Self-Care 2025: PPCP, Regulatory, Cultural Aspects

5 core components of PPCP

collect, assess, plan, implement, follow up

collect

Collection of the necessary subjective and objective information about the patient in order to understand the relevant medical/medication history and clinical status of the patient

assess

Assess the information collected and analyze the clinical effects of the patient's therapy in the context of the patient's overall health goals in order to identify and prioritize problems and achieve optimal care

plan

Develop an individualized patient-centered care plan in collaboration with other health care professionals and the patient or caregiver that is evidence-based and cost-effective

implement

Implement the care plan in collaboration with other health care professionals and the patient of caregiver

follow up

Monitor and evaluate the effectiveness of the care plan and modify the plan in collaboration with other health care professionals and the patient or caregiver as needed

why pharmacists are responsible for knowing exclusions for self-treatment

The patient may need additional drug therapy that requires a prescription and assessment from another health care provider. A medication solution may not be applicable and the patient may need a therapy alternative. To ensure the best health outcomes it is important to know when to refer a patient to seek other help.

QuEST

quickly, establish, suggest, talk

Qu

Quickly and accurately assess the patient

E

Establish that the patient is an appropriate self-care candidate

- no severe symptoms

- no symptoms that persist or return repeatedly

S

Suggest appropriate self-care strategies

T

Talk with the patient

SCHOLAR-MACS

- symptoms

- characteristics

- history

- onset

- location

- aggravating factors

- remitting factors

- medications

- allergies

- conditions

- social history

symptoms

What are the main and associated symptoms?

characteristics

What is the situation like? Is it changing?

history

What has been done so far? Has this happened before, and, if so, what was done then? What was successful? What wasn't?

onset

When did it start?

location

Where is the problem?

aggravating factors

What makes it worse?

remitting factors

What makes it better?

medications

Prescription and nonprescription as well as complementary and alternative products

allergies

To medications and other substances

conditions

Coexisting health conditions

social history

Ask about alcohol, tobacco, diet, occupation, etc.

SCHOLAR-MAC PPCP step

collect

establish PPCP step

assess

suggest PPCP step

plan

talk PPCP step

implementation

prescription vs. non-prescription standards of safety and efficacy

they are regulated differently but both are held to the same standards of safety and efficacy

Pure Food and Drug Act of 1906

Prohibits adulteration and misbranding

Food, Drug and Cosmetic Act (1938)

Mandated safety of foods, drugs and cosmetics

Durharm-Humphrey Amendment (1951)

Provided statutory basis for two classes of drugs prescription and nonprescription

Kefauver-Harris Drug Amendments (1962)

Required proven efficacy for marketed products including nonprescription drugs

FDA mandated components of a "Drug Facts" label

active ingredients

purpose

uses

warnings

directions

inactive ingredients

Dietary Supplement Health and Education Act (DSHEA) (1994)

Defines dietary supplements as vitamins, minerals, herb or other botanical, amino acid, a substance which increases the dietary intake of it or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above

The Food and Drug Modernization Act (1997)

Established inactive ingredient labeling requirements

Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006)

Mandated reporting of serious adverse drug reactions by dietary supplement and nonprescription drug manufacturers

Pseudoephedrine limit per person within 24 hours

3.6g

pseudoephedrine limit per person within 30 days

7.5g

pseudoephedrine schedule class

class V

how long pseudoephedrine log should be kept

24 months

minimum age to purchase pseudoephedrine

18

pseudoephedrine maintained ____ the counter

behind

patient must sign and present ID with purchase of pseudoephedrine

true

OTC labeling components

- active ingredient

- purpose

- uses

- warnings

- directions

- other information

- inactive ingredients

nonprescription medication regulation

Regulated by CDER (Center For Drug Evaluation and Research) of FDA

nutritional/dietary supplements regulation

Regulated as foods not drugs

natural products and homeopathic remedies regulation

•Regulated by HPCUS (Homeopathic Pharmacopoeia of the US)

•Must have a self-limiting, self-diagnosable condition

key considerations for Rx switch to OTC

•Can the patient adequately self-diagnose the clinical abnormality?

•Can the clinically abnormal condition be successfully self-treated?

•Is the self-treatment product safe and effective for consumer use under conditions of actual use?

behind the counter medications

•Rx not required but product kept behind pharmacy counter and requires pharmacist to dispense.

•Benefit to consumer: Greater access to meds that require safeguards to use.

•Current examples:

•Sudafed (Pseudoephedrine-PSE)

Plan B One Step (Levonorgestrel)

liability nonprescription products

•Products liability refers to the liability of any or all parties along the chain of manufacture of any product for damage caused by that product. This includes the manufacturer of component parts (at the top of the chain), an assembling manufacturer, the wholesaler, and the retail store owner (at the bottom of the chain).