MEP Flashcards
1
Q
What are the elements of professional judgement?
A
Professional Judgement
* Identify the ethical dilemma or professional issue
* Gather all the relevant information and research the problem
* Weigh up the benefits and risks of each option
* Choose an option – ensuring you can justify the decision
* Record the decision-making process
2
Q
How many CPD logs must be submitted each year?
A
- Four continuing professional development records (at least two planned)
3
Q
What is the revalidation process for pharmacy professionals?
A
Pharmacy professionals must submit the following records each year:
* Four continuing professional development records (at least two planned)
* A peer discussion
* A reflective account
4
Q
What is an independent prescriber?
A
A practitioner, who is responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and can make prescribing decisions to manage the clinical coniditon of the patient
5
Q
What is a supplementary prescriber?
A
practitioner that prescribes within an agreed patient specific written clinical management plan, agreed in partnership with a doctor or dentist
6
Q
How are adverse events reported?
A
reported via the yellow card scheme. Reports the adverse event to the MHRA.
7
Q
Discuss near miss errors in the pharmacy
A
regular review can prevent similar mistakes happening again in the future. Helps to support clinical governance in pharmacy and to promote an open culture of near miss errors so that all staff can learn from them.
8
Q
How are dispensing errors handled?
A
- Take steps to let the patient know promptly
- Make things right (may involve contacting the prescriber)
- Offer an apology
- Let involved colleagues know
9
Q
When can legal defences be used?
A
Can be used when the error has been:
* Dispensed in a registered pharmacy and
* Dispensed under the supervision of a registered pharmacist and
* Supplied against a prescription, pgd or direction from prescriber and
* Promptly notified to the patient once the pharmacy team are aware of the error
10
Q
Discuss sexual activity in children
A
- Children under 13 are legally too young – report to social services
- Under 16 may be an offence but consensual
- Can provide contraception either on prescription or under PGD to a child or young person under 16 as long as the fraser criteria are met
11
Q
What are the fraser criteria?
A
they have sufficient maturity and intelligence to understand the nature and implications of the proposed treatment, they cannot be persuaded to tell their parents or allow the practitioner to tell them, they are very likely to begin or continue having sexual intercourse without contraception, their physical/mental health is likely to suffer without advice or treatment and it is in their best interest.
12
Q
When must the pharmacist report something associated with sexual health
A
When female genital mutilation is reported
13
Q
Discuss vulnerable adults
A
May fall into one of the following groups:
* Suffers from mental/physical disability
* Has learning difficulties
* Is frail or elderly
* Is in a abusive relationship
* Is a substance misuser
Vulnerable adult’s wishes should be considered at all times. Obtain consent from the patient before disclosing any information about them.
14
Q
What are GSL medications?
A
- Made available for self-selection, and can be sold in retail outlets that can close as to exclude the public
- Can be sold in the absence of the pharmacist (must be signed in as responsible but can be absent from the pharmacy
15
Q
What are pharmacy medicines?
A
- Can be sold from a registered premises by the pharmacist or a person acting under the supervision of a pharmacist
- Must not be accessible for self selection
16
Q
What is a prescription only medicine?
A
- Requires a prescription written by an appropriate prescriber
17
Q
Discuss amorolfine nail lacquer
A
over 18 years old, limited to a maximum of two infected nails at a time, contraindicated in pregnanct and breast feeding. Applied once a week.
18
Q
Discuss legalities/counselling with chloramphenicol
A
acute bacterial conjunctivitis. 2 years and older. Contraindicated in pregnancy/breastfeeding, any blood disorders, bone marrow problems. If both drops and ointment are being used, the drops should be used during the day and ointment should be used at night. Interacts with bone marrow depressant drugs. REFER: eye inflammation, eye pain, swelling, dry eyes, glaucoma, recent eye infection, new infection during treatment. URGENT REFERRAL: cloudy looking eye, unsual looking pupil, affected vision, photophobia, painful eye movements, eye pain, worsening symptoms despite use, contact lenses In the shower, eye/head injury, recent eye surgery. Refer after treatment if: symptoms don’t improve after 48 hours, symptoms worsen, any side effects. Drops in fridge (2-8 degrees), ointment no more than 25 degrees.
