Objectives: To create a heightened awareness of the issues confronting
pharmacists in the self-care arena. To educate pharmacists about newly introduced
nonprescription products, devices, and diagnostic products. Data Sources: Recently published governmental, clinical, and
pharmaceutical industry literature. Data Synthesis: Several developments during the previous year
have important implications for patient self-care. The Food and Drug Administration
recommended the withdrawal of phenylpropanolamine from the market and denied proposals
to switch lovastatin, pravastatin, and omeprazole to nonprescription status. Widespread
use of dietary supplements in the face of insufficient data on their safety and
efficacy continued to be a problem in 2000, although there were several encouraging
developments. In 2000, new over-the-counter products were introduced for, among
other purposes, treating acid-peptic disorders, musculoskeletal injuries, dermatologic
disorders, and minor wounds. Numerous nonprescription products, including sophisticated
home diagnostic products and accessories, continue to become available on the
U.S. market. It is important that the pharmacist become as knowledgeable as possible
about these products so he or she can educate patients about their appropriate
use. Conclusion: Patients will continue to place an increasing emphasis
on self-care. To assist them, pharmacists must remain up to date on trends and
have a balanced understanding of new products. The new nonprescription medications
and diagnostic products discussed in this review article represent valuable additions
to the growing array of self-care products.
Consistent with previous installments in this series of annual reviews of new
over-the-counter (OTC) products, the first section of this article highlights
the developments or issues arising over the past year that we view as the most
significant to patient self-care. The second section describes the OTC medications,
diagnostic products, and accessories introduced during the past year that we believe
will generate the most questions from, or pose potential problems for, patients.
Self-Care Products:Major Regulatory Actions in 2000
In October 2000 the Nonprescription Drugs Advisory Committee (NDAC) of the Food
and Drug Administration (FDA) met to discuss the safety of phenylpropanolamine
(PPA), which has been used in nonprescription weight loss and cough-and-cold products.
After reviewing the results of a study by Kernan et al.,
which would not be published in the New England Journal of Medicine until
December 21, the committee agreed with the researchers that there was an association
between ingestion of PPA and hemorrhagic stroke in women. Kernan et al. determined that, among women using PPA-containing
products for weight control and nasal decongestion, risk of hemorrhagic stroke
increased within 3 days after starting the medication. Men may also be at risk.
Hence NDAC recommended that PPA be withdrawn from the market. In November 2000
FDA took the first steps toward the removal of PPA from all drug products by asking
manufacturers to voluntarily discontinue marketing products that contain it as
an active ingredient. Even though the risk of hemorrhagic stroke is very low with
PPA use, FDA ruled that the conditions for which these products were used were
not serious enough to warrant this increased risk.
Since the FDA announcement, pharmacies have been removing PPA-containing products
from their shelves. Manufacturers are now working with FDA to remove PPA from
OTC products. It appears that pseudoephedrine will be reformulated into nasal
decongestant products that formerly contained PPA. There is no FDA-approved alternative
chemical entity to PPA for weight control. However, one can envision unscrupulous
advertisers extolling the (thus far unproved) merits of using ephedrine (e.g.,
ephedra, ma huang) as an alternative and further endangering the public. Therefore,
the situation provides an opportunity for pharmacists to educate patients about
PPA and provide guidance on selecting alternative cough-and-cold products and
avoiding unapproved OTC weight loss products. No doubt, patients will have questions
about this action ("Why was such a drug left on the market for so long if there
was a danger?" "Can I continue to use what I have at home?"), and pharmacists
must be knowledgeable enough to provide thorough and accurate answers.
Pharmacists should advise patients to look for "phenylpropanolamine" in the listing
of active ingredients on the labels of any previously purchased OTC products.
If the product contains the drug, it should be discarded. If the consumer is unsure,
he or she should be advised to bring the product to the pharmacist for verification.
Patients using a prescription nasal decongestant or cough-and-cold product should
be encouraged to contact the pharmacist to determine whether it contains PPA.
If it does, the patient should work with his or her physician and pharmacist to
find a suitable therapeutic alternative.
In July 2000 NDAC, along with FDA's Endocrinologic and Metabolic Drugs Advisory
Committee, concluded that there was insufficient evidence that the cholesterol-lowering
drugs lovastatin (Mevacor -- Merck) and pravastatin (Pravachol -- Bristol-Myers
Squibb) could be used safely and effectively on a nonprescription basis.
