Pharmacy Law 2

PPCP

pharmacist use a patient centered approach in collaboration with other providers and on health care team to optimize patient health and medication outcomes

Collect

The pharmacist assures the 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

The pharmacist assesses the information collected and analyzes the clinical efforts of the patients therapy in the context of the patients overall health goals in order to identity and prioritize problems and achieve optimal care

Plan

The pharmacists develops 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

The pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregover

Follow-up: Monitor and Evaluate

The pharmacist monitors and evaluates the effectiveness of the care plan and modifies the plan in collaboration with other health care professionals and the patient or caregiver as needed.

Patient

Anyone under the care of any healthcare provider

Adherence

the extent to which an individual's behavior, taking a medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider

Compliance

The range of patient conformity to the recommendations about day-to-day treatment by the provider with respect to the timing, dosage, and frequency

Factors influencing adherence

Social/economic

Condition related

Patient related

Therapy related

Health system

Culture

Shared system of values, beliefs, and learned patterns of behavior

Health literacy

the degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make appropriate health decisions

Public health

the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals

primary prevention

prevents an illness or injury from occurring at all

Secondary prevention

minimizes the severity of the disease or injury once it has occurred

Tertiary prevention

minimizes disability by providing medical care and rehabilitation services

Primary examples

Immunization

Tobacco cessation programs

Needle exchange programs

Micro nutrient supplementation programs

Secondary example

Pap clear

Mammography

Colonoscopies

Blood pressure screening

Tertiary example

Occupational and physical therapy in burn patients

Cardiac rehab in post heart attack patients

Diabetic foot care

Epidemiology

Seeks to describe the distribution and determinants of disease, injury, mortality, and other health outcomes

Diagnostic discipline of public health

Is a major part of public health assessment function

Investigated cause of diseases

Identifies trends in disease occurrence

Evaluates effectiveness of medical and public health interventions

Epidemiology def

The study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to the control of health problems.

94 C Section 17

No II can be dispensed without a electronic script unless in emergency

What is an emergency?

Patient needs controlled substance asap and it's not possible to send it electronically

II script is invalid

30 days after date of issuance

II requirements

No refills and script must be kept in a separate file pharmacist filling needs to endorse their signature on the face

94 C Section 23 D

II or III can be a 90 day supply if it's for opioid use disorder (Suboxone) its not an opioid (meth and testosterone) or it's an implantable infusion pump everything else has to be 30

94C Section 23 EFG

All control substances scripts need to be kept for 2 years (10years Medicare)

No refills unless stated

Prescribers should do electronic script s

94 C section 23 H

Scripts by Vets can be oral

Tech failure

Economic hardship on practitioner

Emergency

No electronic under fed and state laws

Scripts outside jurisdiction commonwealth

94C Section 23 I

All written prescriptions should be written in ink, indelible pencil or by other means on a tamper resistant form consistent with federal requirements for Medicaid and signed by the prescribing practitioner

105 CMR 721 A

Electronic scripts in accordance with 105 CMR 721.000 and include electronic signature unless it's in accordance with exception list 105 CMR 721.070

105 CMR 721 B

Has to say no substitution to be brand name

Medicaid scripts

Must be tamper resistant

Failover

Oral script and doesn't need a written follow up if it has all the info but signature of doctor

94C section 22 C

Notation that says the patient can fill upon request a lesser amount of the script

105 CMR 721.50

Only one script per blank

Medication order can have many drug products on it

Patient request for partial of II

if the patient request a partial they have to to 30 days to fit it for in and out of state scripts as long as it's before 5 days after initial fill

Remainder of script must be filled at same pharmacy and within 30 days of when script was issued

Must make a notation of the partial and how many were dispensed

105 CMR 721.060

Written script needs to be attached to oral one and DEA has to be notified if no written one is provided

Oral and written ok when

Script is from a vet

Tech is out

Practitioners who have applied for and received a waiver pursuant

Scripts in emergency situations

Scripts that can't be electronic

Script issued under commonwealth of MA

scripts for treatment of chlamydia which needed to be dispensed to patients partner

Scripts for compounded drug preps

Scripts for VI

Scripts for durable medical equipment

Scripts issues prior to Jan 1 2025 to residents I, II, III Long term care facilities

Scripts for public health emergency or for treatment STIs

CMR 721.070 needs written script for II-V in

7 business days

94 C section 20

Electronic script needed within 2 days after oral or written in 7 days if they exempt from electronic

Practitioner defined MGL 94 C

A

A physician, dentist, vet, podiatrist, scientific investigator or other person registered to distribute, dispense, conduct research with respect to or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research in the commonwealth

Practitioner B

A pharmacy, hospital, or other institution registered to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional price or research in the commonwealth

Practitioner C

An optometrist authorized by sections 66, 66B, and 66C of chapter 112 and registered pursuant to paragraph (h) of section 7 to utilize and prescribe therapeutic pharmaceutical agents in the course of professional practice in the commonwealth

Practitioner D

A nurse anesthetist registered pursuant to subsection (f) of section 7 and authorized by section 80H of chapter 112 to distribute, dispense, conduct research with respect to or use in teaching or chemical analysis a controlled substance in the course of professional practice or reaserch in the common wealth

Practitioner F

A physiocratic nurse mental health clinical specialist registered pursuant to subsection (f) of section 7 and authorized by section 80J of chapter 112 to distribute, dispense, conduct research with respect to or use in teaching or chemical analysis a controlled substance in the course of professional practice or research in the common wealth

Oral script can be issued to a pharmacist by who to the practitioner

An expressly authorized employee or agent of the practitioner

Why was the food drug and cosmetic act of 1938 created?

