From: Oregon Board of Pharmacy
Date: September 3, 2014
Re: Hydrocodone Rescheduling Information
Federal Law has rescheduled all hyrdocodone combination products (HCPs) as Schedule II, effective October 6, 2014.
The new scheduling impacts all hydrocodone-containing products, including liquids such as Tussionex, Hycodan and all generic equivalent products. Single-entity hydrocodone has always been C-II drug.
INVENTORY: All pharmacies and any persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with or possess) hydrocodone products, must take an inventory of their current stock on October 6, 2014. Please keep a record of this inventory on site.
C-II RECONCILIATION: Beginning October 6, 2014, pharmacies are required to include HCPs in C-II reconciliation audits, pursuant to OAR 855-019-0300(5)(e) and OAR 855-041-6610(1)(b).
STORAGE: Regulations require pharmacies to store C-II drugs in a locked area or secure storage system in accordance with 21 CFR 1301.75
o Retail pharmacies may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
o Hospital pharmacies are require to store Schedule II drugs in a locked area or secured storage system according to OAR 855-041-6610(1)(d), however, hospital pharmacies will be given until April 8, 2015 to comply with this rule.
RECORDKEEPING: All hydrocodone prescriptions and invoices must be filed with C-II prescriptions and invoices beginning October 6, 2014.
Prescriptions for HCPs written before October 6, 2014 are:
o valid for up to six months, from original date of issuance – through April 8, 2015.
o valid if written by prescribers with C-III prescriptive authority
Prescriptions for HCPs written on or after October 6, 2014 are:
o rescheduled as C-II. (Note, Oregon law does not speak to the expiration of a C-II; pharmacists and prescribers must use professional judgment)
o valid only if written by prescribers with C-II prescriptive authority
This ‘phase in’ period completely ends April 8, 2015.
Note: Not all pharmacy prescription processing systems may be capable of accommodating this distinction. Corporate/outlet policy may be more restrictive. It is recommended that communication between pharmacists, prescribers and patients is thoughtful and ongoing during this transitional phase.
o Electronic prescribing of scheduled drugs (including C-II) is permitted in Oregon, if the pharmacy and prescriber have authenticated software systems in accordance with 21 CFR 1311. See ORS 475.185(1)(a) clarified during the 2014 Legislative session: https://www.oregonlegislature.gov/bills_laws/lawsstatutes/2014R1orLaw0055ss.pdf
o Federal and state rules permit a prescriber to issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of HCPs. Prescriptions must be written in accordance with 21 CFR 1306.12.
o A practitioner may verbally issue an emergency prescription for a C-II for an amount deemed to cover the emergency period of time. A written prescription must be mailed (postmarked) or delivered to the pharmacy within 7 days in accordance with 21 CFR 1306.11.
o For HCP prescriptions written before October 6, 2014, a pharmacy may assign a new prescription number for an authorized refill with proper documentation of reference to original prescription.
o There is no legal quantity limit on a single C-II prescription; however as with any prescription the pharmacist must perform a DUR for appropriateness. Additionally, large quantities can potentially create a challenge for third party drug coverage.
For the complete Final Rule published in the Federal Register on August 22, 2014, please visit http://go.usa.gov/mc8d
TRAMADOL: SCHEDULE IV CONTROLLED SUBSTANCE, EFFECTIVE AUGUST 18, 2014
Effective August 18, tramadol and products containing tramadol will be classified as Schedule IV controlled substances pursuant to 21 CFR 1308.
INVENTORY: All pharmacies and any persons who handle- manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with or possess- tramadol, must take an inventory of their current stock of tramadol and other products containing tramadol on August 18, 2014.
REGISTRATION: Any location possessing tramadol or products containing tramadol that is not currently registered with US Drug Enforcement Agency (DEA) must apply for and receive a DEA registration prior to August 18, 2014. Alternatively, those locations not wishing to seek DEA registration must remove all tramadol products from their possession prior to August 18, 2014.
o All current prescriptions for tramadol and products containing tramadol must be treated as controlled substance prescriptions on and after August 18, 2014.
o Prior to filling/refilling a tramadol prescription on or after August 18, 2014, ensure that the prescriber has a valid DEA registration, as required for all controlled substance prescriptions. All prescribers who do not have a valid DEA registration will not be able to issue prescriptions or personally furnish tramadol or tramadol containing products.
o If a prescription for a tramadol product was issued prior to August 18, 2014 and refills were authorized, as of August 18, 2014 those refills must be limited to no more than five and must be dispensed no later than six months after the date the prescription was initially issued.
o No electronic prescriptions for tramadol or products containing tramadol may be sent to a pharmacy using an electronic prescription transmission system unless the prescriber’s and the receiving pharmacy’s systems meet the DEA authenticated system requirements addressed in 21 CFR 1311.
