Additional legal and professional issues 3.7 Flashcards
Expiry dates 3.7.1
‘Use by’ or ‘Use before’, this means that the product should be used before the end of the previous month eg ‘Use by 06/2024’ = not used after 31 May 2024.
‘expiry date’ = not be used after the end of the month stated. eg expiry date of 12/2024 = not used after 31 December 2024
Waste medicines 3.7.2
England and Wales:
* Enforcement body- Environment Agency
* Can pharmacies receive waste medicines?
Yes. They dont need licence to receive waste. some cases they could need licence.
More info on MEP
Scotland
* Enforcement body Scottish Environment Protection Agency (SEPA) www.sepa.org.uk.
* Can pharmacies receive waste medicines?
Yes. Regulations 2011 allow registered pharmacies to accept returned medicines from patients or individuals and care services.
More info on MEP
England, Scotland and Wales
* Where should waste medicines be stored?
In secure waste containers in chosen area away from normal meds. SHARPS = sharps container
* Dealing with confidential information
Ensure that any patient identifiable information is destroyed or totally obscured.
* Tablets and capsules
Blister strips can be removed from their inert outer packaging but tablets and capsules should not be de-blistered.
NB: exemption applies to CD tablets and capsules, which require denaturing - 3.6.10
* Sharps
Syringes & needles = sharps container.
* Liquids
The whole bottle (including empty bottles that can contain residue) should be placed into a pharmaceutical waste container because the mixing of different medicines could be hazardous.
NB: Exceptions apply to CD liquids, which require denaturing – 3.6.10
* Advice for patients
Advised that unused, unwanted meds should be returned to a pharmacy for safe disposal.
Requests for poisons and chemicals 3.7.3
CHECK OUT DIAGRAM ON CANVAS
Pharmacies to report suspicious transactions, significant stock loss and theft to the local police (dial 101) or the anti-terrorism hotline (dial 0800 789321).
Public need to present a valid licence issued by the Home Office before being able to purchase the most dangerous poisons or chemicals which could be used as explosive precursors. (EPP license)
Pharmacy teams will need to check that the licence is valid, unaltered and matches the request.
Transaction details must be added to the licence, substances must be suitably labelled and regulated poisons require additional record keeping in a poisons register.
Where Licences aren’t required, the pharmacist should consider whether requests are suspicious and whether commercial ALT or commercial retailers are appropriate to refer to.
LABELLING
packaging must also be labelled with the phrase. ‘Acquisition, possession or use by the general public is restricted’ or similar
STORAGE
main requirement = poisons must be stored separately from other items especially away from food and drink
EXEMPTIONS
EG: medicines, cosmetics, adhesives, builders
materials are all exempt.
RECORDS
Must make record of part 2 substances. (regulated non medicinal poisons)
Supply to private individual:
1. date of supply
2. name and address of the purchaser
3. name and quantity of the regulated poison supplied
4. the purpose for which it is required
5. the signature of the purchaser
Supply to trade, business or profession:
Same as above just get business details instead of purchaser.
Delivery and posting of medicines to patients 3.7.4
Should you deliver/post:
* Patient consent for delivery/ posting
* Patient confidentiality during the delivery/ posting process
* Is face-to-face contact needed with the patient to ensure meds can be safely, effectively and appropriately used
* Is interview needed
* Has the patient been assessed or directly interviewed by the prescriber?
* Medicines and medical devices are not ordinary items of commerce and must be handled and supplied to the patient safely. An adequate audit trail must be in place for delivery and receipt from the point at which the medicine leaves the pharmacy and is received by the patient/patient representative or returned to the pharmacy in the event of delivery failure. Wherever possible a signature should be obtained to indicate safe receipt of medicines.
* Storage requirements during transit.
* When posting – will the postal carrier agree to transport the medicinal product (check terms of carriage, prohibited and restricted goods)
* When posting abroad – are there legal restrictions in the destination country which would prevent you from posting? (E.g. guidance produced by the FDA makes it clear its illegal for a foreign pharmacy to ship prescription medicines that are not approved by the FDA to the US
* When posting abroad – are there UK legal restrictions which would prevent you dispensing in the first place? (e.g. is the prescriber recognised as an appropriate practitioner (3.1.3) for the medicinal product in the UK?).
