Chapter 7 - The Role of Complementary and Alternative Therapies Flashcards
Complementary & Alternative Medicine (CAM)
A diverse set of therapies that are considered to be outside of mainstream healthcare.
- Have not been subjected to the same scientific scrutiny as pharmaceuticals
- Most common
- Biologic-based therapies - vitamins, minerals, herb
- Alternative healthcare - homeopathy, Chiropractic
- Manual healing - massage, pressure point therapy
- Mind-body - yoga, pilates
- Spiritual - shaman, faith healer
- 4/10 Americans use some form of CAM
- Focus on treating the whole individual
From a pharmaceutical perspective, their value lies in their ability to reduce the need for medications
Dietary Supplements
Products available over the counter (OTC) that are intended to add or supplement the nutritional value of a diet
- Ask client to bring medications with them to be reviewed
- Patients need to know CAMs can interact with other meds
- Rationale for Use
- Perceived to be safer than conventional drugs
- Sense of control over care
- Emotional comfort from taking action
- Cultural Influence, Convenience
- Uninsured with limited access to professional care
- Media hype and aggressive marketing
- Recommendations from family and friends
Herb
- Technically - A botanical (plant-based substance) that does not contain woody tissue
- Common use - refer to any plant product with some useful application either as a food enhancer or medicine
- When the pharmaceutical industry introduced synthetic medications in the 1800s popularity decreased
- Criticized as being unscientific and relics of the past
- 1970s - alternative therapies experienced a resurgence
- The majority to returned to taking herbal therapies
Standardization of Herbal Products
- Herbal products are available in a variety of formulations some containing standardized extracts and others containing whole herbs
- Active chemicals may be present in one part (leaves, stems) or the whole plant.
- May contain many active chemicals
- Not all have been isolated and studied
- Strength varied from batch to batch
- To achieve consistency scientists have attempted to standardize herbal products based on 2 methods:
- Active ingredient extracts
- Marker extracts
- Allows consumers to compare products and know the strength of herb*59
Standardization of Herbal Products: Active Ingredient extracts
Standardize the amount of biologically active substances in the herb
- Ex. Saw Palmetto is a fatty acid, therefore, used to standardize extracts of herb
Marker extracts
Standardize the potency of the herb based on a common substance in the whole herb that may nio be the active ingredient
- Ex. Ginseng is standardized on the % of ginsenosides in the ecxtract
Dietary Supplement Regulation
- Not regulated in the same manner as prescriptions
-
Dietary Supplement Health and Education Act (DSHEA) - exempts dietary supplements from the Food, Drug, and Cosmetic Act - not classified as drugs or approved by FDA
- Gives the FDA authority to remove any dietary supplement that poses a “significant or reasonable” risk to the public
- Action only when adverse effects already have occurred
- Required to be labeled as dietary supplements that is not intended to treat, cure, or prevent disease
- May make claims to effect body systems:
- helps promote healthy immune systrem
- reduce anxiety and stress
DSHEA flaws
- The manufacturer does not need to test the safety prior to marketing
- If removed from the market the FDA has the burden to prove unsafe
- Effectiveness does not need to be demonstrated
- Accuracy of the label is not regulated
- Product may or may not contain the product listed
Dietary Supplement and Nonprescription Drug Consumer Protection Act
- 2007
- Companies required to provide their contact information to prevent adverse events
- Must notify FDA of any serious adverse event within 15 days of receiving report
- A serious adverse event is defined as any reaction resulting in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, congenital anomaly, birth defect
- Companies must keep records of such events for at least 6 years
Current Good Manufacturing Practices
- 2007
- Current Good Manufacturing Practices
- Purity, composition, and potency labeled accurately
- Ingredients listed
- Free of toxins, pesticides, glass or heavy metals
U.S Pharmacopeial Convention (USPC)
Non-profit public organization health organization that works to raise standards and quality of pharmaceuticals and dietary supplements
- Publishes United States Pharmacopeia (USP)
- Developed a voluntary process buy which manufacturers may submit a product for the USP Verification Program
USP Verification Program
- Examines the manufacturer’s process used to create the product, tests for labeled ingredients, and measures bioavailability
- if passes product can place USP verified on label
- Does not indicate if the product is safe or effective
Privacy Quality Certification Programs
Test for quality and include U.S. Pharmacopeia (USP) whose standards are enforceable by FDA
Consumer Lab; Natural Products Association; and National Sanitation Foundation - all require manufacturers to pay for tests and report on following:
- Current Good Manufacturing Practices
- Purity
- Identity
- (strength)
- Dissolution
- Accuracy of Labeling
Herb-Drug Interactions
- Herbal medication can interact with conventional drugs
- May cause additive, synergistic or antagonistic interactions with prescriptions or OTC drugs
- Ginkgo biloba and ginger can increase bleeding time especially with anticoagulants
- St. John’s Wart, kava, and valerian cause relaxation and may result in excessive sedation if taken with depressants
Specialty Supplements
Dietary supplements used to enhance or complement a specific function in the body
- Supporting joint health and immune function
- probiotics, fish oils, amino acids, and enzymes
- Widely used OTC The enhance wellness
- Typically have a legitimate rationale for use
- ex. amino acids are natural building blocks of muscle protein
- Link to intended benefits is unclear and in most cases the body already have sufficient quantities
- Generally harmless unless taken in large amounts, but may provide false hope
- Be cautious of claims
