Prescription Writing and Narcotic Law–Module Twelve
DEHY 34, Pharmacology for Dental Hygiene
Instructor and Contact:  Jim Middleton, RPh


Objectives
By the completion of this section, the participant shall be able to:
 1. Convert pounds to kilogram and kilograms to pounds
 2. Understand basic Latin abbreviations
 3. List the requirements for a properly written prescription
 4. Convert standard household measurements to metric quantities
 5. Understand the division of drugs within various controlled substance categories based on level of addiction potential
 6. Name at least one drug in the C-I category of controlled substances
 7. Identify the refill limitations on controlled substances


I. PRESCRIPTION LAW regarding Narcotics
 A. Background
  Before 1906, there was no control of any kind over drugs on the market.  Morphine was being sold as a cure for tuberculosis (it stopped the cough, so it must be a cure!), cocaine was given to teething babies, and opium was being sold as a cure for alcoholism.  There was no such thing as drug testing, people who were active in the Temperance movement were addicted to the patent medicine Per-U-Na (at 40 proof, it was pretty easy to do), and even Battle Creek was host to a dozen disreputable companies.

  In 1906, after a series of articles in Collier’s magazine and pressure from Commissioner Wiley of the Department of Agriculture (obviously a more powerful post then than now) and President Theodore Roosevelt, the FDA (Food and Drug Administration) was born.  Not that this was a solution–its first regulations could only require that the patent medicines have the ingredients on the label (lobbyists were powerful then, too).  Fines for selling cyanide as a treatment for epilepsy, for example, were a whopping $5.

  It took a series of medical disasters in the 1930s and further public outrage in the 1940s about drug toxicity and addiction to put more pressure on Congress for some control on drug safety.
 
 B.  The Durham-Humphrey act of 1952 (yes, that's Humphrey as in Hubert Horatio Humphrey, a Minnesota pharmacist who gave it all up for the Senate and the Vice presidency and a failed run against Nixon in '68), divided drugs into two broad classes:

  1. prescription only
   a. “legend” or regular prescription (as in medicine for blood pressure, diabetes, etc.)
   b. controlled substances, or those drugs with the likelihood for abuse or addiction

  2. non prescription, or “over the counter drugs” (OTC)

 C. Later categories, or “Schedules,” further described drugs in terms of their potential for addiction.  These categories are all “controlled substances” and each one begins with the letter “C.” Drugs in this category have to be carefully inventoried by pharmacies and have special paperwork and filing requirements by federal and state laws.  The DEA (Drug Enforcement Agency) keeps a very close eye on these regulations. The DEA has absolutely no sense of humor. None. Zip. Nada.


 CHART I:  DEA Schedules


No.    Abuse Potential               Example                                                      Notes and Comments

I         Big time abuse                  LSD, heroin
         potential, no “accept-
         ed medical use”                                                                      unavailable legally in any form; some investigational use
                                                                                                        from governmental sources in special circumstances
 
II     Great Abuse potential          morphine                                      prescription must be hand signed by the
                                                                                                        prescriber cannot be phoned into the pharmacy
                                                                                                        no refills allowed (see notes on Michigan exceptions to
                                                                                                        this for paperwork and special forms)

III     Some abuse                      codeine
                                                containing
                                                                                                        analgesics  prescriptions can be phoned in; but no more
                                                                                                        than 5 refills in 6 months; prescription expires in 6 months
                                                                                                        and requires a physician or dentists' DEA number

IV Potential                              benzodiazepines                                     as above
                                                (Valium, Librium)

V Potential                                  codeine cough
                                                        syrups
                                                    (Robitussin AC)
                                                      and Lomotil                                      if pharmacy is willing, codeine cough syrups can be
                                                                                                            dispensed without a prescription by having the patient
                                                                                                            sign a prescription "log" for a maximum of 120ml (4oz)
                                                                                                                in a 72 hour period (but fewer and fewer
                                                                                                                pharmacies are willing)



 D. Some other random observations
  1. “Oral orders”
   --any prescription EXCEPTING C-II controlled substances may be phoned in to a pharmacy
   –-prescriptions in the C-II controlled substance category MUST BE FILLED within FIVE DAYS of the date on the prescription.  After five days, the prescription is no longer valid.
 
