Professional and legal issues: POM 3.3 Flashcards
General prescription requirements 3.3.1
Prescription requirements (6/7):
Signature, address of prescriber, date (prescription valid 6 months except for a CD 2, 3, 4 = 28 days), particulars of prescriber (what r they), name of patient, address of patient, age (if under 12).
Need to be signed in indelible ink.
Private and NHS prescriptions have same requirement.
Should be able to make carbon copies as long as they are signed with ink.
Same requirements also apply to homecare prescriptions but they might ask extra like GMC number of prescribing Dr.
Advanced electronic signature - specific to the person who made it, you can identify who made it, only the maker should have control over the signature.
Copies of electronic prescription via phone or email don’t meet requirements the electronic prescription needs to be sent to pharmacy from prescriber. Electronic prescription need same requirement.
Welsh prescription -
If can’t read pass on the prescription to someone who can PATIENT SAFTEY 1ST.
Prescription from Crown dependencies -
(Jersey, gurnersy, Isle of men)
Same Requirements BUT CD 2 and 3 address needs to be in the UK.
Repeatable prescriptions -
Private prescription that have instructions on how much to repeat.
IF NO NUMBER only REPEAT ONCE except for oral contraception = 5 repeats.
CD 2,3 CANT repeat. CD 4,5 can.
First dispensing for a POM or CD 5 must be made within six months of the appropriate date, following which there is no legal time limit for the remaining repeats.
CD 4 has 28 days. No limit on repeats too.
NO LIMIT REPEAT = pharmacist need to use judgement to decide when repeat is OK.
To maintain an audit trail mark on the prescription the name and address of the pharmacy from where supply has been made and the date of supply.
PRISONS/ other secure environments -
Don’t use FP10 have their own prescription forms. They are still considered NHS prescriptions. FP10 can be used in this setting as emergency or when a person is being released and meds can’t get to them in time.
3.3.1 continued
Repeat can be used in other ways:
Repeat slips- Not prescriptions, themselves, but a list of medications which patients can use to reorder their regular medication.
Instalment prescriptions - provide for a single prescription for a CD to be dispensed in several instalments (3.6.7).
NHS repeat dispensing service - prescriber authorises a prescription with a specified number of ‘batch’ issues that may be dispensed at specified intervals from a pharmacy (England and Wales only).
RECORD KEEPING -
Must keep private prescription for 2 years from date of supply/sale. For repeats it on the last sale/supply.
Private prescription for CD 2/3 must be given to relevant NHS agency.
All records (except CD 2) must be made in POM register which must be kept for 2 years from date of last entry/register.
Record must include:(5)
Supply date, prescription date, medicine details (quantity, name, formulation, strength), prescriber details, patient details.
Record should be made on day of supply or next day.
Oral contraception prescription are exempt from record keeping as are CD 2. CD 2 need to be in CD register.
Prison discharge prescription-
Can use FP10 and name and address of prison should be on the prescription. So they don’t need to pay.
Dental prescription 3.3.2
Dentist can prescribe anything but recommended to prescribe dentistry medicine and area of competency.
But with NHS dental prescriptions they restricted to the dental formulary (in BNF).
Faxed/digital copies of prescriptions 3.3.3
Fax doesn’t fall in legally valid category because its not done in indelible ink or signed in indelible ink.
Risks of supplying on faxed prescription:
1. Uncertainty that the supply has been made in accordance with a legally valid prescription
- Risks of poor reproduction
- Risks of non-receipt of the original prescription and therefore inability to demonstrate that a supply had been made in accordance with a prescription
- Risks that the original prescription is subsequently amended by the prescriber in which case the supply would not have been made in accordance with the prescription
- Risks the fax/digital copy of prescription is sent to or received by multiple pharmacies and duplicate supplies are made.
- Risks that the prescription is not genuine
- Risks that the system of sending and receiving of the fax/digital copy of prescription is not secure or from a reputable source
Alt ways to prescribe: EPS, under emergency prescription.
If pharmacist decides to prescribe with fax/digital prescription they need to make informed decsion and safeguard patient saftey. They also need to mitigate the risks mentioned above. Should record reasons to why this supply was made.
However CD 2,3 drugs supply without valid lawful prescription is a criminal offence so can’t give this.