19
Q
Discuss legalities and counselling with desogestrel
A
progesterone only pill. Contraindicated if: blood clot, active/history of liver disease or liver cancer, active/suspected sex-steroid sensitive cancer, undiagnosed vaginal bleeding, person is allergic or intolerant to any of the ingredients, pregnant. Administration: new: start on day 1 of period, can start on days 2-5 but will need additional protection for 7 days. If previous: start taking day after without a break. After EHC: levonorgestrel – start straightaway and use additional barrier for seven days. Ulipristal – wait 5 days after as can stop from working and use an additional barrier method, then start and continue with barrier method for a further 7 days. Childbirth: if period then same as normal. If period hasn’t started and <21 days after delivery then start. If >21 days, exclude pregnancy then start and use additional barrier for 7 days. Miscarriage/abortion: start straightaway or within 5 days. Switching: Fom combined – start taking day after the last active tablet. Ring, cap, patch – start day of removal. Use barrier method for 7 days if started during the break. POP: day after. Long acting reversible: start taking day after removal or when next injection due. Late pill: <12 hours: protected. >12 hours: unprotected, use barrier for 7 days and consider ehc. Interactions: anti-convulsants, st johns wort, antibiotics. Can be used in breastfeeding but not in pregnancy. If diarrhoea or vomiting: Within 3-4 hours, follow missed pill rules.
20
Q
Compare ulipristal to levonogestrel
A
UA - within 5 days, take another if vomit in 3 hours, do not bf for a week, express milk and discard to maintain lactation, can reduce efficacy of contraceptives, so dont restart for 5 days and use appropriate barrier
L - within 3 days, 2x if taken cyp inducers in last 4 weeks, less effective in high BMI, Take after bf, can continue regular contraceptive
21
Q
What are the legalities around EHC?
A
Can supply to someone else if it is a genuine request, but should speak to patient if the representative cannot provide the information required.
Can make an advanced supply
Discuss long term contraception/ STI risk
22
Q
What are the legalities around mometasone
A
clarinaze allergy spray. For hayfever and allergic rhinitis. Over 18 years old. 2 sprays once a day.can commonly cause nose bleeds. Interacts with cyp inducers. If symptoms do not improve within 14 days, refer. Do not use for more than 3 months. DO NOT SUPPLY IF: under 18, more than 3 months, untreated localized infection, recent nasal surgery. Refer if: no improvement, symptoms persist
23
Q
What are the legalities around orlistat
A
adults, 18+, BMI>28. REFER: Diabetes, hypertension/hypercholesterolaemia, amiodarone, levothyroxine, antiepiletptics, 6 months use or longer, unable to lose weight after 12 weeks, rectal bleeding, kidney disease. Caution with fat soluble vitamins.
24
Q
Which PPIs are available otc
A
omeprazole 10mg and pantoprazole 20mg. over 18 years old. Don’t supply if over 55 years old, and any red flag symptoms
25
What are the legalities with sildenafil
Viagra 50mg. Men over 18 years old with ed. CONFIRM diagnosis, contraindicated in ritonavir, nitrates, severe cv disorder, hepatic impairment, hypotension, loss of vision, women, under 18 yo.
26
When should patients requesting tranexamic acid be referred?
refer if: under 18/over 45, taking for three cycles without a reduction in bleeding, breastfeeding women, obese/diabetic, PCOS, oestrogen/tamoxifen.
27
Discuss the legalities of pseudoephedrine and ephedrine
* Potential for misuse in production of crystal meth
* Cannot supply a product/combination that contain more than 720mg pseudoephedrine or 180mg epdedrine
* Cannot sell pseudo/ephedrine together
* Should be made by pharmacist/competent pharmacy staff
28
What are the signs of potential misuse of pseudo/ephedrine
lack of symptoms, rehearsed answers, impatient or aggressive, opportunistic, specific products, paraphernalia such as lithium batteries or acetone, large quantities, frequent requests.
29
What are the 3 main types of EHC
1. Copper IUD
2. Oral ulipristal acetate (EllaOne) – 120 hours
3. Levonorgestrel – 72 hours
30
Can pharmacists give an advanced supply of EHC?
Pharmacists can provide advanced supply, but patient should be assessed that they are competent and intend to use the medication appropriately
31
What are the legalities for paracetamol and aspirin?
