1: Intro to Pharm

Role of FDA

Established in 1906 to protect public from drugs that cause harm due to adulteration/mislabeling

Durham-Humphrey Amendment

1951, defined 2 drug classes:

- Legend (prescription only) - requires adequate direction for provider to prescribe

- OTC - manufacture provide general directions for use

Kefauver-Harris Amendment

Requires proven efficacy of drugs

Manufactures demonstrate.... to FDA

- No adulteration

- No misbranding

- Safe

- Effective

Controlled Substances Act

- 1971

- Enforced by DEA, Department of Justice

- Schedules regarding potential for abuse/addiction

- Persons who produce, distributes, dispense must register with DEA

Enforced substances of CSA

Opiates, sedatives, stimulants, hallucinogens

Schedule I

- High potential for abuse

- No accepted medical use

Schedule I drugs

- Heroin

- LSD

- Marijuana

- Peyote

- Methylenediomethamphetamine (ecstasy)

Schedule II

- High abuse potential

- NO refills

- Paper, electronic, fax prescription

- Severe psych/physical dependent

Schedule II drugs

- Oxycodone

- Hydrocodone

- Amphetamine

- Fentanyl

- Cocaine

Schedule III

- Some abuse potential

- Moderate psych dependency

- 5 refills within 6 months

- Allows oral prescription

Schedule III drugs

- Ketamine

- Codein w/ tylenol

- Anabolic steroids

- Testosterone

Schedule IV

- Low abuse potential

- Limited psych dependency

- 5 refills within 6 months

- Allows oral prescription

Schedule IV drugs

- Benzos

- Tramadol

Schedule V

Rx or OTC depending on state/local regulation

Schedule V drugs

- Lomotil

- Robitussin w/ codeine

- Pregabalin

Dietary Supplement Health and Education Act (DSHEA)

Framework for dietary supplements

FDA conditions for removal of dietary supplements from marketplace

- Significant/unreasonable risk to consumers

- Adulterated

- Inaccurate labeling

Comprehensive Addition and Recovery Act (CARA)

- Addresses opioid epidemic

- Naloxone available to police/1st responder

- Expansion of unwanted prescription disposal sites

- Strengthens prescription drug monitoring programs (CT Prescription Monitoring and Reporting System)

Drug development process

1. Discovery / development

2. Preclinical research

3. Clinical research

4. FDA review

5. FDA post-market safety monitoring

Discovery of drugs

- Existing treatments with unanticipated effects

- Technology to target body sites / manipulate genetic material

Development of drugs

Experimentation for:

- Absorption, distribution, metabolism, excretion

- Mech of action

- Best route

- Effectiveness vs. existing drugs

Preclinical research / Types

- Determine dosing / toxicity

- In vivo

- In vitro

What needs to be done before clinical research phase?

Investigational New Drug (IND) Application

Clinical research phases

Phase 1: 20-100 healthy volunteers to assess safety and dosage

Phase 2: 100s w/ disease to assess efficacy and side effects

Phase 3: 1000s w/ disease to assess efficacy, monitor adverse reactions

What needs to be done after clinical research phase?

New Drug Application (NDA) to FDA for review

New Drug Application (NDA)

- Proposed labeling

- Safety

- Abuse information

- Institutional review board compliance information

Post-marketing safety monitoring

Programs for manufacturers, providers, consumers to report issues with approved drugs

Examples of post-marketing safety monitoring

MedWatch - Drugs and devices

Medical Product Safety Network - Devices

Off-label use

- FDA-approved drug prescribed for condition, age, or in a manner not approved by FDA

- CANNOT be marketed for off-label use

Rational prescribing

- WHO aims to reduce medical errors

- "Use what you know"

Common causes of medication errors

- Poor drug distribution practices (mail)

- Drug access by non-pharmacy

- Inadequate pt understanding when leaving appt

Safe medication practices/recommendations

- FDA oversight with similar named drugs

- National reporting systems for reporting errors (makes med errors public, confidential feedback of providers to learn from mistakes)

