Access to controlled medicines

[Guest guest]

Hi,

I am surprised to see that States of India like Rajasthan, Madhya

Pradesh have legalised the sale of substances of abuse.While a person

can enter the kiosk and buy/consume the products, it is funny that Inj

morphine is not available for the patients easily.

During our treks in high altitude areas of Himalayas we have found

areas below the snow line in Himachal Pradesh having wild forests full

of marijuana. People freely pluck, use, carry home the natural products

and the access of medics to medicines is controlled !

Vijay

[Guest guest]

Hello Dr Thawani Sir,

Thank you very much for your words of appreciation. It is only because of your help and support.

You have rightly described the condition of person suffering from pain.

Pain got its proper scientific definition in 1979 (by IASP) as "an unpleasant sensory & emotional experience due to tissue damage or described in terms of that damage"

India receives about 10 lakhs new cancer patients every year. As statistical data suggest approximately 60-80% patients, when they are diagnosed, are advanced cases and hence incurable. Often, their major symptom is moderate to severe pain. According to present estimates about 56% cancer patients in India require relief of symptoms (palliative care) at any given time, however, only 28% are provided some sort of palliative care before they die. There is an immediate need to address this issue at all levels. Clinicians should reassure patients and their families that most pain could be relieved safely & effectively. Clinicians should assess patients and provide optimal relief throughout the course of illness. Health professionals should be properly educated about pain and its management in the treatment plan and encourage patients to be active participants in pain management. State regulatory bodies should not hamper the supply and appropriate use of opioid analgesics for cancer pain. Clinicians should collaborate with patients and families tackling the costs of the drugs and technologies in selecting pain management strategies. Pain associated with cancer is frequently under-treated in adults and children. The incidence of pain in patient with cancer depends on the type and stage of the disease. At the time of diagnosis and intermediate stages, 30% to 45% of patients experience severe pain. In approximately 90% of patients, pain can be controlled through relatively simple means. Because of cancer pain is a problem of international scope, the World Health Organization (WHO) has urged that every nation give high priority to establishing a cancer pain relief policy.