Merck and Bristol-Myers Squibb proposed their respective drugs for nonprescription
use by persons with a total cholesterol level of 200 mg/dL to 240 mg/dL and a
low-density lipoprotein (LDL) value > 130 mg/dL. As the basis for its proposal,
Merck cited the increasingly widespread availability of cholesterol testing, which
makes consumer self-medication for lowering cholesterol feasible. The company
announced that it planned to support the drug's switch to nonprescription status
with an extensive consumer education program. Bristol-Myers Squibb proposed the
nonprescription use of Pravachol by patients who have been instructed by their
physician to lower their cholesterol levels but are not taking a prescribed cholesterol-lowering
The advisory committees unanimously agreed that both drugs demonstrated effectiveness
in lowering LDL cholesterol levels. However, they questioned whether the labeling
in the manufacturer's proposals was sufficiently clear that consumers could understand
when the products were appropriate for self-care. The committees recommended additional
studies to support approval of these drugs for nonprescription status. They also
recommended that Bristol-Myers Squibb support its switch application with additional
label comprehension studies and a better definition of the target population for
During a joint meeting in October 2000 the FDA's NDAC and Gastrointestinal Drugs
Advisory Committees decided that the proposed labeling for Prilosec 1 (the OTC
version of omeprazole) was not sufficient to convey the benefits and long-term
risks of the drug; therefore, they declined to grant it OTC status. The committees
were equally divided as to whether gastroesophageal reflux disease and chronic
heartburn are appropriate for OTC treatment.
Dietary supplements are becoming more numerous in the marketplace and the "structure
and function" claims made for them are increasing and becoming more complex. For
example, 100% Bovine Colostrum (i.e., IGF-1 [insulin-like growth factor]) is being
touted by one Internet company (Sam's General Store) as a substance "that contains
an amazing complex of immunoglobulins, growth factors, antimicrobial proteins,
and carbohydrates, and is beneficial for adults as well as infants." One must
wonder how the 500 mg capsules of this product would be orally administered to
Consumers' use of dietary supplements as part of their self-care regimen for health
maintenance is well documented in the professional and consumer literature. Unfortunately,
this use is often unsupported by reliable data, because the information source
is typically a friend or family member or a questionable site on the Internet.
In addition, consumers are frequently reticent to inform their health care providers
about the dietary supplements they are taking. There are several reasons for this,
including the desire for privacy and the belief that their physician or pharmacist
might chastise them for using dietary supplements. Pharmacists must be aware that
patients often fail to volunteer this information. When taking a medication history
or attempting to answer a self-care inquiry, pharmacists must specifically ask
about use of dietary supplements and alternative therapies.
In March 2000 the director of California's Department of Health released a statement
urging consumers to immediately stop using five specific herbal products: Diabetes
Hypoglucose Capsules, Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel
Pearly Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Hypoglycemic Capsules,
and Zhen Qi Capsules. The manufacturers claimed these products contained only
natural Chinese herbal ingredients for the treatment of diabetes. However, analysis
revealed that they contain two prescription drugs (glyburide and phenformin).
The state's investigation was launched in response to a report that a patient
with diabetes suffered several episodes of low blood sugar after taking one of
the aforementioned products. Several articles in the scientific/professional
literature have documented adverse interactions between herbal products and prescribed
The potential for these hazards underscores the importance of pharmacists educating
patients about herbal products and monitoring their use of these products. Pharmacists
must listen to patients' concerns and encourage them to discuss any problems encountered
with dietary supplements. In their discussions with patients, pharmacists must
also identify any drug-drug interactions they suspect might have occurred. To
this end, it is essential that pharmacists also take time to report suspected
adverse drug reactions from these medications to the Special Nutritionals Adverse
Event Monitoring System (SN/AEMS) (http://vm. cfsan.fda.gov/~dms/aems.html).
In July 2000 the General Accounting Office (GAO) concluded in a report that FDA
regulations and federal law provide limited assurances on the safety of functional
foods and dietary supplements. GAO cited as
areas of concern a lack of defined safety standards, inadequate labeling, and
a lack of FDA oversight. Furthermore, the report criticized FDA for not providing
sufficient guidance to industry on the evidence needed to support safety and/or
label claims and for not taking action against companies making questionable claims.
Among other recommendations, GAO asked the agency to establish clear time frames
for addressing these issues.
Because many herbal drugs, for example, are not eligible for patent protection,
pharmaceutical manufacturers have little, if any, incentive to perform or support
research leading to a New Drug Application (NDA). Manufacturers' incentive to
support research is further reduced because ingredients fall under the purview
of the 1994 Dietary Supplement Health and Education Act (DSHEA) rather than under
the more stringent Food and Drugs Act. The federal government is funding research
on dietary supplements through grants and projects administered by the National
Institutes of Health National Center for Complementary and Alternative Medicine
(NCCAM) and carried out by university medical centers. This program is the government's
opening salvo in an attempt to answer persistent questions about dietary supplements
and their value in disease treatment and health maintenance.
As one example of this government-funded research, NIH has allocated $6.6 million
for a nine-center trial on dietary supplements containing glucosamine and chondroitin
and such products' role in relieving the pain of osteoarthritis. Approximately
1,000 patients with osteoarthritis will be enrolled in the study.
