Law Flashcards
1
Q
What is NFA-VPS
A
- medicine for non-food animals that can be supplied by a veterinary surgeon, a pharmacist or a suitably qualified person
- written prescription not required
- not accessible by public in a pharmacy
2
Q
What is POM-V
A
- POM that can only be prescribed by veterinary surgeon and supplied by a veterinary surgeon or a pharmacist with a written prescription
3
Q
What is POM-VPS
A
- POM that can be prescribed and supplied by veterinary surgeon, pharmacist, or suitably qualified person on an oral or written prescription.
- written prescription only required if supplier is not the prescriber
4
Q
What is AVM-GSL
A
- authorised veterinary medicine that is available on general sale
5
Q
What does exempt medicines under schedule 6 of the veterinary medicines regulations - exemptions for small pet animals (SAES) mean
A
unlicensed vet medicine that does not need marketing authorisation because it meets criteria laid out in schedule 6 of the veterinary medicines regulations - exemptions for small pet animals
6
Q
What is an unauthorised veterinary medicine
A
- unlicensed medicine that does not have a marketing authorisation and is not eligible for exemption through the SAES
- it can only be prescribed by a veterinary surgeon under the cascade. Including any human medicine used for animals
7
Q
Prescription requirements for POM-V, POM-VPS and medicines supplied under the veterinary cascade
A
- name, address, phone, qualification, signature of prescriber. If S2or3 CD, include RCVS registration number
- name and address of owner
- identification and species of the animal and its address (if different to owners)
- date - valid for 6 months, all repeats must be made within 6 months. 28 days if S2,3,4 CDs.
- name, quantity, dose and administration instructions of required medicine. ‘As directed’ not appropriate
- any necessary warnings and withdrawal period (time between taking make and being used as food)
- prescribed under the cascade - or similar
- number of times it can be repeated
- if S2 or 3 CD - ‘the item has been prescribed for an animal or herd under the care of the vetinarian’
8
Q
How long should veterinary prescriptions be retained
A
- 5 years
9
Q
Difference between quantity of CDs supplied on a vet prescription compared to human
A
- vet = 28 days
- human = 30 days - S2,3,4
10
Q
Schedule 2 and 3 CD prescription requirements for human and for Vet
A
- vet = RCVS registration number
- human = prescriber identification number
11
Q
4 principles of medicines optimisation
A
- understand patient experience
- choose medicine with best evidence, clinically appropriate and cost effective
- ensure safe use
- make medicines optimisation routine practice
more about patients taking ownership of their meds (not about cost)
12
Q
pharmaceutical care definition
A
the responsible provision of drug therapy (by a pharmacist) for the purpose of achieving definite outcomes that improve the patient’s health and quality of life e.g PCP
13
Q
what is GSL
A
- general sales list
- retail outlets that can ‘close so as to exclude the public’ or in registered retail pharmacy
14
Q
what is P
A
- pharmacy only under RP
- not accessible to pubic by self selection
15
Q
What is POM
A
- prescription only by appropriate prescriber
16
Q
Which class of medicine does OTC refer to
A
GSL and P
17
Q
what is PO
A
- Pharmacy only
- a GSL med that the manufacturer restricts sales to only pharmacies
18
Q
Pseudoephedrine/ephedrine details
A
- P
- abused to make crystal meth
- no more than 720mg pseudo
- no more than 180mg ephedrine
- not both at once unless on Rx
19
Q
Paracetamol and Aspirin as P details
A
- max 100 non-effervescent tablets/caps
- no legal limit for effervescent - use judgement
20
Q
Codeine and dihydrocodeine details
A
- P
- licensed in acute/mod pain not relieved by OTC analgesic alone
- > 32 = POM
- sell only one pack
- “can cause addiction. For 3 days use only” on front of pack
- PIL must state indication and can cause addiction and overuse headache if used continuously > 3 days. Must contain signs of addiction
21
Q
Cough/cold medicines in children details (P)
A
- codeine linctus 18+
- certain ingredients not for <6 years
- used second line to best practice in 6-12 years for 5 days
22
Q
Name OTC antitussives
A
- inhibit cough through either a central or a peripheral mechanism, or mix of the 2
- pholcodine
- dextromethorpan
23
Q
Name OTC expectorants
A
- for mucusy cough
- guaifenesin
- ipecacuanha
24
Q
Name OTC nasal decongestants
A
- ephedrine
- pseudoephedrine
- phenylephrine
- xylometazoline
- oxymetazoline
25
Name OTC antihistamines
- brompheniramine
- chlorphenamine
- diphenhydramine
- promethazine
- tripolidine
- doxylamine
26
Emergency hormonal contraception (P) details
- ulipristal <120 hours, women of child bearing age
- levonorgestrel <72 hours, 16+
- advanced supply
- children under 13 can't legally consent to sexual activity - report to social services
27
Oral isotretinoin PPP (POM)
- teratogenic
- PPP = monthly follow up, effective contraception and pregnancy tests
- Rx valid 7 days
- max 30 days supply
- dont accept fax or repeat Rx
- emergency supply ONLY if requested by phone by PPP specialist prescriber with confirmed negative pregnancy test in last 7 days
28
Sodium valproate PPP (POM)
- specialist use for epilepsy and bipolar
- CI in childbearing age unless PPP
- discuss risks, pt card and warning stickers when dispensing
- check if taking highly effective contraception and discussed tx with GP/specialist