  2. “prn refills”
   a. this means “may refill when needed” but it now has limits, by standards of practice and more recently by State regulations

   b. a non-controlled prescription with “prn” refills may be refilled for one (1) year from the date the prescription was written (not from the date the prescription was brought in to the pharmacy)

   c. CII prescriptions can NEVER be refilled; however, there is a variation on this NEVER in the case of patients with chronic and ultimately terminal pain:
   A C-II prescription written for a large quantity can now be "partially" filled by the pharmacy for up to 60 days (ie, in batches of 30).  This is intended to cut down on waste, especially for hospice patients. (MS-Contin, a controlled release version of morphine, is very expensive and a lot of tablets were being wasted)

   d. on other controlled substances, the maximum number of refills is 5, and that is for a 6 month period.  After 6 months, prescriptions for controlled substances expire, regardless of the number of refills remaining.  This would apply to drugs like Vicodin ES (hydrocodone with acetaminophen) or Valium (diazepam).

   e. also, by Federal law, once dispensed, no prescription can be returned to the pharmacy.  Federal regulations assume that any drug brought back to the pharmacy has been adulterated.

 
 D. Controlled substances–examples
  1. Schedule I “C-I” : absolutely, positively no-nos
   --heroin, delta-9-THC and derivatives (the one exception is Marinol™/dronabinol for chemotherapy induced nausea and vomiting),  marijuana, LSD, peyote
            --and any unauthorized variations of above (to cut down on “home based labs”)

        2. Schedule II “C-II”: high abuse potential, but with medical value
            --morphine (also, MS Contin, MS-IR), codeine (alone), meperidine (Demerol), camphorated tincture of opium (“Paregoric”, although now it is essentially a derivative of morphine), oxycodone (with aspirin: Percodan, with acetaminophen: Percocet or Tylox), hydromorphone (Dilaudid), cocaine, secobarbital (Seconal), amobarbital (Amytal), methylphenidate (Ritalin), dexamphetamine (Dexedrine)
  --Michigan has specially printed prescription blanks which are required for use with C-II narcotics (the exception is methylphenidate [Ritalin])

        3. Schedule III-IV: abuse possible, less likely
            --acetaminophen and aspirin with codeine, diazepam (Valium, also any benzodiazepine), propoxyphene (Darvon), pentazocine (Talwin)
 

II. Warnings about addicts

 Dental offices are especially prone to scam artists or patients who “exhibit drug seeking behavior.”
 
III. Basic principles in prescription writing
    A. Guidelines
 (per some texts, obviously not accustomed to the "real world")
       1. typed or clearly written in ink
           --no erasures, please
   erasures indicate to the pharmacist that a possible alteration has been made, as in number of doses to dispense or number of refills that may be authorized

  2. date is required, name of patient is required, address of patient is required for controlled substances



 In Michigan, if the address for the patient is not on the prescription, the pharmacy is allowed to add the address.  However, for CII prescriptions, the pharmacy is not allowed to make any alterations to the face of the specially-printed CII prescription form.  If the date is left off, especially on a CII prescription, it may be refused. State regulations prohibit the “post dating” of prescriptions by a prescriber

      3. drug name, dosage form, strength, number of units, and number of refills
          --SOMETHING NEW HERE, HOWEVER: FOR CONTROLLED SUBSTANCES (TYLENOL #2, EMPIRIN #4, PERCODAN, ETC.), THE QUANTITY DESIRED MUST BE STATED BOTH NUMERICALLY AND IN WORDS--
  --for example, "24" must be written BOTH "24" and "twenty-four" on the prescription
  --some strict drug inspectors have even taken pharmacies to task for not transcribing phone orders in this manner for drugs in control categories II, III, IV, and V

       4. "Latin is discouraged" –however, it is still in vogue; abbreviations will follow

      5. "Separate blank for each prescription" (see comment in #4)
   –in Michigan, regulations as of April 1998 stipulate that no more than two prescriptions can be written on one blank
   –in addition, a controlled and non-controlled substance cannot be written on the same blank (ie Ampicillin and Tylenol #3)
   –this regulation is currently under appeal by the medical community, but is in effect until a ruling has been made or until the regulation has been changed

  6. Dentist must sign at the time prescription is given to patient
   –this means, no pre-signed stacks of prescriptions should be lying around, tempting some ne’er do well...

  7. DEA (Drug Enforcement Agency) number must appear for any controlled substance


  Digression: How to check the validity of a DEA number:

  The DEA number is seven digits long with a two-letter prefix.
  The two letter prefix begins with either an “A” or a “B” and ends with the first letter of the prescriber’s last name.  For example:
   Dr. Schantz’s DEA number would begin with an “AS” (if she has been practicing before around 1988) or a “BS” (since they ran out of combinations for “AS” around 1988).