Another example is the creation by NCCAM of two Centers for Dietary Supplement
Research that will focus on the health effects of botanicals. The first center
will study the health effects of polyphenols from nutritional sources (e.g., grapes,
soy, green tea). This research is clinically relevant to heart disease, cancer,
osteoporosis, and cognitive decline. The second center will identify the active
constituents of ginger, tumeric, and Boswellia, all herbs used in Native American
medicine for the treatment of inflammatory disease.
The White House Commission on Complementary and Alternative Medicine Policy was
created in March 2000. This 20-member panel will focus on the following items:
(1) education and training of health care providers in complementary and alternative
medicine; (2) coordination of research to increase knowledge about complementary
and alternative medicine; (3) provision to health care providers of reliable and
useful information that can be readily accessible and understandable to the general
public; and (4) guidance on appropriate access to and delivery of complementary
and alternative medicine. The commission is expected to release its findings in
late 2001 or early 2002.
In another encouraging development, in March 2000 the Consumer Healthcare Products
Association (CHPA) adopted a voluntary labeling program for dietary supplements.
The program specifies when manufacturers must include the following statement
on supplement product labels: "If you are pregnant or nursing a baby, ask a health
professional" [before using this product]. Subsequently, CHPA also announced that member companies
agreed to use the following statement when marketing products containing St. John's
wort: "If you are taking a prescription medicine, ask a health professional."
Again, however, the question arises as to whether the consumer will read the label
warnings and take appropriate action.
New OTC Drugs and Devices -- 2000
The following new product reviews were developed in the spirit of professional
obligation. The authors are hopeful that the information will assist pharmacists
in their interactions and consultations with patients. For each product covered,
the Discussion subsection provides background and context, while the Patient Information/Instructions
subsection highlights information that the pharmacist should share with the patient
in the course of counseling.
Pepcid Complete (Johnson & Johnson/Merck Consumer Pharmaceuticals) Active Ingredients: Famotidine 10 mg, calcium carbonate 800 mg,
magnesium hydroxide 165 mg Indication: Relief of heartburn associated with acid indigestion
and sour stomach Availability: Packages of 5, 15, 25, and 50 chewable tablets Discussion: An estimated 7% of Americans suffer daily episodes
of heartburn, and as many as 50% suffer occasional occurrences of heartburn symptoms. The variety of nonprescription products available
for the relief of minor gastric distress fall into two therapeutic categories:
antacids and histamine H2 receptor antagonists
(H2RAs). Antacids relieve symptoms by neutralizing gastric acid, resulting in
a decrease in gastric pH. Their advantage is that patients often realize relief
within minutes of ingestion. Their disadvantage is that, to provide sustained
relief, most antacid products must be ingested multiple times throughout the day.
In contrast, H2RAs competitively and reversibly block histamine at the H2
receptors in parietal cells. This results in an overall decrease in gastric acid
secretion and relief of gastric symptoms. Although they have a slower onset of
action than antacids, some products containing H2RAs can provide sustained relief
for up to 12 hours.
In this context, it is not surprising that the immediate and sustained relief
of heartburn often requires a combination of an antacid and an H2RA. Pepcid Complete
is the first combination product formulated with calcium carbonate and magnesium
hydroxide for rapid alleviation of heartburn and famotidine for sustained relief
The product should not be used in conjunction with other famotidine products
or acid reducers.
Patients 12 years of age and older should use one tablet up to twice daily,
chewing thoroughly before swallowing.
Patients who are allergic to famotidine or other acid reducers, or who have
trouble swallowing, should not use Pepcid Complete.
Discontinue use of the product if stomach pain persists beyond 14 days.
Musculoskeletal Injuries and Disorders/Topical Analgesic (Thermotherapy Device)
ThermaCare (Procter & Gamble) Active Ingredients: Iron, charcoal, sodium chloride, water Indication: Topical pain relief Availability: Menstrual cramp relief wraps (three per box); back
pain relief wraps (two per box; small-medium or large-extra large sizes) Discussion: Menstrual cramping is thought to be caused by prostaglandin
from sloughed uterine lining, which induces uterine contractions. It is severe
in 23% of high-school-aged girls.[14 ]Also, sore muscles and back pain are extremely
common in our increasingly sedentary society.
Local heat has long been known to be effective for dysmenorrhea when applied to
the lower abdomen or for pain when applied to the back or other sore muscles.
Unfortunately, the most widely used methods of delivering thermotherapy have significant
problems: Heating pads require an electrical source and are therefore not portable;
hot water bottles deliver inconsistent and rapidly diminishing heat. Until now,
it has been difficult to treat these discomforts with a consistent and reliable
source of heat while at work, during recreation, or when traveling.
ThermaCare, a wearable thermotherapy device, is a wrap containing circular heat
discs. When the wrap's pouch is opened, room air begins to oxidize the iron, which
is an exothermic reaction. Within about 30
minutes, the wrap reaches its maximum temperature. The oxidation reaction produces
a low-level and consistent heat for 8 hours.
This product should not be used by patients with diabetes, young children,
individuals who are insensitive to heat, or anyone who cannot remove the product
by him- or herself.