Elixir sulfonamide 1937

1937 Elixir Sulfanilamide Incident

73-107 deaths from new oral preparation of sulfa with antifreeze no law so no real issue

1946

Hospital surgery and construction act

1951

Durham-Humphrey Amendment created prescription drugs

1965

Tittles XVIII and XIX amend 1935 social security act to create Medicare and Medicaid

Health Maintenance Organization (HMO) 1973

Increased prevalence of managed care and cost containment

Diagnosis related groups

Creates incentive for hospitals to discharge patients sicker and quick

Pharmaceutical care

the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life

Outcomes of pharmaceutical care

-Cure of disease-Elimination or reduction of a patient's symptomatology

-Arresting or slowing of a disease process

-Preventing a disease or symptomatology

Basic functions of pharmaceutical care

-identify potential or actual drug-related problems

-resolving actual drug-related problems

-preventing potential drug-related problems

Medication therapy management

- similar to pharmaceutical care Emphasizes importance of medications in public health and safety and recognizes importance of health care collaboration

Pharmaceutical care barriers

1. Drug focus

2. Service focus

3. Other healthcare professionals

4. Lack of incentives

5. Logistical

Medicare Prescription Drug Improvement and Modernization Act of 2003

Medicare Part D

1st professional pharmacy organization

American pharmaceutical association (APhA) in 1852. Now called the American pharmacists association with state affiliates

ASHP

American Society of Health-System Pharmacists

Amcp

Academy of Managed Care Pharmacy

1. This law prohibited the adulteration and misbranding of foods and drugs in interstate commerce. The law fell short of short of providing that protection that Congress intended, because of a US Supreme Court decision held that the misbranding provision in the law did not prevent false of misleading efficacy claims.

Pure Food and Drug Act

1. This law along with amendments forms the nucleus of todays' law. It provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. This law also expanded the definitions of misbranding and adulteration, requiring that labels must contain adequate direction for use and warning about the habit-forming properties of certain drugs.

Food, Drug, and Cosmetic Act of 1938 (FDCA)

1. This amendment established two classes of drugs-prescription and OTC- and provided that the labels of prescription drugs need not contain "adequate directions for use" so long as they contain the legend "Caution: Federal law prohibits dispensing without a prescription". This amendment also authorizes oral prescriptions and refill of prescription drugs.

Durham-Humphrey Amendment of 1951

1. This amendment requires that components added to food products receive premarket approval for safety. Also contain in this law is the anticancer provision (Delaney Clause) which prohibits the approval of any food additive that might cause cancer.

Food Additives Amendment of 1958

1. The amendment requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics. Under this amendment the FDA can approve a color for one use but not for others (e.g. external use only).

Color Additive Amendments of 1960

1. This amendment is also called the Drug Efficiency Amendment, it strengthen the new drug approval process by requiring that drugs be proved not only safe but also effective. The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962. In addition, the amendment also transferred jurisdiction of prescription drug advertising form the FTC to the FDA, established GMP requirements and added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions.

Kefauver-Harris Amendment of 1962

1. This amendment requires classification of devices according to their function, premarket approval, establishes performance standards, conformance of GMP requirement and adherence to record and reporting requirements of medical devices.

Medical Device Amendment

1. Congress passes this Act to provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of "rare diseases or conditions (defined as those affecting fewer than 200,000 Americans.)

Orphan Drug Act

1. Also called the Waxman-Hatch Amendment, that act was enacted to streamline the generic drug approval process while giving patent extensions, in certain cases, to innovator drugs.

Drug Price Competition and Patent Term Restoration

1. Congress enacted this act in response to the growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening the public health and safety. Further this law establishes sales restrictions and record keeping requirements for prescription drug samples and prohibits hospitals and other healthcare entities from reselling their purchases to other businesses and requires the state licensing of drug wholesalers.

Prescription Drug Marketing Acts

1. This act further strengthened the Medical Device Amendment giving the FDA additional authority especially related to post marketing requirements and premarket notification and approval, while expediting the premarket device approval process.

Safe Medical Devices Act

1. This act resulted from a scandal that occurred when some FDA staff accepted bribed from generic drug industry personnel in order to facilitate the approval process of certain generic drug products. This law authorizes the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.

The Generic Drug Enforcement

1. The act requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies. The fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and speed up the NDA reviews. In addition, this Act must be reauthorized every 5 years.

Prescription Drug User Fee Act

1. The Act mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as that are made in compliance with FDA regulations.

Nutrition Labeling and Education Act of 1990

1. This act defines dietary supplements and permits manufacturers to make certain claims that otherwise would be illegal under the FDCA. Under this Act FDA regulates dietary supplements more as foods than as drugs.