Forged prescriptions 3.3.4
Checklist to help detect forged 1s and prompt further investigations:
Is a large/excessive quantity prescribed and is this appropriate for the medicine and condition being treated?
Is the prescriber known?
Is the patient known?
Has the title ‘Dr’ been inserted before the signature?
Is the behaviour of the patient indicative? (e.g. nervous, agitated, aggressive, etc.)
Is the medicine known to be commonly misused?
Further investigations may be needed. Actions to take for investigation:
Scrutinise the signature carefully – can check against a known genuine prescription from the same prescriber
Confirm details with the prescriber (e.g. whether or not a has been issued, the original intention of the prescriber and alteration or not)
Use contact details for the prescriber that are obtained from a source other than the suspicious prescription (e.g. directory enquiries)
Reporting
Depends on nature of fraudulent prescription use judgement to decide weather it should be reported to police/NHS counter fraud services/ or resolved with discussion with patient and prescriber
Prescriptions from the EEA or Switzerland 3.3.5
prescriptions/ repeats/ emergency are recognised legally in the UK when done by approved HCP.
Approved HCP = DRs, dentists, and other professions with prescribing rights (ALL IPs)
Approved countries = Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland.
If prescription not from a valid country use judgement on how to help patient.
PRESCRIPTION REQUIRMENTS:
Patient names and DOB
Prescriber names, qualifications, contact details (email, address, telephone, FAX).
Medicine details (name [brand if needed], form, quantity, strength, dose details).
Prescriber signature
Date of issue (validity is same) date of which prescriber signed is date of issue.
*Foreign language can still be accepted
*need to check registration of prescriber.
If unable to confirm registration you can still supply but its at your risk.
CD 1,2,3 not prescribable if there is no UK marketing authorisation. Refer patient to UK prescriber.
Emergency supplies are allowed from prescriber as long as prescription is given in 72 hours. However, CD1,2,3 (+Phenobarbital) NOT allowed to be supplied.
YOU CAN REFER if not happy clinically with prescription or emergency supply.
Military prescriptions 3.3.6
Some smaller military medical centres no longer have in house dispensary’s so they outsource from designated community pharmacies under a Ministry of Defence (MOD) contract. Other community pharmacies that dont have this contract wont routinely deal with military medicines.
Military prescriptions are written on a military form FMed 296. Pharmacies with a dispensing contract with the MOD will usually invoice the MOD directly.
IF non contracted pharmacy is contacted then the prescription should be treated as a private 1. These pharmacies are not to invoice the MOD but directly charge patient, then the patient needs to be reimbursed from their military unit. they need to request a receipt for this. UNLESS ITS A NHS prescription - they will fall in to exemption or they will present a exemption certificate.
CD 2,3 written on an MOD FMed296 form cannot be legally dispensed by community pharmacies. Should be on pink FP10PCD. - prescribers obtain from their regional Defence Primary Health Care headquarters supplied by NHS England and NHS Scotland.
DOUBTS OF PRESCRIPTION:
Apply normal checking procedures look out for:
Handwritten FMed 296 The majority of FMed 296 prescriptions will be computer generated. It is highly unusual to see handwritten prescriptions, especially for MOD accountable drugs (these include Schedule 3, 4 and 5 CDs, codeine, sedatives and medicines for erectile dysfunction).
British Forces Post Office (BFPO) address stamp Prescriptions with a BFPO address stamp have been generated abroad and are normally not seen in the UK. If there is any doubt, pharmacists are advised to check the registration status of the doctor, dentist or independent prescriber
Labelling of dispensed medicinal products 3.3.7
Legal requirement to be on a dispensed product: (6)
1. Name of the patient
2. Name and address of the supplying pharmacy
3. Date of dispensing
4. Name of the medicine
5. Directions for use
6. Precautions relating to the use of the medicine: “(e.g. For external use only)”.
RPS RECCOMENED TO ADD:
‘Keep out of the reach and sight of children’
‘Use this medicine only on your skin’ where applicable.
Secure environments recommended to add prisoner number.
Should label actual container rather then outer due to the outer being thrown away.
if certain things are not necessary pharmacist can use judgment to replace or remove them without telling prescriber.
Use supplier contact when possible of helped is needed.