Patients with poor circulation or patients who want to place heat on the
abdomen when pregnant should check with a physician before using the product.
After opening the pouch, immediately position the wrap on the body as directed
or wait for it to reach its full temperature.
If the material covering any of the heat discs is torn, discard the entire
Place the side of the wrap with the darker heat discs next to the skin.
If the wrap still seems too cool after 30 minutes, remove it, fold it up
for a few minutes, and reapply.
ThermaCare should be worn for at least 3 hours to obtain therapeutic benefit.
It may be worn during normal activities (e.g., exercise, sports, family outings,
manual labor); while sitting or standing for long periods (e.g., while traveling
by plane or car); or while performing seasonal activities such as gardening
or shoveling snow.
Do not use the product for more than 8 hours in a day or more than 7 consecutive
days (4 days for menstrual cramping). If still experiencing discomfort, consult
Check the skin periodically if it is sensitive to heat, if heat tolerance
is reduced, if lying or leaning back against ThermaCare, or if wearing a tight-fitting
belt or waistband over the wrap.
Do not use ThermaCare on areas of the body that are insensitive to heat.
Never use ThermaCare in conjunction with medicated creams, ointments, gels,
or liniments, on damaged or broken skin, or on any area where bruising or
swelling has occurred within the last 48 hours.
Abreva (Glaxo SmithKline) Active Ingredient: Docosanol 10% Indication: Treatment of recurrent oral-facial herpes simplex
in adults Availability: Cream in 2 gram tubes Discussion: Cold sores or fever blisters are painful, recurrent
lesions that occur most often on or near the lips. They are caused by herpes simplex
virus type 1 (HSV-1). After the virus enters the body (i.e., primary herpes infection),
it migrates to the sensory nerve ganglia. It remains there for the lifetime of
the individual and may trigger lesions at any time (i.e., recurrent infection).
Approximately 90% of the United States population is infected with HSV-1. Most
primary infections occur during childhood. Some patients develop immunity after
the primary infection, but 20% to 45% experience recurrent infections. Primary
triggers for recurrences include ultraviolet radiation, stress, fatigue, chills,
windburn, infectious diseases, fever, and trauma secondary to injury or dental
work. Regardless of the trigger, cold sores are self-limiting and heal within
10 to 14 days.
Until recently, nonprescription products available for the treatment of cold sores
only relieved symptoms. These products contain external analgesics, anesthetics,
and protectants, alone and in combination, to alleviate the pain, itching, burning,
and cracking associated with cold sore lesions.
Abreva is the first topical antiviral for the treatment of cold sores to be approved
for nonprescription sale. Its approval was due, in part, to its unique mechanism
of action, which minimizes the likelihood of viral resistance. Unlike its prescription
counterparts, Abreva prevents viral particle fusion with host cell membranes and
has no direct viricidal activity. In contrast, prescription products such as acyclovir
and penciclovir treat cold sores by inhibiting DNA synthesis of HSV-1, thereby
preventing viral replication. Because these products have been associated with
viral resistance, their approval for nonprescription use is unlikely.
Patients with known hypersensitivity to any product ingredient should not
Pregnant women should consult a physician before using Abreva.
Apply the product at the first sign of a fever blister or cold sore, then
five times daily until the lesion is healed.
Use Abreva only to treat lesions on the lips and face.
Do not apply Abreva near the eyes, as it may cause irritation.
Lamisil AT (Novartis Consumer Health, Inc.) Active Ingredient: Terbinafine hydrochloride 1% Indications: Tinea pedis, tinea cruris, tinea corporis Availability: Cream (12 grams or 24 grams), solution (30 mL),
spray pump (30 mL) Discussion: Superficial fungal infections are among the most
common skin infections for which pharmacist advice is solicited. Dermatophytic
conditions affect about 10% to 20% of people in the United States at any given
time. The most common are tinea pedis (athlete's foot), which occurs in up to
70% of adults, tinea cruris (jock itch), and tinea corporis (ringworm).
Patients may contract the fungus by coming into contact with an infected human
(anthrophilic spread), a diseased animal (zoophilic spread), or soil (geophilic
One drawback of existing antifungal treatments is the time required for a complete
course of therapy: 4 weeks for tinea pedis and corporis and 2 weeks for tinea
cruris. Most patients simply treat until the skin looks or feels better, and discontinue
the product prematurely, which leads to recurrences.
Lamisil AT shortens the time to a complete cure and may lessen the number of recurrences.
Lamisil AT contains terbinafine 1%, which can cure tinea cruris, tinea corporis,
and some cases of tinea pedis between the toes in 1 week. The cream also cures athlete's foot on the soles
of the feet in 2 weeks.
Parents should consult a physician before allowing children under the age
of 12 years to use the product.
Lamisil AT relieves the itching, burning, cracking, and scaling associated
with athlete's foot, jock itch, and ringworm.
