© 2004, 2005, William E.
Fassett
i.
The FDA web site
provides several articles on the History of the FDA and the
food and drug laws.
ii.
The Pure Food
and Drug Act, also known as the Wiley Law, was passed in 1906, as the first
comprehensive federal statute to assure purity and truthful labeling for foods
and drugs.
iii.
Growing problems with modern
chemicals, and limits on the applicability of the Wiley Law, led to the
passage in 1938 of the FDCA, which has been amended several times since then. A
major impetus to the passage of the FDCA was an influential book by Ruth DeForest Lamb, “The
American Chamber of Horrors.” A precipitating event was the marketing of “Sulfanilamide Elixir”
by the S.E. Massengill Company, which contained diethylene glycol as the solvent – 107 deaths occurred
before the FDA could get the product removed from the market.
1. The FDCA improved on the Wiley Law in three ways:
a. Required proof of safety before marketing drugs
b. Required pre-marketing approval of “new drugs” by the
FDA.
c. All drugs marketed after 1938 in the
iv.
Prior to 1951,
pharmacists could dispense any drug – except narcotics – without a
prescription. As a matter of professional ethics and courtesy, however, most
pharmacists required prescriptions for many drugs, although refill procedures
were somewhat lax. After 1951, however, the Durham-Humphrey Amendments created
a new class of drugs that could not be dispensed without a prescription. These
have become called “legend drugs,” because they were required to bear a
“legend” on their label: “Caution: Federal Law prohibits dispensing without
prescription.”
1. All existing drugs could be sold over the counter
(OTC), without prescription.
2. New drugs that could not bear adequate labeling for
safe use by the consumer would now be able to be marketed if information was
provided to the physician, and these required a prescription.
3. The law allowed for oral prescriptions, and for
refills.
v.
In 1962,
additional amendments, the Kefauver-Harris Amendments, were passed, triggered by
problems with thalidomide, a drug which had not actually been marketed in the
1. Proof of efficacy (effectiveness) as well as safety
prior to marketing.
a. All drugs marketed between 1938 and 1962 had to be
reviewed for efficacy, in a long-lasting effort by FDA known as the Drug
Efficacy Study Implementation (DESI). Many marketed drugs – especially
combination products – were removed from the market by this process (e.g.,
combinations of meprobamate and conjugated estrogen,
combinations of antibiotics with antihistamines).
2. Established regulations called Good Manufacturing
Practices (GMPs) requiring significant monitoring of
manufacturers’ facilities and processes
3. Moved control of advertising for Rx drugs from the
Federal Trade Commission to the FDA
4. Improved procedures and requirements for obtaining
informed consent during clinical trials of new drugs.
vi.
Other amendments
since 1976 have largely affected marketing, patent rights, and promotion of
generic drugs. These include:
1. Orphan Drug Act of 1983, extending patent protection
and giving tax relief to companies that develop needed drugs without
significant market potential. One such drug, however, was AZT (zidovudine).
2. Waxman-Hatch Amendment of 1984, which streamlined
processes for approval of generic drugs, and gave extended terms of patents for
certain drugs.
3. Prescription Drug Marketing Act of 1987, which
controls distribution of legend drug samples, reselling of drugs by hospitals,
and requires state licensing of drug wholesalers.
vii.
FDAMA. The Food
and Drug Administration Modernization Act of 1997 created significant changes
in the FDCA, predominantly affecting manufacturers. A major section dealt with
pharmacy compounding, but was invalidated by the US Supreme Court in Thompson v.
Western States Medical Center, 238 F.3d 1090
(2002)
viii.
Rx-to-OTC
Switches
1. Most modern new drugs begin their marketed lives as
legend drugs. However, after some time on the market, their general safety and
usefulness for the lay public may become better known, and manufacturers may
seek to have them moved to OTC status. This process is known as an Rx to
OTC switch.
i.
Preclinical
testing, in vitro and in animals.
ii.
Filing with the
FDA of a Notice of Investigational New Drug (
1. This allows the drug to shipped in interstate
commerce for purposes of testing
iii.
Clinical testing
1. Phase I – a small number of healthy volunteers to
determine pharmacodynamic and pharmacokinetic
properties
2. Phase II – a limited number of patients who have the
target disease, to determine efficacy and dose-response.
3. Phase III – large-scale clinical trials in patients
with the disease. At least two clinical trials must be conducted that are
double-blinded and placebo-controlled.
iv.
Filing of a New
Drug Application (NDA). This filing describes the drug, the results of
preclinical and clinical trials, sets forth the proposed labeling, a Risk
Management Plan, and describes manufacturing and testing processes. If the NDA
is approved, the drug may be marketed.
v.
Post-marketing
surveillance (also called Phase IV). The manufacturer must maintain records and
file annual reports which include summaries of adverse reactions and problems
discovered after marketing. Significant problems must be reported promptly,
which may lead to revisions in the labeling.
vi.
Supplemental NDAs are filed when the manufacturer seeks additional
indications or changes in the labeling or production of the drug.
vii.
Abbreviated NDAs are filed by manufacturers who wish to market generic
versions of approved drugs after patent rights expire. (See drug product
selection section.)
viii.
New products are
classified by the FDA using a rating scheme, which is indicated in information
announcing the drug’s approval. A number indicates the chemical type and a
letter (P or S) indicates the therapeutic potential. The FDA considers 1P (New
Chemical Entity that is a Therapeutic Advance) the most important kind of new
drug:
1. Chemical Type (1-6)
a. 1 = New Chemical Entity (NCE), a novel chemical agent
b. 2 = New salt or ester of a previously approved drug
c. 3 = New formulation of previously approved drug(s)
d. 4 = New combination of previously approved drugs
e. 5 = Duplicate of another product
f.
6 = Previously
marketed by the same firm
2. Therapeutic Potential (P or S)
a. P = Therapeutic advance
i.
No other
effective drugs for the indication
ii.
More effective
or safe than other drugs for the indication
iii.
Other important
advantages compared to other drugs
b. S = Similar to other drugs on the market for the
condition
i.
articles used
for food or drink for man or other animals,
ii.
chewing gum, and
iii.
articles used for
components of any such article.(21 USC § 321(f))
i.
articles
intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or
otherwise applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance, and
ii.
articles intended for use as a component of any such
articles; except that such term shall not include soap. (21 USC § 321(i))
i.
recognized in
the official National Formulary, or the United States Pharmacopeia,
or any supplement to them,
ii.
intended for use
in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other animals, or
iii.
intended to affect the structure or any function of the body
of man or other animals, and which does not achieve its primary intended
purposes through chemical action within or on the body of man or other animals
and which is not dependent upon being metabolized for the achievement of its
primary intended purposes. (21 USC § 321(h))
1. Class I – Common and simple devices needing to
conform to general standards (e.g., tongue depressors, bandages, neck braces)
2. Class II – Devices needing to meet specific
performance standards (e.g., thermometers)
3. Class III – Devices that pose risk of injury if not
properly used or produced, that require pre-market approval (e.g.,
defibrillators, pacemakers, IUDs)
ii.