Assembly/pre packing supplied to separate legal entity requires appropriate MHRA licence.
Labelling medicine broken down from BULK:
this can be done if need a smaller quantity for a prescription or preparation for a expected prescription.
**prep for expected labelling requirements: ** (6)
1. Name of the medicine
2. Quantity of the medicine in the container
3. Quantitative particulars of the medicine (i.e. the ingredients)
4. Handling and storage requirements where appropriate
5. Expiry date
6. Batch reference number (e.g. LOT number or BN).
When dispensing the usual requirements are needed. above is for preparing for a prescription yet to come.
If Assembly and pre-packing medicines and Labelling of medicines broken down from bulk containers for dispensing) do not apply to you, you should contact the MHRA for further information.
Administration 3.3.8
In healthcare, policies define who can administer medicines, or the appropriate delegation of the administration of medicines, within that setting.
Org should have a policy for self administration of medicines.
Registered HCP who administer medicines, or when appropriate delegate the administration of medicines, are accountable for their actions, non-actions and omissions, and exercise professionalism and professional judgement at all times. They would be expected to meet their own professional and regulatory standards and guidance. Non registered HCP are appropriately trained, assessed as competent and meet relevant organisational guidance on medicines administration.
B4 administration person doing it must have overall understanding of medicine.
When possible actions of prescribing, dispensing/supply and administration are performed by separate HCP. Some exceptional circumstance HCP can do both. audit trails, documents and processes are in place to stop errors.
Parenteral POMs can only be administered to another person with the directions of an appropriate practitioner or by an appropriate practitioner. There is an exemption allowing administration for saving life in an emergency and a list of parenteral medicines authorised for this purpose can be found in Schedule 19 HMR 2012
Eg = naloxone emergency first aid for opioid overdose. or adrenaline for anaphylaxis
Specific classes of persons, such as midwives, paramedics etc can also administer POMs under certain conditions. Details are available in Schedule 17 HMR 2012. Certain HCP can also administer medicines in accordance with a PGD.
Medicines that are not POMs may be administered according to a locally agreed homely remedy protocol.
Administration 3.3.8 Cont.
COVERT ADMINISTRATION OF MEDICINES
Covert administration’ = when medicines are administered in a disguised format without the knowledge or consent of the person receiving them.
Only given to ppl who actively refuse, and considered to lack mental capacity to stick to agreed management plan.
Pharmacists who are asked to sign covert administration documentation should check carefully what they are being asked to sign off as this may indicate they have performed a clinical medication review, and provided advice on medicines administration or what to do if a patient consumes only part of their food or drink.
ADMINISTRATION OF ADRENALINE IN AN EMERGENCY
A POM. given IM treat anaphylaxis. Brands in pharmacy Epipen®, Emerade® and Jext®.
Pharmacist expected to recognise and treat anaphylactic reaction. must have access to an anaphylaxis pack and have required training in the seeing anaphylaxis and giving adrenaline.
Anaphylaxis pack = ampoules of adrenaline and syringes and needles or prefilled syringes which should be used in preference to auto injectors such as those listed above.
ADMINISTRATION OF ADRENALINE
Allowed to save a life.
Use PRO judgement
MUST ALSO CALL 999 AND REPORT THE CASE OF ANAPHYLAXIS.
Patient specific directions and administration, sale or supply in hospitals and other settings 3.3.9
HMR 2012 provides loads of exemptions to the restrictions on the sale, supply and administration of medicines.
Many exemptions are together called patient specific directions (PSDs).
Means= written instruction from a DR, dentist or non-medical prescriber for a medicine to be supplied or administered to a named patient after the prescriber has assessed that patient on an individual basis.
Some organisations may limit who is authorised to supply and/or administer medicines under a PSD within their local medicines policies and governance arrangements. Any trained and competent health professional would be suitable. PSDs relate to a specific named patient but do not need to comply with the requirements specified for a prescription.
In a hospital ward, written PSDs are encountered on inpatient charts as directions to administer. While the law does not stipulate what should be included in a PSD, sufficient information must be available for the person administering the specified medicine to do so safely.
And PSD, if sufficiently clear, can be a direction to make a sale or supply.