Do not use Lamisil AT to treat vaginal yeast infections or infections in
or near the eye.
Infections of the scalp or nails require prescription therapy in all cases.
Wash the skin with soap and water and dry thoroughly before applying the
If athlete's foot is on the soles or bottom of the foot, use the cream,
not the dropper or spray.
Apply the product once in the morning and once at night.
Wash the hands after applying the cream.
Do not cover treated skin with a bandage.
When treating athlete's foot, wear shoes that fit comfortably and allow
the foot to "breathe."
Change shoes and socks at least once daily.
If the product causes additional irritation or if the condition worsens,
stop using Lamisil AT and contact a physician.
If Lamisil AT accidentally contacts the eyes, rinse them thoroughly with
Minor Wounds and Skin Infections
Wound Wash Saline (Blairex Laboratories, Inc.) Active Ingredients: Sterile sodium chloride solution 0.9% Purpose: Cleansing of minor wounds Availability: 90 mL and 210 mL aerosol cans Discussion: Most minor wounds, such as paper cuts and small punctures
(splinters), are relatively clean. However, a child who falls down while running
may suffer an abrasion wound that is contaminated with gravel, grass, dirt, and
other foreign substances. Material in the wound and the fresh bleeding hinder
visibility, to the frustration of a parent trying to gauge the nature and extent
of the injury. Yet, dressing the wound without first cleansing it can allow the
foreign material to granulate into the healing tissues.
Tap water is often used to clean the wound, but it is not isotonic. Furthermore,
because of variations in the effectiveness of sanitation systems, any particular
township may not produce tap water that is ideal for cleansing. For these reasons,
patients may benefit from use of Wound Wash Saline. This product is a sterile
0.9% sodium chloride packaged in an aerosol can. The nature of aerosol packaging
prevents contamination of the contents of the isotonic, sterile fluid in the can.
Hospitals often use sterile saline in plastic bottles for irrigation of wounds.
These containers are costly, because they must be discarded 24 hours after first
being opened to prevent accumulation of undue levels of bacteria inside them.
An advantage of Wound Wash Saline is that it may be used at any time throughout
its 2-year shelf life.
If the wound is deep or if it was caused by a puncture or an animal bite,
seek care from a physician.
Expel a short stream of Wound Wash Saline fluid to clear the nozzle.
Aim the nozzle at the wound and press. The distance may be adjusted to effect
full cleansing. The can may be held in any position during use, as it is effective
over a 360o area of movement.
The manufacturer's instructions specify that each can is to be used on a
single patient only.
First Aid Hurt-Free Tape (Johnson & Johnson) Active Ingredient: Hypoallergenic, latex-free tape Purpose: Secure bandages and dressings to wounds Availability: Package of 5 yards of tape in 1- or 2-inch widths Discussion: Most minor wounds need not be dressed by a health
care provider. Dressing a wound serves several purposes.
An absorbent dressing will wick exudate and any contaminated wound fluids away
from the wound and help protect healthy surrounding tissue from further maceration
or contamination. The dressing also protects the wound from environmental filth,
bacteria, fungi, and other potential contaminants and helps prevent further damage
from brushing or scraping the healing tissues against surfaces. The dressing can
also accelerate healing by retaining a small amount of healthy moisture in the
Some dressings have their own adhesive, but others require a separate tape to
secure them to the wound site. Tape has two
components: backing and adhesive. The adhesives can cause problems. Patients may
develop an allergy to them, and they may tear or damage the skin when they are
Hypoallergenic and latex-free, Hurt-Free Tape prevents these problems. It is less
irritating to the skin than comparable products and leaves no sticky residue.
It will not stick to skin or hair, and will not tear the skin upon removal.
Use the 1-inch-wide tape for smaller body parts, such as the hands and feet,
and on children or adults with small builds. Use the 2-inch tape on the arms
Place an appropriate dressing over the wound, then wrap Hurt-Free Tape over
the dressing, overlapping layers of tape and wrapping it around the area several
times until the dressing is fully secured.
Do not wrap the tape so tightly that circulation to the area is hampered.
Band-Aid Advanced Healing (Johnson & Johnson) Active Ingredient: Hydrocolloid bandage Purpose: Primary dressing for minor skin wounds Availability: Boxes of 10 regular-sized or 6 large-sized strips Discussion: A scab is a temporary wound barrier consisting of
a mixture of fibrin, blood products, necrotic cells, and exposed cells. Although
the scab serves as a barrier, it also delays the process of wound healing. As
healing commences, the scab separates the edges of the wound; thus, healing can
only start at the bottom and periphery of the scab. Epithelial cells must form
healthy granulation tissue by detouring around and under the scab. Eventually,
the scab is loosened by epidermal-cell-derived proteases.