Restricted
Devices. Some devices require a prescription or order of a prescriber to sell
or dispense. These are labeled “Caution: Federal law restricts this device to
sale by or on the order of a physician.”
i.
·
Making it lawful
for “any person over the age of eighteen to possess sterile hypodermic syringes
and needles for the purpose of reducing bloodborne
diseases” (RCW 69.50.412(5)).
·
Specifying that
nothing in the Drug Paraphernalia Act “prohibits legal distribution of
injection syringe equipment through public health and community based HIV
prevention programs, and pharmacies.” (RCW 69.50.4121(3))
·
Specifying that
“Nothing contained in [the Drug Paraphernalia Act] shall be construed to
require a retailer to sell hypodermic needles or syringes to any person.” (RCW
70.115.060)
Under
these provisions, needle exchange programs are legal in
ii.
A summary of
state laws regulating syringe sales is available on the internet at http://www.temple.edu/lawschool/phrhcs/otc.htm
iii.
The Journal of the American Pharmaceutical Association devoted a special issue to
syringe laws and access to syringes in 2002 (Nov-Dec; 42(6 Suppl
2)).
iv.
Over 100
pharmacies in
21
USC § 321:
(g) (1)
The term ''drug'' means
(A)
articles recognized in the official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National Formulary, or any
supplement to any of them; and
(B)
articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals; and
(C)
articles (other than food) intended to affect the structure or any function of
the body of man or other animals; and
(D)
articles intended for use as a component of any article specified in clause
(A), (B), or (C). A food or dietary supplement for which a claim, subject to
sections 343(r)(1)(B)
and 343(r)(3) of
this title or sections 343(r)(1)(B)
and 343(r)(5)(D)
of this title, is made in accordance with the requirements of section 343(r) of this title
is not a drug solely because the label or the labeling contains such a claim. A
food, dietary ingredient, or dietary supplement for which a truthful and not
misleading statement is made in accordance with section 343(r)(6) of this
title is not a drug under clause (C) solely because the label or the labeling
contains such a statement.
i.
Any article
listed in the official compendium (i.e., the USP/NF) must conform to compendial standards for purity, quality, strength, and
appropriate assays.
ii.
Drugs must be
stored in accordance with USP standards, and any special requirements specified
on the manufacturer’s label.
iii.
The USP defines
the following temperature ranges for storing drugs:
1. Controlled room temperature
2. Cool place
3. Cold place
iv.
Pharmacies must
maintain their drug storage areas within a controlled range, which requires air
conditioning in most areas of the
v.
Refrigerators or
freezers used to store drugs may not be used to store food or non-drug
products.
i.
The “label” of a
drug is the actual label affixed to the bottle or box containing the
medication. The “labeling” includes the label, and any other printed or written
material accompanying the drug. Labeling also includes statements made by the
manufacture or seller in promotional materials, advertisements, or other
communications to patients or health professionals.
ii.
OTC drugs must
bear adequate directions so that lay persons can use the product safely and effectively.
If a product cannot be labeled in such a way that the consumer can use it just
by reading the label, it will be restricted to sale by prescription.
iii.
Specific
elements are required by the FDCA on the labels of OTC drugs. The “7-point
label” must contain:
1. Name of Product
2. Name and address of manufacturer, packager,
distributor
3. Net contents
4. Active ingredients and quantity of certain other
ingredients
5. Name of any habit forming drug
6. Cautions and warnings
7. Adequate directions for use
iv.
The FDA has
recently developed new
regulations that have changed the look of OTC drug labels and require the
same format for all labels.
i.
Covered OTC
products include
1. Aspirin
2. Acetaminophen
3. NSAIDs
4. Iron preparations > 250 mg elemental iron per
package
5. Diphenhydramine > 66 mg per package
6. Lidocaine and Dibucaine
7. Minoxidil
8. Methyl salicylate
9. Ethylene glycol
10. Methyl alcohol
11. Hydrocarbons and solvents
12. NaOH, KOH
ii.
For OTC drugs,
each manufacturer must make at least one package size with a CRC. A
manufacturer may make one size only that is intended for households without
small children. It must bear the caution “This Package for Households without
Young Children.”
iii.
i.
An indicator of
tampering or barrier to entry, that
ii.
If breached or
missing provides visible evidence of tampering
iii.
A label statement
must describe the barrier or indicator
i.
Pharmacists are
allowed to make recommendations to customers about the hazards and benefits of
medications, consistent with their knowledge, training, experience, and good
judgment.
ii.
Specific assurances
(“this is perfectly safe for your baby”) may create a warranty of fitness for a
particular purchase that can lead to liability to the consumer if the product
does not perform as stated or is harmful.
i.
Vitamin
ii.
Mineral
iii.
Herb or other
botanical
iv.
Amino acid
i.
Intended to
supplement the diet by increasing total dietary intake, or
ii.
A concentrate,
extract, metabolite, constituent or combination of the above.
i.
Intended for
ingestion
ii.
Not represented
for use as a conventional food or sole item of a meal or diet
iii.
Labeled as a
dietary supplement
i.
Claim benefit
related to a classic nutritional deficiency disease (e.g., scurvy, beri-beri)
ii.
Describe the
role of a nutrient intended to affect the structure or function of the body
iii.
Characterize the
mechanism of action
iv.
Describe general
well-being gained from consuming a nutrient
v.
Must state that
the FDA has not evaluated any labeling claims
i.
Sellers may sell
or display articles, books, and abstracts of peer-reviewed scientific
publications.
1. These must be reprinted in their entirety
2. Must be presented with other publications to present
a balanced view
3. Must be physically separate from the product
ii.
Sellers may not
apply information to the product by sticker, shelf-talker, etc., that would
make claims not allowed in labeling
i.
The “label” of a
legend drug is the actual label affixed to the bottle or box containing the
medication. The “labeling” includes the label, and any other printed or written
material accompanying the drug. Labeling also includes statements made by the
manufacture in promotional materials, advertisements, or other communications
to patients or health professionals.
ii.