Paracetamol: no more than 100 non effervescent tablets or capsules can be sold at any one time. In practice, this is 96. There is no legal limit on the quantity of effervescent forms
Aspirin: no more than 100, 96 in practice. NO legal limit on effervescent forms
32
What are the legal considerations for codeine and dihydrocodeine?
Indications: restricted to short term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone.
Pack sizes: any pack containing more than 32 is a POM.
PIL and labels: the warning ‘can cause addiction, for 3 days use only’ must be prominent and clear on the pack. PIL, packaging must state the indication and that the medicine can cause addicition or headache if used continuously for more than 3 days, must also contain information about the warning signs of addiction.
33
What are the general prescription requirements?
A pharmacist is able to sell or supply a POM under the authority of an appropriate practitioner or via an exemption.
1. Signature
Must be signed in ink by prescriber. Advanced electronic signature can be used for an electronic prescription
2. Address of prescriber
3. Date
Valid for up to 6 months from the appropriate date. NHS prescriptions, the date is the later of either the date the script was signed, or a date indicated by the practitioner as the date before which it should not be dispensed.
For private scripts, this is always the date it was signed.
4. Particulars of prescriber (type)
5. Name of patient
6. Address of patient
7. Age if under 12 years
34
Can pharmacists dispense prescriptions from the crown dependencies (jersey, guernsey, IOM)
You should be satisfied that all requirements are present for it to be legally valid. For schedule 2/3 CDs, address must be within the UK.
35
What are the legalities for repeatable RX's?
Private prescriptions that contain a direction that they can be dispensed more than once e.g repeat x5
If number not stated, repeat once (dispense twice), unless it is for an oral contraceptive, which can be repeated 5x (dispensed 6x)
Schedule 2&3 NOT repeatable, but can repeat sched 4/5
First dispensing must be within 6 months of date, and then there is no legal limit for following repeats.
Schedule 4 CD – first dispense within 28 days, then there is no time limit for remaining repeats.
Patient can have repeats from different pharmacies and can retain the script.
Mark on the script the name/address of pharmacy and make a note of the date to maintain an audit trail.
36
How long are owings for POM and sched 5 drugs valid for?
POM & sched 5 – 6 months from date
37
How long are owinga for sched 2,3,4 valid?
28 days
38
How long are owings for oral retinoids or SV valid for?
owing can exceed 7 days if the pharmacist is sure there is no risk of pregnancy
39
What are the legal requirements for record keeping for private rx's
Private prescriptions – POM for 2 years from date of supply/or repeatable from date of last supply. Schedule 2 and 3 musst be submitted to NHS agency. Records made in POM register, which should be retained for 2 years from date of last entry.
POM Entries: supply date, prescription date, medicine name, quantiy, formulation, strength, presciber name and address, name and address of patient. Made on day of or next day. Oral contraceptives are exempt, and schedule 2 CDs go in a separate register.
40
What entry should be made into the POM register for private rx's?
supply date, prescription date, medicine name, quantiy, formulation, strength, presciber name and address, name and address of patient. Made on day of or next day. Oral contraceptives are exempt, and schedule 2 CDs go in a separate register.
41
Can faxed prescriptions be dispensed?
NO, Not a legally valid script, as it is not in indelible ink and has not be signed by prescriber. Should make informed decision and take steps to safeguard. Make a record of decision. Cannot supply schedule 2/3.
42
Can scripts from the EEA/Switzerland be dispensed?
If issued by approved health professional, repeats and scripts can be dispensed, emergency supplies can also be provided
43
What must be present on a prescription from approved EEA countries/switzerland
* Patient details, full first name surname, date of birth
* Prescriber full name, surname, professional qualifications, contact details including email address, telephone number, work address including country
* Prescribed med details, form, quantity, strength, dosage
* Signature
* Date of issue. 6 months validity and 28 days for CD
44
How fast should a script for emergency supply from EEA/SWITZ be recieved?
Within 72 hours
45
Can emergency supplies be made for EEA/Swiss
Yes, but Schedule 1,2,3 including phenobarbital cannot be supplied
46
What is legally required on the dispensing label?
