|
"You matter to the last moment of your life, and we will do all we can, not only to help you die peacefully, but to live until you die." Dame Cicely Saunders
NCCDP has no control over the nature, content, and availability of the Web sites listed. The inclusion of a link on this page does not imply NCCDP recommendation or endorsement of the views expressed within the entity’s Web site
Medication Resources.
March 21, 2011
Donald Berwick, M.D.
Administrator, Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201
Subject: Implementation of Long-Term Care Alternative Dispensing Provisions of P.L. 111-148
Dear Dr. Berwick:
We are writing to convey our concerns with the Centers for Medicare and Medicaid Services’ (CMS) recently published proposed rule implementing Section 3310 of the Patient Protection and Affordable Care Act with the goal of reducing waste in long-term care settings for residents of nursing homes. CMS proposes to require that pharmacies dispense brand name medicines to Part D beneficiaries in 7-day supplies or less, rather than the 30-day supplies pharmacies commonly dispense. We believe that more information is necessary to assess the proposed rule’s true systemic costs and potential impacts on patient care before implementation.
In all, the organizations signing this letter represent …
“Only when data has been systematically collected will the extent of waste of Part D drugs be quantifiable on other than an anecdotal basis.”
-Pg. 71206 of the 2012 Proposed Part C&D Rule
Industry shares CMS’s interest in reducing waste in the provision of pharmaceuticals. Pharmacies currently utilize a number of different techniques in an attempt to achieve this goal, including the use of shorter dispensing cycles for a limited number of expensive medications, automated dispensing systems, and drug take-back and credit programs. However, the relative costs and effectiveness of these techniques in reducing waste have not been adequately studied or reported in peer-reviewed literature.
To our knowledge, there has been no study or pilot testing of the proposed 7-day-or-less dispensing cycles showing systemic cost savings. As discussed in the proposed rule, CMS has based its estimates of program cost on one unpublished survey done by a single pharmacy using expensive and proprietary dispensing techniques. Further, these data showed savings in drug costs only without considering the actual cost of dispensing an additional three or more times per month. A recent industry survey suggests that the number of drugs dispensed and not consumed by Part D-covered residents is far lower than CMS estimates. This study concluded that it will cost far more to implement a 7-day dispensing requirement than can possibly be saved through waste reduction. A single survey and studies published before 1986 are not adequate evidence to justify a comprehensive launch of this program without further evaluation.
In an effort to collect the data necessary to obtain reliable information on the extent to which a problem exists, CMS proposes to require pharmacies to collect unused drugs from nursing homes and report their quantities to Medicare drug plan sponsors. This provision implicates a cornucopia of disposal regulations, such as those requiring specific handling of drugs that are considered hazardous waste. In addition, neither the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA), nor its implementing regulations promulgated by the DEA, explicitly spells out how excess controlled drugs may be properly disposed of by patients. As a result, pharmacies are currently not allowed to take back controlled substances dispensed to patients in long-term care settings. Assuming the purpose of this provision is to accurately determine waste, a study or pilot would be a much less onerous way for CMS to quantify the amount of waste purportedly being created by 7-day-or-less dispensing.
The significant time and resources necessary to implement this new system (including addressing technical requirements such as adding claims and reporting capability) for pharmacies, facilities, and plans, as well as its potential impact on patient care, supports conducting a valid unbiased study for use in assessing any newly proposed dispensing methodology requirements. Informed policy decisions are necessary when creating and changing rules which place administrative burdens on nursing staff, reduce time for patient care, and increase the risk of medication errors and missed doses. In closing, we respectfully request that CMS postpone its implementation of the rules for 7-day-or-less dispensing (using authority granted by the implementing statute to allow the effective date to be for plan years beginning on or after January 1, 2012) while conducting a proper analysis of the rule’s true costs by using a comprehensive study or pilot of realistic alternative dispensing options.
We appreciate the opportunity to share our views on this issue, and we are committed to working with you to help develop a study that can be used to gather this critical information. Should you have any questions or need additional information, please contact one of us or Susan Janeczko, Pharm.D. Director of Long-Term Care for the National Community Pharmacists Association (NCPA) at (703) 600-1223. Thank you for your continued support of our patients and our efforts to care for them.
Sincerely,
1. On October 12th, 2010, the President signed the Secure and Responsible Drug Disposal Act of 2010 into law. This Act amends the Controlled Substances Act by authorizing the DEA to implement regulations to permit take-back programs for the disposal of controlled substances in certain instances and eliminates the legal barriers that have prohibited these initiatives in the past. For example, if the DEA implements such regulations, an “ultimate user” or patient would be able to deliver unused controlled substance to entities authorized to engage in drug disposal in accordance with regulations to be issued by the DEA. However, unless and until DEA implements such regulations, this practice is not yet permissible.
