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PH1121 - Pharmacy > revision > Flashcards

revision Flashcards

1
Q

what are the general principles of drug movement in the body ?

A

General Principles of drug movement in the body

1.Bulk flow within circulatory systems over long distances
• blood flow, lymph flow

  1. Diffusion in body fluids (extracellular water, intracellular cytoplasm)
  2. Transfer across barriers and membranes
    • epithelial barriers
    • endothelial barriers
    • cell plasma membranes
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2
Q

What are the two major superfamilies of transporters in membranes ?

A

There are two major superfamilies of transporters present in membranes:

ATP-dependent Binding Cassette (ABC) efflux proteins (ABC family)
• P-glycoprotein (P-gp)
• Multidrug Resistance Proteins (MRPs)
• Breast Cancer Resistance Protein (BCRP)

Solute carriers SLC family
• Organic cation transporters (OCTs) 
• Organic cation/carnitine transporters (OCTNs) 
• Organic anion transporters (OATs) 
• Organic anion transporting polypeptides (OATPs) 
• Peptide transporters (PEPT1/PEPT2) 
• Amino acid transporters 
• Monocarboxylate transporters
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3
Q

What are transcellular diffusion and paracellular diffusion ?

A

Transcellular movement, which involves the passage of drug through cells, is the most common route of drug transport.

Some drugs, however, are too polar to pass across the lipoidal cell membrane, and for them, only the paracellular pathway, between the cells, is generally available.

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4
Q

What are the key phases of the drug discovery process ?

A
  • Drug Discovery
  • Drug Development
  • Clinical Trials
  • Manufacturing & Marketing
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5
Q

What are biologics ?

A

Agents derived from a biological source

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6
Q

what are some issues for biologics ?

A

Cost
Delivery challenges
More demanding manufacture, formulation, testing and storage

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7
Q

What is pharmacodynamics ?

A

Pharmacodynamics is the relationship between Concentration and effect – What the drug does to the body

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8
Q

what is pharmacokinetics ?

A

Pharmacokinetics- The relationship between dose and concentration but relationship changes with time.

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9
Q

What does ADME stand for ?

A

Absorption
distribution
metabolism
excretion

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10
Q

Define a clinical trial

A

any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’

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11
Q

Explain lipinskis rule of 5

A 
The rule predicts that good oral bioavailability is when:
Molecular weight is less than 500
Log P is less than 5
No more than 5 hydrogen bond donors
NO more than 10 hydrogen bond acceptors
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12
Q

Why does the body attempt to remove drugs via metabolism ?

A

they are seen as foreign substances

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13
Q

Explain the steps that the body takes in order to remove drugs via metabolism ?

A

Phase 1:
Functionalisation (Usually oxidation reactions and mostly in the liver, catalyzed by cytochrome P450 enzymes)

Phase 2: Conjugation (With a water soluble group such as a sugar, to aid excretion)
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14
Q

Define a bioisostere:

A

Bioisostere: atoms or groups with similar chemical properties but potentially different biological properties

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15
Q

Define clinical governance

A

• Definition : “A framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish”.
or
• Definition: “The recognition and maintenance of good practice, learning from mistakes and improving quality of services provided to patients”.

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16
Q

What is pharmacovigilance ?

A

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

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17
Q

What is an adverse drug reaction ?

A

An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended. This includes adverse reactions which arise from:
• use of a medicinal product within the terms of the marketing authorisation
• use outside the terms of the marketing authorisation, including overdose, misuse, abuse, and medication errors
• occupational exposure
Adverse event – not necessarily caused by administration of drug

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18
Q

What are the two classes of Adverse Drug Reactions ?

A

Type A – Augmented
Due to normal (although exaggerated) pharmacology of drug
Predictable and dose-dependent
Incidence is high – account for majority of reactions (~80%)
Morbidity is high
Mortality is low

Type B – Bizarre

  • Unrelated to normal pharmacology of drug
  • Unpredictable
  • Rarely seen in clinical trials
  • Morbidity and incidence are low
  • Mortality is high
  • Treat by withdrawing drug from patient
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19
Q

What methods are used to assess safety of drugs post-marketing?

