Sunday, October 14, 2012

PET PRESCRIPTIONS AND PHARMACIES





"Autumn is a second spring where every leaf is a flower."
 --Albert Camus, French writer


This past week the golden colors of aspens have swathed the contours of the San Francisco Peaks here in northern Arizona.  Desperado and Helpful Buckeye had a really nice picnic lunch with friends on this spot last week, surrounded by golden leaves and Arizona's highest peak, Mt. Humphreys, in the background.  More on that later....

Many of our dog-owning pet lovers don't want to spend much time reading about cats and most of our cat owners will say the same about dogs.  So, with each issue of Questions On Dogs and Cats that Helpful Buckeye puts together, it's difficult to please both groups.  However, this week's topic is one that has application to all dog and cat owners.  At some point during your dog's or cat's life, you will need to give it some form of prescription medicine and, in many cases, on a regular basis.  Being the responsible pet owners that you are, you surely want those medicines to be properly manufactured, compounded, labeled, and/or packaged before you acquire them.

The American Veterinary Medical Association has put together a very thorough question and answer brochure that addresses those very concerns:

Prescriptions and Pharmacies: For Pet Owners
(Frequently Asked Questions)

Below are answers to the most common questions we receive at the AVMA about veterinary prescriptions and pharmacies.
Q: Why do I need a prescription?
A: When you are given a prescription for a medication for your pet, it means that your veterinarian has made a decision that the medication is recommended or necessary to treat your pet's health problem. Many prescription drugs are only effective for specific problems, and may actually be harmful to your pet if used without that critical veterinary examination and diagnosis. Having these drugs available as prescription-only medications ensures that they are used appropriately.