- if planning/unplanned preg - tell GP - don't stop
- report side effects via yellow card scheme
29
What is a biologic (POM)
medicine made from human, animal or microorganism e.g. blood
30
What is a biosimilar (POM)
- medicine similar to an already licensed biologic
- not a generic because identical can't be produced
- rx by brand
- ADR = give batch no and brand
- dont switch between brand for biologics/similars
- e.g. glargine (biologic), Absalgar (biosimilar)
31
UK prescribers
- doctors, dentists, vets
- IP within their competence:
nurse or pharmacist
optometrist (no CDs or parenteral POMs)
podiatrists, physios, therapeutic radiographer IPs (POMs, only certain CDs, and Off-label medicines)
- supplementary prescribers according to clinical management plan - all of the above
- community practitioner nurses (not CDs/unlicensed meds, only limited POMs)
32
EEA/Swiss prescribers
- doctors/dentists/pharmacists/nurses (not CDs 1, 2, 3 or UK unlicensed meds)
33
General prescription requirements
1. pt name and address
2. age if under 12, DOB
3. prescriber signature
4. particulars of prescriber
5. address of prescriber
6. prescriber signature in indelible ink or advanced electronic signature
7. 6 month expiry from appropriate signature (28 days if CD 1, 2, 3, 4)
- owings last until expiry date
34
Private prescription requirements
- same general prescription requirements. No standardised form
- private POMs valid for 6 months from date signed
35
EEA/Swiss prescription requirements
- legally recognised in UK (excepts CDs 1, 2, 3, and UK unlicensed medicine)
- can accept Rx in a different language
1. Patients full name and DOB
2. Prescribers full name, professional qualifications, work address with country
3. direct contact details: email and tel/fax, number with international pre-fix
36
NHS dental prescriptions
- yellow FP10D
- can only prescribe medicines listed under dental prescribers formulary
37
Are faxed prescriptions valid
No
38
Military prescriptions details
- written on FMED 296 military form
- handled by community pharmacies with a dispensing contract with the Ministry of Defence otherwise treat as a private prescription
- particular attention to handwritten FMED, unusual as most are computer generated. If in doubt check registration details of prescriber
39
What is a repeatable prescription
- where medicines can be dispensed more than once against the same prescription
- not the same as repeat requests or NHS repeat dispensing
- NHS prescriptions, Schedule 1, 2, 3 CDs NOT repeatable
40
Repeatable prescription requirements
- Private Rx's must state it is repeatable e.g. repeat x3 = dispense 4 times total
- if number of repeats not stated only repeat once (2 total)
- exception for oral contraceptives, can repeat x5 all within 6 months
- first dispensing within 6 months (28 days S4 CD) then no legal time for remaining repeats
- for audit trail of number of repeats dispensed - stamp the pharmacy name, address and date supplied on the prescription each time it is dispensed
41
Emergency supply not allowed under patient or prescriber request
- CDs 1, 2 , 3 except phenobarbital for epilepsy by a UK prescriber
- Swiss/EEA prescriber cannot prescribe or request any CD 1, 2, 3 or UK unlicensed medicine
42
Emergency supply patient request record keeping
- record in POM register on day of supply or day after
- Date (POM supplied)
- Medicine details (name, strength, formulation, quantity)
- name & address of patient
- nature of emergency
43
Emergency supply prescriber request record keeping
- record 3 dates (POM supplied, Rx received and date on Rx)
- medicine details (name, strength, formulation and quantity)
- name and address of prescriber and patient
44
emergency supply - patient request
- previously prescribed by appropriate practitioner
- pharmacist must know the dose needed
- CD (4, 5, Phenobarbital) = 5 days
- POM = 30 days
- oral contraceptives = full treatment cycle i.e. 28 days
- inhaler, insulin, creams; packs that cannot be broken = smallest pack size
- liquid abx = smallest quantity to complete course
45
emergency supply - prescriber request
- receive prescription within 72 hours
- make supply according to the direction of the prescriber
46
Define emergency for an emergency supply
- an immediate need and not practical to get Rx without undue delay
- conduct patient interview for patient requests
47
Record keeping general rule
- vet and RP = 5 years
- everything else e.g. CDs, private Rx's for 2 years
48
Private prescription record keeping
- retain for 2 years from last date of supply (private S2, 3 sent to NHS agency at end of month)
- POM register - record supply of private POMs
- keep POM register for 2 years from date of last entry except for oral contraceptives and S2 CD (recorded in CD register)
- record following info on the day or day after:
1. dates of supply and on prescription
2. medicine name, strength, formulation, quantity
3. patient and prescriber name and address
49
Legal requirements of a dispensary label
1. medicine name
2. directions of use
3. any precautions/warnings
4. patient name
5. pharmacy name and address
6. date of dispensing
7. "emergency supply" for emergency supply under patient request
- recommended: "keep out of sight and reach of children"
50
Labelling broken bulk containers
1. name and medicine and quantitative particulars i.e. the ingredients
2. quantity
3. handling and storage requirements
4. expiry date and batch no.
