What Qualifies as Extra Label Drug Use

Q: How do I know what qualifies as ELDU?

A: Specific criteria must be followed:

  • A valid VCPR is a prerequisite for all ELDU;
  • Only a veterinarian can determine that ELDU is needed and can administer, prescribe or dispense a medication extralabelly. The veterinarian must direct or supervise ELDU in an animal;
  • ELDU rules only apply to FDA-approved animal and human drugs;
  • ELDU is intended for prevention, treatment, and control purposes only when an animal’s health is threatened. ELDU of drugs for production use and/or in feed is not approved;
  • ELDU is not permitted if it results in an illegal food residue, or any residue which may present a risk to public health;
  • A veterinarian must not pursue use of certain FDA-prohibited drugs in food-producing animals.

ELDU of an FDA approved drug may be used if:

  • There is no approved animal drug that is labeled for such use, or that contains the same active ingredient in the required dosage form and concentration.
  • Alternatively, an approved animal drug for that species and condition exists, but a veterinarian finds, within the context of a VCPR, that the approved drug is clinically ineffective for its labeled use.

There are few restrictions on extralabel use in non-food-producing animals compared to food-producing animals. If the intended use is in a non-food-producing animal, then an approved human drug may be considered for extralabel use even when an approved animal drug for that species and condition exists. Economic reasons for ELDU of a human drug over the approved drug for that species are valid to treat the medical condition. Veterinarians should recognize, however, that human-labeled drugs are approved based on studies in people and their use in animals could vary. In addition, minor differences in the formulation may produce alterations in the pharmacokinetics and biological availability in the animal species compared to humans. Also keep in mind that consistent use of human-labeled drugs when approved animal-labeled drugs are available could create relative disincentives for the animal health industry to pursue new animal drug approvals and could further limit the availability of veterinary drugs.

The following additional conditions must be met for ELDU in food-producing animals:

  • Such use must be accomplished in accordance with an appropriate medical rationale; and
  • If scientific information on the human food safety aspect of the use of the drug in food producing animals is not available, the veterinarian must take appropriate measures to assure that the animal and its food products will not enter the human food supply.

If the veterinarian determines the food-producing animal needs a drug administered in an extralabel fashion, an approved animal drug must be considered for the particular use before a drug labeled for humans is considered. The prescribed or dispensed extralabel drug (prescription legend or over-the-counter) must bear labeling information which is adequate to assure the safe and proper use of the product.

Social Media and the Dental Practice

The online world is growing. Facebook now boasts a “population” larger than the United States. Thousands of dentists are currently taking advantage of all types of social media. It is important to take a brief look at some important issues and areas of concern for dental professionals using or considering the use of social media to build and promote their public, patient, and employee relationships.

Public Relations

The advantages of a strong social media presence are clear. Information may be shared with colleagues to sustain camaraderie, with patients to strengthen dentist-patient relationships, and with the public to bolster your reputation. It is vitally important to consult with your legal advisers early and often when bringing your professional presence to an online forum.

Patient Relations

If content on your social media page is also medical in nature, depending on the forum, the Health Information Portability and Accounting Act (HIPAA) may be implicated.

Members of the dental profession should adhere to the following guidelines:

(a) Dentists should be cognizant of standards of patient privacy and confidentiality that must be maintained in all environments, including online.

(b) When using the Internet for social networking, dentists should use privacy settings to safeguard personal information and content to the extent possible.

(c) If dentists interact with patients on the Internet, dentists must maintain appropriate boundaries of the patient-dentist relationship.

(d)  To maintain appropriate professional boundaries dentists should consider separating personal and professional content online.

(e)  Dentists must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, and may have consequences for their professional careers (particularly for dentists-in-training and dental students), and can undermine public trust in the dental profession.

When dental professionals provide a social media forum for patient feedback, they risk running afoul of HIPAA rules and regulations. Prior to building a social media presence, it is important to develop policies and procedures designed to guide appropriate use of the relevant forum.  A few key points follow:

Under the Health Information Technology for Economic and Clinic Health Act (HITECH Act), there are substantial penalties and fines that may be assessed for HIPAA violations that occur during social media exchanges. Under the HITECH Act, fines range from $100.00 to $100,000.00.

Be clear with a disclaimer that patient information is personal and should never be shared via the Internet. Inform participants that any posting that appears to be a violation of this policy will be removed.

Employee Relations

It is important to keep your employees from becoming lax about privacy rules when it comes to social media.

Education is always the first line of defense when it comes to privacy and security safeguards. Make sure all employees are trained and up to date about the privacy and security rules and be sure to disseminate a written company policy outlining permissible and impermissible actions. Make social media training a part of your HIPAA compliance program.

Social media is a powerful tool for expanding a dental practice, but be aware of the potential complications. Always consult your legal adviser before branching out into online forums.

7 Types of Records Your Veterinary Practice Should Be Keeping

What records should your veterinary practice keep, and how long should you keep them? There are several categories of records that are important to a practice, some for internal purposes and some for tax returns and other government requirements. Let’s take a look at these by category.

 

  1. Tax records. First, consider the records you need to substantiate your annual income tax return. The IRS says that you must maintain adequate records, to support the items of income and expenses that you claim. That means you must be able to produce receipts, invoices, cancelled checks, or banking records supporting expense items. Similarly, you should keep sales slips, invoices, or bank records to support income items.
  2. Accounting records. Most practices have adequate accounting systems to capture routine transactions, but not for nonroutine transactions such as the purchase of depreciable assets. When you buy a car, computer, or piece of office equipment, be sure to file all purchase documents, assign an inventory number, and immediately set up a depreciation schedule.
  3. Travel and entertainment expenses. Good recordkeeping for travel and entertainment expenses is essential. Although the rules can be complex, in general you should capture where, when, who, how much, and the business purpose for each expense. A well-designed standard expense report form can help insure that your records contain all the required information.
  4. IRS audits. Generally, the IRS can audit a tax return for three years after the date it was due or the date the tax was paid, whichever is later. However, if there is a major understatement of income, they can audit for six years after the due date (or seven years after the tax year). For that reason, you should keep most income tax records for seven years.
  5. The IRS requires records relating to employment taxes to be kept for at least four years after the date of the return or the date the tax was paid, although here again a seven-year rule is safer.
  6. Corporate records. Every incorporated  practice (or Limited Liability Company) needs good corporate records, including documents associated with forming the company, bylaws, business licenses, and minutes of all board meetings. Shareholder records should include stock registers and records of all share issuances and redemptions. Also keep copies of all contracts and leases. Finally, don’t forget current and terminated employee files, and records of employee pension or profit sharing plans. Most corporate and employee pension plan records should be kept indefinitely.
  7. Computer recordkeeping. The IRS has established a series of rules and recommendations concerning how electronic records must be maintained. Generally, such records should contain the same information as paper records and should be kept for the same length of time.

Now is a good time to start planning for the rest of 2012.