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.
I Big time abuse
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
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
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)
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
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
2. date is required, name of patient is required, address of
patient is required for controlled substances
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
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?!
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
60mg = 1 gr (grain)
1gm = 15 gr (grains)
4gm = 60 gr (grains) = 1 dram
30gm = 1 oz (ounce, apothecary)
1Kg = 2.2 lbs
5ml = 1 dram (approx. 1 teaspoonful)
30ml = 1 fluid ounce
480ml = 1 pint
960ml = 1 quart
15ml = 1 tablespoonful
gram = g or G
milligram = mg or mG
microgram = mcg
kilogram = kg or kG
liter = l
milliliter = ml or mL
1 teaspoonful = 5ml
1 tablespoonful = 15ml
COMMONLY USED LATIN ABBREVIATIONS
a.c. before meals
q.o.d. every other day
bid twice daily
tid three times daily
qid four times daily
prn as needed (Pro Re Nata)
q4h every four hours (q6h = every six, etc)--also, q4hrs or q6hrs
sometimes even q6°, q4°
nr (or NR) no refill
hs at bedtime
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
weight of child (kg) x adult dose
Narcotic law changes
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.