1. Name of patient
2. Name and address of pharmacy
3. Date of dispensing
4. Name of medicine
5. Directions for use
6. Precaution relating to use
7. Keep out of sight and reach of children - suggested not legal req.
47
What must be present on a label if from bulk
1. Name of medicine
2. Quantity
3. Handling and storage
4. Expiry date
5. Batch number
48
When can covert administration be used
To people who actively refuse to take their medications, and who lack mental capacity in accordance with agreed management plan
49
Can pharmacists supply and administer diamorphine and morphine?
Pharmacists can supply and administer diamorphine and morphine under a PGD for the immediate, necessary treatment of sick persons
50
When can emergency supplies be made?
* to humans not animals
* on request of prescriber or patient
* relevant prescriber: doctor, dentist, supplementary prescriber, nurse independent, pharmacist independent, community nurse, physiotherapist, podiatrist, radiographer, optometrist, EEA or Swiss health professional, paramedic
* from prescriber – must receive script within 72 hours
* NOT for CDs except phenobarbital
51
What must be entered into the POM register for emergency supplies at the request of a prescriber?
Date, name, name and address of prescriber, name and address of patient, date on prescription, date script received
52
What are the legal restrictions on quantities of medication provided as an emergency supply?
Anything else, maximum is 30 days except if the POM is insulin, ointment, cream or inhaler then give smallest pack, or if it is an oral contraceptive, then give full cycle
53
What must be recorded in the POM register for an emergency supply at the request of a patient?
name and quantity of drug, name and address of patient, information of the nature of the emergency.
54
What must be present on the dispensing label for emergency supplies?
Must say EMERGENCY SUPPLY on the dispensing label
55
What legal requirements apply to signed orders from schools?
* Autoinjectors
* Salbutamol
Signed order
* Name of school
* Product details
* Strength
* Purpose
* Quanity
* Signature of prinicipal or head teacher
How many – not specified
Retain signed order for 2 years or an entry made in POM register.
56
Which legal restrictions apply to prescriptions for oral retinoids?
* Prescriptions are only valid for 7 days and should be dispensed on the day it is written. Prescriptions presented after 7 days have expired and should be referred back to prescriber for another pregnancy test
* Quantity cannot be for more than a 30 day supply
57
What are the legal requirements when valproate is dispensed?
* Speak to patients to check if they have been reviewed
* Do not stop if become pregnant, arrange to speak to prescriber
* Provide patient card every time valproate is dispensed
* Dispense in original packs where possible
* Ensure label does not cover sticker
* Report any side effects via yellow card scheme
58
What is a biologic?
medicine made from a variety of natural sources. First on the market is termed the originator or reference product
59
What is a biosimilar?
biologic which is similar to an already licensed biologic in terms of safety, quality and efficacy. Specifically developed and licensed to treat same diseases. Can only be marketed after the patent protecting originator has run out.
60
What are the legal restrictions on sched 2/3 CDs in the UK
must be prescribed by a prescriber with a UK address
61
Who can prescribe sched 1?
Only people that possess a home office license
62
Can vets prescribe schedule 2-5 CDs?
can prescribe schedule 2-5 cds, but prescriptions must included the RCVS registration number of the prescriber. Can prescriber unlicensed and/or off label medicines but if the medicine is not licensed for the animal intended then it must be prescribed under the veterinary cascade. Cannot give emergency supply
63
What are the legal restrictions on paramedics?
no CDs, only off label supply, can authorize emergency supply but not schedule 1/2/3 CDs
64
Which drugs can physios prescribe?
only can prescribe: diazepam, dihydrocodeine, lorazepam, morphine, oxycodone and temazepam. Morphine for injection, fentanyl patches. Can only prescribe off label medicines. Can authorize emergency supply but not for any CDs.
65
What can podiatrists prescribe?
can prescribe oral diazepam, dihydrocodeine, lorazepam and temazepam. Only off label and can authorize an emergency supply but not CDs
66
What can EEA or swiss professionals prescribe?
schedule 4 and 5 CDs only. Off label meds. Can only prescribe medicines which have a recognized marketing authorization in the UK.
67
What is the guidance on prescribing and dispensing by the same person
Should remain separate
Where exceptionally it is in the interests of the patient for the same pharmacist to be responsible for whole process, have processes in place to limit errors such as taking time away from the prescription then going back to it.
68
What are the legal requirements for wholesaling?
