Establishment Wages War On Supplements. Part1

[Guest guest]

Wed, 13 Oct 2004 17:44:16 +0200

bert

" Sepp (Josef) Hasslberger " <sepp

 

Subject:American Society of Health-System Pharmacists

 

 

The American Society of Health System Pharmacists is calling on

Congress for tight regulations for the " dangerous " supplements many

people in the US are taking and is exhorting pharmacists to " reduce

the risks associated with dietary supplement use " .

 

For information

 

Kind regards

Sepp

 

 

Original article is here: http://www.medscape.com/viewarticle/488945

 

From American Journal of Health-System Pharmacy

ASHP Statement on the Use of Dietary Supplements

Posted 09/20/2004

 

Position

The American Society of Health-System Pharmacists (ASHP) believes that

the widespread, indiscriminate use of dietary supplements presents

substantial risks to public health and that pharmacists have an

opportunity and a professional responsibility to reduce those risks.

ASHP recognizes that patients may choose to use legally available

dietary supplements, but believes that the decision to use substances

that may be pharmacologically active should always be based on

reliable information about their safety and efficacy. The current

regulatory framework governing dietary supplements does not provide

consumers or health care providers with sufficient information on

safety and efficacy to make informed decisions. Furthermore, standards

for product quality are currently inadequate. ASHP recognizes the

concerns raised by the dietary supplement industry regarding

regulating dietary supplements as nonprescription drugs because of the

industry´s inability to patent product ingredients. Still, ASHP urges

Congress to amend the Dietary Supplement Health and Education Act of

1994 (DSHEA) to require that the Food and Drug Administration (FDA)

develop a regulatory scheme to ensure that dietary supplements are

safe and effective. ASHP believes that dietary supplements, at a

minimum, should (1) receive FDA approval for evidence of safety and

efficacy, (2) meet manufacturing standards for identity, strength,

quality, purity, packaging, and labeling, and (3) undergo mandatory

postmarketing reporting of adverse events, including drug interactions.

 

ASHP strongly encourages in vitro and clinical studies of interactions

between dietary supplements and medications. Because of the

demonstrated risk of these interactions, ASHP discourages the

concurrent use of dietary supplements and drug therapy, especially

those therapies for which failure may have irreversible consequences

(e.g., immunosuppressive therapy, cancer chemotherapy, treatment for

human immunodeficiency virus infection, anticoagulation therapy, and

hormonal contraceptive therapy).

 

ASHP believes that the criteria used to evaluate dietary supplements

for inclusion in health-system formularies should be as rigorous as

those established for nonprescription drugs and that the

self-administered use of dietary supplements during a health-system

stay may increase risks to patients and liabilities to health care

professionals and institutions.

 

ASHP urges pharmacists and other health care practitioners to

integrate awareness of dietary supplement use into everyday practice

and encourages pharmacists to increase efforts to prevent interactions

between dietary supplements and drugs. ASHP also supports the

education of pharmacists and other health care practitioners in the

taxonomy, formulation, pharmacology, and pharmacokinetics of dietary

supplements and believes that such education should be required in

college of pharmacy curricula.

 

Background

 

Dietary supplements are defined in DSHEA as products 'intended to

supplement the diet' that contain vitamins, minerals, herbs or other

botanicals, amino acids; 'a dietary substance for use by man to

supplement the diet by increasing the total daily intake'; or 'a

concentrate, metabolite, constituent, extract, or combinations of

these ingredients.'[1]

 

Evidence of variability in dietary supplement content[2-8] has spurred

efforts to standardize products. Current federal regulations regarding

the manufacture of dietary supplements are not adequate.[9] Some

manufacturers voluntarily follow good manufacturing practices (GMPs)

devised by their own trade groups (e.g., the National Nutritional

Foods Association GMP Certification Program[10]), and the U.S.

Pharmacopeia (USP) has created voluntary standards for a handful of

dietary supplements.[11] Manufacturers that wish to carry the 'USP

approved' seal on their product labels have to subject their products

to testing by USP. The creation of these voluntary programs reflects a

widespread concern, even on the part of dietary supplement

manufacturers, that production processes must be regulated. Although

FDA has had the authority to establish dietary supplement GMPs for

almost a decade, it issued its first proposed rule on the topic in

2003.[12]

 

DSHEA does not require FDA to review evidence of the efficacy or

safety of dietary supplements, so manufacturers have no burden to

prove that their products are effective or safe. Although dietary

supplement labeling cannot claim activity in the treatment of a

specific disease or condition, claims that suggest an effect on the

'structure or function of the body' are allowed.[1] For example,

dietary supplements containing echinacea can be labeled as supporting

immune health (as a 'function') but cannot be labeled as preventing or

ameliorating colds (treating a disease). Regardless of this

distinction between function and treatment, consumers are bombarded by

the lay press (and even some scientific literature) with what can only

be described as specific-disease indications for dietary supplements

(e.g., glucosamine for osteoarthritis, black cohosh for menopausal

symptoms, and St. John´s wort for depression).