- e.g. dispensing 60 tablets from pack size of 100
51
Parenteral POMs administration
- the law prevents a person from administering a parenteral POM to another person unless acting under directions of an appropriate practitioner
- Exceptions:
1. emergency e.g. adrenaline anaphylaxis
2. midwives and paramedics for specified parenteral POMs under certain conditions
3. smallpox vaccine or after medical exposure
52
Non-parenteral POMs administration
- legislation does not restrict thee administration of non-parenteral POMs
- but it should only be done under the authority of a prescription, PGD, or PSD
53
Patient specific directions details
- written instructions from a prescriber for a medicine to be supplied or administered to a named patient after they are individually assessed e.g. inpatient drug chart
- for purpose of administration (not supply) - directions can be verbal or telephone from appropriate practitioner
54
POM supply without prescription
- emergency supply
- PGD
- pandemic exemptions
- optometrist and podiatrist signed orders
- signed order of salbutamol inhalers to school
- supply of naloxone by individuals providing drug treatment services
55
PGD details
- written direction to supply or administer specified medicines by authorised health care professionals to a well-defined group of patient requiring treatment for specific condition
- e.g. doxycycline for malaria prophylaxis
56
Pandemic declared by the department of health
- pharmacist don't need to interview patient who required emergency supply of a medicine
- allows supply from designated collection points when a disease is pandemic and there is a serious or potentially serious risk to human health
- collection points need to be registered pharmacy premises or under the supervision of a pharmacist
57
Optometrist and podiatrist signed orders
- certain POMs supplied directly to patients via signed order by a registered podiatrist or optometrist
- signed order is not a prescription, rx requirements are not needed
- must be a med they can legally supply
- still label properly, provide PIL and record in POM register
58
Signed order for supply of salbutamol inhalers to schools
- schools can purchase from pharmacies, for use in emergencies
- signed order from head teacher including school name, purpose, total quantity and their signature
- retain signed order for 2 years OR make entry into POM register and record date given, medicine details, name, address and profession of person supplied to and purpose
59
Supply of Naloxone by those who provide drug treatment services
- can be supplied to anyone for purpose of saving a life in an emergency opioid overdose
- e.g. community pharmacies that provide needle exchange services can supply naloxone for a friend or family member to administer in heroin overdose
60
Wholesale Dealing
- Pharmacist exempt from requiring a wholesale dealer's license in certain circumstances:
1. occasional basis
2. small quantity of medicines
3. profit is not made
4. not for onward wholesale distribution
- if wholesale dealer license is required - this means that if supplies include CDs 2-5, a home office license is also needed
61
Drugs and Driving
- offense to driver whilst impaired through drugs regardless if they are used legitimately
- a statutory medical defence can be raised if driving not impaired, lawfully obtained, Rxed or purchased OTC, taken in accordance with advice of HCP or written instructions
- keep suitable evidence whilst driving to show the medicine is being take as it should e.g. PIL
62
Group 1 driving drugs
- commonly abused - lower limits
- cannabis (THC)
- MDMA (ecstasy)
- ketamine
- methylamfetamine
- cocaine (and a cocaine metabolite, BZE)
- lysergic acid diethylamide (LSD)
- heroin/diamorphine metabolite (6-MAM)
63
Group 2 driving drugs
- licensed medicines - higher limits
- clonazepam
- diazepam
- lorazepam, oxazepam, temazepam
- methadone
- morphine
- amfetamine
- selegiline (metabolised to amfetamine)
64
use before/use by
use before the beginning of the month e.g. 06/2017 = expires 1st June 2017
65
Expiry date
do not use after the end of the month e.g. 06/17 expired 30th June 2017
66
Waste disposal
- essential service provided by community pharmacies enforced by environmental agency
- registered pharmacies exempt from requiring a license for waste disposal; accept patient returns
- remove all patient identifiable information
- dispose in secure waste containers < 5m2 for < 3 months, in designated area
- sharps in sharps container
- do not treat waste medicine e.g. de-blister tabs/cap, decant liquids unless it is CDs that require denaturing
- CD 2, 3, 4.1 need denaturing
- CD 2 expired stock required authorised witness
67
Cosmetic contact lenses (zero-powered)
- not advised to sell unless supervised by an optician or doctor and under the legal requirements of the opticians act 1989
68
Requests for chemicals/poisons
- home office license for most dangerous chemicals/poisons e.g. explosive pre-cursors.