Academy of Managed Care Pharmacy
Judith A. Cahill
GeriMed, Inc.
John Schutte
Managed Health Care Associates, Inc.
Michael Sicilian
National Community Pharmacists Association
Kathleen Jaeger
RetireSafe
Al Cors, Jr.
National Council for Prescription Drug Programs
Lee Ann Stember
|
New Jersey Association of Long Term Care Pharmacy Providers
Robert Fusco
National Alliance of State Pharmacy Associations
Rebecca Snead
Omnicare, Inc.
Paul Baldwin
Long Term Care Pharmacy Alliance
Bill Daniel
LeadingAge
Marsha Greenfield
PharMerica Corporation
Gregory S. Weishar |
National Association for the Support of Long Term Care
Cynthia Morton
AMDA-Dedicated to Long Term Care MedicineTM
Jacqueline Vance
|
|
COCONUT OIL DIETARY GUIDELINES AND SUGGESTIONS
By Mary T. Newport, MD – Updated September 2009
See www.coconutketones.com for more information
HOW CAN COCONUT OIL BE USED IN THE DIET?
Coconut oil can be substituted for any solid or liquid oil,
lard, butter or margarine in baking or cooking on the stove, and
can be mixed directly into foods already prepared. Some people
take it straight with a spoon, but for most people it may be hard to
swallow this way and more pleasant to take with food. When
cooking on the stove, coconut oil smokes if heated to greater than
350 degrees or medium heat. You can avoid this problem by
adding a little olive or peanut oil. Coconut oil can be used at any
temperature in the oven when mixed in foods.
WHAT IS THE NUTRIENT CONTENT OF COCONUT
OIL? DOES IT CONTAIN OMEGA-3 FATTY ACIDS?
Coconut oil has about 117-120 calories per tablespoons,
about the same as other oils. It contains 57-60% medium chain
triglycerides, which are absorbed directly without the need for
digestive enzymes. Part of it is metabolized by the liver to ketones
which can be used by most cells in the body for energy. This
portion of the coconut oil is not stored as fat. Coconut oil is about
86% saturated fat, most of which is the medium chain fats that are
metabolized differently than animal saturated fats. It contains no
cholesterol and no transfat as long as is non-hydrogenated. An
advantage of a saturated fat is that there is nowhere on the
molecule for free radicals or oxidants to attach. About 6% of the
oil is monounsaturated and 2% polyunsaturated. Coconut oil also
contains a small amount of phytosterols, which are one of the
components of the “statins” used for lowering cholesterol.
Coconut oil contains omega-6 fatty acids but no omega-3 fatty
acid, so this must be taken in addition to coconut oil. You can
obtain all of the essential fatty acids required by using just
coconut oil and omega-3 fatty acids. If you were to use coconut
oil as your primary oil, the only other oil you would need is an
omega-3 fatty acid, which you can get by eating salmon twice a
week, or taking fish oil or flax oil capsules, 2-3 per day. Some
other good sources of omega-3 fatty acids are ground flax meal,
chia (a fine grain), walnut oil and walnuts. Lauric acid is a
medium chain triglyceride that makes up almost half of the
coconut oil. Scientific studies show that lauric acid has
antimicrobial properties and may inhibit growth of certain
bacteria, fungus/yeast, viruses and protozoa. It is one of the
components of human breast milk that prevents infection in a
newborn.
WHAT KIND OF COCONUT OIL SHOULD I USE?
Look for coconut oils that are non-hydrogenated with no
transfat. Avoid coconut oils that are hydrogenated or superheated
because it changes the chemical structure of the fats. If you
like the odor of coconut, look for products called “virgin,”
“organic,” or “unrefined,” which are generally more expensive
than “refined,” or “all natural,” or “RBD” (refined, bleached and
deodorized) coconut oil, which do not have an odor. The oil itself
is tasteless. Any of these have essentially the same nutrient with
about 57-60% MCT oil (medium chain triglycerides.) The least
expensive that I have been able to find so far is the Louanna brand
at Walmart, priced locally at $5.44 per quart. Using coconut oil
capsules is not an efficient way to give the oil since the capsules
are relatively expensive and contain only 1 gram of oil per
capsule, whereas the oil is 14 grams per tablespoon. Capsules
might be useful for someone who will not take the oil.
WHY DOES THE COCONUT OIL LOOK “CLOUDY?”