Anyone trading medicines other than to a patient must:
* hold a license – wholesale distribution authorization
* comply with GDP standards
* have a responsible person on the license
pharmacies supplying stock to another pharmacy within the same legal entity do not need a WDA
if legal entity does hold WDA, pharmacy supplying medicines for wholesaling must be named on the WDA
if it happens occasionally, small quantity, not for profit, not for onward wholesale distribution, for onward continued supply to patients via healthcare professional, do not need WDA.
Can be obtained from MHRA
69
Which records should be kept relating to supplied orders?
POM to healthcare professionals or organizations, an entry must be made in the POM register, or the signed order/invoice must be retained for 2 years from date of supply.
70
What should be entered into the POM register for supplied orders?
* date supplied
* name, quantity, strength and form
* name and address of trade, business or profession of person supplied
* purpose for which is was sold or supplied
71
What is an NFA-VPS
non-food animals that can be supplied by a veterinary surgeon, pharmacist or qualified person. Written prescription not required but not accessible by the public in a pharmacy
72
What is a POM-V
prescription only medicines that can only be prescribed by a vet/supplied by a vet or a pharmacist with a prescription
73
What is a POM-VPS
Prescription only that can be prescribed and supplied with an oral or written script. Written prescription only required if the prescibrer is not the supplier
74
What is an AVM-GSL
Vet med that is only available on general sale
75
What is an Exempt under schedule 6 – small pet animals
unlicensed vet med that does not require a marketing authorization
76
What is an Unauthorized veterinary medicine
does not have marketing authorization and is not eligible for exempetion. Can only be prescribed under the veterinary cascade
77
What are the prescription requirements for VET scripts?
1. name, address, telephone number, qualification and signature of the prescriber. Schedule 2 or 3 CDs, the registration number of the vet must also be included
2. name and address of owner
3. identification and species of animal and it’s address
4. Date. Valid for 6 months or shorter as indicated by prescriber, and if repeatable script, all supplies must be made within 6 months. Schedule 2,3,4 CDs valid for 28 days
5. Name, quanity, dose and administration instructions of the medicine
6. Any necessary warnings and if relevant, the withdrawal period (time before it can be used as food)
7. If appropriate, the words prescribed under the veterinary cacade
8. Number of repeats
9. Schedule 2/3 – ‘item has been prescribed for an animal or herd under the care of the veterinarian
78
What are the Similarities and differences – veterinary and human controlled drug prescriptions
Differences:
* Standardized forms not required but must include statement above
* Vet scripts retained for 5 years and not submitted to NHS agency
* 28 days vs 30 days max for humans
* RCVS vet number
Similarities
* Both valid for 28 days
* Total quantity in both words and figures
79
What is the veterinary cascade?
Unlawful to supply a human medicine against a veterinary prescription unless it is prescribed by a veterinary surgeon and specifically states it is for administration under the cascade
The cascade is an exemption within the regulations that specifies that where a licensed veterinary product is not available, other medicines in a strict order of preference can be considered
1. Supply a vet med with MA for the species and condition indicated
2. A vet med with NI MA for the species/condition indicated
3. A GB/NI/UK wide licensed for another species or different condition
4. A GB/UK/NIK human med
5. Vet med outside UK
6. Extemporaneous or special can be considered
Cannot sell or supply unauthorized vet meds for animal use unless by cascade, including OTC meds even if verbally suggested by vet
80
What is the process of the vet cascade?
1. Supply a vet med with MA for the species and condition indicated
2. A vet med with NI MA for the species/condition indicated
3. A GB/NI/UK wide licensed for another species or different condition
4. A GB/UK/NIK human med
5. Vet med outside UK
6. Extemporaneous or special can be considered
81
What applies to the sale of NFA-VPS and POM-VPS
* Advise on how to use safely
* Advise on warnings
* Satisfied that it will be used correctly
* Supply minimum quantity required for treatment
Pharmacist must be present for POM-V, POM-VPS and NFA-VPS to be handed out
82
What are the legal requirements for labelling of Vet scripts?
1. Name of presciber
2. Name and address of animal owner
3. Name and address of pharmacy
4. Identification and species of animal
5. Date of supply
6. Expiry of product
7. Name or description of product or API
8. Dosage and administration instructions
9. Special storage instructions
10. Warnings
11. Withdrawal period
12. ‘for animal treatment only’
13. ‘keep out of reach of children
83
What records must be kept after supplying a vet med?
