Law and Ethics MDA lectures; Jenny Scott Flashcards
When dispensing CDs, what act requirements apply?
Medicines act requirements apply, PLUS additional requirements of the Misuse of drugs act (MDA)
What is a controlled drug?
One that is controlled under the Misuse of Drugs act (1971)
Controlled drugs in healthcare are medicines subject to both the Medicines act and the MDA (misuse of drugs act).
The MDA places additional controls on certain substances that are likely to be misused or abused. What two substances omit this? (ignored?)
Nicotine
& alcohol
Two of the most harmful and commonly used drugs
The misuse of drugs act makes total prohibition (totally bans) possession, supply, manufacture, import and export of certain substances, except as allowed in ___________________ regulations, or under ______.
Allowed in the Misuse of drugs act regulations
Or under LISCENCE
How many schedules are CDs classified into?
What does this depend on?
5 schedules
Depends on their perceived likelihood to be misused and the potential risks that misuse may present to the individual or society.
Tricky question: what are the 5 different CD schedules abbreviations?!
Sch 1: CD Lic POM
Sch 2: CD POM
Sch 3: CD no register POM
Sch 4: Part I (CD Benz POM)
Part II (CD Anab POM)
Sch 5: CD Inv POM or CD Inv PHow to find out what schedule a CD is?
Look up RPS (royal pharmaceutical society)
Look up list of medicines for human use
Their classes will be listed
What are the Schedule 1 drugs? (CD Lic POMs)
These drugs have no current therapeutic use
Such as LSD, Ecstasy, MDMA, also cannabis
Production, supply and possession of these drugs needs home office Liscense
What about patients confidentiality when handing in schedule 1 controlled drugs such as cannabis and LSD?
patient’s confidentiality should normally be maintained and the police should be called on the understanding that the source will not be identified. If, however, the quantity is so large that the drug could not be purely for personal use the pharmacist may decide that the greater interests of the public require identification and the identity of the person should be asked.
Can you just grab a schedule 1 CD off a patient, as the shouldn’t have it on them anyway?
No, The patient should give authority for the drug to be removed and destroyed.
If the patient refuses, the pharmacist may feel that they have no alternative other than to call in the police. ☎
Are there any circumstances when you can give a schedule 1 controlled drug (eg LSD, cannabis) back to a patient?
NO
Under no circumstances can a suspected illicit drug be handed back to a patient.
When can a pharmacist possess schedule 1 controlled drugs without a home office LISCENCE?
When possession is for destruction
When possession is for handing to police
What is the only exception to schedule 1 requirements?
Why?
Sativex
It does have therapeutic use
Pharmacists DO NOT need a Liscence to possess or supply this
Sativex is a cannabinoid medicine for multiple sclerosis
What are schedule 2 drugs?
Opiates, major stimulants, quinalbarbitone
Eg of opiate: Methadone
Do pharmacists have legal authority to handle schedule 2 CDs? (CD POMS)
They have general authority to possess, supply, and procure (obtain) schedule2 CDs when Acting professionally.
can only supply if a VALID prescription is present.
License is needed to import or export.
Production or compounding (making up in the pharmacy) can be done by a pharmacist, practitioner or Liscence holder.
Who can schedule 2 drugs be administered to patients by
Doctor, dentist, nurse IP, pharmacist IP (independent prescriber)
What are schedule 3 controlled drugs? (CD No register POM)
Minor stimulants such as benzphetamine Buprenorphine Temazepam Phenobarbital Midazolam
Less overdose risk with these, less risk of misuse/ harm than with Sch 2 drugs.
Do schedule 2 drugs require a CD register?
Yes!!!
CD registers need to be kept for 5 years
Do schedule 3 drugs require a CD register?
No!
These are CD No Register POMs
Are there controls over destruction of Sch2 and Sch3 drugs?
There are for schedule 2 drugs,
But not for schedule 3 drugs
Do safe custody rules apply to schedule 2 and schedule 3 drugs?
They do for schedule 2 drugs…
But many schedule 3 drugs are exempt to safe custody requirements
How long should invoices (prescriptions?) of schedule 3 drugs be kept ?
Retained for 2 years
don’t need to do this for Sch 2 drugs
Schedule 3 drugs have the same controls as schedule 2 drugs except….
Different groups can possess and supply
No requirements for CD register records
No MDA controls for destruction
Many are exempt from safe custody requirement
Schedule 4 CDs: what are the two parts and examples of drugs in those parts?
Part I (CD Benz POM): most benzodiazepines and ketamine. Part II (CD Anab POM) anabolic and androgenic steroids, clenbuterol, growth hormones
Schedule 4 CDs have same restrictions/ controls as schedule 3, but what are the exceptions?
No special labelling required with Sch 4
No safe custody at all
No CD register (same as with Sch 3)
No need by law to keep invoices for 2 years
What are schedule 5 controlled drugs? (CD InvP or CD InvPOM)
Preparations containing CDs in low strength (eg codeine, morphine, pholcodeine)
(how much of certain drugs is in the formulation determines what schedule a drug is, Sch 5 contain low amounts of CDs)
What are the restrictions/ controls on Sch 5 drugs?
No MDA restrictions on import, export, possession, supply or administration
Pharmacists can make up/ compound schedule 5 drugs
Note: a drug may be contained in a schedule 2 product and also in a schedule 5 product but in lower amounts (how you manage the schedule depends on the Quantity, not just the drug!!)
What is the schedule of a drug determined by?
