PHARMACY PRACTICE

What is self-care?

• The practice of individuals looking after their own health using the knowledge and information available to them…in collaboration with health and social care professionals as needed.”

  • The patient takes their own care into their own hands.

    • Good…or bad?

Think about what a patient can do for their health on their own:

• Dietary changes

• Exercise habits

• Over-the-counter (non-prescription) medications

• Disease testing

• Online and print reading

• Complementary medicine (acupuncture, hypnotherapy)

When a patient engages you in the self-care space…

• This would technically be “pharmacist-assisted self-care.”

  • You screen for what they’ve been doing for themselves.

  • You decide whether continued self-care is appropriate.

  • You make a recommendation, if appropriate.

    • Again, YOU are the face of the patient’s healthcare!

Is pharmacist-assisted self-care different from primary care?

• The distinction between these two concepts is blurring.

  • Pharmacists are closer to being labeled “healthcare providers”. 

    • The billing implications in this designation are huge.

  • Pharmacists often serve as first point of contact.

    • They also often serve as point of ongoing contact.

  • The orders of a physician often involve pharmacist-assisted self-care.

The role of a pharmacist is expanding:

• Medication Therapy Management (MTM)

  • Comprehensive medication reviews (nonprescription, prescription)

    • Provide service, document, submit claim

• Point-of-Care Testing (BP, Diabetes, Cholesterol, Bone Density)

  • Also think of rapid diagnostic tests and pharmacogenomics.

The technical exploration of self-care:

• his is a fast-growing part of healthcare. Why?

  • Patients don’t want to go to an office! Wait in a room. Pay a copay.

    • Even if they do want to go, provider shortages…

  • The Internet has more information than ever!

    • Artificial Intelligence is confidently giving answers.

  • The pandemic changed expectations.

    • What can be accomplished in a pharmacy? Or at home?

  • Insurance companies and employers are driving growth.

    • Free telemedicine visits.

    • HSA/FSA for purchase of self-care products.

    • Funding pharmacist review of self-care and medication regimens:

      • Pharmacists can receive payment for these services.

    • Placement of clinics in pharmacies.

  • Crazy cost savings!

    • Consumer Healthcare Products Association, 2022 survey:

      • Availability of OTC products = $167 billion annual savings

      • For each $1 spent on OTC medication, save $7.33 for system

      • If OTCs weren’t available, 18% of families would not seek care.

      • Use of OTCs = $36 billion in annual productivity benefit

What are patients looking for?

• Nonprescription Medications:

  • Of U.S. total pharmaceutical sales…

    • 60% = OTC products

  • Old adage in community pharmacy:

    • Top 4 sellers:  CCCA

      • Cold, Cosmetics, Candy, Alcohol

• Dietary Supplements:

  • Vitamin D, Zinc, Vitamin C, and so on

    • How many Americans take > 1? 80%.

• Complementary Health Therapies

  • Think yoga, acupuncture, home exercises/rehab

    • Yes, patients will ask your opinion.

• Behind-the-Counter Products:

  • Mostly products containing pseudoephedrine

    • But also think about diabetic testing supplies

    • Insulin (OTC in many states) and syringes

    • Contraceptives

    • Nicotine replacement therapy

    • Codeine products < 200mg/100mL or 100g (some states)

What do you need to educate your patients about?

• Up and Away

  • “Out of sight – and reach – of young children.”

• Know Your Dose

  • So many overlapping ingredients in OTC products

    • Particularly acetaminophen-containing products

• OTC Medicine Safety Campaign

  • Is that nasal spray from seven years ago still good?

What barriers exist to your provision of pharmacist-assisted self-care?

• APhA 2015 survey of 394 pharmacists reported:

  • Patient seeking recommendation when medical care is indicated (66%)

  • Patients are in a hurry to leave the pharmacy (65%)

  • Patients erroneously consider OTCs overly safe (64%)

    • Medications can be safe when…used safely. 

      • All medications are toxic…just a matter of when.

• Oh, right! What about the law?

  • “A pharmacist practitioner must be aware of the regulatory paradigm for OTCs in the U.S., as well as the civil and professional obligations that arise from recommendations on use of these drugs in consumer self-care.”

    • Remember:

      • The patient is placing their health (sometimes life) in your hands.

      • The recommendations you make have consequences (good or bad).

You have YEARS of regulation and policy-making to help you.

• Pure Food and Drugs Act, 1906:

  • Prohibits adulteration and misbranding

    • “The patent-medicine industry [is] strong arming, deceiving, addicting, poisoning, and killing the public with their outrageous cure alls for everything from babies’ teething to old age.”

      • Samuel Hopkins Adams, “The Great American Fraud”

• Harrison-Narcotic Act, 1914

  • Required prescriptions for opium and other narcotics

• Food, Drug & Cosmetic Act (FDCA), 1938

  • Mandated safety standards for foods, drugs, and cosmetics

    • “Elixir of Sulfanilamide”, 1937, killed > 100 people

      • OTC product that induced kidney failure

• Durham-Humphrey Amendment, 1951

  • Further establishment of standards from FDCA

    • Before enactment, manufacturers determined OTC vs RX status

      • Some said OTC…some said prescription.

  • Many OTC products were still “grandfathered” in, allowed to be OTC

• Kefauver-Harris Drug Amendments, 1962

  • Required proven efficacy for marketed products, including OTCs

    • Review of prescription drugs ensued

  • Not until 1972 did we see the “OTC Review” process – a 50-year ordeal!

    • Classify product as…

      • GRASE (generally recognized as safe & effective) or NOT GRASE

        • Or Category III, not enough information

• Nutrition Labeling and Education Act, 1990

  • Standardized labeling for food products

• Division of Nonprescription Drug Products, 1991

  • Part of Center for Drug Evaluation and Research (CDER)

• Dietary Supplement Health and Education Act, 1994

  • Defined and regulated dietary supplements

• Food and Drug Modernization Act, 1997

  • Expanded FDA’s authority over OTCs 

    • Established inactive ingredient labeling requirements

• Coronavirus Aid, Relief and Economic Security Act (CARES), 2020

  • Amends FDCA, easier updating of drug monographs

• FDA continues oversight of nonprescription drugs.

  • Numerous documents are available for your reading.

    • Cease/Desist Guidance

    • Warning Standardization

    • Determination Standards for Safety

You do have professional responsibilities in self-care.

• Adverse Drug Reaction Reporting:

  • Dietary Supplement and OTC Consumer Protection Act, 2006

    • Mandated reporting of serious ADRs by manufacturers

    • You share this responsibility professionally.

      • MedWatch; HHS Safety Reporting

  • As recently as 2023, FDA issued Safety Alerts for OTC eye drops…

    • CAUSING BLINDNESS

• Labeling:

  • Do you assume a patient will read them? Or CAN read them?

    • You need to review them when recommending a product.

      • In many ways, they are life-savers.

        • Inactive ingredients? Dyes? Alcohol content? Sugar?

• Packaging:

  • Has the product been tampered with?

    • Chicago Tylenol Murders, 1982

      • OTC Tylenol laced with potassium cyanide causing 7 deaths

  • Is the product expired? You would be shocked!

  • Is the product damaged?

• Liability:

  • “The pharmacist may be liable for negligence and/or intentional misconduct…”

    • Example:  pharmacist sold patient camphorated oil instead of castor oil, harm brought to patient, court held pharmacist negligent

  • “Pharmacists can be sued for malpractice and negligence for inaccurate advice regarding OTCs that harm the patient.”