The FDCA and
state law requires the following on the label of a prescription dispensed by a
pharmacist to a patient:
|
Elements required on a prescription label dispensed
to a patient |
||
|
|
FDCA |
RCW 18.64.246 |
|
Name
and address of the pharmacy |
ü |
ü |
|
A
serial number |
ü |
ü |
|
Name
of prescriber |
ü |
ü |
|
Name
of patient, if on the prescription |
ü |
|
|
Name
of patient |
|
ü |
|
Directions
for use, if on the prescription |
ü |
|
|
Complete
directions for use |
|
ü “As directed” prohibited. (WAC 246-875-020(1)(h)) |
|
Date
of filling or refilling |
ü |
ü |
|
Name
and strength of drug |
|
ü* |
|
Quantity
dispensed |
|
ü* |
|
An
expiration date. Often called a “use before” or “discard after” date |
|
ü |
|
The
statement, “Warning: State or Federal law prohibits transfer of this drug to any
person other than the person for whom it was prescribed” |
|
ü |
|
Identity
of pharmacist responsible for dispensing. |
|
ü** |
|
Supplemented
by additional oral or written written information as
required by regulation. Includes auxiliary labels. |
|
ü |
|
* May be omitted if prescriber requests. |
||
i.
Oral
contraceptive inserts consist of a complete insert and a brief insert. Both
must be dispensed to ambulatory patients each time the drug is dispensed. In
hospitals, these must be provided to the patient at the first dispensing, and
once every 30 days.
ii.
Estrogens and progestins also require a single patient information
leaflet be dispensed with each prescription and each refill. In hospitals,
these must be provided to the patient with first use of the drug, and every 30
days.
i.
All states allow
physicians, podiatrists, dentists, and veterinarians to prescribe legend and
controlled substances. Other practitioners may or may not have prescriptive
authority for one or more classes of drugs
ii.
Most states
honor prescriptions from out of state physicians, podiatrists, dentists, and
veterinarians.
1.
2. Practitioners – out of state prescriptions are
acceptable. WA allows the following prescribers who
are licensed in any state, or in
a. Physicians (MD) and Osteopathic Physicians (DO)
b. Dentists (DMD, DDS)
c. Podiatrists (PodD, DPM)
d. Veterinarians (DVM)
3. “Mid-level” practitioners – out of state
prescriptions are not allowed from these practitioners.
a. Physician’s Assistants (PA, PA-C)
b. Nurse Practitioners (ARNP) (includes Nurse Midwives)
c. Nurse Anesthetists (CRNA)
d. Optometrists (OD)
e. Naturopaths (ND)
f.
Midwives (very
limited)
g. Pharmacists (R.Ph., Pharm.D.) under collaborative practice agreements
Revised January 2005
|
Designation* |
Indicates |
Prescribing
Limits |
|
A.R.N.P. |
Advanced
Registered Nurse Practitioner |
Drugs
necessary for treatment of patients within specialty; C-5 controlled substances.
If has a joint practice agreement with a physician, can be eligible to
prescribe C-2, 3, and 4. If has C-2 to 4 authority,
may dispense up to a 72 hr supply, in addition to prescribing. Example
specialty areas: family practice (children and adults); psychiatric;
pediatric; women’s health; nurse midwife |
|
B.N., B.S.N. |
Bachelor of
Nursing, Bachelor of Science in Nursing |
Same
scope as RN – no prescriptive authority unless further certified as ARNP. |
|
B.Pharm. |
Bachelor
of Pharmacy (Cougars only) |
Same
scope as Pharm.D.; the B.Pharm. and B.S.Pharm. indicate the 5-year bachelors degrees offered in the |
|
C.R.N.A. |
Certified
Registered Nurse Anesthetist |
Drugs
used in anesthesia practice; scope of practice established by American
Association of Nurse Anesthetists. Is a specialty area practiced by ARNPs in WA. |
|
D.C. |
Doctor of
Chiropractic |
No
prescriptive authority |
|
D.D.S., D.M.D. |
Doctor of
Dental Surgery, Doctor of Dental Medicine |
Same
scope as MD as long as treating diseases of the head and neck. |
|
D.O. |
Doctor of
Osteopathy; |
Osteopathic
Physician and Surgeon; same scope as MD |
|
D.P.M |
Doctor of Podiatric Medicine, see also Pod.D. |
Same scope as MD as long as treating or performing
surgery on feet and ankles. |
|
D.V.M. |
Doctor of Veterinary Medicine |
Unlimited scope as long as treating animals. May
prescribe for animals and prescriptions may be filled by pharmacists. |
|
J.D. |
Juris Doctor (doctor of law) |
Attorney.
No prescriptive authority. By convention, within legal circles attorneys who hold
the J.D. do not use the title “doctor,” but are referred to as “Mr.,” “Ms.,”
etc. |
|
M.D. |
Doctor of
Medicine, Physician and Surgeon |
All drugs
needed for his or her patients. No limits on controlled substances unless restricted
for a given practitioner by medical examiners. |
|
Midwife |
Licensed
Midwife (not a nurse midwife) |
May order
and use drugs needed in delivery and immediately
post-partum. May prescribe a limited list of products, and pharmacists may
fill their orders for diaphragms issued for post-partum women – see WAC
246-834-250. |
|
Nurse
Midwife |
ARNP |
A
specialty area of practice for ARNPs, same
authority as ARNPs. |
|
M.N., M.S.N. |
Master of
Nursing, Master of Science in Nursing |
Same
scope as RN unless MN or MSN was designed to also lead to ARNP or CRNA
certification. |
|
N.D. |
Doctor of
Naturopathy |
May use homeopathic
and natural products, plus if specially trained may prescribe a limited list
of drugs – see list
on DOH website, which was revised in January 2004. |
|
O.D. |
Doctor of
Optometry |
May order
and use topical ophthalmics for diagnosis and
refraction. If shows TX after license number, may prescribe topical
ophthalmic drugs in WA. May prescribe certain oral drugs including C-3, 4,
and 5 drugs, and may administer epinephrine injection for anaphylactic shock.
