Brand Name, Generic, Compounded or Refilled: A Prescription Primer

February 18, 2015

Confusion about prescriptions reigned in my clinic this past week. I spent a lot of time explaining the intricacies of brand name versus generic drugs. There was a lot of confusion about refills as well. So, I am reprising a condensed version of my discussions about drugs for the benefit of all.

motrinBrand name drugs are the easiest to recognize because the label on the box has ® or possibly™ after a bold-faced drug name like Benadryl® or Motrin®. Drugs recently approved by the Food and Drug Administration (FDA) cannot be made as generic drugs until the patent or exclusivity expires. The FDA approves everything surrounding the manufacture, quality control and packaging of brand name drugs. This process assures the consumer the product is both safe and efficacious. Drugs for animals are approved by the FDA’s Center for Veterinary Medicine.

ibuprofenThe box, carton or tube of generic drug appears more utilitarian than the brand name drug, but the medication inside is a copy of the brand name drug, which is the same as the brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Generic drugs meet the same rigid standards as the brand name drug. All generic drugs approved by FDA have the same high quality, strength, purity and shelf life as brand name drugs. The generic drug manufacturing, packaging and testing must pass the same quality standards as those of brand name drugs.

Specialist veterinarians like those of us at The Animal Medical Center use compounded medications every day to provide drugs in formulations our patients will agree to take. Most commonly, we have medications flavored with beef and turkey or have bad tasting powdered medications put in gelatin capsules to hide their nasty taste. But compounded medications should not be confused with generic medications. Compounded medicines do not have the FDA assurance of safety and efficacy because they do not undergo FDA-mandated quality control testing. In most cases, the absorption properties and the shelf life of compounded medications are unstudied and may differ from brand name or generic medications. Because different compounding pharmacies use different “recipes” to create your pet’s specialized medication, the same prescription may not have the same effect when compounded by a different pharmacist. While the lack of FDA oversight may be a negative, if compounding helps you to get your pet to take its medications, compounding becomes positive.

animal medical center prescriptionWhen I call or fax a prescription to a pharmacy for a medication that a dog or cat will take for a long time, I will pre-authorize refills. The number of refills remaining on a prescription is indicated on the label of the medication bottle. In the sample label shown here, the red circle highlights the number of refills available without the need to call your veterinarian. You simply call the pharmacy and ask for one of the refills. The next prescription label will indicate only 4 available refills. I often choose the number of refills to coincide with an anticipated recheck examination since you need to call my office to get more refills, you can also set up the recheck appointment at the same time.

Understanding medications is critical to their successful use. The FDA Center for Veterinary Medicine has a wealth of information on their website for the pet owing public.


Is Your Dog Down in the Dumps?

May 29, 2014

depressed dogRecently, I answered questions from a New York Times science writer who inquired about depression in dogs for an article she was writing. The short article received a lot of attention, so I decided to expand on the topic for my readers.

Dogs Have Feelings Too
Depression is a specific psychiatric diagnosis in humans. If you look at the National Institutes of Health (NIH) definition of depression, many of the symptoms of depression cannot be applied to dogs, since they revolve around feelings. While we believe dogs have feelings, they cannot articulate sadness, helplessness, pessimism or suicidal thoughts as would humans suffering from clinical depression.

Yet, there are some signs of depression in dogs similar to those experienced by humans. Their owners may notice abrupt changes in behavior including irritability, loss of interest in activities, decreased energy and changes in appetite, all of which may signify depression. Dog owners frequently report these symptoms in their dog when a child in the family goes away to college, a favorite human or animal family member dies or the family moves to a new home. But because these are non-specific findings, they could be attributed to medical conditions as well. So it is wise to bring your pet to a veterinarian whenever you see behavioral changes in order to rule out illness.

Depression Means Two Things
Because veterinarians use the term “depression” in a different way than physicians do about their patients, some pet owners may misunderstand a diagnosis of depression. Veterinarians use “depressed” to describe one of five levels of consciousness in their four-legged patients:

  1. Normal. Of course there are many variations of normal between pets of the same breed. Veterinarians will require input from owners to determine if the pet is behaving in its normal manner.
  2. Depressed, dull, quiet. These pets prefer to sleep and have responses to stimuli that are appropriate. Animals diagnosed with a disease may be dull quiet, or depressed. A thorough examination of a pet with these signs and symptoms is required to rule out behavior resulting from a change in environment or illness.
  3. Disoriented, demented. This is similar to a dull animal, but responses to stimuli are inappropriate. Pets may be hyperactive, hysterical or irritable.
  4. Stuporous, obtunded. These pets do not respond to normal stimuli but will respond to strong, noxious stimuli such as a toe pinch.
  5. Comatose. These pets are unresponsive to all stimuli.