Coconut oil is a clear or slightly yellow liquid above 76
degrees but becomes solid at 76 degrees and below. If your house
is kept right around 76 degrees you may even see partly liquid oil
with solid clouds of oil floating in it. If your home is generally
kept at 75 degrees or below, the oil will tend to be a white or
slightly yellow soft semi-solid.
WHAT OTHER COCONUT PRODUCTS CONTAIN
COCONUT OIL?
Coconut milk is a combination of the oil and the water from
the coconut and most of the calories are from the oil. Look for
brands with 10 to 13 grams of fat in 2 ounces. Look in the grocery
store’s Asian section. Some brands are less expensive but are
diluted with water. Coconut cream is mostly coconut milk and
sometimes has added sugar. Flaked or grated coconut can be
purchase unsweetened or sweetened and is a very good source of
coconut oil and fiber and has about 15 grams oil and 3 grams fiber
in ¼ cup. Frozen or canned coconut meat usually has a lot of
added sugar and not much oil per serving. A fresh coconut can be
cut up into pieces and eaten raw. A 2” x 2” piece has about 160
calories with 15 grams of oil and 4 grams of fiber. MCT Oil
(medium chain triglycerides) are part of the coconut oil and can
also be purchased in some health food stores or on-line. This may
be useful for people who are on the go and do not have much time
to cook. Also, MCT oil is used as energy and not stored as fat, so it
may be useful for someone who wants to lose weight, if substituted
for some of the other fats in the diet. Coconut water does not
usually contain coconut oil, but has other health benefits. The
electrolyte composition is similar to human plasma and is useful to
prevent or treat dehydration.
HOW SHOULD I STORE COCONUT PRODUCTS?
Coconut oil is extremely stable with a shelf life of at least two
years when stored at room temperature. It does not need to be
refrigerated and becomes extremely hard when cold. If you wish
to keep it in the refrigerator, you can measure out 1 or 2
tablespoons into each section of a plastic ice cube tray. The
coconut oil easily pops out of the plastic tray. Coconut milk is
mostly coconut oil and can be substituted for the oil in many ways.
Coconut milk must be refrigerated after opening and should be
used within a few days or tossed out. Grated or flaked coconut can
be stored at room temperature for a few weeks, but may last longer
if stored in a refrigerator. A freshly cut up coconut can be stored in
the refrigerator for a few days or freezer for a couple of weeks.
WHO SHOULD TRY THIS?
People who have a neurodegenerative disease that involves
decreased glucose uptake in neurons could benefit from taking
higher amounts of coconut and/or MCT oil to produce ketones
which may be used by brain cells as energy. These diseases
include Alzheimer’s and other dementias, Parkinson’s, ALS (Lou
Gehrig’s), multiple sclerosis, Duchenne muscular dystrophy,
autism, Down’s syndrome, and Huntington’s chorea. Ketones can
also serve as an alternative fuel for other cells in the body that are
insulin resistant or cannot transport glucose, and could potentially
1
lessen the effects of diabetes I or II on the brain and other organs.
If you are at risk due to family history, you consider making this
dietary change as well. If your loved one is in assisted living, the
doctor may be willing to prescribe coconut oil to be given at each
meal, increasing gradually.
HOW MUCH SHOULD I TAKE?
If you take too much oil too fast, you may experience
indigestion, cramping or diarrhea. To avoid these symptoms, take
with food and start with 1 teaspoon coconut oil or MCT oil per
meal, increasing slowly as tolerated over a week or longer. If
diarrhea develops drop back to the previous level. For most
people, the goal would be to increase gradually to 4-6 tablespoons
a day, depending on the size of the person, spread over 2-4 meals.
Mixing MCT oil and coconut oil could provide higher levels and
a steady level of ketones. One formula is to mix 16 ounces MCT
oil plus 12 ounces coconut oil in a quart jar and increase slowly as
tolerated, starting with 1 teaspoon. This mixture will stay liquid
at room temperature.
WHAT ABOUT CHILDREN?
Children with Down’s syndrome and some children with
autism show decreased glucose uptake in parts of the brain. A
reasonable amount to give a child would be about ¼ teaspoon of
coconut oil for every 10 pounds that the child weighs, 2 or 3 times
a day. Also, some children like the taste of coconut milk - 1 ½ to
2 teaspoons per 10 pounds weight can be added to the diet 2 or 3
times a day. If you use coconut milk for a child be sure to
refrigerate it and toss after two days. Do not add honey to
coconut milk for children under 1 year old due to risk of infection.
DO I NEED TO BE WORRIED ABOUT GAINING
WEIGHT FROM THE EXTRA FAT IN THE DIET?