Let's take heartworm preventives as an example. Heartworm preventives are labeled as "prescription-only" because it's critical that your veterinarian makes sure the medication is the right one based on your pet's health status. The preventives target the infective larvae as they are migrating through the tissue prior to reaching the bloodstream and developing to adult heartworms. If your dog (or cat) has heartworms, giving a preventive medication will not effectively treat the disease because the preventives don't readily kill adult heartworms. In some cases, administering preventives to heartworm positive dogs can cause a rapid kill of circulating microfilariae, leading to a life-threatening anaphylactic reaction.
There are drugs, called "over the counter" (OTC) drugs, that don't require prescriptions. Drugs can be bought OTC when the Food and Drug Administration (FDA) determines that the directions for the drug's use aren't overly complicated and are adequate for the public to follow. In some cases, such as the common headache medications for people, the OTC version is just a weaker strength than the prescription form. However, in many cases, a medication is only available with a prescription for the reasons we mention above.
Q: What's the difference between the brand name, trade name and generic name of a medication?
A: Brand names and trade names are also called proprietary names, and are just what they sound like – they are the trademarked names you recognize on the shelves and see in advertisements. The generic name, on the other hand, is the nonproprietary name of the drug and is the same for all versions (brand-name and otherwise) of that drug. For example, take ibuprofen: there are several brand names for the drug, including Motrin® and Advil®, but the generic name of the drug is ibuprofen. If you were to buy the brand/trade name of the drug (for yourself, not your pet), you'd purchase Motrin® or Advil®, but if you were to buy the generic version, it would just be labeled "ibuprofen."
Q: Is there a difference between the brand name version and the generic version of a medication?
A: For the most part, no. The United States Pharmacopeia (USP) sets the standards for the quality, purity, strength and consistency of all prescription and OTC medications in the U.S. – the goal is to make sure that the product you purchase meets these standards. If you look closely at the drug labels, you'll see "USP" printed after the drug name in the ingredients list – and sometimes it's printed clearly on the front label of the bottle/box. Based on USP standards, for example, generic ibuprofen is the same drug as the brand name-versions of ibuprofen (of the same strength) as far as the quality, purity, and consistency are concerned.
However, we have heard some anecdotal and unconfirmed reports of pets that had been receiving a brand name medication, but did not do as well when given a generic version of the same medication. Although all USP versions of a drug meet the purity standards for that drug, all of the ingredients and the processes involved in making the trade name versions are often protected by patent or other intellectual property laws, and there may be differences in the minor ingredients that could produce slightly different results between the versions, while still providing the main drug that meets USP standards. Think of it as following a recipe – even if you have the same ingredients and follow the instructions, the end result might vary a little bit. This is not a common problem with medications, and is often resolved by switching back to the effective version of the medication.
Q: Why are some spot-on flea and tick preventive medications only available through my veterinarian?
A: Some manufacturers have decided to sell their products only through veterinarians so that the veterinarian and pet owner can discuss the situation and work together to determine the best flea and tick treatment for that pet. It's not that the product is "prescription-only" – it's that the manufacturer believes the product should only be sold through veterinarians. In addition, it seems more likely that the product will be used properly (for example, a cat won't be treated with a product labeled only for use in dogs) if the veterinarian is supplying the medication and is counseling the pet owner on the proper use of the medication.
If the spot-on flea and tick product is also labeled for heartworm prevention, it is only available through your veterinarian for the reason we previously described – it is critical that your veterinarian checks for a heartworm infection before your pet is given a heartworm preventive medication.
Q: My veterinarian gave me a prescription for a pain reliever for my pet. Why can't I just buy one of the over-the-counter pain relievers at my local drug store?
A: Don't do it! Although these products are approved for use in people, many of them are not safe for pets. For example, acetaminophen (Tylenol® is the most common example) can cause severe illness, and even death, in pets. Talk to your veterinarian before you give ANY medication to your pet.
Q: Where can I get my pet's prescriptions filled?
A: You have several options when your pet needs a prescription medication:
•You can get it from your veterinarian if they keep it in stock;
•Your veterinarian can write (or call in) a prescription to a local pharmacy that stocks the medication;
•Or your veterinarian can provide a prescription so you can get the medication from an online pharmacy.
Q: Can I get my pet's prescription medications from Canada?
A: No. Drugs from Canada are not approved by the federal government for use in the United States. It is illegal for you to get medications shipped from Canada for yourself or your pet.
Q: The pharmacy told me I don't need a prescription for a medication. Is that true?
A: For some OTC medications, it is true. However, if your veterinarian tells you that you need a prescription for the medication but the pharmacy tells you that you don't need it, this might indicate that the pharmacy's staff is either confused or misinformed, or the pharmacy's ethics and standards are questionable. If this happens, talk to your veterinarian, contact the state board of pharmacy, or contact the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA CVM)
Contact Us by Mail or Telephone
If you have comments or questions you can also contact us by mail:
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
or by telephone:
1-888-INFO-FDA (1-888-463-6332)—main FDA Phone Number (for general inquiries)
Q: Why should I consider getting my pet's medications from my veterinarian?
A: There are several reasons you should consider getting your pet's medications from your veterinarian:
•If your veterinarian has the medication in stock, you immediately have it and you don't have to wait to get it from a pharmacy;
•Your veterinarian or a veterinary technician can answer your questions, provide you with instructions for use, and maybe even demonstrate how to give your pet the medication;
•If you order from a pharmacy and the medication isn't properly shipped (for example, it is allowed to get too hot or too cold) or isn't properly packaged, it could be ineffective or damaged and unusable; whereas if you get it from your veterinarian, you know it has been properly handled until it reaches you and they can inform you how to make sure you handle the medication properly.
Q: If I choose to get my pet's prescriptions filled elsewhere, can my veterinarian refuse to give me a prescription?
A: Your veterinarian might strongly recommend that you get the medication directly from them, but some states actually require veterinarians to write prescriptions for clients to have filled elsewhere if requested by the client. Some states do not require this of veterinarians.