Not Just Depression
The NIH says depression in humans is often associated with other mental health disorders such as anxiety, post traumatic stress disorder (PTSD), phobias and obsessive compulsive disorders. Veterinarians do diagnose obsessive compulsive disorders, PTSD, aggression, separation anxiety, and noise phobia (commonly fear of thunderstorms) in dogs and urine spraying and predatory aggression in cats. These disorders are commonly treated with antidepressants and behavioral modification therapy, suggesting depression may also be associated with these other mental health disorders in pets.

Antidepressants for Your Dog and Cat
Some of the antidepressants veterinarians use in pets include:

  • Clomipramine [Clomicalm®] is approved by the FDA for treatment of separation anxiety in dogs.
  • Fluoxetine [Reconcile®] is approved by the FDA for treatment of separation anxiety in dogs and contains the same active ingredient as Prozac®.
  • Selegiline (L-deprenyl) [Anipryl®] is approved by the FDA for treatment of cognitive dysfunction in dogs.
  • Nortriptyline, amitriptyline [Elavil®] and doxepin are not FDA approved for use in dogs or cats, but are frequently prescribed by veterinarians “off-label.”

If your pooch is punky or your cat is catatonic, it is important to find out the cause. Have them checked by their veterinarian immediately.


Drug Fright: Scary Medication Labels

April 3, 2013

Everyone has heard them: the rapid fire voiceovers on television advertisements for medications. They sound something like this, “Do not use this medication if you have serious heart disease, suicidal thoughts, liver problems or hangnails. Ask your doctor if this drug is right for you.” If you fast forward through commercials on your DVR and have missed the voiceover, then perhaps you have opened a bag from your pharmacy and found the accordion pleated paper, printed in size two font, containing drug information, warnings, contraindications, precautions, adverse reactions and risks.

Here is a portion of one for a commonly used human medication:

  1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat
  2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles
  3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis
  4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions
  5. Gl System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation
  6. GU System: Urinary frequency, difficult urination, urinary retention, early menses
  7. Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness

Here is a portion of a drug label for a canine chemotherapy agent:

Anorexia, lethargy, vomiting, lameness, weight loss, blood in stool/GI bleed/hemorrhagic diarrhea, musculoskeletal disorder, dehydration, dermatitis, pruritus tachypnea, localized pain, nausea, general pain, polydipsia, pyrexia, flatulence, pigmentation disorder, neutropenia, thrombocytopenia, increased alanine, aminotransferase, hypoalbuminemia, decreased hematocrit, hyperbilirubinemia, increased creatinine, urinary tract infection.

The United States Food and Drug Administration has strict regulations governing drug labels. Drug labels should be accurate and not promotional. The list of possible side effects is comprehensive to help prescribers, like me, alert their patients, like your pet, to possible problems that might arise while the medication is being taken. Without this critical information, you might keep giving a medication that is actually making your pet worse. The information on a drug label helps me to weigh the risk of not treating a disease with benefits of a medication used to treat the disease.

The warning labels for both the commonly used human drug and the canine chemotherapy agent sound moderately frightening and yet these drugs are critical to improving a patient’s quality or quantity of life. What the drug labels can’t substitute for is experience. Once your veterinarian or physician has used a drug on many patients, we know what to expect and what to tell you to expect. Reading the drug label is a good thing since it helps you to recognize any adverse reactions to medications early. Not giving a drug to your sick pet because the drug label is frightening is foolish, unless you tell your veterinarian about your concerns and together you decide the best course of action for your pet. Remember, we love to talk about sick pets and about medications; it’s what we do every day!

Oh, by the way, the human drug with the seven body system long list of adverse effects was Benadryl.


Thiamine Deficiency in Cats: Q & A for Cat Families

March 20, 2013

kittens-in-bedLast week the Food and Drug Administration reported a voluntary cat food recall. The recall was voluntary because routine testing performed by the food manufacturer identified an inadequate amount of thiamine in the cat food. No sick cats had been reported following consumption of the food, but thiamine deficiency in cats can be a serious problem and the company was exercising an abundance of caution.

What is thiamine?

Thiamine is a member of the B vitamin group and is also known as vitamin B1. The liver heart and kidneys are the organs with the highest levels of thiamine. Thiamine and all the B vitamins play a critical role in energy metabolism throughout the body. Thiamine interacts with other B vitamins to improve the efficiency of energy metabolism.

How does thiamine deficiency occur in cats?