Allowed drugs are listed in WAC
246-851-580 and -590. Limits: Benzodiazepines for anti-anxiety associated
with procedures – single doses per Rx; CSA not more than 7 days; C-3 or C-4,
not more than 30 dosage units/Rx. Must place “notation of purpose” on all Rxs. |
|
PA PA-C |
Physician’s
Assistant Physician
Assistant-Certified Osteopathic
Physician’s Assistant Osteopathic
Physician’s Assistant-Certified |
May
prescribe legend drugs and controlled substances (EXCEPT, Osteopathic PA may
not prescribe Schedule II), as approved by physician supervisor. Must write on
supervising physician’s prescription blank. Needs own DEA number if
prescribing CSAs. May dispense drugs from office
when prescribed by supervising physician. Indicates “PA” or “PA-C” after name. |
|
Ph.D. |
Doctor of
Philosophy |
Research
degree in many fields, including pharmacy, nursing, psychology, pathology,
etc. Has prescriptive authority only related to an
prior professional degree. May be addressed as “doctor,” but should not use
the title to imply expertise outside their training. |
|
Pharm.D. |
Doctor of Pharmacy |
May prescribe (“initiate or modify therapy”) in
accordance with approved protocol as part of collaborative practice
agreement. Same limits for his or her protocol as the authorizing prescriber. |
|
Pod.D. |
Doctor of Podiatry – see also D.P.M. |
Same scope as M.D. if treating or performing
surgery on feet or ankles. |
|
R.Ph. |
Registered Pharmacist |
Same scope as Pharm.D. |
|
*Designations
in BOLD
ITALIC indicate academic degrees. |
||
ÓWilliam
E. Fassett, 2002, 2004, 2005.
i.
Must be
prescribed in the context of a bona fide prescriber-patient relationship. Prior
to issuing a prescription, for example, the prescriber must have conducted an
appropriate examination and maintained proper records, and made a professional
judgment.
1. Prescriptions that are “sold” to patients are not
valid. For example, Internet prescribing seldom involves a bona fide
patient-prescriber encounter. Likewise, prescription “mills” where patients pay
to have prescriptions written (often for CSAs) do not
produce valid prescriptions that a pharmacist can lawfully dispense.
ii.
Must be within
the scope and authority of the prescriber. A podiatrist cannot prescribe medications
for congestive heart failure, even though ankle edema is a result of CHF. A
dentist cannot normally prescribe birth control pills. Likewise, some
practitioners, such as optometrists, are not able to prescribe Schedule II
drugs in most states. Veterinarians cannot prescribe drugs for humans, and MDs
cannot prescribe drugs for cats or dogs. A pharmacist who knows, or should
know, that a particular prescription is not within the scope or authority of
the issuing prescriber has a corresponding responsibility not to fill the
prescription. The pharmacist must be aware, however, of current trends in use
of drugs by the various practitioners who normally prescribe for his or her
clients. If in doubt, ask the prescriber to fill you in on how they intend the drug
to be used, so you can help the client understand its use better.
i.
Drugs used for
non-medical purposes include stimulants for “recreational use” or androgens for
weight training. This could include Ipecac used by persons with eating
disorders. Non-legitimate drug use is a greater problem with controlled
substances than with legend drugs. Nevertheless, if a pharmacist knows or
should know that the drug is being used for a non-medical purpose, he or she is
not authorized to dispense the product.
ii.
Specific
statutory prohibitions exist against prescribing, administering, or dispensing
“steroids,” or any form of autotransfusion, for the
purpose of manipulating hormones to increase muscle mass, strength, or weight,
or to enhance athletic ability unless medically necessary (e.g., runner’s
anemia). Steroids include
1. “Anabolic steroids”
2. “Androgens”
3. “Human growth hormone” (RCW 69.41.300-310)
i.
RCW
69.41.010(11) defines a “legible prescription” as “capable of being read and
understood by the pharmacist filling the prescription or the nurse or other
practitioner implementing the medication order.”
ii.
RCW 69.14.120
requires prescriptions to be legible.
iii.
Pharmacists who
fill illegible prescriptions without verifying the prescription are liable for
damages caused to their patients.
i.
Date written
ii.
The patient’s
address must be on the prescription or available in patient medication record,
a record book, or hospital or clinic record. (WAC 246-869-100(2)(a))
1. The definition of “address” as it applies to the
patient is not clear under federal or state law. And, frankly, some patients
don’t have a home. The only description under federal law of an “address” is
contained in the US Postal Service Domestic Mail Manual, which indicates that “the delivery address
specifies the location to which the USPS is to deliver a mailpiece.”
The DMM indicates that for “street and number” the sender shall “Include the
apartment number, or use the post office box number, or general delivery, or
rural route or highway contract route designation and box number, as
applicable.” Thus, it appears the patient may provide any location to which the
USPS could deliver mail. It is a common practice for the Medicaid program to
use a physician’s office address as the address for a homeless Medicaid
recipient.
iii.
Directions for
use.
1. Some products are clearly labeled on the container,
such as birth control pills. In these cases, UD should be interpreted to read
“as directed on the container.”
2. Some directions are for complicated doses. The
prescriber may have given a written schedule to the patient, such as in
step-down dosing of prednisone. In such a case, the pharmacist needs to know
what those instructions were, to determine compliance. The pharmacist should
make a copy of the instructions and attach them to the original prescription,
and use them to estimate a days’ supply. The directions would then be interpreted
as “Take according to written sheet provided by physician.” If appropriate, a
“not to exceed” limit should be specified on the label.
3. Sometimes the patient is given the drug, and told to
confirm the dosage with the prescriber, or will take differing doses in
accordance with monitoring of therapy, as in treatment with Coumadin®.
In such cases, the directions should be interpreted as “take on a [daily] basis
per consultation with [physician].” Maximum dosing should be specified if
appropriate.
iv.
Instructions regarding
generic substitution. This is automatic with two-line prescription blanks, but
the information needs to be gathered specifically on telephoned orders, and
recorded on the face of the prescription by the pharmacist. (RCW 69.41.120).
1. Prescriptions written by generic name (or telephoned
by generic name) do not come under the requirements of the substitution law.
v.
The pharmacist
must place a serial number, the date of dispensing, and the initials of the
responsible pharmacist on the face of the prescription. (WAC 246-869-100(2)(c)).
vi.
In all cases
where product interchange has occurred (see below), the pharmacist must record
the identity of the actual drug dispensed on the prescription and in the
patient record. (RCW 69.41.120) This is most easily and clearly done by
recording the National Drug Code (NDC) of the product dispensed.
i.
Must contain the
date, time, and telephone number and location of the transmitting FAX machine.
ii.
The pharmacist
is responsible for assuring that the FAX will be legible for two years (i.e.,
not printed on thermal paper).
iii.
The pharmacist
is responsible for verifying that each FAX is valid and shall verify the
authenticity of the prescription with the prescriber if there is a question.
iv.
There cannot be
an exclusive agreement concerning FAXed orders
between the pharmacy and the prescriber.
(Additional requirements have been established for FAXes
of controlled substances in Schedule II.)
i.
The law allows
for electronic transmission of prescriptions, (RCW 69.41.055) and permits the
Board to adopt specific rules. The law requires the following:
1. Transmission is directly from the prescriber to a
pharmacy of the patient’s choice, with no intervening person having access to the
information. (This prohibits orders being transmitted through an insurance
company.)
