4 Flashcards
Latest regs on CD’s
Controlled drugs (Supervision of management and use) regulations 2013Misuse of drugs act 1971 (imposed total ban)Misuse of drugs regs 2001 (imposed limitation on possession)
Who enforces the law?
Secretary of state can give licenses via the home officeHome office enforces rules through the police
MDR 2001 classes: Sch 1
No therapeutic use License needed for production, possession or supplyeg. cannabis, ecstasy,hallucinogens etc
MDR 2001 classes: Sch 2
Pharmacists when acting in their professional capacity have authority to possess, supply and procure theseEg. Morphine, dimorphine, amphetamines etc
MDR 2001 classes: Sch 3
Minor stimulants less likely than Sch 2 to be abused eg. benzphetmaine, buprenorphine, temazepam, tramadol etc
MDR 2001 classes: Sch 4
Part 1: Benz POMBenzopdiazepines, non-bz hypnotics and sativex (CB mouthspray)Part 2: Anab POMAnabolic and androgenic steroids, clenbuterol and growth hormones
MDR 2001 classes: Sch 5
Not under full control as they are at such low strengthseg codiene, pholcodiene, morphine
Who can possess/supply?
Pharmacist/doctor/dentists have general authority over sch 2-5 which includes administration and/or prescriptionOthers can be given authority via home office license, paramedics/midwives (certain drugs)Patients can have them if they have a valid prescription
Sch 1 special rules
Usually requires special license from home office Pharmacists can have them on grounds of either destroying it or handing over as evidence to the policeCan also be administered or prescribed with special license
Import/export
License needed for import/export of sch 1-4No license necessary for patients transporting sch 4No license for import/export of sch 5’s
Traveling abroad
Patient with less than 3 months of CD’s need no license Advisable to carry prescriber letter sating name, travel plans, drug name, dose and quantityShould also have a quick check with embassy/airline about restrictions
Safe custody requirements
Sch 2/3’s must be kept in a locked ‘safe, cabinet or room which is constructed so as to prevent unauthorised access’Exemptions possible for other non regulation storage eg. gun cabinet, bank safe’s etcAccess to CD’s should b documented
Exceptions to safe custody
Sch 2: Some liquid preparations and quinalbarbitoneSch 3: Phenobarbital, midazolam, tramadolWhen a CD’s is not in safe custody it should be under the personal supervision of the pharmacist
Resources can be categorised as..
Land LabourCapitalTime
Satisfaction in economics is known as…
Utilities We gain a certain amount of satisfaction from each economic decision and therefore will make such decisions based on the satisfaction we gain
Marginal utility
The point at which where it isn’t really worth investing in the same product as the utility gained is less the money invested. This is tied to the principle of diminishing utility
Opportunity costs
The cost of be unable to spend time/money on an opportunity due to the capital be locked up in other assets
Economic evaluation
Comparison of two or more alternative treatments in terms of costs and consequences
Quality adjusted life years (QALY)
Utility is quality of life and is deteremined by EQ-5D-5L health questionnaire giving a score out of 1 This is multiplied by the number of years
Cost minimisation
Assumes effectiveness is equal Intervention which achieves the desired outcome at the lowest price
Cost effectiveness
Does not make assumptions on effectiveness Beneifts usually measured in QALYs Essentially looks for best value for money but only considers costs to the NHS
Incremental cost effectiveness ratio (ICER)
Difference in treatment costs/ difference in effectivenessTied to diminishing utility of the utility gained decreasing over many repititions
Cost benefit analysis
Compares medical outcomes and expresses it in monetary terms Difficult due to the need to cost every factor Most common method of assigning value is the ‘willingness to pay’ approach ie what are those extra few years actually worth to you
Important questions to ask: Nausea/vomiting
• Blood in vomit?• Weight loss?• Have you travelled recently?• Can you keep fluids down?
Refer if (nausea/vomiting):
• Severe abdominal pain• Dehydration• Vomiting in <1 months• Projectile vomiting in <3 months• 24hr vomiting in <1 year • Pregnant and uncontrollable vomiting • Blood in vomit• Weight loss
Nausea/vomiting treatments: Re-hydration
Only if fluids tolerated Replaces lost fluids Offer range of flavours
Nausea/vomiting treatments: Anti-emetics
-Migraine associated: prochlorperazine buccal tabs for 18+>1-2 tabs daily for 2 days only
Nausea/vomiting treatments: Anticholinergics
-Travel sickness (anticholinergics) >Hyoscine: 300mcg tab 20mins before travel repeat every 6 hours if needed (max of 3 tabs/24 hours)
Dyspepsia
Upper abdominal symptoms caused by:-Indigestion -Heartburn -Increased gastric content -Gastritis -Duodenal/gastric ulcers
Dyspepsia symptoms
-Belching -Nausea/vomiting-Early satiety -Upper ab/lower discomfort -Bloating-Flatulence -Heartburn -Duodenal ulcer (2-3hrs after food, especially at night)-Gastric ulcer (sharp pain in stomach, 30mins after food)
Important questions (Dyspepsia)
-Describe pain (sharp, gnawing, stabbing)-Point to where the pain is-Does the pain radiate anywhere?-Does food make it better or worse?-Any other lifestyle factors that make it worse?