It was long thought that minor wounds healed better if the scab was left intact,
but this is a misconception. It is now understood
that prevention of scab formation is preferable, because all surfaces of the wound
are actively involved in the healing process. The best way to prevent scabs from
forming is by early application of a dressing that allows the minor wound to remain
moist. Some dressings are designed to wick
fluid away from wounds, but most minor wounds do not produce sufficient exudate
for active wicking. Wounds heal more rapidly when moisture level is controlled;
yet most minor wound dressings are not designed to actively retain moisture to
Band-Aid Advanced Healing is composed of a hydrocolloid that has been used in
hospitals for decades. Unlike other bandages, Band-Aid Advanced Healing does not
have a small absorbent pad in the middle. Rather, the entire strip is composed
of hypoallergenic polymer and is active in healing.
The new product meets the need for moisture retention. The translucent bandage
seals the wound completely, preventing contact with environmental filth, bacteria,
and external moisture. The body's natural healing fluids are sealed in, but the
bandage also absorbs excess fluid and allows it to evaporate.
Position the strip over the wound and leave it in place for several days.
As the strip absorbs moisture, a white gel is formed that allows the wearer
to see the healing area.
The bandage may be worn while bathing or showering.
Ophthalmic Disorder/Dry Eye
GenTeal Lubricant Eye Gel (Ciba Vision) Active Ingredients: Hydroxypropyl methylcellulose 0.3%, carbopol
980, phosphonic acid, purified water, sorbitol, sodium perborate Indication: Dry eye Availability: 10 mL tubes Discussion: There are many causes of dry eye, but the most common
is partial or absolute tear deficiency, often caused by lacrimal gland occlusion.
Dry air, medications (e.g., antihistamines, anticholinergics), and contact lenses
may also cause dry eye. Dry eye may also be a symptom of a serious medical condition
such as Sjögren's syndrome or keratoconjunctivitis sicca.
Dry eye treatments have come in several dosage forms, each with its own drawbacks.
Multidose bottles may contain allergenic or irritating preservatives. Preservative-free
dry eye products packaged in unit-of-use containers are expensive. Ophthalmic
dry eye ointments containing petrolatum are inconvenient to apply and can cause
GenTeal Lubricant Eye Gel contains sodium perborate as a preservative. When placed
in the eye, this preservative converts to water and oxygen. The gel vehicle liquifies on contact with the eye,
spreading rapidly and yielding relief that lasts long enough that only three to
four applications per day are needed.
The product temporarily relieves discomfort due to minor irritation of the
eye from exposure to wind, sun, or other irritants.
Instill one to two drops in the affected eye(s) three to four times daily
or more frequently if needed.
Hold the tube vertically, allowing a small drop to form and drop into the
Do not touch the tip to any surface.
Close the tube immediately after use.
If eye pain, changes in vision, continued redness or irritation of the eye
is experienced, or if the condition worsens or persists for more than 72 hours,
stop using the product and consult a physician.
Prevention of Hygiene-Related Oral Disorders/Tooth Whitener
Crest Whitestrips (Procter & Gamble) Active Ingredients: Hydrogen peroxide, glycerin, carbopol 956,
sodium hydroxide, sodium acid pyrophosphate, sodium stannate impregnated on thin,
flexible strips Purpose: Whitening natural teeth Availability: Boxes of 56 strips -- 28 for lower teeth, 28 for
upper teeth Discussion: Many whitening toothpastes have been marketed to
clean unsightly stains on teeth, but they can only clean surface stains. Other
products may contain harmful abrasives. Crest Whitestrips contain hydrogen peroxide in
a unique strip form. The strip increases the
effectiveness of the active ingredients by keeping them in contact with teeth
for a longer period.
Patients who wear braces and/or are under 16 years of age should not use
Use the product within 4 weeks of purchase.
After brushing the teeth, open the blue pouch labeled "Upper." Peel the
backing from the whitening strip. Using a mirror, place the strip on the front
upper teeth (with the gel side next to the teeth), aligning the edge of the
strip with the gingival line. Press gently to ensure that the strip adheres
to all tooth surfaces.Wear the strip for 30 minutes, remove it, and wipe off
any remaining gel.
Perform this procedure twice daily for the upper teeth.
To treat the lower teeth, one strip may suffice, but a second strip may
be used to enhance the whitening effect.
If both upper and lower teeth are treated at the same time, the strips do
not stay in place as well.
Do not eat, drink, smoke, or sleep while the strips are in place.
The whitening effect lasts for at least 6 months. To maintain that level
of whitening, use a new box of strips every 6 months.
Use of tobacco, coffee, tea, dark colas and red wine causes teeth to stain
Crest Whitestrips will not whiten caps, crowns, veneers, or fillings. Therefore,
if these items were previously matched to the teeth, there may be a noticeable
difference between the dental work and the gradually whitening natural tooth
Sensitivity of the teeth when using the strips may be eased by using the
product only once daily or suspending use for a 2- to 3-day interval.
Users may notice gingival discomfort, which is most often caused by brushing
too vigorously or using a medium or hard-bristled brush while also using the
whitening strips. In this instance, use a soft-bristled brush, and take care
to brush gently.