 

The health claims allowed in dietary supplement labeling by current

interpretation of DSHEA create further confusion for consumers. FDA´s

attempt to hold these health claims to the same scientific standard

required for conventional foods was struck down in Pearson v. Shalala,

so FDA must permit dietary supplement labels to carry 'qualified'

health claims based on equivocal scientific evidence.[13]

Although DSHEA does require that dietary supplements be safe, it does

not require prospective testing to ensure safety. To remove a product

from the market, FDA must prove that the product is unsafe. Under

DSHEA, some dietary supplements that were banned from the U.S. market

because of concerns about their safety have been allowed to return

(e.g., sassafras tea, dehydroepiandrosterone). Demonstrably unsafe

products have made their way onto the market, and fatal adverse

reactions have been reported.[14,15]

 

Establishing the safety record of dietary supplements has been

complicated by the lack of systematically collected data about their

adverse reactions. The MedWatch system has been used to a limited

extent to report adverse events related to dietary supplement use,

but, nine years after the passage of DSHEA, FDA is still developing an

adverse-reaction-reporting system for dietary supplements. Despite the

limited data, however, the number of case reports of interactions

between dietary supplements and medications is growing.[16-21] The

safety of dietary supplements for special populations (e.g., children,

pregnant women, people with impaired organ or immunologic function)

has also not been demonstrated.

 

 

Dangers to Public Health

 

It has been estimated that 40% of the U.S. population uses dietary

supplements often and that almost twice as many have used at least 1

of the estimated 29,000 dietary supplements on the market.[22]

Out-of-pocket expenditures on dietary supplements total approximately

$18 billion annually.[23] Such widespread and indiscriminate use of

dietary supplements presents five dangers to the public health:

 

1. Some dietary supplements are inherently unsafe when

ingested orally (e.g., chaparral, ephedra, comfrey, tiractricol,

aristolochic acid, pennyroyal).[24-28]

2.

Lax regulation of dietary supplement manufacturing presents the risk

of contamination or adulteration with harmful substances, including

carcinogens,[29-32] and of dangerous variability in active ingredient

content among products.[2-8]

3.

The use of dietary supplements may compromise, delay, or supplant

treatment with therapies of proven efficacy.[16-21,25]

4.

Dietary supplements may present dangers to special populations (e.g.,

children, pregnant women, patients undergoing surgery, patients with

impaired organ or immunologic function).

5.

Spending on dietary supplements represents an enormous health-related

expenditure of unsubstantiated value.[33]

 

Since the mid-19th century, the federal government has exercised its

responsibility to protect Americans from hazardous or adulterated

foods and medicines. ASHP believes that, with the passage and

implementation of DSHEA, the federal government has abandoned its duty

to create a regulatory scheme for dietary supplements that adequately

protects the health of consumers. Under DSHEA, consumers and health

care practitioners are not provided with the information they need to

use dietary supplements safely. To reduce the dangers posed by the

current regulatory framework, Congress should amend DSHEA to

 

1. Require that dietary supplements undergo FDA approval

for evidence of safety and efficacy,

2.

Mandate FDA-approved dietary supplement labeling that describes safe

use in a clear, standardized format, including the potential for

interaction with medications and cautions for special populations,

3.

Require FDA to promulgate and enforce GMPs for dietary supplements,

4.

Require that dietary supplements meet FDA-established standards for

identity, strength, purity, and quality, and

5.

Empower FDA to establish and maintain an adverse-event-reporting

system specifically for dietary supplements, and require dietary

supplement manufacturers to report suspected adverse reactions to FDA.

 

 

Implications for Practice

Although examples of persons rejecting potentially life-saving medical

interventions in favor of alternative therapies can be found in the

medical and lay press,[34] the presumption that most users of dietary

supplements reject traditional treatments is unfounded. One survey

found that most individuals who use alternative therapies for a

specific symptom or disease are also receiving care and prescription

medications from a physician or surgeon.[35] In a more recent

nationwide survey, almost 20% of adults taking prescription drugs

reported that they were taking at least one dietary supplement, not

including vitamin or mineral supplements.[36]

Pharmacists and other health care practitioners therefore have an

opportunity to reduce the risks associated with dietary supplement

use. Health care providers face unfamiliar challenges in this effort,

however, because much of the information they typically use to

establish pharmaceutical treatment regimens is lacking for dietary

supplements. Product content is not standardized, therapeutic goals

are vague, and evidence of efficacy and safety is absent or ambiguous.