Yes!! The best way to avoid gaining weight is to substitute
coconut oil for most other fats and oils in the diet, and if that isn’t
enough, cut back on portion sizes of carbohydrates, such as
breads, rice, potatoes, cereals, and other grains. In general it is a
good idea to use whole milk products but, if weight gain is a
problem, you can also compensate for some of the new fat in the
diet by changing from full fat to lower fat dairy products, such as
milk, cheese, cottage cheese and yogurts, as well as low-fat or fatfree
salad dressings, to which you can add coconut oil. Also, use
a measuring spoon and remove the excess by leveling it with a
knife to avoid overestimating, which can make a big difference in
the number of calories consumed. Tiny glass measuring cups are
available at grocery stores with markings for teaspoons and
tablespoons. These are especially useful for combining salad
dressing with coconut oil.
DOES COCONUT OIL INCREASE CHOLESTEROL?
Hydrogenated coconut oil can increase cholesterol.
Therefore look for non-hydrogenated coconut oil with no transfat.
There is no cholesterol in coconut oil itself, and with nonhydrogenated
coconut oil, most people will see little difference or
will see an improvement in their HDL (“good”) and a decrease in
LDL (“bad”) cholesterol. Some see an increase in total
cholesterol, usually as a result of an increase in HDL (“good”)
cholesterol.
SOME OTHER BENEFITS OF COCONUT OIL AND
OTHER COCONUT PRODUCTS
Coconut oil is easily absorbed by the body and increases
absorption of certain vitamins and minerals and other important
nutrients. This would also hold true for coconut milk, coconut
meat, whether wet or dry, such as flaked or grated coconut. The
fiber in coconut meat may be especially beneficial to persons with
Crohn’s or other types of inflammatory bowel disease or
malabsorption syndromes and people who have diarrhea from MCT
or coconut oil.
All of your cell membranes and about 60-70% of the brain and
are made up of fats. Cholesterol is a very important component of
the support structure of the brain. Many cell functions take place
within the cell membrane. Since about the 1950’s many people in
this country have been using 100% vegetable oil, which is usually
hydrogenated polyunsaturated fat and contains transfat, which can
carry free radicals into your cell membranes. If you begin to
substitute coconut and other natural oils, such as olive oil and even
butter, along with omega-3 oils you may be able to undo some of
the damage. Most of the cells of the body turn over within 3 to 6
months and you may notice a nicer texture to your skin, and a
decrease in certain problems such as yeast and fungal infections.
FOOD IDEAS
· Use coconut oil instead of butter on toast, English muffins,
bagels, grits, corn on the cob, potatoes, sweet potatoes, rice,
vegetables, noodles, pasta.
· Mix coconut oil into oatmeal or other hot cereal.
· Add coconut oil or milk to smoothies, yogurt or kefir.
· Mix coconut oil half and half with salad dressings.
· Mix coconut oil into your favorite soup, chili or sauce.
· Use a measured amount of coconut oil to stir fry or sauté (add
peanut oil over medium heat)
· Purchase or make coconut macaroons made from all natural
products.
· Eat a 2” x 2” square of raw coconut for a snack to provide 15
grams of oil.
· Add flaked or grated coconut to hot or cold cereal, yogurt, fruit
or vegetable salads.
· “The Coconut Lover’s Cookbook,” Bruce Fife – many more
great ideas
Coconut macaroons:
2 egg whites Dash of salt 1/2 tsp vanilla
2/3 cup sugar or 1/4 cup sugar and 1 to 2 dashes of Stevia extract
1 cup shredded coconut
Beat egg whites with salt and vanilla until soft peaks form.
Gradually add sugar (and stevia), beating until stiff. Fold in
coconut. Coat cooking sheet with generous amount of butter.
Drop by the rounded teaspoon onto cookie sheet. Bake at 325
degress for 20 minutes. Makes about 18 cookies. Each cookie at
this size would have about 4 grams of coconut oil.
Coconut Milk:
Mix in a container and shake well before use:
1 can of coconut milk ½ can of water Dash of salt
1-2 tablespoons of honey or other sweetener to taste
- Store in refrigerator and discard unused portion after 4 days.
MCT Oil/Coconut oil Mixture
Store at room temperature, in a quart size jar:
16 ounces MCT oil + 12 ounces coconut oil
“Fudge”
Melt and mix together 1 cup each of coconut oil and chocolate
chips and divide equally into a plastic ice cube tray and place in
freezer. In a 16 cube tray, each cube will equal 1 tablespoon
coconut oil. Add grated coconut and/or nuts for variety. |
|
