact canvass that indicates Micotil can be fatal in humans and that there is no antitoxin for this medication, every time they purchase the production.

Word: Breezy telephone and on-site verbal surveys with veterinarians were conducted throughout this investigation. They take shown that some veterinarians ever warn their customers, either verbally or through manufacturer'southward supplied literature, every time they purchase Micotil. Others take stated that if there has been a long-term human relationship between them and the user, they practice not always warn them of the possible dangers, bold they remember.

Verbal surveys conducted with the customers indicated that most had originally been told of the dangers of Micotil, but had become conceited until this incident. Several admitted that although they purchased the medication, they were not the actual person that injected information technology, leaving that task to a hired employee. Near said that they had non discussed specific Micotil dangers with their employees, simply had trained them on proper injection techniques.

Elanco does provide "prescription pads" specific to Micotil to all its customers (meet photos 6 & 7). This sail is intended for utilise by the issuing veterinarian or beast health distributor each and every time they distribute Micotil to a user. The front side contains general information well-nigh the user, injection dosage, suggested injection sites, comments by the issuing veterinarian and a line for the veterinarian's signature. There is no signature line for the purchaser . A completed copy should be placed in the purchaser'south file, and a re-create sent with the purchaser.

Proffer: Add a signature line for the "purchaser". Their signature will ensure that the information was presented to them and that they had opportunity to inquire questions from the issuing veterinarian or animate being health distributor.

Recommendation #ii: Users of syringe-loaded medications should exercise prophylactic handling procedures during all phases of brute treatment.

Word: The victim had used this product many times before. Even though his cattle had the reputation of being extremely gentle and like shooting fish in a barrel to piece of work with, he notwithstanding placed the heifer in the squeeze chute to medicate her, for both his and the beast'southward safety.

Syringes should always exist transported, whether total or empty, with the protective needle cap on. The investigator could not determine if the syringe was capped or not. The hard plastic needle cap, although extremely rigid and generally tight fitting, may not have been able to withstand the force of a direct blow from the horned moo-cow if it were to contact the needle directly, or from an individual falling directly on the needle tip. The tip of the needle, when fully capped on this model, is approximately ¼ inch from the protective cap end.

Recommendation #iii: Veterinarians/Cattlemen, when practical, should consider using another less-hazardous antibiotic.

Discussion: Co-ordinate to the Federal Drug Administration's (FDA) Center for Veterinary Medicine and their Office of New Creature Drug Evaluation (ONADE), Micotil is not the only FDA approved veterinarian drug without an antidote, but in that location is no published list of those medications.

The FDA does not require an antidote for whatsoever new animal drug that is approved. In order to exist approved, veterinary drugs must exist safe for the animal, for humans who consume products from the animal, and for the environs. In addition, they must be constructive for the creature. As well FDA regulations require that adequate directions tin be prescribed for the prophylactic administration of the product, i.due east. the establishment of a veterinarian/client/patient relationship.

The end-user can purchase Micotil from either a state licensed/registered veterinarian or an animal health distributor. In either situation, the cease-user must take a valid prescription from a veterinarian before obtaining the product.

While an antidote is 1 possible solution to an accidental poisoning, information technology is not necessary to make the administration of the product safe. The FDA ensures that products are labeled properly then accidental injection and the demand for an antitoxin do non happen if the user reads and understands the label and adheres to its recommendations. Micotil does deport warning labeling on the source canteen and as well a warning sheet inside the container's box that states in part "Not for human use. Injection of this drug in humans may be fatal…". However, the warning sheet does non warn that in that location is no antidote to this medication.

For most drug evolution companies, during the discovery and testing phases, drugs are selected that ideally have therapeutic/toxicity safety margins built into the molecule, so that when they're developed the toxicology is at not-lethal therapeutic doses or concentrations that hopefully human being or animals will never experience. Although there take been other fatal cases in the Us associated with Micotil, all simply 2 have all been ruled every bit "suicides" by law enforcement personnel. The remaining ii do not have an absolute explanation.