- when supplying add transaction details to license, label the chemical/poison and record in poisons register
69
Child-resistant-containers (CRC)
all solid, all oral and external liquid dose medicines must be given in CRCs unless specific request not to or original pack is not CRC
70
Emergency connection to ex-directory telephone numbers
- only in a life or death emergency situation where information needs to be passed on immediately and patients telephone number cannot be found from another source e.g. GP surgery
- pharmacist must give their name and pharmacy name
71
Homeopathic ('like-treat-like') and herbal remedies (plant derived)
- help patients distinguish the difference
- no clinical evidence for efficacy for homeopathic - do not endorse this as treatment, especially for serious conditions
72
Charitable donations
- WHO encourages donating standardised health kit medicines in acute stage of emergency, and then donation of money to purchase essential medicines
- WHO advises against donating patient returns
73
Delivery and posting medicines to patients (including abroad)
- patient consent for delivery or posting
- patient confidentiality during the delivery of posting process
- is F2F contact or a patient interview necessary
- has the patient been assessed by the prescriber
- adequate audit trail for delivery and receipt from point at which medicine leaves the pharmacy. Signature on receipt of delivery
- storage requirements during transit
- internet pharmacies must be registered with MHRA and display the EU common logo, meds supplied must have MA for use in the destination European Economic Area country
74
Medical devices
- must carry the CE mark (EU) UKCA (UK)
- regulated by the MHRA - medicines and healthcare products regulatory agency
75
Electronic cigarettes
- resemble cigarettes and deliver nicotine via inhalation
- the RPS supports nicotine-containing products that have a MA
76
Collection and purchase of medicines by children
professional judgement to decide on case-by-case basis if it is appropriate
77
Protecting children, young people and vulnerable adults
- pharmacists have a professional, legal and moral duty to protect these patients
- raise concerns to the social services if maltreatment suspected; however consider patient consent and confidentiality
78
Veterinary cascade exemption
- allows supply of a medicine that is not licensed in the animal through a written prescription by a veterinary surgeon that must state "for administration under the veterinary cascade" or similar
- this is required as it is a legal requirement for pharmacists to supply a licensed veterinary medicine for animals
79
steps of veterinary cascade
1. vet medicine licensed for the species or condition
2. vet medicine licensed for another species or condition
3. UK licensed human medicine or EU licensed vet medicine
4. specially manufactured or extemporaneous medicine (unlicensed)
80
Dispensary label for vet med NOT prescribed under the cascade
not legally required to have a dispensary label
81
Dispensary label for vet med under cascade
1. Name of prescribing vet surgeon
2. name + address of owner
3. medicine name, strength, dosage and administration instructions
4. necessary warnings or withdrawal period
5. any special storage instructions
6. "for animal treatment only"
7. name and species of animal
8. expiry date
9. date of supply
10. pharmacy name and address
11. "keep out of reach of children"
82
Vet record keeping
- retain for 5 years
- for receiving and supplying POM-V and POM-VPS:
1. medicine name, batch no and qty
2. date of supply or receipt
3. name and address of supplier or recipient
- written Rx = also record name and address of prescriber and keep copy of Rx
- other info:
1. pharmacists keep documents that show required info or record in private POM register
2. records can be kept electronically
3. pharmacies that supply POM-V and POM-VPS must undertake annual audit
83
When is physical presence of a pharmacist required - vet med
- to supply POM-V, POM-VPS, NFA-VPS
- unless authorised in advance and delegated to a competent person to hand out
84
Vet med - legal issues
- unlawful to sell/supply POM, P, GSL human medicined unless under cascade
- ADRs reported to adverse reaction scheme for veterinary medicines
85
Legal requirement for pharmacist who prescribes/supplies NFA-VPS, POM-VPS medicines
- advise on how to use the product safely, any applicable warnings and contraindication on the packaging or label
- be satisfied that animal owner intends and is competent to use the medicine correctly
- prescribe or supply the minimum quantity required for treatment
86
Vet meds - wholesale dealing
- manufacturers of vet medicines or those who have a wholesale dealers authorisation can routinely supply authorised retailers
- EXEMPTION - an authorised retailer of vet meds can supply products to another authorised retailer to relive a temporary supply shortage without needing WDA license
87
Schedule 1 CD Lic POM
- need home office license to possess, produce or supply
- no therapeutic use e.g. cannabis, LSD
- never return illegal drugs to pt - get consent to destroy or give to police w/o identifying pt
- if too large qty for personal use, can disclose confidentiality in the greater public interest
88
Schedule 2 CD POM
- opiates - morphine, oxy, methadone, pethidine, diamorphine
- major stimulants - amphetamines, methylphenidate
- quinalbarbitone
- ketamine
- record in CD register
- CD Rx requirement
- 28 day validity
- safe custody - except quinalbarbitone
89
Schedule 3 CD POM, NO register
- minor stimulants
- buprenorphine, temazepam, tramadol, midazolam, phenobarbital
- keep invoices
- CD Rx requirements
- 28 day validity
- safe custody - except tramadol, phenobarbital, midazolam
