Medicine And Law Part 2 Flashcards
1
Q
What legislation governs the sale and supply of medicines?
A
- The Medicines Act 1968
- The Human Medicines Regulations 2012
2
Q
What is the purpose of The Medicines Act 1968?
A
- Regulates the use of medicines in the UK
- Medicines must obtain a Marketing Authorisation from the MHRA
3
Q
Define a medicinal product:
A
- Any substanve or combination of substances presented as having properties of preventing or treating diseases in humans
Or - products which may be used or administered to human beings with a view to restore, correct or modify physiological function by exerting a pharmacological, immunlogical or metabolic action
Or - Products to make a medical diagnosis
4
Q
Define medicinal purpose:
A
Used for:
- Treating or preventing disease
- Diagnosing disease or ascertaining the existence, degree or extent of a physilogical condition
- Contraception
- Inducing anesthesia
- Preventing or interfering with the normal operation of a physiological function
5
Q
Describe the purpose of getting medicinal products licensed:
A
- New medications are granted a licence under The Human Medicines Regulations 2012
- This follows intensive research and trials into safety and effectiveness
- Sets out indications for use as well as the appropriate dose
- Prescribing and supply outside of the licence carries implications of greater liability for both the prescriber and the pharmacist
6
Q
What are the three classes of medicines for human use:
A
POM
P
GSL
7
Q
Discuss the restrictions of POM medications:
A
- Generally supply is restricted to requiring a prescription from an appropriate practitioner (authorised prescriber)
- Originally only doctors, dentists and vets could prescribe (medical prescribers)
- Now some other healthcare professionals invluding pharmacists may qualify to prescribe these (non-medical prescribers)
- In some emergency situations pharmacists can supply these medicines without a prescription
8
Q
What is a medical prescription?
A
- A communicaiton between the prescriber and the pharmacist
- Can be via a paper documnet, electronic communication or verbally communicated
- An order for a medicine for a particular individual with instructions for use
9
Q
What is a prescription?
A
- An order or instruction to supply medicine to an indivdually named patient
- Written and issued by an appropriate practitioner (authorised prescriber)
- By law it must contain certain information
- Legal requirments are determined by both the type of prescription and the medicinal product itself
10
Q
List the legal requirements of private prescriptions:
A
- Written in indelible ink (e.g. typewriting or computer generated)
- Signed in ink by the appropriate practitioner (prescriber) giving it
- Address of the appropriate practitioner giving it
- Appropriate date
- An indication of the kind of the appropriate practitioner giving it
- Name and address of the patient
- The persons age if the patient is under 12 years old
- Not dispensed after the end of the period of six months of the appropriate date (unless repeatable)
11
Q
Patient details legally required for a prescription:
A
- Name of the patient (ideally the full name and title)
- Address, enough that you can locate the person again but does not legally have to include the postcode
- Age is required only if the patient is under 12 years old
(Date of birth is not legally required)
12
Q
A prescriptino has been generated for a medicine. What information must be provided in regards to the medicine supplied?
A
- Name of the medicine
- Strength of the medicine
- Dosage of the medicine
- Formulation of the medicine
- Total amount to be dispensed (legal requirment for NHS prescriptions only)
- Directions for use (how to take/use the medicine, can be written ‘as directed’)
13
Q
What should you do if a prescription is incomplete?
A
- Attempt to contact the prescriber to confirm intentions
- Return the prescirption to the prescriber for details of quanitity, strength and dose to be inserted
14
Q
What prescriber details must be written on a prescription?
A
- Address opf the prescriber
- Details of the kind of prescriber (indicaiton of qualifications) (Can include registration number or post-nominal letters)
- For Doctors and dentists, they can be registered in the Uk, EEA or switzerland
15
Q
Discuss repeatable POM medicine prescriptions:
A
- Repeatable prescriptions may be dispesned more than once
- Can only be Private Prescriptions
- All the usual legal private prescription requirements must be met
- FIrst dispensing must be within six months for POM medicines and 28 days for controlled drugs
- Prescriptions must be recorded in the private prescription register
- The prescription must state repeat and can state how many times a prescription can be repeated (except from OCP’s)
- For most POM medicines, if the prescription states repeat it can be dispensed twice - the original dispensing and one repeat
- If a prescription states ‘repeat x3” it can be dispensed 4 times
16
Q
Discuss controlled drug repeatable prescriptions:
A
- No repeatable prescriptions for schedules 2 and 3
- Schedule 4 and 5 drugs can be repeated
- First dispensing of schedule 4 drugs must be within 28 days
- First dispensing of schedule 5 drugs must be within 6 months
17
Q
Discuss oral contraceptive repeatable prescriptions”
A
- Private prescriptions only
- All usual legal requirments of private prescriptions must be met
- First dispensing must be within 6 months
- Prescription must be recorded in the private prescriptino register
- If the prescription states repeat and there is no number of repeats stated, the prescription may be dispensed 6 times within 6 months of the appropriate date
18
Q
Discuss the record keeping and endorsements required for private prescriptions:
A
- Record all the information required for a private prescription
- Include the information about the repeat
- Ensure you allocate a referene number
- State whether this is the first, second or third etc supply
- Stamp the prescription with the pharmacy name, address and write the date of dispensing and reference numberon the prescription
- On the final dispense, the pharmacist keeps the prescription and must retian it for 2 years
19
Q
How could you check to ensure that prescriptions have not been forged?