There are certainly situations where it is in your pet's best interest to get the medication directly from your veterinarian, and we encourage you to discuss your options with your veterinarian. The AVMA's Principles of Veterinary Medical Ethics recommends that veterinarians comply with their client's wishes and provide written prescriptions if the client prefers having the prescription filled elsewhere.
Q: Can my veterinarian charge me a fee for writing a prescription for my pet?
A: There is no federal law preventing your veterinarian from charging you a fee for their services and time invested in writing a prescription. Some veterinarians charge a nominal fee for writing prescriptions, but others don't. Individual states might have specific guidance for veterinarians on prescription fees.
Q: My veterinarian is telling me that I have to bring my pet in for an examination before they'll write a prescription or authorize a refill. Why?
A: According to the AVMA Principles of Veterinary Medical Ethics, it is unethical, and in most states, unlawful, for a veterinarian to write a prescription or dispense a prescription drug outside a Veterinarian-Client-Patient Relationship (VCPR). For more information about the VCPR, including a definition, see Section III of the AVMA's Principles of Veterinary Medical Ethics at https://www.avma.org/KB/Policies/Pages/Principles-of-Veterinary-Medical-Ethics-of-the-AVMA.aspx  . For a simpler explanation of the VCPR, read our "Frequently Asked Questions by Pet Owners about the Veterinarian-Client-Patient Relationship" at https://www.avma.org/public/PetCare/Pages/VCPR-FAQs.aspx .
In order to maintain a VCPR, your veterinarian must see your pet regularly – how regularly they need to see your pet depends on your pet's health. If your pet is on a prescription medicine, your veterinarian may need to reexamine your pet, check blood work, or perform other tests to monitor your pet's response to treatment and determine if the medication needs to be changed. For example, a dog being treated for hypothyroidism needs to be reevaluated regularly to make sure the dosage is having the effect it needs to have.
Q: If I choose to get my pet's prescription filled elsewhere, will my veterinarian refuse to see my pet anymore?
A: That's not likely. We encourage you to talk to your veterinarian about your concerns and discuss what's best for your pet.
Q: Why do some medications cost more from my veterinarian than from an online store?
A: Online pharmacies may buy larger volumes of the medications at a time, so they may get bulk pricing that might be lower (or much lower) than your veterinarian pays - so, even with a markup, some medications from an online source are being sold to you for less than your veterinarian pays to get the medication. Anybody who keeps medications in stock has to mark up the prices above what they paid because of the overhead costs involved in keeping those medications on the shelf and the losses if the medication expires and has to be discarded
Q: What are the risks of ordering from an online pharmacy?
A: The amount of risk depends on the quality of the pharmacy. Human error is a risk with any source, but the risk is minimal if the proper procedures are in place.
When you order from an online pharmacy, the product must be shipped to you. If the medication isn't properly shipped (for example, it is allowed to get too hot or too cold) or isn't properly packaged, it could be ineffective or damaged and unusable.
If there is a problem with the medication received from an online pharmacy, there might be a period of time when your pet isn't getting its medication while you wait for the replacement medication to arrive.
Q: How do I know the pharmacy is trustworthy?
A: Prior experience with a pharmacy is a good indication – ask your veterinarian if there is a pharmacy they recommend. You can also inquire with the state board of pharmacy at http://www.nabp.net/boards-of-pharmacy/   to determine whether a pharmacy is licensed within the state and the status of the pharmacy's license.
In addition, accreditation by independent bodies can give you more information about an online pharmacy. Two examples of third-party accreditation include the National Association Boards of Pharmacy Vet-VIPPS program at http://www.nabp.net/programs/accreditation/vet-vipps/ and, for compounding pharmacies, the Pharmacy Compounding Accreditation Board at http://www.pcab.org/ . (Your prescription might be called in to a compounding pharmacy if your pet needs a medication tailored just for him or her – an example would be a flavored liquid medication for a cat who otherwise won't take the medication. It is NOT legal, however, to have a compounding pharmacy make a "cheaper" version of an identical product that has been approved by the FDA.)
Q: How will I know if there are problems with the medications I get from a pharmacy?
A: First of all, talk to your veterinarian about the signs of a problem with the medication. Make sure you know what to look for, and what to do if you see it. Don't hesitate to contact your veterinarian if you are concerned that your pet is having a problem with or a reaction to the medication.
If you receive a shipped medication and the package is damaged or it appears to have been allowed to get too hot or too cold, contact the pharmacy immediately and notify them of the problem. If you are not sure if the medication is safe to use in that condition, contact your veterinarian.
If you have concerns or complaints about a pharmacy's practices or the quality of its products, you can report the pharmacy to your state board of pharmacy.
Q: My veterinarian said that my pet needs to get a different dose than what the drug package insert says. Is this legal?
A: If your veterinarian thinks the labeled dose isn't right for your pet but a different dose is what your pet needs, this is a federally regulated activity called "extralabel drug use." Basically, if the medication is used in any other way than the label dictates, this is extralabel use, and it is legal as long as your veterinarian follows the regulations. Your veterinarian can also prescribe a human medication for your pet, and this is also considered extralabel use.
Please note that we're only talking about extralabel drug use in pets here. Extralabel use is legal in food-producing animals, but the rules are much more strict.
This FAQ was produced by the AVMA Scientific Activities and Communications Divisions, with assistance from the Council on Biologic and Therapeutic Agents and the Clinical Practitioners Advisory Committee.
Purchasing Pet Drugs Online: Buyer Beware (video)
Online Pet Pharmacies: Protect Yourself and Your Pet: Be Online Pet Pharmacy A.W.A.R.E.
The topics of the preparation/compounding of medications and where these medicines might be available are frequently a source of confusion for pet owners.  Ann Hohenhaus, a practicing veterinary internal medicine specialist offers these tips for helping you through that maze:
The Compounding Pharmacy Problem: What Pet
 Owners Should Know
By Ann Hohenhaus, DVM, DACVIM
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 here:
Pet Medications: 6 Tips to Keep Pets Safe (a summary)
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 (in NYC) 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.”
These reviews provide pet owners with everything they need to know concerning medicines that have been prescribed for their pets.  Always be sure you fully understand what medicines you are giving to your pets and why.
Any questions or comments, send them to Helpful Buckeye at: dogcatvethelp@gmail.com or register them at the "comments" section at the end of this issue.
 