Regards,

Dr Deepali> >> > > > HELLO TO AII,> > > > Regulations made under the Health Act 2006 require each healthcare> > organisation to appoint an Accountable Officer, responsible for > the safe> > and effective use of controlled drugs in their organization. The> > Regulations also introduce standard operating procedures (SOPs) > for the> > use and management of controlled drugs. (Please read CD as > controlled> > drugs).> > > > · A SOP is a document that describes the responsibilities and the> > procedures, including audit, necessary to safely and accountably > manage> > controlled drugs. The standard operating procedures must include:> > > > o Ordering and receipt of CDs> > > > o Assigning responsibilities> > > > o Where the controlled drugs are stored> > > > o Who has access to the controlled drugs> > > > o Security in the storage and transportation of controlled > drugs> > as required by misuse of drugs legislation> > > > o Disposal and destruction of controlled drugs> > > > o Who is to be alerted if complications arise> > > > o Record keeping, including:> > > > § Maintaining relevant controlled drugs registers under> > misuse of drugs legislation> > > > § Maintaining a record of the controlled drugs specified in> > Schedule 2 to the Misuse of Drugs Regulations 2001 that have been> > returned by patients> > > > · The practice SOP should also include:> > > > o Responsibilities within the practice team> > > > o Review period, e.g. one, two or three years> > > > o Lead author and named people contributing to the SOP> > > > Prescriptions for Controlled Drugs> > > > · The amendments to the Misuse of Drugs Regulations 2001 that came> > into force in November 2005 removed the requirement that > controlled drug> > prescriptions should be written in the prescriber's own > handwriting was> > removed. This means that CD prescriptions can be type-written,> > handwritten or computer printed. Only the signature of the > prescriber> > has to be handwritten.> > > > · Further changes following amendments to the Misuse of Drugs> > Regulations came into force in July 2006. These include:> > > > o A new requirement that patients or other people collecting> > medicines on their behalf must sign for them.> > > > o Validity of any prescription for schedule 2, 3 & 4 > controlled> > drugs to be restricted to 28 days.> > > > o Strong recommendation that the maximum quantity is > limited to> > 30 days for prescriptions of schedule 2, 3 and 4 controlled drugs.> > > > o Re-emphasis of professional guidance that doctors should> > prescribe controlled drugs for themselves or family members only in> > exceptional circumstances.> > > > · Doctors are only able to prescribe diamorphine, dipipanone and> > cocaine to substance misusers for the treatment of addiction if > they> > hold a licence issued by the Home Office. All doctors may > prescribe such> > drugs for patients, including substance misusers, for the relief > of pain> > due to organic disease or injury without a specific licence.> > > > · Prescriptions for temazepam and for Schedule 4 and 5 controlled> > drugs are exempt from the specific prescription requirements of the> > Misuse of Drugs Regulations 2001. However, they must still comply > with> > the general prescription requirements as specified under the > Medicines> > Act.> > > > · Emergency supplies of Schedule 2 and 3 controlled drugs, for a> > specific patient, are not permitted either at the request of the > patient> > or a practitioner. The only exception to this rule is > Phenobarbital for> > the treatment of epilepsy.> > > > Prescription Form> > > > · Prescription forms now include a box on the back of the> > prescription where the signature of the patient or other person> > collecting a Schedule 2 or 3 CD must be recorded.> > > > · The prescriber should include the patient's number on the> > prescription form.> > > > · The prescriber should sign any script changes. The prescription> > must contain the following details:> > > > o The patient's full name, address and, where appropriate, > age.> > > > o The name and form of the drug, even if only one form > exists.> > > > o The strength of the preparation, where appropriate.> > > > o The dose to be taken.> > > > o The total quantity of the preparation, or the number of > dose> > units, to be supplied in both words and figure.> > > > Prescribing in Installments> > > > · The prescription must be dispensed on the date on which it is > due.> > If the client does not collect an installment when it is due that > supply> > is no longer valid. The client cannot collect that supply the > following> > day.> > > > · If a controlled drug prescription is to be dispensed in> > installments, e.g. daily, then the must specify:> > > > o The number of installments> > > > o The intervals to be observed between installments (if> > necessary, instructions for supplies at weekends or bank holidays > should> > be included)> > > > o The total quantity of controlled drug that will provide> > treatment for a period not exceeding 14 days> > > > o The quantity to be supplied in each installment> > > > · Current legislation does not allow Schedule 2 and 3 controlled> > drugs to be prescribed as repeat prescriptions (i.e. to be part of > the> > repeat prescribing or dispensing system)> > > > Ordering, Possessing and Supplying Controlled Drugs> > > > · Doctors, dentists and pharmacists are authorized under the Misuse> > of Drugs Regulations 2001 to possess, supply and compound > controlled> > drugs in Schedules 2, 3, 4 and 5. They may only supply controlled > drugs> > to those who may lawfully possess them, including patients for > whom a> > drug is prescribed.> > > > · Practitioners must not use patient-specific controlled drug> > prescriptions to replace or top-up their bags or practice stock, > even if> > the stock was used for that patient initially.> > > > · Practitioners may obtain Schedule 2 and 3 controlled drugs from> > pharmacies or wholesalers for practice use or stock upon the > production> > of a written requisition. The requisitions must be:> > > > o Signed by the prescriber.> > > > o State the transcriber's name and address, and their> > profession or occupation.> > > > o Specify the total quantity of the drug> > > > o Specify the purpose for which it is required, e.g. for > practice> > use.> > > > · Suppliers must keep all requisitions for a minimum of two years. > A> > requisition is not required before supplying or obtaining Schedule > 4 or> > 5 controlled drugs.> > > > · A practitioner who requires a Schedule 2 or 3 controlled drug> > urgently and who is unable to supply a signed order can request the> > drugs to be supplied in an emergency. The practitioner may be > supplied> > with the controlled drug provided he or she gives an undertaking to> > supply a written, signed requisition within 24 hours. Failure to > do this> > is a criminal offence on the part of the practitioner.> > > > · It is the responsibility of the pharmacist or doctor, when> > receiving a supply of controlled drugs from the wholesaler, to > ensure> > that the correct item is delivered and that all appropriate > entries are> > made in the CD register on the day of supply, or the day following > the> > day of supply.> > > > · There is now a requirement for persons asked to supply Schedule 2> > CDs on prescription to seek to establish whether the person > collecting> > the drug is the patient, the patient's representative or a health > care> > professional acting in his professional capacity on behalf of the> > patient.> > > > · Where the person is the patient or the patient's representative,> > e.g. a friend, neighbour, the dispenser:> > > > o May request evidence of that person's identity, and> > > > o May refuse to supply the drug if he is not satisfied as > to the> > identity of that person.> > > > · Where the person collecting the prescription is a health care> > professional acting in his professional capacity on behalf of the> > patient, the dispenser:> > > > o Must obtain that person's name and address.> > > > o Must, unless he is acquainted with that person, request> > evidence of that person's identity; but> > > > o May supply the drug even if he is not satisfied as to the> > identity of that person.> > > > · The new regulations do allow discretion not to ask patients or> > patient representatives for proof of identity if for example they > have> > concerns that to do so may compromise patient confidentiality or > deter> > patients from having their medicine dispensed.> > > > Requirements for records> > > > · Records for Schedule 2 CDs must be kept in a CD register. This is> > not a legal requirement for Schedule 3, 4 or 5 CDs.> > > > · All health care professionals who hold personal CD stock must > keep> > their own CD register, and they are personally responsible for > keeping> > this accurate and up-to-date.> > > > · The register must:> > > > o Be bound (not loose-leaved) or a computerized system > which is> > in accordance with best practice guidance.> > > > o Contain class sections for each individual drug.> > > > o Have the name of the drug specified at the top of each > page.> > > > o Have the entries in chronological order and made on the > day of> > the transaction or the next day.> > > > o Have the entries made in ink or otherwise so as to be > indelible> > or in a computerized form in which every such entry is > attributable and> > capable of being audited.> > > > o Not have cancellations, obliterations or alterations;> > corrections must be made by a signed and dated entry in the margin > or at> > the bottom of the page.> > > > o Be kept at the premises to which it relates and be > available> > for inspection at any time. A separate register must be kept for > each> > set of premises (e.g. at each branch surgery).> > > > o Be kept for a minimum of two years after the date of the > last> > entry, once completed.> > > > o Not be used for any other purpose.> > > > · For CDs received into stock the following details must be > recorded> > in the CD register:> > > > o The date on which the CD was received> > > > o The name and address of the supplier, e.g. wholesaler, > pharmacy> > > > o The quantity received> > > > o The name, form and strength of the CD> > > > · For CDs supplied to patients (via prescriptions), or to> > practitioners (via requisitions), the following details must be > recorded> > in the CD register:> > > > o The date on which the supply was made> > > > o The name and address of the patient or practitioner > receiving> > the CD> > > > o Particulars of the authority of person who prescribed or> > ordered the CD> > > > o The quantity supplied> > > > o The name, form and strength in which the CD was supplied> > > > · The Secretary of State for Health can authorise the medical > adviser> > of the Primary Care Trust or other appointed doctor to ask general> > practitioners(GPs) to produce records and to view stocks. Failure > to> > comply is an offence.> > > > Destroying Controlled Drugs> > > > · Professional guidance strongly recommends that any medication> > returned from patient stocks should not be re-issued or used to > treat> > other patients.> > > > · There is no current legal requirement that 'patient-returned'> > Schedule 2 and 3 controlled drugs should be destroyed in the > presence of> > an authorised witness, but it is strongly recommended that doctors > and> > pharmacists have the destruction of these returns witnessed by > another> > member of staff (preferably by a registered health care > professional)> > and to make a record of the destruction in a separate book set > aside for> > this purpose.> > > > · Those health care professionals and service providers required by> > law to maintain a CD register are not allowed to destroy expired> > Schedule 2 (or 1) controlled drugs from their stock without > destruction> > being witnessed by an authorised person.> > > > · When a controlled drug is destroyed, details of the drug must be> > entered into the CD register. This should include: the name of the > drug;> > form; strength and quantity; the date it was destroyed; and the> > signature of the authorised person who witnessed the destruction > and the> > professional destroying it (i.e. two signatures).> > > > · The list of those authorised to witness the destruction of> > controlled drugs includes:> > > > o A chief pharmacist or pharmaceutical prescribing adviser > who> > reports directly to the chief executive or to a director of the > PCT.> > > > o A registered medical practitioner who has been appointed > to the> > PCT Professional Executive Committee or equivalent.> > > > o The board executive member with responsibility for > clinical> > governance or risk management.> > > > Regards,> > > > Dr Deepali> >>