  The seven digits are specifically chosen to have an automatic internal check.  This is how the check is done:

  Seven digits: XYXYXYZ

  Add up the “x” digits.  Then add up the “y” digits and multiply the “y” sum by 2.  Add the new Y total to the X total and the last digit of the sum will equal Z.

  Confusing?  It’s meant to be!  Here’s a specific example:

  Dr. Schantz’s DEA is BS3076216.  The BS checks out.  Now we add the “x” digits: 3+7+2 = 12.  The “y” digits: 0+6+1 = 7.  Multiply the “y” digits by 2: 2 x 7 = 14.  Add the two sums: 12 + 14 = 26. The “6" of the “26" serves as “z” or the last digit of the DEA number.  This is what pharmacists do when they want to verify a DEA number.  Isn’t pharmacy math FUN?!



 B. The Written Prescription: The Big “Rx”
      1. The superscription: patient name, address, age, date
      2. The inscription: name of drug and amount
      3. The subscription: directions to that old darned pharmacist
      4. The transcription or signa: directions to the patient
         "the sig"
      5. The signature: of the dentist
 

   C. Generic vs brand names
      --drug patents run 12-17 years--
      --5 year guarantee for "trade" brands--
      --after that, anything goes--

   D. Expressions of dosage
      1. Metric vs apothecary
          (grams)  (grains)

WEIGHT
        60mg = 1  gr (grain)
         1gm = 15 gr (grains)
         4gm = 60 gr (grains) = 1 dram
        30gm = 1  oz (ounce, apothecary)
         1Kg = 2.2 lbs

LIQUID
         5ml = 1 dram (approx. 1 teaspoonful)
        30ml = 1 fluid ounce
       480ml = 1 pint
       960ml = 1 quart
         15ml = 1 tablespoonful

GENERAL ABBREVIATIONS
       gram = g or G
       milligram = mg or mG
       microgram = mcg
       kilogram = kg or kG
       liter = l
       milliliter = ml or mL

HOUSEHOLD APPROXIMATES
       1 teaspoonful = 5ml
       1 tablespoonful = 15ml

COMMONLY USED LATIN ABBREVIATIONS
       a.c.     before meals
       aq.      water
       qd       daily
       q.o.d.   every other day
       bid      twice daily
       tid      three times daily
       qid      four times daily
       gtt      drop
       prn      as needed (Pro Re Nata)
       q4h      every four hours (q6h = every six, etc)--also, q4hrs or q6hrs
   sometimes even q6°, q4°
       c        with
       s        without
       ss       one-half
       nr (or NR) no refill
       hs       at bedtime
       stat     immediately
       pc      after meals
       au,as,ad   both ears/left ear/right ear
       ou/os/od       both eyes/ left eye/ right eye
       po       by mouth

III. Dosing determination
    A. generally, by weight--for children, can use these formula
 
       weight of child (lbs)  x adult dose
              150
    or--
       weight of child (kg)   x adult dose
              70
 

Narcotic law changes
 A. Exceptions
  Methylphenidate (Ritalin), still classified as a C-II narcotic, no longer has to be prescribed on a special C-II prescription form.  They cannot be phoned in, however; an actual written prescription is still required. (In 1992, 70% of the CII prescriptions were for methylphenidate in the State of Michigan)

 B. The form itself
  The specially printed and registered triplicate prescription form, required for all other C-II narcotics in the State of Michigan, was phased out in January, 1995. The new forms for C-II drugs are not a “triplicate form.”   Physicians and dentists will be required to keep specific records on C-II prescribing, and pharmacists will be sending the original copies of the prescriptions to the State Board of Licensing.
   --the State had been providing the forms to physicians and dentists; the production cost was becoming prohibitive in these "austere" times, and it has been taking many people to process the mandated monthly paperwork
   —Y2K update: the department of Commerce, in an attempt to further streamline its budget, is planning to cease the use of these special forms completely by 2002

 C. One more thing! (Hospice pushed for this change, since Medicare benefits pay a total of $80/day for each patient; wasted medications were eating into this-- to the tune of $50,000-100,000/year per county in the State [putting it into perspective, sustained release morphine is very expensive, and once dispensed, cannot be legally returned or transferred to another patient; physicians were ordering it in large quantities to be certain that their terminally ill patients were never without pain relief]). This is how some C-II prescriptions may be “partially filled” over a 90 day period.

 Presently there are further bits of legislation being converted to regulations that will make other provisions for pain management.  These will doubtless have a further effect on the prescribing protocols for controlled substances.



No Homework on this Section
Special Study Module will be provided
Contact: Jim Middleton
January 2002
KCC Dental Hygiene Pharmacology