Typically the directions within an inpatient chart are copied onto an order form for the pharmacy to prepare discharge medicines. The pharmacist in this instance is not prescribing, and the supply is made under the authority of the original written direction to supply. This process should be carried out or counter-checked by a pharmacist. This order form does not replace a discharge letter but can form part of the discharge letter.
Some hospitals have formulated policies for the supply and/or administration of POMs (and P/GSL meds) to ensure that meds are handled safely, securely and properly. Such policies should be carefully considered and agreed by medical, nursing and pharmacy staff to ensure patients safety. The policy should be cross-referenced against standards set by any applicable body, including regulatory and professional bodies of relevant HCP involved in the process.
IF IN DOUBT, the Department of Health should be consulted for hospitals in England (+ the hospital’s legal advisors). Hospitals in Scotland should contact the Scottish Executive, while hospitals in Wales should contact the Department of Health and Social Services.
Exemptions: sale and supply without a prescription 3.3.10
Several exemptions that allow POMs to be sold or supplied without a prescription.
Pharmacists need to be aware of:
* Patient group directions (PGDs)
* Patient specific directions (PSDs)
* Emergency supplies
* Optometrist or Podiatrist signed patient orders
* Supply of salbutamol inhalers/adrenaline autoinjectors to schools
* Supply of naloxone by individuals providing recognised drug treatment services
PGDs
Written direction allows the supply and/or administration of a specified med/s by named authorised HCP, to a defined group of patients requiring treatment for a specific condition.
Pharmacists involved with PGDs have to know scope and limitations of PGDs and the context which they fit to ensure safe, effective services for patients.
Supply and administration of meds under PGD should only be reserved for those limited situations where this offers an advantage for patient care, without compromising patient safety.
PGD should only be made after proper considerations of all methods of supply/administration of meds.
Pharmacists can supply, offer to supply and administer diamorphine or morphine under a PGD for the immediate, necessary treatment of sick or injured persons.
LABELING OF PGDs
Labelled the same as normal.
EMERGENCY SUPPLY
Pharmacist can give POMs to a patient without prescription.
Judged on case by case basis.
Relevant prescriber:
Drs, dentist, supplementary prescriber, Nurse IP, Pharmacist IP, Community practitioner nurse prescriber, Physiotherapist IP, Podiatrist IP, therapeutic radiographer IP, Optometrist IP, EEA or Swiss HCP, paramedic IP.
**NO HCP outside EEA or Switzerland.
EMERGENCY SUPPLY AT THE REQUEST OF A PRESCRIBER
Conditions:
Relevant prescriber
Emergency
Prescription within 72 hours - need to receive (3 days)
Directions - supplied with correct directions from prescriber
NO CDs 1,2,3 except phenobarbital
* Record kept - entry must be made in POM register on supply day or the next entry needs: (6)
- Date of supply
- Name (strength and form) and quantity
- names and address of prescriber requesting
- name and address of patient
- date of prescription
- date when prescription was received.
* LABBELLING IS NORMAL.
EMERGENCY SUPPLY AT THE REQUEST OF A PATIENT
Conditions:
- Interview = patients interviews. In cases where this can’t be done (child patient) pharmacist needs to use professional judgement and see best interest of patient.
- Immediate need = Cant get prescription without delay
- Previous treatment = Must’ve used the treatment B4/ be prescribed b4.
use judgement to see if time interval from last prescription for this medicine is appropriate.
- Dose = pharmacist must be ok with dose
- Not for CD’s except phenobarbital = Cant give CD1,2,3 and substances with: ammonium bromide, calcium bromide, calcium bromidolactobionate, embutramide, fencamfamin hydrochloride, fluanisone, hexobarbitone, hexobarbitone sodium, hydrobromic acid, meclofenoxate hydrochloride, methohexitone sodium, pemoline, piracetam, potassium bromide, prolintane hydrochloride, sodium bromide, strychnine hydrochloride, tacrine hydrochloride, thiopentone sodium
- Length of treatment = Max for CD 4,5 is 5 days. POM max is 30 days EXCEPT IF:
1. POM is an insulin, an ointment, a cream, or an inhaler for asthma (i.e. the packs cannot be broken), the smallest pack available in the pharmacy should be supplied)
2. POM is an oral contraceptive, a full treatment cycle should be supplied
3. POM is antibiotic in liquid or oral= smallest quantity to provide full course should be supplied.
- Record kept = entry must be made in POM register on same day of supply or next day. ENTERIES NEED:
1. Date of supply
2. Name including strength and form where appropriate) and quantity of medicine
3. Name and address of the patient
4. Information on the nature of the emergency
- Labelling standard requirements + words “emergency supply” needs to be added to dispensing label.
