Drug Legislature & POM-S Flashcards
What are the three categories of medicine as outlined by the Medicines Act of 1986?
General Sales List (GSL) - Medicines which can be purchased from any shop without a prescription
Pharmacy Medicines (P) - Medicines only available from a pharmacist that do not require a prescription
Prescription Only Medicines (POMs) - Medicines available from a pharmacist only if they have been prescribed by an appropriate practitioner
What are the four categories of controlled drugs as laid out by the Misuse of Drugs Act (1971)?
Class A - Heroin, Cocaine, Morphine, Oxycodone, Fentanyl, MDMA, Methamphetamine, DMT etc
Class B - Amphetamine, Cannabis, Codeine, Ketamine, Barbituates etc
Class C - Benzodiazepines (e.g Diazepam), Pregabalin, Gabapentin, Anabolic Steroids, Nitrous Oxide etc
Temporary Class - A temporary classification
What do the abbreviations CD5, CD4, CD3, CD2 & CD1 refer to?
They refer to the 5 ‘schedules’ of controlled drugs, as laid out by the Misuse of Drugs Regulations (2001), which defines the classes of person who are authorised to supply and possess controlled drugs while acting in their professional capacities. The schedules correspond to the level of therapeutic usefulness and the potential for harm from misuse. The drugs with the highest levels of abuse, and potential for psychological and/or physical dependence, are placed in schedule 1. Those with the lowest potential for abuse/ dependence are in schedule 5.
Schedule 1 (CD1) - Includes drugs not used medicinally such as hallucinogenic drugs (e.g LSD), ecstasy, raw opium and cannabis
Schedule 2 (CD2) - includes opiates (e.g diamorphine hydrochloride, morphine, oxycodone hydrochloride), major stimulants (e.g amphetamines), ketamine, cocaine and medicinal cannabis.
Schedule 3 (CD3) - includes barbiturates, gabapentin, tramadol hydrochloride, buprenorphine and pregabalin
Schedule 4 (CD4) - includes drugs that are subject to minimal control (such as benzodiazepines), non-benzo hypnotics, androgenic and anabolic steroids etc
Schedule 5 (CD5) - includes preparations of certain controlled drugs (such as codeine, morphine or pholcodine) which due to their low strength, are exempt from virtually all controlled drugs requirements other than retention of invoices for 2 years.
What are Patient Specific Directions?
A written and signed instruction, given by a doctor, dentist or non-medical prescriber to another professional to supply and/or administer medicines to named person (who has been individually assessed by the prescriber)
A PSD can be for a list of named patients/service users who have all been individually assessed. A PSD for supply of medicines is in a prescription form.
Podiatrists could supply or administer medicines based on a PSD, however there are very few scenarios where this would be of value to the patient or podiatrist so it is not commonly seen
What is a Patient Group Direction?
Written instructions for the supply and or administration of medicines to certain groups of patients by certain named professionals.
PGDs are more commonly seen in podiatry, as prior to the introduction of POM-S and A into undergraduate podiatry, and podiatrist being allowed to train as independent prescribers, these were used often in diabetic foot clinics to allow the supply of antibiotics to patients with DFIs, and in orthopaedics and rheumatology to allow podiatrists to use corticosteroids.
PGDs are not straightforward to set up, as they require authorisation from within the NHS board or local authority. In Scottish health boards they usually require the signature of a consultant physician/surgeon + head or pharmacy + service manager.
What is a Signed Order?
A document that allows pharmacists to supply selected POMs directly to the patient. Registered podiatrists with the POM-S annotation are able to write signed orders to request the supply of any medicine that can be legally sold or supplied by the podiatrist (as opposed to medicines only the podiatrist can administer e.g LA and injected corticosteroids etc)
They are not prescriptions - therefore the usual prescription requirements are not technically required on the part of the pharmacist, however pharmacists should be satisfied that the podiatrist has provided sufficient advice to enable the patient to use the medicine safely and effectively
What are the requirements for a Signed Order to be valid?
They must be signed by the podiatrist
They must be for a medicine from the POM-S list
They must include the date the order was written
They must include both the podiatrist’s and patient’s details
They must describe the purpose of the order (e.g management of infection or pain etc)
What are the three oral antibiotics available on the POM-S annotation?
Amoxicillin
Erythromycin
Flucloxacillin
What topical antibiotic is available through the POM-S annotation?
Silver Sulfadiazine (Flamazine Cream)
What topical anti-mycotic medicines can be sold/supplied by podiatrists with the POM-S annotation?
Amorolfine Hydrochloride Cream (no greater than 0.25%)
Amorolfine Hydrochloride Lacquer (no greater than 5%)
Tioconazole 28% Lacquer
What analgesic medicines can be sold/supplied by podiatrists with the POM-S annotation?
Co-Codamol
Co-Dydramol 10/500 Tablets
Codeine Phosphate
What topical steroid can be sold and supplied by podiatrists with the POM-S annotation?
Topical Hydrocortisone Cream (no greater than 1%)
What limitation is recommended by the Royal College of Podiatry and the Royal Pharmaceutical Society regarding the supply of analgesics containing codeine and dihydracodieine by podiatrists?
What is the rationale for this limitation?
That registered podiatrists should only provide patients with a supply of codeine/dihydracodeine based analgesics for a duration of 3 days maximum (so essentially you can only give patients a 3 day supply or less), and that the dosage you supply is limited to available pack sizes.
This also applies to the supply of opioid analgesics from a pharmacist directly to a patient via a signed order, or to a podiatry practice.