Dietary Supplement Health and Education Act of 1994

1. This act was passed primarily to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. The intent of this act is to eliminate backlogs in the approval process and ensure the timely review of applications. This act creates a fast-track approval process for drugs intended for serious or life threatening diseases, establishes a databank of information on clinical trials, authorizes scientific panels to review clinical investigations and expands the rights of manufacturers to disseminate unlabeled use information. This act also expands the FDA's authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients.

The law also affects the regulation of medical devices in part by mandating priority review for breakthrough technologies in medical devices and allowing the FDA to contract with outside scientific experts for review of medical device applications.

Food and Drug Administration Modernization Act

1. This act established user fee requirement for premarket reviews of medical devices and also established performance goals for many types of premarket reviews, inspections that can be conducted at establishments by accredited third parties and new regulatory requirements for reprocessed single use devices. This also must be renewed by Congress every 5 years.

Medical Device User Fee and Modernization Act

1. This act reauthorized and amended many drug and medical device provisions that were set to expire, also provided the FDA with new funding and significantly more authority over drug safety. This act allows the FDA broader use of the fees generated by PDUFA, while increasing the fees. The law also provides the FDA with significantly enhanced responsibilities and authorization to regulate drug safety, authority to mandate labeling changes related to safety, require clinical trial data reporting and registries, require postmarket clinical studies to assess risk, and require companies to implement risk evaluation and mitigation strategies (REMS) when necessary.

Food and Drug Administration Amendments Act

1. The law allows the FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals. It also adds the Generic Drug User Fee Act and Biosimilar User Fee Act. The purpose of imposing fees on these manufacturers is to increase resources for the FDA in order to speed the generic drug and biosimilar approval process. The law also contains several provisions directed at reducing drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines. Additionally this law enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.

FDA Safety and Innovation Act

1. Two titles under this act. Title 1 also called the Compounding Quality Act, clarifies and strengthens FDA oversight over pharmacies engaged in the large scale compounding and shipping of sterile products to other licensed entities. The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMOP, labeling and the new drug approval process. Title II known as the Drug Supply Chain Security Act, adds "track and trace" requirements for all entities in the chain of distribution of pharmaceutical products. Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers. The law also mandates an electronic, interoperable product tracing system by 2023, strengthens wholesaler and third party logistics licensure requirements and requires manufacturers to serialize drugs by 2017.

Drug Quality and Security Act

1. This Act was passed in large part to streamline and add flexibility and innovation to the drug development and approval process, primarily by creating new clinical trial design options and by accelerating the pathways to market for drugs intended to treat certain serious or life threatening diseases. This law also provides for billions of dollars of additional funding to the National Institute of Health (NIH).

The 21st Century Cures Act of 2016

1. This act reauthorized the user fee programs and enhanced the goals of the Cures Act and created a new category of OTC hearing aids.

FDA Reauthorization Act

1. Describe the composition of the Massachusetts Board of Pharmacy (Board).

8 pharmacists, 1 technician, 1 nurse, 1 representative of the public with experience in health care service delivery of the public administration or consumer advocacy, 1 physician, 1 expert in patient safety and quality improvement.

Of the 8:

2 from independent

2 from chain

1 hospital

1 long term care

1 in sterile compounding

1 from academic or scholarly position

1. How many members are on the Board?

13

1. What are the requirements to becoming a Board member?

Pharmacists need 7 years of consequtive yyear's experience and employed in the commonwealth of ma

7 years as a tech and employed in commonwealth

No disciplinary action with board or DEA and have to have a clean record 10 years before being appointed on the board

1. Who appoints the Board members?

The governor

1. What are the experience requirements for a Board member?

2 from independent

2 from chain

1 hospital

1 long term care

1 in sterile compounding

1 from academic or scholarly position

1. How is an Independent Pharmacist defined?

Has 9 or fewer stores in commonwealth and less than 20 full time pharmacies

1. How is a Chain Pharmacist defined?

10 or more pharmacies

1. What is the term of years that a Board member can serve?

3 years

1. Can a Board member be re-appointed

Yes but no member can serve more than 2 consecutive terms on the board

1. What are the requirements for a Board Meeting?

The board shall meet on the first Tuesday of December in each year at such time and place as it may determine, and shall organize by electing a president and secretary, who shall be members of the board, and shall hold their offices for one year. The secretary shall give to the state treasurer a bond, with sufficient sureties to be approved by the governor and council, for the faithful performance of his official duties. The board shall annually hold regular meetings on the first Tuesdays of January, May and October, and additional meetings at such times and places as it shall determine. A member may serve up to 1 year as secretary and up to 1 year as president during any single term.

1. How often does the Board meet?

The first Tuesday of December each year

1. Can the Board appoint agents? If yes, describe who the agents are and their roles.

Yes, inspect drug stores and should make a report of that to the board. Agents are the Board of Pharmacy inspectors.

1. What training is required for Board agents?

Chapters 795(nonsterile compounding) and 797(sterile compounding) of the USP.

2012: New England compounding center, they weren't trained in 795 and 797