The Oregon Board of Pharmacy is currently evaluating its Pharmacy Technician (PT) and Certified Oregon Pharmacy Technician (CPT) regulations and seeks your input. The Board is working to resolve what it perceives as licensure challenges and appreciates comments via the survey linked below. The Board will use your input as it moves forward to revise rules later this year. The goal is to send the rules to a hearing on November 25, 2014 and possible final adoption December 2014.
This survey will be available until July 31, 2014. Please note that it can also be accessed on the Board website and will take approximately 5-8 minutes to complete. We appreciate your participation!
This is a reminder to all immunizing pharmacists: The Oregon Health Authority Immunization Division protocols direct and require you to access the consolidated record and forecast immunizations due for the patients that you are vaccinating. You must be prepared to demonstrate to the inspectors that you can access and utilize the ALERT Immunization Information System (ALERT IIS) to comply with this requirement.
Remember: OAR 855-019-0270 A pharmacist may administer vaccines under section (1) or section (2) of this rule only if: (c)The vaccines are administered in accordance with an administration protocol written and approved by the Oregon Health Authority (OHA).
The current protocols require the look up of each patient in ALERT IIS - Step 1 of each protocol states “Check the ALERT Immunization Information System to determine whether the patient needs this vaccine and any other vaccines.”
Here is additional information from the OHA Immunization website:
Implementation date is no later than January 1, 2014.
For each vaccine encounter, prior to administering vaccine, pharmacy personnel will look up each patient in the ALERT Immunization Information System (IIS) to determine the patient's vaccine history and to forecast recommended vaccines.
· This is not required when administering only influenza vaccines, but will continue to be recommended to help increase pneumococcal and all other recommended vaccine rates.
· This is not required when the pharmacy/pharmacist conducts a remote vaccine clinic, but will continue to be recommended when remote connectivity is available.
For more information on registering and using ALERT IIS, please contact the ALERT IIS Help Desk at 800-980-9431 or email@example.com, or click on the following link:
Prescriptions & Veterinary Medicine
Working together for animal patient health
As more consumers look to have their veterinary prescriptions filled by a community or mail order pharmacy, pharmacists are playing an increasing - and important - complementary role in the health care of animal patients. Given this emerging role, it is important that pharmacists contact veterinarians directly with any concerns about the patient’s prescription. It also is good to keep the following in mind when filling and dispensing prescriptions:
· The federal government has clarified that veterinarians are not eligible to have a National Provider Identifier (NPI) number. This unique 10-digit identification number is only issued to human health care providers by the Centers for Medicare and Medicaid Services.
**Please read this clarification from CMS: Veterinarians Not Eligible for NPIs**
Centers for Medicare and Medicaid Services (CMS) has become aware of cases in which veterinarians are told, incorrectly, that they must provide a National Provider Identifier (NPI) number for prescriptions they have written to be dispensed. The agency has issued a clarification, stressing that veterinarians do not meet the regulatory definition of “health care provider,” and thus may not obtain NPI numbers. Please speak to your corporation if you have any difficulties processing prescriptions for providers who do not have NPI numbers - this should not be a barrier to prescription processing and patient care.
· The Drug Enforcement Administration (DEA) advises veterinarians to not provide their DEA license number for non-controlled substance prescriptions. Pharmacies that dispense from a veterinarian’s prescription should instead request the practitioners veterinary license number.
· If a veterinarian writes “No Substitution” or “Dispense As Written” next to the prescribed product’s name, a pharmacist cannot provide the client with an equivalent product without the veterinarian’s authorization.
· Oregon pharmacies must have a veterinary reference readily accessible. References to consider include Plumb’s Veterinary Drug Handbook and The Merck Veterinary Manual.
Examples of important differences between veterinary and human use of medications:
◗ Insulin: There are various forms of insulin available, but not all forms can be used to treat veterinary patients. Although an alternative form of insulin may be less expensive for the veterinary client, substitution should not be made without consulting with a veterinarian and obtaining his or her authorization. Example: Glargine has a higher cost, but NPH is less effective in treating diabetic cats.
◗ Thyroid hormone: Thyroid disease is common in both the dog and cat. It is almost uniformly hypothyroidism for dogs, and hyperthyroidism for cats. The best treatment for cats with thyroid disease is radioactive iodine, I-131. For dogs that have been diagnosed with a thyroid disorder, veterinarians prescribe the same thyroid supplement that many humans take: Soloxine or Levothyroxine. The one important difference for pharmacists to recognize is that dogs will receive a much higher dosage of a thyroid medication than will people. A change in dosage without the veterinarian’s authorization can result in sub-therapeutic treatment for the animal and extra expense for the pet’s owner because of the need to run additional diagnostic testing to re-stabilize the patient’s hormone level.
◗ Phenobarbital: Phenobarbital is the most widely prescribed medication for treating seizure disorders in dogs and usually is the first medication given to a dog with epilepsy. Phenobarbital is effective in 60 to 80 percent of dogs with idiopathic epilepsy. It is important that pharmacists understand that the barbiturate is prescribed for dogs at a much higher dose than used in humans to treat seizure disorders. Because of the serious nature of seizure disorders, it is essential that these medications are filled exactly as prescribed by the veterinarian. Pharmacists should contact the attending veterinarian directly with any concerns they may have about the prescribed dosage.