90
Schedule 4 CD
1. Part 1
- benzodiazepines
- Z-drugs
- sativex
2. Part 2
- anabolic/androgenic steroids e.g. testosterone
- clenbuterol
- growth hormones e.g. HCG, somatotrophin
* all = 28 day validity
91
Schedule 5 CD
1. CD INV P
- pholcodine
- codeine linctus
- kaolin and morphine
2. CD INV POM
- morphine oral solution <13mg/5mL
* keep invoices
* 6 month validity
92
CD Summary points
- validity = 28 days except CD5 = 6 months
- Rx requirements/CD requisition form/ not repeatable = CD2 and CD3
- prescriber must be in UK for CD2 and CD3
- No emergency supply for CD2+3, except phenobarbital for epilepsy
- safe custody for CD2 and CD3 except quinalbarbitone (2), tramadol, phenobarbital, midazolam (3)
- in CD register = CD2 (3 in POM)
- keep invoices - CD3 and CD5 invoice P/POM
- license to import and export = all CDs except CD5 and CD4 part 2 if for personal use
93
Who can administer CDs
- doctors, dentists
- IP - nurse/pharmacist
- supplementary prescribers
- patient or person acting in accordance with directions of prescriber
94
Midwife supply orders CDs
- midwives can obtain supply order for diamorphine, morphine and pethidine
- must contain:
1. name and occupation of midwife
2. name of patient administered or supplied to
3. purpose
4. total quantity of drug
5. signature of appropriate medical officer (e.g. Dr authorised to supervise midwives)
95
License to import, export CDs
- license required for all CDs except 5 and 4.2 if for personal use as medicine
96
Travelling abroad with a CD
- don't need a personal license from home office if taking less than 3 months supply
- advised to carry covering letter by GP that confirms the name of the patient, travel plans, name of CD, total qty and dose
97
CD2 and CD3 prescription general info
- rx not repeatable
- EEA/swiss prescribers cant prescribe, even in emergency
- no emergency supply except phenobarbital by UK prescriber
- validity of any CD owing balance is same as expiry date
98
What amendments can pharmacists make to CD2 and CD3 prescription
- typos or spelling mistakes
- if total quantity either word or figure is missing
- attribute amendment e.g. mark with initials
99
CD2 and CD3 legal requirements
1. patient name and address or NFA (PO Box not valid)
2. medication strength, formulation, dose and directions
3. total quantity in words and figures (max 30 days)
4. 28 days expiry
5. prescriber signature
6. prescriber name and UK address
- name of medication is good practice
100
Who can prescribe CD2 and CD3
- doctors, dentists, vets
- IP nurse/pharmacist prescriber
- supplementary nurse/pharmacist prescriber
101
Private CD2/3 prescription
1. standardised form FP10PCD in England (WPCD - wales, PPCD - scotland)
2. prescriber ID number
3. submit to NHS agency at end of month
- practice issues - prescribe private POM separately to private CD2/3 because POM needs to be kept for 2 years and CD needs to be submitted at end of month
- record in POM register except CD2 goes in CD register
102
Dental CD2/3
Must state "for dental treatment only"
103
Instalment CD2/3 (FP10MDA) approved wording
1. dispense instalments due on pharmacy closed days on a prior suitable day
2. if an instalments collection day has been missed, please still dispense the amount due for any remaining day(s) of that instalment
3. consult the prescriber if 3 or more consecutive days of a prescription have been missed
4. supervise consumption on collection days
5. dispense daily doses in separate containers
104
Instalment CD2/3 (FP10MDA) details
- 1st instalment dispensing within 28 days of appropriate date
- mark date of supply at the time supply is made
- if 2 days missed = contact prescriber to discuss next steps
- diamorphine, dipanone, cocaine to addiction - only doctors with special license can legally prescribe
- collecting CDs for a drug misuse patient - authorising letter from patient, stating name of representative a separate letter for each time; representative should have ID
105
Collecting CD2
- must ascertain if person is patient of patients representative - may request ID
- if it is a HCP must obtain name, address and request ID
- this is for purposes of recording supply in CD register
106
CD record keeping
- 2 years
- CD register for S1 and S2
- Sativex CD4.1 required to keep records, home office strongly recommends using CD register to do this
107
Minimum information legally required to be recorded in CD register
- date received/date supplied
- if received: name and address from whom, qty
- if supplied: name and address, details of authority to possess - prescriber or license holder's details, person collecting S2 name and address, ID requested? ID provided? qty
- running balance is good practice
108
Nature of CD register
- bound book with drug class, brand, strength and form at head of each page
- different section for different drug class
- separate pages for different strengths or formulations
- keep at premises
- keep for 2 years from date of last entry
- enter chronologically, promptly on day or following day in indelible ink and unaltered i.e. no crossing out. Corrections must be dated and attributed e.g. initial or signed
109
Electronic controlled drug register
- attributable, audited, compliant with best practice, accessible and printable
- safeguarding to ensure author identifiable, entries cannot be changed at later date, a log of all data entered is kept
- controlled access and adequate backup
110
CDs - when a standardised form is required
- S2 and 3 CD requisition in the community must be on standardised form for human and vet medicine; hospices and prisons exempt
- requisition received by a hospital pharmacy from a ward/department of different legal entity = standard form
111
Legal requirements of a CD requisition