The minimum amount of this medication needed to cause a fatality when injected into a human being is not known. Interviews conducted with both veterinarians and users indicated they believed any amount greater than vi ccs could evidence fatal, depending upon the road of exposure or injection, e.m. subcutaneous, intramuscular, intravenous, oral, etc. ¹This may exist based on a case of unintentional human exposure that occurred several years ago in Nebraska . The subject field, a 28-year-onetime male, using a 12-cc syringe with Micotil, was attempting to inject a steer merely inadvertently injected less than one-half of the contents into his left forearm. He felt no ill effects until approximately v hours later on when he developed severe breast pain and was transported to a nearby hospital where he was intubated. He was extubated approximately ten hours after arrival and remained costless of chest pains for the 3 days of hospitalization and was discharged.

Several veterinarians queried during the investigation indicated they personally did not want to use this product due to the possible fatal homo consequences. They all indicated that needle sticks in their business concern is unfortunately all besides common, and to use a substance that may have no treatment depending on the corporeality and road injected or ingested was not their option. They felt that there were other drugs on the market that would produce the same results and were safer to work with. Many indicated that since this incident they have received numerous calls from not only their customers about Micotil, but too from concerned family members that were looking for alternative medications.

Cattlemen like the drug because of its lower per dose volume, cost per treatment and reaction time. The majority of the current Micotil users that the investigator spoke with stated they would probably continue to employ it, merely be a little more cautious. Those that had employees had already discussed proper injection procedures with them later on becoming aware of this incident.

Recommendation #4: All companies/agencies responsible for the manufacture and/or approval of veterinary medicines and supplies should continue to devise new products that volition reduce unintentional human exposure to accidental needle sticks/injections.

Discussion: Interviews conducted during the investigation showed that users of disposable plastic syringes received needle sticks from a variety of situations. The preferred combination of having both medication and receiving animal next to each other, thereby reducing user exposure fourth dimension, very seldom happens in the rural environment.

Elanco has developed a plastic shield for the 250-ml Micotil bottle that provides more protection to the user'south hand belongings the bottle when inserting the needle. At this time it is only available for 250-ml bottles.

They as well developed an Injection Administration Kit for hand operated syringes that allows multiple dosing, thereby reducing the number of needle/skin exposures. A center spike fastened to tubing is inserted into the bottle, which is hung above the user.

The victim in this incident had just a few feet to travel from his vet room to the squeeze chute, only other users tell of traveling many miles with the loaded syringes to care for cattle. Unfortunately the majority of the time they place these syringes in bib overall pockets, toss them on the dash of the pickup, lay them on the vehicle'south seat side by side to them or place them in horse and ATV saddle numberless.

An endeavor was fabricated to locate/identify some form of conveying case for these needles that would encapsulate the entire syringe/needle during transport, but none were identified by the investigator at the time of this study.

Proposition: A device as elementary as, and similar to, a hard plastic eyeglass example that would hold these plastic syringes with capped needles would further split the user from possible accidental injection or exposure.

1. Von Essen S. Unintentional Homo Exposure to Tilmicosin (Micotil® 300) Journal of Toxicology Vol. 41, No. 3, pp. 229-233, 2003.
2. Web site http://www.elanco.u.s.a./. Terminal accessed July 29, 2003.
3. Data is summarized from electronic correspondence with the Federal Drug Administration's Center for Veterinary Medicine.
   

While conducting this investigation the Nebraska FACE plan requested the contents be reviewed for both the incident scenario & production/policy for factual data accuracy prior to publication.

Though we are not able to acknowledge specific individuals for their input, we would like to recognize the post-obit for their back up of this investigation:

• Victim's immediate family
• Federal Drug Administration, Center for Veterinary Medicine
• Elanco Brute Health
• The Kendall Company
• National Institute for Occupational Safety & Health, Division of Safety Research

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