Do not allow the whitening gel to touch fabrics.
Do not allow the material on the strip to touch the eyes.
Home Diagnostic Testing and Monitoring Devices
Alternative Site Blood Glucose Monitoring Products
Freestyle Blood Glucose Monitoring System (TheraSense) Purpose: Measurement of blood glucose Availability: 1 meter with case, 10 test strips, 10 sterile lancets,
1 vial of control solution, lancing device, and an 8-month personal logbook. Additional
test strips are available in quantities of 50 and 100. AtLast Blood Glucose Monitoring System (Amira) Microlet Vaculance (Bayer) FastTake Test Strips (Lifescan) Purpose: Measurement of blood glucose and/or obtaining a blood
sample for blood glucose measurement Availability: The AtLast Blood Glucose Monitoring System contains
1 meter with protective cover and case, 25 test strips, 25 lancets, 2 lancet holders,
a calibration chip, a check strip, and a 12-week logbook. Additional test strips
are available in quantities of 50. The Microlet Vaculance package contains 1 lancing
device and 10 sterile lancets. FastTake Test Strips are available in packages
of 50 and 100. Discussion: As of 1998, approximately 10.5 million people in
the United States had received diagnoses of diabetes. Of those, only about 10%
had received diagnoses of Type 1 diabetes mellitus. Diabetes is particularly prevalent
among African Americans and Mexican Americans.
Poor glycemic control contributes to a number of complications in patients with
diabetes. Advanced glycosylation end products are known to contribute to renal
damage. Poorly controlled diabetes can also
lead to cardiovascular complications. Studies have shown that patients with diabetes
are two to four times as likely to develop some form of cardiovascular morbidity
or death than nondiabetic subjects of the same age. Blood glucose and glycosylated protein testing
are integral to reducing the likelihood of diabetic complications.
Until recently, patients had to lance their fingertips to obtain blood samples
for glucose testing. Because the fingertips contain a large number of sensory
nerve endings, this procedure can be quite painful, especially for patients who
test multiple times a day. Each of these new devices allows patients to obtain
samples from sites other than their fingertips.
The Freestyle System permits patients to obtain blood samples from the forearms.
It does this through the patented "Nano-Sample" technology designed to measure
a blood sample of only 0.3 microliters (i.e., the size of a pinhead). Older meters
require samples between 8 and 15 microliters in size to obtain an accurate measurement.
The smaller sample size permits sampling from sites that are less sensitive and
less highly vascularized than the fingertips.
The AtLast System requires a larger sample size of 2 microliters. It permits sampling
from the forearm, upper arm, and thigh using a built-in lancing device. A custom-made
lancet creates a small break in the skin, then a gentle "press and release" motion
draws blood to the skin surface. The meter itself employs precision optics to
measure and report the blood glucose level in 15 seconds.
The Microlet Vaculance is designed for use with Bayer blood glucose test sensor
systems with patented MicroEase sampling (Glucometer Elite, Glucometer Elite XL,
and Glucometer DEX). It can be used to obtain blood samples from soft, fleshy,
nonvenous areas of the skin that are free of hair, such as the fleshy portion
of the palm between the wrist and middle finger, the medial aspect of the forearm,
the abdomen, and the outer thigh. After lancing the skin, the device creates a
vacuum seal around the sampling site that draws the required amount of blood (2
mL to 4 mL, depending on the meter) to the skin surface.
The FastTake System is not in itself a new product, but the test strips it uses
are new. The new test strips require a 40% smaller blood sample than the original
strip (1.5 mL instead of 2.5 mL). In addition, the new strips employ capillary
action to draw the smaller blood into the strip on contact. This makes it possible
to obtain adequate blood samples from soft, fleshy areas of the arms in addition
to the fingertips.
Patient Information/Instructions: Freestyle Meter
First, set up the lancing device. To do so, snap off the clear cap, insert
a lancet in the white cup, twist off the lancet top, and replace the cap.
Next, turn the settings dial on the lancing device to the desired depth level
(an initial setting of three is recommended) and set the device aside.
Insert a test strip into the meter. The meter will turn on automatically.
As soon as a code number appears on the meter display, use the "c" button
to scroll to the number that matches the number on the test strip vial.
Wait until the "Apply Sample" message appears on the meter display before
obtaining a blood sample.
Bring fresh blood to the surface on the top of the forearm by rubbing the
test site briefly until it feels warm.
Place the lancing device on the test site and press the release button.
Hold the device on the arm and gradually increase the pressure for several
When a drop of blood about the size of the head of a pin appears under the
clear device cap, lift the device straight up without smearing the sample.
To fill the test strip with blood, hold the meter at a slight angle and
touch only one side of the strip to the blood sample. Like a straw, the strip
draws in an adequately sized sample. The meter beeps when an adequate sample
has been obtained.
Do not press the strip hard against the arm or scrape blood with the flat
end of the strip.
