Self Care: PPCP, SDOH, & Legal/Regulatory Issues

Why was the PPCP created?

Unified effort by 13 national Rx organizations

Created to ensure consistent process taught to student pharmacists

Can be applied to any practice setting or service where pharmacists provide patient care

What are the 5 core components of the PPCP?

Collect

Assess

Plan

Implement

Follow-up

What does collect mean in the PPCP?

Collection of information from patient/caregiver through interviews, review of medical/pharmacy records, direct obs, & physical assessment

Includes chief complaint, HPI, past medical hx, health maintenance & immunizations, family/personal/social hx, review of systems & physical exam, & medication hx

What does assess mean in the PPCP?

Assessment & analysis of information collected to identify & prioritize patient's problems

Categorized into CMR, patient hx & risk assessment, & preventative care assessment

What does plan mean in the PPCP?

Results in self-care plan and includes

- Recommended self-care with (non)pharmacologic/alternative med products

- Reference to appropriate PCP for treatment if needed

- Recommended self-care until PCP can be consulted

- Confirmation that condition is self-resolving

- Medication-related problems

- Goals of therapy

- Patient engagement

- Care continuity in collab with other healthcare professionals & patient

What does implement mean in the PPCP?

The execution of the developed plan & communication of goals of therapy

Includes clinical parameters, desired value or change, & time frame in which the goal is met

What does follow-up mean in the PPCP?

May not be routine or include pharmacist

If return visit occurs, PPCP eval should be restarted & new info collected.

Goals of therapy & medication/therapy adherence should be reviewed

Why are pharmacists responsible for knowing exclusions for self-treatment for presenting disorders or symptoms?

Could result in med-related problem where patient needs additional drug therapy but that needs assessment from another healthcare provider

A procedure/specific medical treatment may be needed & OTC therapy will not help

What does the acronym QuEST represent?

Qu - Quickly & accurately assess the patient

E - Establish the patient is an appropriate self-care candidate

S - Suggest appropriate self-care strategies

T - Talk with the patient

What does the acronym SCHOLAR-MACS represent?

S - Symptoms

C - Characteristics

H - History

O - Onset

L - Location

A - Aggravating factors

R - Remitting factors

M - Medications

A - Allergies

C - Conditions

S - Social history

Where do QuEST/SCHOLAR-MACS overlap with the PPCP?

Qu = Start of PPCP

SCHOLAR-MACS = Collect

E = Assess

ST = Plan & implement

What are other diverse patient factors that can be a cause of health disparities & should be considered by pharmacists when providing self-care services?

- Gender identity

- Gender expression

- Sexual orientation

- Socioeconomic status

- Physical abilities

- Veteran status

- Religious affiliation

What are the 6 specialized communication skills that providers can utilize to gather information about a patient's health-related beliefs?

1. Openness to alternative viewpoints & approaches

2. Use of inclusive language in gathering demographic information

3. Self-awareness of one's own prejudice & biases

4. Engagement to identify barriers to care & individual SDOH

5. Understanding of how the patient's beliefs & attitudes may influence the treatment plan

6. Negotiating treatment that is acceptable to the patient

What are strategies that pharmacists can use to an effective self-care plan that promotes patient involvement in their care while considering values & barriers to care?

- Encourage patients' and their families' participation in self-care to promote patient independence & empowerment

- Teach-back method to ensure clarity

- Use of images, pictograms, or demonstrations

- Follow-up phone calls for important medications

Are prescription drugs held to higher standard for safety & efficacy when compared to non-prescription drugs?

Both are held to high standards because they can affect the patient's health & outcomes regardless

What is the importance of the Pure Food and Drugs Act (1906)?

Prohibited adulteration & misbranding

What is the importance of the Food, Drug, and Cosmetic Act (1938)?

Mandated safety standards for foods, drugs, & cosmetics

What is the importance of the Durham-Humphrey Amendment (1951)?

Provided statutory basis for two classes of drugs in US (prescription & nonprescription)

Mandated nonprescription availability as default status for FDA-regulated products in absence of medical need to restrict distribution

What is the importance of the Kefauver-Harris Drug Amendments (1962)?

Required proven efficacy for marketed products including nonprescription drugs

What is the importance of the Dietary Supplement Health and Education Act (1994)?

Defined & regulated dietary supplements

Labels must bear the term "dietary supplement" and the quantity of each ingredient must be stated

What is the importance of the Food and Drug Modernization Act (1997)?

Expanded FDA's authority over nonprescription drugs by establishing inactive ingredient labeling requirements

Preempts states from establishing state-specific labeling requirements

What is the importance of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006)?

Mandated reporting of serious ADRs by dietary supplement & nonprescription drug manufacturers

Which of the routes for Rx to OTC switch is most popular with manufacturers & why?

Monograph

Manufacturers don't have to obtain FDA approval for the product

How is an Rx to OTC switch beneficial to patients?

Can broaden access to important medications & are more cost-effective?

What is adulteration of a product?

Contains a substance that may make the product harmful to consumers under customary conditions for sue

If it contains filthy, putrid, or decomposed substance

If its container is composed of a harmful substance

If it is manufactured or held under unsanitary conditions

What is misbranding of a product?

If labeling is false or misleading

If it does not bear the required labeling information

If the container is made or filled in a deceptive manner

What is the quantity limit/person within 24 hours for pseudoephedrine?

1 package

What is the monthly limit/person within 30 days for pseudoephedrine?

7,500 mg

What scheduled class is pseudoephedrine?

V

How long should the seller maintain a log regarding pseudoephedrine purchases?

24 months from date of last entry

What is the minimum age to purchase pseudoephedrine?

18 years

Is pseudoephedrine maintained OTC or BTC?

BTC

When purchasing pseudoephedrine, patients must sign & present what form of personal infromation with them at the counter?

Government-issued photo ID card

What is the pharmacist's liability for the sale of a product of an OTC product?

May still be liable for negligence and/or intentional misconduct as appropriate to the facts of the case

What is the pharmacist's liability for the advice given of an OTC product?

Can be sued for malpractice & negligence for inaccurate advice that harm the patient

Risk increases if a recommendation for use is not in accordance with the labeling

What is the pharmacist's liability for the timely removal of an expired/recalled nonprescription product?

If a pharmacy repackages the drug with its own label, it may be held liable

No liability for defective meds sold in prepackaged containers

Strict liability for failure to affect timely removal of a recalled/expired product from the shelves when a patient is harmed