3.3.10 cont.
OTHER POINTS TO CONSIDER WHEN FACED WITH REQUESTS FOR AN EMERGENCY SUPPLY
Pharmacists should be mindful of patients abusing emergency supplies (eg too many supplies).
possible to make an emergency supply even during surgery opening hours.
REFUSAL TO SUPPLY
patient should be advised on how to get prescription. could involve referral. record could be made on refusal for audit purpose.
COMMUNITY PHARMACY CONSULTATION SERVICE (CPCS) - ENGLAND
NHS Advanced Service, enables NHS 111, urgent care settings and 999 providers to refer patients to a community pharmacy for an emergency supply of regular medicines under the NHS.
UNSCHEDULED CARE - SCOTLAND
a national PGD allows participating pharmacies and pharmacists to supply medicines for the urgent provision of current repeat medicines, appliances and ACBS (borderline) items.
Emergency supply remains an option for patients who are not eligible for treatment under the national PGD.
OPTOMETRIST OR PODIATRIST SIGNED PATIENT ORDERS
They need to be IPs to prescribe. however a signed order from them can help for pharmacist to supply a POM directly to patient. Med requested needs to be allowed to be supplied/administered by them. MHRA site for list.
Optometrists with additional valid training can give signed order for extended medicines.
Signed Patient order not the same as prescription but pharmacist needs to be satisfied enough detail for patient safety is given.
If supplied need to ensure label is correct, PIL is given, and records made in POM register.
Additional INFO that’s not given should be provided for patient safety.
SUPPLY OF MEDICINES TO SCHOOLS
Can get Adrenaline auto injectors and/or salbutamol inhalers from pharmacy on signed order. Can be used in emergency by trained persons to previously prescribed students and with parental consent.
INFO included on SIGNED ORDER:
Name of school, product details (Inc. spacer), strength (if needed), Purpose of product needed, Total quantity needed, signature of principal/head teacher.
Schools advised to use 1 brand of adrenaline to stop confusion.
Amount allowed:
NO SPECIFIC NUMBER BUT pharmacist needs to use judgement and see: school size and number of sites, number of affected children, past exps.
What records pharmacy need to keep:
* Signed order for 2 years from supply date or an entry made in POM register. Good practise to do both.
Normal POM register requirements:
Date of supply, name, quantity and formulation and strength where needed, Name and address of place supplied, purpose of supply.
Finding details of school inc head teacher/principal details:
sources of info=
1. Department for Education’s register of educational establishments in England and Wales
2. Ofsted reports
3. Information on the individual school’s website.
Type of school I can supply?
ALL primary and secondary schools in UK.
Additional advice I can give:
Explain/advise to store and use correctly, advise on most appropriate spacer for different ages and how to use, advise importance of record keeping, regular date checking and when to replace.
SUPPLY OF NALOXONE BY INDIVIDUALS EMPLOYED OR ENGAGED IN THE PROVISION OF RECOGNISED DRUG TREATMENT SERVICES
Naloxone is an opioid /opiate antagonist which can completely or partially reverse the CNS depression, especially respiratory depression, caused by natural or synthetic opioids and is licensed for the treatment of suspected acute opioid overdose.
Naloxone is a POM but people under lawful drug treatment services allow them to buy from wholesaler and make direct supply to patient.
Lawful drug treatment services = “Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies: (a) an NHS body (b) a local authority (c) Public Health England, or (d) Public Health Agency”.
Definition extends to needle and syringe programmes and pharmacies providing drug treatment services.
Any1 can give naloxone to save a life and there is evidence for the effectiveness of training family members or peers in how to give the drug. Naloxone can be given to people who are in direct contact with drug users. A pharmacy may be commissioned to participate in a local take home naloxone scheme.
Pregnancy prevention programmes (PPP) 3.3.11
Some medicines are high risk causing foetal malformations and/or can increase the risk of spontaneous abortion when taken by women and girls. (e.g., oral retinoids, valproate, thalidomide, lenalidomide, and pomalidomide)
PPP protects females of child-bearing age by preventing pregnancy.