2. The Board must approve the systems for sending and
receiving the information.
3. The information must include an “explicit
opportunity” for prescribers to communicate preferences
regarding generic substitution.
4. Confidentiality and security of the information must
be assured.
a. The pharmacist in charge (responsible pharmacy
manager) shall establish or verify procedures and policies to ensure integrity
and confidentiality of the prescription information.
b. All managers, employees, and agents of the pharmacy
must read, sign, and comply with the established procedures
5. The pharmacist must exercise professional judgment
regarding the accuracy, validity and authenticity of the drug orders
transmitted electronically.
ii.
The Board
publishes a list of
approved systems on its website.
i.
When a drug is
prescribed by its official or “generic” name (e.g., Ibuprofen tablets 800 mg),
the prescriber has left it to the pharmacist to determine the particular
manufacturer or source of the product, secundum
artem (“according to the art” of the apothecary).
ii.
When a drug is
prescribed by brand name (e.g., Motrin tablets 800 mg), it is understood that
the prescriber intends a particular product from a particular manufacturer.
i.
Pharmacist’s
Reference Sources
In all states, a prescription written by generic (nonproprietary) name permits
the pharmacist to choose the source of the product, whether it is bioequivalent
to a brand name drug or not.
1. Orange Book
The “Orange Book” is officially entitled “Approved Drug Products with
Therapeutic Equivalents,” and is published by the FDA. The only products
listed are drugs with NDAs and/or ANDAs.
Old drugs (including digitalis, Phenobarbital, etc.), which were marketed prior
to 1938, do not have NDAs and are not included in the
Orange Book. Drugs that are considered therapeutically equivalent are given an
“A” rating; those that are not are rated “B.” A second letter is appended to
indicate the basis for the rating, and all generically equivalent products are
rated “AB.” In every case, the rating of a generic drug is related to a specific
innovator’s product. In some cases, two innovator’s products have the same
chemical ingredient, but are not, themselves, bioequivalent. This is most often
the case with sustained-release preparations that use different formulations to
achieve their release characteristics. For example, Adalat
CC™ and Procardia XL™ each contain nifedipine HCl. However, they use
different formulations, and are not interchangeable as generics. Procardia XL was marketed first, and is given a
three-symbol rating: AB1; Adalat CC is rated AB2.
Generic nifedipine formulations that are
interchangeable with Procardia XL are rated AB1, and
those that can be substituted for Adalat CC are rated
AB2.
2. Positive Formularies
Some states do not allow the pharmacist to substitute
any equivalent generic, but require the pharmacist to choose from drugs on a
specific list. This list is often called a “positive formulary.” Some states
specify the Orange Book as their positive formulary, while others have a
special commission that develops the list.
3. Negative Formularies
A few states have lists of drugs that cannot be substituted. Many of these
lists include so-called “narrow therapeutic index drugs,” such as levothyroxine, warfarin, digoxin, and furosemide. The
drugs placed on these lists are often placed there as a result of a political
process in which manufacturers and physicians have lobbied to limit generic
substitution.
ii.
“DAW”
instructions and special prescription blanks.
Most states allow prescribers to prevent generic
substitution on a per-prescription basis. Some will allow the prescriber to
indicate “Dispense As Written” or “DAW” in writing on
the prescription. Others allow a check-box (þ DAW).
1. Dealing with out-of-state prescriptions.
According to the statute,
a. The pharmacist has personal knowledge of the rules in
the state of origin; or
b. The pharmacist has obtained authorization from the
prescriber; or
c. The pharmacist obtains current information on the
rules in the other state from
i.
The
ii.
The Board of
Pharmacy in the other state
iii.
Some other
reliable professional means.
iii.
Generic
substitution is required in
1. The pharmacy does not have a generic product in stock
which is, in the pharmacist’s professional judgment, bioequivalent to the drug
prescribed; or
2. The patient or the patient’s agent requests the
branded product, and the product is not being paid for by public funds.
iv.
Savings must be
passed on to purchaser in
Savings |
= |
Actual Acquisition Cost of Brand Name Drug |
– |
Actual Acquisition Cost of Generic Drug |
|
Maximum Price |
= |
Normal Price of Brand Name Drug |
– |
(Savings ´ 0.6) |
Example: Your pharmacy’s normal cash price for a
brand-name drug is $85.00 for 90 tablets. The Average Wholesale Price (AWP) for
this product is $83.00 per 100. Your Actual Acquisition Price (AAC) from the
wholesaler is AWP less 18% for this drug. Your AAC for the generic equivalent
is $41.00 per 100. What is the maximum price you can charge the patient for 90
tablets under WA law?
Savings = ($83 ´ 90/100 ´ 0.82) – ($41 ´ 90/100) = $24.35
Max. Price = $85.00 – ($24.35 ´ 0.6) = $70.39
Margin
on brand name drug: $23.75 ¸ $85.00 ´ 100% = 27.9%.
Margin
on generic drug: $33.49 ¸ $70.39 ´ 100% = 47.5% (assuming competition will allow you to
charge the maximum allowed price).
v.
Notice to
Public. RCW 69.41.160 requires the following notice to be displayed to the
public in every pharmacy: “Under
vi.
Pharmacists are
protected by RCW 69.41.170 from being coerced by employers to dispense a
particular generic drug or to substitute a generic drug for another drug.
i.
With prior authorization
(
ii.
Specific
authorization on an individual prescription
iii.
Via
Collaborative Practice Agreement (in this case, the pharmacist is not
performing therapeutic interchange as much as is prescribing a different drug.)
iv.
In accordance
with the Therapeutic Interchange Program and Preferred Drug List (WA)
1. The 2003 Legislature passed SB
6088, which creates a Preferred Drug List (PDL) for use in all state-funded
drug programs, including Medicaid and the Uniform Medical Plan (UMP) for state
employees. The Washington Health Care Authority (HCA) administers the program,
which is entitled Rx Washington.
2. The current Preferred Drug List is updated
frequently on the Rx Washington web site.
3. The Pharmacy & Therapeutics Committee that
determines the PDL is composed of 10 members (4 physicians, 4 pharmacists, 1
PA, 1 ARNP). Currently (1/05), three of the 10 members are on the WSU faculty:
Angelo Ballasiotes, PharmD;
Jason Iltz, PharmD; John
White,
4. A Therapeutic
Interchange Program (TIP) is established by the legislation. This program
went into effect in mid-2004, and pharmacists dispensing prescriptions that are
paid for by a state program are authorized and required to perform therapeutic
substitution using drugs on the PDL, where a non-preferred drug has been
ordered.
a. Eligible prescriptions must be have been written by
an “endorsing practitioner.”
i.