SPORTS NEWS
The Ohio State Buckeyes put up a lot of points again this week and beat Indiana.  The game wasn't pretty but we are still undefeated and in the Top 10 rankings.

The Pittsburgh Steelers lost another road game, after being ahead in the 4th quarter...this time at the Tennessee Titans.  The once proud Steeler defense can't seem to stop anybody in the 4th quarter.
  
PERSONAL STUFF
This past week was pretty busy as Desperado and Helpful Buckeye tried to do as much as possible ahead of Desperado's shoulder surgery.  We went to see Pitch Perfect, which was a very enjoyable movie...granted, a "chick flick" but a lot of fun!

Helpful Buckeye took a 70-mile bike ride on what turned out to be a perfect day...warm, sunny, and empty country roads.  That might be my last really long ride before the Tour de Tucson 60-mile race in mid-November.

Even though we had a beautiful warm day for the picnic among the golden aspens and it was 70 degrees for my long bike ride, we still experienced northern Arizona in mid-October when it turned cold and snowed on Friday.  We had planned one of our favorite homemade soups (Swiss potato chowder) for the cold, snowy day and then visited friends the next evening for their version of a creamy carrot soup.  Great soups for cooler weather!  Desperado wrote this limerick to commemorate some of the dinner table conversation:

As Teresa and Karen get older,
Each complains more and more of her shoulder.
Says Dave: "Here's the reason,
It's just an adhesion."
And Bill says, "This beer should be colder."

This whole week can be summed up by a Navajo saying: "Walk on a rainbow trail; Walk on a trail of song, and all about you will be beauty." 

~~The goal of this blog is to provide general information and advice to help you be a better pet owner and to have a more rewarding relationship with your pet. This blog does not intend to replace the professional one-on-one care your pet receives from a practicing veterinarian. When in doubt about your pet's health, always visit a veterinarian.~~

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