- name, address, signature and profession of the recipient
- purpose of requisition and total quantity of drug
112
Practice issues with CD requisitions
- faxed/photocopies not acceptable
- requisition must be obtained in writing before supplying (except when to another pharmacy)
- in emergencies doctor or dentist can be supplied and requisition must be given within 24 hours
- if stock collected by messenger, written authorisation needed - retain for 2 years
- pharmacists cannon requisition CD1s
113
Processing a CD requisition
- legal requirement to mark the requisition indelibly with the supplier details e.g. pharmacy name & address upon receipt and send off to relevant NHS agency
- does not apply to supply by pharmaceutical wholesaler of manufacturer, vet requisition (retain for 5 years), supply by person responsible for dispensing in a hospital, care home, hospice, prison or ambulance services. Just mark requisition and retain for 2 years
114
Which drugs does safe custody of CDs not apply to
- CD2 - secobarbital/quinalbarbitone
- CD3 - phenobarbital, mazindol, midazolam, tramadol, pentazocine, phentermine
- safe custody applies to patient-returned, out of date and obsolete CDs until they are denatured
115
CD waste disposal & destruction
- required a license but pharmacies can register an exemption without needing one
- must denature 2, 3, 4.1 prior to disposal
- authorised witness for CD2 expired stock and record in CD register
- record destruction for CD2 patient-returns in a separate CD register (keep for 7 years)
- in prisons CD records should be kept for CD3 therefore destruction should also be recorded to maintain a robust audit trail. Also recommended for CD4
116
CD methods of destruction
- CD denaturing kit used in preference to other materials e.g. cat litter
- for destruction using a CD denaturing kit:
1. find/crush solid dosage forms
2. pour liquids and rinsing from bottles
3. open liquid amps and pour
4. mix powder amps with water and pour mixture
5. fold patches over onto itself
6. expel aerosols into water and pour or expel into absorbent material then add to CD denaturing kit
117
Disposing of spent methadone bottle
- once bottle emptied as far as possible, rinse the bottle and pour liquid into CD denaturing kit
- disposal of irretrievable amounts of CDs do not need to be recorded
- remove any patient information from labels or other identifiers
118
GPhc standards of pharmacy professionals (9)
1. provide person-centred care
2. work in partnership with others
3. communicate effectively
4. maintain, develop and use their professional knowledge and skills
5. use professional judgement
6. behave in a professional manner
7. respect and maintain the person's confidentiality and privacy
8. speak up when they have concerns or when things go wrong
9. demonstrate leadership
119
GPhC standard of registered pharmacies (5)
1. governance arrangements
2. staff are empowered and competent
3. environment and condition of premises
4. the way pharmacy services, including the management of medicines and medical devices are delivered
5. the equipment and facilities used in the provision of pharmacy services
** ALL to safeguard the health, safety and wellbeing of patients and the public
120
GPhC revalidation
- 4 CPDs - 2 must be planned learning activities, rest can be unplanned
- peer discussion - dont have to disclose subject of discussion, GPhC contacts peer to confirm it happened
- reflective account - summary of practice history for year
121
GPhC revalidation recording
- electronically on myGPhc
- approved format
- meet core criteria
- real examples of benefit for people using your service
- relevant
- your own
- patient confidentiality
122
GPhC revalidation - if some/all records not submitted with good reason
- e.g. maternity, break from practice, sick leave, military posts
- inform GPhC at point of renewal and give evidence
- if good reason - GPhC will renew registration w/o submitting records
- if can't submit all records - may accept records you can complete (no gaps larger than 12 months) OR GPhC may extend date to submit all records
123
GPhc revalidation - if some/all records not submitted w/o good reason
- remediation process - another chance to submit
- then administrative removal
- if removed through this process and later reapply for registration, the GPhc will expect to receive records as part of reapplication
124
GPhc review
- if selected for review and meet the review criteria - personalised feedback and your records won't be reviewed for 2 years
- if not selected for review - summary feedback based on reviews done
- if selected for review and dont meet criteria = remediation process. GPhc gives developmental feedback for future records and may be reviewed again next year. GPhc will follow steps in their statutory rules and may administratively remove you from the register
125
Patient confidentiality
- applies to all patients of any age even after death
- includes patient data and details, medication or medical history, treatment or carry that could identify them
- does not include anonymous information, coded information, and information that is legitimately in the public domain
126
Protecting confidential information
- protect the confidentiality of information
- take steps to prevent accidental disclosure
- only access for permitted purpose
- raise concerns if lack of security
- store securely
- dont leave confidential information unauthorised
- dont discuss any information that can identify a patient
- dont disclose information online
- continue to protects confidentiality except when required by law or in public interest
127
Disclosing confidential information case-by-case
- can disclose information if you have patients consent
- disclose without consent if:
