Pharmacy Law and Opioid Regulations Quiz

The maximum number of tablets allowed in a pack for over-the-counter sales, with a limit of 100 units (96 in reality) for non-effervescent aspirin or paracetamol tablets and capsules.

The maximum number of repeats allowed for liquid paracetamol on a private prescription.

Schedule 2 and 3 drugs cannot be repeated on a private prescription. This means a new prescription is required for each refill.

The NHS does not allow repeating the same prescription for the same medication. If a prescription has multiple repeats, a repeat dispensing scheme must be used.

Every supply of a prescription-only medicine (POM) must be recorded, except for specific situations such as NHS prescriptions, oral contraceptives, or when a separate record is made in the CD register.

The record of a private prescription for a POM must be made on the day of dispensing unless it is not practical, in which case it can be made the next day.

The record of a private prescription must include all details from the prescription, along with the date of supply, reference number, and price charged.

Private prescription records must be kept for two years from the date of supply. For repeatable prescriptions, this period is two years from the date of the last supply.

A type of opioid that can be purchased over-the-counter (OTC) without a prescription. Examples include codeine and dihydrocodeine combined with other analgesics like paracetamol, ibuprofen or aspirin.

The maximum pack size for OTC codeine or dihydrocodeine combination products is restricted to limit the potential for misuse or addiction.

Naloxone is a medication used to reverse an opioid overdose. Certain healthcare professionals, like those providing drug treatment services, can obtain naloxone directly from wholesalers and supply it to patients without a prescription or other authorization.

The MHRA (Medicines and Healthcare products Regulatory Agency) requires OTC opioid packaging to display a warning about the potential for addiction.

The MHRA advises healthcare professionals to discuss the risks of dependence and addiction with patients who are taking or considering taking opioid medications.

The Misuse of Drugs Act 1971 (MDA) is the primary legislation governing controlled drugs in the UK. It sets out strict regulations for possessing, supplying, manufacturing, importing and exporting controlled drugs, except in cases permitted by regulations or licenses issued by the Secretary of State.

The Misuse of Drugs Regulations 2001 (MDR) are secondary legislation detailing the specific controls for legitimate use of controlled drugs. It establishes different schedules for drugs based on their potential for misuse, with Schedule 1 being most restrictive and Schedule 5 being least restrictive.

The Advisory Council on Misuse of Drugs (ACMD) is responsible for recommending drug classifications based on their harmfulness and determining the appropriate penalties for drug offences under the Misuse of Drugs Act 1971. Their recommendations influence the scheduling of controlled drugs by the Misuse of Drugs Regulations 2001.

Class A drugs are considered the most harmful, with strict penalties for offences. They include heroin, cocaine, ecstasy, LSD, and methadone. Typically, these drugs have high potential for addiction and misuse, and there are limited legitimate medical uses.

Class B drugs are less harmful than Class A but still have potential for addiction and misuse. They include cannabis, amphetamines, barbiturates, and codeine. There may be some legitimate medical uses, but they are subject to stricter controls than Class C drugs.

Class C drugs have the lowest risk of addiction and misuse among the three classes. They include anabolic steroids. There may be legitimate medical uses, but they are subject to less strict controls than Class A and Class B drugs.

Schedule 1 drugs are the most strictly regulated, with very limited therapeutic uses. They include hallucinogenic drugs like LSD, ecstasy-type substances, and raw opium. Hospital pharmacists can take possession of these drugs from patients to destroy or hand over to the police.

Schedule 2 drugs include strong opioids like diamorphine, morphine, methadone, oxycodone, and pethidine, as well as major stimulants. These drugs have legitimate medical uses but require controlled dispensing and administration.

A private prescription for a veterinary medicine can be repeated if the first dispensing occurs within the period of validity (either 28 days or 6 months, whichever is longer).

The standard form used for private prescriptions for veterinary medicines is FP10PCD.

Private prescriptions for veterinary medicines are subject to regulations similar to those for human medicines, with some exceptions.

Unlike human prescriptions, veterinary prescriptions don't require a standardized form. However, they must include specific details like the prescriber's declaration, RCVS registration number, and the prescription must be retained for 5 years.

Good practice dictates that veterinary prescriptions should only cover a maximum of 30 days of treatment, aligning with the guidelines for human prescriptions.

A standardized form, FP10CDF, is used for requisitions of Schedule 2 and 3 drugs. This form must be completed in the community or presented to a Controlled Drug (CD) pharmacy.

Hospitals and prisons are exempt from using the standard FP10CDF form for requisitioning controlled drugs, as long as they're within the same trust or institution.

In emergencies, a doctor or dentist can supply a patient with a Schedule 2 or 3 controlled drug without first obtaining the FP10CDF form.

Any authorized individual or group designated to witness the destruction of controlled drugs (CDs). This includes law enforcement officers, pharmacy inspectors, and individuals appointed by the CD Accountable Officer. They cannot be involved in the daily management of CDs or be the Accountable Officer.

The process of making controlled drugs unusable or irretrievable, often by rendering them chemically inactive, rendering them irretrievable. This is required for expired or returned CDs to prevent misuse.

The person or authority accountable for the safe and proper use of controlled drugs within an organization. This includes oversight of storage, dispensing, and destruction of CDs. They monitor any concerns or incidents related to CDs and may be a senior pharmacy manager or representative of a health authority.

A group of individuals who have specific legal permission or authorization to possess controlled drugs (CDs), including pharmacists, prescribers, and certain research institutions. This authorization is usually granted by the Home Office or a designated authority.

The requirement that controlled drugs (CDs), particularly Schedules 2 & 3, must be stored securely to prevent theft, loss, or unauthorized access. This involves secure storage facilities, restricted access, and proper inventory control.

A process involving a designated individual verifying and recording the destruction of controlled drugs (CDs), ensuring accountability and compliance. It often involves a running balance of CDs in the pharmacy.

Specific guidelines and regulations related to the handling, storage, and destruction of CDs, usually outlined in pharmacy regulations or guidelines.

A registered pharmacist within a community pharmacy, GP surgery, or dental practice, responsible for overseeing the safe and legal handling of controlled drugs within their organization. They report to the Regional CDAO.

Schedule 2 drugs, except for Quinalbarbitone, must be stored in a secure location like a safe or locked room when not in use.

Temazepam and buprenorphine are the two most commonly dispensed Schedule 3 drugs that are NOT exempt from the safe custody rule.

Records must be kept for all Schedule 1 and 2 drugs.

Records for Controlled Drugs (CD) can be maintained in both handwritten and electronic formats.

Separate pages must be dedicated to each drug class, strength, form, and brand in the CD register.

When receiving a CD from a wholesaler, the date of supply received, the name and address of the supplier, and the quantity received must be recorded.

When supplying a CD, the date supplied, the name and address of the recipient, the details of the authority to possess the CD, the quantity supplied, the details of the person collecting the CD, whether proof of identity was requested and provided, and any additional relevant information must be recorded.

Corrections to written CD records should be made in a footnote, not by scribbling out or using correction fluid.