A
- Scrutinise the signature and check against an example that is known to be genuine
- Check large doses or quantities with the prescriber in order to detect alterations to previously valid prescriptions
- IS the quantity large or excessive?
- Are they appropriate for the condition being treated?
- Do you know the prescriber?
- Do you know the patient?
- Does the prescription appear to have been altered?
- Is the medicine one that is commonly misused?
- Does the patient appear to be nervous or agitated?
20
Q
Discuss the risks of faxing prescriptions
A
- A fax of a prescription does not meet the legal requirements
- It has not actually been signed by the practitioner
- It is not indelibly written and can fade
- It does indicate that the prescription exists but not that it is a legal prescription
- It could have been transmitted to more than one pharmacy
- Often not clearly legible so could be a source of error
21
Q
What does ‘name of the medicine’ indicate?
A
- Can be a branded name, also known as a proprietary name. If prescribed by this name, that is what must be supplied
- Generic name - unbranded so any brand can be supplied
- May be a single active ingredient or a combination of more than one active ingredient
- Can sometimes indicate a strength in the name e.g .’forte’
22
Q
What does ‘formulation’ indicate?
A
- Can be solid forms or liquids, to be used on the skin, injected, swallowed
- Syrup, tablet, capsule, pessary, suppository, patch, injection, infusion, cream, ointment, drops, sprays, suspension, rub etc
- The form in which the medicine is presented for the patient to use
23
Q
What does ‘strength’ indicate?
A
- Generally expressed as the amount of active ingredient in a dosage unit
- DOsage unit is dependant upon the formulation
- Strength may be expressed as a concentration e.g. 30% or 25mg/5ml
- Strength is not the same as potency
24
Q
What does ‘dose instructions’ indicate?
A
- Hhow much, how, when and for how long a medicine should be used
- Usually the number of dosage units a patient has to take at any one time along with instructions for how often it should be taken
- Dosage units can be tabley, capsule or even 5ml spoonful
25
What does ‘quantity’ indicate?
- Can be written as the total amount to be supplied e.g. 500ml of a 5mg/5ml syrup
- Or number of original packs (OP) e.g. 2xOP where the OP might be a packet of 28 tablets
- The number of dosage units to be supplied e.g. 28 tablets
26
What information must go on a dispensing label?
- The name of thr person that the product is for
- The date in which the product was sold or supplied
- Name and address of the supplying pharmacy
- Name of the product or its common name
- DIrections for use
- Precautions related to use
It is a professional requirment to inlcude the quantity in the container as well as the pharmacy phone number and check boxes.
Professional requirement ‘Keep out of sight and reach of children’
Legal requirement ‘Keep out of reach of children’
27
Can dispensing labels be handwritten?
- It is good practice but not a legal requirement to produce labels using a computer or typewriter
- Computer generated labels will automatically contain the required caution and advisory labels
- Labels can be handwritten but must contain all of the required information
28
Where should the dispensing label be placed?
- Medicines can be dispensed in glass/plastic bottles or into white cardbaord cartons; in this case, the laebl is fixed where it can be clearly seen by the patient
- If the manufacturers container is supplied, these often have a space for fixing the label, otherwise try not to cover up information that may be important to the patient
29
Discuss the uses of a patient information leaflet
- It is a legal requirement for a PIL to be supplied with every licensed medicine
- This is generated as part of the licensing approval process by the manufactuere
- The PIL is aimed at the medicine user and provides them with important information about the medicine
- The pharmacist must supply a copy of the PIL even if a part pack of medicine is dispensed
30
When are private prescriptions issued?