The meter will beep two times and display the results when the test is complete
(average time is 15 seconds after the sample is obtained).
To prepare the AtLast meter, unscrew the lancet holder from the meter and
insert an uncapped lancet, metal tip first, into the holder until it stops.
Screw the lancet holder back on the meter until it snaps into place.
The package contains both a blue and gray lancet holder. The gray holder
permits the lancet to penetrate more deeply into the skin and need only be
used if the patient fails to get a blood sample of adequate size using the
After loading the lancet device, insert the short end of the test strip
into the meter so that the test tip points outward.
To engage the lancet, pull the knob on the end opposite the test strip until
Press the gray start button.
To obtain a blood sample, place the bottom of the meter on the forearm,
upper arm, or thigh.
Press the entire unit against the sample site until it clicks and hold it
in this position for about 3 seconds.
Keeping the meter pressed to the skin, release the pressure by allowing
the meter to slide up fully so that it rests lightly on the skin and hold
the meter briefly in this position.
Slowly repeat this process of press and release four more times at the same
site to obtain an adequate blood sample.
To perform the test, lift the meter from the skin, taking care not to smear
the droplet of blood that has formed.
Holding the meter at an angle, gently touch the test tip to the outer edge
of the blood droplet until the meter beeps. In about 15 seconds, the meter
will beep again and display the results of the test.
To obtain a blood sample with the Microlet Vaculance, remove the end cap
from the device, insert a lancet into the holder, twist off the lancet protector,
and replace the end cap.
Position the device firmly on the lancing site (i.e., so that the entire
edge of the end cap is in contact with the skin) and depress the plunger until
Maintaining pressure between the end cap and the skin, slowly release the
plunger to create a vacuum under the end cap. This vacuum draws blood to the
When an adequate amount of blood has formed on the skin, press the plunger
three-quarters of the way down to release the vacuum.
Remove the device from the skin.
Insert a test strip into the meter.
Match the code number on the test vial with the meter display by pressing
the "C" button on the meter until the appropriate number appears.
Lance the side of a finger or a soft, fleshy area of the arm that is free
of visible veins or excess hair. When using a sample site on the arm, hold
the lancing device firmly against the skin for a few seconds before and after
lancing the skin to bring an adequate sample to the surface.
Touch the blood sample to the top, white edge of the test strip until the
blood has completely filled the confirmation window.
Test results are displayed in 15 seconds.
Multi-Test Blood Chemistry Monitor
BioScanner 2000 (Polymer Technology Systems) Purpose: Measurement of blood glucose, total cholesterol, high
density lipoprotein cholesterol (HDL-C), and ketone Availability: The BioScanner packaging tube contains one meter
with case, a lancing device, lancets, literature about the product, a user guide,
and AAA batteries. Strips are sold separately in a variety of quantities: glucose
strips are available in quantities of 25, 50, and 100; cholesterol, HDL-C, and
ketone strips are available in quantities of 6, 50, and 100. Each vial of strips
includes a corresponding, color-coded memory chip. Discussion: Diabetes and heart disease are "silent killers" that
affect more than 200 million Americans. Since 1900, heart disease has been the
leading cause of death in the United States, costing the health care system more
than $326.6 billion annually. Risk of heart disease or stroke is two to four
times greater for people with diabetes than for the average person. Of people receiving diagnoses of type 2 diabetes,
50% are not aware of their risk until after their first heart attack or stroke.
For most of the patients with type 2 diabetes, an average of 7 to 10 years elapses
from the time that heart disease develops to its diagnosis.
The most important way that patients with diabetes can reduce their risk of diabetic
complications and heart disease is by achieving and maintaining good glycemic
control through diet and exercise. Patients can use the Bioscanner 2000 to monitor
glycemic control by measuring blood glucose levels. The meter also measures blood
ketones. Ketones are byproducts of fat metabolism that appear in the blood of
patients with elevated blood sugar and signal the potential development of life-threatening
The Bioscanner 2000 also permits patients at risk for the development of heart
disease, such as those with diabetes, to monitor blood levels of total cholesterol
and HDL-C. Given that elevated cholesterol levels are a treatable risk factor
for heart disease, regular monitoring should lead to early detection and treatment
before the development of complications such as heart attack and stroke.
Insert the memory chip corresponding to the desired test into the meter
and turn on the meter.
Wash and dry hands thoroughly, and lance the side of one finger to obtain
a blood sample.
Apply enough blood to cover the testing area of a strip.
The strip may be inserted into the meter either before or after the blood
sample has been applied.
The meter displays the test results in approximately 1 minute.
We anticipate that the trend toward self-care will continue, or even increase.
Pharmacists must make the commitment to remain up to date on trends and new products
in order to give patients comprehensive and balanced information. The new nonprescription
medications and diagnostic products cited in this review represent valuable additions
to the increasing array of self-care products.
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Received December 8, 2000, and in revised form January 17, 2001. Accepted
for publication January 17, 2001.