A 
§	Cohort studies
§	Case control studies 
§	Record linkage
§	Prescription event monitoring
§	Spontaneous reporting
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20
Q

what is the black triangle ?

A

Medicines under additional monitoring carry a black triangle symbol (an inverted equilateral black triangle (▼)).The black triangle alerts both patients and healthcare professionals (HCPs) that the medicine is being closely monitored by European regulatory authorities. The black triangle is a mechanism to strengthen monitoring and to actively encourage patients and HCPs to report any possible adverse reactions observed with these medicines. The black triangle symbol does not mean that a medicine is unsafe for use in patients, it just highlights that all information on the safety of the product should be gathered.

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21
Q

Give a list of as many things as possible that an advert for medicine must do.

A

All adverts for medicines must:
§ Comply with particulars in SmPC
– Only for patients and diseases for which it is licensed
§ Encourage rational use of medicine by presenting it objectively and without exaggerating its qualities
– Factual accuracy which can be verified, how / when to take, refer to limitations etc.
§ Not be misleading
– E.g. with regard to potential risks / benefits
§ NB applies to internet / broadcasts as well as written materials
§ Only allowed for P / GSL meds (except approved vaccination campaigns)
§ Can’t advertise to children (<16y)
§ No improper / alarming / misleading terms re claims of recovery
§ Can’t say health enhanced by taking / affected by not taking
§ Can’t imply seeing Dr or Pharmacist is unnecessary
§ Must be clear it is an advert for a medicine
§ Must contain name (and common name if one / active ingredient)
§ Must contain info for correct use of medicine (at least one indication)
§ Must contain instruction to read the label / leaflet
§ NB if there are conditions associated with use e.g. first need medical diagnosis then advert should make this clear

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22
Q

What further rules should adverts to the public obey ?

A

§ Can’t suggest better than / equivalent to another identifiable product
§ Can’t say effects are guaranteed
§ Can’t suggest no side effects
§ Can’t suggest efficacy / safety due to being natural
§ No case histories which may lead to incorrect self-diagnosis

§ No recommendations by
– scientists or healthcare professionals
– celebrities who, because of their celebrity, could encourage consumption of products
§ Can’t suggest product is “special” because it has been granted a marketing authorisation / registration
§ Can’t state that product has MHRA or Department of Health “approval”

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23
Q

Give 3 roles of NICE

A

§ Produces evidence-based guidance and advice for health, public health and social care practitioners (NICE guidelines - England, technology appraisals guidance etc.)
§ Develops quality standards and performance metrics for those providing and commissioning health, public health and social care services (quality standards for improvements, Quality Outcomes Frameworks for GPs, Clinical Commissioning Group Outcomes Indicator Set)
§ Provides a range of information services for commissioners, practitioners, managers (NHS Evidence, providing access to BNF/ cBNF, medicines and prescribing support)

24
Q

Name 4 social economic factors that may influence how and if a patient is taking their medication:

A

Cost of medication if patient has to pay
Low literacy / health literacy
Pattern of work e.g. shifts
Lack of family or social support

25
Q

Name 5 therapy related factors that may influence how and if a patient is taking their medication:

A 
Failure to see immediate benefits
Side-effects, or fear of
Complexity of the treatment regimen
Frequent changes in treatment regimen
Previous experience with treatment failures
26
Q

Name 5 patient related factors that may influence how and if a patient is taking their medication:

A

Hearing impairment (verbal information)
Poor eyesight (written information)
Age (e.g. possible swallowing difficulties)
Understanding of disease/treatment
Attitude towards disease/treatment
Level of involvement in treatment decisions

27
Q

Give 5 condition related factors that may influence how and if a patient is taking their medication:

A

Symptomatic (e.g. acne) vs. asymptomatic (e.g. high blood pressure) conditions (if people can see the illness they are possibly more likely to want to take the medication so that they can see results
Acute (e.g. cold) vs. chronic (e.g. arthritis) conditions
Severity of disease
Rate of disease progression
Availability of effective treatments

28
Q

Give 4 healthcare system related factors that may influence how and if a patient is taking their medication:

A

Clinical tools/time/reimbursement to address problems
Understanding of patient factors
Communication of treatment decisions between members of healthcare team and between HCPs and patient
Training of HCPs

29
Q

Give some examples of unintentional non-adherence:

A
  • Forgot to take / difficult to remember
  • Too busy / inconvenient
  • Did not have them with me / away from home
  • Time of week (weekend, evenings)
  • Timing (exact time, inconsistent intervals, in relation to food)
  • Change to routine
  • Difficult to swallow / no water
  • Dosing complexity
  • Dropped some of the medicine
30
Q

Give some examples of intentional non-adherence

A
  • No symptoms to remind me
  • Did not feel it was important to me
  • I was not actually feeling ill or unwell
31
Q

how could you improve adherence to taking medication ?

A
  • To improve adherence you need patient-centred care
  • Collaboratively work with patients to understand their perspective, support them to make better-informed decisions and manage their own health and care
  • Standards of conduct, ethics and performance
  • NICE CG76: Involving patients in decisions about prescribed medicines and supporting adherence
  • Everything we teach you in the MPharm has patient-centred care at its core!
32
Q

Explain what DNA microarray is.

A

a technology that investigates how genes interact with one another and how they control biological mechanisms in the body.
The heart of the technology is a glass slide or membrane that consists of a regular array of genes
Thousands of genes can be spotted on the array, using a photolithography method. DNA samples extracted from healthy and diseased cells are mixed with the genes on the array. In this way, many genes can be studied, and their expression levels in healthy and diseased states can be determined within a short time. The gene that is responsible for a particular disease can be identified.

33
Q

How do we make better drugs ?

A

By altering the chemical structure of a molecule to interact with its biological target in a more effective manner. Determine structure activity relationships (SAR).

34
Q

Why are drugs with chiral centres avoided where possible ?

A

Stereoisomers often have very different biological properties often causing drug toxicity.
enantiomers are often metabolised and exerted differently.
stereoisomers are difficult to synthesise and manufacture

35
Q

When screening drugs is the drug more active with a higher or lower IC50 score ?

A

lower.

36
Q

Explain why the delivery of biologics is complex.

A
  • their instability to environmental triggers such as moisture or temperature make them some of the most challenging molecules to formulate and deliver.
  • The high MW of biologics causes a substantial reduction in permeability across biological barriers, which means that injection is currently the primary mode of administration.
37
Q

What is important about disposition processes ?

A

The disposition kinetics (DME) of the drug remain unchanged by the route of administration

38
Q

what is steady state ?

A

Steady state means that the peak in concentrations of a drug with multiple doses are the same and the troughs in concentrations are the same.

39
Q

explain solubility.

A

Solubility is the property of a solid dissolve in a liquid to form a homogeneous solution. The solubility depends on the physical and chemical properties of the solute and solvent as well as on temperature, pressure and the pH of the solution.

40
Q

Please describe first order elimination kinetics. how is this different to zero order kinetics ?

A

1st order kinetics - occur when a constant proportion of drug is eliminated per unit time
Rate of elimination is proportional to the amount of drug in the body
for zero order- a constant amount of drug is eliminated per unit time.
Rate of elimination is constant and independent of the total drug concentration in the plasma.

41
Q

Define the elimination half life of a drug.

A

The elimination half-life of a drug is a pharmacokinetic
parameter that is defined as the time it takes for the
concentration of the drug in the plasma or the total
amount in the body to be reduced by 50%.

42
Q

can all drugs diffuse through cell membranes ?

A

Only unbound drug is capable of diffusing through cell membranes. Proteins, and hence protein-bound drugs, are much too large to do so. Hence, the unbound concentration, not the total concentration, is the driving force for drug transport across a cell membrane.

43
Q

What is distribution limited by ?

A

Distribution can be rate-limited by either perfusion (a delivery limitation) or permeability (ease of crossing a membrane). A perfusion rate limitation prevails when the tissue membranes present essentially no barrier to distribution.