Improving accuracy of prescription writing

1. Legible; minimal verbal orders

2. Purpose (unless inappropriate)

3. Metric system

4. Age of pt, weight if appropriate

5. Drug name, exact metric weight/concentration, dosage

Indicating dosing strength

- Leading 0 for decimal (0.5 g)

- NO terminal 0 after decimal (5 g NOT 5.0 g)

Information included when writing prescription

Prescriber ID: Name, degree, office address, phone #

Patient ID: Name, address, DOB

Inscription: Name/strength of drug

Subscription

Instructions to the pharmacist of dosage & dosage units

Subscription for controlled substances

Write out quantity as word AND number

Signa (sig)

Instruction by provider to pt

Refills

- Non-controlled can be refilled up to 1 year after date written

- Schedule III-V have 5 refill, 6 month limit

gm

gram

gtts

drops

mcg

microgram

ad

right ear

as

left ear

au

both ears

od

right eye

os

left eye

ou

both eyes

ac

before meals

hs

at bedtime

pc

after meals

q

every

qd

every day

qid

four times a day

tid

three times a day

cap

capsule

tab

tablet

aq

water

Indicating name of drug

- Generic name

- Drug substitution laws allow pharmacist to substitute generic for brand name

Indication substitution CANNOT be made

"dispence as written" DAW

Medications that should not be substituted for generic

- Warfarin

- Digitalis

- Phenytoin

- Levothyroxine

- Theophylline

**Brand and generic can have different effects

Required information of provider when prescribing controlled substances

- Name, address of provider

- Date of issuance

- DEA number

- Signanture

Old pregnancy categories

A-X, progressively worse to fetus

Pregnancy & Lactation Labeling Rule

- All prescriptions removed categories in June 2020

- Clearly described data for complex risk/benefit between prescribers and patients

- Includes male reproductive potential

Questions for providers to consider before writing prescription

- Addressed need to monitor effects?

- Done all to ensure patient compliance?

- Medication cost for patient?

- Shared decision-making with patient? (Improves compliance)

Considerations before deciding to utilize medication in treatment regimen

- Non-drug alternatives FIRST

- Treat underlying cause NOT just symptoms

Adverse effect vigilance

- Education of drug withdrawal symptoms masking disease relapse

- Allows pt to ID adverse early

Barriers to effective communication

Physical — space, white coat syndrome

Personal/emotional barriers

Techniques for effective communication

- Open-ended messages

- "I" messages (can also help pt compliance to meds)

"I" messages

- Providers thoughts/feelings

- What effect the conversation is having on health professional

Providers role in ensuring medication safety

At EVERY visit, verify med history and review med lists

Commonly overlooked medications

- BC

- Inhaler

- Eyedrops

- Patches

- Herbal

- Medications from other providers

Important step in providing culturally competent care

ID and address biases

Technique for communication & empowerment with children/adolescence

- Introduce to child first, inform parent you will be talking directly to child

- Ask child if they have questions for you

Challenges of communication with older patients

- Varying life experiences/backgrounds alter perception of health/illness, willingness to adhere to regiments

- Polypharmacy

Technique for communication & empowerment with older patients

- Appt earlier in day, w/ extra time

- Speak slow, load

- Simplify and write down instruction

- Use chart/models

Challenges of polypharmacy

- Increased risk of drug interactions / adverse rxns

- Increased risk of hospitalization

- Med errors

Guidance to mitigate risks of polypharmacy

- Drug review session

- Advise use of 1 pharmacy

- Advise report of new symptoms to provider

Nonadherence

- Continuing issue → ensure compliance of medications regardless of length taking med

Example of how to ask about if patient can afford medication

"Any concerns about filling this prescription today?"

Techniques on making medications more affordable

- Prescribe half a pill

- Pharmaceutical assistant programs

Identifying drug-seeking behaviors

1. Ensure prescription cannot be tampered with

2. Informed on epidemiology of abuse behavior; signs of toxicity, withdrawal, interactions, etc.

3. 1-provider-1 pharmacy

What can a provider do to ensure safety of a patient with prescription with high potential for abuse and show signs of drug-seeking behavior?

Drugs with potential for abuse → patient sign consent to document agreement with decision-making process/treatment plan, deviation is at patient's own risk