  1. Decreased intake. Processing decreases thiamine and additional thiamine is added after processing to be sure our pets’ food has adequate levels.
  2. Destruction by an enzyme known as thiaminase. This enzyme is found in raw fish, shellfish and microorganisms. If you feed your cat raw fish or shellfish, the enzyme could deplete the natural thiamine and lead to thiamine deficiency. Cooking destroys the enzyme.
  3. Increased excretion. All the B vitamins, including thiamine, are water soluble and if your cat consumes more B vitamins than they need, the excess is excreted in the urine. Cats with chronic kidney disease may lose more B vitamins than usual through their diseased kidneys.

How would I know if my cat was thiamine deficient?

If your cat became thiamine deficient, you might notice a decrease in appetite or an increase in drooling. If you have a kitten, it might not grow as expected. The nervous system is most severely affected by thiamine deficiency and you might see weakness, stumbling or convulsions. The handful of cats I have seen with thiamine deficiency held their chins to their chest, or in doctor’s terms had “ventral neck flexion.”

Thiamine deficiency sounds bad. Can it be treated?

Here is the best part of the blog. YES! A simple injection of thiamine under the skin should have a thiamine deficient cat on the road to recovery in a day or so. Thiamine is extremely safe and if your cat’s illness is not caused by thiamine deficiency, the kidneys will filter the excess thiamine and excrete it in the urine with no adverse effects for your cat.

In addition to the FDA website, The AMC website posts food recalls and here is another site that posts information about pet food recalls. If your cat is sick, be sure to tell your veterinarian the brand and flavor of food your cat is eating. If your pet eats a food that is recalled, check with your veterinarian for advice on how best to manage your cat and its diet.


The Compounding Pharmacy Problem: What Pet Owners Should Know

October 10, 2012

A rare form of human meningitis has recently been in the news. The outbreak, believed to stem from fungal contamination of a medication compounded to treat back pain, has resulted in several fatalities. The manufacturer of the implicated medication is not a big pharma or an overseas company; the medication was produced by a compounding pharmacy in Massachusetts. The Food and Drug administration has identified fungal organisms in a sealed vial of methylprednisone acetate produced by the compounding pharmacy.

Pets not affected

This outbreak is unusual since the fungi involved, aspergillus and exserohilum, live in soil and water. Exactly how they came to contaminate the medication is under intense investigation. Since veterinarians don’t treat back pain in dogs and cats with steroids like methlyprednisone acetate injected around the spinal cord, there are no reports of fungal meningitis in pets, but veterinarians do use compounded medications, and understanding their role in managing disease in your pet is important.

Compounding defined

Compounding is the alteration of the original drug dosage form for the purposes of ease of administration or because the original dosage form is unsuitable for the purpose intended. Translated for the pet owner, compounding is flavoring a medication to hide the bad taste, dissolving pills into a liquid to facilitate administration, or putting multiple medications into one capsule to help a pet owner comply with a multidrug treatment protocol. Without a good compounding pharmacy, my job would be impossible.

Compounding dangers

Compounding is not regulated by the FDA because it is a process initiated by prescription and on a case-by-case basis. In veterinary medicine, compounding rules have been stretched in an attempt to create cheaper medications. Some compounding pharmacies offer expensive medications at unbelievably low prices. I suspect these cheaper products are being produced by what is known as bulk compounding from raw materials. Just last week, I had to advise a pet owner against using the compounding pharmacy’s cheaper “house” brand of an expensive medication. That medication is not currently available as a less expensive generic. Although I am sympathetic to the financial burden of treating a pet with cancer, my overriding concern is for the patient and the efficacy and safety of the prescribed treatments. Prescribing an approved medication provides some assurance of efficacy and safety for my patients.

Medication safety

Listen to your veterinarian. If they believe a particular medication is better, ask why. If they are concerned about the safety and efficacy of a compounded medication, I recommend trying to make the standard formulation work for your pet.

Learn more about safely medicating your pet.


Protect Your Pet, Skip the Jerky Treats

September 27, 2012

Recently, the Food and Drug Administration (FDA) issued an update to its ongoing investigation of animal illnesses linked to jerky style pet treats.

One of The Animal Medical Center’s own, Dr. Richard Goldstein, Chief Medical Officer, has been serving as an advisor to the FDA and the American Veterinary Medical Association since the investigation into this issue began in 2007. Dr. Goldstein is internationally recognized for his work during the massive pet food recall related to melamine contamination in 2006.

The FDA has logged an estimated 2,200 reports of pet illnesses related to these jerky pet treats, and Dr. Goldstein was instrumental in first establishing the link between the jerky treats and kidney disease in dogs.

Now, the FDA investigation has taken a new direction. In consultation with NASA, the FDA has expanded its investigation into byproducts of irradiation, which is part of the process used to make jerky treats.