- If an appropriate practitioner (authorised prescriber) is consulted by a private patient
- Blacklisted medicines (those that are not permitted to be supplied on the NHS)
- Holiday or travel medicines including those for use outside of the UK
- Prescription written by a EEA doctor or dentist (not NHS or UK registered)
31
Discuss how private prescriptions are priced:
- Pricing is determined by the pharmacy
- There is no recommended price
- Price covers the cost of items and costs involved in dispensing such as time, counselling ,container and profit margin
- No VAT is chargeable if it is a medicine for human use
32
Discuss prescription retention and prescription records:
- Retain (keep) prescriptions for 2 years
- If prescriptoino is repeatable, retain for 2 years from final supply of medication
- Records must be made in the prescriptino record book and this must be retaiend in the pharmacy for 2 years after the final entry
33
What is the purpose of the prescription Record (register)?
- A written or computerised entry in the prescription only register
- Must be a bound book for paper records
- Can be electronic if the system meets legal requirements
- Record every sale or supply of a POM medicine unless It is:
- An NHS supply or an oral contraceptive
- A medicine which has to be recorded in the controlled drugs register
- Wholesale transacion with invoice and order number retained
34
What information must be written in the private prescription register:
- Date the supply was made
- NAme and address of the patient
- Name, quantity, form and strength of the product supplied
- Date on the prescription
- Name and address of the prescirber
- Date orescription was received
35
What are some restrictions on prescribing?
- All precribing should relate to the practitioners area of competence e.g. a detists to oral hygeine areas of prescribing
- Independent prescirbers are able to prescribe from a wide range of medicines with a few restirctions
- Supplementary prescribers can only authorise prescriptions in relation to the clinical management plan agreed with an independent presciber
- NHS prescribers may be subject to greater restrictions
36
What are the two main groups of people authorised to write prescriptions for POM under the human medicines regulations 2012
1. Medical prescribers
| 2. Non-medical prescribers
37
What are examples of medical prescirbers?
- Doctors
- Dentists
- Vets
- They are independent prescribers
Includes EEA or swiss registered doctors or dentists
38
What can doctors prescribe?
- Doctors can write prescriptions for any POM, P’s and GSL’s
- The misuse of drugs act 1971: Doctors can prescirbe all controlled drugs
- Under the NHS, doctors are not permitted to prescribe medicines on the NHS selected lists
- NHS prescription forms
- FP10SS
- FP10NC
- FP10HNC
- FP10MDA
39
What can dentists prescribe?
- Private Prescriptions for any POM, P or GSL
- The misuse of drugs act 1971: Dentists can prescribe all controlled drugs except from diamorphine, dipipanone and cocaine for drug misusers
- Dentists can only supply NHS prescriptions for medicines on the Dental Practitioners formulary
- NHS prescription form (FP10D)
40
Can community practitioner nurse prescribers prescribe any medication?
No, can only prescribe a limited number of POM medicines listed on the Nurse Prescribers Formualry (NPF)
41
What do independent prescribers take responsibility for and give examples of independent prescirbers:
They take responsibility for:
- Clincal assessment and diagnosis
- Clincial management and prescribing
- Appropriateness of prescribing
Examples include: Trained and accredited nurses, optometrists and pharmacists
42
What supplementary prescribers take responsibility for and give examples of independent prescirbers:
- Responsible for continuing care of the patient within a clinical managment plan
- Shared prescribing responsibitly
- Includes nurses, pharmacists, optometrists, podiatrists and others
- Not as commonly seen as independent prescribers
43
What is a clincal managment plan (CMP)?
- The CMP is a voluntary partnership between a doctor (or dentist), the patient and the supplementary prescriber
- The SP can only prescribe medications indicated in the CMP
44
What are the other legal arragments for the supply opf POMs?
- Patient group directions (PGD)
- Emergency supplies
- Wholesale supplies
45
What is a PGD?
- Patient group direction.
- A written direction allowing supply or administration of a POM to personals generally and signed by a doctor or dentists and by a pharamcist
- Supply or administration is restricted to specified individuals including pharmacists and nurses
- Supply on behalf of an NHS body by healthcare professionals
- To assists a doctor or dentist in providing primary care NHS services
- NHS authorised supply or administration by a named person, lawfully conducting a retail pharmacy business
46
What are the two types of emergency supplies?
1. When a prescriber cannot provide a prescription but undertakes to supply one within 72 hours
2. At the request of ther patient, who has previously been provided with the medicine on prescription but for reason of emergency is unable to get a prescription
47
Discuss the wholesale supply of POMs
- Wholesale supply is to a person who then supplies someone else as part of their business
- Wholesaling of medicines requires the person wholesaling to hold a wholesale dealers licence from the MHRA
- Pharmacies are permitted to make suppies of small quantites by wholesale supply within healthcare setting without a licence (according the MHRA guidance)