1. Name of medicine
2. Date of receipt or supply
3. Batch number
4. Quantity
5. Name and address of the supplier or recipient
6. Name and address of presciber, keep copy if written
7. POM register entry
8. Keep for 5 years
9. Must undertake annual audit
84
What is an accountable officer?
* Responsible for supervising and managing the use of CDs in their organization or setting. Oversight of the monitoring of management, prescribing and use of Cds.
* Systems in place for recording concerns and incidents involving CDs and the operation of these systems
* Attendance at local intelligence network meetings
* Submission of occurrence reports which describe the details of any concerns
* Appointment of authorized witness for the destruction of CDs
85
What is a sched 1 CD
no therapeutic use and a license is required for their production, possession and supply
86
What is a sched 2 CD?
prescription requirements apply valid for 28 days UK prescriber
Can be prescribed, possessed and supplied when healthcare professional is acting in the correct capacity. Opiates, major stimulants, quinalbarbitone and ketamine
No emergency supplies
Requisition necessary
License required to export or inport
87
What is a sched 3 CD
CD NO REGISTER POM prescription requirements apply valid for 28 days UK prescriber
Buprenorphine, temazepam, tramadol, midazolam, phenobarbital, gabapentin and pregabalin. Less likely to be misused and less harmful if they are. Buprenorphine and temazepam kept in CD safe
No emergency supplies except phenobarbital
Requisition necessary
Retain invoice for 2 years
License required to export or inport
88
What is a sched 4 part 1 CD
valid for 28 days repeatable
Part I – CD benz POM
Most benzodiazepenes, zopiclone and Sativex
89
What is a sched 4 part 2 CD
Part II – CD anabolic POM
Anabolic and androgenic steroids – clenbuterol and growth hormones
License required to export or inport
90
What is a sched 5 cd?
CD INV POM Or CD INV P valid for 6 months repeatable
Codeine, pholcodine and morphine that are exempt from full control when present in low strengths
Retain invoice for 2 years
91
Who can possess and supply CDs?
Pharmacists, doctors and dentists can possess, supplt and procure schedule 2,3,4 and 5 CDs
Home office License: can possess and supply CDs with terms of license
Home office group authority: covered by license group authority can possess in terms with the license
Legislation: class of person e.g postal operator, registered midwife
Class of drug: schedule 4 part 2 and schedule 5
Patients: who have been prescribed
92
What is the legal advice around sched 1 CDs
* Home office license required to possess, but a pharmacist can take possession with the purpose of destruction and hand over to a police officer
* Police informed on the understanding that confidentiality is maintained and the source is not revealed
* If large quantity, then may be appropriate to alert the police
* Patient should give authority for the drug to be removed or destroyed. If refused, pharmacist can alert police. Under no circumstances can the illicit drug be given back to the patient.
93
Discuss administration of schedule one CDs
Schedule one controlled drugs can only be administered by someone with a home office license
94
Discuss administration of sched 2,3,4 CDs
* Doctor, dentist, pharmacist or nurse independent prescriber
* Supp prescriber in line with management plan
* Accordance with directions of a prescriber entitled to prescribe CDs
Special license from home secretary or medical officer can prescribe cocaine, diamorphine, dipipanone for treating addiction. Do not need license if it is for organic disease/injury
Pharmacist/nurse independent precribers cannot prescribe those above for addiction, but can for organic disease/injury
95
Which drugs require a license for import/export
* License needed for import, export of 1,2,3,4 pt 1 CDs
* License for schedule 4CDs part 2 unless for self administration
* No restrictions on schedule 5.
96
Do patients travelling for 3 months require a license for taking CD out of the country?
* Home office regulatory body for taking controlled drugs abroad
* Less than 3 months supply, do not need a license. But do need a covering letter signed by the prescriber that confirms patient’s name, travel plans, name of CDs and quanity/dose
* Check with embassys of countries travelling to, to check if matches entry requirements
97
What is required on a requisition for sched 1/2/3 CDs?
* Approved form for the requisitioning of 2/3 in the community is mandatory
* Hospices and prisons exempt
1. Signature of recipient
2. Name of recipient
3. Address of recipient
4. Profession or occupation
5. Total quantity of drug
6. Purpose of requisition
* Hospital pharmacy – request for a ward or department within same legal entity does not need to use approved form
* Prisons – hospital style form must be used, in a bound book with a carbon copy so that an audit trail is possible.