To help keep your pets safe, Dr. Goldstein suggests the following:

  • Immediately eliminate all imported jerky treats from your cats’ or dogs’ diets. Feed them a commercially prepared diet which carries the “AAFCO” (Association of American Feed Control Officials) adequacy statement to ensure it provides all the nutritional requirements your pet needs to stay healthy and strong.
  • If your pet’s jerky treats do not list a country of origin, call the company’s toll free number listed on the bag or box to confirm the country of manufacture.
  • Make your own jerky treats.
  • If you choose to feed your pet a commercial jerky pet treat product, watch for any signs of illness: decreased appetite, decreased activity, vomiting, diarrhea (sometimes with blood), increased water consumption, and/or increased urination.
  • If any of these symptoms occur, stop feeding your pet the treats and see your veterinarian immediately. Take a sample of your pet’s urine to the veterinary visit.
  • Blood tests performed by your veterinarian can help determine if the jerky treats are causing a problem. The tests may indicate kidney disease (increased blood urea nitrogen and creatinine) and increased liver enzymes. Urine tests may indicate Fanconi like syndrome (glucose in the urine).
  • Although most pets appear to recover, some reports to the FDA have involved dogs and a cat that have died.
  • If your pet is diagnosed with a jerky treat-related illness, report that illness to the FDA’s Safety Reporting Portal or call the FDA Consumer Complaint Coordinators.

Pet Medications: 6 Tips to Keep Pets Safe

August 30, 2012

All of us want to give the best and safest medications to our pets. Here are my tips to make sure your pet gets the medications he needs.

1. Approved is easy

Some of the work of selecting safe medications for your pet has already been done for you. The United States Food and Drug Administration (FDA) approves medications for use in pets by a similar process used for human drugs. Animal vaccines receive approval from the United States Department of Agriculture and treatments to prevent ectoparasites, also known as flea and tick preventatives, by the Environmental Protection Agency. Approved medications help you ensure you are administering drugs that have met standards for both safety and efficacy.

2. Don’t play veterinarian and give your own medications to your pet.

Certain human medications can be lethal to pets. For example, acetaminophen (a common brand is Tylenol) in cats, ibuprofen (a common brand is Advil) in dogs. The leading phone call to animal poison control experts is about accidental or owner administered human medications.

3. Human pharmacies

Like nearly all veterinarians, I too prescribe human medications for my patients. I do this for convenience when the pet owner is far from The Animal Medical Center or because there is not a veterinary-approved version of the drug. Human medications are most often a solution for dogs over 40 or 50 pounds, since tablet and pill sizes are too big for cats and little dogs. So if it is Saturday night and your veterinarian tells you to come to the clinic to pick up medication, it is because nothing but a doggie drug or kitty capsule will do.

4. Legal drugs

The law requires all veterinarians to prescribe medications only in the context of a valid veterinarian-client-patient relationship. Translated from the legalese, the statement means I have to examine your pet in order to prescribe a medication. This is all about safety –Fluffy’s safety. Although you are sure she has the same skin condition as last year, I need to be sure you are correct in order to prescribe the medication with the best chance of fixing the problem with the least risk of an adverse reaction.

5. Custom compounding

Veterinarians rely on compounding pharmacies to convert pills and tablets into chicken-flavored liquids, to place multiple medications into a single capsule to simplify medicating the pet with bear trap-like jaws, or to scale down a large tablet for a tiny terrier. Regulations govern compounding like they do for any prescription. Prescriptions for compounded medications can only be written on a case-by-case basis and must be made specifically for an individual pet. Compounded medications may mean the difference between therapeutic success and failure, but because compounded products are not regulated, products may be of variable quality as demonstrated in a recent scientific study of compounded trilostane. Using a pharmacy certified by the Pharmacy Compounding Accreditation Board assures you of a compounding pharmacy that adheres to established principles, policies and standards.

6. Internet pharmacies

The challenge in using an internet pharmacy is finding the right one. Although the prices offered by electronic drug stores are attractive, high-quality service may be lacking. Red flags in online reviews include companies who fill email boxes with spam, distribute counterfeit products, or never ship product at all. I spoke with the CEO of PetCare Rx, Jonathan Shapiro, about how his company ensures the quality of medications they ship. “PetCare Rx purchases product directly from the manufacturer or veterinary purchasing groups to protect our customers from counterfeit products. Consumers should look for an internet pharmacy accredited by the Veterinary Verified Internet Pharmacy Practice Sites (Vet-VIPPS). This accreditation ensures the pharmacy complies with regulations and laws governing pharmacy practice.”


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