HCA maintains a database to identify endorsing practitioners
ii.
Prescriptions
written by non-endorsing practitioners
1. Will be filled at Tier-3 rates for UMP beneficiaries
2. Will be subject to prior authorization for other
state plans
3. May be substituted via prior authorization
iii.
The endorsing
practitioner may indicate “DAW” – the drug will NOT be subject to prior
authorization, but will be subject to Tier-3 pricing for UMP recipients.
1. This “DAW” does not relate to generic substitution,
which is indicated by a signature on a two-line blank.
iv.
A UMP recipient
may request DAW, and pay the Tier-3 price, if the drug is covered.
b. Substitutions are to be made from within the same
therapeutic class.
c. Refills of certain types of drugs are not subject to
substitution
i.
Antipsychotics
ii.
Antidepressants
iii.
Chemotherapy
iv.
Antiretroviral
v.
Immunosuppressive
d. When a substitution is made, the pharmacist shall
notify the prescriber of the specific drug and dose dispensed (can be by FAX,
etc.)
5. A new paragraph is added at the end of RCW 69.41.150:
(3) A pharmacist who substitutes a preferred drug for a nonpreferred
drug pursuant to section 5 of this act assumes no greater liability for
substituting the preferred drug than would be incurred in filling a
prescription for the preferred drug when prescribed by name.
i.
May be refilled
X times. In this case, the pharmacist may refill the drug up to X times, in the
same quantity as the original.
ii.
May be refilled
through a certain date. In this case the pharmacist may refill the drug as
often as needed until the date shown.
iii.
May be refilled
“PRN.” In
iv.
Refills may be
authorized by the prescriber after the prescription is written, typically upon
a call from the pharmacist. The Board requires pharmacies to treat a refill
authorization occurring more than a year after the prescription is written as a
new prescription, with a new prescription number.
i.
Note that this
regulation applies to all legend drugs in
ii.
In determining
how many doses to give the patient, the pharmacist must estimate how soon the
prescriber will be available, and dispense enough to last until the prescriber
is available, but not more than a 72 hours’ supply.
iii.
The pharmacist,
when finally contacting the prescriber, does not need to obtain the
prescriber’s permission to have dispensed the emergency supply – the pharmacist
needs merely to inform the prescriber that the supply was given. However, the
prescriber must authorize any additional refills.
i.
For financial
reasons (including insurance coverage) the patient doesn’t want to purchase the
full amount. A prescription written for levothyroxine
100 mcg, #90, can be filled for any quantity less than 90, e.g., 30 tablets. It
may be refilled in quantities of 30 until a total of 90 have been dispensed.
ii.
When the patient
has not received the drug before and is unsure whether he or she will tolerate
it or if it will meet the patient’s needs.
iii.
When the
pharmacy does not have sufficient medication in stock.
1. Handling of out-of-stock creates problems when third
parties (especially government payors) are to be
billed for the drug. These parties do not want to pay for unused drug or drug
that is not delivered to patients. When partial fills have been made with the
expectation that patients will pick up the remainder, and the third party is
billed for the full amount due to transaction requirements, the third party
will feel defrauded if the patient forgets to pick up the drug. The
a. If possible, 3rd parties should not be billed
until the full quantity has been dispensed.
2. The pharmacy cannot legally reuse drugs that have
been sold to a patient, even if the patient “abandons” the drug by not
returning. Most states, including
3. If the pharmacy wants to deliver or mail the
remainder of the product to the patient, that may raise problems of making
drugs available to children or others without the knowledge of the patient that
the drug was to be mailed.
a. If possible, obtain the patient’s written permission
to mail the remainder of the drug to their home in the event that they have not
picked up the drug in a certain length of time.
iv.
It is a
long-standing standard of practice that the pharmacist may dispense more than
the amount specified in the prescription when refills have been allowed, and
the patient’s interests warrant it. For example, the physician prescribes Lipitor 10 mg, #30, and labels the prescription “Refill
PRN.” It is known and obvious that if the patient tolerates the initial
prescription, he or she will be continuing to take the drug chronically. If the
insurance allows a 90-day supply, the patient will want to obtain the drug in
the larger quantities on refills. Using good judgment, the pharmacist may
reasonably refill the Lipitor in quantities of 90,
without consulting the physician. If no refills were allowed, however, this
would not be possible. Generally, controlled substance prescriptions cannot be
refilled in larger amounts than specified on the original prescription.
1. Judgment is important. Just because a drug is not a
controlled substance does not justify refilling in larger quantities than
originally specified. For example, a patient with a history of attempted
suicide may be placed on tricyclic antidepressants in
quantities of 10 to 30 tablets per refill. Even if additional refills are
allowed, the pharmacist must be cognizant of the reality that dispensing 100
tablets at a single time provides the patient with the opportunity of taking a
fatal overdose.
i.
A prescription
written for prednisone 10 mg tablets #50, ½ tablet daily,
may be filled with prednisone 5 mg #100, provided the label directions
correctly specify one tablet instead of ½ tablet as the dose. The patient must
clearly understand what has been done, and it is a good practice to notify the
prescriber.
ii.
A prescription
written for levothyroxine 225 mcg cannot be dispensed
as such because no manufacture makes a 225-mcg tablet. The pharmacist may wish
to verify the dose to be sure an error was not made, but otherwise has the
choice of dispensing the prescription as follows:
1. Levothryoxine 113 mcg, with directions of 2 tablets per dose.
2. Levothyroxine 200 mcg, 1 tablet per dose, plus
Levothryoxine 25 mcg, 1 tablet per dose, as two
separate prescriptions.
In either situation,
it is advisable to notify the prescriber what was actually dispensed.
iii.
Tablet splitting
programs. Many insurers or third party payers encourage patients to split
tablets to achieve cost savings. For example, Lipitor®
20 mg tablets are available at DrugStore.Com (based on an internet search on
1/5/05) for $94.99 for 30 tablets, while the 10-mg tablets are $128.98 for 60,
or about 36% more expensive per mg. Many pharmacists consider a request by a
patient to adjust the dose on the prescription to be within the general
reasonable deviation from the prescription discussed here. Not all patients are
good candidates for tablet-splitting programs, however. Because the primary
interest served here is cost savings, not patient care issues, the pharmacist
should probably only proceed with tablet splitting programs only when based on
prior authorization from the prescriber.
·
It is important
that the prescriber’s records of what is dispensed are consistent with the
pharmacist’s actions to avoid confusion and possible overdose. Confusion over a
tablet splitting program led to a recent federal lawsuit when a patient
suffered rhabdomyolysis after he was instructed by a
nurse practitioner to increase his simvastatin dose
to “1 whole tablet.” The nurse practitioner believed he was inappropriately
taking only 20 mg per day, when in fact he was taking half of an 80-mg tablet
as part of a tablet splitting program.
i.