98
What are the issues with CD requisitions
* Faxed/photocopied not acceptable
* Requisition in writing must be obtained by the supplier. GPhC registered pharmacises not included.
* From one pharmacy to another, should only be made after receiving a written requisition or an approved requisition form
* In an emergency, doctors or dentists can be supplied provided the requisition is received within 24 hours of supply
* Messenger on behalf of purchaser, written authorization must be provide to the pharmacist. Retained for 2 years
99
What is required for the processing of requisition forms?
* Legal requirement to mark the requisition indelibly with the supplier’s name and address, send original requisition to the NHS agency
* Good practice to retain copy for 2 years from date of supply
* Does not apply when:
* Person responsible for dispensing and supply at hospital, care home, hospice prison or ambulance, who must mark and retain for 2 years
* Pharmaceutical manufacturers and wholesalers
* Vet requisitions – must be retained for 5 years
100
What must be included on midwife supply orders for CDs?
* Diamorphine, morphine, pethidine
* Must contain:
1. Name
2. Occupation
3. Name of person whom the CD is to be administered to or supplied
4. Purpose for which required
5. Total quantity obtained
6. Signature of the authorized medical officer
101
What are the prescription requirements for schedule 2/3 CDs?
1. Signature of prescriber: recognized/genuine. Can be signed by another prescriber than name and still be legal, however address must reflect this. CD register records details of the actual presciber rather than named. EPS electronic signatures approved
2. Date: valid for 28 days from appropriate date indicated. Applies to owed balances too
3. Prescriber’s address – must be within UK
4. Name of CD
5. Form, clear and umambiguous.
6. Strength – only if available in more than one strength. If requests more than one strength, each should be prescribed separately.
7. Dose – clearly defined
8. Quantity – must be in both words and figures. Total number of units (10mg x 10 (ten), total quanity of drug 100 (one hundred). ML for volume
9. Quantity should not exceed 30 days supply
10. Name of patient
11. Address of patient
12. For dental treatment only
13. Instalment direction
14. Must mark the prescription with the date and time of supply
102
What is increased in sugar/colour free CDs
Sugar free/colour free have a greater potential for abuse, so only supply if specifically prescribed.
103
What is not acceptable on a CD script
* As directed
* When required
* Prn
* As per chart
* Titration dose
* Weekly
* Decrease by 3.5ml every four days
* Twice a day
104
What is acceptable on a CD script?
* One as directed
* Two when required
* One PRN
* Three ampoules to be given as directed
* One or two when required
105
What must be included on instalment directions
1. Amount of medicine per instalment
2. Interval between each time the medicine can be supplied
An instalment direction must have both a dose and an instalment amount specified separately
First instalment must be dispensed within 28 days of the appropriate date, remainder should be dispensed within the instructions
Must mark prescription with the date of each supply
106
What is the home office approved writing for instalments?
* dispense instalments due on pharmacy close days on a prior suitable day
* if a collection day is missed, dispense amount due for remaining days of that instalement
* consult prescriber if three or more consecutive days missed
* supervise consumption on collection days
* dispense daily doses in separate containers
107
What can pharmacists do with regards to instalments?
* supply balance of an instalment if the interval date is missed
* supply treatment prior to the start date if the day is the pharmacy is closed, for example during bank holiday periods
108
What is the advice for missed doses of instalments?
* three days, there is a risk of lost tolerance and the usual dose may cause OD, contact prescriber
pharmacist can amend prescription indelibly, so that it becomes compliant with legislation, if minor typographical error or spelling mistake or where words or figures or total quantity has been omitted, but not both.
cannot correct missing date, incorrect dose or strength
109
What can medical prescribers prescribe for treating addiction?
* Medical prescribers with a special license can prescribe, cocaine, diamorphine or dipipanone for treating addiction.
110
What requirements apply to private CD scripts?
* Standardised forms, unless vet
* Presciber identification number
* Submission – must submit original script to relevant NHS agency
Vet scripts do not need to be on a form or submitted, must be retained for 5 yeara
Medicines that are not CDs should not be prescribed on the same form, because the form needs to be sent to the relevant agency. Pharmacist could not comply with the requirement to keep POM scripts for 2 years.