[Guest guest]

Hello to all, Here is a PDF attachment, having 2 parts; Part 2- “Obtaining morphine for cancer pain relief and palliative care” Part 2 – A Proposal to Simplify India Narcotic Drugs and Psychotropic Substances Act (NDPS); To Improve Cancer Patient Access to Pain Medications. Kindly find the attachment, Regards, Dr Deepali Vijay <drvijaythawani@...> wrote: Hi Anupama,Useful article.Goes on to prove that while developing economies labour to produce poppy, extract and purify morphine, developed economies enjoy the final product.The developing world has more population than developed. The incidence and prevalence of CA is not less in the developing countries. Yet the quantum of morphine use is abysmal.This goes on to indicate the cruel mismanagement and virtual denial of morphine, which is

unethical.But very few care. In developing economies since the other problems are too many which have greater priority, not many are concerned with this -terminally ill patients dying in pain.Medical activists are a rare breed and those who come up on the scene, do not sustain for long due to various reasons. It is cherished that NetRUM will build that force, which will matter. Ours may be a small effort but then we are proud of what NetRUM is doing. Thanks to NetRUM moderators and members. Cheers! May we succeed with our mission.Vijay>> Dear friends,> I am attaching interesting articles on opioids.> -Anupama.> > > ---------------------------------> Get the freedom to save as many mails as you wish. Click here to

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