ASHP believes that pharmacists, as medication-use experts and

accessible members of the health care team, are uniquely qualified and

positioned to counsel patients using or considering the use of dietary

supplements. Despite their professional responsibility to provide

patients with sound advice, pharmacists (like other health care

providers) are frustrated by the lack of reliable information about

the safety and efficacy of dietary supplements. Pharmacists have shown

that they can improve medication safety by identifying and preventing

adverse drug events,[37] and they could play a similar role in

preventing adverse events due to dietary supplement use if they had

sound, evidence-based professional resources.

 

Incorporate Awareness of Dietary Supplement Use Into Practice

 

ASHP urges pharmacists and other health care practitioners to

integrate awareness of dietary supplement use into everyday practice.

ASHP believes that all health systems should have an institutional

policy regarding the use of dietary supplements. Such policies should

allow pharmacists and other health care practitioners to exercise

their professional judgment and try to balance patient autonomy and

institutional concerns.

Patient Counseling

 

Although most consumers of alternative therapies also take

prescription medications,[35] one survey found that 72% of respondents

who used alternative therapies did not report that use to their health

care providers.[38] Pharmacists and other health care practitioners

must therefore routinely inquire about a patient´s current or planned

use of dietary supplements, providing examples so that patients

understand what is meant (e.g, asking 'Do you use dietary supplements,

such as St. John´s wort or gingko?').[39] This information will allow

pharmacists and other health care practitioners to counsel the patient

about dietary supplement use and monitor for adverse reactions and

drug interactions.

When counseling patients about dietary supplements, the concept of

caveat emptor (buyer beware) must be emphasized because the content

and safety of dietary supplements are not well regulated. ASHP

believes that all pharmacists, at a minimum, should be familiar with

the pharmacology and pharmacokinetics of common dietary supplements

that might contraindicate concurrent use with a therapeutic regimen

(i.e., proven and potential pharmacokinetic and pharmacodynamic

interactions with prescription and nonprescription medications) to the

extent that sound evidence exists. To provide informed counsel to

patients using or considering the use of dietary supplements,

pharmacists further need to be familiar with the following:

 

* The typical uses of common dietary supplements and the

scientific literature regarding their efficacy and safety,

*

The proven and potential interactions between common dietary

supplements and prescription and nonprescription medications,

*

The methods of therapeutic monitoring for common dietary supplements,

including signs and symptoms of potential adverse effects and toxicities,

*

The proven and potential effects of certain disease states on

supplement absorption, distribution, and elimination, and

*

The safety of using dietary supplements before or after surgery.

 

Despite the shortcomings of the data on dietary supplements, the

limited references on the topic that are available should be

consulted.[40-45]

 

Patients stabilized on a combination of a supplement and medication

should be cautioned not to suddenly discontinue the use of either

without first consulting with the prescriber. The potential for

adverse effects from an interaction exists both when a dietary

supplement is discontinued and when it is initiated.

 

Dietary supplement sales have a very high potential for profit.

Despite the expectation that pharmacies should receive a profit from

the sale of products, professional ethics mandate that any

recommendations or purchasing suggestions be made with the well-being

of the customer or patient as the primary concern. Pharmacists should

also review promotional and reference materials promulgated in or by

their workplaces to ensure that these materials are evidence based and

not misleading or deceptive. The scientific literature about the

safety and efficacy of dietary supplements is updated continually.

Pharmacists have a responsibility to continually monitor that

literature and incorporate the evolving knowledge into their care for

and advice to patients.

Inclusion in Formularies

 

ASHP believes that the criteria used to evaluate dietary supplements

for inclusion in health-system formularies should be as rigorous as

those established for prescription and nonprescription drugs. The

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

has recommended that medical staff weigh the patient care implications

of dietary supplements with the same rigor applied to prescription and

nonprescription medications,[46] and all JCAHO medication management

standards apply to dietary supplements, as well as prescription and

nonprescription drugs.[47] ASHP believes that the decision to include

any product in a health-system formulary should be based on

comparative data regarding efficacy, adverse effects, cost, and

potential therapeutic advantages and deficiencies.[48] The lack of

definitive evidence of efficacy and safety and the demonstrated

variability in product content make most dietary supplements

unsuitable for inclusion in health-system formularies.[49] More

research is needed to determine the relative effectiveness of dietary

supplements and their safety for all patient populations, especially

drug-supplement interactions.

 

The shortcomings that make most dietary supplements unsuitable for

inclusion in formularies also argue strongly against their use by

patients via self-administration during a health-system stay. ASHP

believes that the use of self-administered medications should be

avoided to the extent possible[50] and that pharmacists should

identify all drug products before their use.[51] There is currently no

way to definitively determine the content of dietary supplements

brought into health systems. In addition, discontinuing supplement use

may be advisable as part of the diagnostic workup, and the possibility

that supplement use may have contributed to hospitalization should be

considered.