◗ Acetaminophen (Tylenol): Although this over-the-counter medication is useful in controlling arthritis in humans, a product containing acetaminophen should never be given to cats. The drug interferes with oxygen uptake in the blood of cats and can result in death if not treated promptly. On occasion acetaminophen is used in dogs, but clients should consult with their veterinarian first before use because an overdose in dogs can cause severe and irreversible liver damage.
◗ Ibuprofen: The NSAID should never be given to dogs or cats, as it can result in severe gastric ulcers or acute kidney failure. Drugs like Rimadyl, Deramaxx, and Meloxicam are NSAIDS that are approved by the FDA for use in animals.
Concerns with other products to keep in mind
◗ Xylitol: While the natural, sugar-free sweetener is safe for humans, it can be harmful for dogs. When ingested in small amounts by dogs, it can cause life-threatening hypoglycemia within 10-15 minutes. Larger ingestions can result in liver failure.
◗ Flea and tick medications: Veterinary products that have been developed for treating fleas and ticks should only be used on the indicated species. Canine flea and tick medications can be extremely toxic to cats. One common complication is seizures.
◗ Vitamin A: This fat-soluble antioxidant is used in veterinary medicine to help a dog with its coat, muscles, nerves, skin and vision. It also helps female dogs maintain ovarian health and reproduce successfully, and it helps puppies grow and develop normally. With some dermatological conditions, Vitamin A may be prescribed in dosages higher than what a human would take.
◗ Minoxidil (Rogaine): This product is used to help hair growth in the treatment of male pattern baldness, but it is not an acceptable treatment for alopecia in pets. It can cause cardiomyopathy in dogs.
Oregon Veterinary Medical Association and Oregon Board of Pharmacy
FDA’s Removal of Unapproved Prescription Drug Products Containing Codeine and Dihydrocodeine from the Market (Q&A)
Q1. What action is FDA taking regarding codeine single-ingredient, codeine combination, and dihydrocodeine combination products?
A1. The U.S. Food and Drug Administration (FDA) has ordered companies to stop manufacturing as of February 24, 2014 and distributing as of April 10, 2014 unapproved prescription drug products containing codeine and unapproved prescription drug products containing dihydrocodeine.
The drugs covered by this action lack the required FDA approval and are:
· single-ingredient codeine sulfate oral tablets;
· single-ingredient codeine phosphate injections;
· combination products containing codeine phosphate; and
· combination products containing dihydrocodeine bitartrate.
This action was published in the Federal Register on January 10, 2014.
Q2. Why is FDA taking this action?
A2. FDA is taking this action as part of our continuing effort to ensure that prescription drugs marketed in the U.S. have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and appropriately labeled.
Q3. When is this action going to take effect?
A3. Individuals and firms must stop manufacturing these unapproved prescription products within 45 days and stop distributing these products within 90 days (deadline of compliance is April 10, 2014). After this date, all of these drug products must have FDA approval to be manufactured or distributed in interstate commerce.
Q4. Are these prescription drug products recalled from the pharmacy?
A4. No, this is not a recall. Previously manufactured unapproved drug products affected by this action may still be found on pharmacy shelves for a short period of time (until the inventory has been depleted or until the products’ expiration date).
Q5. How can I tell the difference between FDA-approved and unapproved prescription drug products?
The NDC Directory is limited to prescription drugs and insulin products. Search results from the NDC Directory include a column marked "Application Number." FDA-approved products will have an associated new drug application (NDA) or abbreviated new drug application (ANDA) number in this column. Identification of a drug product as "other" indicates that the product has not been FDA approved (unless there is a data error or the firm did not provide the product's application number).
Q6. Is it safe to use the unapproved prescription drug products?
A6. The safety of unapproved drugs is unknown. Approved prescription drug products have a label that has been specifically reviewed and approved by FDA, and that reflects the risks, benefits, and safe use of these drugs. This information may not be contained in the label of the unapproved prescription drug products.
The drug approval process enables FDA to evaluate the drug’s formulation, manufacturing process, and label, as well as any changes that occur after approval.
Q7. Should I keep taking my medications?
A7. Patients who have concerns about their medications should speak to their health care professionals about replacement prescriptions.
Q8. What do pharmacists do if they have this product on hand?
A8: FDA is directing this action at drug manufacturers and distributors in an effort to ensure that these unapproved drugs are removed from the market. FDA strongly encourages pharmacists who are presented with prescriptions for unapproved codeine products to contact the prescriber and suggest an FDA-approved prescription product.
**If you have further questions regarding this action, please contact the Division of Drug Information at: 888-INFO.FDA (888-463-6332), or email at: firstname.lastname@example.org **