“Copies.” The
original of every prescription must be retained in the pharmacy. Sometimes
patients will request a “copy” of their prescription for informational
purposes. Such copies may be made, but must be clearly labeled as such. (WAC
246-869-100(e)).
1. Prescriptions may be photocopied and provided to the
patient or others to whom the patient has authorized, stamped with “COPY”.
2. Pharmacists may hand copy the prescription on the
pharmacy’s prescription form, indicating a COPY.
a. It was the practice of pharmacists in past years to
include pricing information on the prescription, often in coded fashion. One
popular code was called the NARD Code, developed by the National Association of
Retail Druggists, now known as NCPA. This code used the word “PHARMOCIST’ where
each letter represented the digits, 1-2-3-4-5-6-7-8-9-0, respectively. The
letters NA preceded the code and it was followed by RD. For example,
“NA-PHM-RD” would indicate a price of $1.25. This practice is uncommon now, in
part because of challenges to its use as a means of price fixing among
competitors.
3. These copies are not valid for filling, so the
pharmacist receiving such a copy must contact the prescriber and obtain a new
oral prescription.
ii.
Pharmacies are
allowed under WAC 246-869-090 to transfer prescriptions, along with available
refills, to another pharmacy. It is important for the pharmacist or intern
involved in the process to follow the steps listed in the regulation. In
1. The originating pharmacist (“transferor
pharmacist”) must perform the following steps:
a. Record that the prescription has been transferred in
the medication record system.
b. Record in the medication record system the
i.
Name and address
of the pharmacy to which it has been transferred
ii.
The name of the
pharmacist (or intern) that received the information.
1. Note: a person’s “name” for the purposes of drug and
practice laws is the full name that the person normally would use to conduct
business. Thus, simply recording the first name of the other pharmacist is not
appropriate.
c. In addition, for controlled substances (schedule III,
IV, and V), the originating pharmacist must follow the procedures specified in 21
CFR § 1306.25,* which include the following:
i.
Locate the
original hard copy of the transferred prescription.
ii.
Write the word
“VOID” on the face of the prescription
iii.
Record the name,
address, and DEA number of the pharmacy receiving the information on the
reverse of the original prescription, along with the name of the pharmacist
receiving the information.
*Note: in the July 2003 version of WAC 246-869-090 (2)(e), the citation to the CFR incorrectly indicates “21 CFR
1300.26” instead of “21 CFR 1300.25”.
2. The receiving pharmacist treats the
prescription as an oral prescription, and must perform the following steps:
a. Reduce the prescription to writing on a prescription
blank, including patient name, address, doctor’s name and address, and other
information required to be on the prescription.
b. Write the word “TRANSFER” on the face of the
prescription.
c. Also record the following:
i.
The date the
prescription was originally written (cannot be refilled for a year after that.)
1. When processing a transferred prescription, it is important
to override the current date in the computer, and record the original date
written
ii.
Number of
refills remaining
iii.
Date of last
refill
iv.
The name and
address of the transferring pharmacy, and the serial number of the original
prescription at that pharmacy
v.
The name of the
transferring (transferor) pharmacist.
d. For controlled substances, the receiving pharmacist
must also record the following:
i.
Number of
original refills allowed on the prescription
ii.
Dates (and
locations) of all previous refills
iii.
Number of valid refills
remaining
iv.
DEA number of
transferring pharmacy
v.
Name, address,
serial number and DEA number of pharmacy at which prescription was originally
filled (if different from transferring pharmacy).
3. Legend drugs may be transferred, and re-transferred
as often as needed until all refills are used. If a patient has had a
prescription transferred to another pharmacy, and now wants to have it refilled
at the original pharmacy, the original pharmacy must contact the other pharmacy
and receive the prescription back as a transferred prescription. At this point,
it should be given a new prescription number.
4. According to DEA rules, controlled substances may be
transferred on a “one-time” basis, unless the transferring pharmacies share a
common electronic database.
5. Pharmacies with a common electronic database may
track refills for non-controlled substances at any outlet in this common
database, without going through the prescription transfer process. Many chains
(e.g., Rite-Aid and Walgreens) have these databases.
i.
All
prescriptions for ORAL dosage forms of legend drugs in WA must be dispensed in CRCs, except for drug products exempted by the CPSC.
Exempted products are listed in 16 CFR § 1700.14, and include:
1. Nitroglycerine sublingual tablets
2. Sublingual and chewable isosorbide
tablets £ 10 mg
3. NaF £
110 mg per package (tablets and liquids, must be £ 0.5% elemental fluoride w/w or w/v)
a. Exercise: how many tablets of Chewable Vitamins with Flouride containing 0.5 mg of fluoride ion per tablet may
be dispensed in a non-CRC? (Hint: 1 mg F- is contained in 2.21 mg of
NaF.)
4. Cholestyramine and colestipol powder
5. Oral cortisteroids
a. Prednisone containing £ 105 mg per package
b. Betamethasone containing £ 12.6 mg per package
c. Methylprednisolone containing £ 84 mg per package
6. Mebendazole £
600 mg per package
7. K+ supplements £ 50 mEq/dose in unit dose
packaging
8. Erythromycin ethylsuccinate,
measured as erythromycin equivalent
a. Granules for suspension and suspensions containing £ 8 g
b. Tablets containing £ 16 g per package
9. Aerosols for inhalation
10. Pancrelipase
11. Hormone products
a. Oral contraceptives in memory aid packages
b. Medroxyprogesterone acetate tablets
c. Conjugated estrogens in mnemonic packages containing £ 32 mg per package
d. Norethindrone acetate in mnemonic packages containing £ 50 mg per package
e. Hormone Replacement Therapy Products relying solely
on one or more estrogens or progestogens for
activity.
12. Sacrosidase (sucrase) in glycerol and
water.
ii.
Pharmacists may
dispense legend drugs in non-CRCs if:
1. The patient or the patient’s agent requests. Such a
request may be a “blanket” request that all drugs dispensed to the patient be
in non-CRCs.
2. The prescriber requests it on the prescription at the
time it is written. Prescribers may not issue
“blanket” requests, either for all drugs dispensed to a particular patient, or
for all of his or her patients.
iii.
Under federal
law, requests for non-CRC containers may be oral or in writing.
1. In writing, by the patient or the patient’s agent, or
in writing by the prescriber; and
2. An indication that a non-CRC has been requested must
be made in the patient medication record system.