If an institution decides, as a matter of patient autonomy, to allow

the use of dietary supplements, such use should require a prescribed

order for the specific dietary supplement in the patient medical

record and pharmacist review and verification of the order. Health

systems should be aware that the use of dietary supplements may expose

patients to risks, and the health system and staff should take steps

to reduce potential liability (e.g., require patients to sign a

liability waiver for dietary supplement use) and decrease those risks.

 

Conclusion

 

Current regulation of the manufacture and labeling of dietary

supplements fails to address substantial risks to the public health.

As the activity of some dietary supplements has become apparent, so

have their dangers and the shortcomings of the current regulatory

framework. These laws and regulations should be revised, with the

primary goal of providing consumers and health care practitioners with

the information they need to use dietary supplements safely and

effectively. In short, dietary supplements should be regulated in a

manner that ensures that they are safe and effective. Pharmacists have

an opportunity and a professional responsibility to reduce the risks

presented by dietary supplement use.

Acknowledgements

 

David J. Kroll, Ph.D., is gratefully acknowledged for authoring the

first draft of this statement. ASHP also acknowledges the following

organizations and individuals for reviewing and commenting on drafts

of the statement: American Dietetic Association (ADA); American

Medical Association (AMA); American Nurses Association (ANA); National

Consumers League; Public Citizen (PC); Ron Barnes, M.S.; Carol J.

Bickford, Ph.D., RN, BC (ANA); Lisa Boothby, Pharm.D.; Cindi Brennan,

Pharm.D., M.H.A.; Sian Carr-Lopez, Pharm.D.; Steven Chen, Pharm.D.;

Kevin J. Colgan, M.A.; David Copelan, Pharm.D.; Joseph Cranston, Ph.D.

(AMA); Denise E. Daly, Pharm.D.; Peter A. G. M. De Smet, Pharm.D.,

Ph.D.; CAPT Joseph Deffenbaugh (USPHS, Ret.), M.P.H.; Kim H. DeRhodes;

Paul Doering, M.S.; Deanna Dreher, Pharm.D.; Christine F. Edie,

Pharm.D.; Steven Eggleston, Pharm.D.; Carla B. Frye, Pharm.D., BCPS,

FASHP; Bill J. Gurley, Ph.D.; Guy Hasegawa, Pharm.D.; COL W. Mike

Heath, M.B.A.; Roxanne Homar, Pharm.D.; Marianne F. Ivey, Pharm.D.,

M.P.H., FASHP; Cherry Jackson, Pharm.D.; Roger Klotz; Cynthia L.

LaCivita, Pharm.D.; Alan H. Mutnick, Pharm.D.; Brian M. Meyer, M.B.A.;

Charlie Myers, Pharm.D.; Keith Olsen, Pharm.D.; Roland Patry, M.S.;

Marjorie S. Phillips, M.S., FASHP; Steven C. Piscitelli, Pharm.D.;

Darryl S. Rich, Pharm.D., M.B.A., FASHP; Larry D. Sasich, Pharm.D.,

M.P.H., FASHP (PC); Douglas Scheckelhoff, M.S.; Gayle N. Scott,

Pharm.D., FASCP, BCPS, ELS, CGP; Kelly M. Shields, Pharm.D.; Susan C.

Smolinske, Pharm.D., BCPS, DABAT; Sharm Steadman, Pharm.D., BCPS,

FASHP, CDE; Gary Stein, Ph.D.; Jennifer Strickland, Pharm.D.; Cynthia

Thompson, Ph.D., RD, FADA (ADA); Kasey K. Thompson, Pharm.D.; Candy

Tsourounis, Pharm.D.; Sherry Umhoeffer, M.B.A.; Paul C. Walker,

Pharm.D.; Dennis M. Williams, Pharm.D.; David R. Witmer, Pharm.D.;

Raymond Woosley, Ph.D.; and William A. Zellmer, M.P.H.

 

 

 

--

 

 

The individual is supreme and finds its way through intuition.

Sepp (Josef) Hasslberger

 

Personal home page on physics,energy technology, social

and economic issues: http://www.hasslberger.com

 

Health Supreme: http://www.newmediaexplorer.org/sepp

 

Antiprohibition and products made from cannabis as a raw

material: http://www.unsaccodicanapa.com

 

Communication Agents: http://www.communicationagents.com/

 

La Leva di Archimede - freedom of choice

main site: http://www.laleva.cc

news: http://www.laleva.org

 

Robin Good - " Understanding comes from exploration "

http://www.masternewmedia.org

 

Trash Your Television!

http://www.tvturnoff.org/

 

Not satisfied with news from the tube and other controlled media?

Search the net! There are literally thousands of alternative sources

out there. Start with the following links. (But there are many more

sites with good, timely information.)

 

http://www.whatreallyhappened.com

http://www.joevialls.co.uk/

http://www.padrak.com/alt/911DD.html