1. law says you must e.g. request from police, other enforcement body or healthcare regulator
2. it is in public interest to do so e.g. serious crime
3. obtaining consent would put you or others at risk of harm, or would prejudice the purpose of disclosure
- ask for requests in writing
128
If you need to disclose information regarding a patient
- get consent unless exceptions
- anonymise if patient doesn't need to be identified
- only disclose relevant information
- release information promptly
- make sure recipient treats as confidential
- make a record of who, what, obtained consent, consent given or refused
- be prepared to justify your decisions and actions
129
What is information governance
the way an organisation processes or handles information
130
what is GDPR
- general data protection regulation
- effect from 25th May 2018
- applies to patient-identifiable data
- applies to controllers and processors
- a controller determines purposes and means of processing personal data and is responsible for and must demonstrate compliance with principles
- a processor is responsible for processing personal data on behalf of a controller
131
Principles for processing personal data under GDPR (6)
1. process lawfully, fairly and in a transparent manner
2. collected for specific, explicit and legitimate purposes
3. adequate, relevant and limited to what is necessary in relation to legitimate purposes
4. accurate and up-to-date; and every reasonable step taken to rectify or delete inaccurate data
5. lept no longer than necessary unless archiving for purposes of public interest, scientific/historical research, statistical purposes
6. protected against unauthorised/unlawful processing, loss, destruction or damage. e.g. use of passwords/locks
132
lawful bases for processing personal data under GDPR (6)
1. consent
2. contract
3. legal obligation
4. vital interests - necessary to protect a life
5. public tasks
6. legitimate interests
133
Individual rights under GDPR
- to be informed
- to access
- to rectify
- to erasure
- to restriction
- to data portability
- to object to the processing of personal data
134
Data protection officer under GDPR
- must appoint a data protection officer you are a public authority e.g. NHS
- OR carry out certain types of data processing e.g. biometric or genetic data
135
Personal data breaches
- duty to report certain types or personal data breach to relevant supervisory authority within 72 hours
- inform individual if breach likely to result in high risk of adversely affecting their rights and freedom
- have robust procedures for detection, investigation and internal reporting of breaches
- keep record of breaches, regardless of whether you are required to notify
136
NHS information governance toolkit
- all NHS contractors must provide assurances to the NHS on annual basis by assessing themselves against 18 requirements for management structures and responsibilities, confidentiality and data protection and information security.
- hee level are 0-3
- pharmacies are expected to get level 2 for each pharmacy information governance requirement
137
The freedom of information act 2000
- provides public access to information held by public authorities e.g. NHS England
- make request in writing - legal obligation to respond within 20 working days
138
When do you need consent
- for any professional service you provide or to use patient information
- if you are unsure - always ask for explicit consent
- ask for consent each time
- when appropriate take a record of explicit consent and what patient has consented to
139
Types of consent
- implied - indicates their consent e.g. handing in a prescription to be dispensed
- explicit - specific permission written or verbal
140
Valid consent - patients with capacity can withdraw their consent at any time
1. must have capacity
2. acting voluntarily and not under pressure from HCP or others
3. have sufficient and balanced information to make informed decision including risks and alternatives
4. capable of weighing up and using that information
141
What is capacity
- ability to make a specific and informed decision at the time it needs to be made
- ability to understand and remember the information provided, use and weigh up the information provided and communicate their decision about their treatment
142
Assessing capacity
- don't assume that if a patient lacks capacity on one occasion that they are unable to make all decisions
- must take steps to support patients make their own decisions about their care
- don't assume lacks capacity based on age, disability, beliefs, condition, behaviour or if you don't agree with their decision
- any advice or assessments you carry out should be recorded with the outcome
143
Who has capacity to consent
- adults and young people ages 16, 17 are presumed to have capacity
- children are not presumed to have capacity and they must demonstrate competence
144
Patients without capacity to consent
- adults - follow codes of practice set out by mental capacity act 2005 and adults with incapacity act 2000 (scot). grant legal authority too certain people to make decisions on their behalf
- young person - in england and wales, a person with parenteral responsibility can give consent. In scotland, young persons over the age of 16 are treated as adults without capacity
- children - a person with parenteral responsibility or the courts can give consent
145
Advanced decisions
- patients can make advanced decisions about their treatment if they later lose the mental capacity
- an advance refusal cannot overs the law to give compulsory treatment under the mental health act
146
Consent in emergencies
- if cant get consent; provide the best treatment in the patients best interests that is needed to save their life, except if there is valid advance decision to refuse a particular treatment