The date of the request should be included in the documentation kept in the
pharmacy. At various times, Washington Board of Pharmacy investigators have
insisted that such requests be renewed after some “reasonable” length of time,
such a one year. This is a good practice, but it is NOT required by current
iv.
Legal liability
for use of non-CRCs.
If a pharmacist dispenses a covered drug in a non-CRC, and a child is injured
as a result of gaining access to the drug, the child, his or her guardian, or the
child’s estate (in case the child dies), may file a lawsuit against the
pharmacist for damages. In an Iowa case (Baas v. Hoye, 766 F.2d 1190), the pharmacist was found liable
for the death of a child who ingested Tedral SA (containing
theophylline) prescribed for her father that was
dispensed in a non-CRC. The pharmacy
argued that the father had requested a non-CRC on the prescription, but didn’t
have a written record to substantiate this, and the parents claimed otherwise.
Normally, being able to document that the parent or guardian of the child
authorized the use of the non-CRC will serve as a defense against liability.
However, most childhood poisonings from legend drugs now occur as a result of
children obtaining access to grandparents’ drugs. Because grandparents are not
normally the legal guardians of their grandchildren, their request for non-CRCs may not provide an adequate defense. Pharmacists
should consider including statements covering the following elements in the form
used by patients to request a non-CRC.
1. CRCs are required by law unless specifically requested
otherwise by the patient.
2. The purpose of these regulations is to prevent
childhood poisoning from prescription drugs.
3. As few as one or two tablets of some drugs may be
fatal to young children.
4. The number one source of childhood poisoning by
prescription drugs is non-CRC containers stored at a grandparent’s house or in
a grandparent’s purse or bag.
5. Over 90% of elderly persons can successfully open
non-CRCs if shown how. The pharmacy is willing to
provide demonstrations and instructions to the patient on how to open a CRC.
There are alternative CRCs that can be used by
patients with arthritis or lack of hand strength, and the pharmacy is willing
to obtain and provide these at cost to the patient.
6. The patient agrees that it is his or her
responsibility to keep medications out of children’s reach, especially when
using a non-CRC container.
7. Having read and understood the above, the patient
nevertheless requests that non-CRCs be used on his or
her prescription, and agrees to indemnify and hold harmless the pharmacy for
any injuries that might occur to a child as a result of the patient’s request
to use non-CRCs.
i.
Wholesaler level
ii.
Retail level
iii.
Consumer level
i.
Class I – there
likelihood of injury or death from the use of the product; may include a public
warning
ii.
Class II –
health problems, if any, are expected to be temporary or reversible
iii.
Class III – use
of the product is NOT likely to cause health problems
iv.
Market
withdrawal – minor health risk or minor FDA violation
(a) To determine
whether or not a solid waste is designated as a dangerous waste a person must:
(i) First, determine if the
waste is a listed discarded chemical product, WAC 173-303-081;
(ii) Second, determine if the waste is a listed
dangerous waste source, WAC 173-303-082;
(iii) Third, if the waste is not listed in WAC 173-303-081
or 173-303-082,
or for the purposes of compliance with the federal land disposal restrictions
as adopted by reference in WAC 173-303-140,
determine if the waste exhibits any dangerous waste characteristics, WAC 173-303-090;
and
(iv) Fourth, if the waste is not listed in WAC 173-303-081
or 173-303-082,
and does not exhibit a characteristic in WAC 173-303-090,
determine if the waste meets any dangerous waste criteria, WAC 173-303-100.
(b) A person must check each section, in the order set
forth, until they determine whether the waste is designated as a dangerous
waste. Once the waste is determined to be a dangerous waste, further
designation is not required except as required by subsection (4) or (5) of this
section. If a person has checked the waste against each section and the waste
is not designated, then the waste is not subject to the requirements of chapter
173-303
WAC.
Any person who wishes to seek an exemption for a waste
which has been designated DW or EHW must comply with the requirements of WAC 173-303-072
(nn)
(i) Controlled substances, legend drugs, and
over-the-counter drugs that are state-only dangerous wastes.
·
(A) Controlled substances as defined and regulated by chapter
69.50 RCW (Schedule I through V);
·
(B) Legend drugs as defined and regulated by chapter 69.41 RCW;
and
·
(C) Over-the-counter drugs as defined and regulated by chapter
69.60 RCW.
(ii) Controlled substances, legend drugs, and
over-the-counter drugs that are held in the custody of law enforcement agencies
or possessed by any licensee as defined and regulated by chapter 69.50 RCW or
Title 18 RCW and authorized to possess drugs within the state of Washington are
excluded, provided the drugs are disposed of by incineration in a controlled
combustion unit with a heat input rate greater than 250 million British thermal
units/hour, a combustion zone temperature greater than 1500 degrees Fahrenheit,
or a facility permitted to incinerate municipal solid waste.
(iii) For the purposes of this exclusion the
term "drugs" means:
·
(A) Articles recognized in the official
·
(B) Substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other animals; or
·
(C) Substances (other than food) intended to affect the structure
or any function of the body of man or other animals, as defined in RCW
18.64.011(3). (Note: RCW 18.64.011 (3)(d) is
intentionally not included in the definition of drugs for this exclusion.)
(iv) When possessed by any
licensee the term drugs used in this exclusion means finished drug products.
i.
These
regulations exclude only “state-only” hazardous substances. Some drugs are
classified under federal law as hazardous waste and the state cannot exempt
these drugs from federal requirements. Chemotherapy wastes are federally
designated, as are flammable or corrosive substances. Lindane
is also federally designated. Bulk chemicals used for compounding are not
included in the exclusions. The Department of Ecology has given the following
examples of pharmaceuticals and how they would be handled:
Some examples of
pharmaceuticals that designate as hazardous waste
Epinephrine is on the list of sole active ingredients as a P listed
waste. Epinephrine would designate as a dangerous waste under the federal
portion of the law. This waste is not eligible for management under the
conditional exclusion.
Some wart removal medications are ignitable. This waste is a dangerous
waste under the federal portion of the law and is not eligible for management
under the conditional exclusion.
Mercurochrome has enough mercury in it to be characteristic waste under
the federal portion of the law. This waste is not eligible for management under
the conditional exclusion.
Extra strength aspirin fails the
ii.
Hospitals may
operate approved incinerators, and hospital pharmacists may be able to use
these facilities.
iii.
Community
pharmacists are increasingly relying on “reverse distributors” to handle
returns and disposal of outdated drugs. The Board has advised pharmacists to
make sure that they obtain confirmation from their “reverse distributor” that
it will dispose of drugs in accordance with WA law, since the person who
“arranges” for the disposal of hazardous waste is ultimately responsible if the
waste is not disposed of properly.
1/5/05