Pharmacists need to prevent certain medications from being dispensed to child-bearing age females. Unless it’s impossible, they can be pregnant (hysterectomy - remove uterus surgery)
EXAMPLES
Oral retinoid PPP:
Oral retinoids (including acitretin, alitretinoin, and isotretinoin) are used for severe skin conditions. They are described in SPCs as ‘a powerful human teratogen inducing a high frequency of severe and life-threatening birth defects’. SO, contraindicated in pregnant women and women of childbearing potential unless all of the conditions of the PPP are met.
Programme is a combo of education for HCP and patients, therapy management (including pregnancy testing before during and after treatment, contraception requirements), and distribution control.
Oral retinoids can only be initiated by/under the supervision of a dermatologist, prescribing GP with an extended role in dermatology, or a specialist dermatology nurse, and under the conditions of the PPP. The prescriber must check that the patient complies with, understands, and acknowledges the reasons for pregnancy prevention and agrees to monthly follow-up, contraceptive precautions, and pregnancy testing.
SPECIAL DISTRIBUTION CONTROLS ON ORAL RETINOIDS FOR FEMALES AT RISK OF PREGNANCY
1. Valid prescription:
Prescription valid 7 days and needs to be dispensed on date of prescription being written. After 7 =invalid + need to reconfirm negative pregnancy via test
- Quantity
Max 30 days supply. Only get more if they aren’t under PPP
Repeat prescription, faxed prescription and free sample should not be accepted. Telephone request only accepted if emergency supply from PPP specialist - need to confirm negative pregnancy in last 7 days.
VALPROATE PPP
Treat eplisply, bipolar and migraine (unlicensed)
Should be last resort for pregnant and women capable of pregnancy. If used you need a PPP.
WHAT PHARMACISTS SHOULD DO:
- have convo with patient to see if they ate aware of the risks.
- people planning pregnancy should be advised to speak to Dr and not stop contraception and valproate.
- if Unplanned pregnancy occurs tell patient don’t stop valproate but see DR ASAP.
- Give patient card each time valproate is useful.
- Dispense valproate preparations in original packs.
- ensure dispensing label don’t cover the warnings.
- Emphasise the need for annual review
- report side effects via yellow card
Full Pack Dispensing of Valproate- containing medicines (October 2023):
Ensure that all patients (male and female) receive their valproate-containing medicine in the manufacturer’s original full pack and so will always receive information on the risks to the unborn child.
Applies to NHS and private prescription.
MHRA gives exceptional circumstances when can be given without original pack. When this is done need to do a risk assessment.
Biosimilar medicines 3.3.12
Patents and marketing exclusivity are expiring for many biologics and biosimilars are more common (eg insulin glargine).
Biosimilar saves NHS money and is more available.
WHAT IS A BIOLOGIC?
made from a variety of natural sources that may be human, animal or microorganism in origin.
Eg: vaccines, blood and blood products, somatic cells, DNA, human cells and tissues and therapeutic proteins.
1st biologic is called originator/ Reference product.
WHAT IS A BIOSIMILAR?
Similar to an already licensed biologic medicine in terms of quality, safety and efficacy.
Biosimilar treat same disease as biologic.
Only be marketed after the patent protecting the originator product and any period of marketing exclusivity have expired.
WHY IS A BIOSIMILAR MEDICINE NOT A GENERIC MEDICINE?
Can’t replicate biologic due to complex structure and greater molecule size.
IS IT POSSIBLE TO SWITCH BETWEEN AN ORIGINATOR BIOLOGIC AND A BIOSIMILAR?
Needs to be discussed with prescriber.
At dispensing pharmacist should confirm patient knows how to store and use biologic.
HOW WILL A BIOSIMILAR BE PRESCRIBED?
All biosimilar have their own brand name and batch number. All biologics to be prescribed by brand to avoid automatic substitution.
HOW ARE ADVERSE DRUG REACTIONS TO BIOSIMILARS REPORTED?
Brand name and batch number are reported with reaction. Helps safety monitoring. Good practice to record the brand name and batch number of any biologic/biosimilar medicine supplied to a patient.
