MEP: Professional and legal issues: pharmacy medicines Flashcards
What are PSEUDOEPHEDRINE AND EPHEDRINE and what risks are associated with them?
Pseudoephedrine and ephedrine are widely used decongestant pharmacy medicines. However, due to their potential for misuse in the illicit production of methylamphetamine (crystal meth)
Therefore, there are legal restrictions on the quantity that can be sold.
The legal restrictions on the sale of PSEUDOEPHEDRINE AND EPHEDRINE are:
It is unlawful to supply a product or combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at any one time, without a prescription (Regulation 237 of Human Medicines Regulations 2012)
It is unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription (Regulation 237 of Human Medicines Regulations 2012).
SIGNS OF POSSIBLE MISUSE of ephedrine:
The following signs in combination can be useful for identifying when a request is more likely to be suspicious:
Lack of symptoms
- Not suffering from cough, cold or flu symptoms, or unable to describe these in the patient if buying for someone else
Rehearsed answers
- Gives answers that appear to be rehearsed or scripted
Impatient or aggressive
- In a rush or hurrying to complete the transaction
Opportunistic
- Waiting for busy periods in the shop or until less experienced staff are available
Specific products
- Wants certain brands that contain only pseudoephedrine or ephedrine
Paraphernalia
- Wishes also to purchase other items which can be used to manufacture methylamphetamine (e.g. lithium batteries, chemicals such as acetone)
Quantities
- Requests large quantities
Frequency
- Makes frequent requests
What are the three methods of emergency contraception?
- copper intrauterine device (Cu-IUD)
- oral ulipristal acetate
- oral levonorgestrel.
What strengths are ulipristal acetate and oral levonorgestrel and what is their classification?
Levonorgestrel 1500 microgram tablet and ulipristal acetate 30mg tablet are licensed as pharmacy medicines
Licensing for age and time frame for levonorgestrel?
Levonorgestrel is licensed for women aged 16 years or over for emergency contraception within 72 hours (3 days) of unprotected sexual intercourse or failure of a contraceptive method.
Licensing for age and time frame for ulipristal acetate?
Ulipristal acetate is licensed for emergency contraception within 120 hours (five days) of unprotected sexual intercourse or failure of a contraceptive method.
What is the law around supplying EHC in advance?
Pharmacists can provide an advance supply of oral emergency contraception (i.e. prior to unprotected sexual intercourse or in case of failure of a contraceptive method) to a patient requesting it at a pharmacy.
The patient should be assessed
to ensure that they are competent, they intend to use the medicine appropriately and it is clinically appropriate.
Things to be aware of when supplying EHC;
Be aware that, in some circumstances, requests for EHC could be linked to abuse (non-consensual intercourse) of children or vulnerable adults. The Department of Health has published a document called Responding to domestic abuse: A handbook for health professionals, which provides practical advice on dealing with domestic abuse, keeping records, confidentiality and sharing information.
Is the supply of ulipristal acetate to patients under 16 a contraindication?
The supply of ulipristal acetate to patients under the age of 16 years is not contraindicated by the manufacturer. However, pharmacists may wish to consider the following additional factors:
- Children under the age of 13 are legally too young to consent to any sexual activity. Instances should be treated seriously with a presumption that the case should be reported to social services, unless there are exceptional circumstances backed by documented reasons for not sharing information
- Sexual activity with children under the age of 16 is also an offence but may be consensual. The law is not intended to prosecute mutually agreed sexual activity between young people of a similar age, unless it involves abuse or exploitation.
- Pharmacists can provide contraception or sexual health advice to a child under the age of 16 and the general duty of patient confidentiality applies, so where there is a decision to share information, consent should be sought whenever possible prior to disclosing patient information. This duty is not absolute and information may be shared if you judge on a case-by-case basis that sharing is in the child’s best interest .
Remember that it is possible to seek advice from experts without disclosing identifiable details of a child and breaking patient confidentiality – and that where there is a decision to share information, this should be proportionate.
What are other mechanisms for supply of EHC?
There are various mechanisms for the supply of EHC and it may be appropriate to refer to other service providers rather than make a sale, in some circumstances (e.g. where a sale would be outside of the terms of the marketing authorisation). Other providers include family planning clinics, general practice clinics and providers of PGDs for EHC and genitourinary medicine (GUM) clinics.
What are the legal restrictions around the OTC supply of paracetamol?
Not more than 100 non effervescent* tablets or capsules can be sold to a person at any one time. Since most OTC pack sizes are for 16 or 32 dose units, this means that, in practice, 96 is the maximum number that can be sold
There are no legal limits on the quantity
of over-the-counter effervescent* tablets, powders, granules or liquids that can be sold to a person at any one time. Use professional judgement to decide the appropriate quantity to supply and what limits to impose.
What are the legal restrictions around the OTC supply of aspirin?
Not more than 100 non-effervescent* tablets or capsules can be sold to a person at any one time. Since most OTC pack sizes are for 16 or 32 dose units, this means that, in practice, 96 is the maximum number that can be sold.
There are no legal limits on the quantities
of over-the-counter effervescent* tablets
or powders that can be sold to a person at any one time. Use professional judgement
to decide the appropriate quantity to supply and what limits to impose.
Indications for solid dose OTC codeine and dihydrocodeine products are now restricted to:
the short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone. All other previous indications, including cold, flu, cough, sore throats and minor pain have been removed.
What classification is any pack containing more than 32 dose units of dihydro-codeine or codeine (including effervescent formulations)
POM