Not only the drug itself but the quantity of that drug In the Formulation. Ie you may have a schedule 2 drug and 5 drug containing the same drug such as morphine, but the schedule 5 drug will contain much lower concentrations,therefore there is less liability for abuse/ misuse
Eg: sevredol tablets containing morphine salt 10mg, a Sch 2 CD POM
Diocalm dual action tablets containing 0.4mg morphine HCL, a Sch 5 CD Inv P ☺☺
Are CD registers need for Sch5 CDs?
No, unless they have been made up from Sch2 drug stock (from the CD cabinet)!
How long should invoices be kept with Sch5 CDs?
For 2 years, as inspectors may make checks if any excessive ordering or sales are done.
Sch 5: CD Inv POM or CD Inv P
What are the requirements for labelling and safe custody for schedule 5 drugs?
No special label requirements (other than those in Medicines act)
No requirements for safe custody
No witness needed for destruction ☺
What’s the only CD sch1 controlled drug pharmacists can possess without having a Liscence?
Sativex
How can you check the authorisation of someone to possess , supply and obtain CDs? Eg if you suspect that a prescription isn’t valid or want to know if the prescriber has a right to prescribe it?
Contact the Home office
What are the rules for importing an exporting CDs for a pharmacist?
Importing or exporting 1,2,3,4 (part I)CDs: pharmacist needs a LISCENCE to do so.
Sch 4 part II or Sch 5 drugs can be imported or exported without a Liscence
What Happens with patients going abroad?
MDA is UK legislation only.
A patient does not need an export license if they’re taking less that 3 MONTHS supply of a CD abroad.
(if they’re going away for longer than this they’ll need to register with a doctor there and get their supplies abroad)
Depending on the laws of the country visited, the person may need an import License, you should check with the embassy of the country in advance to travel.
For patients taking drugs abroad, how’s it best to take them?
Carry in their original pack
Take letter from prescriber with details of name, quantity etc
What does “safe custody” mean?
Stored in a CD cabinet or other approved storage facility.
Follows the MDA Safe custody Regulations
Sch 2 of the MDA safe custody regulations specify the CD storage specifications. There must be no indication as so what’s in the cabinet.
You could also have a secure room, but mustn’t be viewable to the public and you’re responsible to ensure it follows the regulations may be more likely to have a secure room in a hospital where more CDs are dispensed.
In prisons and hospitals, what standard must be met for CD cabinets and rooms? Why?
The “Sold Secure silver standard” (a lot more secure)
This is because quantities of CDs will be larger
Pharmacies must have a written policy in place which describes access to CDs (Seperate from the SOP that describes dispensing of CDs!) what should the policy prevent? What does it require there to be means of identity of?
policy prevents unauthorised access to CDs
should identify everyone who has had access to the CDs in that pharmacy and when, you can get electronic access which keeps and electronic log
It’s normal practice for the pharmacist to have key in their pocket
Which Sch 1 CDs should be kept in the CD cabinet?
ALL!
Exception: Sativex: should be stored in a lockable fridge
Which Sch 2 CDs should be kept on the CD cabinet/ room? Exceptions?!
All of them,
Except for quinalbarbitone and some liquids (unless they’re in injection form )
It’s still good practice to put these in CD cabinet to prompt you to still do a CD register
Which Sch3 CDs should the kept in CD cabinet? Can you think of the 4 which definitely should be?
Many exceptions with Sch 3 drugs.
The ones that definitely should be are;
Tamezepam, buprenorphine, flunitrazepam, diethylproprion (expected to know these for exam! )
Are Sch 4 and Sch 5 CDs kept in the Cd safe/cabinet?
No
When CDs are not in the safe where must they be?
Under direct personal supervision of the pharmacist
If you hand over the keys to someone else, must have record of when and to who!
What about out of date CDs? And unwanted CDs returned by patients? What applies?
Safe custody still applies
Still need to keep in the safe, but if you only have one safe, make sure you have a Seperate shelf for these so you don’t accidentally dispense these.
What’s the difference between a prescription and a Requisition?
Prescription is a request to supply one individual patient
A requisition is a request from a proffessional to obtain a supply of medicines so they can supply a number of patients themselves, eg a person in charge of a care home may request this, or a nurse in charge of a ward, or a doctor for his on call medical bag.
Requisitions are more of a formal written request
When does a prescription have to be present to supply a CD?
All the time, for all schedules, except Sch 5, although some Sch 5 CDs are POM so these need a prescription.
In community, what kind of prescription form needs to be presented in order to dispense Sch 2+3 CDs?
In England its an FP10PCD which is Pink, MUST be on one of these, illegal to be written on normal private Rx paper, APART from in hospitals where the CDs are being dispensed in the same hospital.
in Wales; WP10PCD, In Scotland: PPCD(1)
Could you have a CD and a Non CD on the same Pink form?
No must be Seperate, as this would not meet MA requirements
What number must be on CD prescriptions?
Private prescriber Identification number
What must be done with the FP10PCD after the items dispensed?
Submit original to payment authority (NHS BSA)
And keep a photocopy for your records for 2 yearsfor good practice!
Keep CD register for 2 years
Date of SUPPLY must be put on CD Rx(for Sch 2& 3)
Exceptions with Vetinary Rxs for Sch 2 and 3 CDs?
Don't need to be on standardised forms (pink forms), Don't need to be submitted to NHS BSA Don't need prescribers ID number Keep Rx for 5 years in pharmacy!