Referral symptoms (Dyspepsia):
-Anaemia (pale, tired, SoB) (!)-Loss of weight (!)-Anorexia (!)-Recent onset of symptoms (!)-Melaena (dark fecal matter,blood in stool) (!)-long standing change in bowel habit-Debilitating pain-Referred pain (possible cardiac problem)-Treatment failure -Indigestion with medicines
Dyspepsia: Lifestyle advice
1st ID the causeThen: modify diet, cease smoking, alcohol, caffeine, reduce weight, correct posture
Treatment: mild dyspepsia
AntacidsAl salts cause constipation, Mg salts cause diarrheaeg.ReneeAlso alginates can be used in combo
H2 antagonists
eg. ZantacBarely better than antacid/alginate16+ only
PPI’s
Highest efficacyeg. Zanprol (Omerazole 10mg) BD until symptoms improve then 1xdailyMax 4 weeks treatment
Mouth ulcer questions
How many?where?Shape and size?Painful?Any new/increased meds?Do you know of any possible cause?
Mouth ulcer referral
<10yrs oldLarger than 1cmin groups larger than 5-10+>14daysPainless ulcers Involvement of eye
Mouth ulcer treatment
Chlorhexidine mouthwash (antibacterial)- reduces pain/symptomsCholine salicylate (analgesic)- 16+ onlyLido/bencocaine available for <16yrsHydrocortisone buccal tabs- reduces inflammation, pain and healing
Anti-emeticsAntihistamines
-Travel sickness (antihistamines) >Cinnarizine: 2 tabs 2 hours before journey and 1 every 8 hours of journey (adult)>Promethazine: 25mg on night before journey then every 6-8 hours as required (adult)
Most common prescribing error
Dosage error Followed by incomplete prescriptions, therapy omission, illegibility…
Stage in dispensing where most errors occur
Stock selection
Greatest impact on dispensing errors
Workload Followed closely by similar drug names/packaging
Clinical governance is defined as…
the framework through NHS organisations are held accountable for continuous improvement of services and safeguarding excellent standards of care by creating an environment where excellence in clinical care will flourish
Ways in which clinical governance is implemented
Audits CPDRemedying under performance Accountability Clinical effectiveness Patient/public involvement
Methods of preventing errors
SOP’s to standardise methods in order to reduce errorsNo blame culture and error reporting allows analysis of procedures to minimise errors Use of dispensing robots to reduce human errors
Duty of candour definition
Legal duty on medical professionals to own up to and apologise for any mistakes that have been made which may have led to harm coming to them.
Contraindication definition
A condition which my make a treatment or procedure possibly inadvisable. Either relative or absolute.Relative: Cation should be used but is acceptable if the benefit outweighs the risksAbsolute: an event or a substance that could cause a life threatening situation. Should be avoided
ADR definition
A noxious reaction that is unintended resulting from the use of a drug not only in the use of a product at normal doses but also outside of market authorisation, including the misuse, off label use and abuse of a medicinal product
Adverse drug event
An event that occurs while a person is on a drug but not necessarily caused by it
Most common adverse drug reaction
GI bleed
ABCDE ADR classification
A- augmented: due to dose/pharmacologyB- bizarre: weird and nobody knows whyC- chronic: due to long term useD- Delayed: occurs some time after drug use has stoppedE- End of use: Occurs due to the cessation of a drug (withdrawal)
DoTS ADR classification
Do- DoseT-TimeS-Susceptibility
Where are ADR’s reported to?
The MHRA yellowcard scheme
AssesSment of ADR
Nature/severity of ADRHistory of ADRDrug history ADR profile for the drug Further monitoring?Review/discuss with patient Management of symptomsReporting?