44
Q

quality assurance vs quality control

A
  • QA involves the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the production process.
  • QA includes regulation of the quality of services, raw materials, assemblies, products and components related to production, and management, production and inspection processes.
  • QC emphasizes testing of products to uncover defects, and reporting to management who make the decision to allow or deny product release.
  • QA attempts to improve and stabilize production, and associated processes to avoid, or at least minimize, issues that led to the defects in the first place.
45
Q

What are the two main classes of drugs ?

A

“the two main classes of drugs are small molecules and biologics”

46
Q

what is a biologic agent ?

A

A biologic agent: A product produced from living organisms or that contains components of living organisms. These drugs are made using biotechnology

47
Q

Where do candidate drug molecules come from?

A
  • Natural sources (plant, marine, animal, mineral)
  • Endogenous compounds
  • Existing compounds (‘me-too’)
  • Chemical libraries
  • In silico modelling/screens
48
Q

What are some central aspects of GxP

A

Some central aspects of GxP are:
• Quality: to ensure a product is safe and meets its intended use.
• Traceability: the ability to reconstruct the development history of a drug or medical device.
• Accountability: the ability to resolve who has contributed what to the development and when.
• Efficiency: to improve the efficiency of the processes through standardization and “best practice”.
• Consistency: to ensure consistency of the product through process controls.
• Clarity: to ensure personnel, reviewers and other stakeholders can understand the function of process controls.

49
Q

What are the three R’s of animal research and what do they refer to ?

A
  • Replacement refers to methods that replace or avoid the use of animals in
  • areas where animals would have otherwise been used
  • Reduction refers to methods which minimise animal use and enable researchers to obtain comparable levels of information from fewer animals or to obtain more information from the same number of animals, thereby reducing future use of animals
  • Refinement refers to improvements to husbandry and procedures that minimise actual or potential pain, suffering, distress or lasting harm and/or improve animal welfare in situations where the use of animals is unavoidable
50
Q

What is the primary aim of formulation ?

A

To ensure that the drug can carry out its intended therapeutic effect by reaching its TARGET at an ADEQUATE CONCENTRATION for an ADEQUATE TIME

51
Q

Explain why amantadine is a non-polar drug and vitamin C is a highly water soluble organic molecule.

A

Amantadine has a complex, and almost entirely hydrocarbon structure (i.e. mostly comprised of “CH” groups. It has one polar group (NH2) but this is against 10 Carbons. Therefore amantadine is non-polar.
Vitamin C has four very polar OH groups and a further two polar O atoms (compared with 6 carbons). Therefore vitamin C HIGHLY polar and hence water soluble (since water is a polar solvent and “like-dissolves-like”.

52
Q

. Can all drugs be formulated as a salt?

A

NO. Only drugs that contain acidic functional groups (e.g. CO2H) or basic functional groups (e.g. NH2) can form salts.

53
Q

Explain why is it desirable to use Lipinski’s Rule of Five very early in the drug development process.

A

To be successful a new drug has to be effectively delivered to a patient. The most effective delivery method to ensure patient compliance (and low cost) is the oral route. Lipinski’s rule can predict very early in the design process IF a molecule is likely to be a candidate for oral delivery. If it is NOT the developers could consider changing the structure to ensure that it is. Such changes must be made early in the development process, it could be impossible to change later, and could even cause the project to fail.

54
Q

. Explain why important, lifesaving cancer drugs such as paclitaxel have to be given by injection. Wouldn’t it be better to formulate them as a tablet?

A

Natural products are an important source of chemical diversity. Would a human scientist think to make paclitaxel (NO!). Their important medicinal properties cannot be ignored, even if it is NOT possible to deliver them by the oral route. Paclitaxel is hard to deliver, but the effort and cost is worth it for treating serious disease.

55
Q

Explain why is it so important that drug development occurs rapidly?

A

Primarily the reason for rapid drug development is economics. Drug development is very expensive (£1bn to bring a new drug to the market). A patent is essential for development and grants a monopoly for the developer. Patents last 20 years so the faster that a drug can be licenced – the more profit will be made. This is required to recover investment costs. Patients also benefit – get a new drug sooner – and also profits will be invested in new research for new treatments.

PH1121 - Pharmacy (1 decks)

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