111
What is the legal requirement for handing out of CDs
* Legally required to determine whether it is the patient, representative or a healthcare professional collection
* Check ID
112
What must be done for a representative to collect on behalf of a drug misuse patient?
* Obtain a letter from the misuser
* Separate letter should be obtained each time and they must bring ID
* Insist on seeing patient at least once a week
* Record of supply in CD register should include the detailes
* If must be supervised, contact prescriber before supplying to a representative. IF representative is a police custody officer or a custody healthcare professional, then not necessary as will be observed by HCP
* Annotate records
113
What must be done with patient returned/OOD cd
Safe custody applies until they can be destroyed. Must be segregated from othr stock and clearly marked.
114
When should denaturing of CDs be witnessed
If there is a requirement to make a CD register entry, denaturing must be witnessed by an authorized person (OOD)
Destruction of patient returns do not need to be witnessed
115
When should patient returns be denatured?
denature if schedule 2/3/4 part 1. Do not need a authorized witness but should be witnessed by someone. Record should be made in CD register, bit patient returns schedule 2 and their destruction should be recorded in a separate register
116
How should expired CDs be disposed of?
DENATUTRE. Schedule 2 destruction must have an authorized witness. Entry should be made in the register.
Dispose in appropriate containers, then send for incineration
Solid dosage forms – grind/crush then add to the kit.
Patches – remove backing and fold over itself
117
What are the legal requirements for CD registers?
* Any schedule ½ CDs.
* Sativex (schedule 4 part 1)
* Date received, name and address of whom received from, quantity
118
What should be written in the cd REg
* date supplied, name and address of recipient, details of authority to posses, quantity, details of person collecting, proof of identity?, if proof was requested.
119
How should entries into the CD register be made?
* chronological order
* entered on day of/following day
* in ink or indelible
* unaltered
* kept at premises
* kept for 2 years since date of last entry
* author must be indentifiable, cannot be altered at a later date
120
Discuss legal requirements for cannabis and cannabis based products
* THC with CBD (Sativex) – schedule 4 CD
* Nabilone - POM
* CBD
* Dronabinol – Schedule 2 CD
Cannabis based products for medicinal use
* Contains cannabis/cannabis resin/cannabinol
* Produced for medicinal use in humans
* Regulated as a medicinal product
* Unlicensed medicines
* Schedule 2 CDs
* Restricted to clinicians on the specialist register
* Private scripts for CBMP must meet legal requirements for schuel 2 CDs
121
What must the RP do?
* Can only be one responsible pharmacist at any one time
* Secure the safe and effective running of the pharmacy, display a notice, complete the pharmacy record, establish, maintain and review pharmacy records
122
What must be present on the RP notice?
* Display a notice with:
- Name of pharmacist
- GPhc Number
- Fact that they are in charge of the pharmacy at that time
123
What must not occur during a period of absence of RP
must not remove notice even if there is a second pharmacist present
124
What must be entered into the RP log?
eflects who the pharmacist is at any time/date including absences, made contemporaneously by the pharmacist
- Name
- Registration number
- Date and time of duties
- Stopped being responsible date/time
- Absence date, time left and returned
* Kept for five years, and available at the pharmacy which it relates to
125
What is the legal restrictions on absence as RP
max of 2 hours between midnight and midnight. Total period must not exceed two hours even if more than one pharmacist
- Only if pharmacy can run safely and effectively
- Remain contactable and can return with reasonable promptness
- Must arrange for another pharmacist to be contactable and to provide advice
126
Which activities must require an RP
* Professional check
* Sale/supply of P medicines
* Sale/supply of POMs, hand out of dispensed medicines
* Wholsesale of medicines
* Emergency supply
* Assembly process of medicines – generating a label, taking medicines off shelves, assembly, labelling, accuracy checking
127
Which activities can take place without supervision of an RP
* Sale of GSL
* Processing of waste stock or patient returns
128
Which activites can take place whilst the RP is absent?
* Ordering stock
* Receiving stock
* Putting stock away
* Date checking stocking consumables
* Cleaning
* Responding to enquiries
* Accessing the PMR
* Receiving prescriptions from EPS
* Processing of dispensed forms
* Receiving returns
* Deliveries