Allergies definition
When immune system reacts to substances in the environment that are harmless to most people With drugs it will occur at doses much lower than therapeutic
Drug intolerance definition
Lower threshold to the normal pharmacological action of a drug
Principles of medicines optimisation
Principle 1: Understand patient experience Principle 2: Evidence based choice of medicines Principle 3: Ensure meds are as safe as possible Principle 4: Make M.O. part of routine practice
Max no. of MUR’s per year
400 per community pharmacy per fiscal year
Aims of an MUR
Establishing patient knowledge and experience of the medicineIdentifying poor use of medication Identifying potential side effects and interactions Improving clinical effectiveness of given medication thereby reducing wastage
Requirements to be able to provide MUR service
Higher education systems will provide courses which will assess a pharmacists ability to do MUR’s Such places include, medway, manchester, keele and cardiff (Universities)
Target groups for MUR’s
70% of MUR’s must include:High risk medicines (NSAIDS, Anticoagulants/platelets, diuretics) Recent discharge from hospital where medication was changed Respiratory disease CVD and has >4 meds regularly prescribed
Requirements for respiratory MUR
Must be on 2 or more medicines 1 of which must be on COPD/asthma list for NMS
Requirements for hospital discharge patients
Within 4 weeks is preferable but up to weeks later is acceptable
Standards for a consultation area
Clearly designated and signed as a consultation area Distinctly separate from public areas and public should not be able to over hear patient/pharmacist talking in normal toneMUR must take place in pharmacy unless a suitable alternative is available
Patient requirements for an MUR
Patient must give consent both for the consult to take place and for the info to be shared May only have 1 every year unless significant benefits May not have 1 within 6 months of an NMSMay not have 1 if there is only one drug unless that drug is a high risk medicine
Difference between prescription intervention MUR and ordinary MUR
The prompt for the consult.P.I.MUR is reactive in response to an significant adherence problem
NMS therapy areas
HypertensionAsthma/COPDAntiplatelets/Anticoagulants Type 2 diabetics
Steps undertaken in an NMS
- Initial consult where patient is given info about new med 2. Patient comes back 1-2weeks later at a time suitable for them and they will be given more advice 3. Patient comes back 2-3 weeks later so pharmacist can find out about adherence and general experience Money for NMS can only be claimed after steps 1-2 have been completed
To obtain consent the patient must..(4 things)
Patient must be able to:1. Understand given info2. Believe the info3. Retain and weigh up info4. Be free from duress
Automatic blood pressure
Unsuitable for those with irregular heartbeats Should be calibrated every yearNot as accurate as manual blood pressure monitor (unless the person is useless at taking blood pressure’s)
Normal glucose range for adults
4-7mmols/lShould be highest after meals and lowest in the morning
Aims of UKmi
To support safe, effective and efficient use of meds by providing evidence based information and advice.This service is for healthcare providers
No of UKmi enquiries per year
300,000
Phase 1 trials
Generates intial PK/PD info20-50 participantsGiven to the healthy if trt is non toxic or the severely ill if very toxicUsually only a single dose or a few weeks of treatment `
Phase 2 trials
Provides exp with trt and administration <100peopleMeasures trt efficacyShort/moderate follow up (few weeks to a year)Determines daily dosage and trt regimen for P3
Phase 3 trials
Gives definitive data against a control Evaluates toxicity/efficacy500-3000 patients
Roles
1) Analyse NHS/private prescribing of CD’s 2)Request declarations of self assessment3)Periodic inspections4)Ensure adequate steps taken to protect patients/public about inappropriate use of CD’s5) Convene incident panels to investigate concerns6) Ensure individuals working with CD’s have appropriate training
What is an LIN?
Local intelligence network Led by lead CDAO, it has representatives from responsible bodies:Police, CCG, prescription pricing division (PPD), care quality commission (CQC), NHS protect, local authorities and designated bodies
Types of incidences that are reported
Suspected fraudulent activity/theftBalance discrepanciesDispensing/prescribing errorsWrong formPoor governence
Part VIII
Basic prices (A)Payments for specials (B)Cat A is readily available, BB allowed if smallest pack>£50Cat C not available as generic, BB allowedCat M reimbursement determined by manufacturer price, BB if samllest pk >£50
Part VI
Payments for essential and advanced services
Part VII
Payments for quality care
Part III
Fees for stuff
Part IX
AppliancesBB for parts B, C and ROOPE for B and C
Part XIV
Payment for fraud and errors
Part XVII
payments for dental, nurse and non medical prescribing
How is reconstitution indicated?
Black circle
Special containers are indicated by…?
Black square
Requirements for part 7 quality payments are?
Must offer MUR/NMSNHS choices page must be upto dateAble to send/recieve NHS emailSupports EPS
What does the double S symbol mean?
Selected list schemeDrugs which can only be given under certain conditions
Part XV
Borderline substancesCan only be given for certain conditions
Part XVIIIA
The black list
FP10CDF
Form filled for audit purposes and sent to NHSBSA
8 headings under the new NHS pharmacy contract
Dispense scriptsDispense repeatsDispense appliancesSignpostSupport self-carePromote healthy lifestylesClinical governance