So a pharmacist should supply a patient with a signed order from a podiatrist, with the closest commercial pack size available for a maximum of 3 days. And when supplying to a podiatrist, pharmacists should provide multiples of the commercial pack sizes available so that the podiatrist can supply these to a patient (e.g if 100 pills are requested, and 32 is the commercial pack size, 3 packs of 32 are supplied)
The rationale for this limitation is to minimise the risk of addiction and abuse from analgesics containing codeine and dihydracodeine
What form and dosage is codeine phosphate available in? And what is its maximum adult dose within 24 hours?
Codeine phosphate is available as:
15mg oral tablets
30mg oral tablets
Both are available in pack sizes of 28 tablets
It’s maximum adult dose is 240mg (delivered orally) within 24 hours
What form and dosage is co-codamol available in? And what is its maximum adult dose within 24 hours?
Co-codamol is available as:
8/500mg (Codeine/Paracetamol) oral tablets (available in pack sizes of 16 tablets)
15/500mg oral tablets
30/500mg oral tablets
Adult maximum dose of co-codamol is governed by the paracetamol component of 4g total within 24 hours (maximum 8 tablets of any strength within 24 hours) with the exception of those under 50kg, who should be not take more than 2g total within 24 hours
What form and dosage is co-dydramol available in? And what is its maximum adult dose within 24 hours?
Co-dydramol is available to podiatrists as:
10/500mg (dihydracodeine tartrate/paracetamol) oral tablets (available in pack sizes of 30 tablets)
Adult maximum dose of Co-dydramol is governed by paracetamol component of 4g total within 24 hours (Maximum 8 tablets per 24 hours), with the exception of those under 50kg, who should be not take more than 2g total within 24 hours
What is the WHO Analgesic Ladder and what 5 key principles should be considered when utilising it?
A system developed by the World Health Organisation to aid clinicians decision making when prescribing analgesia and assessing the need for dosage titration of pain relieving medication. It was initially developed for use in cancer patients, but can be applied to any patient presenting with acute or chronic pain requiring analgesia.
The five key principles of the WHO Analgesics Ladder are as follows:
Oral administration should be used wherever possible
Analgesics should be given at regular intervals, with the duration and dose of medication appropriate to the patients level of pain
Analgesics should be prescribed according to the intensity of the pain described by the patient (this should be free of judgment from the clinician)
Dosage should be adapted to the individual, starting at the lowest dose duration possible but titrating according to response
Consistent administration of analgesics is vital for effective pain management
What are the three ‘steps’ of the WHO Analgesics Ladder?
STEP 1 - Non-Opioid Analgesics
Paracetamol, NSAIDs (ibuprofen, naproxen, diclofenac e.t.c)
If pain increases or persists…
STEP 2 - Weak Opioids (Mild to Moderate Pain)
Can be codeine alone or combined with paracetamol (Codeine phosphate, co-codamol, co-dihydramol)
If codeine/ codeine combined with paracetamol is ineffective, Tramadol is considered as it is another ‘weak opioid’
Remember; opioids are not useful for mechanical back pain, fibromyalgia or non-specific visceral pain (pain felt in the trunk of the body, including the heart, lungs, abdomen and pelvic organs)
STEP 3 - Strong Opioids (Moderate to Severe Pain)
Morphine, Oxycodone, Fentanyl, Buprenorphine e.t.c
Who should you report adverse drug reactions (ADRs) to and what system should you use to do so?
The Medicines and Healthcare products Regulatory Agency (MHRA), through the yellow card scheme, by filling out online form on the yellow card website, or by downloading and using the yellow card app.
What does it mean if a podiatrist is a ‘Supplementary Prescriber’?
The SP (supplementary prescriber) annotation means that a podiatrist is able to prescribe medicines to individual patients as part of a ‘clinical management plan’. This is a plan agreed between the supplementary prescriber, a doctor and a patient. The clinical management plan can include any licensed or unlicensed medicines and all controlled drugs, as long as they are being prescribed in partnership with a doctor.
What does it mean if a podiatrist is an ‘Independent Prescriber’?
The IP annotation means the podiatrist is able to prescribe any medicine (excluding controlled drugs with a few exceptions) within their scope of practice and legislation. The following controlled oral drugs are able to be prescribed by podiatrists with the IP annotation, but cannot be possessed or supplied by them:
Temazepam
Lorazepam
Diazepam
Dihydracodeine Tartrate
What three levels of evidence can be attributed to drug interactions listed in the BNF?
Study - Meaning the information regarding the drug interaction is based on a formal study, including those for other drugs with the same mechanism of action
Anecdotal - Meaning that the evidence regarding the drug interaction is based on either a single case report or a limited number of case reports
Theoretical - Meaning that the drug interaction is predicted to occur based on sound theoretical conclusions. The information may have been derived from in vitro studies or based on the way other members of the same drug class act.
What are the four levels of severity that can be attributed to drug interactions listed in the BNF?
Severe - The result of the drug interaction may be a life-threatening event or have a permanent detrimental effect
Moderate - The result could cause considerable distress or partially incapacitate a patient; they are unlikely to be life threatening or result in long-term effects
Mild - The result is unlikely to cause concern or incapacitate the majority of patients
Unknown - Means that there is insufficient evidence to hazard a guess at the outcome of an interaction. This is often used for interactions that are theoretical/predicted.
If a patient required 500mg of flucloxacillin 4 times a day for a duration of 1 week, and your practice only had 250mg capsules of flucloxacillin in stock, how many 250mg capsules would you need to supply the patient?
56 capsules
A patient requires 60/1000mg of co-codamol every 4-6hrs as needed; maximum 240/4000mg per day
Within your practice you only have 30/500mg tablets, how many tablets wound you need to supply your patient with for them to have enough for 3 days?
24 tablets
