Clinical Pharmacology Flashcards
what are the 3 types of MHRA licenses
- clinical trial authorization: license to test developing drug in clinical trial
- product license/marketing authorization: once the drug has been approved, this license is needed for it to be distributed in the market.
- company license: license for manufacture, distribution, and supply of medicine
what is the main method of reporting of ADRs during the monitoring period of a new drug, and what kinds of things are reported?
Yellow Card Scheme allows healthcare professionals and patients to report ADRs of new drugs
- ADR of a new drug (inverted black triangle means this drug is still under surveillance)
- severe but known ADR of an existing drug (not severe ADR not reported)
- ADR where children are involved
what information must be included on the yellow card? (4)
- the ADR
- the medication
- patient info: gender, age, initials
- reporter’s address (if healthcare profession use work address and not home address for confidentiality)
define unlicensed, off label, and special medications - what implications do these have for the prescriber?
means that these medication are not properly licensed and prescriber would need to take full responsibility of the consequences
- unlicensed - no marketing authorization
- off label - licensed medication, but prescribed outwith the marketing authorization (used for a different purpose)
- specials - slight adjustments to things like formulary of licensed medication to suit the need for a specific patient
classification of medicine (prescribed and over the counter)
- prescription only medicine (POM): only prescribed by certified people, new medications should be POM in the first instance before becoming P medications after years of proven safe use
- over the counter medicine (OTC)
- pharmacy medicines (P): sold in registered pharmacies only
- general sales list medicines (GSL): accessible in supermarkets by the public, P medicines become GSL after years of proven safe use
who has the right to prescribe medicine?
- doctors
- nurse/pharmacist independent prescribers
what things are required in the general prescription? (6)
- patient name + address
- DOB + age (if < 12 yrs)
- medication: name, dose, frequency, quantity
- signed
- dated
- prescriber type + address (work address)
what additional things are required for controlled drug prescription? (4)
- schedule (controls the export/import, distribution, selling, record keeping of controlled drugs)
- formulary + strength
- specify dose
- total dose written in figures AND words
what are some rules to keep in mind when writing down the dosage of any prescribed medicine?
- avoid decimal points
- only use abbreviations for g/mg, the rest of the units should be written out in full
- fluids should be written in weight of the active ingredient instead of the mL, since these all come in different concentrations
what are some rules to keep in mind when writing inpatient PAR/Kardex
- all patients must have a PAR - include their name, DOB, height/weight, date of admission, allergies, etc.
- all of the patient’s medication that they are taking (whether regularly taken (regular therapy) or being prescribed as a one-off drug (as needed therapy)) should be included in the same place
- max 2 PAR per patient at any given time
- write legibly, with permanent ink, and in block capitals
- use 24 hr clock
- refer to medicine with their generic name and not brands (exception is insulin and some inhalers where formulary varies considerable btw different brands)
- insulin and warfarin have separate charts
- prescriber must sign and PRINT their name for every prescribed medication
- to stop a medication, score a line through the medication name AND the rest of the space + sign + date
- if patients don’t need daily medication draw an ‘X’ over the dates where no meds need to be given
- if the time for prescription is not the same as what is given in the chart, the actual time must be written in the space given on the side and nurses must be informed
which of the over-arching body in the regulation of medicine have the final say about the distribution of a new medicine?
the MHRA (medicines and healthcare products regulatory agency)
is MHRA a part of the department of health? Why is it important that this is so?
no, it is not
- important because it prevents the final MHRA decision to be influenced by the public or politics
explain the steps that drug manufacturers must go through when trying to get a marketing authorization for a newly developed drug
preclinical test –> global trial on humans –> make sure benefits > risks –> submit application to national health authorities –> once approved, it will be available on the market, if rejected the company can submit another application –> surveillance period of the new drug
what are the differences between end of life medicines, orphaned medicines, and ultra-orphaned medicine?
- end of life medicines: used to treat a condition where with current treatments will result in death within 3 yrs
- orphaned medicines: medicine for conditions with prevalence < 2,500 ppl in a population of 5 million
- ultra-orphaned medicines: medicine used to treat VERY rare conditions affecting < 1/50,000 ppl
types of approval for use in new formulary additions (4)
- approved for general use
- approved for restricted use under supervision
- restricted funding approved by NHS G under strict use protocol
- approved by SMC, but cost-effective alternatives are available and therefore not recommended for use within NHS G
