Watts- ETEC 5123 -Pharmacy Law Review -pt 2Presentation Transcript
Poison Prevention Packaging Act (PPPA) The Poison Prevention Packaging Act (PPPA) of 1970 regulates household substances and requires that they be packaged for consumer use in Child-Resistant Packaging (C-RP). C-RP is defined as special packaging that is significantly difficult for children under the age of five to open. Some of you may be saying, “I can never get those darn caps off, and I’m an adult!” Well, interestingly enough, the PPPA also says that not more than 10% of adults should be unable to open the Child-Resistant container. Are you part of the 10%?
Poison Prevention Packaging Act (PPPA) Medication Packaging There are some instances when both prescription & non-prescription drugs may be exempt from the PPPA’s child-resistant container specifications. Patient requests non-compliant packaging Requests should be made in writing (could possibly be an annotation on the back of a prescription or a permanent record to be filed). There are a limited number of prescription drugs that are exempt for varying reasons. One example is sublingual Nitroglycerin because quick access to the drug may be needed. Still others may be packaged to help the consumer comply with directions (e.g., oral contraceptives).
There is a new classification of medication brought on by the Combat Methamphetamine Epidemic Act of 2005 that covers over-the-counter (OTC) Pseudoephedrine It is now in a class called "Scheduled Listed Chemical Products" and went into effect March 2006 The term “Scheduled Listed Chemical Product” means: (1) a product that contains Ephedrine, Pseudoephedrine, or Phenylpropanolamine; and (2) may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act (FDCA) as a non-prescription drug
Scheduled Listed Chemical Products The Combat Methamphetamine Epidemic Act of 2005: Limits daily retail sales to 3.6 grams per person Limits 30-day retail purchases to 9 grams per person Requires non-liquid forms to be sold in blister packs (with some exceptions) Requires sellers to place the product behind-the-counter It also requires sellers to maintain a written or electronic list “logbook” of sales
Prescribers are licensed by their governing bodies The Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) have no authority in determining prescribers Standard practitioners in all 50 states are physicians, surgeons, doctors of osteopathy, dentists, podiatrists, veterinarians, and optometrists (Note: Military pharmacies only accept prescriptions from military veterinarians and only for military dogs and horses)
Schedule I Controlled Substances Schedule IV Controlled Substances (C-I) Substances in this schedule (C-IV) have a high potential for abuse, Substances in this schedule have a low have no currently accepted medical potential for abuse relative to use in treatment in the U.S., & substances in schedule III. (Examples: there is a lack of accepted safety (Xanax®, Valium®, and Restoril®) for use of the drug or other substance under medical Schedule V Controlled Substances supervision. (Example: Heroin) (C-V) Substances in this schedule haveSchedule II Controlled Substances a low potential for abuse relative to (C-II) Substances in this schedule substances listed in schedule IV and have a high potential for abuse consist primarily of preparations which may lead to severe containing limited quantities of certain psychological or physical narcotics. These are generally used for dependence. (Examples: Ritalin® antitussive, antidiarrheal, and analgesic and Morphine) purposes. (Example: Robitussin AC®)Schedule III Controlled Substances (C-III) Substances in this schedule have a potential for abuse less than substances in schedules I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence. (Example: Vicodin®)
C-II Prescriptions have strict guidelines: ◦ No C-II orders may be received orally, by fax, or by e-mail ◦ Faxed C-II orders are in essence ONLY for the purpose of advising pharmacy personnel the patient is en-route with the original order ◦ Only original hand-written orders may be dispensed ◦ C-II prescriptions cannot designate refills. If the prescriber wants the patient to continue the C-II medication, a new prescription for the drug must be written Providers who are authorized to prescribe controlled drugs are given a registration number by the DEA. This registration or DEA number must be written or embossed on the patient’s controlled drug prescription/order for that prescription to be valid.
DEA numbers should have two letters and seven digits …for example, the DEA number AR5472612 To verify the numbers are valid: The second, fourth, and sixth digits are added and their sum is multiplied by 2 That result is added to the sum of the first, third, and fifth digits The last digit of the total of the two sums should equal the seventh digit of the DEA number Confused? Let’s break it down…
Sample DEA Number AR5472612 The second, fourth, and sixth digits (4 + 2 + 1) add up to 7, and 7 times 2 equals 14. The first, third, and fifth digits (5 + 7+ 6) add up to 18. The total of the two sums (14 + 18) is 32. Finally, if the DEA number is valid, the last digit of the total (2) is the seventh digit of the DEA number, and the second letter in the DEA number is the same as the first letter of the last name of the prescriber. For example, the second letter in the DEA number below is an “R”, so your provider’s last name would be something like Roberts, Ricardo, or Rutabaga.
Let’s try one more time…You receive a prescription at your pharmacywindow. The prescriber is Dr. Lynette K. Watts.The DEA number written on the prescription isAW3284065. Is this a good DEA number?
AW3284065 2 + 4 + 6 =12 x 2 = 24 3 + 8 + 0 = 11 11 + 24 = 35 The last digit in the calculated sum is 5, which matches the last digit of the DEA number The second letter of the DEA number is W matching the first letter of the prescriber’s last name, Watts This is a valid DEA number .
0 Food, Drug, and Cosmetic Act 0 Scheduled Listed Chemical Products0 Durham-Humphrey Amendment 0 Prescribing prescriptions0 Poison Prevention Packaging Act 0 Controlled substances 0 Verifying DEA numbers
Congratulations! You have reached the last slide of the mainlesson. Although all of the information is important, I have setup a short interactive exercise so the class can ensure that itunderstands the formula for DEA numbers. Click on theinteractive DEA numbers link to reach the exercise. After youhave completed the exercise, you are free to attempt theassessment. Remember, this is only a small piece of a much morecomprehensive law curriculum that an upgraded pharmacytechnician must complete. Furthermore, if you remember fromthe initial surveys, this is one course in ten in the completecurriculum. If you have further interest, I have providedadditional “exploratory links” for any added interest you may have. Secundum Artem…Gar