Secure environments 3.7.5
Secure environments include prisons, police custody suites, secure hospitals, immigration removal centres and other places where persons are detained.
When medicines are dispensed from an ‘in-house’ pharmacy for administration or supply to patients within a prison, the pharmacy does NOT need to be registered with the GPhC.
If provision of a pharmacy service to another prison is being considered from an in-house pharmacy, get advise from the GPhC and MHRA to discuss whether the pharmacy premises would require registration or whether a Wholesale Dealer’s Licence will be required.
Child-Resistant Packaging 3.7.6
Suitable, child-resistant packaging should be used for supplying ALL solid, ALL oral and external liquid dose preparations unless there is a good reason for not doing so. Such reasons may include:
1. Specific request:
Difficult for them to open = give a non child resistant lid.
2. Original pack
May not be child resistant. certain meds dont have child resistant pack.
Homeopathic and herbal remedies 3.7.7
DIFFERENCES BETWEEN HOMEOPATHIC AND HERBAL PRODUCTS
Homeopathy = holistic complementary and ALT therapy based on the concept of ‘like to treat like’ and involves the administration of dilute and ultra dilute products prepared according to methods given in homeopathic pharmacopoeias.
Herbal preparations contain plant-derived materials, either as raw or processed ingredients can be from one or + plants.
NO evidence for homeopathy. Not endorsed by RPS.
Advise patients on lack of evidence on efficacy of products. Ensure they dont stop prescribed meds for homeopathic.
REFERRAL
Homeopathic only used for minor, self-limiting conditions and not for serious.
LICENSING
MHRA DONT require homeopathic products to demonstrate efficacy, ONLY QUALITY AND SAFETY.
Charitable donation of medicines 3.7.8
If pharmacy supplies meds to another business who takes it to supply elsewhere a WDA(H) is needed - regardless if its extra stock or general stock or if it is to be donated to charity or conflict. THEY NEED A WDA.
CONSIDER ALTERNATIVES:
WHO recommend cash donations and acute phase of emergency a standardised health kit. Cash donations can get medicines for reduced price from manufacture.
PATIENT RETURNS:
WHO- CANT donate patient returned meds.
RE-use not allowed of returned meds.
Returned meds only accepted for destruction.
If a pharmacy takes patients meds and supplies to another legal entity then they need a WDA as they are wholesaling.
Collection and purchase of medicines by children 3.7.9
Child may collect for themselves, or another person, or someone they have personal relationship with.
Decision to supply is case by case.
Factors to consider
* Knowledge of the child - child known to pharmacy?, information is known?
* Maturity of child - Capable and competent to understand medicine importance?, confident they wont misuse or tamper with medicines.
* Nature of medicine supplied - what? can be misused?
* Prior arrangement - Are they regular collector?, is there a plan in place for their collection?
* Reason for collection - is there 1?, person meds is for is home bound?, is the child a carer for the person?, are they to self medicate?
* Advise on use of medicines - can they understand additional info?, if special instructions needed adult may need to be contacted.
* Local policies - is there a local policy?, SOP?, Make record of child supply.
* Proof of ID - CD 2 needs proof child wont have this. use pro judgement to supply.
Medical devices 3.7.10
Definition of medical device:
Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease
- diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap
- investigation, replacement or modification of the anatomy or of a physiological process
- control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
EGs: dressings, thermometers, needles, syringes, BP monitors, stoma care products, condoms, test kits (cholesterol test kits, pregnancy test kits, etc.), inhalers, glucose meters and test strips, screening tests, some emollients, some eye drops, etc.
All devices regulated by MHRA
All devices need the CE or UCKA mark = shows compliance to regulations and device works.
Multi-compartment compliance aids (MCA) 3.7.11
Help patients manage their medicines. may not be best intervention there are others.
MCA not suitable for all medicines. usage of MCA needs to be regularly reviewed and reassessed to ensure it is beneficial for user.
RPS says keep meds in original packs unless there is obvious need for MCA.
ALT to MCA:
* Medicines administration record (MAR) charts
* Labels with pictograms
* Large print labels
* Information sheets
* Reminder alarms
* IT solutions and new technology such as phone apps and telemedicine
All interventions ensure patients take or receive the correct medicines at the right time.
Drugs and driving 3.7.12
Background
an offence of driving whilst impaired through drugs, regardless if they are used legitimately.