147
Raising concerns
- raise if risk to public health and safety
- if you don't, questions FTP
- public interest disclosure act 1998 (PIDA) protects employees who raise concerns
148
How to raise concerns
- organisation whistle blowing policy
- report without delay if serious risk
- first raise with immediate supervisor
- report to another suitable person in authority or an outside body
- keep record of the concern, who with and response
- maintain confidentiality if about a specific patient or colleague, disclose only with consent
149
Raising concerns - guidance for employers
- employees should be aware of procedures
- create open working environment
- encourage all staff to raise concerns
- take concerns seriously, investigate, provide support, remain confidential, take steps to deal with concern
- keep record
- don't stop anyone from raising concern
150
What to do in case of a dispensing error
- apologise and don't minimise the seriousness of the error
- establish if patient is safe
- inspect medicine, don't dispose unless consented
- supply correct medicine
- ask what the patient wants to do about complaint
- establish RP at time and notify them if it was not you
- inform professional indemnity insurer incase legal claim made against you
151
Reviewing dispensing errors
- do a root cause analysis
- make a written record of complaint, findings and audit regularly
- Condition in the pharmacy at the time
- Health of the pharmacist and other members of the team
- Assistance - pharmacist alone or not?
- Prescription recovered from file
- Systems used for dispensing and checking must be reviewed
- CHAPS
152
Maintaining clear sexual boundaries
- power imbalance in personal relationship between HCP and patient
- if attracted to patient don't act on it
- if patient attracted to you - constructively reestablish professional relationship or hand over care
- sensitive to cultural differences
- always offer chaperone and ask for consent for examinations/consultations - record conversations about chaperones
- raise concern if another HCP breaking boundaries
153
Religion, personal values and beliefs
- e.g. contraception, fertility medicines, hormonal therapies, mental health, substance misuse, sexual health
- ensure patient-centred care not compromised
- consider referral to another HCP if appropriate
- referral may not be appropriate in every situation
154
Consider work location and range of services
- professional judgement to make sure patient has access to care
- think in advance about range of services you can provide, roles you can carry out and how to handle requests sensitively
- don't knowingly put yourself in a position where you are unwilling to deliver timely care
- consider suitability of location, environment, working hours, other service providers opening hours
155
Consider openness with your employer about your beliefs
- work in partnership with employers
- think in advance about areas of practice affected and make arrangements to ensure patient care is not affected
- tell employer ASAP if your beliefs might prevent you from providing pharmacy services
156
Employers towards employees beliefs
- must be sensitive towards pharmacy professionals beliefs to maintain fair working environment
- must have governance and staff management processes in place to support and enable pharmacy professionals to provide continuous care for patients using their services
157
Making the care of the patient the priority
- patients at centre of decision-making
- work with patients so they can make informed decisions on how to access the care and services they need
- understand barriers patients may face
- check patient understands full range of information
- make it as easy as possible for patients to recieve care
- open to discussing how patients beliefs relate to their care
- recognise when a patient may need extra care or advice
158
Handling requests sensitively
- don't imply or express disapproval or judgement
- treat patient sensitively
- communicate professionally and with respect
- adapt communication
- consider body language, tone of voice and words
- safeguard, respect and maintain privacy
159
Roles of a RP
- registered pharmacist must be in charge of registered pharmacy as the RP
- can't open pharmacy to public if RP not present
- RP of one pharmacy at one time
- secure safe and effective running of the pharmacy before operating
- establish maintain and review SOPs - every 1-2 years or after incident
- if you make a temporary amendment to procedures keep a record of this
160
RP - displaying the notice
- must be cubically viewable
- must state name, GPhC number and that you are the RP
161
Pharmacy record details
- retained for 5 years
- contain RP name, GPhc number, date and time they started and stopped being RP and absent if applicable
- must personally make the entries, can be done remotely
- electronic or paper format
162
RP absence
- maximum 2 hours between midnight and midnight - total, not 2 hours each
- remain contactable and able to return with reasonable promptness
- if RP not signed in - can't open pharmacy, can only dispense and accuracy check
- if RP signed in but absent - can dispense, check and sell GSL only (cant hand out). Pharmacist present to do clinical check, sell P, PGDs, emergency supply, wholesale dealing or supplying POMs e.g. handing out
163
Owners and superintendent pharmacists who employ RPs
- appoint and support the RP to safely and effectively run the pharmacy
- pharmacy record - 5 years
- ensure RP maintains record
- available on premises for inspection
- if recorded electronically ensure it is backed up and any alterations must identify when and by whom they were made