And offence to drive over a certain limit with some drugs in your body.
1st group - commonly abused drugs for which low limits have been set
2nd group - mainly of licensed medicines that have a significant liability to be abused - higher limit than group 1.
STATUTORY MEDICAL DEFENCE
- exists to protect patients who may test positive for these specified drugs (see below) due to taking medicines in line with advice from a HCP or the PIL.
It can be used if the drug:
* Lawfully prescribed, supplied or purchased OTC, for medical or dental purposes AND
* Taken in line with advice given by the prescriber or supplier, and in line with any extra written instructions (provided instructions are the same as the prescriber).
Patient specific advise can differ from PIL if this is the case the advise is used as basis for defence.
Summary of how the statutory medical defence fits in with existing legislation
CHECK MEP but Statutory medical defence only applies if driving isn’t impaired and evidence of this is how drug was prescribed.
Pharmacist need to consider drug interactions that can effect drug metabolism.
Specified drugs
1. Group 1
* Cannabis (delta-9-tetrahydrocannabinol [THC])
* Cocaine (and cocaine metabolite, benzoylecgonine [BZE])
* Heroin/diamorphine metabolite (6-monoacetylmorphine [6-MAM])
* Ketamine
* LSD
* MDMA (ecstasy)
* Methylamfetamine.
- Group 2
* Amfetamine
* Clonazepam
* Diazepam
* Flunitrazepam
* Lorazepam
* Methadone
* Morphine or opiate and opioid-based drugs, e.g. codeine, tramadol
* Oxazepam
* Temazepam.
ADVICE FOR PATIENTS
* mustn’t drive if you feel sleepy, dizzy, are unable to concentrate or make decisions, have slowed thinking, or if you experience sight problems. If not sure how med affects you check before driving.
* if on new meds check with pharmacist if it can affect your driving.
* Alcohol + meds can increase accident chance
* Untreated condition can impair driving so dont stop meds.
+ FOR ANY1 TAKING DRUGS MENTIONED ABOVE:
* Limit for certain amount of drugs in your bloodstream- there is defence for ppl whose driving is not impaired.
* Keep evidence with you to prove your taking meds as prescribed. eg Inc. repeat prescription slip or PIL for OTC.
IF driving is impaired they can be prosecuted regardless of legality.
MEDICAL CONDITIONS & DRIVING:
NEED TO BE FIT TO DRIVE.
Retention of pharmacy records 3.7.13
Refer to MEP for links (waffle)
New Psychoactive substances (NPS) 3.7.14
UK Psychoactive Substances Act (PSA) 2016= ‘substances’ that are ‘capable of producing a psychoactive effect’.
WHY YOU SHOULD KNOW ABOUT NPS?
NPS - offence to possess them within custodial institutions, or anywhere with intent to supply them to another. It is also an offence to import them (e.g. by buying them from a foreign website).
NPS can have CD 1,2 substances.
Pharmacist need to be aware of NPS/POM interactions. can be unclaimed API in NPS. NPS haven’t replaced traditional abused drugs but added on to them.
NPS can affect driving with drugs affect i.e. patient takes an NPS that inhibits the metabolism of a prescribed CD 2 POM, a road-side test may show greater concentrations of the CD2 than that allowed whilst driving = ARREST
Pharmacists should be aware of the ‘re-classification’ of OTC and P medicines to NPS when used for recreational purposes.
NPS may induce addiction and psychosis, therefore, there are legal (under the Mental Health Act 2007), professional, clinical and cost implications.
Working during a pandemic 3.7.15
CHANGES IN LEGISLATION DURING A PANDEMIC
legislation relaxes emergency supply requirements. allows pharmacist to make emergency supply without interview.
Provisions in place to let supply happen from collection points where there is serious risk to human health.
Government also has ‘emergency powers’ to respond rapidly during a public emergency like a pandemic by making new legislation or enacting existing legislation.
Changes made in emergency power are temporary apply to certain circumstance and are under review. some changes happen immediately some over time or after a certain time.
CANT ASSUME CHANGE IS IMMEDIATE OR APPLIES EVERYWHERE NEED TO READ GUIDANCE.
WORKING OUTSIDE YOUR SPECIALITY/SCOPE
Is allowed during pandemic but if can be avoided you should avoid.
if you dont feel competent/ are concerned speak to your manager.
